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Public Health Law
and Ethics
A Reader
Revised and Updated Second Edition
Edited by Lawrence O. Gostin
University of California Press
Berkeley . Los Angeles . London
The Milbank Memorial Fund
New York
Public Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Public Health Law and Ethics
Public Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Created from apus on 2022-02-16 10:21:21. Copyright 2010. University of California Press. All rights reserved.
California/Milbank Books on Health and the Public
1. The Corporate Practice of Medicine: Competition and Innovation in
Health Care, by James C. Robinson
2. Experiencing Politics: A Legislators Stories of Government and Health
Care, by John E. McDonough
3. Public Health Law: Power, Duty, Restraint, by Lawrence O. Gostin
4. Public Health Law and Ethics: A Reader, edited by Lawrence O. Gostin
5. Big Doctoring in America: Profiles in Primary Care, by Fitzhugh
Mullan, M.D.
6. Deceit and Denial: The Deadly Politics of Industrial Pollution, by
Gerald Markowitz and David Rosner
7. Death Is That Man Taking Names: Intersections of American Medicine,
Law, and Culture, by Robert A. Burt
8. When Walking Fails: Mobility Problems of Adults with Chronic
Conditions, by Lisa I. Iezzoni
9. What Price Better Health? Hazards of the Research Imperative,
by Daniel Callahan
10. Sick to Death and Not Going to Take It Anymore! Reforming Health
Care for the Last Years of Life, by Joanne Lynn
11. The Employee Retirement Income Security Act of 1974: A Political
History, by James A. Wooten
12. Evidence-Based Medicine and the Search for a Science of Clinical Care,
by Jeanne Daly
13. Disease and Democracy: The Industrialized World Faces AIDS,
by Peter Baldwin
14. Medicare Matters: What Geriatric Medicine Can Teach American
Health Care, by Christine K. Cassel
15. Are We Ready? Public Health since 9/11, by David Rosner and
Gerald Markowitz
16. State of Immunity: The Politics of Vaccination in Twentieth-Century
America, by James Colgrove
17. Low Income, Social Growth, and Good Health: A History of Twelve
Countries, by James C. Riley
18. Searching Eyes: Privacy, the State, and Disease Surveillance in America,
by Amy L. Fairchild, Ronald Bayer, and James Colgrove
19. The Health Care Revolution: From Medical Monopoly to Market
Competition, by Carl F. Ameringer
20. Real Collaboration: What It Takes for Global Health to Succeed, by
Mark L. Rosenberg, Elisabeth S. Hayes, Margaret H. McIntyre, and
Nancy Neill
Public Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Public Health Law
and Ethics
A Reader
Revised and Updated Second Edition
Edited by Lawrence O. Gostin
University of California Press
Berkeley . Los Angeles . London
The Milbank Memorial Fund
New York
Public Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
Central, http://ebookcentral.proquest.com/lib/apus/detail.action?docID=919287.
Created from apus on 2022-02-16 10:21:21. Copyright 2010. University of California Press. All rights reserved.
University of California Press, one of the most
distinguished university presses in the
United
States,
enriches lives around the world by advancing
scholarship in the humanities, social sciences,
and natural sciences.
Its activities are supported
by the
UC Press
Foundation and by philanthropic
contributions from individuals and institutions. For more information, visit www.ucpress.edu. The Milbank Memorial Fund is an endowed
operating foundation that engages in nonpartisan
analysis, study, research, and communication on
significant issues in health policy.
In the
Funds own
publications, in reports or books it publishes with
other organizations, and in articles it commissions
for publication by other organizations, the
Fund
endeavors to maintain the highest standards for
accuracy and fairness.
Statements by individual
authors, however, do not necessarily reflect opinions
or factual determinations of the
Fund.
For more
information, visit www.milbank.org. University of California Press Berkeley and Los Angeles, California University of California Press, Ltd.
London, England
2010 by
The
Regents of the
University of California
Library of Congress Cataloging-in-Publication
Data
Public health law and ethics : a reader / edited by
Lawrence
O. Gostin.
Rev. and updated 2nd ed.
p. cm. (California/Milbank books on health
and the public ; v. 4)
Includes bibliographical references and index.
ISB
N 978-0-520-26192-1 (alk. paper)
1. Public health laws
United
States. 2. Public
healthMoral and ethical aspects.I. Gostin,
Lawrence
O. (Lawrence
Ogalthorpe)II
. Milbank
Memorial
Fund.
KF3775.P83 2010
344.73’04dc22 2010007682
Manufactured in the
United
States of
America
19 18 17 16 15 14 13 12 11 10
10
9
8
7
6
5
4
3
2
1
This book is printed on Cascades Enviro 100, a 100%
post consumer waste, recycled, de-inked fiber. FSC
recycled certified and processed chlorine free.
It is
acid free, Ecologo certified, and manufactured by BioGas energy.
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Contents
List of Illustrations xi
List of Tables xiii
List of Boxes xv
Foreword by Carmen Hooker Odom and
Samuel L. Milbank xvii
Preface xix
Conventions Used in This Book xxv
Abbreviations xxvii
Introduction: Mapping the Issues 1
Part One . Foundations of Public Health Law
and Ethics
1. The Publics Health 23
sources: Ali H. Mokdad et al., Actual Causes of Death in the
United States, 2000 / 24 Geoffrey Rose, Sick Individuals and
Sick Populations / 29Dan Beauchamp, Community: The
Neglected Tradition of Public Health / 35Norman Daniels,
Bruce Kennedy, and Ichiro Kawachi, Justice Is Good for Our
Health / 41 Lawrence O. Gostin and Madison Powers, What
Does Social Justice Require for the Publics Health? Public
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vi Contents
Health Ethics and Policy Imperatives / 46 Lawrence O.
Gostin, Jo Ivey Boufford, and Rose Marie Martinez,
The Future of the Publics Health: Vision, Values, and
Strategies / 50
2. Public Health Ethics 59
sources: The National Commission for the Protection of
Human Subjects of Biomedical and Behavior Research, The
Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research / 61Ronald Bayer
and Amy L. Fairchild, The Genesis of Public Health
Ethics / 65 James F. Childress et al., Public Health Ethics:
Mapping the Terrain / 70Daniel Callahan and Bruce
Jennings, Ethics and Public Health: Forging a Strong
Relationship / 75Supreme Court of Vermont, Benning
v. State / 80 Marian Moser Jones and Ronald Bayer,
Paternalism and Its Discontents: Motorcycle Helmet Laws,
Libertarian Values, and Public Health / 82Stephen Breyer,
Breaking the Vicious Circle: Toward Effective Risk
Regulation / 86Richard Wilson and E.A.C. Crouch,
Risk Assessment and Comparisons: An Introduction / 91
Part Two . The Law and the Publics Health
3. Public Health Duties and Powers 99
sources: Supreme Court of the United States, DeShaney v.
Winnebago County Department of Social Services / 107
Supreme Court of the United States, Castle Rock v.
Gonzales / 110 William J. Novak, Governance, Police, and
American Liberal Mythology / 114Supreme Court of the
United States, South Dakota v. Dole / 119Supreme Court
of the United States, United States v. Lopez / 121Supreme
Court of the United States, Gonzales v. Raich / 124Supreme
Court of the United States, New York v. United States / 129
4. Public Health and the Protection of Individual Rights 135
sources: Supreme Court of the United States, Jacobson
v. Massachusetts / 140 Circuit Court, Northern District
of California, Jew Ho v. Williamson / 148Supreme Court
of the United States, City of Cleburne v. Cleburne Living
Center / 151Bureau of National Affairs, Inc., Second
Amendment Shields Individual Rights, Is Violated by
D.C.s Prohibition of Handguns / 158Supreme Court
of Appeals of West Virginia, Greene v. Edwards / 162
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Contents vii
5. Public Health Governance: Direct Regulation for
the Publics Health and Safety 167
sources: Supreme Court of the United States, Gonzales v.
Oregon / 171Supreme Court of the United States, Food
and Drug Administration v. Brown & Williamson Tobacco
Corp. / 172New York Court of Appeals, Boreali v.
Axelrod / 178Supreme Court of the United States,
Massachusetts v. EPA / 182 Lawrence O. Gostin, The
Deregulatory State / 189
6. Tort Law and the Publics Health: Indirect Regulation 195
sources: Stephen P. Teret, Litigating for the Public
Health / 198 Wendy E. Parmet and Richard A. Daynard,
The New Public Health Litigation / 199Tom Christoffel
and Stephen P. Teret, Epidemiology and the Law: Courts and
Confidence Intervals / 204Supreme Court of the United
States, Daubert v. Merrell Dow Pharmaceuticals, Inc. / 208
Peter W. Huber, Galileos Revenge: Junk Science in the
Courtroom / 213 Jon S. Vernick, Lainie Rutkow, and
Stephen P. Teret, Public Health Benefits of Recent Litigation
against the Tobacco Industry / 215 Court of Appeals for
the Second Circuit, Pelman v. McDonalds Corp. / 222
Lawrence O. Gostin, The Deregulatory Effects of Preempting
Tort Litigation / 225
7. Global Health Law: Health in a Global Community 233
sources: Lawrence O. Gostin, Why Rich Countries Should
Care about the Worlds Least Healthy People / 237 Laurie
Garrett, The Challenge of Global Health / 241David P.
Fidler and Lawrence O. Gostin, The New International Health
Regulations: An Historic Development for International Law
and Public Health / 248Allyn L. Taylor and Douglas W.
Bettcher, WHO Framework Convention on Tobacco Control:
A Global Good for Public Health / 254 Jonathan M.
Mann et al., Health and Human Rights / 259United Nations
Committee on Economic, Social, and Cultural Rights, The
Right to the Highest Attainable Standard of Health / 263
M. Gregg Bloche and Elizabeth R. Jungman, Health Policy and
the WTO / 269 Lawrence O. Gostin, Meeting the Survival
Needs of the Worlds Least Healthy People: A Proposed Model
for Global Health Governance / 276
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viii Contents
Part Three . Public Health and Civil Liberties
in Conflict
8. Surveillance and Public Health Research: Privacy and
the Right to Know 285
sources: Ronald Bayer and Amy L. Fairchild, Public Health:
Surveillance and Privacy / 286Amy L. Fairchild, Ronald
Bayer, and James Colgrove, Panoptic Visions and Stubborn
Realities in a New Era of Privacy / 289Sandra Roush et al.,
Mandatory Reporting of Diseases and Conditions by Health
Care Providers and Laboratories / 292Ronald Bayer and
Kathleen E. Toomey, HIV Prevention and the Two Faces of
Partner Notification / 294 James G. Hodge Jr., An Enhanced
Approach to Distinguishing Public Health Practice from
Human Subjects Research / 299David R. Buchanan and
Franklin G. Miller, Justice and Fairness in the Kennedy Krieger
Institute Lead Paint Study: The Ethics of Public Health Research
on Less Expensive, Less Effective Interventions / 306Supreme
Court of the United States, Whalen v. Roe / 311 Centers for
Disease Control and Prevention and Department of Health and
Human Services, HIPAA Privacy Rule and Public Health:
Guidance from CDC and the U.S. Department for Health and
Human Services / 314 Lawrence O. Gostin, James G. Hodge
Jr., and Ronald O. Valdiserri, Informational Privacy and the
Publics Health: The Model State Public Health Privacy
Act / 316
9. Health, Communication, and Behavior 323
sources: Sonya Grier and Carol A. Bryant, Social Marketing
in Public Health / 325Ruth R. Faden, Ethical Issues in
Government-Sponsored Public Health Campaigns / 328
Supreme Court of the United States, 44 Liquormart, Inc. v.
Rhode Island / 338Supreme Court of the United States,
Lorillard Tobacco Co. v. Reilly / 343 Court of Appeals for
the Second Circuit, International Dairy Foods Association v.
Amestoy / 350United States District Court for the Southern
District of New York, New York State Restaurant Association
v. New York City Board of Health / 356
10. Medical Countermeasures for Epidemic Disease:
Bodily Integrity 365
sources: Garrett Hardin, The Tragedy of the Commons / 369
Supreme Court of the United States, Zucht v. King / 376
Supreme Court of Mississippi, Brown v. Stone / 380United
States District Court for the Eastern District of Arkansas,
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Contents ix
Boone v. Boozman / 382 James Colgrove, Expansion
and Backlash: Vaccination at the Turn of the Twenty-first
Century / 387Ruth R. Faden, Nancy Kass, and Madison
Powers, Warrants for Screening Programs: Public Health, Legal
and Ethical Frameworks / 390Supreme Court of the United
States, Ferguson v. City of Charleston / 395Ronald Bayer
and David Wilkinson, Directly Observed Therapy for
Tuberculosis: History of an Idea / 399Supreme Court
of Wisconsin, In re Washington / 401 James Hodge et al.,
Expedited Partner Therapy for Sexually Transmitted Diseases:
Assessing the Legal Environment / 405
11. Public Health Strategies for Epidemic Disease:
Association, Travel, and Liberty 411
sources: J.M. Eager, The Early History of Quarantine:
Origin of Sanitary Measures Directed against Yellow
Fever / 413Supreme Court of South Carolina, Kirk
v. Wyman / 416Supreme Court of Ohio, Ex parte
Company / 418Supreme Court, Queens County, City
of New York v. Antoinette R. / 420 Lawrence O. Gostin,
Ronald Bayer, and Amy L. Fairchild, Ethical and Legal
Challenges Posed by Severe Acute Respiratory Syndrome:
Implications for the Control of Severe Infectious Disease
Threats / 424 Howard Markel, Lawrence O. Gostin, and
David P. Fidler, Extensively Drug-Resistant Tuberculosis:
An Isolation Order, Public Health Powers, and a Global
Crisis / 429 Ezekiel J. Emanuel and Alan Wertheimer, Who
Should Get Influenza Vaccine When Not All Can? / 433
Lawrence O. Gostin, Public Health Law in an Age of
Terrorism: Rethinking Individual Rights and Common
Goods / 436 George J. Annas, Bioterrorism, Public Health,
and Human Rights / 443
12. Economic Liberty and the Pursuit of Public Health 449
sources: Supreme Court of the United States, Dent v.
West Virginia / 451Supreme Court of the United States,
Camara v. Municipal Court of the City and County of San
Francisco / 455United States District Court for the Southern
District of New York, Players, Inc. v. City of New York / 458
Supreme Court of New York, New York v. New St. Marks
Baths / 463Supreme Court of the United States, Lochner v.
New York / 464Supreme Court of the United States, Lucas
v. South Carolina Coastal Council / 468Supreme Court of
the United States, Kelo v. City of New London / 472
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x Contents
Part Four . The Future of the Publics Health
13. Concluding Reflections on the Field: Case Studies
on Biosecurity, Genomics, and Obesity 481
sources: Donald A. Henderson, The Looming Threat
of Bioterrorism / 486David L. Heymann, The Evolving
Infectious Disease Threat: Implications for National and
Global Security / 493 Halla Thorsteinsdttir et al.,
Genomicsa Global Public Good? / 503 Wendy C. Perdue,
Obesity, Poverty, and the Built Environment: Challenges and
Opportunity / 510
Selected Bibliography 521
Table of Cases 545
Index 551
About the Author 563
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xi
Photographs
1. Deaths Dispensary xxx
2. Boy crosses bridge in Masiphumelele 22
3. The colossal task facing Indiasmallpox eradication 40
4. The Cuyahoga River in flames 58
5. Helmetless motorcyclists at rally 80
6. Nuclear waste dump 98
7. San Franciscos Chinatown District 134
8. Personal liberty and bodily integrity 157
9. Federal meat inspection workers examining pigs 166
10. Childrens toy recall 188
11. Ford Motor Company executives at House committee
investigation of Firestone tire recall 194
12. Buyers at a traveling gun show in Florida 220
13. Fast food in New York City 223
14. Measles vaccination program in the Sudan 232
15. Treatment Action Campaign march 248
16. Bed nets and malaria 264
17. Community-based diabetes screening 284
18. Tuskegee patient receiving injection 305
19. Screening for elevated blood lead levels 310
Illustrations
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xii Illustrations
20. Singapores cigarette warnings 322
21. Abstain, Be Faithful, Condomise 334
22. Farmers demonstrating against growth hormones 350
23. Diphtheria immunization 364
24. Pasteur vaccinating a sheep 385
25. Directly observed therapy in a Siberian prison 398
26. The Quarantine Question 410
27. Britannia holding back cholera at British ports, 1892 423
28. Europeans in a North African smallpox quarantine
camp 437
29. Property Wrongs: Public perceptions of Kelo 448
30. SARS and biosecurity 480
31. Urban poverty, the built environment, and health 506
Figures
1. Determinants of health 5
2. The field of public health: Alternative visions 7
3. Life expectancy and per capita GDP 43
4. Constitutional triangle 100
5. Constitutional functions 136
6. Public health agency functions 168
7. Climate change and public health 184
8. Tort law as a tool in public health 196
9. A governmental role in health promotion and
education 324
10. Biosecurity and disparities 493
11. Obesity trends in the United States (1987, 1997, 2007) 507
12. Ecological model: The influence on body weight of
factors derived from physical and socioeconomic
environments 509
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xiii
1. Public health 2
2. Public health ethics 11
3. Principles of the ethical practice of public health 13
4. Actual causes of death in the United States in 1990
and 2000 25
5. Time line of selected federal and state court decisions
on vaccination 372
6. School immunization laws, by state 378
7. Five deadliest biological agents 484
Tables
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xv
1. Tuskegee: Race, research, and bioethics 64
2. Public health and democracy: From Jacobson to
Abigail Alliance 138
3. Parental rights and contraceptive access for minors 156
4. Greenhouse gases and health 183
5. Firearms and tort litigation 221
6. The Sydney Resolution: Healthy people in healthy places
on a healthy planet 247
7. Outbreak of influenza A (H1N1): Time line (April 12
June 11, 2009) 253
8. The licensing of dental health aide therapists 453
Boxes
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xvii
The Milbank Memorial Fund is an endowed operating foundation that
works to improve health by helping decision makers in the public and
private sectors acquire and use the best available evidence to inform
policy for health care and population health. The Fund has engaged
in nonpartisan analysis, study, research, and communication about
significant issues in health policy since its inception in 1905.
Public Health Law and Ethics: A Reader was the fourth of what
are now twenty California/Milbank Books on Health and the Public.
The publishing partnership between the Fund and the University of
California Press encourages the synthesis and communication of findings from research and experience that could contribute to more effective health policy.
Now in its second edition, Public Health Law and Ethics: A Reader
is intended as a stand-alone text for those in the interrelated fields of
public health, law, and ethics, including scholars, students, practitioners, and the informed public; the Reader can also be used as a companion to Public Health Law: Power, Duty, Restraint, another book
in the California/Milbank series. Containing mostly new material on
timely and relevant issues that have been public health staples for years,
each chapter offers a detailed commentary that defines a public health
problem, frames the relevant questions, and introduces the selected
readings, which are certain to provoke debate and informed discussion.
Foreword
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xviii Foreword
Larry Gostin has carefully chosen selections that explore issues such
as emergency preparedness, chronic disease prevention, and the control
of infectious disease. Together the selections provide a framework for
rigorous analysis of the intersecting philosophical, political, economic,
and jurisprudential dimensions of government intervention to ensure
and improve population health.
Carmen Hooker Odom
President
Samuel L. Milbank
Chairman
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xix
The field of public health is typically regarded as a positivistic pursuit,
and without doubt our understanding of the etiology and response to
disease is heavily influenced by scientific inquiry. Public health policies,
however, are shaped not only by science but also by ethical values,
legal norms, and political oversight. Public Health Law and Ethics: A
Reader probes and seeks to illuminate this complex interplay through
a careful selection of government reports, scholarly articles, and court
cases together with discussion and analysis of critical problems at the
interface of law, ethics, and public health. This short preface explains
the various ways to use the resources in the Reader, describes its organization, and acknowledges my colleagues who have supported this
scholarly project.
An Anthology
Public Health Law and Ethics: A Reader, now in its second edition,
is intended as an independent resource for scholars, students, practitioners, and the informed public. Each chapter offers a detailed commentary that defines a public health problem and frames the relevant
questions. The commentary then introduces the selected reading and
provides additional resources for readers interested in further pursuing
the chapters subject.
Preface
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xx Preface
The Reader can also be used as a companion to Public Health Law:
Power, Duty, Restraint (Berkeley: University of California Press; New
York: Milbank Memorial Fund, 2d ed., 2008). That treatise offers a
theory and definition of public health law, an explanation of its principal analytical methodologies, and an analysis of the major conflicts
in public health theory and practice. The books are designed to be
used together: the treatise provides a careful description and analysis
of public health law, while the Reader offers cases and materials that
provoke debate and informed discussion. Each provides resources for
research, teaching academic courses and seminars, professional practice, and thinking about fascinating problems in public health theory
and daily practice.
Teaching Public Health Law: Using the Reader
and Treatise
The purposes of the main treatise and the Reader are to aid scholarship, inform the public, and support teaching. Faculty in schools of
law, public health, medicine, nursing, and public administration in the
United States and abroad have adopted these books for courses and
seminars on public health law and/or ethics and on related subjects.
Some professors prefer to use the Reader alone in their classes. Others
use both books, as I do at Georgetown University: the main text offers
a scholarly but accessible description and analysis of the field, while the
Reader provides supplemental materials and an introduction to public
health ethics. Each chapter in the second edition of the Reader provides
resources and reflections on the corresponding chapter in the treatise,
enabling readers to easily transition back and forth between the books.
Organization of the Reader
The introductory chapter of the Reader explores the scope and content
of the three fields that intersect in the theory and practice of public
healthnamely, public health, public health law, and public health
ethics. The remainder of the volume is divided into four parts, complementing the organization of the accompanying treatise.
Part 1, Foundations of Public Health Law and Ethics, contains
two chaptersone on the publics health and the second on ethical
values and risk regulation. These chapters cover the major concepts in
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Preface xxi
the field of public health (e.g., prevention and the population perspective), ethics (e.g., paternalism and the harm principle), socioeconomic
disparities, and the regulation of dangerous activities. Because Part 1
introduces readers to the central issues in the areas of public health law
and ethics, these chapters diverge slightly in scope and organization
from the corresponding treatise chapters.
Part 2, The Law and the Publics Health, examines important
doctrines and controversies in public health law. The powers and duties
of the state in the area of public health and the limitations that our
constitutional system places on the exercise of public health powers
are addressed in chapters 3 and 4, respectively. The ensuing chapters
in Part 2 focus on three areas that are key to the practice of public
health law: administrative law, which delineates when an agency is
allowed to directly regulate for the publics health (chapter 5); tort law,
which indirectly regulates behavior through civil liability (chapter 6);
and transnational law, which facilitates a globalized approach to public
health (chapter 7). Chapter 7covering international public health law,
world trade law, and human rightsis new to the second edition.
Part 3, Public Health and Civil Liberties in Conflict, addresses
some of the major controversies and trade-offs involved in contemporary public health theory and practice. Chapter 8 discusses surveillance, public health research, and the right to privacy. The interplay
between speech and behavior is explored in chapter 9, which looks at
health communications and commercial speech against the backdrop of
free expression. Chapters 10 and 11 discuss medical countermeasures
(immunization, screening, and treatment) and public health strategies
(isolation, quarantine, and community containment) for preventing
and mitigating the spread of epidemic disease, and the effects of those
measures and strategies on bodily integrity and liberty. Chapter 12 is a
new chapter, which examines the regulation of businesses and the value
of economic liberty.
Concluding reflections on the field of public health law are offered
in Part 4, The Future of the Publics Health. This part consists of
chapter 13, which presents case studies on three of the most complex
and important of todays public health challenges: bioterrorism and
biosecurity, public health genomics, and obesity. The chapter highlights
the various themes developed in the Readerpublic health ethics, the
interconnectedness between domestic and global health, and the effects
of socioeconomic disparities on public health.
The second edition of this Reader contains mostly new materials;
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xxii Preface
they reflect the contemporary political significance of public health
preparedness for emergencies, of the need to prevent chronic diseases
that are exacerbated by poor diets and sedentary lifestyles, and of the
inexorable spread of infectious and chronic diseases across national
borders and regions.
The Readers Objectives
The Reader probes the interrelated fields of law and ethics and their
application to problems affecting the publics health and safety. Its goal
is to raise the most important and enduring issues in public health theory and practice. In so doing, it should provoke discussion and debate
among students, scholars, practitioners, and policy makers. More
importantly, the Reader provides a framework for rigorous analysis
of the philosophical, political, economic, and jurisprudential dimensions of government intervention to ensure the health of the populace.
Nothing is so important to the security and vibrancy of a nation as the
well-being of its people.
A Renaissance for Public Health:
Acknowledging Leaders
Historians may look at the early twenty-first century as a period of
renaissance for public health law and ethics. The field of public health,
now expressing its own identity and importance, is reemerging from
the shadows of high-technology medicine. Government and the private
sector are engaged in a broad set of initiatives to reinvigorate the field.
The following list describes many of the important people and organizations that have made my work in national and global health possible,
and endlessly fascinating.
The Milbank Memorial Fund and University of California Press
jointly publish the treatise and the Reader. Daniel M. Fox, then
president and now president emeritus of the Fund, and Lynne Withey,
director of the Press, above all, have supported and nurtured my scholarship, for which I will always be grateful. I also want to thank the
Funds energetic and talented new president, Carmen Hooker Odom.
Since the publication of the previous edition, remarkable changes
have taken place at my home institution. Georgetown University established the ONeill Institute for National and Global Health Law with
the mission of finding innovative solutions to the most complex and
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Preface xxiii
enduring problems, thereby enabling people in the United States and
throughout the world to lead healthier and longer lives.
I had exceptional editorial and research assistance at the ONeill
Institute. Among the stellar students participating in the research
team over several years were Ilina Chaudhuri, Brian A. Fox, Kristen
Henderson, Meir Katz, Faiza Mathon-Mathieu, Victoria Ochanda,
Morgan Rog, Alia Udhiri, Meagan Winters, and Stelios Xenakis.
I want to especially thank a few talented students who played particularly valuable roles in researching and editing the book: Lauren
Dunning, Nancy Fullmann, Aimee Kelley, Meredith Larson, Una Lee,
and Kate Stewart. The book is much richer for their contributions.
Also making valuable contributions to the research and editing effort
were the current ONeill Institute deputy director, Oscar Cabrera; the
former deputy director, Ben Berkman; and several ONeill Institute law
fellows: Elenora Connors, John Kraemer, and Paula OBrien. I want
to express my particular gratitude to Susan Kim, who coordinated the
final edits, updates, and revisions of the manuscript.
When I began work on the second edition, we had recently hired
Katrina Pagonis as a fellow at the ONeill Institute. Katrina, one of the
most talented students I have ever had at Georgetown Law, had just
finished her LL.M. at the Yale Law School and a federal District Court
clerkship. It would be impossible to overstate the crucial role that she
played, brilliantly working with me as a full partner in conceptualizing
and writing this book. It is sad to have Katrina leave Georgetown, but
she is going on to a bright academic future at Hamline Universitys
Health Law Institute.
Finally, and most important, I express my love and devotion to my
family: Jean, Bryn, and Kieran.
Lawrence O. Gostin
Linda D. and Timothy J. ONeill Professor of Global Health Law
Faculty Director, ONeill Institute for National and Global Health Law
Georgetown University Law Center
Washington, D.C.
January 2010
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xxv
The excerpted materials in the Reader have been edited for clarity and
length. These edits have been made carefully so as not to compromise
the meaning or substance of the readings. My intent is to communicate the substance of the case or article, in the words of the author(s),
without interfering with its readability. The following editing and other
conventions have been used consistently throughout the volume.
Citations follow The Chicago Manual of Style (15th ed.). All original
references or notes in the excerpts have been deleted, except where they
support quotations. In those instances, the references have been added
to the bibliography and are indicated within the text of the reading.
Citations to and within court cases follow Bluebook style (18th ed.), as
is usual for legal documents. The styling of headings and subheadings
within articles or cases has been standardized, regardless of how they
appear in the original text. The indications of deletions and insertions
(ellipses and square brackets) follow standard editorial practice.
Abbreviations are spelled out in full at their first appearance in each
chapter (e.g., Institute of Medicine [IOM]), unless the abbreviation is
more common than the full form (e.g., AIDS ); thereafter, the abbreviation is always used. A list of abbreviated terms is included in the front
matter.
I welcome comments from readers about the comprehensiveness,
readability, and clarity of the Reader. I would appreciate being informed if I have omitted major articles or cases important to public
health law or ethics.
Conventions Used
in This Book
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xxvii
ABATE A Brotherhood against Totalitarian Enactments
ACET Advisory Council for the Elimination of Tuberculosis
ACIP Advisory Committee on Immunization Policy
ADA A merican Dental Association
AMA American Medical Association
AVIP Anthrax Vaccine Immunization Program
BST bovine somatotropin
CDC Centers for Disease Control and Prevention
CEA cost-effectiveness analysis
CLPH Center for Law and the Publics Health
CSA Controlled Substances Act
D&E dilation and evacuation
DES diethylstilbestrol
DG director general
DHATs dental health aide therapists
DHFS Department of Health and Family Services
DHMH Department of Health and Mental Hygiene
DoD Department of Defense
Abbreviations
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xxviii Abbreviations
DOT directly observed therapy
EC European Communities
EPA Environmental Protection Agency
EPT
EtO ethylene oxide
FAAAA F ederal Aviation Administration Authorization Act of
1994
FCGH Framework Convention on Global Health
FCTC Framework Convention on Tobacco Control
FDA F ood and Drug Administration
FDCA Food, Drug, and Cosmetic Act
FTC Federal Trade Commission
GATT Global Agreement on Trade in Services
GDP gross domestic product
GDPpc per capita gross domestic product
GOARN Global Outbreak Alert and Response Network
HHS [Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act
HPV human papillomavirus
ICCPR International Covenant on Civil and Political Rights
ICESCR International Covenant on Economic, Social, and
Cultural Rights
IHR International Health Regulations
IOM Institute of Medicine
IRB institutional review board
IRPOP investment refinement combined with the public-order
principle
KKI K ennedy Krieger Institute
MDA Medical Device Amendments
MDR multidrug resistant
MDR-TB multidrug-resistant tuberculosis
MMR measles, mumps, and rubella
MSA Master Settlement Agreement
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Abbreviations xxix
MSEHPA Model State Emergency Health Powers Act
MUSC Medical University of South Carolina
NCDs non-communicable diseases
NGO nongovernmental organization
NLDC New London Development Corporation
NVAC National Vaccine Advisory Committee
NVICP National Vaccine Injury Compensation Program
NYRSA N ew York State Restaurant Association
ODWDA Oregon Death with Dignity Act
OECD Organisation for Economic Co-operation and
Development
OSHA Occupational Safety and Health Administration
PEPFAR Presidents Emergency Plan for AIDS Relief
PHC Public Health Council
PHI Protected Health Information
PI principal investigator
PLCAA Protection of Lawful Commerce in Arms Act
rBST recombinant bovine somatotropin
RICO Racketeer Influenced and Corrupt Organizations
RWJF Robert Wood Johnson Foundation
SARS severe acute respiratory syndrome
SES socioeconomic status
SPS Agreement on Sanitary and Phytosanitary Measures
STD sexually transmitted disease
STI sexually transmitted infection
TB tuberculosis
TRIPS Trade-Related Aspects of Intellectual Property Rights
UDHR Universal Declaration of Human Rights
WHO World Health Organization
WTO World Trade Organization
XDR-TB extensively drug-resistant tuberculosis
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Photo 1. Here Death pumps cholera-bearing water from the Broad Street
pump in London. John Snow famously proved that its water was the source of
a cholera outbreak by removing the pumps handle. Snow went door-to-door
in different areas of London to find people suffering from the disease and to
pin down its source, a practice described as shoe-leather epidemiology.
Reproduced by permission, Mary Evans Picture Library/The Image Works.
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1
The issues and questions presented in the theory and practice of public
health are not resolved solely through scientific inquiry; rather, law and
ethics also guide our efforts. Yet despite the closeness of the interplay
between public health, law, and ethics, each of these three fields has its
separate identity, and cross-fertilization is rare. For the most part, each
field has adopted distinct terminologies and forms of reasoning. To the
extent that scholars and practitioners in the fields of law and ethics
have engaged in sustained examinations of issues in health, they have
focused principally on medical care. This introductory chapter maps
the important features of, and issues in, law and ethics as they pertain
to the theory and practice of public health.
I. Public Health
In thinking about the application of ethics or law to problems in public
health, it is important first to understand what we mean by public
health. How is the field defined and what is its contentits mission,
functions, and services? Who engages in the practice of public health
government, the private sector, charities, or community-based organizations? What are the principal methods or techniques of public health
practitioners (Novak 1996; Turnock 2001)? In truth, finding answers
to these fundamental questions is not easy, because the field of public
health is highly eclectic and conflicted (Beaglehole and Bonita 1997).
In t roduction
Mapping the Issues
Public Health, Law, and Ethics
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2 Introduction
For a summary of the definition, mission, functions, and jurisdiction
of public health, see table 1.
Definitions of public health vary widely, ranging from the World
Health Organizations (1946) utopian conception of an ideal state of
physical and mental health to a more concrete listing of public health
practices. Charles-Edward A. Winslow (1920, 30), for example, defined public health as the science and the art of preventing disease,
prolonging life, and promoting physical health and efficiency through
organized community efforts for the sanitation of the environment,
the control of community infections, the education of the individual
in principles of personal hygiene, and the organization of medical and
nursing service for the early diagnosis and preventive treatment of disease. More recent definitions focus on positive health, emphasizing
a persons complete well-being. Definitions of positive health include
at least four constructs: a healthy body, high-quality personal relationships, a sense of purpose in life, and self-regard and resilience.
The Institute of Medicine (IOM) (1988, 19), in its landmark report
The Future of Public Health, proposed one of the most influential contemporary definitions: Public health is what we, as a society, do collectively to assure the conditions for people to be healthy. The IOMs
Table 1. Public health
Definition Societys obligation to ensure the conditions for
peoples health
Mission Promote physical and mental health; prevent disease,
injury, and disability
Functions Assessmentassemble and analyze community
health needs
Policy developmentadvance plans informed by
scientific knowledge
Assuranceprovide services necessary for
community health
Jurisdiction/Domain Narrow focusimmediate risk factors (e.g.,
infectious disease control)
Broad focusfundamental social structures (e.g.,
discrimination, homelessness, socioeconomic
status)
Expertise/Skills Epidemiology and biostatistics, education and
communication, leadership and politics
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Introduction 3
definition can be appreciated by examining its constituent parts. The
emphasis on cooperative and mutually shared obligation (we, as a
society) reinforces the notion that collective entities (e.g., governments and communities) take responsibility for healthy populations.
Individuals can do a great deal to safeguard their health, particularly
if they have the economic means to do so. They can purchase housing, clothing, food, and medical care. Each person can also behave in
ways that promote health and safety by eating healthy foods, exercising, using safety equipment (e.g., seat belts, motorcycle helmets, and
smoke detectors), and refraining from smoking, using illicit drugs, or
drinking alcoholic beverages to excess. Yet there is a great deal that
individuals cannot do to secure their health, and therefore these individuals need to organize and collaborate on building infrastructure
and developing shared resources. Acting alone, people cannot achieve
environmental protection, hygiene and sanitation, clean air and surface water, uncontaminated food and drinking water, safe roads and
products, or control of infectious disease. All these collective goods,
and many more, are achievable only through organized and sustained
community activities.
The IOM definition also makes clear that even the most organized
and socially conscious society cannot guarantee complete physical and
mental well-being. There will always be a certain amount of injury
and disease in the population that is beyond the reach of individuals
or government. The role of public health, therefore, is to ensure the
conditions for people to be healthy. These conditions include a variety
of educational, economic, social, and environmental factors that are
necessary for good health.
Most definitions share the premise that the subject of public health is
the health of populationsrather than the health of individualsand
that this goal is reached by a generally high level of health throughout
society, rather than the best possible health for a few. The field of public health is concerned with health promotion and disease prevention
throughout society. Consequently, public health is interested in devising broad strategies to prevent or ameliorate injury and disease, and to
promote longevity and well-being.
Scholars and practitioners are conflicted about the reach, or do –
main, of public health. Some prefer a narrow focus on the immediate
risk factors for injury and disease (Epstein 2003). The role of public
health agencies, according to this perspective, is to identify risks or
harms and then intervene to prevent or reduce them. This has been
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4 Introduction
the traditional role of public healthexercising discrete powers such
as surveillance (e.g., screening and reporting), injury prevention (e.g.,
ensuring the safety of consumer products), and infectious disease control (e.g., vaccination, partner notification, and quarantine).
Others prefer a broad focus on the socioeconomic foundations of
health (Gostin and Bloche 2003). Those favoring this position see
public health as an all-embracing enterprise united by the common
value of societal well-being. They claim that the jurisdiction of public
health reaches social ills rooted in distal social structures (Meyer and
Schwartz 2000, 1189). Ultimately, the field is interested in the equitable distribution of social and economic resources because social status,
race, and wealth are important influences on the health of populations (Marmot and Wilkinson 1999). Similarly, the field is interested in
social capital because social networks of family and friends, as well
as associations with religious and civic organizations, are important
factors in individual well-being and community functioning.
This inclusive view of public health is gaining popularity. Figure 1
illustrates the determinants of health according to the U.S. Department
of Health and Human Services: physical environment, behavior and
biology, and social environment. In accord with this vision, public
health researchers and practitioners have ventured into areas of general
social policy, ranging from city planning, safe housing, and diet and
exercise to violence, war, and discrimination.
The expansive view of public health may well be justified by the
importance of culture, poverty, and powerlessness to the health of
populations. Social epidemiologists have found an association between
these factors and increased morbidity and premature mortality. Yet to
many, this all-embracing notion is troublesome. The first problem is
its excessive breadth. Almost every activity in which human beings are
engaged affects the populations health, but this fact does not justify an
overly inclusive definition of public health. The field of public health
appears less credible if it overreaches.
The second problem is lack of expertise. Admittedly, the public
health professions incorporate a wide variety of disciplines (e.g., occupational health, health education, epidemiology, laboratory technology, and nursing), with different skills and functions. But public health
professionals do not possess the competence in behavioral and social
sciences, economics, engineering, and other skills necessary to intervene on behavioral, social, physical, and environmental levels.
The final problem is insufficient political and public support (Burris
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Introduction 5
1997). By espousing controversial issues of economic redistribution and
social restructuring, the field risks losing its legitimacy. Public health
gains credibility from its adherence to science, and if the field strays too
far into political advocacy, it may lose the appearance of objectivity.
If public health has such a broad meaning, then who engages in
the work of public health? The IOMs sequel to its first report, The
Future of the Publics Health in the 21st Century (2002), stressed the
importance of a public health system comprising a wide array of
public and private entitiesgovernment, industry, academia, charities,
and community-based organizations. At the governmental level, public
health has a significant jurisdictional problem. Even the most powerful
public health agency cannot exercise direct authority over the full range
of activities that affect health. Many of the determinants of health are
Determinants of Health
Policies and Interventions
Access to Quality Health Care
Individual
Behavior
Biology
Social
Environment
Physical
Environment
Figure 1. Determinants of health. Source: U.S. Department of Health and
Human Services [2000a].
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6 Introduction
normally the province of other agencies (e.g., agencies concerned with
education, agriculture, transportation, housing, child welfare, and
criminal justice). Furthermore, much of the behavior that public health
agencies try to change (e.g., exercise and diet) is not subject to direct
legal regulation at all. At the same time, many of the institutions that
affect the publics health are outside government, such as managed
care organizations, business and labor, community-based groups, and
academic institutions. It is for these reasons that government and its
partners should pursue a strategy of health in all policies.
The breadth and variety of public health actors are a relevant practical and theoretical consideration. It matters a great deal in law and
ethics to understand who is acting, with what authority, and with what
resources. For example, society is prepared to allow government to
wield powers to coerce (e.g., to tax, inspect, license, and quarantine)
that would be unacceptable in the private sector.
What are the principal methodologies of public health practitioners?
Because of the fields broad sweep, the techniques of public health are
highly diverse. For example, public health practitioners monitor health
status, which calls for skills in epidemiology and biostatistics; inform
and educate the public, which calls for skills in education and communication; and create health policy and enforce laws, which call for
legal, political, and leadership skills. This description does not account
for the many subjects in the field of public health requiring expertise
in domains such as infectious diseases (e.g., virology and bacteriology),
the environment (e.g., toxicology), and injuries (e.g., behavioral and
social sciences). As the IOM (1988, 40) has observed, Public healths
subject matter . . . necessitate[s] the involvement of a broad spectrum
of professional disciplines. In fact, . . . public health is a coalition of
professions united by their shared mission.
As illustrated in figure 2, the field of public health is caught in a
dilemma. If it conceives itself too narrowly, then public health will be
accused of lacking vision. It will fail to tackle the root causes of ill
health and be unable to employ the broad range of social, economic,
and behavioral tools necessary to achieve healthier populations. At the
same time, if it conceives itself too expansively, then public health will
be accused of overreaching and invading a sphere reserved for politics,
not science. It will lose the ability to explain coherently its mission and
functions and, consequently, to sell public health in the marketplace of
national priorities.
There may be a deeper level of tension here. Public health is an arm
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Limited Vision
Traditionally accepted and
potentially safe but fails to
address root causes
Bolder vision but politically
misunderstood, imprecise, and
difficult to accomplish
Expansive Vision
Discrete
Public
Health
Interventions
Socioeconomic
Foundations
Socioeconomic Impacts on
Health
Interventions/Tools to
Improve Public Health
– Social status
– Race
– Wealth
– Education
Proximal Risk Factors and
Interventions (e.g.)
– Control of infectious disease
– Hygiene and sanitation
– Clean air and water
– Safe roads and products
– Health education and
promotion
– Economic redistribution
– Social restructuring
– Behavioral modification
– Social science
Public Health
What we as a society
do collectively to
assure the
conditions for
people to be healthy
(IOM 1988)
Figure 2. The field of public health: Alternative visions.
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8 Introduction
of the state and a profession involving public service. It must work
within the bounds of the law and respect the judgments of elected officials. At the same time, public health professionals often function as
voices of social conscience and champions for the disadvantaged who
disproportionately suffer from injury, disability, and disease. It is not
always easy for public health officials to speak truth to power. Yet
balance can be achieved by those who understand the myriad political
and economic considerations that underlie public policy judgments and
the numerous openings in the democratic process for drawing attention
to relevant scientific evidence and public health values.
II. Public Health Law
As we have just seen, answering the question What is public health?
is much more difficult than it first appears. Despite this lack of conceptual clarity, it is important to carefully study the legal foundations of
public health, as well as its ethical dimensions. Public health law has
long taken a backseat to health care law, which primarily examines
the financing, organization, and delivery of personal medical services.
But important scholarly studies of public health law are gaining prominence both in the United States (Goodman et al. 2007; Grad 2004;
Wing 2003) and internationally (Bailey, Caulfield, and Ries 2005;
Reynolds 2004; Martin and Johnson 2001). The emergence of the
field is underscored by a public health law program at the Centers for
Disease Control and Prevention (CDC), a public health law association,
and numerous academic centers and institutes devoted to this subject
(Goodman et al. 2007).
The preservation of the publics health is among the most important
goals of government. The enactment and enforcement of law, moreover, are a primary means by which government creates the conditions
for people to lead healthier and safer lives. Laws establish a mission for
public health officials, assign their functions, and specify the manner
in which they may exercise their power. The law is a tool that is used to
influence norms for healthy behavior, to identify and respond to health
threats, and to set and enforce health and safety standards. The most
important social debates about public health take place in legal fora
legislatures, courts, and administrative agenciesand in the laws language of rights, duties, and justice. It is no exaggeration to say that the
field of public health . . . could not long exist in the manner in which
we know it today except for its sound legal basis (Grad 2004, 4).
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Introduction 9
In this volumes companion text, I define public health law as the
study of the legal powers and duties of the state, in collaboration with
its partners (e.g., health care, business, the community, the media, and
academe), to ensure the conditions for people to be healthy and of the
limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals. Public health law scholars are therefore interested in government
authority to prevent injury and disease and to promote the publics
health, as well as in the constraints on state action to protect individual
freedom. The U.S. government has ample authority to act for the common good, employing police powers to safeguard the health, safety,
and morals of the population. But the state must exercise that power
within the constraints of the Constitution.
Law can be an effective tool to achieve the goal of improved health
for the population. Law, regulation, and litigation, like other public
health prevention strategies, intervene at a variety of levels, each designed to secure safer and healthier populations. First, government interventions are aimed at individual behavior through education (e.g.,
health communication campaigns), incentives and disincentives (e.g.,
taxing and spending powers), and deterrents (e.g., civil and criminal
penalties for risk behaviors). Second, the law uses regulations to change
behavior by requiring safer product design (e.g., safety standards and
indirect regulation through the tort system). Finally, the law alters environmentsinformational (e.g., through advertising restraints), physical (e.g., through city planning and housing codes), and business (e.g.,
through inspections and licenses).
Government engages in the work of public health in its three separate brancheslegislative, executive, and judicialwith their distinct,
albeit overlapping, constitutional authorities: (1) legislatures create
health policy and allocate the resources necessary to effect it; (2) executive agencies implement health policy, promulgate health regulations,
and enforce regulatory standards; and (3) courts interpret laws and
resolve legal disputes. As a society, we forgo the possibility of bold
public health governance by any single branch in exchange for constitutional checks and balances that prevent government from overreaching
and ensure political accountability.
In practice, public health agencies in the modern state go beyond
traditional executive branch functions of implementation and enforcement. Certainly, the legislature assigns the responsibilities and activities of public health agencies. But public health agencies can, in a
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10 Introduction
sense, go beyond that legislation to create law through administrative
regulations and interpret law through the regulatory process and their
own practices. They can also adjudicate disputes, making such determinations as when a business has violated a safety standard or when a
professional is eligible for a license.
Public health law is concerned with the trade-offs that the exercise
of government power entails. Under what circumstances should government be permitted to act to achieve a public good when the consequence of that act is to invade a sphere of personal or economic liberty?
This is the kind of question that intrigues scholars interested in law and
the publics health. Rather than using ethical discourse to resolve these
conflicts, the law uses the language of duties, powers, and rights.
It is clear from the above description that public health law is a vast
field that incorporates thinking from a variety of legal subspecialties
constitutional, administrative, and tort law. Constitutional law deals
with the powers that the Constitution affords the federal government
and with limits on the authority of governments at every level in order
to protect a sphere of freedom. Administrative law is concerned with
the body of statutes and regulations that set health and safety standards, together with the powers of agencies to interpret and enforce
those standards. Tort law provides a method of indirect regulation
through the courts. By levying damages for certain kinds of harm,
tort law can provide powerful disincentives to engage in risk behaviors
(e.g., litigation against cigarette and firearm manufacturers). A fourth
body of lawinternational lawis becoming increasingly relevant as
infectious and even chronic diseases spill over national borders. International law includes a wide array of treaties involving health, trade,
human rights, arms control, and the environment. These legal dimensions will be explored further as the Reader unfolds, particularly in
Part 2, The Law and the Publics Health.
III. Public Health Ethics
The fields of bioethics and medical ethics have richly informed the development and use of biotechnologies, the practice of medicine, and the
allocation of health care resources. Ethicists have not devoted the same
sustained attention to problems in public health, but that situation is
beginning to change with the appearance of interesting and important
scholarship in public health ethics. The Association of Schools of Public Health, for example, has developed a model curriculum for courses
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Introduction 11
in public health ethics that includes materials on the traditions and
values of public health, as well as on the ethical issues raised by infectious disease control, environmental health, and health care reform.
Public health ethics seek to understand and clarify principles and
values that guide public health actions, offering a framework for making decisions and a means of justifying them. Because public health
actions are directed toward populations, the principles and values of
the field can differ from those that guide actions in biology and clinical medicine (bioethics and medical ethics), which tend to center on
individuals and specific patients.
This discussion raises a critical unanswered question: What are the
features that distinguish public health ethics from conventional medical
ethics or bioethics? Are ethical principles and values, or the methods
of ethical analysis, materially different when applied to populations
rather than to individuals? In thinking about this question it will be
helpful to consider public health ethics from at least two perspectives:
the ethics of public health professionals (professional ethics) and ethics
in public health theory and practice (applied ethics and advocacy ethics). See table 2.
Table 2. Public health ethics
Branches of Public Health Ethics Principal Concerns
Ethics of Public Health
(i.e., professional ethics)
Ethical dimensions of professionalism
Moral trust society bestows on
professionals to act for the common
good
Ethics in Public Health
(i.e., applied ethics:
situation or case oriented)
Ethical dimensions of public health
enterprise
Moral standing of populations
health
Trade-offs between collective goods
and individual interests
Social justice: equitable allocation of
benefits and burdens
Advocacy Ethics
(i.e., goal-oriented,
populist ethics)
Overriding value of healthy
communities
The interests of populations,
particularly the powerless and
oppressed
source: Hastings Center Project on Ethics and Public Health.
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12 Introduction
The ethics of public health are concerned with the ethical dimensions of professionalism and the moral trust that society bestows on
public health professionals to act for the common welfare. This form of
ethical discourse stresses the professionalism among public health students and practitioners. It instills in professionals a sense of public duty
and trust. Professional ethics are role oriented, helping practitioners to
act in virtuous ways as they undertake their functions.
Many professional groups, such as physicians, nurses, and attorneys, hold themselves accountable through a set of ethical guidelines,
but public health professionals have no official code of ethicsperhaps
because there is no single public health profession. Indeed, some of
the different public health disciplines that make up the profession have
their own ethical codesfor example, epidemiologists, health educators, and health services researchers.
A code of ethics, or at least a well-articulated values statement, could
be helpful to the field. A code could give the profession a moral compass, providing concrete guidelines to help clarify the ethical dilemmas
that frequently arise. Public health professionals work in a field of considerable moral ambiguity where guidance could be instructive. A code
could also give the field both moral credibility and a higher professional status. After a systematic consultative process, the Public Health
Leadership Society developed an unofficial code of ethics, which is
reproduced in table 3.
One salient issue in the ethics of public health professionals is
that of fiduciary duty. To whom do public health professionals owe
a duty of loyalty, and how can these professionals know what actions
are morally acceptable? Physicians, attorneys, and accountants have
a fiduciary duty to their clients that informs their moral world. For
example, client-centered professions usually adhere to the principle that
the professional serves the client, advises the client fully and honestly,
takes instructions from the client, and avoids acting against the clients
best interests.
In the context of public health, the community might be regarded
as the client, but the notion of a community is often vague and
fragmented. In any given situation, different groups may claim to represent community interests. If the communitys wants and needs are
not easily ascertained, should public health professionals make their
own judgments about communal interests? Public health professionals
may, at times, coerce some members of the community to take actions
that are in the best interests of others but not necessarily themselves. In
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Introduction 13
thinking about public healths complex relationship to populations, is
the concept of fiduciary duty helpful as an ethical value?
Do public health professionals have a duty to tell the full truth and, if
so, by what standard should they be judged? Public health professionals
may earnestly believe that their mission requires vigorous interventions
to prevent risk behaviors (e.g., smoking and illicit drug use) or encourTable 3. Principles of the ethical practice of
public health
1. Public health should address principally the fundamental causes of
disease and requirements for health, aiming to prevent adverse health
outcomes.
2. Public health should achieve community health in a way that respects the
rights of individuals in the community.
3. Public health policies, programs, and priorities should be developed and
evaluated through processes that ensure an opportunity for input from
community members.
4. Public health should advocate and work for the empowerment of
disenfranchised community members, aiming to ensure that the basic
resources and conditions necessary for health are accessible to all.
5. Public health should seek the information needed to implement effective
policies and programs that protect and promote health.
6. Public health institutions should provide communities with the
information they have that is needed for decisions on policies or
programs and should obtain the communitys consent for their
implementation.
7. Public health institutions should act in a timely manner on the
information they have within the resources and mandate given to
them by the public.
8. Public health programs and policies should incorporate a variety of
approaches that anticipate and respect diverse values, beliefs, and
cultures in the community.
9. Public health programs and policies should be implemented in a manner
that most enhances the physical and social environment.
10. Public health institutions should protect the confidentiality of
information that can bring harm to an individual or community if made
public. Exceptions must be justified on the basis of the high likelihood of
significant harm to the individual or others.
11. Public health institutions should ensure the professional competence of
their employees.
12. Public health institutions and their employees should engage in
collaborations and affiliations in ways that build the publics trust
and the institutions effectiveness.
source: Public Health Leadership Society, http://phls.org/CMSuploads/PHLSposter-68526.pdf.
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14 Introduction
age health-promoting behaviors (e.g., exercise and a healthy diet). To
achieve these beneficent objectives, public health professionals may
exaggerate risks or benefits, or may make claims that are insufficiently
grounded in science. Suppose public health professionals know that
the risk of sexual transmission of HIV in a middle-class, rural neighborhood is relatively low. Are they obliged to disclose this fact when
advising men to wear condoms? How would an ethical code address
the nuanced question of truth telling by public health professionals?
Another area of public health ethics might be called ethics in public health theory and practice. Ethics in public health are concerned
not so much with the character of professionals as with the ethical
dimensions of the public health enterprise itself. Here, scholars undertake a philosophical analysis of the kind of reasoning necessary for
careful thinking and decision making in creating and implementing
public health policy. This type of applied ethics is situation or case
oriented, seeking to understand morally appropriate decisions in concrete cases. Scholars can make significant contributions to this area
by applying general ethical theory and disinterested reasoning to the
societal debates common in public health. In each case, public health
ethicists could identify and clarify the ethical dilemma posed, describe
the benefits and burdens, specify the alternative courses of action, and
offer guidance about an ethically appropriate intervention.
The application of ethical principles and values to public health
decisions can be complex and controversial. Problems in public health
often involve numerous risk factors, multiple stakeholders, and diverse
perspectives on matters of individual liberty and the populations wellbeing. Since a principal aim of public health is to achieve the greatest
health benefits for the greatest number of people, it draws from the traditions of consequentialism, which judges the rightness of an action by
the consequences, effects, or outcomes that it produces. Utilitarianism,
one of the most influential forms of consequentialist ethical theory,
holds that actions are justified insofar as they promote the greatest
happiness of the greatest number of people.
The public health model of ethical reasoning, argue Allen
Buchanan and colleagues (2000), uncritically assumes that the appropriate mode of evaluating options is some form of cost-benefit (or costeffectiveness) calculationthe aggregation of goods and bads (benefits
and costs) across individuals. Public health, according to this view,
appears to permit, or even require, that the most fundamental interests
of individuals be sacrificed in order to produce the best overall outcome.
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Introduction 15
This characterization is based on an erroneous or, at best, oversimplified understanding of the public health approach. The field of public
health is certainly interested in securing the greatest benefits for the
most people. And public health officials, as part of government, must
concern themselves with efficiencies, benefits, and costs. But public
health does not simply aggregate benefits and burdens, choosing the
policy that produces the most good and the least harm. Rather, the
overwhelming majority of public health interventions are intended to
benefit the whole population without knowingly harming individuals
or groups. Public health authorities working in the areas of tobacco
control, the environment, and occupational safety, for example, believe
that everyone will benefit from smoking cessation, clean air, and safe
workplaces.
Certainly, public health focuses almost exclusively on one vision
of the common good (health, not wealth or prosperity). And public
health actions can diminish personal and economic freedoms such as
privacy or free enterprise. But such individual losses are not the salient
characteristics of public health ethics. The field rarely sacrifices fundamental interests to produce the best overall outcome, except perhaps
when an individuals behavior threatens the equally fundamental interests of others to live in health and safetyfor example, persons with
multidrug-resistant tuberculosis are sometimes forced into isolation.
At the very least, when a public health action pits one fundamental
interest against another, public health ethics should facilitate vigorous
debate, and the action should be subject to legal oversight.
Of course, the public health approach does follow a version of the
harm principle. Thus, public health authorities regulate individuals or
businesses that endanger the community. The objective is to prevent
unreasonable risks that jeopardize the publics health and safetyfor
example, by polluting a stream, exposing others to infectious disease,
or selling dangerous toys for children. When public health officials
regulate to curtail activities that harm others, they are acting squarely
within a widely accepted Western liberal tradition.
More controversially, public health officials at times recommend
and undertake paternalistic interventions, such as mandating the wearing of motorcycle helmets or banning trans fat in foods. Public health
officials reason that the sacrifice asked of individuals is relatively small
and the communal benefits are substantial. Few public health experts
advocate that truly fundamental individual liberties be taken away in
the name of paternalism. In the public health model, individual interPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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16 Introduction
ests in autonomy, privacy, liberty, and property are taken seriously, but
they do not invariably trump community health benefits.
The public health approach thus differs from modern liberalism primarily in how it balances interests: public health places greater weight
on community benefits, whereas liberalism favors individual liberty.
Characterizing public health as a utilitarian sacrifice of fundamental
personal interests is as unfair as characterizing liberalism as an individualistic sacrifice of vital communal interests. Both traditions would
protest this kind of oversimplification.
Scholars in medical ethics and bioethics have convincingly demonstrated the power and importance of individual freedom. However,
until recently they have paid insufficient attention to the equally strong
values of partnership, citizenship, and community (Beauchamp 1988).
As members of a society in which we have a common bond, we also
have an obligation to protect and defend the community against threats
to health, safety, and security. Members of society owe one another a
duty to promote the common good. A new public health ethic should
advance the idea that individuals benefit from being part of a wellregulated society that reduces the risks that all members share.
There remains much work to do in public health ethics. What is the
moral standing that should be attached to the collective good? Does
the health of a community have a moral standing that is independent of
the health of individuals within that population? Under what circumstances should individual interests yield in favor of an aggregate benefit
for the population? And, at a more fundamental level, what counts as
a harm or benefit? Must the persons behavior pose a risk to others for it to become a matter of concern, or can public health officials
justifiably restrict self-regarding behavior?
Social justice is one of the most basic and widely understood aspects
of public health ethics. Justice requires fairness or reasonableness,
especially in the way people are treated or decisions are made. Social
justice stresses the importance of fair distribution of common advantages and the sharing of common burdens. Does an otherwise effective
policy become unfair if it disproportionately disadvantages a particular
racial, ethnic, or religious group? For example, public health professionals often advocate primary enforcement of seat belt laws so that
police can stop a driver simply for failure to comply with the law. But
what if the primary enforcement of such laws falls disproportionately
on African Americans, as now appears to be the case?
Social justice, of course, not only encompasses fair distribution of
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Introduction 17
resources but also requires the preservation of human dignity and the
showing of equal respect for the interests of all members of the community. As Hurricane Katrina taught us, [a] failure to act expeditiously
and with equal concern for all citizens, including the poor and less
powerful, . . . erod[es] public trust and undermin[es] social cohesion. It
signals to the disadvantaged and to everyone else that the basic human
needs of some matter less than those of others, and it thereby fails to
show the respect due to all members of the community (Gostin and
Powers 2006, 105859).
In addition to professional and applied ethics, it is possible to
think of an advocacy ethic informed by the single overriding value
of a healthy community. According to this rationale, public health
authorities perceive of themselves as knowing what is ethically appropriate and understand their function as advocating for that social goal.
This populist ethic serves the interests of populations, especially the
powerless and oppressed, and its methods are mainly pragmatic and
political. Public health professionals strive to convince the public and
its representative political bodies that healthy populations and reduced
inequalities are the preferred social goals.
The language and concepts of human rights are often invoked by
those advancing an advocacy ethic, and with good reason. Human
rights, as part of the body of international law, afford individuals rights
against state interference. These include civil and political rights, such
as autonomy, bodily integrity, privacy, and nondiscrimination. Human
rights, moreover, impose affirmative duties on states to act for the welfare of society. Economic, social, and cultural rights include the rights
to social security, education, work, and enjoyment of the benefits of
scientific advances.
Most importantly, human rights require governments to recognize
the right of everyone to the highest attainable standard of physical
and mental health (International Covenant on Economic, Social, and
Cultural Rights, art. 12). Critics of this approach point to the vagaries of the right to health, such as its lack of definable standards and
enforcement mechanisms. Although this critique has force, the United
Nations Committee on Economic, Social and Cultural Rights and a
UN special reporter have offered more detailed guidance on the meaning and implementation of the right to health. Public health advocates
often invoke this right when seeking improvement in health conditions,
reduction of socioeconomic disparities, and universal access to health
care.
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18 Introduction
Public health ethics, therefore, can illuminate the field of public
health in several ways. Ethics can offer guidance on (1) the meaning of
public health professionalism and the ethical practice of the profession,
(2) the moral weight and value of the communitys health and wellbeing, (3) the recurring themes of the field and the dilemmas faced in
everyday public health practice, and (4) the role of advocacy to achieve
the goal of safer and healthier populations, highlighting the importance of the human right to health.
There needs to be a much more sustained, sophisticated discussion
of ethics among students, practitioners, and scholars in public health.
Today, ethics instruction in schools of public health is scarce and targeted primarily at biomedical or medical ethics, but this too may be
changing, as the Association of Schools of Public Healths model curriculum illustrates (available at www.asph.org/document.cfm?page=782).
Further, few public health employers in the public and private sectors
offer continuing education that includes ethical issues. Government
and academic institutions should consider the value of including ethics in their accreditation of schools, credentialing of professionals, and
promotion of public health research.
IV. Conclusion
Ensuring and improving population health requires the consideration
of broad and divergent issues, from the philosophical to the economic
and jurisprudential. Traditionally, these dimensions of public health
theory and practice have been analyzed independently by public health
practitioners, lawyers, and ethicists, who each apply the distinctive terminology and analytical methods of their respective fields. That these
approaches differ is not inherently problematic: members of each field
bring their own richly diverse expertise to the theory and practice of
public health. But the key to analyzing and practicing public health in
a coherent way is the integration of these methodologies into a unified
framework. In pursuit of this goal, the Reader seeks to integrate and
foster dialogue among the fields of public health, law, and ethics.
Recommended Readings
Beaglehole, Robert, and Ruth Bonita. 1997. Public Health at the Crossroads:
Achievements and Prospects. New York: Cambridge Univ. Press. (Considers the global and interdisciplinary aspects of public health and describes
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Introduction 19
the need to integrate rigorous epidemiological research with broad-minded
policy making)
Burris, Scott. 1997. The invisibility of public health: Population-level measures
in a politics of market individualism. American Journal of Public Health
87: 160710. (Examines the methods and flaws of the prevailing political
attack on public health regulation)
Epstein, Richard A. 2003. Let the shoemaker stick to his last: A defense of the
old public health. Perspectives in Biology and Medicine 46: 13859.
(Argues for a traditional definition of public health that limits its scope to
communicable diseases and pollution)
Gostin, Lawrence O., and M. Gregg Bloche. 2003. The politics of public
health: A response to Epstein. Perspectives in Biology and Medicine 46:
16075. (Contends that public health must be understood to have a wider
scope that encompasses non-communicable diseases and social determinants of health)
Marmot, Michael, and Richard G. Wilkinson, eds. 1999. Social Determinants
of Health. Oxford: Oxford Univ. Press. (Sets forth the idea that population
health is largely determined by social factorsthe social determinants of
health)
Powers, Madison, and Ruth Faden. 2006. Social Justice: The Moral Foundations of Public Health and Health Policy. New York: Oxford Univ. Press.
(Confronts foundational issues about health and justice, such as how much
inequality in health a just society can tolerate and which inequalities matter
most and are the most morally urgent to address)
Turnock, Bernard J. 2001. Public Health: What It Is and How It Works.
Gaithersburg, MD: Aspen. (Provides a guide to the scope of public health
systems, research, and policy development)
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Part One
Foundations of Public
Health Law and Ethics
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Photo 2. A South African boy crosses a bridge over a heavily polluted river
running through Cape Towns densely populated Masiphumelele slum. Left
to rely on contaminated water supplies, children in Masiphumelele are at
high risk for waterborne diseases, particularly diarrheal diseases. Diarrheal
diseaseseasily preventable and treatable in the developed worldare often
deadly in the developing world, claiming millions of lives each year. Reprinted
by permission, Nic Bothma/epa/Corbis, April 6, 2008.
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23
The readings in this chapter and the next examine the fields of public
health and public health ethics. The first chapter contains classic readings that illuminate the core values of public health: prevention and
the population-based perspective, the role of community and civic participation, the significance of social justice, and modern perspectives
on the public health system. Chapter 2 then turns to contemporary
explanations of public health ethics, examining how ethical principles
and values can inform society about the justifiability of actions taken
to safeguard the publics health and safety. The readings on public
health ethics analyze the inevitable trade-offs between personal liberty
and public health, and discuss the ethics of risk regulation.
I. Prevention and the Population-Based
Perspective
Public health interventions are designed to prevent or ameliorate injury,
disease, and premature death among populations. This section offers
One
The Publics Health
Health is among the most important conditions of human
life and a critically significant constituent of human
capabilities which we have reason to value. Any conception
of social justice that accepts the need for a fair distribution
as well as efficient formation of human capabilities cannot
ignore the role of health in human life and the opportunities
that persons, respectively, have to achieve good healthfree
from escapable illness, avoidable afflictions and premature
mortality. Equity in the achievement and distribution of
health gets, thus, incorporated and embedded in a larger
understanding of justice.
Amartya Sen, 2002
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24 Foundations of Public Health Law and Ethics
two foundational articles explaining the population-based focus of the
field of public health. The article by Ali H. Mokdad and colleagues
from the Centers for Disease Control and Prevention (CDC) is based
on the groundbreaking work of J. Michael McGinnis and William H.
Foege (1993), who described the major preventable causes of death in
the United States. Mokdad and colleagues introduce readers to differences in the way causes of mortality are framed in medicine and public
health.
Medical explanations of death, often in the form of code numbers
from the International Classification of Disease (ICD) on death certificates, point to discrete pathophysiological conditions, such as cancer,
heart disease, cerebrovascular disease, and pulmonary disease. The
biomedical model of record keeping and the societal need to explain a
cause of death with a discrete medical condition can distract the public
from real contributors to mortality. In contrast, public health explanations examine the root causes of disease. Seen in this way, the leading
causes of death are environmental, social, and behavioral factors. The
statistics cited by Mokdad and colleagues demonstrate the magnitude
of the mortality associated with preventable causes of death and the
potential impacts of successful public health campaigns.
Actual Causes of Death in the United States, 2000*
Ali H. Mokdad, James S. Marks, Donna F. Stroup, and Julie L. Gerberding
In a seminal 1993 article, McGinnis and Foege described the major external (nongenetic) modifiable factors that contributed to death in the United States and labeled
them the actual causes of death. During the 1990s, substantial lifestyle pattern
changes may have led to variations in actual causes of death. Mortality rates from
heart disease, stroke, and cancer have declined. At the same time, behavioral
changes have led to an increased prevalence of obesity and diabetes.
Most diseases and injuries have multiple potential causes and several factors and
conditions may contribute to a single death. Therefore, it is a challenge to estimate
the contribution of each factor to mortality. In this article, we used published causes
of death reported to the [CDC] for 2000, relative risks (RRs), and prevalence estimates from published literature and governmental reports to update actual causes of
death in the United Statesa method similar to that used by McGinnis and Foege. . . .
Results
The number of deaths in the United States in 2000 was 2.4 million, which is an
increase of more than 250,000 deaths in comparison with the 1990 total, due largely
*Reprinted from JAMA 291 (2004): 123845. Copyright 2004 American Medical
Association. All rights reserved.
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The Publics Health 25
to population growth and increasing age. Leading causes of death were diseases of
the heart, malignant neoplasms, and cerebrovascular diseases. . . .
Tobacco
. . . A slight decline in smoking was observed from 19951999 to 2000. The prevalence of smoking in 19951999 was 22.8% for current smokers, 24.1% for former
smokers, and 53.1% for never-smokers. In 2000, these estimates were 22.2% for
current smokers, 24.4% for former smokers, and 53.4% for never-smokers. [Men
were consistently more likely than women to be current or former smokers.]
We estimate that approximately 435,000 deaths were attributable to smoking in
2000, which is an increase of 35,000 deaths from 1990 [see table 4]. This increase
is due to the inclusion of 35,000 deaths due to secondhand smoking and 1,000 infant
deaths due to maternal smoking, which were not included in the article by McGinnis
and Foege.
Poor Diet and Physical Inactivity
To assess the impact of poor diet and physical inactivity on mortality, we computed
annual deaths due to overweight. [Increases in overweight and obesity have been
reported frequently in recent years, and National Health and Nutrition Examination
Surveys from 1999 and 2000 indicate that nearly 30% of Americans are overweight
or obese.] . . .
. . . In 2000, the mean estimate of the total number of overweight-attributable
deaths among nonsmokers or never-smokers was 543,797. [The estimate of overweight-attributable deaths increased 76.6% from 1991.]
The prevalence of overweight used in this study is based on data from 1999
2000. Because the effects of overweight on mortality may not appear until some
years after a person becomes overweight, it is likely that the increase in prevalence
of overweight in the 1990s overestimates the current actual number of deaths.
However, the total number of deaths from the 19992000 data may well be the
Table 4. Actual causes of death in the United States
in 1990 and 2000
Actual Cause No. (%) in 1990* No. (%) in 2000
Tobacco 400,000 (19) 435,000 (18.1)
Poor Diet and Physical Inactivity 300,000 (14) 400,000 (16.6)
Alcohol Consumption 100,000 (5) 85,000 (3.5)
Microbial Agents 90,000 (4) 75,000 (3.1)
Toxic Agents 60,000 (3) 55,000 (2.3)
Motor Vehicles 25,000 (1) 43,000 (1.8)
Firearms 35,000 (2) 29,000 (1.2)
Sexual Behavior 30,000 (1) 20,000 (0.8)
Illicit Drug Use 20,000 (<1) 17,000 (0.7)
Total 1,060,000 (50) 1,159,000 (48.2)
source: Mokdad et al. 2004, 1240, table 2.
*Data are from McGinnis and Foege 1993. The percentages are for all deaths.
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26 Foundations of Public Health Law and Ethics
expected number of deaths in the next few years. Thus, we believe a more accurate
and conservative estimate for overweight mortality in 2000 [would be] 385,000,
which is the rounded average of 2000 and 1991 estimates. . . .
[In addition to overweight-attributable deaths,] we estimate that poor diet and
physical inactivity will cause an additional 15,000 deaths a year, although this too
may be conservative.
We estimate that 400,000 deaths were attributable to poor diet and physical
inactivity, an increase of one third from 300,000 deaths estimated by McGinnis and
Foege, and the largest increase among all actual causes of death. However, poor diet
and physical inactivity could account for even more deaths (>500,000) when the
19992000 prevalence estimates of overweight have their full effect. . . .
Alcohol Consumption
. . . In 2000, 18,539 deaths were reported . . . as alcohol induced. In addition, 16,653
persons were killed in alcohol-related crashes. We estimate another 34,797 deaths
in 2000 using . . . alcohol consumption data and [relative risks for a number of alcohol-associated diseases]. This totals to 69,989 deaths in 2000 from these factors
alone. . . .
Total alcohol-attributable deaths would reach about 140,000 if mortality among
previous alcohol drinkers were included. It is unclear whether excess mortality among
former alcohol drinkers is due to damage or illness from past alcohol consumption.
Taking these various numbers into account, our best estimate for total alcoholattributable deaths in 2000 is approximately 85,000, based on the conservative
estimate from cause-specific deaths and the high estimate using all-cause mortality.
This is a reduction of 15,000 deaths from the 1990 estimates. . . .
Microbial Agents
. . . In the past, infectious agents were the leading cause of mortality. These agents
still present a major threat to the nations health and are associated with high morbidity. Several improvements in the health system have led to a decline in mortality
from infectious diseases. The increase in US immunization rates led to a decline in
mortality from many vaccine-preventable diseases. . . . There also have been substantial improvements in sanitation and hygiene, antibiotics and other antimicrobial
medicines, and hospital-infection control.
In 2000, influenza and pneumonia accounted for 65,313 deaths, septicemia for
31,224, and tuberculosis for 776. In general, mortality from infectious and parasitic diseases has declined since 1990. Because pneumonia and septicemia occur
at higher rates among patients with cancer, heart disease, lung disease, or liver
disease, some of these deaths really are attributable to smoking, poor diet, and
alcohol consumption. We estimate that approximately 75,000 deaths were attributable to microbial agents in 2000. . . . This contrasts with 90,000 deaths attributed
to microbial agents in 1990 estimates. [These deaths caused by microbial agents
do not include those from HIV/AIDS, which are included under Sexual Behavior.]
Toxic Agents
. . . In the 1990s, many improvements were made in controlling and monitoring
pollutants. There is more systematic monitoring of pollutants at state and county
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The Publics Health 27
levels, and exposure to asbestos, benzene, and lead have declined. In fact, the US
Environmental Protection Agency reported a decline of 25% from 1970 to 2001 in 6
principal air pollutants: carbon monoxide, lead, ozone, nitrogen dioxide, sulfur dioxide, and particulate matter.
Toxic agents are associated with increased mortality from cancer, respiratory,
and cardiovascular diseases. [We estimate] 24,000 deaths per year from air pollution alone.
The National Institute for Occupational Safety and Health (NIOSH ) estimates that
about 113,000 deaths are due to occupational exposure from 1968 to 1996 [with
deaths declining during this period]. Although particulate air pollution accounts for
the majority (about 60%) of mortality related to toxic agents, indoor air pollution,
environmental tobacco smoke, radon, lead in drinking water, and food contamination
are associated with increased mortality. We estimate that toxic agents (excluding
environmental tobacco exposure) were associated with 2% to 3.5% of total mortality in 2000. We estimate approximately 55,000 deaths attributable to toxic agents
in 2000. . . .
Motor Vehicles
Motor-vehicle crashes involving passengers and pedestrians resulted in 43,354
deaths in 2000. This decline from 47,000 deaths in 1990 represents successful
public health efforts in motor-vehicle safety. Deaths from alcohol-related crashes
declined from 22,084 in 1990 to 16,653 in 2000. Major contributing factors include
the use of child safety seats and safety belts, decreases in alcohol-impaired driving,
changes in vehicle and highway design, and national goals to reduce motor-vehiclerelated mortality and injury. . . . Efforts to educate the public and enforce laws
against driving while intoxicated have accounted for most of the decline in deaths
related to motor-vehicle crashes.
Firearms
Firearm-related incidents resulted in 28,663 deaths among individuals in the United
States in 2000. This is a decline from approximately 36,000 deaths in 1990. The
largest declines were in deaths from homicides and unintentional discharge of firearms. In 2000, 16,586 deaths were due to intentional self-harm (suicide) by discharge of firearms. Assault (homicide) by discharge of firearms resulted in 10,801
deaths. Unintentional discharge of firearms resulted in 776 deaths, while discharge
of firearms, undetermined intent, resulted in 230 deaths. The remaining 270 deaths
were due to legal intervention. . . .
Sexual Behavior
Sexual behavior is associated with an increased risk of preventable disease and disability. An estimated 20 million persons are newly infected with sexually transmitted
diseases each year in the United States. Mortality from sexually transmitted diseases
is declining due to the availability of earlier and better treatment, especially for HIV.
In 2000, HIV disease resulted in 14,578 deaths [a 48% decline from the 27,695 HIV
deaths in 1990. In total,] we estimate that 20,000 deaths in 2000 were due to sexual
behavior, [including deaths from HIV, hepatitis B and C, and cervical cancer].
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28 Foundations of Public Health Law and Ethics
Illicit Use of Drugs
Illicit drug use is associated with suicide, homicide, motor-vehicle injury, HIV infection, pneumonia, violence, mental illness, and hepatitis. An estimated 3 million
individuals in the United States have serious drug problems. . . . In keeping with the
report by McGinnis and Foege, we included deaths caused indirectly by illicit drug
use in this category. . . . Overall, we estimate that illicit drug use resulted in approximately 17,000 deaths in 2000, a reduction of 3,000 deaths from the 1990 report.
Other Factors
Several other factors contribute to an increased rate of death. There are factors that
we do not know of such as unknown pollutants or perhaps exposures that may cause
a considerable number of deaths. Poverty and low education levels are associated
with increased mortality from many causes, partly due to differential exposure to
the risks described above. However, controlling for differential exposure to risk factors is unlikely to explain the entire impact on mortality. Lack of access to proper
medical care or preventive services is associated with increased mortality. Biological
characteristics and genetic factors also greatly affect risk of death. In most studies
we reviewed, low education levels and income were associated with increased risk
of cardiovascular disease, cancer, diabetes, and injury. The Healthy People 2010
initiative has made the elimination of health disparities, especially racial and ethnic
disparities, a primary goal.
Comment
We found that about half of all deaths that occurred in the United States in 2000 could
be attributed to a limited number of largely preventable behaviors and exposures.
Overall, we found relatively minor changes from 1990 to 2000 in the estimated number of deaths due to actual causes. Our findings indicate that interventions to prevent
and increase cessation of smoking, improve diet, and increase physical activity must
become much higher priorities in the public health and health care systems.
The most striking finding was the substantial increase in the number of estimated
deaths attributable to poor diet and physical inactivity[which now stand at roughly
400,000 a year]. The gap between deaths due to poor diet and physical inactivity
and those due to smoking has narrowed substantially. Because rates of overweight
increased rapidly during the 1990s, we used a conservative approach to make our
estimates, accounting for the delayed effects of overweight on mortality. . . . It is
clear that if the increasing trend of overweight is not reversed over the next few
years, poor diet and physical inactivity will likely overtake tobacco as the leading
preventable cause of mortality.
The most disappointing finding may be the slow progress in reducing tobaccorelated mortality. A few states, notably California, have had major success in programs that led to reducing deaths from heart disease and cancer. However, efforts in
most other states are too recent or short-term to have a similar effect. . . .
Despite the call to action on these risk factors a decade ago, there has been little
progress in reducing the total number of deaths from these causes. The progress
that has occurred primarily involves actual causes of death that are less prominent.
With the shift in the age distribution of the population, more adults now are in the
age group at highest risk because of the cumulative effects of their behavior. The
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The Publics Health 29
net effect is that both total deaths and total burden due to the actual causes have
increased. . . .
In summary, smoking and the deaths attributed to the constellation of poor diet
and physical inactivity currently account for about one third of all deaths in the United
States. . . . In ancient times, Hippocrates stated that the function of protecting and
developing health must rank even above that of restoring it when it is impaired. The
findings in this study argue persuasively for the need to establish a more preventive
orientation in health care and public health systems in the United States.

Like Mokdad and colleagues, Geoffrey Rose offers a comparison of
medicine and public health. In his influential article, Rose compares
the scientific methods and objectives of medicine with those of public
health. Why did this patient get this disease at this time? is a common question in medicine, and it underscores a physicians central concern for sick individuals and an individual etiology. By contrast, those
interested in public health seek knowledge about why ill health occurs
in the population and how it can be prevented.
According to Roses prevention paradox, measures that have the
greatest potential for improving the publics health (e.g., seat belt use)
offer little absolute benefit to any individual, whereas measures that heroically save individual lives (e.g., heart transplants) make no significant
contribution to the populations health. This tension between the individual and the population can also be seen in how success is quantified
for health interventions. The answer to the question Did this person
survive? indicates success for the physician. For the public health professional, the key question is How many person-years of life were saved?
Although Rose acknowledges that medical interventions appear more
heroic and are more likely to be welcomed by patients, he favors the
broad and powerful impact of successful population-based campaigns.
Sick Individuals and Sick Populations*
Geoffrey Rose
The Determinant of Individual Cases
In teaching epidemiology to medical students, I have often encouraged them to consider a question which I first heard enunciated by Roy Acheson: Why did this patient
*Reprinted from International Journal of Epidemiology 14 (March 1985): 3238 by
permission of Oxford University Press.
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30 Foundations of Public Health Law and Ethics
get this disease at this time? It is an excellent starting-point, because students and
doctors feel a natural concern for the problems of the individual. Indeed, the central
ethos of medicine is seen as an acceptance of responsibility for sick individuals.
It is an integral part of good doctoring to ask not only, What is the diagnosis,
and what is the treatment? but also, Why did this happen, and could it have been
prevented? Such thinking shapes the approach to nearly all clinical and laboratory research into the causes and mechanisms of illness. Hypertension research,
for example, is almost wholly preoccupied with the characteristics which distinguish
individuals at the hypertensive and normotensive ends of the blood pressure distribution. . . . The constant aim in such work is to answer Achesons question: Why did
this patient get this disease at this time?
The same concern has continued to shape the thinking of all of us who came to
epidemiology from a background in clinical practice. The whole basis of the casecontrol method is to discover how sick and healthy individuals differ. Equally the
basis of many cohort studies is the search for risk factors, which identify certain
individuals as being more susceptible to disease; and from this we proceed to test
whether these risk factors are also causes, capable of explaining why some individuals get sick while others remain healthy, and applicable as a guide to prevention. . . .
Applied to aetiology, the individual-centered approach leads to the use of relative
risk as the basic representation of aetiological force: that is, the risk in exposed
individuals relative to risk in non-exposed individuals. . . . It may generally be the
best measure of aetiological force, but it is no measure at all of aetiological outcome
or of public health importance. . . .
The Determinants of Population Incidence Rate
I find it increasingly helpful to distinguish two kinds of aetiological questions. The
first seeks the causes of cases, and the second seeks the causes of incidence. Why
do some individuals have hypertension? is a quite different question from Why do
some populations have much hypertension, whilst in others it is rare? The questions require different kinds of study, and they have different answers. . . .
To find the determinants of prevalence and incidence rates, we need to study characteristics of populations, not characteristics of individuals. . . . Within populations it
has proved almost impossible to demonstrate any relation between an individuals diet
and his serum cholesterol level; and the same applies to the relation of individual diet
to blood pressure and to overweight. But at the level of populations it is a different
story: it has proved easy to show strong associations between population mean values
for saturated fat intake versus serum cholesterol level and coronary heart disease
incidence, sodium intake versus blood pressure, or energy intake versus overweight.
The determinants of incidence are not necessarily the same as the causes of cases.
How Do the Causes of Cases Relate to the Causes of Incidence?
This is largely a matter of whether exposure varies similarly within a population and
between populations (or over a period of time within the same population). Softness
of water supply may be a determinant of cardiovascular mortality, but it is unlikely to
be identifiable as a risk factor for individuals, because exposure tends to be locally
uniform. Dietary fat is, I believe, the main determinant of a populations incidence
rate for coronary heart disease; but it quite fails to identify high-risk individuals.
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The Publics Health 31
In the case of cigarettes and lung cancer it so happened that the study populations contained about equal numbers of smokers and non-smokers, and in such a
situation case-control and cohort studies were able to identify what was also the
main determinant of population differences amid time trends.
There is a broad tendency for genetic factors to dominate individual susceptibility, but to explain rather little of population differences in incidence. Genetic
heterogeneity, it seems, is mostly much greater within than between populations.
This is the contrary situation to that seen for environmental factors. Thus migrants,
whatever the colour of their skin, tend to acquire the disease rates of their country
of adoption.
Most non-infectious diseases are still of largely unknown cause. . . . We know
quite a lot about the personal characteristics of individuals who are susceptible to
them, but for a remarkably large number of our major non-infectious diseases we
still do not know the determinants of the incidence rate. . . .
There is hardly a disease whose incidence rate does not vary widely, either over
time or between populations at the same time. This means that these causes of
incidence rate, unknown though they are, are not inevitable. It is possible to live
without them, and if we knew what they were it might be possible to control them.
[Identifying them, however, requires a difference of exposure within the population;
if such variation does not exist,] the clues must be sought from differences between
populations or from changes within populations over time.
Prevention
These two approaches to aetiologythe individual and the population-basedhave
their counterparts in prevention. In the first, preventive strategy seeks to identify
high-risk susceptible individuals and to offer them some individual protection. In
contrast, the population strategy seeks to control the determinants of incidence
in the population as a whole.
The High-Risk Strategy
This is the traditional and natural medical approach to prevention. If a doctor
accepts that he is responsible for an individual who is sick today, then it is a short
step to accept responsibility also for the individual who may well be sick tomorrow.
Thus, screening is used to detect certain individuals who hitherto thought they were
well but who must now understand that they are in effect patients. . . .
What the high-risk strategy seeks to achieve is something like a truncation of
the risk distribution. This general concept applies to all special preventive action in
high-risk individualsin at-risk pregnancies, in small babies, or in any other particularly susceptible group. It is a strategy with some clear and important advantages.
Its first advantage is that it leads to intervention which is appropriate to the
individual. A smoker who has a cough or who is found to have impaired ventilatory
function has a special reason for stopping smoking. . . . The intervention makes
sense because that individual already has a problem which that particular measure
may possibly ameliorate. . . .
For rather similar reasons the high-risk approach also motivates physicians.
Doctors, quite rightly, are uncomfortable about intervening in a situation where
their help was not asked for. Before imposing advice on somebody who was getting
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32 Foundations of Public Health Law and Ethics
on all right without them, they like to feel that there is a proper and special justification in that particular case.
The high-risk approach offers a more cost-effective use of limited resources. . . .
[I]t is more effective to concentrate limited medical services and time where the
needand therefore also the benefitis likely to be greatest.
A final advantage of the high-risk approach is that it offers a more favourable
ratio of benefits to risks. If intervention must carry some adverse effects or costs,
and if the risk and cost are much the same for everybody, then the ratio of the costs
to the benefits will be more favourable where the benefits are larger.
Unfortunately the high-risk strategy of prevention also has some serious disadvantages and limitations. The first centers around the difficulties and costs of
screening. [Consider screening for high cholesterol.] The disease process we are
trying to prevent (atherosclerosis and its complications) begins early in life, so we
should have to initiate screening perhaps at the age of ten. However, the abnormality we seek to detect is not a stable lifetime characteristic, so we must advocate
repeated screening at suitable intervals.
In all screening one meets problems with uptake, and the tendency for the
response to be greater amongst those sections of the population who are often least
at risk of the disease. Often there is an even greater problem: screening detects
certain individuals who will receive special advice, but at the same time it cannot
help also discovering much larger numbers of borderliners, that is, people whose
results mark them as at increased risk but for whom we do not have an appropriate
treatment to reduce their risk. . . .
The second disadvantage of the high-risk strategy is that it is palliative and
temporary, not radical. It does not seek to alter the underlying causes of the disease but to identify individuals who are particularly susceptible to those causes.
Presumably in every generation there will be such susceptibles, and if prevention
and control efforts were confined to these high-risk individuals, then that approach
would need to be sustained year after year and generation after generation. It does
not deal with the root of the problem, but seeks to protect those who are vulnerable
to it; and they will always be around.
The potential for this approach is limitedsometimes more than we could have
expectedboth for the individual and for the population. There are two reasons for
this. The first is that our power to predict future disease is usually very weak. Most
individuals with risk factors will remain well, at least for some years; contrariwise,
unexpected illness may happen to someone who has just received an all clear
report from a screening examination. One of the limitations of the relative risk statistic is that it gives no idea of the absolute level of danger. . . .
This point came home to me only recently. I have long congratulated myself on
my low levels of coronary risk factors, and I joked to my friends that if I were to
die suddenly, I should be very surprised. I even speculated on what other disease
perhaps colon cancerwould be the commonest cause of death for a man in the
lowest group of cardiovascular risk. The painful truth is that for such an individual
in a Western population the commonest cause of deathby faris coronary heart
disease! Everyone, in fact, is a high-risk individual for this uniquely mass disease. . . .
A further disadvantage of the high-risk strategy is that it is behaviourally inappropriate. Eating, smoking, exercise and all our other lifestyle characteristics are
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The Publics Health 33
constrained by social norms. If we try to eat differently from our friends, it will not
only be inconvenient, but we risk being regarded as cranks or hypochondriacs. If a
mans work environment encourages heavy drinking, then advice that he is damaging his liver is unlikely to have any effect. No one who has attempted any sort of
health education effort in individuals needs to be told that it is difficult for such
people to step out of line with their peers. This is what the high-risk preventive
strategy requires them to do.
The Population Strategy
This is the attempt to control the determinants of incidence, to lower the mean level
of risk factors, to shift the whole distribution of exposure in a favourable direction.
In its traditional public health form it has involved mass environmental control
methods; in its modern form it is attempting (less successfully) to alter some of
societys norms of behaviour.
The advantages are powerful. The first is that it is radical. It attempts to remove
the underlying causes that make the disease common. It has a large potentialoften
larger than one would have expectedfor the population as a whole. . . .
The approach is behaviourally appropriate. If nonsmoking eventually becomes
normal, then it will be much less necessary to keep on persuading individuals.
Once a social norm of behaviour has become accepted and (as in the case of diet)
once the supply industries have adapted themselves to the new pattern, then the
maintenance of that situation no longer requires effort from individuals. The health
education phase aimed at changing individuals is, we hope, a temporary necessity,
pending changes in the norms of what is socially acceptable.
Unfortunately the population strategy of prevention has also some weighty drawbacks. It offers only a small benefit to each individual, since most of them were going
to be all right anyway, at least for many years. This leads to the Prevention Paradox
(Rose 1981): A preventive measure which brings much benefit to the population
offers little to each participating individual. This has been the history of public
healthof immunization, the wearing of seat belts and now the attempt to change
various lifestyle characteristics. Of enormous potential importance to the population as a whole, these measures offer very littleparticularly in the short termto
each individual; and thus there is poor motivation of the subject. . . .
In mass prevention each individual has usually only a small expectation of benefit, and this small benefit can easily be outweighed by a small risk. . . . This makes it
important to distinguish two approaches. The first is the restoration of biological normality by the removal of an abnormal exposure (e.g., stopping smoking, controlling air
pollution, moderating some of our recently acquired dietary deviations); here there
can be some presumption of safety. This is not true for the other kind of preventive
approach, which leaves intact the underlying causes of incidence and seeks instead to
interpose some new, supposedly protective intervention (e.g., immunization, drugs,
jogging). Here the onus is on the activists to produce adequate evidence of safety.
Conclusions
Case-centered epidemiology identifies individual susceptibility, but it may fail to
identify the underlying causes of incidence. The high-risk strategy of prevention
is an interim expedient, needed in order to protect susceptible individuals, but only
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34 Foundations of Public Health Law and Ethics
for so long as the underlying causes of disease remain unknown or uncontrollable; if
causes can be removed, susceptibility ceases to matter.
Realistically, many diseases will long continue to call for both approaches, and
fortunately competition between them is usually unnecessary. Nevertheless, the
priority of concern should always be the discovery and control of the causes of
incidence.
II. Community and Civic Participation
A prevention-oriented and population-based approach requires evaluating health risks and intervening to improve health on a community
level. The interaction between public health practitioners and communities should not be only in one direction, however. Experience has
shown that community involvement and civic participation at every
stage of public interventionsfrom the initial assessment of health
needs to the ultimate evaluation of an interventions impactpromote
effective public health activities. Community action itself may also
improve the publics health (Putnam 2000, 326): Social connectedness
is one of the most powerful determinants of our well-being. The more
integrated we are with our community, the less likely we are to experience colds, heart attacks, strokes, cancer, depression, and premature
death of all sorts. [Thus growing social disconnectedness] represents
one of the nations most serious public health challenges.
In emphasizing the value of community, those in public health
should not elide the underlying tensions between the community and
the individual. It is important to consider the nature of our social and
moral obligations to those in our community. Why should society prefer population health over other social values? That disease prevention
is possible does not necessarily make it a desirable goal. Why should
the government promote the publics health?
As the following discussion suggests, some political theorists see the
common good of society as an ethical imperative, even if the benefit to
individuals is small. In Spheres of Justice (1983, 65), Michael Walzer
explains the value and importance of membership in a community as
a vehicle for the provision of communal needs. He tells us that men
and women come together because they literally cannot live apart. By
providing for those needs on a community basis, individuals reaffirm
and strengthen the sense of membership in a political community.
In the following reading, Dan Beauchamp, a pioneer of public health
ethics, builds on the work of Walzer. He analyzes a classic conflict
between the need for population-based measures to improve the wellPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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The Publics Health 35
being of the entire community and the ethos of American individualism, which, at times, seems to require only restraint from harming
others. Beauchamp argues that communal needs often are mistakenly
framed as collections of individual needs to prevent harm to other individuals. For example, instead of viewing pollution controls as fulfilling
the societal need for clean air, we often perceive regulations as laws
that prevent harm to individuals who may be affected by poor-quality
air. To advance his argument, he describes the second language of
republicanisma language that acknowledges the community roots of
the republican tradition, a language that is not drowned out by individualism and paternalism. This second language, he claims, brings
the community together to work toward common goals and, in turn,
strengthens its desire to achieve public health goals.
Community: The Neglected Trad ition of Public Health*
Dan Beauchamp
What are the limits of government in protecting the health and safety of the public?
As more and more states regulate personal behavior to protect the public health and
safety, this question again becomes central. Can there be good reasons for public
health paternalism in a democracy? Are health and safety individual interests, or
also common and shared ends?
The growing public awareness of the role of personal behavior in determining the
health of the public can be traced to the limits to medicine debates of the early
seventies. A substantial literature questioned the efficacy of medical care expenditures for improving health. . . . This new perspective was quickly taken up by many
Western governments, particularly in the U.S. and Canada, where national budgets
were straining under escalating costs of medical care. . . .
[Proposals to influence lifestyle choices] stirred rhetoric but produced little
action. To the contrary the lifestyle debate worked to undermine the legitimacy of
the idea that the government is responsible for the health and safety of the public.
The lifestyle debate reopened an old theme in democratic theorypaternalism and
the meaning of the common good.
The Meaning of the Common Good
In one version of democratic theory, the state has no legitimate role in restricting
personal conduct that is substantially voluntary and that has little or no direct consequence for anyone other than the individual. This strong antipaternalist position is
associated with John Stuart Mill. In this view the common good consists in maximizing the freedom of each individual to pursue his or her own interests, subject to a like
freedom for every other individual. . . .
*Reprinted from Hastings Center Report 15, no. 6 (December 1985): 2836.
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36 Foundations of Public Health Law and Ethics
In a second version, health and safety remain private interests but some paternalism is accepted, albeit reluctantly. . . . Common sense makes us reject a thoroughgoing antipaternalism. Many restrictions on liberty are relatively minor and the
savings in life and limb extremely great. Further, often voluntary choices are not
completely so; many choices are impaired in some sense. . . .
This reluctant acceptance of paternalism leaves many democrats uneasy. Another alternative is to redefine voluntary risks to an individual as risks to others.
Indeed, many argue that all such risks have serious consequences for others, and
that the state may therefore limit such activities on the basis of the harm principle.
Others challenge the category of voluntariness head on, arguing that most such
risks, like cigarettes and alcohol use, have powerful social determinants.
The constitutional basis for the protection of the public health and safety has
largely been ignored in this debate. This tradition, and particularly the regulatory
power (often called the police power), flows from a view of democracy that sees
the essential task of government as protecting and promoting both private and
group interests. Government is supposed to defend both sets of interests through
an evolving set of practices and institutions, and it is left to the legislatures to determine which set of interests predominate when conflicts arise.
In the constitutional tradition, the common good refers to the welfare of individuals considered as a group, the public or the people generally, the body politic or
the commonwealth as it was termed in the early days of the American Republic.
The public or the people were presumed to have an interest, held in common, in
self-protection or preservation from threats of all kinds to their welfare. The commonwealth idea was widely influential among New England states during the first
half of the nineteenth century.
. . . The central principles underlying the police or regulatory power were the
treatment of health and safety as a shared purpose and need of the community and
(aside from basic constitutional rights such as due process) the subordination of the
market, property, and individual liberty to protect compelling community interests.
This republican image of democracy was a blending of social contract and republican thought, as well as Judeo-Christian notions of covenant. In the republican vision
of society, the individual has a dual status. On the one hand, individuals have private
interests and private rights; political association serves to protect these rights. On
the other hand, individuals are members of a political communitya body politic.
This common citizenship, despite diversity and divergence of interests, presumes
an underlying shared set of loyalties and obligations to support the ends of the political community, among which public health and safety are central. In this scheme,
public health and safety are not simply the aggregate of each private individuals
interest in health and safety, interests which can be pursued more effectively
through collective action. Public health and safety are community or group interests
(often referred to as state interests in the law), interests that can transcend and
take priority over private interests if the legislature so chooses.
The idea of democracy as promoting the common or group interest is captured in
Joseph Tussmans classic work (1960, 2728) on political obligation: [T]he governments concern for the individual is not to be understood as special concern for this
or that individual but rather as concern for all individuals. Government, that is to say,
serves the welfare of the community. . . .
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The Publics Health 37
The Language of Public Health
What are we to make of this constitutional tradition surrounding the development of
the regulatory power for health and safety? What relevance does it have for the policy disputes of today, particularly those concerning the limitation of lifestyle risks?
The constitutional tradition for public health constitutes one of those second
languages of republicanism that Robert Bellah and his coauthors speak of in . . .
Habits of the Heart. In their book, the first language (or tradition of moral discourse)
of American politics is political individualism. But there are second languages of
community rooted in the republican and biblical tradition that limit and qualify the
scope and consequences of political individualism.
Public health as a second language reminds us that we are not only individuals,
we are also a community and a body politic, and that we have shared commitments
to one another and promises to keep. . . .
The danger is that we can come to discuss public health exclusively within the
dominant discourse of political individualism, relying either on the harm principle or
a narrow paternalism justified on grounds of self-protection alone. By ignoring the
communitarian language of public health, we risk shrinking its claims. We also risk
undermining the sense in which health and safety are a signal commitment of the
common lifea central practice by which the body politic defines itself and affirms
its values.
. . . Public health belongs to the realm of the political and the ethical. Public
health belongs to the ethical because it is concerned not only with explaining the
occurrence of illness and disease in society, but also with ameliorating them. Beyond
instrumental goals, public health is concerned with integrative goalsexpressing the
commitment of the whole people to face the threat of death and disease in solidarity.
Public health is also a practical science. Spanning the world of science and practical action, it seeks reasonable and practical means of altering property arrangements or limiting liberty to promote the health of the public generally.
These two ideas, the ideas of second languages and of social practices, shed
light on why paternalismat least public health paternalismplays an affirmative
role in the republican tradition. In the constitutional categories for protecting the
public health, the regulatory power is to protect not individual citizens, but rather
citizens considered as a group, the public health. In this tradition, the public, as
well as the community itself, has a reality apart from the citizens who comprise it.
Fundamental constituents of the community and the common life are its practices
and institutions.
Practices are communal in nature, and concerned with the well-being of the community as a whole and not just the well-being of any particular person. Policy, and
here public health paternalism, operates at the level of practices and not at the level
of individual behavior. . . .
This distinction between practices and behavior should help us see the difference between public health paternalism aimed at the group and the personal
paternalism of the doctor-patient, lawyer-client relationship. While there are public elements of these professional relationships, and while the state can (rightly or
wrongly) structure these relationships in a paternalistic fashion, their essence is
based on a personal encounter between a professional and a client. This is not the
case with public health paternalism. Public health paternalism should also be kept
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38 Foundations of Public Health Law and Ethics
separate from the legal doctrine of parens patriae, where the state assumes the role
of parent in instances where parental supervision is absent or deemed deficient.
This suggests that public health paternalism and the language of community on
which it is based fit the parent-child analogy very poorly. To Mill (1961, 273), all
paternalism was wrong because the individual is best placed to know his own good:
He is the person most interested in his own well-being: the interest which any other
person, except in cases of strong personal attachment, can have in it, is trifling. . . .
But precisely because public health paternalism is aimed at the group and its practices, and not the specific individual, Mills point is wrong. The good of the particular
person is not the aim of health policy in a democracy which defends both the community and the individual. In fact, Mill is wrong twice, because particular individuals
are often very poorly placed to judge the effects that market arrangements and practices have on the population as a whole. This is the task for legislatures, for organized
groups of citizens, and for other agents of the public, including the citizen as voter.
Mills dichotomy of either the harm principle or self-protection is too limited; the
world of harms is not exhausted by self-imposed and other-imposed injuries. There
is a third and very large set of problems that afflicts the community as a whole and
that results primarily from inadequate safeguards over the practices of the common life. Economists and others often refer to this class of harms as summing up
problems or .
Creating, extending, or strengthening the practices of public healthand the collective goods principle that underlies itought to be the primary justification for
our health and safety policy. Instead we usually base these regulations on the harm
principle. We usually justify regulating the steel or coal industry on the grounds that
workers and the general public have the risks of pollution or black lung visited on
them, but consumers are not obliged to drink alcohol or smoke cigarettes. While this
may be true, in the communitarian language and categories of public health, fixing
blame is not the main point. We regulate the steel or coal industry because market competition undervalues collective goods like a clean environment or workers
safety. Using social organization to secure collective goods like public health, not
preventing harms to others, is the proper rationale for health and safety regulations
imposed on the steel or coal industry, or the alcohol or cigarette industry. . . .
The main lesson to learn from public health paternalism as it has developed in the
constitutional tradition may well be that the second language of community and the
virtues of cooperation and beneficence still exist, albeit precariously, alongside a
tradition of political individualism. Strengthening the public health includes not only
the practical task of improving aggregate welfare, it also involves the task of reacquainting the American public with its republican and communitarian heritage, and
encouraging citizens to share in reasonable and practical group schemes to promote
a wider welfare, of which their own welfare is only a part. In political individualism,
seat belt legislation or signs on the beach restricting swimming when a lifeguard is
not present restrict the individuals liberty for his or her own good. In this circumstance the appropriate slogan is: The life you save may be your own. But in the
second language of public health these restrictions define a common practice which
shapes our life together, for the general or the common good. In the language of
public health, the motto for such paternalistic legislation might be: The lives we
save together might include your own.
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The Publics Health 39
III. Social Justice: Socioeconomic Inequalities
Demography is destiny.
Attributed to Auguste Comte (17981857)
Deep and enduring socioeconomic inequalities form the backdrop to
any public health policy, and these disparities help explain why social
justice is a core value of public health. As Angus Deaton (2002, 13)
explains, Poorer people die younger and are sicker than richer people;
indeed, mortality and morbidity rates are inversely related to many
correlates of socioeconomic status [SES] such as income, wealth, education, or social class. Scholars often refer to the relationship as a
gradient to emphasize the correlation between SES and health, with
health improving continuously as wealth and social status rise. Various
explanatory variables for the gradient have been proposed. The poor
and uneducated may not have sufficient access to lifes necessities, such
as food, clothing, housing, and health care. Or they may engage more
frequently in risk behaviors, such as smoking, illicit drug use, and
high-fat diets. Alternatively, poor health may impede individuals from
making a living and getting an education. Whatever the explanation,
inequalities in health appear persistent over time and across cultures.
The British epidemiologist Sir Michael Marmot offers a powerful
illustration of the SES gradient (2006). For every mile traveled on the
Metros Red Line in the District of Columbia from the impoverished
northeast to the affluent northwest, the population lives one and a half
years longer. Marmot, a pioneer of the theory of a social gradient
for health, elsewhere observes that a persons relative social standing
appears to be important for a healthy, happy, and long life (2004).
Relying on Marmots work, the London Times offers some intriguing, tongue-in-cheek pointers on how to better ones lot in life in its
editorial Social Climbing Is Good Exercise (June 7, 2004):
First, be very intelligent, very well educated and very married. If you are
not those things, become them as soon as possible. Being a homeowner is
also a key. But dont set up home in places where all the neighbours are
likely to be richer than you. So avoid Silicon Valley, Dubai and pockets
of Hampshire and West Sussex (though the ambitious should start
house-hunting there immediately). Youll also do better in an inclusive
society not one where some are excluded from social situations, such
as Hollywood or Londons Ivy Restaurant on Saturday night. Last, you
should not be hostile. Except, of course, to the maitre d who forgets
just how winning you are.
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40 Foundations of Public Health Law and Ethics
Acknowledging the social gradient for health, public health advocates
often favor redistributive social policies to reduce health disparities.
This big idea, as the British Medical Journal (Editors Choice 1996,
985) has called it, suggests that what matters in determining mortality and health in a society is less the overall wealth of that society
and more how evenly wealth is distributed. The more equally wealth is
distributed the better the health of that society. Some ethicists, relying
on these studies, say that justice is good for our health, as argued by
Norman Daniels and colleagues below.
But before turning to Danielss claim, it is worth considering whether
there is indeed sufficient evidence for this big idea. John Lynch and
Photo 3. This photo from the 1960s shows a child
suffering from smallpox at the Infectious Diseases
Hospital in Madras. He bears the multiple small
lesions typical of smallpox. International cooperation,
intensive disease surveillance, and targeted vaccination
efforts led to the eradication of smallpox in 1979.
Reproduced by permission, Bettman/Corbis.
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The Publics Health 41
colleagues (2004, 5) draw the following conclusion after reviewing
ninety-eight studies examining the associations between income in –
equality and health:
Overall, there seems to be little support for the idea that income inequality is a major, generalizable determinant of population health differences
within or between countries. Income inequality may, however, directly
influence some health outcomes, such as homicide in the United States,
but even that is somewhat mixed. Despite little support for a direct effect
of income inequality on health per se, reducing income inequality by
raising incomes of the most disadvantaged will improve their health,
help reduce health inequalities, and generally improve population health.
Norman Daniels and his colleagues, using a Rawlsian theory, predict the political conditions necessary to achieve health equity. In the
excerpt that follows theirs, Madison Powers and I go further, offering
a template of what social justice requires for the publics health. In
particular, we claim that social justice demands more than fair distribution of resources. Fundamentally, justice requires treating the
most disadvantaged in society with dignity and as equal members of
the political community. Our commentary explores how social justice
sheds light on major ongoing controversies in the field and provides
examples of the kinds of policies that public health agencies, guided by
a robust conception of justice, would adopt.
Justice Is Good for Our Health*
Norman Daniels, Bruce Kennedy, and Ichiro Kawachi
We have long known that the more affluent and better-educated members of a society tend to live longer and healthier lives. . . . Recent research suggests that the
correlations between income and health do not end there. We now know, for example, that countries with a greater degree of socioeconomic inequality show greater
inequality in health status; also, that middle-income groups in relatively unequal
societies have worse health than comparable, or even poorer, groups in more equal
societies. Inequality, in short, seems to be bad for our health.
. . . Universal access to health care does not necessarily break the link between
social status and health. Our health is affected not simply by the ease with which
we can see a doctorthough that surely mattersbut also by our social position and
the underlying inequality of our society. We cannot, of course, infer causation from
these correlations, [but] the evidence suggests that there are social determinants
of health.
*Reprinted from the Boston Review, February/March 2000: 615.
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42 Foundations of Public Health Law and Ethics
These social determinants offer a distinctive angle on how to think about justice,
public health, and reform of the health care system. If social factors play a large
role in determining our health, then efforts to ensure greater justice in health care
should not focus simply on the traditional health sector. . . . We should be looking as
well to improve social conditionssuch as access to basic education, levels of material deprivation, a healthy workplace environment, and equality of political participationthat help to determine the health of societies. . . .
We hope to [explore] some broader issues about health and social justice. To
avoid vague generalities about justice, we shall advance a line of argument inspired
principally by the theory of justice as fairness put forth by the philosopher John
Rawls. . . .
Rawlss theory of justice as fairness was not designed to address issues of health
care. He assumed a completely healthy population, and argued that a just society
must assure people equal basic liberties, guarantee that the right of political participation has roughly equal value for all, provide a robust form of equal opportunity, and limit inequalities to those that benefit the least advantaged. When these
requirements of justice are met, Rawls argued, we can have reasonable confidence
that others are showing us the respect that is essential to our sense of self-worth.
Recent empirical literature about the social determinants of health suggests that
the failure to meet Rawlsian criteria for a just society is closely related to health
inequality. The conjecture we propose to explore, then, is that by establishing equal
liberties, robustly equal opportunity, a fair distribution of resources, and support for
our self-respectthe basics of Rawlsian justicewe would go a long way to eliminating the most important injustices in health outcomes. . . .
Social Determinants of Health
Cross-National Inequalities
A countrys prosperity is related to its health. . . . In richer countries people tend
to live longer. . . . As a country or region develops economically average health
improves. But the evidence suggests that things are more complicated. Figure [3]
shows the relationship between the wealth of nations, as measured by per capita
gross domestic product (GDPpc), and the health of nations, as measured by life
expectancy. Clearly, GDPpc and life expectancy are closely associated, but only up to
a point. The relationship levels off when GDPpc reaches $8,000 to $10,000; beyond
this threshold, further economic advance buys virtually no further gains in life expectancy. This leveling effect is most apparent among the advanced industrial economies, which largely account for the upper tail of the curve in figure [3]. [Ed.Figure
3 updates Daniels and colleagues figure comparing life expectancy and income.]
Relative Income
. . . The health of a population depends not just on the size of the economic pie, but on
how the pie is shared. Differences in health outcomes among developed nations cannot be explained simply by the absolute deprivation associated with low economic
development. . . . The degree of relative deprivation within a society also matters.
. . . This relative-income hypothesis [states that] inequality is strongly associated
with population mortality and life expectancy across nations. To be sure, wealthier
countries generally have higher average life expectancy. But rich countries, too,
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The Publics Health 43
vary in life expectancy (see the tail of figure [3]), and that variation dovetails with
income distribution. Wealthy countries with more equal income distributions, such
as Sweden and Japan, have higher life expectancies than does the United States,
despite their having lower per capita GDP. Likewise, countries with low GDPpc but
remarkably high life expectancy, such as Costa Rica, tend to have a more equitable
distribution of income. . . .
Individual [Socioeconomic Status (SES)]
Finally, when we move from comparing whole societies to comparing their individual
members, we find, once more, that inequality is important. . . . Numerous studies have
documented what has come to be known as the socioeconomic gradient: at each step
along the socioeconomic ladder, we see improved health outcomes over the rung
below. This suggests that differences in health outcomes are not confined to the
extremes of rich and poor, but are observed across all levels of socioeconomic status.
Moreover, the SES gradient does not appear to be explained by differences in
access to health care. Steep gradients have been observed even among groups of
individuals, such as British civil servants, who all have adequate access to health
care, housing, and transport. . . .
The slope of the gradient [varies substantially across societies and] appears to
be fixed by the level of income inequality in a society: the more unequal a society is
in economic terms, the more unequal it is in health terms. Moreover, middle income
groups in a country with high income inequality typically do worse in terms of health
than comparable or even poorer groups in a society with less income inequality. . . .
United States Luxembourg
Japan
Costa Rica
Russia
Botswana
Zambia
85
80
75
70
65
60
55
50
45
40
35
Life Expectancy (years)
0 10,000 20,000 30,000
GDP Per Capita (purchasing power parity US dollars)
40,000 50,000 60,000
Figure 3. Life expectancy and per capita GDP. Data source: United Nations
Human Development Report Statistics 2007/2008.
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44 Foundations of Public Health Law and Ethics
Pathways
. . . Correlations between inequality and health do not necessarily imply causation.
Still, there are plausible and identifiable pathways through which social inequalities
appear to produce health inequalities. In the United States, the states with the most
unequal income distributions invest less in public education, have larger uninsured
populations, and spend less on social safety nets. . . . Educational opportunities for
children in high-income-inequality states are quite different from those in states
with more egalitarian distributions. These effects on education have an immediate
impact on health. [Similarly, between countries, differential investment in human
capital is a strong predictor of health. For example, adult literacy (particularly the
disparity between male and female adult literacy) is one of the strongest predictors
of life expectancy.]
These societal mechanismsfor example, income inequality leading to educational inequality leading to health inequalityare tightly linked to the political processes that influence government policy. For example, income inequality . . . erodes
social cohesion [leading] to lower participation in political activity, [which], in turn,
undermines the responsiveness of government institutions in addressing the needs
of the worst off. States with the highest income inequality, and thus lowest levels of
social capital and political participation, are less likely to invest in human capital and
provide far less generous social safety nets.
In short, the case for social determinants of health is strong. What are the implications of this fact for ideas of justice?
Inequalities and Inequities
When is a health inequality between two groups inequitable? Margaret Whitehead
and Goran Dahlgren [Dahlgren and Whitehead 1991] have suggested a useful and
influential answer: health inequalities count as inequities when they are avoidable,
unnecessary, and unfair.
. . . The analysis of inequity is only as good as our understanding of what is avoidable or unnecessary. [Biological differences might be unavoidable, but what about
behavioral differences between cultural groups and social classes?] Whitehead
and Dahlgrens term leaves us with an unresolved complexity of judgments about
responsibility, . . . fairness and avoidability.
The poor in many countries lack access to clean water, sanitation, adequate shelter, basic education, vaccinations, and prenatal and maternal care. As a result of
some, or all, of these factors, infant mortality rates for the poor exceed those of the
rich. Since social policies could supply the missing determinants of infant health,
these inequalities are avoidable.
Are these inequalities also unfair? Most of us would think they are, perhaps
because we believe that policies that create and sustain poverty are unjust, and
perhaps also because we object to social policies that compound economic poverty with lack of access to the determinants of health. [But] we cannot eliminate
health inequalities simply by eliminating poverty. Health inequalities persist even in
societies that provide the poor with access to [social services, including health and
education], and they persist as a gradient of health throughout the social hierarchy,
not just between the very poorest groups and those above them.
[Does justice require then that all socioeconomic inequalities be eliminated to
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The Publics Health 45
eliminate health inequalities? Or are some socioeconomic inequalities not unjust?]
On issues of this kind, we should take guidance from a well-articulated account of
social justicethe one put forth by John Rawls.
Justice as Fairness
In A Theory of Justice, Rawls sought to show that a social contract designed to be fair
to free and equal people would lead to equal basic liberties and equal opportunity, and
would permit inequalities only when they work to make the worst-off groups fare as
well as possible. Though Rawlss account was devised for the most general questions
of social justice [and did not deal with health or disease, it nonetheless] provides a set
of principles for the just distribution of the social determinants of health. . . .
Let us start by considering what a just society would require with regard to the
distribution of the social determinants of health. In such an ideal society, everyone
is guaranteed equal basic liberties, including the right to participate in politics. . . .
Since, as we argued above, there is evidence that political participation is a social
determinant of health, the Rawlsian ideal assures institutional protections that
counter the usual effects of socioeconomic inequalities on participationand thus
on health.
Moreover, according to Rawls, justice requires fair equality of opportunity. This
principle condemns discriminatory barriers and requires robust measures aimed
at mitigating the effects of socioeconomic inequalities and other contingencies on
opportunity. [Such measures would include equitable public education, appropriate
day care, and accessible graduate and professional education.]
The equal opportunity principle also requires extensive public health, medical, and social support services aimed at promoting normal functioning for all. . . .
Obviously, this focus requires provision of universal access to comprehensive health
care, including public health, primary health care, and medical and social support
services. . . .
Finally, a just society restricts allowable inequalities in income and wealth to
those that benefit the least advantaged. . . .
In short, Rawlsian justicethough not devised for the case of healthregulates
the distribution of the key social determinants of health, including the social bases
of self-respect. There is nothing about the theory that should make us focus narrowly on medical services. Properly understood, justice as fairness tells us what justice requires in the distribution of all socially controllable determinants of health. . . .
Suppose we reduce socioeconomic inequalities, and thereby reduce health
inequalitiesbut the result is that the health of all is worsened because productivity
is reduced so much that important institutions are undermined. That is not acceptable. Our commitment to reducing health inequality should not require steps that
threaten to make health worse off for those with less-than-equal health status. So
the theoretical issue reduces to this: would it ever be reasonable to allow some
health inequality in order to produce some non-health benefits for those with the
worst health prospects? . . .
Rawls gave priority to the principle of protecting equal basic liberties because he
believed that once people achieve some threshold level of material well-being, they
will not trade away the fundamental importance of liberty for other goods. Making
such a trade might deny them the liberty to pursue their most cherished ideals. . . .
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46 Foundations of Public Health Law and Ethics
Can we make the same argument about trading health for other goods? [Perhaps
rational people should refrain from trading health for other goods because, without
health, they cannot pursue what they value most. But this priority is not clear-cut
where the conditions on choice are fair, particularly if goods gained are highly valued. Refusing to allow trades of health risks in such cases might be unjustifiably
paternalistic in a way that refusal to allow trades of basic liberties is not.]
We propose a pragmatic route around this problem. Fair equality of opportunity
is only approximated even in an ideally just system. . . . We cannot achieve complete equality in health any more than we can achieve completely equal opportunity.
Justice is always rough around the edges.
[Provided that] everyone has a fair chance to participate [in the political process
and that participants span the health gradient,] a democratic process that involved
deliberation about the trade-off and its effects might be the best we could do to
provide a resolution of the unanswered theoretical question.
In contrast, where the fair value of political participation is not adequately
assuredand we doubt it is so assured in even our most democratic societieswe
have much less confidence in the fairness of a democratic decision about how to
trade health against other goods. It is much more likely under actual conditions that
those who benefit most from the inequalitiesthat is, those who are better offalso
wield disproportionate political power and will influence decisions about trade-offs
to serve their interests. It may still be that the use of a democratic process in nonideal conditions is the fairest resolution we can practically achieve, but it still falls
well short of what an ideally just democratic process involves.
If we were to achieve a just distribution of resources, then, with the least well-off
being as well off as possible, there would still be health inequalities. But decisions
about whether to reduce those inequalities even more are matters for democratic
process. Justice itself does not command their reduction.
What Does Social Justice Require for the Publics Health?
Public Health Ethics and Policy Imp eratives*
Lawrence O. Gostin and Madison Powers
Justice is viewed as so central to the mission of public health that it has been
described as the fields core value: The historic dream of public health . . . is a
dream of social justice (Beauchamp 1999). This Commentary addresses a single
question of extraordinary social and political importance: What does social justice
require for the publics health? Our thesis is that justice can be an important organizing principle for public health. . . .
What Is Justice, and How Imp ortant Is It in Public Health?
Among the most basic and commonly understood meanings of justice is fairness or
reasonableness, especially in the way people are treated or decisions are made. Our
account of justice stresses the fair disbursement of common advantages and the
*Reprinted from Health Affairs 25 (July/August 2006): 105360.
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The Publics Health 47
sharing of common burdens. It captures the twin moral impulses that animate public
health: to advance human well-being by improving health and to do so by focusing on
the needs of the most disadvantaged. . . .
A core insight of social justice is that there are multiple causal pathways to
numerous dimensions of disadvantage. These include poverty, substandard housing, poor education, unhygienic and polluted environments, and social disintegration. These and many other causal agents lead to systematic disadvantage not
only in health, but also in nearly every aspect of social, economic, and political life.
Inequalities beget other inequalities, and existing inequalities compound, sustain,
and reproduce a multitude of deprivations. . . .
The Justice Perspective in Public Health
. . . Some believe that governments purpose should not be to redress economic and
social disadvantage, and this may be doubly so for administrative agencies dedicated to public health and the pursuit of science. We believe that it is time to rethink
this view, and the justice perspective offers an alternative. Values of socioeconomic
fairness are just as important to health as the prevailing values of personal license
and free enterprise. The justice perspective offers a different way of seeing problems that have long plagued the field of public health.
Legitimate Scope of the Public Health Enterprise
Perhaps the deepest, most persistent critique of public health is that the field has
strayed beyond its natural boundaries. Instead of focusing solely on narrow interventions for discrete injuries and diseases, the field has turned its attention to broader
health determinants. It is when public health strays into the social/political sphere in
matters of war, violence, poverty, and racism that critics become most upset.
The justice perspective does not provide a definitive defense against claims
of overreaching. But social justice does provide a counterweight to the prevailing
political view of health as primarily a private matter. The justice perspective shows
why health is a matter of public concern, with the state having a role not only in
the traditional areas of infectious diseases and sanitation, but also in emerging
areas such as chronic diseases caused by diet, lifestyle, and the environment. Public
health agencies have an obligation to address the root causes of ill health, even while
they recognize that socioeconomic determinants have many causes, and solutions,
that are beyond public healths exclusive expertise.
Balancing Individual and Collective Interests
The exercise of the states coercive power has been highly contentious throughout
U.S. history. When public health officials act, they face troubling conflicts between
the collective benefits of population health on the one hand, and personal and economic interests on the other. Public health powers encroach on fundamental civil
liberties such as privacy, bodily integrity, and freedom of movement and association
[as well as economic liberties]. Justice demands that government take actions to
safeguard the publics health, but that it do so with respect for individuals and sensitivity to the needs of the underprivileged.
In the realm of public health and civil liberties, then, both sides claim the mantle
of justice. . . . What is most important to justice is abiding by the rule of law, which
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48 Foundations of Public Health Law and Ethics
requires modern public health statutes that designate clear authority to act and
provide fair processes. Policymakers, therefore, should modernize antiquated public health laws to provide adequate power to reduce major risks to the population
but ensure that government power is exercised proportionately and fairly. Fairness
requires just distributions of burdens and benefits to all, but also procedural due
process for people subjected to compulsory interventions.
Certainly, the justice perspective cannot answer many of the most perplexing
problems at the intersection of public health and civil liberties such as paternalistic
interventions (for example, seat belt laws) or the exercise of powers in health emergencies (for example, avian flu or bioterrorism). However, a more serious failure of
public policy would be a failure to recognize and give great weight to the demands of
social justice when faced with such challenges. . . .
The Policy Imp eratives of the Justice Perspective
The public health community has not been successful in gaining attention to or
resources for its core mission and essential services. [Public health efforts directed
at prevention and population-based services are chronically underfunded, and
resources are frequently allocated only in response to a disaster or threat, rather
than in response to long-term needs.] This leads not to core, stable funding and
attention but, rather, to a disease du jour mentality. This type of response creates
silos, disproportionately funds biomedical solutions, and poses a no-win situation
for public health agencies, which must respond to the latest fashion but seldom gain
the kind of ongoing political attention and economic resources they need to improve
the publics health.
The justice perspective offers an opportunity to change this dynamic, and the
remainder of this Commentary offers concrete proposals based on the imperatives
of population improvement and just distribution of benefits.
The Public Health System
Justice, with its concern for human well-being, requires a serious commitment to
the publics health. It is for that reason that justice demands a tangible, long-term
pledge to the publics health and the needs of the least well-off. Such a commitment,
as countless reports have made clear, is lacking. Funding for prevention and population-based services is inordinately low, and categorical funding for special programs
such as bioterrorism and avian flu is limited to a single issue and is time restricted.
. . . There must be a substantial and stable commitment to the publics health at
the federal, state, and local levels. . . . Congress and the executive branch should
create a Trust Fund for Public Health to provide generous and stable resources to
rebuild the eroded public health infrastructure and implement core public health
functions.
Addressing Health Determinants
If justice is outcome oriented, then inevitably public health must deal with the underlying causes of poor and good health. The key health determinants include the built
environment (e.g., transportation and buildings); the natural environment (e.g., clean
air and water); the informational environment (e.g., health information and advertising restrictions); the social environment (e.g., social networks and support); and
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The Publics Health 49
the economic environment (e.g., socioeconomic status). These are all public health
problems, but they are not solvable solely by public health agencies. Public health
researchers and agencies can provide the intellectual tools for understanding the
factual basis of the problems policymakers face. They can act directly and as conveners that mobilize and coordinate government agencies, health care institutions,
businesses, the media, academia, and the community.
Fair Treatment of the Disadvantaged
Fair distribution of burdens and benefits, as discussed, is a core attribute of justice.
Allocations based on the market or political influence favor the rich, powerful, and
socially connected. Even neutral or random allocations can be unjust because they
do not benefit those with greatest need. For example, health officials who direct a
population to evacuate or shelter in place should foresee that the poor will not have
private transportation or the means to stock up on food or supplies. For that reason,
justice requires public health officials to devise plans and programs with particular
attention to the disadvantaged. . . .
. . . Social justice thus demands more than fair distribution of resources in
extreme health emergencies. A failure to act expeditiously and with equal concern
for all citizens, including the poor and less powerful, predictably harms the whole
community by eroding public trust and undermining social cohesion. It signals to
those affected and to everyone else that the basic human needs of some matter less
than those of others, and it thereby fails to show the respect due to all members of
the community. Social justice thus encompasses not only a core commitment to a
fair distribution of resources, but it also calls for policies of action that are consistent with the preservation of human dignity and the showing of equal respect for the
interests of all members of the community. . . .
A Policy Landscape Informed by Social Justice
What would the policy landscape look like if it were informed by a robust conception
of social justice? The political community would embrace, rather than condemn, a
wide scope for the public health enterprise; value the public good as much as personal and economic liberty; [and] view the public good as involving a commitment to
the health and equal worth of all members of the community. . . .
The central claim of this Commentary is that a commitment to social justice lies
at the heart of public health. This commitment is to the advancement of human
well-being. It aims to lift up the systematically disadvantaged and in so doing further
advance the common good by showing equal respect to all individuals and groups
who make up the community. Justice in public health is purposeful, positivistic, and
humanistic. The aims of public health deserve a great deal more societal attention
and resources than the political community has allowed.
IV. The Public Health System
Our modern understanding of public health entails a more nuanced
and coherent understanding of the causes of ill health that encompasses
socioeconomic factors as well as the environmental, behavioral, and
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50 Foundations of Public Health Law and Ethics
microbial causes of disease. The evolution from a focus on infectious
diseases to todays more expansive approach to public health has
occurred largely over the past few decades. In 1988, the Institute of
Medicine (IOM) released its groundbreaking report, the Future of
Public Health, which defined public health as the obligation of organized society to assure people of the conditions to be healthy. In the
sequel published in 2003, The Future of the Publics Health, the IOM
expounded on this understanding and proposed bold and innovative
strategies for health promotion and prevention.
The public health vision articulated by the IOM involves (1) strengthening the governmental public health infrastructure, (2) encouraging
major private-sector actors to promote the health of their members and
surrounding communities, and (3) improving the broad determinants
of population health. This vision pits those advocating on behalf of an
expansive public health philosophy grounded in fundamental socioeconomic and cultural transformation against critics in and outside of
the public health community who charge that such an ethos moves far
beyond public healths conventionally understood purview. In the following paper, Jo Ivey Boufford, Rose Marie Martinez, and I defend the
IOM committee of which we were a part, while proposing strategies
for achieving an expansive construct of the public health enterprise.
The Future of the Publics Health: Vision, Values,
and Strategies*
Lawrence O. Gostin, Jo Ivey Boufford, and Rose Marie Martinez
The health of the U.S. public continuously improved throughout the twentieth century. By every measure, Americans are now healthier, live longer, and enjoy lives
that are less likely to be marked by injury, ill health, or premature death. During the
past century, for example, infant mortality decreased, and the average life span
rose from forty-five years to nearly eighty. Public health achievements include safer
foods, fluoridation of drinking water, control of infectious diseases, fewer deaths
from heart disease and stroke, motor vehicle safety, and safer workplaces.
The publics health still has room to improve. Although the United States has
one of the highest levels of per capita gross domestic product (GDP) in the world,
Americans health status is poor compared with the health status of populations
that have similar levels of economic development. [Among the thirty member countries of the Organisation for Economic Co-operation and Development (OECD), the
United States has the third-highest GDP, but] it ranks twenty-third in infant mortal-
*Reprinted from Health Affairs 23 (July/August 2004): 96107.
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The Publics Health 51
ity (7.1 deaths per 1,000 live births) and eighteenth in life expectancy at birth (76.7
years for both sexes). The World Health Organization (WHO) ranks the United States
thirty-seventh among global health systems, reflecting concerns about access to
and cost of health care, relatively poor health indicators, and sizable racial and
socioeconomic disparities.
The relatively poor U.S. health status is even more noteworthy because of high
U.S. health spending$4,373 per capitawhich is the highest in the world and more
than double the OEC D median of $2,000. . . .
. . . More than 95 percent of U.S. federal and state health spending is directed
toward personal health care and biomedical research; only 12 percent is directed
toward prevention. These governmental funding priorities, consistent for decades,
do not reflect scientific understandings of population health. There is strong evidence that access to medical care is a less important determinant of health than
behavior and environment, which are responsible for more than 70 percent of avoidable deaths. This history of investment skewed toward personal health care offers
a political strategy that is unlikely to achieve a maximum impact on the publics
health.
Strategies for Impr oving the Publics Health
If current policies do not ensure the highest attainable health for the U.S. population, then what strategies would be more effective? . . .
Strengthen the Governmental Public Health Infrastructure
Government has primary authority and responsibility for assuring the conditions
in which people can be healthy. Yet public health agencies are structurally weak
in each of their core components, which led the IOM to conclude that the agencies
are largely in disarray. [The CDC similarly concluded that the public health infrastructure is structurally weak in nearly every area. Structural deficiencies include
outdated statutes, a poorly prepared workforce, and inadequate facilities (e.g., information and communications systems and laboratory capacity).]
To address these weaknesses, we offer the following recommendations.
Recommendation 1: Congress should establish a national Public Health Council
(PHC). The PHC, comprising the secretary of the Department of Health and Human
Services (HHS) and state health commissioners, with representative local health
officials and outside experts, would (1) collaborate on action to achieve national
health goals as articulated in Healthy People 2010; (2) advise the HHS secretary on
financing, policy, and regulations affecting the publics health; (3) develop a funding
system to sustain the public health infrastructure; and (4) evaluate the impact of
domestic policies on national health outcomes and reductions of health disparities.
It would improve collaboration among levels of government, provide a forum for
strategic planning and monitoring progress, and elevate the status of public health
within government.
Recommendation 2: HHS should report annually to Congress on the state of
the nations health. . . . The assessment should include a systematic evaluation of
progress in meeting national health goals (for example, leading health indicators);
funding and technical assistance for public health agencies to ensure sustainability;
and identification of strengths and gaps in system capacity. Such assessments are
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52 Foundations of Public Health Law and Ethics
needed to keep Congress and the public informed and would play an important role
in policy development.
Recommendation 3: Congress should establish a stable funding mechanism, such
as a trust fund to support state and local public health agencies. Agencies suffer from two interrelated problems: lack of adequate funding to support ongoing
services, and inflexible sources of funds. . . . Silo or stovepipe funding [which is
earmarked for particular purposes or constituencies] cannot sustain a permanent
infrastructure and discourages evidence-based planning, policies, and programs. . . .
Recommendation 4: Congress should set conditions for receipt of funds based on
states progress toward and adherence to quality standards. HHS, through the PHC,
should establish national standards of quality and hold states accountable for meeting them. . . . If agencies are charged with improving the publics health and receive
adequate funding, they should be held accountable under these quality standards.
Engage Nongovernmental Actors in Partnerships for Public Health
Although the duty to safeguard the publics health has been assigned historically to
government, through the work of national, state, tribal, and local health agencies, no
single agency can assure all of the conditions for the publics health. Public health
agencies can act as a catalyst for action by other government departments and
nongovernmental actors. . . .
[On this point,] we propose the following governmental programs and incentives.
Recommendation 5: The federal government should lead a national effort to
achieve stable health care coverage for every person residing in the United States.
This coverage should include age-appropriate preventive services and oral health,
mental health, and substance abuse treatment. The uninsured have difficulty getting
care, and the services they receive may not be timely, appropriate, or well coordinated. Insurance coverage is associated with better health outcomes for children
and adults.
Recommendation 6: Federal and state governments should support communityled public health efforts. Community organizations are close to the populations they
serve and therefore are a crucial part of the public health system. Public health
agencies should provide adequate funding and technical assistance to, and engage
in partnerships with, communities. . . .
Recommendation 7: Public health agencies should create incentives for (and, if
necessary, regulate) businesses to strengthen health promotion and disease and
injury prevention for their employees and communities. Government should provide
incentives through the tax code and conditional spending to encourage the private
sector to engage in health-promoting activities. [Furthermore,] the state must
strengthen regulations relating to occupational health and safety, sanitary food and
living conditions, and the environment, among other areas.
Recommendation 8: The media should increase the time devoted to public service announcements and contribute to a well-informed public on matters of health.
An ongoing dialogue and collaborative efforts between public health agencies and
the media would benefit the publics health. . . .
Recommendation 9: Academic institutions should increase interdisciplinary
learning opportunities for public health students, strengthen and expand their training of the current public health workforce, and reward faculty for both basic and
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The Publics Health 53
applied public health research. Academe is critically important in the education and
training of the public health workforce and in providing a science base for public
health policy. . . .
Improve the Multiple Conditions for the Publics Health
. . . To achieve population health, it is necessary to transform national health policy,
with its traditional dominant investments in personal health care and biomedical
research to treat disease after it happens, to a more balanced policy that invests in
the multiple determinants of societal health. . . .
Perhaps the two farthest-reaching, and therefore most controversial, determinants of health relate to the built and socioeconomic environments. Public health
has a long history of designing the built environment to reduce injury (workplace
safety, traffic calming, and fire codes), infectious diseases (sanitation, zoning, and
housing codes), and environmentally associated harms (lead paint, asbestos, and
toxic emissions). The United States is facing an epidemiological transition from
infectious to chronic diseases such as cardiovascular disease, cancer, diabetes,
asthma, and depression. The challenge is to enable communities to facilitate physical and mental well-being. . . .
A strong and consistent finding of epidemiological research is that socioeconomic status (SES) is correlated with morbidity, mortality, and functioning. SES is a
complex phenomenon based on income, education, and occupation. The relationship
between SES and health often is referred to as a gradient because of the graded
and continuous nature of the association. . . .
Some researchers go further, suggesting that the overall level of socioeconomic
inequality in a society affects health. That is, societies with large disparities between
the rich and poor tend to have inferior health status. The validity of these studies
has been challenged recently. However, some claim that from an ethical perspective,
social justice is good for our health. Government can take active steps to improve
the built and socioeconomic environments in several ways.
Recommendation 10: State and local governments should engage in land-use
planning to encourage healthier lifestyles and habitats. [Strategies include] economic incentives to encourage green spaces and recreational facilities; building and
housing codes to reduce toxic exposures; zoning to increase availability of wholesome foods and products; and school requirements to serve healthy foods and promote exercise among students. . . .
Recommendation 11: The federal government and the states should adopt more
comprehensive strategies to reduce health disparities. Health policymakers have
documented major health disparities within the population and have set a goal of
reducing them. . . . Disparities can be reduced through targeted public health interventions to serve . . . populations [with the greatest need, including the poor and
racial minorities, and through] general improvements in access to essential services
such as income support, education, and health care.
Justifications for an Expanded Vision of Public Health
Critics have argued powerfully against the foregoing proposals for achieving a
healthier population. In this section we respond to these challenges, recognizing
that the questions posed are incisive and deserve careful scrutiny.
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54 Foundations of Public Health Law and Ethics
Why should health be a primary social undertaking? [Although other priorities,
such as transportation, energy, education and national security, compete with
health] there are good reasons to give special attention to health. . . .
. . . If individuals have physical and mental health, they are better able to socialize, work, and engage in the activities of family and social life that bring meaning and
happiness. . . . Health is also essential for the functioning of populations. Without
minimum levels of health, people cannot fully engage in social interactions, participate in the political process, exercise rights of citizenship, generate wealth, create
art, and provide for the common security. Notably, evidence is emerging that direct
investments in health can have positive effects on the economy. A safe and healthy
population builds strong roots for a countryits governmental structures, social
organizations, cultural endowment, economic prosperity, and national defense.
Understood in this way, then, population health becomes a transcendent value.
Are fundamental changes in physical [and social] conditions warranted? Critics
argue that public health agencies overreach and lose their legitimacy when they
address the broad determinants of health. There are . . . political dangers in straying
too far from what many consider public healths traditional mandate [but] addressing the broad determinants of health leads to more effective social policy. . . . As the
main proponent of population health in society, the public health community must
call attention to the upstream causes of morbidity and premature death and must
propose a broad range of social, economic, and behavioral tools needed to make
populations healthier.
[Though critics may challenge evidence of an SES gradient, the fact that the
causal pathways between low SES and poor health are not fully understood should
not doom public health to waiting for definitive research before helping the poor.
Critics also challenge the appropriateness of efforts to modify the built environment
in healthful ways, characterizing efforts as coercive and moralistic. But the government has been and is actively involved in land-use planning; therefore, it has an]
obligation to carefully consider the populations health in its land-use policies.
Assuring the Publics Health: Future Challenges
We are acutely aware that key obstacles await the strategies we have enumerated.
Achieving a highly functioning governmental public health system is difficult; the
necessary tasks are technically within our reach but require political will. There are
many reasons to question the political commitment to population healtha history
of underinvestment, silo funding, and a culture of individualism. In matters of funding, standard setting, and accountability, federalism poses another problem. Which
governmentfederal, tribal, state, or localholds the power and duty to devote
resources and create policy?
The challenges to achieving effective partnerships in public health are equally
apparent. The private and voluntary sectors possess no duty to act for the public
good, and there is little political consensus about creating incentives and requirements to do so. The governments role vis–vis the private sector has always been
controversial. Those who support limited government and a broad sphere of economic freedom may oppose partnerships that go beyond the purely voluntary, but
the potential value of closer cooperation is becoming more clear.
Finally, and self-evidently, there are deep challenges in creating policy to improve
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The Publics Health 55
the socioeconomic conditions of health. Socioeconomic determinants evoke images
of redistribution of wealth and status, which are unpopular in many circles. However,
this is not merely a question of ideology but one of science. The task will be to demonstrate an evidence-based way to reduce socioeconomic disparities and to show
that this improves health outcomes.
Given these challenges, we understand that our aspirations for healthy people
in healthy communities need to compete in the marketplace of ideas. Yet we think
that population health does deserve a special place in national debates and priorities, and it has taken a backseat to other political interests for too long.
V. Conclusion
The field of public health, as we have seen, is deeply complex, riddled
with contradictions, and influenced by politics, culture, and economics, and it has undergone profound developments over the past few
decades. Practitioners and scholars have cultivated a common understanding of core concepts in public health, the contours of which are
being delineated through experience and scholarly debate. Likewise,
the practice of public health has improved; workers in this field are
beginning to develop a sense of professionalism, expertise, and competency comparable to that of practitioners of older disciplines such as
medicine.
The field of public health has struggled through the years to gain
attention, respect, and adequate resources. In the aftermath of recent
natural and human-caused tragedies, however, public health has
become more visible. The terrorist attacks of 9/11 and subsequent
anthrax letters have driven momentous changes in public health policy.
The United States and the rest of the world have witnessed the devastation wrought by natural disasters, such as the South Asian tsunami
and the Gulf Coast hurricanes. Global society also faces the threat
of the catastrophic health consequences of an emerging infectious
disease, such as smallpox, severe acute respiratory syndrome (SARS ),
or pandemic influenzawhether naturally occurring or intentionally
inflicted.
Consequently, policy makers have been preoccupied by the perceived
need for preparedness for public health emergencies, including stockpiles of vaccines and pharmaceuticals and surge capacity for hospital
beds and equipment. Emergency public health preparedness funding
purportedly allows for dual use, meaning that funds can also go
toward strengthening the public health infrastructure and basic public
health activities (e.g., routine surveillance and prevention activities).
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56 Foundations of Public Health Law and Ethics
Improved visibility and funding constitute only one edge of the doubleedged sword of public health preparedness, however. Preparedness
activities have also created special programs and silos that divert
attention from traditional public health services.
But when one steps back from the day-to-day struggles for funding
and attention, it is apparent that the field of public health holds great
promise for the future. No endeavor is more important than promoting
health and preventing injury and disease among the population. As the
field improves its scientific methods for measuring effectiveness and
as it demonstrates its importance, public health will gain the political
attention and resources it deserves.
Recommended Readings
Community and Civic Participation
Beauchamp, Dan. 1988. The Health of the Republic: Epidemics, Medicine,
and Moralism as Challenges to Democracy. Philadelphia: Temple Univ.
Press. (Provides an expanded vision of republican equality and further
develops his community-oriented perspective on health)
Pearce, Neil, and George Davey Smith. 2003. Is social capital the key to
inequalities in health? American Journal of Public Health 93: 12229.
(Questions some of Putnams conclusions, arguing that social capital has a
marginal impact on health as compared to macro-level economic and social
policies and that overemphasizing the role of social capital produces ineffective or potentially harmful policies)
Putnam, Robert D. 2000. Health and happiness. In Bowling Alone: The Collapse and Revival of American Community, 32635. New York: Simon &
Schuster. (Asserts that social connectedness is itself a determinant of health)
Social Justice: Socioeconomic Inequalities
Daniels, Norman. 2006. Equity and population health: Toward a broader bioethics agenda. Hastings Center Report 36 (4): 2235. (Argues that bioethics traditionally narrow focus on clinical relationships and new technologies should be broadened to address population health, health disparities,
and issues of justice)
Deaton, Angus. 2002. Policy implications of the gradient of health and wealth.
Health Affairs 21 (2): 1330. (Explains the deep, persistent, and cross-cultural relationship between socioeconomic status and health outcomes,
which he terms the gradient of health and wealth)
Lynch, John, George Davey Smith, Sam Harper, Marianne Hillemeier, Nancy
Ross, George A. Kaplan, and Michael Wolfson. 2004. Is income inequality
a determinant of population health? Part 1: A systematic review. Milbank
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The Publics Health 57
Quarterly 82: 595. (Casts doubt on the assertion that societies where
income is distributed on a more equal basis are necessarily healthier)
Powers, Madison, and Ruth Faden. 2006. Social Justice: The Moral Foundations of Public Health and Health Policy. New York: Oxford Univ. Press.
(Outlines a theory of social justice focused on the nondistributive aspects of
well-being and applies it to public health)
The Public Health System
Institute of Medicine. 2003. The Future of the Publics Health in the 21st Century. Washington, DC: National Academies Press. (Articulates a broad and
ambitious vision for public health that is centered on strengthening government public health infrastructure, coordinating the activities of various
state and nonstate actors, and addressing the multiple determinants of
health)
Rothstein, Mark A. 2002. Rethinking the meaning of public health. Journal of
Law, Medicine & Ethics 30: 14449. (Argues for a narrower understanding
of public healths scope that is focused on government officials providing
traditional public health services)
Weeks, Elizabeth. 2006. After the catastrophe: Disaster relief for hospitals.
North Carolina Law Review 85: 223300. (Provides an evaluation of the
public health infrastructure supplied by hospitals in times of disaster, with a
specific focus on the Gulf Coast hurricanes)
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Photo 4. The Cuyahoga River in flames on November 3, 1952. The Cleveland,
Ohio, river caught fire several times during the twentieth century when oil
and other contaminants on the waters surface ignited. The 1969 river fire
prompted outrage nationwide and galvanized the environmental movement.
Today, the Environmental Protection Agency regulates the risks posed by
environmental contaminants like those responsible for the Cuyahoga fires.
Photograph courtesy of James Thomas.
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59
The field of public health ethics applies principles and values to evaluate
the justifiability of public health actions. A central question posed is,
What are the appropriate limits on the states power when its exercise
to safeguard the publics health and safety interferes with individual
interests? In answering this question, ethicists take account of the
personal and economic interests of individuals, as well as the collective
benefits to the population of improved health and safety. This ethical
analysis of public health interventions does not dictate policy choices;
rather, it enables public health ethicists to identify a range of ethically
appropriate actions to promote health and prevent diseases. It is then
up to democratically elected officials to choose among ethically viable
alternatives for public health action.
The field should not be understood as providing the right answer,
because public health practice is far too complex to be amenable to simple
solutions. The principles and values that ethicists use, moreover, are often
in tension. It is not unusual for ethicists to arrive at differing conclusions on the same question, at least in part because ethicists may differ
in the values they emphasize. Consequently, public health ethics should
be understood more as a helpful methodology for examining difficult
problems in public health than as a means of finding ideal solutions.
The companion text to this volume discusses three general ethical justifications for coercive public health interventions: risk to others, protection of incompetent persons, and risk to self. The first justificationthe
harm principleholds that the state may prevent harm to others or
Two
Public Health Ethics
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60 Foundations of Public Health Law and Ethics
punish individuals for inflicting such harm. The second justificationthe
best interests of the individualholds that the state may protect the
health and safety of those individuals, such as children or persons with
mental disabilities, who are incapable of safeguarding their own interests. These two justifications are widely accepted by ethicists. However,
the third justificationpaternalismis deeply controversial. Paternalism
is the interference with a persons liberty of action justified by reasons
referring exclusively to the welfare, good, happiness, needs, interests, or
values of the person being coerced (Dworkin 2008, 281). Paternalistic
interventions are those designed solely or primarily to protect a competent persons own health and safety, irrespective of her wishes. They typically regulate self-regarding behaviorsthose behaviors that only, or
primarily, endanger the health of the actor (e.g., not wearing a seat belt).
The extent to which the government should compel a competent
person to refrain from self-regarding behaviors is far from settled. On
the one hand, self-destructive behaviors (e.g., high-fat diets, sedentary
lifestyles, and smoking) pose a heavy burden of disease and early death
in the population. Should public health officials intervene to prevent
individuals from engaging in such behaviors even when there is no
harm posed to others? If doing so is off-limits, then public health officials miss an important opportunity to prevent injuries and diseases,
especially among the vulnerable populations that disproportionately
bear the burden of such injuries and diseases. Further, by intruding
a little on a persons autonomy now, a health-promoting intervention
may provide much greater autonomy later by enabling that person to
avoid the constraints on choice that diseases cause (Gostin and Gostin
2009). On the other hand, individuals are supposed to have the freedom to make their own choices. If they make an unhealthy choice,
whose responsibility is ittheirs or the states?
The companion text to this reader discusses five ethical criteria
for systematically evaluating government regulation. The first step is
determining whether the risk is sufficiently significant to warrant state
action. To do so, one must assess the nature of the risk (the hazard
faced), the duration of the risk (when the risk will diminish or end), the
probability of harm (the likelihood of the event), and the severity of the
harm (the degree of injury to individuals and populations). The second
step focuses on whether the proposed regulation is likely to be effective
in preventing or ameliorating the harm. If the intervention is unlikely
to succeed, it is usually not worth undertaking.
Third, the cost of the intervention should be evaluated. Public health
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Public Health Ethics 61
regulations impose economic costsresources of agencies to devise
and implement policies, costs to individuals and businesses subject to
regulation, and lost opportunities to intervene with a different measure
that might be more effective. Fourth, it is important to consider the
burden that the regulation will place on individuals. State interventions
can infringe on a variety of individual interests, including bodily integrity, privacy, freedom of expression, freedom of association, freedom of
religion, and liberty of person. The final step is to determine whether
the policy is fair. That is, does the policy demonstrate equal respect for
all persons and fairly allocate benefits, burdens, and costs? These five
ethical criteria for evaluating public health regulations are not a means
of correctly determining whether a particular regulation should be
implemented, but they do provide a structured method for assessing the
appropriateness of coercive state action.
This chapter provides an overview of public health ethics, in three
parts. It begins with the evolution from bioethics to public health
ethics, moves to the most controversial aspect of public health ethics
(paternalism), and concludes with the subject of risk regulation.
I. From Bioethics to Public Health Ethics
When thinking about the most appropriate principles and values for
evaluating public health actions, it is useful to start with perhaps the
most famous articulation of bioethical principles, the 1978 Belmont
Report of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. Although this report
is geared principally to the ethics of human subjects research, its explanation of three basic principlesrespect for persons, beneficence, and
justicehas been highly influential in the broader field of bioethics.
The Belmont Report: Ethical Principles and Guidelines for
the Protection of Human Subjects of Research*
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
Three basic [ethical] principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects:
the principles of respect of persons, beneficence, and justice.
*Federal Register 44 (April 18, 1979): 2319297.
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62 Foundations of Public Health Law and Ethics
1. Respect for Persons
Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with
diminished autonomy are entitled to protection. The principle of respect for persons
thus divides into two separate moral requirements: the requirement to acknowledge
autonomy and the requirement to protect those with diminished autonomy.
An autonomous person is an individual capable of deliberation about personal
goals and of acting under the direction of such deliberation. To respect autonomy
is to give weight to autonomous persons considered opinions and choices while
refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that persons
considered judgments, to deny an individual the freedom to act on those considered
judgments, or to withhold information necessary to make a considered judgment,
when there are no compelling reasons to do so.
However, not every human being is capable of self-determination. The capacity
for self-determination matures during an individuals life, and some individuals lose
this capacity wholly or in part because of illness, mental disability, or circumstances
that severely restrict liberty. Respect for the immature and the incapacitated may
require protecting them as they mature or while they are incapacitated.
. . . The extent of protection afforded should depend upon the risk of harm and
the likelihood of benefit. The judgment that any individual lacks autonomy should be
periodically reevaluated and will vary in different situations.
In most cases of research involving human subjects, respect for persons de –
mands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The
involvement of prisoners as subjects of research provides an instructive example.
On the one hand, it would seem that the principle of respect for persons requires
that prisoners not be deprived of the opportunity to volunteer for research. On the
other hand, under prison conditions they may be subtly coerced or unduly influenced
to engage in research activities for which they would not otherwise volunteer. . . .
Whether to allow prisoners to volunteer or to protect them presents a dilemma.
Respecting persons, in most hard cases, is often a matter of balancing competing
claims urged by the principle of respect itself.
2. Beneficence
Persons are [also] treated in an ethical manner . . . by making efforts to secure their
well-being. . . . The term beneficence is often understood to cover acts of kindness
or charity, [but here] beneficence is understood in a stronger sense, as an obligation.
Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and
minimize possible harms.
. . . Claude Bernard extended [the Hippocratic maxim do no harm] to the realm
of research, saying that one should not injure one person regardless of the benefits
that might come to others. However, even avoiding harm requires learning what is
harmful; and . . . learning what will in fact benefit may require exposing persons to
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Public Health Ethics 63
risk. The problem posed by these imperatives is to decide when it is justifiable to
seek certain benefits despite the risks involved, and when the benefits should be
forgone because of the risks. . . .
The principle of beneficence often occupies a well-defined justifying role in many
areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy
development are benefits that serve to justify research involving childreneven
when individual research subjects are not direct beneficiaries. . . . But the role of the
principle of beneficence is not always so unambiguous. A difficult ethical problem
remains, for example, about research that presents more than minimal risk without
immediate prospect of direct benefit to the children involved. . . . Here again, as with
all hard cases, the different claims covered by the principle of beneficence may come
into conflict and force difficult choices.
3. Justice
Who ought to receive the benefits of research and bear its burdens? . . . An injustice occurs when some benefit to which a person is entitled is denied without good
reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement
requires explication. . . . Almost all commentators allow that distinctions based on
experience, age, deprivation, competence, merit, and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary,
then, to explain in what respects people should be treated equally. There are several
widely accepted formulations of just ways to distribute burdens and benefits. Each
formulation mentions some relevant property on the basis of which burdens and
benefits should be distributed. These formulations are (1) to each person an equal
share, (2) to each person according to individual need, (3) to each person according
to individual effort, (4) to each person according to societal contribution, and (5) to
each person according to merit.
. . . During the 19th and early 20th centuries the burdens of serving as research
subjects fell largely upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients. Subsequently, the exploitation of unwilling
prisoners as research subjects in Nazi concentration camps was condemned as a
particularly flagrant injustice. In this country, in the 1940s, the Tuskegee syphilis
study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived
of demonstrably effective treatment in order not to interrupt the project, long after
such treatment became generally available. [See box 1.]
Against this historical background, it can be seen how conceptions of justice are
relevant to research involving human subjects. For example, the selection of research
subjects needs to be scrutinized in order to determine whether some classes . . . are
being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related
to the problem being studied. Finally, whenever research supported by public funds
leads to the development of therapeutic devices and procedures, justice demands
both that these not provide advantages only to those who can afford them and that
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64 Foundations of Public Health Law and Ethics
such research should not unduly involve persons from groups unlikely to be among
the beneficiaries of subsequent applications of the research.

One of the central debates in the field of public health ethics is whether
the bioethical principles enunciated in the Belmont Report are sufficient
for assessing population-based interventions. It may be that these principles can be adapted to the needs of public health interventions by focusing on publicinstead of individualwell-being. Alternatively, bioethical
principles may overly constrain public health activities because they stress
individual autonomy at the expense of a more communitarian view of
the public good. As the bioethicist and prominent political philosopher
Onora ONeill (2004, 1135) notes, road safety, food safety, water safety,
safe medicines and measures that protect against infection cannot be tailored to individual choice, making an individualistic, autonomy-centered
Box 1
Tuskegee: Race, research, and bioethics
The Belmont Report was published seven years after accounts of the infamous Tuskegee syphilis study appeared on the front pages of national
newspapers in July 1972. The study, which was begun in 1932, was framed
as a study in nature that focused on observing the course of untreated
syphilis. The test subjects (all African American men living in Macon, Alabama) were denied standard medical treatments throughout the study
even after penicillin became widely available in the 1940s. In fact, as Allan
M. Brandt, a professor of the history of medicine, details, the doctors devising and directing the study recruited subjects under the guise of providing
care. They provided ineffectual ointments and characterized diagnostic
tests (including painful and risky spinal taps) as treatment. In order to
ensure that accepted medical therapies would not interfere with the study,
the doctors prevented test subjects from receiving treatment from other
sourcesincluding local doctors, the Alabama Health Department, and the
U.S. Army. Brandt (1978, 23) describes the essentially racist nature of the
study: The premise that blacks, promiscuous and lustful, would not seek or
continue treatment, shaped the study. A test of untreated syphilis seemed
natural because the [U.S. Public Health Service] presumed the men would
never be treated; the Tuskegee Study made that a self-fulfilling prophecy.
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Public Health Ethics 65
ethic less applicable in public health. Other ethical traditions that focus
on values of community, solidarity, and the needs of the collective provide
a useful counterbalance to the more individualistic bioethical principles.
Many notable scholars are now writing on the subject of public health
ethics (e.g., Bayer, Gostin, et al. 2007; Dawson and Verweij 2007; Kass
2001, 2004; Bradley and Burls 2000; Coughlin and Beauchamp 1996),
but I have chosen three contributions. First, Ronald Bayer and Amy L.
Fairchild offer a historical account of public health ethics origins and
evolution. They start with the autonomy-centered values of bioethics
(in the beginning there was bioethics) and then trace more modern
efforts to articulate an ethics of public health.
In the second excerpt, James F. Childress and colleagues provide an
overview of the basic principles of and tensions in public health ethics,
identifying and weighing general moral considerations in public health:
benefits, harms, utility, justice, autonomy, privacy, honesty, transparency, and trust. Like Bayer and Fairchild, Childress and colleagues
struggle with how and to what extent individual autonomy should be
integrated into public health ethics. They, too, are also interested in
teasing out a rubric for determining whether paternalistic interventions
are ethically justified in particular cases.
In the last excerpt of this section, Daniel Callahan and Bruce Jennings
helpfully examine the scope of public health ethics, which they claim is
as broad as public health itselfcovering activities ranging from health
promotion and disease prevention to the amelioration of socioeconomic
disparities. In the process, they draw attention to the correspondingly
wide-ranging methods of ethical analysis that are applicable to the
practice of public health. Public health ethics continue today to rapidly
evolve and develop. Greater engagement of public health practitioners,
scholars, and students in ethical discourse will enrich the field and the
ongoing political, academic, popular, and professional debates concerning the proper scope of public health and the appropriateness of government interventions to protect communal well-being.
The Genesis of Public Health Ethics*
Ronald Bayer and Amy L. Fairchild
In the beginning there was bioethics. The 1960s and 1970s witnessed extraordinary
challenges to the broadly understood authority of medicine. Perhaps most strik-
*Reprinted from Bioethics 18, no. 6 (2004): 47392.
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66 Foundations of Public Health Law and Ethics
ingly, the paternalistic authority of physicians was brought into question by a new
medical ethics that gave pride of place to the concept of autonomy. Paralleling the
challenges to medical practice were those that involved the research enterprise.
Against a backdrop of scandal and abuse, . . . a new ethics of research took hold. . . .
The ethics of clinical research and the ethics of medical practice were conjoined by
a commitment to autonomy and individual rights.
Remarkably, as bioethics emerged and began to have enormous impacts on the
practice of medicine and research . . . little attention was given to the question of the
ethics of public health. This was all the more striking since the core values and practices of public health, often entailing the subordination of the individual for the common good, seemed to stand as a rebuke to the ideological impulses of bioethics. . . .
Of what relevance is autonomy-focused bioethics for public health, with its mix
of justifications including those that are either implicitly or explicitly paternalistic
or that seek to impose strictures on individuals and communities in the name of
collective welfare? To examine the deep divide between the central commitments
of bioethics and the values that animate the practice of public health, we focus on a
series of controversies implicating the concepts of privacy, liberty, and paternalism.
First Encounters: Epidemiological Research and the Limits of Consent
. . . Beginning in the 1970s, a discussion began about whether the emerging rules and
regulations for human subjects research would apply to epidemiological studies.
Was informed consent necessary when research involved the use of extant records?
Would imposing consent requirements for the examination of data sets involving large numbers of people . . . render epidemiological research virtually impossible? . . . In 1981, . . . regulations for the protection of human subjects explicitly
exempt[ed] epidemiological research involving already existing data from informed
consent requirements provided the risk to subjects was minimal, the research did
not record data in a way that was individually identifiable, and the research could
not otherwise be conducted. The concession represented a relaxation of the fundamental principle that individuals could not be conscripted into research without
their consent. . . .
AIDS, Public Health, and Ethics
. . . It is not surprising that when those schooled in bioethics first sought to address
the ethical challenges posed by AIDS, they did so guided by the principles and values
that had shaped the confrontation with medicine and the research enterprise. Their
efforts were informed by the intense concern of gay men about threats to privacy
and civil liberties advocates fearful that AIDS would provide the occasion for the
erosion of a set of substantive and procedural constitutional rights forged by the US
Supreme Court. . . .
. . . In lieu of the compulsory tradition [for controlling epidemics] that often
involved mandatory case reporting by name, contact investigation, and where necessary the use of isolation, an exceptionalist perspective took hold. Focused on
the centrality of education for mass behavioural change, the protection of the rights
and privacy of people infected with HIV, and a rejection of coercive measures, the
approach to AIDS was voluntarist at its core. A simple dictum emerged: no public
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Public Health Ethics 67
health policy that violated the rights of individuals could be effective in controlling
the spread of HIV. There was, therefore, no tension between public health and civil
liberties. Indeed, the protection of civil liberties was critical to the public health. . . .
Surveillance and the Limits of Privacy
Since the end of the nineteenth century, surveillance has served as a critical element
in the practice of public health. Central to the effort to monitor and intervene in the
face of threats to the public health, surveillance has imposed on healthcare institutions and especially physicians the duty to report cases to confidential registries.
Almost always such reports have included the names of the afflicted. . . .
[Soon after the first cases of AIDS were identified, state health departments
began to require that physicians report by name each newly diagnosed case. Once a
test for the HIV antibody became available, it was only a matter of time until reporting requirements were extended to HIV.] The rationale for such reporting drew
upon the history of public health: reporting would alert public health officials to the
presence of individuals infected with a lethal infection; would allow them to counsel
infected individuals about what they needed to do to prevent further transmission;
would permit the authorities to monitor the incidence and prevalence of infection.
Alert to concerns about privacy and confidentiality, health officials underscored
the existence of administrative, regulatory, and statutory protections for reported
names. . . .
To these propositions, gay community-based antagonists to name-based reporting and civil liberties advocates retorted that AIDS was different: social hostility and
AIDS-related hysteria could lead to changes in policy, legislatively imposed, that
would permit breaches that would never occur with other conditions. And then those
in registries would lose their jobs, their housing, and perhaps their liberty. . . . Many
health officials in states with relatively large AIDS caseloads [came to believe that
reporting] would be counterproductive; it would drive people away from testing and
counseling. . . . It did not matter that public health departments had an exemplary
record in protecting name-based reports. If those most at risk for HIV had fears
about what would happen to them, then that was all that mattered. . . .
The debates that occurred over name-based reporting in the context of the AIDS
epidemic would inevitably raise questions about the practice of surveillance itself as
advocates of privacy, to the astonishment of public health practitioners, suggested
that the warrant for the violation of privacy in the early twentieth century no longer
deserved unquestioned obeisance.
Confinement and the Limits of Liberty
Isolation and quarantine represent the most plenary exercise of the states authority
in the name of public health. Historically, the imposition of isolation and quarantines
to control infectious threats was bounded by few procedural protections. The rights
of the individual were viewed as subservient to the judgements of those with public
health authority. As the pattern of morbidity and mortality underwent an epidemiological transformation in the twentieth century, as chronic conditions replaced
infectious diseases as the pre-eminent threat, the role of quarantine and isolation
became marginal to the practice of public health in the United States. . . .
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68 Foundations of Public Health Law and Ethics
[During the 2002 outbreak of severe acute respiratory syndrome (SARS), however, countries relied on these ancient public health toolsisolation and quarantine
to contain the epidemic.] Confinement of individuals with disease and those exposed
raised questions about the level of risk that justified loss of liberty. . . . Uncertainty
about how wide to cast the net of quarantine for exposed, asymptomatic individuals was framed by the absence of a diagnostic assay that could rapidly distinguish
between the infected and merely exposed with high specificity. But very broad quarantines were viewed as justifiable because of the uncertainties of risk. . . .
In the fall of 2003, as the international community braced for the possibility of
a resurgence of SARS, it became clear that the isolation procedures used during
the initial outbreak had been far too stringent. . . . The [Centers for Disease Control
and Prevention (CDC) responded by elaborating] a finer range of surveillance and
quarantine recommendations. . . .
Paternalism and the Limits of Autonomy
For government to impose restrictions on those who represent a risk to others falls
clearly within the broadly accepted exercise of state power in liberal societies and in
principle entails no fundamental problem for the autonomy-focused perspective of
bioethics. Problems emerge where the risk to others is uncertain. It is here that an
important divide emerges between the judgements of those committed to autonomy
and those whose first priority is the public health. It is a divide characterised by
complex questions of what moral weight to give to the likelihood and severity of
harm. However these matters are resolved, they raise issues that are fundamentally different from those posed by behaviours that represent primarily a threat to
individuals themselves. It is here that the spectre of paternalism emerges, and that
the tension between public health perspectives and autonomy-focused bioethics is
positioned in its boldest relief.
Tobacco consumption . . . serves as an object lesson in the ways in which the
antagonism towards paternalism has both shaped and limited public health policy.
Three broad sets of policies were adopted to confront the challenge posed by
tobacco [from the 1960s through the turn of the century]: restrictions on advertising; the imposition of taxes; and limits on public smoking. In each case, a public
warrant for the measures adopted sought to demonstrate that it was third parties,
innocent victims, or children that were the object of protective measures. Only insofar as warnings about tobacco, weak as they were, were posted on cigarette packages, did public health efforts direct themselves to those who bore the full burden of
cigarette-related suffering, disease, and death. . . .
. . . By the end of the twentieth century, the willingness to embrace explicitly
paternalistic justifications for antismoking policy was becoming more evident, no
doubt facilitated by the emergence of a sharp social gradient in cigarette consumptionthose who are educated smoke less and less, those at the bottom of the social
ladder continue to smoke.
The most dramatic reflection of the willingness to embrace paternalism was to
be found in measures seeking to denormalise smoking. We typically do not think of
health promotion campaigns as paternalistic. But when they go beyond the provision
of information and systematically seek to transform the very desires and preferences of those to whom they are directed, they assume a fundamentally different
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Public Health Ethics 69
character. Indeed, the use of social marketing techniques to undercut smoking
behaviour must be viewed as paternalistic in impulse as well as practice. . . .
Toward an Ethics of Public Health
What the foregoing discussion has demonstrated is that those involved in the
practice of public health embrace a set of values that are often, if not always, in
conflict with the autonomy-centred values of those who take an individualistic and
antipaternalistic stance. But ethos is not ethics. . . . In the context of public health,
the question that needs to be addressed is whether paternalism and subordination
of the individual for the good of the commonwealth should serve as the foundation
for an ethics of public health or whether the perspective derived from the dominant autonomy-focused and antipaternalistic currents in bioethics should serve as
a point of departure for a thoroughgoing challenge to the fundamental values and
practices of public health.
We begin with the conviction that at the core of public health practice is the
charge to protect the common good, to intervene for such ends even in the face of
uncertainty. This stance may, we believe, necessitate limits on the choices of individuals on grounds of communal protection against both hazard and paternalism. . . .
[During the twentieth century, public health interventions were often justified
by invoking the harm principle. While the harm principle finds support in legal tradition and ethics, there are nonetheless limits to its application.] In recent decades,
efforts to bind the harm principle have focused on employing the least restrictive or
intrusive alternative that could protect the public health against significant risk. But
what constitutes a least restrictive/intrusive alternative and how the significance
of risk is to be judged are only in part empirical matters. . . . The tension between
autonomy and public health perspectives is reflected in all such judgements. We
believe that the standard appropriate to public health cannot be derived from the
basic assumptions of a bioethics dominated by individualism.
The case of tuberculosis makes this clear. When individuals fail to complete the
course of treatment they run the risk of reactivation and of developing multi-drug
resistant strains of mycobacterium tuberculosis. . . . When noncompliance characterises large numbers of individuals . . . there is no question but that the threat to
public health attains significance. It is therefore the collective hazard that provides
the warrant for intervention even when the threat posed by any individual may not
attain the standard of significance. This is, of course, a point suggested by Geoffrey
Rose in his now famous formulation of the ways in which small benefits to individuals
from public health interventions may produce quite significant collective goods. . . .
In the end, a focus on population-based health requires a population-based analysis and a willingness to recognise that the ethics of collective health may require far
more extensive limitations on privacy, as in the case of public health surveillance,
and on liberty, as in the case of isolation and quarantine, than would be justified from
the perspective of the autonomy-focused orientation of the dominant current in bioethics. Compulsion and, indeed, coercionso anathema to this tradition of bioethicsare central to public health. Nevertheless, it is important to recognise that while
mandatory measures and recourse to coercion may be necessary, efforts designed
to elicit the voluntary co-operation of those at risk for acquiring or transmitting
infectious diseases are preferable [from an ethical perspective] and, [as a practical
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70 Foundations of Public Health Law and Ethics
matter], may be more effective. . . . Thus, while a public health perspective will not
privilege liberty and privacy, it does not follow that it should be insensitive to the
importance of protecting individual rights.
More challenging is the question of the role of paternalism in public health. . . .
Antipaternalism has struck a powerful cord in American political culture. . . .
Animated by a broad utilitarianism that seeks to maximise communal well-being,
public health has embraced measures that go far beyond the very limited recognition of justifiable paternalism in conventional bioethical accounts.
. . . [Some defend paternalism by focusing on the protection of those whose
choices are limited by a lack of knowledge or understanding, but the] central commitment to collective well-being requires a much more robust embrace of paternalism. . . . We ought, for example, to protect motorcyclists from the hazards of unhelmeted riding not because they may impose costs on the community in the event of
accidents or because they are too young to appreciate the hazards entailed, but
because we are morally bound to prevent avoidable suffering and death.
. . . Robert Goodin (1989, 3031), a utilitarian, [offers a forthright defense of public health paternalism]: We do not leave it to the discretion of consumers, however
well informed, whether or not to drink grossly polluted water, ingest grossly contaminated foods, or inject grossly dangerous drugs. We simply prohibit such things. . . .
The justification of public health measures, in general, must be baldly paternalistic.
Their fundamental point is to promote the wellbeing of people who might otherwise
be inclined cavalierly to court certain sorts of diseases. The challenge, we believe,
for public health ethics is to define those moments when public health paternalism
is justified and to articulate a set of principles that would preserve a commitment to
the realm of free choice.
The effort to shape public health policy in liberal societies will require a forthright acknowledgement of the tensions and trade-offs that will inevitably arise when
the claims of public welfare and well-being intrude on privacy, individual choice, and
liberty. Recognising the role of moral values in decision-making was one of the signal
contributions of bioethics in its formative period. . . . [But] bioethics cannot serve as
a basis for thinking about the balances required in the defence of the publics health.
As we commence the process of shaping an ethics of public health, it is clear that
bioethics is the wrong place to start.
Public Health Ethics: Mapping the Terrain*
James F. Childress, Ruth R. Faden, Ruth D. Gaare, Lawrence O. Gostin,
Jeffrey Kahn, Richard J. Bonnie, Nancy E. Kass, Anna C. Mastroianni,
Jonathan D. Moreno, and Phillip Nieburg
Public health ethics, like the field of public health it addresses, traditionally has
focused more on practice and particular cases than on theory, with the result that
*Reprinted from Journal of Law, Medicine, & Ethics 30 (2002): 17078. (Blackwell
Publishing)
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Public Health Ethics 71
some concepts, methods, and boundaries remain largely undefined. This paper
attempts to provide a rough conceptual map of the terrain of public health ethics. . . .
General Moral Considerations
. . . The terrain of public health ethics includes a loose set of general moral considerationsclusters of moral concepts and norms that are variously called values,
principles, or rulesthat are arguably relevant to public health. . . .
. . . We can establish the relevance of a set of these considerations in part by
looking at the kinds of moral appeals that public health agents make in deliberating
about and justifying their actions as well as at debates about moral issues in public
health. The relevant general moral considerations include:
producing benefits;
avoiding, preventing, and removing harms;
producing the maximal balance of benefits over harms and other costs
(often called utility);
distributing benefits and burdens fairly (distributive justice) and ensuring
public participation, including the participation of affected parties (procedural justice);
respecting autonomous choices and actions, including liberty of action;
protecting privacy and confidentiality;
keeping promises and commitments;
disclosing information as well as speaking honestly and truthfully (often
grouped under transparency); and
building and maintaining trust.
Several of these general moral considerationsespecially benefiting others, preventing and removing harms, and utilityprovide a prima facie warrant for many
activities in pursuit of the goal of public health. It is sufficient for our purposes to
note that public health activities have their grounding in general moral considerations, and that public health identifies one major broad benefit that societies and
governments ought to pursue. The relation of public health to the whole set of general moral considerations is complex. Some general moral considerations support
[the pursuit of improved population health]; institutionalizing several others may be
a condition for or means to public health; . . . and . . . some of the same general moral
considerations may limit or constrain what may be done in pursuit of public health.
Hence, conflicts may occur among these general moral considerations.
. . . Whatever theory one embraces, the whole set of general moral considerations
roughly captures the moral content of public health ethics. It then becomes necessary to address several practical questions. First, how can we make these general
moral considerations more specific and concrete in order to guide action? Second,
how can we resolve conflicts among them? Some of the conflicts will concern how
much weight and significance to assign to the ends and effects of protecting and
promoting public health relative to the other considerations that limit and constrain
ways to pursue such outcomes. While each general moral consideration may limit
and constrain public health activities in some circumstances[,] . . . justice or fairPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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72 Foundations of Public Health Law and Ethics
ness, respect for autonomy and liberty, and privacy and confidentiality are particularly noteworthy. . . .
Specifying and Weighting General Moral Considerations
General moral considerations have two major dimensions. One is their meaning and
range or scope; the other is their weight or strength. The first determines the extent
of conflict among themif their range or scope is interpreted in certain ways, conflicts may be increased or reduced. The second dimension determines when different considerations yield to others in cases of conflict. . . .
Resolving Conflicts among General Moral Considerations
[The various general moral considerations are not absolute. Each may conflict
with another and each may have to yield in some circumstances. In such cases, it
is necessary to determine which has priority based on their relative weighting in
the particular context at issue. Five justificatory conditions can be used to assess
the relative weight of general moral considerations:] effectiveness, proportionality,
necessity, least infringement, and public justification. These conditions are intended
to help determine whether promoting public health warrants overriding such values
as individual liberty or justice in particular cases.
Effectiveness: It is essential to show that infringing one or more general moral
considerations will probably protect public health. For instance, a policy that in –
fringes one or more general moral considerations in the name of public health but
has little chance of realizing its goal is ethically unjustified.
Proportionality: It is essential to show that the probable public health benefits
outweigh the infringed general moral considerations. . . . For instance, the policy may
breach autonomy or privacy and have undesirable consequences. All of the positive
features and benefits must be balanced against the negative features and effects.
Necessity: Not all effective and proportionate policies are necessary to realize
the public health goal that is sought. The fact that a policy will infringe a general
moral consideration provides a strong moral reason to seek an alternative strategy
that is less morally troubling. . . .
Least infringement: Even when a proposed policy satisfies the first three justificatory conditions . . . public health agents should seek to minimize the infringement
of general moral considerations. For instance, when a policy infringes autonomy,
public health agents should seek the least restrictive alternative; when it infringes
privacy, they should seek the least intrusive alternative; and when it infringes confidentiality, they should disclose only the amount and kind of information needed, and
only to those necessary, to realize the goal. . . .
Public justification: When public health agents believe that one of their actions,
practices, or policies infringes one or more general moral considerations, they also
have a responsibility . . . to explain and justify that infringement . . . to the relevant
parties, including those affected by the infringement. . . . This transparency stems
in part from the requirement to treat citizens as equals and with respect by offering
moral reasons, which in principle they could find acceptable, for policies that infringe
general moral considerations. Transparency is also essential to creating and maintaining public trust; and it is crucial to establishing accountability. . . .
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Public Health Ethics 73
Process of Public Accountability
[The fifth justificatory conditionpublic justificationis particularly applicable] in
the political context. While public accountability includes public justification, it is
broaderit is prospective as well as retrospective. It involves soliciting input from
the relevant publics (the numerical, political, and communal publics) in the process
of formulating public health policies, practices, and actions, as well as justifying to
the relevant publics what is being undertaken. . . . At a minimum, public accountability involves transparency in openly seeking information from those affected and in
honestly disclosing relevant information to the public; it is indispensable for engendering and sustaining public trust, as well as for expressing justice. [Procedural
fairness is particularly important to public accountability, because in a pluralistic
society we are likely to find disagreement about which principles should govern.
As Norman Daniels (2000, 1301) further explains, Since we may not be able to
construct principles that yield fair decisions ahead of time, we need a process that
allows us to develop those reasons over time as we face real cases.]
Public Health Interventions vs. Paternalistic Interventions
An important empirical, conceptual, and normative issue in public health ethics is
the relationship between protecting and promoting the health of individuals and protecting and promoting public health. Although public health is directed to the health
of populations, the indices of population health, of course, include an aggregation of
the health of individuals. [And individual health may be influenced by substantially
voluntary, self-regarding behavior.] The ethical question then is, when can paternalistic interventions . . . be ethically justified if they infringe general moral considerations such as respect for autonomy, including liberty of action? . . .
Whether an agents other-regarding conduct is voluntary or non-voluntary, the
society may justifiably intervene in various ways, including the use of coercion, to
reduce or prevent the imposition of serious risk on others. Societal intervention in
non-voluntary self-regarding conduct is considered weak (or soft) paternalism, if it
is paternalistic at all, and it is easily justified. By contrast, societal interference in
voluntary self-regarding conduct would be strong (or hard) paternalism. Coercive
intervention in the name of strong paternalism would be insulting and disrespectful
to individuals because it would override their voluntary actions for their own benefit,
even though their actions do not harm others. Such interventions are thus very difficult to justify in a liberal, pluralistic democracy.
Because of this difficulty, proponents of public health sometimes contend that
[there are only a small class of cases in which an individuals actions are both
self-regarding and voluntary;] individuals risky actions are, in most cases, otherregarding or non-voluntary, or both. Thus, they insist, even if we assume that strong
or hard paternalism cannot be ethically justified, the real question is whether most
public health interventions in personal life plans and risk budgets are paternalistic
at all, at least in the morally problematic sense.
To a great extent, the question is where we draw the boundaries of the self and
its actions; that is, whether various influences on agents so determine their actions
that they are not voluntary, and whether the adverse effects of those actions extend
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74 Foundations of Public Health Law and Ethics
beyond the agents themselves. . . . On the one hand, it is not sufficient to show that
social-cultural factors influence an individuals actions; it is necessary to show that
those influences render that individuals actions substantially non-voluntary and
warrant societal interventions to protect him or her. Controversies about the strong
influence of food marketing on diet and weight (and, as a result, on the risk of disease and death) illustrate the debates about this condition.
On the other hand, it is not sufficient to show that an individuals actions have
some adverse effects on others; it is necessary to show that those adverse effects
on others are significant enough to warrant overriding the individuals liberty. [For
example, even if the societal costs of an activity] are morally relevant as a matter of
social utility, it [is] still necessary to show that they are significant enough to justify
the intervention.
Either kind of attempt to reduce the sphere of autonomous, self-regarding
actions, in order to warrant interventions in the name of public health, or, more
broadly, social utility, can sometimes be justified, but either attempt must be subjected to careful scrutiny. Sometimes both may represent rationalization and bad
faith as public health agents seek to evade the stringent demands of the general
moral consideration of respect for autonomy. Requiring consistency across an array
of cases may provide a safeguard against rationalization and bad faith, particularly
when motives for intervention may be mixed.
Much of this debate reflects different views about whether and when strong
paternalistic interventions can be ethically justified. In view of the justificatory conditions identified earlier, relevant factors will include the nature of the intervention,
the degree to which it infringes an individuals fundamental values, the magnitude of
the risk to the individual apart from the intervention (either in terms of harm or lost
benefit), and so forth. . . .
Social Justice, Human Rights, and Health
We have noted potential and actual conflicts between promoting the good of public
health and other general moral considerations. But it is important not to exaggerate
these conflicts. . . . Social injustices expressed in poverty, racism, and sexism have
long been implicated in conditions of poor health. In recent years, some evidence
suggests that societies that embody more egalitarian conceptions of socioeconomic
justice have higher levels of health than ones that do not. Public health activity has
traditionally encompassed much more than medicine and health care. Indeed, historically much of the focus of public health has been on the poor and on the impact of
squalor and sanitation on health. The focus today on the social determinants of health
is in keeping with this tradition. The data about social determinants . . . warrant close
attention to the ways conditions of social justice contribute to the publics health.
. . . Some in public health argue that embodying several other general moral
considerations, especially as articulated in human rights, is consistent with and
may even contribute to public health. . . . Sometimes public health programs burden
human rights, but human rights violations have adverse effects on physical, mental,
and social well-being and promoting and protecting human rights is inextricably
linked with promoting and protecting health (Mann 1997, 1112). [Often, the most
effective ways to protect public health respect general moral considerations rather
than violate them.]
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Public Health Ethics 75
While more often than not public health and human rightsor general moral
considerations not expressed in human rightsdo not conflict and may even be synergistic, conflicts do sometimes arise and require resolution. . . . We have tried to
provide elements of a framework for thinking through and resolving such conflicts.
This process needs to be transparent in order to engender and sustain public trust.
Ethics and Public Health: Forging a Strong Relationship*
Daniel Callahan and Bruce Jennings
[Bioethics emerged as a discipline separate from medical ethics in the 1960s and
1970s. Today, public health ethics have begun to emerge as a discipline distinct from,
but still connected to, bioethics and its principles. In part, this emergence is due to
the unwelcome reminder that infectious disease has not, in fact, been conquered
and the recognition that the health of populations is a function more of good public
health measures and socioeconomic conditions than of biomedical advances.]
[Incorporating bioethics principles and public health principles is not always
easy. While bioethics emphasizes an individualistic orientation, public health maintains a focus on populations and societies. There is an additional] tension produced
by the predominant orientation in favor of civil liberties and individual autonomy
that one finds in bioethics, as opposed to the utilitarian, paternalistic, and communitarian orientations that have marked the field of public health throughout its history.
The ethical and policy issues concerning, for example, HIV and multidrug-resistant
tuberculosis already have thrust public health ethics into the thick of this clash of
values. And, if the issue of paternalism (limiting the freedom of the individual for the
sake of his or her own greater good or best interests) were not enough, the cognate
clash between individualistic civil liberties and a communitarian orientation (limiting
the freedom of the individual for the sake of the common good or public interest) will
also provoke lively discussion. . . .
The Scope of Public Health Ethics
Just as public health is broad in its scope, the range of ethical issues in the field
is uncommonly wide, encompassing ethics in public health as well as the ethics
of public health. If ethics is understood to be a search for those values, virtues,
and principles necessary for people to live together in peace, mutual respect, and
justice, then there are few issues in public health that do not admit of an ethical
perspective. To begin to map the scope of this broad terrain, general categories of
such issues should be noted: health promotion and disease prevention, risk reduction, epidemiological and other forms of public health research, and structural and
socioeconomic disparities in health status.
Health Promotion and Disease Prevention
Programs designed to promote health and prevent disease and injury raise questions about the responsibility of individuals to live healthy lives; about the govern-
*Reprinted from American Journal of Public Health 92 (2002): 16976.
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76 Foundations of Public Health Law and Ethics
ments role in creating an environment in which individuals are able to exercise their
health-related responsibility; about the role of government in coercing or influencing health-related behavior or in developing educational programs; about the use of
incentives, economic or otherwise, to promote good health; and about the relative
importance for society of pursuing good health, particularly in a culture that prizes
autonomy and does not always look fondly on government intervention.
Risk Reduction
Risks to the health of the public are many, and many methods are used to reduce or
eliminate them. Almost all can pose one or more ethical problems. The concept of
risk itself is seemingly impossible to define in value-neutral terms and is inherently
controversial. Even more ethically charged is the question of what level or degree
of risk is socially acceptable to individuals and communities. Who should decide
about that, and how should exposure to risk be distributed across the affected
population? . . .
Epidemiological and Other Public Health Research
. . . Is the biomedical modelfocused on individual informed consent and tightly
regulated research with those at risk of exploitationan appropriate model for public
health, one that may either pose no medical or other risks to individuals or make
consent impractical to gain in research encompassing large communities? And
should the research standards used in the United States be exactly the same for
research in other countries, particularly developing countries?
Structural and Socioeconomic Disparities
It has been known for many years that socioeconomic disparities have a major
impact on health status. Equitable access to decent health care and reductions in
health status disparities have been long-sought goals in American society but have
not always been dealt with in the context of socioeconomic disparities. What is the
appropriate role for the public health community in seeking greater justice in health
care, and how should it balance its fact-finding and educational role with its historically strong advocacy mission? . . . Finally, to what extent, if any, should the field
adopt a politically partisan posture, taking a public stand on important policy issues
and legislative initiatives?
Types of Ethical Analysis
While the preceding classification of broad issues by no means exhausts the possible
categories of topics, it is sufficient to make evident that no single method of ethical analysis can be used for all of them. . . . Ethical analysis can be usefully divided
into a number of different types, depending on the point of view and needs from
which it originates. One or more of them might be appropriate for any specific ethical problem.
Professional Ethics
The study of professional ethics tends to seek out the values and standards that
have been developed by the practitioners and leaders of a given profession over a
long period of time and to identify those values that seem most salient and inherent
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Public Health Ethics 77
in the profession itself. Applied to public health, this perspective entails identifying
the central mission of the profession (e.g., protection and promotion of the health
of all members of society) and building up a body of ethical principles and standards
that would protect the trust and legitimacy the profession should maintain.
Applied Ethics
. . . The applied ethics perspective differs from the professional ethics perspective
principally in that it adopts a point of view from outside the history and values of
the profession. From this more general moral and social point of view, applied ethics
seeks to devise general principles that can then be applied to real-world examples of
professional conduct or decision making. These principles and their application are
designed to give professionals guidance and to provide those individuals affected by
professional behavior, as well as the general public, with standards to use in assessing the professions. Thus, in applied ethics, there is a tendency to reason abstractly
and to draw from general ethical theories rather than from the folkways and knowledge base of the professions. . . .
Advocacy Ethics
. . . While on occasion it can pose difficulties for civil servants, the ethical persuasion
most lively in the field is a stance of advocacy for those social goals and reforms
that public health professionals believe will enhance general health and well-being,
especially among those least well off in society. Such advocacy is in keeping with the
natural priorities of those who devote their careers to public health. It has a strong
orientation toward equality and social justice. Much of the research and expertise
in public health throughout its history has shown how social deprivation, inequality,
poverty, and powerlessness are directly linked to poor health and the burden of
disease. . . .
Critical Ethics
. . . For want of a better term, we label [this final perspective] critical ethics. In
many ways, it attempts to combine the strengths of the other perspectives mentioned. Like professional ethics, it is historically informed and practically oriented
toward the specific real-world and real-time problems of public health, but, like
applied ethics, it brings larger social values and historical trends to bear in its understanding of the current situation of public health and the moral problems faced.
These problems are not only the result of the behavior of certain disease organisms
or particular individuals. They are also the result of institutional arrangements and
prevailing structures of cultural attitudes and social power.
. . . One possible advantage of critical ethics is its call for discussions of ethics
and public health policy to be genuinely public or civic endeavors: not the advocacy
of a well-intentioned elite on behalf of needy clients, but a search for forums and
programs of meaningful participation, open deliberation, and civic problem solving
and capacity building. . . .
An Ethical Code?
The work of the Public Health Leadership Society in initiating a process to establish
a code of ethics for public health is important. Where does a code of ethics fit into
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78 Foundations of Public Health Law and Ethics
a broader confrontation with ethical issues? Most professions have a code, and of
course many professionals in public health belong to one or another of such professions. Considering this, is there any need for an additional code for public health?
There are at least 3 reasons to have a code. One . . . is to respond to scandals in a
field, aiming to ensure better future conduct. . . . Another is to help establish the
moral credibility of a field and its professional status and to provide principles to
deal with common dilemmas. . . . Still another purpose is to provide a profession with
a moral compass and to set forth its ideals. . . .
. . . [But codifying ethical norms in a field is not without difficulties.] The greatest
challenge in writing a code is to specify clearly the ideals of the field and then to
specify some general guidelines that will be illuminating for the wide array of problems practitioners can encounter. Historically, many if not most professional codes
have been written because of structural changes in a profession that have generated
new ethical problems and made it necessary to shore up public confidence in the
professions integrity.
We believe that the integrity of the profession of public health is sound, but the
changing situation of public health practice may be a good reason to more precisely
specify the ethical obligations that those in the field take on when they become practitioners. Code developments and revisions, it might be noted, have often been most
successful when they are accompanied by lengthy and strenuous debate engaging the
entire professional community and not simply those with a special interest in ethics.
Law and Ethics
Public health is one of the few professions that has, in many matters, legal powerin
particular, the police power of the statebehind it. It can, through use of the law,
coerce citizens into behaving in some approved, healthy way. . . . Public health also
has the distinction . . . of being a profession in which many practitioners are government employees and officials. It thus has an obligation both toward government,
which controls it, and toward the public that it serves.
Because of its public and governmental roles, public health has ethical problems
unlike those of most other professions. The relationship between ethics and law is
a long and tangled one, but it is safe to say that most public health laws and regulations have behind them an explicitly moral purpose: that of promoting and protecting
the lives of citizens. Because the police power of the state is involved, however, a
number of moral conflicts are generated. The tension between individual health and
rights, on the one hand, and government obligations and population health, on the
other, is an obvious instance of this kind of conflict. The economic and social impact
on communities of public health measures, requiring some form of cost-benefit
analysis, is another.
Health is an important human need, and good health is highly valued. But health
is not the only need or good health the only value. Laws must always find ways of balancing various goods, and the centrality of laws for the work of public health brings
uncommon visibility to its actions and an uncommon need for public accountability.
Politics and Public Health
As public arguments over fluoridation or HIV disease amply demonstrate, public
health measures can quickly become politicized. Political controversy is often
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Public Health Ethics 79
treated as some kind of disaster for calm reflection and measured rationality . . .
[but] politics is unavoidable and necessary. It is unavoidable because there is no
way to stop the public from turning to legislatures or the courts to express their
values and needs; nor should there be. Politics is a necessary component of public
health, moreover, precisely in order to achieve public health policies and practices
consistent with American traditions and values. Politics is the messy arena in which
ultimate questions of the public good are worked out. . . .
Yet, there can be responsible and irresponsible politics. Public health can best
serve the cause of responsible politics, even when it has a self-interested stake in
the outcome, when it makes available good data, when it is sensitive to community
sentiments, and when it makes clear by all of its actions that it is not (as the stereotype would have it) just one more self-serving, distant government bureaucracy. . . .
The Teaching of Public Health Ethics
[A crucial question, then, is how to promote greater awareness and a more sustained, sophisticated discussion of ethical issues among public health practitioners
and researchers themselves, as well as among the broader public. An important
step is to promote the teaching of ethics in all schools of public health and among
practitioners through continuing education programs. This may be controversial,
intellectually difficult, institutionally challenging, and expensive, but it needs to be
done if there is going to be serious study and discussion of the myriad ethical issues
arising in public health.]
II. Public Health Paternalism: A Case Study on
Motorcycle Helmet Laws
As mentioned, paternalism remains the most politically controversial
justification for public health action. Classic liberalism rejects paternalism, holding that the only justification for interference with liberty is to
prevent harm to others. There are many examples of paternalistic policies, including seat belt laws, water fluoridation, and prohibitions on
gambling and illicit drugs. In the treatise accompanying this volume,
I use motorcycle helmet laws as an illustration. Here, I present two
readings offering starkly different justifications for motorcycle helmet
laws. In Benning v. State, the Vermont Supreme Court upholds a state
law mandating that motorcycle riders wear helmets, stressing the socioeconomic harms that motorcycle crashes cause to families and society.
The public health ethicists Marian Moser Jones and Ronald Bayer also
support these laws, but they rely primarily on paternalistic arguments.
In both pieces, it is clear that antipaternalistic rhetoricoften
couched in terms of liberty and free choicehas been central to motorcyclists efforts to repeal helmet laws. Recent data, however, confirm
the danger of a strict antipaternalistic stance: repeals of motorcycle
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80 Foundations of Public Health Law and Ethics
helmet laws increase motorcyclist fatality rates by more than 12 percent on average (Houston and Richardson 2007). At times, choice has
disastrous consequences. Those states that adhere to a classic liberal
tradition eschewing paternalism may face an increased social and economic burden of injury and disease.
Benning v. State*
Supreme Court of Vermont
Decided January 28, 1994
Justice DOOLEY delivered the opinion of the court.
[Plaintiffs bring a state constitutional challenge against Vermonts motorcycle
law, Vermont Statutes Annotated, Title 23, 1256, which requires motorcyclists to
wear reflective helmets with neck or chin straps when on highways. The challenge is
based on the language in the first amendment of the Vermont Constitution guaranPhoto 5. A parade of motorcyclists in Wyoming rides to the annual Sturgis
motorcycle rally in South Dakota. The riders are largely helmetless, reflecting
the absence of motorcycle helmet laws in both Wyoming and South Dakota.
Avid motorcyclists frequently oppose motorcycle helmet laws, claiming that
motorcyclists themselves should be responsible for making personal safety
decisions. Reproduced by permission, Peter Turnley/Corbis, August 8,
2007.
*641 A.2d 757 (Vt. 1994).
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Public Health Ethics 81
teeing citizens the right of enjoying and defending . . . liberty and pursuing and
obtaining . . . safety.]
At the center of plaintiffs argument is the assertion that Vermont values personal liberty interests so highly that the analysis under the federal constitution
or the constitutions of other states is simply inapplicable here. In support of this
contention, plaintiffs rely on political theorists, sociological materials, and incidents
in Vermonts history. Without detailing this argument, we find it unpersuasive not
because it overvalues Vermonts devotion to personal liberty and autonomy, but
because it undervalues the commitment of other governments to those values. . . .
Certainly, if there was a heightened concern for personal liberty, there is no evidence of it in the text of the Constitution. . . .
As a result, we reject the notion that this case can be resolved on the basis of a
broad right to be let alone without government interference. We accept the federal
analysis of such a claim in the context of a public safety restriction applicable to
motorists using public roads. We agree with Justice Powell, recently sitting by designation with the Court of Appeals for the Eleventh Circuit, who stated:
There is no broad legal or constitutional right to be let alone by government.
In the complex society in which we live, the action and notation of citizens are
subject to countless local, state, and federal laws and regulations. Bare invocation
of a right to be let alone is an appealing rhetorical device, but it seldom advances
legal inquiry, as the rightto the extent it existshas no meaning outside its
application to specific activities. . . . (Picou v. Gillum, 874 F.2d 1519, 1521 [11th
Cir. 1989])
. . . We are left then with the familiar standard for evaluating police power regulationsessentially, that expressed in State v. Solomon, 260 A.2d 377, 379 (Vt. 1969)
[holding that 1256 did not exceed the states police power or violate due process of
law and was directly related to highway safety because without a helmet, a motorcyclist could be affected by highway hazards, lose control, and injure other motorists]. Plaintiffs urge us to overrule Solomon because it was based on an analysis of
the safety risk to other users of the roadway that is incredible. In support of their
position, they offered evidence from motorcycle operators that the possibility of an
operator losing control of a motorcycle and becoming a menace to others is remote.
On the other hand, these operators assert that helmets make a motorcycle operator
dangerous. Plaintiffs also emphasize that even supporters of helmet laws agree that
their purpose is to protect the motorcycle operator, not other highway users.
We are not willing to abandon the primary rationale of Solomon because of plaintiffs evidence. The statute is entitled to a presumption of constitutionality. Plaintiffs
are not entitled to have the courts act as a super-legislature and retry legislative
judgments based on evidence presented to the court. Thus, the question before us
is whether the link between safety for highway users and the helmet law is rational,
not whether we agree that the statute actually leads to safer highways. The Solomon
reasoning has been widely adopted in the many courts that have considered the
constitutionality of motorcycle helmet laws. We still believe it supports the constitutionality of 1256.
There are at least two additional reasons why we conclude 1256 is constitutional. . . . Although plaintiffs argue that the only person affected by the failure to
wear a helmet is the operator of the motorcycle, the impact of that decision would
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82 Foundations of Public Health Law and Ethics
be felt well beyond that individual. Such a decision imposes great costs on the public.
As Professor Laurence Tribe (1988, 1372) has commented, ours is a society unwilling to abandon bleeding bodies on the highway, [and] the motorcyclist or driver who
endangers himself plainly imposes costs on others. This concern has been echoed
in a number of opinions upholding motorcycle helmet laws. . . . Whether in taxes or
insurance rates, our costs are linked to the actions of others and are driven up when
others fail to take preventive steps that would minimize health care consumption.
We see no constitutional barrier to legislation that requires preventive measures to
minimize health care costs that are inevitably imposed on society.
A second rationale supports this type of a safety requirement on a public highway. Our decisions show that in numerous circumstances the liability for injuries
that occur on our public roads may be imposed on the state, or other governmental
units, and their employees. It is rational for the state to act to minimize the extent of
the injuries for which it or other governmental units may be financially responsible.
The burden placed on plaintiffs who receive the benefit of the liability system is
reasonable. . . .
As a result, we reiterate our conclusion that 1256 in no way violates any of the
provisions of our state and federal constitutions. Solomon, 260 A.2d at 380.
Paternalism and Its Discontents: Motorcycle Helmet Law s,
Libertarian Values, and Public Health*
Marian Moser Jones and Ronald Bayer
In the face of overwhelming epidemiological evidence that motorcycle helmets
reduce accident deaths and injuries, state legislatures in the United States have
rolled back motorcycle helmet regulations during the past 30 years. . . . There are
many ways to account for the historical arc; we focus here on the enduring impact
libertarian and antipaternalistic values may have on US public health policy. . . .
The Origin of Motorcycle Helmet Law s
. . . The 1966 National Highway Safety Act introduced drastic and unwelcome
changes to US motorcycle culture. The law . . . included a provision that withheld
federal funding for highway safety programs to states that did not enact mandatory motorcycle helmet laws within a specified time frame. This provision was added
after a study showed that helmet laws would significantly decrease the rate of fatal
accidents. . . . Adoption of this measure drew upon a broader movement within public
health to expand its purview beyond infectious disease to prevention of disability
and postponement of untimely death. Several years later, this shift sparked debate
on the role of both individual and collective behaviors in contemporary patterns of
morbidity and mortality. . . .
As of 1966, only 3 states . . . had passed motorcycle helmet laws, but between
1967 and 1975, nearly every state passed statutes to avoid penalties under the
National Highway Safety Act. . . .
*Reprinted from the American Journal of Public Health 97 (2007): 20817.
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Public Health Ethics 83
The Biker Lobby Roars into Action
Motorcyclists had long been organized . . . and the passage of motorcycle helmet
laws galvanized the groups to become political. [During the 1970s, state-level and
nationwide groups committed to advocating the repeal of helmet lawsso-called
motorcyclists rights organizationsbegan to form around the country. Soon,
motorcyclists evolved into an organized and powerful national lobby. Group representatives were invited to hearings in July 1975 to discuss revisions to the National
Highway Safety Act.]
Recognizing that proponents of motorcycle helmet laws, in the tradition of public health, had used statistical evidence of injury and death to make their case, the
first motorcyclist to speak at these hearings, Bruce Davey of ABATE [A Brotherhood
against Totalitarian Enactments] opened with a frontal attack on such data. . . . Davey
then advanced a series of constitutional claims that were rooted in an antipaternalistic ethic, which enshrined a concept of personal liberty. . . . Not surprisingly, the issue
of choice emerged as the central theme in the arguments of those opposed to helmet
laws. . . . ABATE chapter literature stated ABATE does not advocate that you ride
without a helmet when the law is repealed, only that you have the right to decide. . . .
[The tide had turned against proponents of mandatory helmet laws.] On December 13, 1975, the Senate voted 52 to 37 to approve a bill that revised the National
Highway Safely Act. The House passed a similar measure. . . . The bill was signed by
President Gerald Ford on May 5, 1976.
Helmetless Riders: An Unplanned Public Health Experiment
During the next 4 years, 28 states repealed their mandatory helmet laws. . . .
Overall, deaths from motorcycle accidents increased 20%, from 3,312 in 1976 to
4,062 in 1977. . . .
For those concerned about public health, the unfolding events were viewed
with alarm. In the June 1980 issue of the American Journal of Public Health, Susan
Baker . . . compared the situation to one where scientists, having found a successful treatment for a disease, were impelled to further prove its efficacy by stopping
the treatment and allowing the disease to recur. Invoking the 1905 US Supreme
Court decision in Jacobson v. Massachusetts that upheld compulsory immunization
statutes, Baker asserted that the state had the authority to limit individual liberty to
protect the publics health and the rights of others. . . . Baker emphasized the social
burden created by motorcycle accidents and fatalities.
In 1981, the American Journal of Public Health published a counterpoint to
Bakers editorial. . . . Richard Perkins . . . attacked the argument that the motorcyclist was reducing the freedom of others by not wearing a helmet as so ridiculous
as to be ammunition for the anti-helmet law forces. . . . He argued that laws should
consider not only safety but also such intangible consequences as potential loss of
opportunity for individual fulfillment and loss of social vitality.
Baker and Stephen Teret [1981] offered a rebuttal to Perkins and stated that his
argument implies that if policy is not applied at the outer limits of a continuum of circumstances, it would be unreasonable to apply that policy at any point along the continuum. They defended their reliance on Jacobson v. Massachusetts by pointing out
that the decision has been used as a precedent for decisions that cover manifold
restraints on liberty for the common good beyond the scope of contagious disease.
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84 Foundations of Public Health Law and Ethics
During the next decade, evidence of the human and social costs of repeal continued to mount. Medical costs among helmetless riders increased 200% compared
with helmeted riders, and in some states, helmetless riders were more likely to be
uninsured. . . . Posing a challenge to the antipaternalism that had inspired the repeal
of laws, [an editorial in Texas Medicine] contended, [a] civilized society makes laws
not only to protect a person from his fellowman, but also sometimes from himself as
well (Narayan 1987, 56). . . .
Helmet Laws in the Congress Once Again
In May 1989, [Senator John Chaffee introduced] a billthe National Highway Fatality and Injury Reduction Act of 1989that would empower the US Department of
Transportation to withhold up to 10% of federal highway aid from any state that did
not require motorcyclists to wear helmets and front-seat automobile passengers to
wear seat belts. . . .
. . . [Robert Ford, representing an antihelmet lobbying group, spoke at a hearing
on the bill.] Ford did not quibble with statistics that showed seat belts make people
safer. Instead, he argued that the issue was about fundamental individual liberty.
We do not want to be told how to behave in matters of personal safety. We do not
want to be forced to wear seat belts or helmets because others think that it is
good for us. We do not want to be forced to eat certain diets because some think
that it too may be good for us, reduce deaths and medical costs, and make us
more productive citizens. We do not want to be forced to give up certain pastimes
simply because some may feel they entail any amount of unnecessary risk.
Instead of confronting the moral arguments made by opponents of helmet laws,
proponents of such measures sought once again to marshal the compelling force of
evidence. In 1991 . . . the General Accounting Office issued a comprehensive report
that documented the toll. The report reviewed 46 studies and found that they overwhelmingly showed helmet use rose and fatalities and serious injuries plummeted
after enactment of mandatory universal helmet laws.
[Despite the fierce opposition of motorcycle groups, a motorcycle helmet
provision was enacted as part of a major highway funding bill in 1991. Under the
law states that failed to pass helmet laws would have 3% of their highway funds
withheld. This public health success was short-lived, however.] In 1995, after the
Gingrich Revolution, in which conservative Republicans took control of Congress,
the national motorcycle lobby succeeded in getting the federal 3% highway safety
fund penalties repealed.
Conclusions
Over the past 30 years, helmet law advocates have gathered a mountain of evidence
to support their claims that helmet laws reduce motorcycle accident fatalities and
severe injuries. Thanks to the rounds of helmet law repeals, advocates have been
able to conclusively prove the converse as well: helmet law repeals increase fatalities and the severity of injuries. But the antihelmet law activists . . . have learned a
lesson about how persuasive unadorned appeals to libertarian values can be.
This history of motorcycle helmet laws in the United States illustrates the profound
impact of individualism on American culture and the manner in which this ideological
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Public Health Ethics 85
perspective can have a crippling impact on the practice of public health. . . . Abundant
evidence makes it clear . . . that in the absence of mandatory motorcycle helmet laws,
preventable deaths and great suffering will continue to occur. The NHTS A [National
Highway Traffic Safety Administration] estimated that 10,838 additional lives could
have been saved between 1984 and 2004 had all riders and passengers worn helmets. The success of those who oppose such statutes shows the limits of evidence in
shaping policy when strongly held ideological commitments are at stake.
Early on in the battles over helmet laws, advocates for mandatory measures
placed great stress on the social costs of riding helmetless. . . . Such a perspective . . . mask[s] the extent to which concerns for the welfare of cyclists themselves
were the central motivation for helmet laws. The inability to successfully and consistently defend these measures for what they wereacts of public health paternalismwas an all but fatal limitation. . . .
The challenge for public health is to expand on this base of justified paternalism and to forthrightly argue in the legislative arena that adults and adolescents
need to be protected from their poor judgments about motorcycle helmet use. . . .
Paternalistic protective legislation is part of the warp and woof of public health practice in America. . . .
With the latest round of helmet law repeals, motorcycle helmet use has dropped
precipitately to 58% nationwide, and fatalities have risen. Need anything more be
said to show that motorcyclists have not been able to make sound safety decisions
on their own and that mandatory helmet laws are needed to ensure their own safety?
III. Ethical Reasoning in Risk Regulation
Scholars have lamented the sharp differences in the way that experts
and laypersons assess risk. Risk is a highly complex concept, and a
great deal of literature exists about its analysis, perception, characterization, communication, and management. Scientists understand risk
according to probabilistic assessments focusing on the chance that a
dangerous event will occur and, if it does, on the severity of its effects.
Such an inquiry is said to be objective. The lay publics understanding
of risk, in contrast, takes account of more subjective matters, including
personal, social, and cultural values. People seem interested in whether
the risk is fairly distributed among the population, voluntarily assumed
or externally imposed, and naturally occurring or introduced by novel
technologies.
Given this apparent rift between scientific and popular risk assessments, how are policy makers in a democratic government to decide
which risks should be regulated and how heavily? Frank B. Cross
(1994, 888), a business law scholar, explains the problem:
Should the government concern itself with public opinion when addressing
public health risks, such as cancer? What if the public opinion is at odds
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86 Foundations of Public Health Law and Ethics
with all the best scientific evidence? Suppose the public demands extensive
government regulation or even prohibition of a valuable substance or
activity, when scientific studies indicate that the substance or activity
presents little or no risk. The result is a conflict between the goals of
a democratically responsive government and an effective public heath
protection program. Because it is impossible to reduce all human health
risks, as publicly perceived or as scientifically identified, a trade-off is
unavoidable. This problem is complicated because the general populace
and scientists do not even agree on the meaning of the term risk.
The current regulatory system purports to use scientific methods to
measure risk, but policy in the real world is complicated by scientific
uncertainties, human values, and political compromises. The result is
a combination of overregulated risk, such as the removal of apples
treated with the pesticide Alar from supermarkets, and underregulated risk, such as the failure to regulate personal handguns.
Justice Stephen Breyers book Breaking the Vicious Circle sharply
criticizes existing public health regulation, particularly in the environmental area. In the excerpt below, Breyer discusses one of the most
important factors contributing to what he sees as inefficient risk regulation: public risk perception. He outlines the cognitive attributions
and schemata the public uses to inaccurately assess risk. Faulty public
perception of risk, together with politics and the technical uncertainties of the regulatory process, creates what he terms the vicious circle
of risk regulation. The vicious circle, argues Breyer, leads agencies to
overregulate tiny health risks while ignoring larger, more pressing
health concerns.

Breaking the Vicious Circle: Toward Effective
Risk Regulation*
Stephen Breyer
Study after study shows that the publics evaluation of risk problems differs radically from any consensus of experts in the field. Risks associated with toxic waste
dumps and nuclear power appear near the bottom of most expert lists; they appear
near the top of the publics list of concerns, which more directly influences regula-
*Reprinted from Breaking the Vicious Circle: Toward Effective Risk Regulation by
Stephen Breyer (Cambridge, Mass.: Harvard University Press) by permission of the publisher. Copyright 1993 by the President and Fellows of Harvard College.
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Public Health Ethics 87
tory agendas. To some extent, these differences may reflect that the public fears
certain risks more than others with the same probability of harm. . . . Of two equal
risks, one could rationally dislike or fear more the risk that is involuntarily suffered,
new, unobservable, uncontrollable, catastrophic, delayed, a threat to future generations, or likely accompanied by pain or dread.
Still, these differences in the source, quality, or nature of a risk may not account
for the different ranking by the public and the experts. A typical member of the
public would like to minimize risks of death to himself, to his family, to his neighbors;
he would normally prefer that regulation buy more safety for a given expenditure or
the same amount of safety for less. Not many of us would like to shift resources to
increase overall risks of death significantly in order to increase the likelihood that
death will occur on a bicycle or in a fire, rather than through disease. There is a far
simpler explanation for the publics aversion to toxic waste dumps than an enormous
desire for supersafety, or a strong aversion to the tiniest risk of harmnamely, the
public does not believe that the risks are tiny. The publics nonexpert reactions
reflect not different values but different understandings about the underlying riskrelated facts.
My assumption that the public assigns rational values to risks, however, does
not entail rational public reactions to risk. Psychologists have found several examples of thinking that impede rational understanding, but may have helped us survive
as we lived throughout much of prehistory, in small groups of hunter-gatherers,
depending upon grain, honey, and animals for sustenance. The following, rather welldocumented aspects of risk perception are probably familiar.
Rules of Thumb
In daily life most of us do not weigh all the pros and cons of feasible alternatives. We
use rules of thumb, more formally called heuristic devices. We simplify radically;
we reason with the help of a few readily understandable examples; we categorize
(events and other people) in simple ways that tend to create binary choicesyes/
no, friend/foe, eat/abstain, safe/dangerous, act/dont actand may reflect deeply
rooted aversions, such as fear of poisons. The resulting categorizations do not
always accurately describe another person or circumstance, but they help us make
quick decisions, most of which prove helpful. This kind of quick decision-making may
help cut a swath through the modern information jungle, but it oversimplifies dramatically and thereby inhibits an understanding of risks, particularly small risks.
Prominence
People react more strongly, and give greater importance, to events that stand out
from the background. Unusual events are striking. We more likely notice the (lowrisk) nuclear waste disposal truck driving past the school than the (much higher-risk)
gasoline delivery trucks on their way to local service stations. Journalists, whose
job is to write interesting stories, know this psychological fact well. The American
Medical Association examined how the press treated two similar stories, one finding
increased leukemia rates among nuclear workers, the other finding no increased
cancer rates among those living near nuclear plants. More than half of the newspapers in the study mentioned the first story but not the second; and more than half of
those that mentioned both emphasized the first.
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88 Foundations of Public Health Law and Ethics
Ethics
The strength of our feelings of ethical obligation seems to diminish with distance.
That is to say, feelings of obligation are stronger (or we have different, more timeconsuming obligations) toward family, neighbors, friends, community, and those with
whom we have direct contact, those whom we see, than toward those who live in
distant places, whom we do not see but only read or hear about.
Trust in Experts
People cannot easily judge between experts when those experts disagree with each
other. The public, since the mid-1960s, has shown increasing distrust of experts and
the institutions, private, academic, or governmental, that employ them.
Fixed Decisions
A person who has made up his or her mind about something is very reluctant to
change it.
Mathematics
Most people have considerable difficulty understanding the mathematical probabilities involved in assessing risk. People consistently overestimate small probabilities.
What is the likelihood of death by botulism? (One in two million.) They underestimate large ones. What is the likelihood of death by diabetes? (One in fifty thousand.)
People cannot detect inconsistencies in their own risk-related choices. . . .
These few, near-commonsense propositions, with strong statistical support in the
technical literature, verify Oliver Wendell Holmess own observation that most people think dramatically, not quantitatively. They also have important consequences.
Consider the public reaction to toxic waste dumps. Start with the mathematical facts
about the probability of various occurrences: In 1985 a New Jersey woman won the
state lottery twice. What are the odds against this, billions to one? Given the vast
number of lotteries in the world, the odds come close to favoring someone somewhere winning a lottery twice. Given the population of the world, and the number
of dreams each night, the odds favor someone somewhere dreaming he marries a
girl who looks very much like the girl he meets the next day and marries. Given
the number of toxic waste dumps in the United States (26,000) and the number of
places with above-average cancer rates (half of all places), obviously many cities,
towns, and rural areas near toxic waste dumps must also have seriously elevated
cancer rates (mathematics).
Add what sells newspapersinteresting storiesand you can be fairly certain the
press will write about the double lottery-winner, perhaps the dreamer, and, if the
mathematical evidence is somewhat less crude than my example, the toxic waste
dump (prominence). Will it be easy to convince the cancer victim that the waste
dump (water that is pure or not pure) had nothing to do with the disease (rules
of thumb)? And how will the public react to the image of the angry family member
on nightly television (ethics), particularly if experts disagree (trust in experts)
as they might, for the relation between the disease and the toxic site may not be
strictly chance (the lottery, too, might be fixed). If further study exonerates the
dump, will the viewing public change its mind (fixed decision)?
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Public Health Ethics 89
When we think about nuclear power controversies, we should take account of
the fact that hearing about an accident is what psychologists tell us is a heuristic
tip-off of danger, whether or not anyone is hurt. We have seen Chernobyl and
Three Mile Island, and we may therefore doubt nuclear powers safety, whether or
not experts tell us that the reactor at Chernobyl was not properly designed, that
the accident at Three Mile Island hurt no one, that military weapons, not electric
power generators, are responsible for 99 percent of all nuclear waste, that nuclear
powers risks are minuscule compared to the risks of coal-generated power. Add a
few disagreements among experts and the fact that most members of the public
made up their minds long ago, and one can understand nuclear powers position on
the public perception risk charts.
These few propositions suggest that better risk communications, such as
efforts to explain risks to the public at open meetings, may not suffice to alleviate risk regulation problems. It is not surprising that, after the EPA [Environmental
Protection Agency] Administrator William Ruckelshaus spent days at such meetings
in Tacoma, Washington, explaining why an ASARCO chemical plant that was leaking small amounts of arsenic could remain open, he was misunderstood, criticized,
and accused of trying to drive a wedge between environmentalists and blue collar
workers. The plant eventually closed, although perhaps for other reasons. Nor is it
surprising that after special public discussions of nuclear power plants were held in
Sweden, surveys of the eighty thousand Swedes who participated showed no consensus, but increased confusion.
There is little reason to hope for better risk communication over time. To the contrary, as science improves, scientists may more easily detect and identify ever tinier
risksthe risks associated, for example, with the migration of a single molecule of
plastic from a container into a soft drink; they may more easily identify geographical
areas near toxic waste dumps with higher than average cancer rates. As international communications improve, the press will have an ever larger pool of unusual,
and therefore more interesting, accident stories to write about. Why should we not
expect an outcry from a public that reads about Love Canal, Times Beach, Alar,
Chilean grapes laced with cyanide, and the leaflet of Villejuif, whether or not such
examples reflect meaningful danger? (At the same time, how can one expect public
reaction to potentially greater but more mundane problems, of which it is unaware?)
It is hard to make the normal human mind grapple with this inhuman type of
problem. To change public reaction, one would either have to institute widespread
public education in risk analysis or generate greater public trust in some particular
group of experts or the institutions that employ them. The first alternative seems
unlikely. The second, over the past thirty years, has not occurred. Ordinary, human,
public perception, then, forms one element of the vicious circle.

The courts appear to apply a scientific understanding of risk. In School
Board of Nassau County, Florida v. Arline, 480 U.S. 273 (1987),
Justice William Brennan reasons that risks should be weighed based
on their nature, the probability of their occurrence, and the severity of
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90 Foundations of Public Health Law and Ethics
the harm should the risk materialize. Although Brennans arguments
are presented in the context of disability discrimination law, they say
something important about how the courts should weigh risk. In actual
cases, the courts confront real and complex problems in digesting
expressions of risks and determining acceptable levels of risks.
A few years before Breaking the Vicious Circle was published,
Justice Breyer, then a judge on the United States Court of Appeals
for the First Circuit, delivered the courts opinion in United States v.
Ottati & Goss, 900 F.2d 429 (1st Cir. 1990), a famous case involving the Superfund toxic cleanup law. The court rejected the claim
of the Environmental Protection Agency (EPA) that the International
Minerals and Chemical Corporation did not clean up a toxic waste site
sufficiently. Breyer expressed frustration at the cost and complexity of
adjudicating a case involving a nearly 50,000-page record:
Why . . . has this case taken ten years to litigate? The issues are complex,
but not unfathomable. Why has the government not found a way to
express its technical problems in English (e.g., small children will eat tiny
amounts of dirt when they play in a yard), instead of relying upon mazelike patterns of cross-references among regulations, statutes, and expert
jargon? . . . Has the government, in fact, spent enormous administrative
(and judicial) resources in an effort to force improvement from quite
clean . . . to extremely clean, at three to four times the quite clean
costs?
Determining appropriate levels of toxicity in Ottati turned on seemingly trivial questions, such as Will a child playing in the dirt consume
contaminated soil on 70 or 245 days out of the year?
Breyers thinking on risk regulation was also influenced by the
Supreme Courts decision in Industrial Union Department, AFL-CIO
v. American Petroleum Institute, 448 U.S. 607 (1980). The benzene
case, as it is often called, illustrates an equally challenging problem in
risk regulation: determining how much exposure to a harmful chemical
is safe. If exposure to benzene at a certain level is associated with
an increased rate of leukemia, does any exposure increase the risk of
leukemia? Alternatively, is there a safe level at which benzene exposure will have no physical effects? The Occupational Safety and Health
Administration (OSHA) decided that in the absence of scientific data,
there is no safe level of benzene exposure. The Supreme Court disagreed, holding that OSHA had the burden of proving, on the basis of
substantial evidence, that long-term exposure to benzene at low levels
presents a significant risk of material health impairment.
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Public Health Ethics 91
Inconsistencies in risk regulation not only are the result of conflicting scientific and popular understandings of risks, but are also the
product of inherent variance in how scientists understand, prioritize,
compare, and express risks. Experts believe that scientific risk assessments lead to more cost-effective interventions because they encourage
policy makers to concentrate resources on preventing hazards that are
highly probable and would cause significant harm. But there are tensions between probability and magnitude of harm. Should policy makers devote resources to events of high likelihood and low consequence,
or vice versa? For example, the common cold is highly likely but of
small consequence, while bioterrorism or avian influenza (H5N1) is
unlikely but of major consequence. So, should policy makers devote
more resources to preventing routine events or catastrophic ones?
Alternatively, should policy makers concentrate on preventing endemic
health threats (both likely and harmful), such as seasonal influenza,
obesity, and smoking? In the following excerpt, the physicists Richard
Wilson and E.A.C. Crouch describe how risksof varying certainties
and magnitudesare assessed, compared, and expressed.
Risk Assessment and Compar isons: An Introduction*
Richard Wilson and E.A.C. Crouch
Every day we take risks and avoid others. . . .
Most of us act semi-automatically to minimize our risks. We also expect society to
minimize the risks suffered by its members, subject to overriding moral, economic,
or other constraints. In some cases these constraints will dominate, in others there
will be trade-offs between the values assigned to risks and the constraints. Risk
assessments, except in the simplest of circumstances, are not designed for making
judgments, but to illuminate them. To effectively illuminate, and then to minimize,
risks requires knowing what they are and how big they are. This knowledge usually
is gained through experience, and the essence of risk assessment is the application
of this knowledge of past mistakes (and deliberate actions) in an attempt to prevent
new mistakes in new situations.
The results of risk assessments will necessarily be in the form of an estimate
of probabilities for various events, usually injurious. The goal in performing a risk
assessment is to obtain such estimates, although we consider the major value in performing a risk assessment is the exercise itself, in which (ideally) all aspects of some
action are explored. . . . Cultural values will presumably be factors influencing societal decisions and may differ even for risk estimates that are identical in probability.
*Excerpted from Science 236 (1987): 26770. Reprinted with permission from the
American Association for the Advancement of Science.
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92 Foundations of Public Health Law and Ethics
Risk and Uncertainty
The concept of risk and the notion of uncertainty are closely related. We may say
that the lifetime risk of cancer is 25%, meaning that approximately 25% of all
people develop cancer in their lifetimes. Once an individual develops cancer, we can
no longer talk about the risk of cancer, for it is a certainty. Similarly if a man lies
dying after a car accident, the risk of his dying of cancer drops to near zero. Thus
estimates of risks, insofar as they are expressions of uncertainty, will change as
knowledge improves.
Different uncertainties appear in risk estimation in different ways. There is
clearly a risk that an individual will be killed by a car if that person walks blindfolded
across a crowded street. One part of this risk is stochastic; it depends on whether
the individual steps off the curb at the precise moment that a car arrives. Another
part of the risk might be systematic; it will depend on the nature of the fenders and
other features of the car. . . .
Some estimates of uncertainties are subjective, with differences of opinion arising because there is a disagreement among those assessing the risks. Suppose one
wishes to assess the risk (to humans) of some new chemical being introduced into
the environment, or of a new technology. Without any further information, all we can
say about any measure of the risk is that it lies between zero and unity. [Extreme
opinions might be voiced in response, with some assuming a risk of unity because
safety has not been demonstrated, and others assuming a risk of zero because nothing has been proven dangerous.] We argue that it is the task of the risk assessor to
use whatever information is available to obtain a number between zero and one for
a risk estimate, with as much precision as possible, together with an estimate of the
imprecision. . . .
. . . The assumption of zero risk can arise because people and government agencies have a propensity to ignore anything that is not a proven hazard. We argue that
this attitude is inconsistent if the objective is to improve the public health, may also
lead to economic inefficiencies, and often leads to unnecessary contention between
experts who disagree strongly. . . .
Risk Value versus Certainty of Information
After risks of a number of situations have been assessed, we often want to order
them in order to decide which should command our attention. [The risk value and the
certainty of information may both influence the ordering.]
Vinyl chloride gas has been found to cause angiosarcomas both in people and in
rats. Since an angiosarcoma is a rare tumor, the risk ratio (the ratio of the observed
number of cancers in those exposed to the number expected by chance) is of order
100 or more in some cases. If an angiosarcoma is seen in a vinyl chloride worker,
the attribution to vinyl chloride exposure is almost certain. On the other hand, the
number of persons who have been heavily exposed to vinyl chloride is small. . . . Now
that exposures in the workplace have been greatly reduced, . . . no more than one
cancer is expected in several years.
We can compare this with the possible cancer incidence that was predicted by
the Food and Drug Administration (FDA) in 1977 from use of saccharin. This was
based on experiments with rats leading to an additional uncertainty. More people
ate saccharin than were exposed to vinyl chloride, and nearly 500 cancers per year
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Public Health Ethics 93
were estimated for the United States alone. For vinyl chloride . . . the individual risk
is now low, yet there is considerable certainty that there is a risk. For saccharin the
risk is higher, but there is more uncertainty about the value of the risk. Some . . . may
demand that more attention be given to the risk from vinyl chloride than to the risk
from saccharin; for other persons or situations the reverse may be the case.
Comparison of Risks
The purpose of risk assessment is to be useful in making decisions about the hazards
causing risks, and so it is important to gain some perspective about the meaning of
the magnitude of the risk. Comparisons can be useful. . . . It is particularly helpful to
compare risks that are calculated in a similar way. For example, the risk of traveling
by automobile can be compared to that of traveling by horse with the use of historical data. . . .
Contrasting Risks
Objections have been raised to risk comparisons on the ground that they are misleading. This would be true if all risks of the same numerical magnitude were treated
in the same way. But they are not. In some cases it is useful to contrast risks to
indicate the different ways in which they are treated in society. . . .
[For example, the] small risk of a large accident in a nuclear power plant can . . .
be contrasted with the more numerous small accidents or events that occur every
day in the mining, transport, and burning of coal. One feature that is brought out
clearly here is that we do not always compare the risk averaged over time, but worry
more about risks that are sharply peaked in time.
Expression of Risks
Just as a comparison of risks is an aid in understanding them, so is a careful selection of the methods of expression. It is hard to comprehend the statistical (stochastic) nature of risk. . . . When we talk about the expectation of life being 79 years (for
a nonsmoking male in the United States) we all know that some die young and that
many live to be over 80. Thus the expression of a risk as the reduction of life expectancy caused by the risky action conveys some of the statistical concept essential
to its understanding. . . .
It is important to realize that risks appear to be very different when expressed
in different ways. One example of this can be seen if we consider the cancer risk
to those persons exposed to radionuclides after the Chernobyl disaster. [Across
the lifetimes of those 24,000 persons living between 3 and 15 kilometers from the
plant, we can expect 131 cancers; in comparison, 31 people within the plant itself
died within 60 days of acute radiation sickness and burns.] Dividing the 131 again by
the approximately 5,000 cancer deaths expected from other causes, the accident
caused only a 2.6% increase in cancer. This seems small compared to the 30%
of cancers attributable to cigarette smoking. [In the total population of Ukraine
and Byelorussia, the 3,500 extra cancers caused by Chernobyl will result in an]
insignificant increase of 0.0047%. Of course, none of the methods of expressing
the risk can be considered right in an absolute sense. Indeed, it is our belief that
a full understanding of the risk involves expressing it in as many different ways as
possible.
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94 Foundations of Public Health Law and Ethics
Cost of Reducing a Risk
Another interesting and instructive way of comparing risks is by comparing the
amount people have paid in the past to reduce them. . . . Society is willing to spend
more on environmental protection to prevent cancer (over $1 million per life) than
on cures (about $50,000 per life with the high value of $200,000 for kidney dialysis
raising some objections). This ratio is in rough accord with the maxim an ounce of
protection is better than a pound of cure. People are willing to spend still more on
radiation protection at nuclear power plants and on waste disposal. Economists and
others often argue that efficiency depends on adjusting society until the amounts
spent to save lives in different situations are equalized. It seems to us that society
does not work that way. People are aware of the order of magnitude of these differences, and approve of them. Nonetheless, we believe that providing this information
to a decision-maker is essential for an informed decision.

As Wilson and Crouch note, the varying prices that society is willing to pay to mitigate various risks might be seen as a reflection of
underlying societal values or as an indication of troubling economic
inefficiencies. Economists generally take the latter view. Using quantitative reasoning, they evaluate public health regulations and seek to
understand both the costs of an intervention and its effects. Economic
costs include the resources of agencies that must devise and implement
the regulation (transaction costs), added expenses to individuals and
businesses subject to the regulation (direct costs), and lost opportunities to intervene with different, potentially more effective techniques
(opportunity costs). Similarly, economists seek to understand the
effects of regulationthe effectiveness of the intervention in the real
world and its societal benefits. Using this cost-effectiveness analysis
(CEA), health economists can compare the estimated costs and benefits
of various proposed interventions. According to standard economic
theory, government should favor regulatory responses that maximize
health benefits (e.g., saving the most years of life or quality-adjusted
years of life) at the least cost.
Much of the CEA scholarship relies on a classic empirical study
by John F. Morrall III (1986) purporting to show that government
often spends exorbitant sums to avert very small risks. However,
Lisa Heinzerling offers a powerful critique of Morralls methods and
thereby calls into question some of the risk scholarship that relies on
his findings (Heinzerling 1998b; Ackerman and Heinzerling 2004).
Heinzerling points out that the work by Morrall and others systemPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Public Health Ethics 95
atically downgrades the importance of regulation aimed at preventing
long-latency diseases and long-term ecological harm. She also suggests
that Morralls estimates are inflated because they reflect only one regulatory benefit (cancer sickness and death) without taking into account
other regulatory benefits, such as preventing respiratory illness and
ecological harms: Given all the benefits, some quantifiable, some not,
most of the regulatory programs that have been portrayed as clunkers are not just barely cost-justified. They are bargains (Heinzerling
1998a, 42).
Methodological debates aside, not everyone believes that sterile
estimates of costs and benefits represent a fair way of evaluating policies. Many argue that market exchanges should not be the principal
measure of the value of human lives. In particular, critics argue that
public health policies cannot be compressed, through ever more complex economic methods, into a single aggregate number, such as costs
per quality-adjusted life saved. Before spending five years working to
pursue smarter regulation as a top official with the Bush administrations Office of Management and Budget, John D. Graham reminded
those advocating greater reliance on CEA that noneconomic factors
are nonetheless relevant to regulatory decisions. He emphasized what
is obvious but sometime forgotten: Cost-effectiveness is only one of
the considerations that should inform allocations of limited resources.
Other important factors include: notions of justice, equity, personal
freedom, political feasibility, and the constraints of current law. It is
important for advocates of CEA to recognize that what they have to
offer should inform rather than dictate allocation of resources within
the health sector of the economy (Graham et al. 1998, 149).
Recommended Readings
From Bioethics to Public Health Ethics
Buchanan, David R. 2008. Autonomy, paternalism, and justice: Ethical priorities in public health. American Journal of Public Health 98: 1520. (Examines the underlying currents of paternalism in public health and incorporates a discussion of justice principles)
Kass, Nancy. 2001. An ethics framework for public health. American Journal
of Public Health 91: 177682. (Introduces public health ethics primarily in
reference to public health programs and provides a set of six framing questions for analyzing the ethics of a particular program)
Thomas, James C., Michael Sage, Jack Dillenberg, and V. James Guillory.
2002. A code of ethics for public health. American Journal of Public Health
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96 Foundations of Public Health Law and Ethics
92: 105759. (Reviews efforts to create an ethical code for public health and
the necessary components found in one such code)
Public Health Paternalism: A Case Study on
Motorcycle Helmet Laws
Dworkin, Gerald. 2008. Paternalism. In Philosophy of Law, ed. Joel Feinberg
and Jules Coleman, 28191. 8th ed. Belmont, CA: Wadsworth Publishing.
(Provides the best-known scholarly examination of paternalism)
Ethical Reasoning in Risk Regulation
Arrow, Kenneth J., Maureen L. Cropper, George C. Eads, Robert W. Hahn,
Lester B. Lave, Roger G. Noll, Paul R. Portney, et al. 1996. Is there a role for
benefit-cost analysis in environmental, health, and safety regulation? Science 272: 22122. (Explains the applications of cost-benefit analysis to
health and environmental regulatory policy and gives eight guiding principles for the use of cost-benefit analysis)
Rodricks, Joseph V. 1994. Risk assessment, the environment, and public
health. Environmental Health Perspectives 102: 25864. (Provides an introduction to the science of risk assessment and argues for broader use of risk
assessment principles and methods in public health)
Sunstein, Cass R. 1996. Health-health tradeoffs. University of Chicago Law
Review 63: 153371. (Explores the problem that arises when averting a
given health risk exacerbates another)
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Part Two
The Law and
the Publics Health
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Photo 6. This photograph depicts a dump in Washington State, where at one
time the nation sent much of its nuclear waste. In the 1980s, the federal government attempted to facilitate cooperative agreements between states for
nuclear waste disposal. But the Supreme Court held in New York v. United
States, 505 U.S. 144 (1992), that Congress had exceeded its authority in
penalizing states for failure to participate in the program. Reproduced by
permission, Roger Ressmeyer/Corbis, October 18, 1988.
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99
The United States Constitution provides the framework for the distribution of governmental power. It divides power between the federal
government and the states, separates power among the three branches
of government, and limits governmental power over individuals to protect a sphere of liberty (see figure 4). Federal and state public health
agencies carry out public health functions within these constitutional
boundaries. Governmental actors must use their power to protect and
promote the publics health according to this constitutional design and
within the scope of legislative mandates. When disputes regarding
governmental powers arise, courts often determine the lawfulness of
particular public health interventions.
In thinking about government intervention to promote the common
good, we should ask at least three important questions: (1) Does government have a duty to protect the publics health and safety? (2) What
power does government have to regulate in the name of public health?
(3) What limits exist in the exercise of public health powers? These
three issuesgovernmental duties, powers, and limitsare central to
understanding the role of public health authorities in the constitutional
design. In the next chapter, I evaluate the third issueconstitutional
restraints on the exercise of public health power. The readings in this
chapter examine governments duty and power and also explore a corollary question: Which governmentfederal or statemay act to avert a
health threat? The first portion discusses American federalismthe allocation of powers between federal and state governmentsand examines
Thr ee
Public Health Duties
and Powers
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100 The Law and the Publics Health
the pivotal role played by federal preemption of state regulation, which
can virtually foreclose effective public health governance. In the second
section, the readings offer historical and modern-day perspectives on the
duties of government to safeguard the publics health and safety. And the
next two sections explore state and federal public health powers.
The chapter concludes by returning to the contentious issue of
public health federalism and the Supreme Courts resuscitation of the
reserved powers doctrine to block federal public health regulation.
The Courts rulings have placed significant obstacles in the way of
public health governance: preemption impedes state regulation, while
reserved powers impede federal regulation. Yet though the current
judicial environment is unfavorable toward regulation, public health
governance is not impossible.
I. American Federalism: The Antiregulatory
Effects of Federal Preemption
One of the Constitutions primary functions is to divide governmental powers between the federal and state governments. Under the
U.S.
Constitution
Equal
Protection
Right to
Life, Liberty,
and Property Freedom
of
Expression
Right
to
Privacy
Procedural
Due
Process
Legislative Executive Judicial
State
and Local Federal
Figure 4. Constitutional triangle.
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Public Health Duties and Powers 101
Constitution, the federal government is a government of limited powers:
that is, for the government to act, the basis of its power must be enumerated in the Constitution. The Constitution grants the federal government
a number of powers, perhaps the most expansive being the power to
regulate interstate and foreign commerce (see Article I, section 8, clause
3). Many federal public health statutes were passed under Congresss
power to regulate interstate commerce, including laws governing food
and drugs, occupational health and safety, and the environment. States,
however, retain those powers inherent in sovereign governments but not
delegated to the federal government by the Constitution. Two powers
retained by the states are particularly relevant in public health law: the
police power (protecting the health, safety, and morals of the community) and the parens patriae power (protecting the interests of minors and
incompetent persons). The police powers are vast and enable states to regulate broadly to protect the health, safety, and morals of the population.
Federalism acts as a sorting device, helping to determine when a
matter is exclusively or primarily a federal or state concern. Sometimes
the boundary lines are uncertain, and in such circumstances decisive
action can be thwarted. One of the principal questions in times of
a public health emergency is, Who is in charge? During the Gulf
Coast hurricanes, for example, lines of authority between the federal
government, the state, and the city were blurred, which hampered the
emergency response.
Conflicts between national and state regulation are resolved in favor
of the federal government because federal law is supreme. The Constitutions Supremacy Clause declares that the Constitution, and the Laws
of the United States . . . and all Treaties made . . . shall be the supreme
law of the Land (Article VI). Consequently, Congress can enact legislation with the express or implied intent to supersede state law.
The doctrine of preemption holds that if Congress has enacted legislation on a particular subject, it is controlling over state or local laws.
At times such federal action advances effective public health governance. For example, federal law sometimes sets a floor of minimum
protection and allows states to go further. As a result, there are myriad
examples of vigorous state regulation addressing health, safety, and
the environment, even in the same sphere as federal legislation. But in
recent years the courts have interpreted some federal statutes to virtually preclude state regulation. The recurrent debate on the interplay
of federal and state regulation has radically shifted from regulatory
compliance to federal preemption (Sharkey 2007, 1018).
Preemption has had antiregulatory effects in fields ranging from
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102 The Law and the Publics Health
tobacco, occupational hazards, and motor vehicle safety to unsafe
foods, pharmaceuticals, and medical devices. Indeed, from 2001 to
2006, Congress enacted twenty-seven statutes that preempted state
health, safety, and environmental regulations or other social policy
(U.S. Congress 2006). The effects of federal preemption are not simply
to block direct state regulation but also to thwart common law tort
actions to redress harms from unsafe products (see chapter 6).
In several cases in the past decade, the Supreme Court has held that
federal laws preempt state tobacco control laws, stymieing state public
health efforts. In Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001),
the Court ruled that the Federal Cigarette Labeling and Advertising Act
preempts Massachusetts regulations governing outdoor and point-ofsale cigarette advertising that were intended to prevent youth exposure
to tobacco ads. (For a discussion of the commercial speech aspects of
Lorillard, see chapter 9.) In 2008, the Supreme Court returned to the
issue of federal preemption of state tobacco regulation in Rowe v. New
Hampshire Motor Transport Association, 128 S. Ct. 989 (2008). At
issue was whether the Federal Aviation Administration Authorization
Act of 1994 (FAAAA ) preempts Maines Tobacco Delivery Law, which
was designed to prevent Internet sales to minors. Maines law required
Internet tobacco retailers to use a delivery service that verifies the buyers age. The Court held that Maines law was preempted, rejecting the
states argument that it helps prevent minors from obtaining cigarettes,
and thereby protects its citizens health. Justice Stephen Breyer stressed
that the FAAAA does not create a public health exception.
The Supreme Court has also held that some tort actions, based on
state common law, are preempted by federal laws and regulations.
In these cases, manufacturers have won by arguing that compliance
with federal regulations for a product provides not only a compliance defense but also a preemptive shield against liability. In Geier v.
American Honda Motor Co., Inc., 529 U.S. 861 (2000), Alexis Geier
sought damages under District of Columbia tort law for injuries he
incurred in a crash while driving a 1987 Honda Accord that did not
have an air bag. At the time, federal regulations required automobile
manufacturers to equip some, but not all, of their vehicles with passive
restraints. The Supreme Court held that the suit was preempted, reasoning that the imposition of liability would conflict with the objectives
of the federal law. Two years later, however, in Sprietsma v. Mercury
Marine, 537 U.S. 51 (2002), the Court held that a preemption provision
in the Federal Boat Safety Act did not bar a husband from suing the
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Public Health Duties and Powers 103
manufacturer of a ski boat for the death of his wife. The boats propeller blades had not been equipped with a guard, and Jeanne Sprietsma
died after she fell overboard and was struck by the propeller.
Similarly, the Supreme Court has turned its attention to preemption in the field of drug and medical device safety. In Buckman Co. v.
Plaintiffs Legal Committee, 531 U.S. 341 (2001), the Court held that
state tort law claims asserting that a medical device manufacturer is liable to injured consumers for having committed fraud on the FDA conflicts with the FDAs statutory responsibility to police fraud itself. The
Medical Device Amendments (MDA) to the Federal Food, Drug, and
Cosmetic Act (FDCA) therefore implicitly preempted the tort action.
The Court recently revisited implied preemption of fraud-on-the-FDA
in Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008). In WarnerLambert, a group of Michigan residents sued for injuries caused by
the diabetes drug Rezulin. At issue was a Michigan statute that shields
pharmaceutical manufacturers from liability for harms caused by FDAapproved drugs, but removes that shield if there is evidence that the
FDA approval was fraudulently secured. The Second Circuit Court of
Appeals distinguished the case from Buckman, finding that the tort
action did not conflict with the FDAs ability to police fraud. Because
the eight Supreme Court justices hearing the case were evenly divided,
the circuit decision was affirmed. While the suit will now be allowed to
move forward, the split decision creates no precedent; thus the underlying legal issues have not been resolved by the Court.
The MDA, in addition to creating the federal scheme for policing
compliance that implicitly preempts fraud-on-the-FDA claims under
Buckman, also expressly preempts state regulation of medical devices.
Recently, the Court has grappled with the question of whether state
tort claims are preempted by state regulations that address medical
devices. In Medtronic v. Lohr, 518 U.S. 470 (1996), the Court held that
FDA approval of a pacemaker does not preempt claims of defective
design under state tort law when the device had not been approved
under the FDAs premarket approval process for new devices, but had
instead been grandfathered in as a device substantially equivalent
to devices on the market when the MDA was enacted. In 2008, the
Supreme Court reconsidered the scope of preemption for medical
devices, this time in a products liability case involving a device that
had undergone the premarket approval process. The plaintiff in that
case, Charles Riegel, brought suit after a balloon catheter burst during his angioplasty. Justice Antonin Scalia, writing for the Court in
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104 The Law and the Publics Health
Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), said that the plaintiffs tort action could not proceed, because the MDA bars common
law claims challenging the safety or effectiveness of a medical device
marketed in a form that received premarket approval from the FDA.
Justice Ruth Bader Ginsburg, the sole dissenter in the case, favored an
approach based on sound regulation for the publics health and safety
and argued, Preemption analysis starts with the assumption that the
historic police powers of the States are not to be superseded . . . unless
that was the clear and manifest purpose of Congress. She referred to
a series of high-profile medical device failures that caused extensive
injuries and loss of life, most notably the deaths and injuries from the
Dalkon Shield intrauterine device (128 S. Ct. at 1013).
Lohr and Riegel both deal with the reach of the express preemption
provision for medical devices. But the recent wave of preemption decisions has raised the question of whether and when FDA approval of
pharmaceuticals similarly preempts state court action. In March 2009,
the Court heard Wyeth v. Levine, 129 S. Ct. 1187 (2009). Diana Levine
claimed that Wyeth was liable for the injury she sustained when she
inadvertently received an intra-arterial injection of an antinausea drug
while a health care provider was attempting to give the drug intravenously. After the injection, Levine developed gangrene and her arm had
to be amputated. The Court considered whether the FDAs approval of
the drug and its label preempted Levines failure-to-warn claim. Wyeth
argued that it could not have more adequately warned of the risk of
administering its drug in the use that led to Diana Levines injury. The
company asserted that it could not alter a drug label that had been
approved by the FDA without rendering the drug mislabeled under
the federal FDCA. Further, it argued that compliance with heightened
state law requirements would obstruct the purposes of the FDCA by
substituting a jurys perceptions of drug safety for FDA expert assessment. The Court disagreed, and instead ruled that Wyeth could have
altered the label under a regulation that allows drug safety information
to be added while FDA approval is pending. The Court also found no
evidence that Congress intended to preempt state law products liability.
Justice Stevens wrote for the majority, If Congress thought state-law
suits posed an obstacle to its objectives, it surely would have enacted
an express pre-emption provision at some point during the FDCAs
70-year history, as it did for medical devices (128 S. Ct. at 1200).
The Supreme Courts preemption jurisprudence, as it has developed
over the past decade, demonstrates the potentially broad sweep of fedPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Public Health Duties and Powers 105
eral supremacy that enables Congress to override state regulation to
promote the publics health.
II. The Negative Constitution: Governments Duty
to Protect Health and Safety
Conventional wisdom holds that the Constitution places no affirmative duty on the government to protect individuals from harm or to
promote the common good. Under this view, the Constitution is purely
negative or defensive in character, protecting individuals against
governments overreaching; it places no positive obligation on government to act. But influential scholars question this conventional position,
arguing that states historically have had responsibilities to protect the
populace. Professor Wendy Parmet (1992), for example, suggests that
protection from infectious diseases was so important to our ancestors
that governments duty to prevent epidemics was in effect assumed. The
DeShaney and Castle Rock cases, excerpted below, make clear that
the modern Supreme Court has a very different understanding of the
extent to which such obligations are imposed under the Constitution.
The tragic case of Joshua DeShaney, a victim of child abuse, sets
the backdrop for a landmark Supreme Court decision that limits the
responsibility of government to protect the health of citizens. Professors
Louis M. Seidman and Mark V. Tushnet (1996, 52) describe the facts
of DeShaney:
In Joshua DeShaneys first year of life, his parents divorced, and a court
granted custody of the infant to his father, Randy DeShaney. For the
next four years, the child lived through a nightmare of pain and violence.
Randy DeShaney beat his son repeatedly and with increasing savagery.
Eventually, the toddler fell into a life-threatening coma, and emergency
brain surgery revealed injuries, inflicted over an extended period, that
left Joshua permanently and severely retarded.
As these tragic events unfolded, many of them came to the attention of
county officials in the Wisconsin community where the DeShaneys lived. A
battery of judges, lawyers, pediatricians, psychologists, police officers, and
social workers became involved in Joshuas case. With Kafkaesque efficiency, these functionaries performed their particular assigned task within
the social welfare bureaucracy. They held hearings, filed reports, completed
forms. Yet despite all the purposeful bustling and the show of activity and
concern, no one actually intervened to stop the violence until it was too late.
After the damage had already been done, Joshua and his mother filed
an action against [Winnebago County] in United States District Court.
They argued that county officials had deprived Joshua of his liberty withPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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106 The Law and the Publics Health
out due process of law, thereby violating his rights under the Fourteenth
Amendment.
If government officials had beaten Joshua themselves, his suiteven
against their employersmight well have succeeded. Supreme Court decisions have made it clear that government agents who unjustifiably inflict
physical injury violate the Due Process Clause. But because Joshua and
his mother could not claim that the injury was directly inflicted by state
officials, the suit foundered on the so-called state action requirement.
The Supreme Courts decision expresses a vision of a negative constitution according to which the judiciary is reluctant to impose on government an affirmative duty to safeguard the well-being of its citizens.
The dissenting opinion of Justice Harry A. Blackmun conveys an alternative view of the constitutional obligation to protect vulnerable citizens.
This dissent also expresses a sense of moral outrage at the notion that
government cannot be held accountable for a failure to act in the interest
of a citizens health. As Justice Blackmun said, simply, Poor Joshua.
The Supreme Court returned to the issue of governments duties to
protect citizens in Castle Rock v. Gonzales. The case poses a set of
heart-wrenching facts, with important public health and constitutional
implications. Simon Gonzales, who had a history of erratic and suicidal
behavior, violated a restraining order by abducting his three young
daughters. His estranged wife, Jessica Gonzales, made repeated pleas to
the police to enforce the restraining order, but to no avail. Nearly eight
hours after she had first contacted police, her husband opened fire on the
police station with a semiautomatic handgun he purchased after abducting his daughters. He was fatally shot, and police found the bodies of
the three young girls, murdered by their father, in the cab of his truck.
The Supreme Court held that state law did not create an entitlement to enforce restraining orders issued in response to domestic
abuse. Justice Scalia, writing for the majority, said that the arrest of a
person who violates a protective order is purely discretionary. However,
the Colorado statute declares that a peace officer shall arrest a person who violates a restraining order. If the state had promised its eligible citizens a service (e.g., education) or a benefit (e.g., Medicaid),
there certainly would be an entitlement. Police protection against
violence is just as valuable as any other government service or benefit.
Unfortunately, the Court made it clear that the Constitution does not
offer vulnerable people a remedy, even in the face of the direst need.
When reading DeShaney and Castle Rock, consider whether the history and text genuinely support the view that the Constitution rarely
imposes a responsibility on government to protect individuals and
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Public Health Duties and Powers 107
populations. Even if the Constitution imposes no affirmative obligations, is there a reason, based on principle, for the distinction between
governments acts and omissions? Suppose a public health department,
knowing there is a high risk of an infectious disease outbreak, does
nothing to inform the public or intervene. Should the agencys failure to
prevent the outbreak be actionable under the due process clause of the
Fourteenth Amendment? Finally, if government does act to establish a
protective agency (e.g., child welfare or public health), should citizens
have a reasonable expectation that they can rely on that agency to safeguard their health and safety?
DeShaney v. Winnebago County Department of
Social Services*
Supreme Court of the United States
Decided February 22, 1989
Chief Justice REHNQUIST delivered the opinion of the Court.
Petitioner [Joshua DeShaney] sued respondents [Winnebago County social workers and other officials] claiming that their failure to act deprived him of his liberty
in violation of the Due Process Clause of the Fourteenth Amendment to the United
States Constitution. We hold that it did not. . . .
The Due Process Clause of the Fourteenth Amendment provides that [n]o State
shall . . . deprive any person of life, liberty, or property, without due process of
law. Petitioners contend that the State deprived Joshua of his liberty interest in
free[dom] from . . . unjustified intrusions on personal security, by failing to provide
him with adequate protection against his fathers violence. The claim is one invoking
the substantive rather than the procedural component of the Due Process Clause;
petitioners do not claim that the State denied Joshua protection without according
him appropriate procedural safeguards, but that it was categorically obligated to
protect him in these circumstances. . . .
. . . Nothing in the language of the Due Process Clause itself requires the State
to protect the life, liberty, and property of its citizens against invasion by private
actors. The Clause is phrased as a limitation on the States power to act, not as a
guarantee of certain minimal levels of safety and security. It forbids the State itself
to deprive individuals of life, liberty, or property without due process of law, but
its language cannot fairly be extended to impose an affirmative obligation on the
State to ensure that those interests do not come to harm through other means.
Nor does history support such an expansive reading of the constitutional text. Like
its counterpart in the Fifth Amendment, the Due Process Clause of the Fourteenth
Amendment was intended to prevent government from abusing [its] power, or
employing it as an instrument of oppression. . . . Its purpose was to protect the
people from the State, not to ensure that the State protected them from each other.
*489 U.S. 189 (1989).
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108 The Law and the Publics Health
The Framers were content to leave the extent of governmental obligation in the
latter area to the democratic political processes.
Consistent with these principles, our cases have recognized that the Due Process
Clause generally confers no affirmative right to governmental aid, even where such
aid may be necessary to secure life, liberty, or property interests of which the government itself may not deprive the individual. . . . As we said in Harris v. McRae:
Although the liberty protected by the Due Process Clause affords protection
against unwarranted government interference . . . , it does not confer an entitlement
to such [governmental aid] as may be necessary to realize all the advantages of that
freedom. 448 U.S. 297, 31718 (1980). If the Due Process Clause does not require
the State to provide its citizens with particular protective services, it follows that
the State cannot be held liable under the Clause for injuries that could have been
averted had it chosen to provide them. As a general matter, then, we conclude that
a States failure to protect an individual against private violence simply does not
constitute a violation of the Due Process Clause.
Petitioners contend, however, that even if the Due Process Clause imposes no
affirmative obligation on the State to provide the general public with adequate protective services, such a duty may arise out of certain special relationships created
or assumed by the State with respect to particular individuals. Petitioners argue that
such a special relationship existed here because the State knew that Joshua faced
a special danger of abuse at his fathers hands, and specifically proclaimed, by word
and by deed, its intention to protect him against that danger. Having actually undertaken to protect Joshua from this dangerwhich petitioners concede the State played
no part in creatingthe State acquired an affirmative duty, enforceable through
the Due Process Clause, to do so in a reasonably competent fashion. Its failure to
discharge that duty, so the argument goes, was an abuse of governmental power
that so shocks the conscience, as to constitute a substantive due process violation.
We reject this argument. It is true that in certain limited circumstances the
Constitution imposes upon the State affirmative duties of care and protection with
respect to particular individuals. In Estelle v. Gamble, 429 U.S. 97 (1976), we recognized that the Eighth Amendments prohibition against cruel and unusual punishment, made applicable to the States through the Fourteenth Amendments Due
Process Clause, requires the State to provide adequate medical care to incarcerated
prisoners. We reasoned that because the prisoner is unable by reason of the deprivation of his liberty [to] care for himself, it is only just that the State be required
to care for him. 429 U.S. at 10304.
In Youngberg v. Romeo, 457 U.S. 307 (1982), we extended this analysis beyond
the Eighth Amendment setting, holding that the substantive component of the
Fourteenth Amendments Due Process Clause requires the State to provide involuntarily committed mental patients with such services as are necessary to ensure their
reasonable safety from themselves and others. . . .
Taken together, [these cases] stand only for the proposition that when the State
takes a person into its custody and holds him there against his will, the Constitution
imposes upon it a corresponding duty to assume some responsibility for his safety
and general well-being. . . . The affirmative duty to protect arises . . . from the limitation which it has imposed on his freedom to act on his own behalf. In the substantive
due process analysis, it is the States affirmative act of restraining the individuals
freedom to act on his own behalfthrough incarceration, institutionalization, or
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Public Health Duties and Powers 109
other similar restraint of personal libertywhich is the deprivation of liberty triggering the protections of the Due Process Clause, not its failure to act to protect his
liberty interests against harms inflicted by other means. . . .
[This] analysis simply has no applicability in the present case. Petitioners concede that the harms Joshua suffered occurred . . . while he was in the custody of his
natural father, who was in no sense a state actor. While the State may have been
aware of the dangers that Joshua faced in the free world, it played no part in their
creation, nor did it do anything to render him any more vulnerable to them. That the
State once took temporary custody of Joshua does not alter the analysis, for when
it returned him to his fathers custody, it placed him in no worse position than that in
which he would have been had it not acted at all; the State does not become the permanent guarantor of an individuals safety by having once offered him shelter. Under
these circumstances, the State had no constitutional duty to protect Joshua . . .
[and] its failure to do sothough calamitous in hindsightsimply does not constitute
a violation of the Due Process Clause.
Judges and lawyers, like other humans, are moved by natural sympathy in a case
like this to find a way for Joshua and his mother to receive adequate compensation for the grievous harm inflicted upon them. But before yielding to that impulse,
it is well to remember once again that the harm was inflicted not by the State of
Wisconsin, but by Joshuas father. The most that can be said of the state functionaries in this case is that they stood by and did nothing when suspicious circumstances
dictated a more active role for them. In defense of them it must also be said that had
they moved too soon to take custody of the son away from the father, they would
likely have been met with charges of improperly intruding into the parent-child relationship, charges based on the same Due Process Clause that forms the basis for the
present charge of failure to provide adequate protection.
The people of Wisconsin may well prefer a system of liability which would place
upon the State and its officials the responsibility for failure to act in situations such
as the present one. They may create such a system, if they do not have it already, by
changing the tort law of the State in accordance with the regular lawmaking process.
But they should not have it thrust upon them by this Courts expansion of the Due
Process Clause of the Fourteenth Amendment.
Affirmed.
Justice BLACKMUN, dissenting.
Today, the Court purports to be the dispassionate oracle of the law, unmoved
by natural sympathy. But, in this pretense, the Court itself retreats into a sterile
formalism which prevents it from recognizing either the facts of the case before it or
the legal norms that should apply to those facts. . . . The facts here involve not mere
passivity, but active state intervention in the life of Joshua DeShaneyintervention that triggered a fundamental duty to aid the boy once the State learned of the
severe danger to which he was exposed.
The Court fails to recognize this duty because it attempts to draw a sharp and
rigid line between action and inaction. But such formalistic reasoning has no place in
the interpretation of the broad and stirring Clauses of the Fourteenth Amendment.
Indeed, I submit that these Clauses were designed, at least in part, to undo the formalistic legal reasoning that infected antebellum jurisprudence.
Like the antebellum judges who denied relief to fugitive slaves, the Court today
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110 The Law and the Publics Health
claims that its decision, however harsh, is compelled by existing legal doctrine. On
the contrary, the question presented by this case is an open one, and our Fourteenth
Amendment precedents may be read more broadly or narrowly depending upon how
one chooses to read them. Faced with the choice, I would adopt a sympathetic
reading, one which comports with dictates of fundamental justice and recognizes
that compassion need not be exiled from the province of judging.
Poor Joshua! Victim of repeated attacks by an irresponsible, bullying, cowardly,
and intemperate father, and abandoned by respondents who placed him in a dangerous predicament and who knew or learned what was going on, and yet did essentially
nothing except, as the Court revealingly observes, dutifully recorded these incidents in [their] files. It is a sad commentary upon American life, and constitutional
principlesso full of late of patriotic fervor and proud proclamations about liberty
and justice for allthat this child, Joshua DeShaney, now is assigned to live out
the remainder of his life profoundly retarded. Joshua and his mother, as petitioners
here, deservebut now are denied by this Courtthe opportunity to have the facts of
their case considered in the light of . . . constitutional protection.
Castle Rock v. Gonzales*
Supreme Court of the United States
Decided June 27, 2005
Justice SCALIA delivered the opinion of the Court.
The horrible facts of this case are contained in the complaint that respondent
Jessica Gonzales filed in Federal District Court. [She] alleges that petitioner, the
town of Castle Rock, Colorado, violated the Due Process Clause of the Fourteenth
Amendment to the United States Constitution when its police officers, acting pursuant to official policy or custom, failed to respond properly to her repeated reports
that her estranged husband was violating the terms of a restraining order. . . .
The Fourteenth Amendment . . . provides that a State shall not deprive any person of life, liberty, or property, without due process of law. . . . Respondent claims . . .
that she had a property interest in police enforcement of the restraining order
against her husband; and that the town deprived her of this property without due
process by having a policy that tolerated nonenforcement of restraining orders. . . .
The procedural component of the Due Process Clause does not protect everything that might be described as a benefit: To have a property interest in a benefit,
a person clearly must have more than an abstract need or desire and more than a
unilateral expectation of it. He must, instead, have a legitimate claim of entitlement
to it. Such entitlements are not created by the Constitution. Rather, they are created
and their dimensions are defined by existing rules or understandings that stem from
an independent source such as state law. . . .
. . . The ultimate issue [is] whether what Colorado law has given respondent constitutes a property interest for purposes of the Fourteenth Amendment. [Stated
differently, the central question is] whether Colorado law gave respondent a right to
police enforcement of the restraining order. . . .
*545 U.S. 748 (2005).
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Public Health Duties and Powers 111
The critical language in the restraining order came not from any part of the order
itself . . . but from the preprinted notice to law-enforcement personnel that appeared
on the back of the order. That notice effectively restated the statutory provision
describing peace officers duties related to the crime of violation of a restraining
order. At the time of the conduct at issue in this case, that provision read as follows:
(a) Whenever a restraining order is issued, the protected person shall be provided
with a copy of such order. A peace officer shall use every reasonable means to
enforce a restraining order.
(b) A peace officer shall arrest, or, if an arrest would be impractical under the
circumstances, seek a warrant for the arrest of a restrained person when the
peace officer has information amounting to probable cause that:
(I) The restrained person has violated or attempted to violate any provision
of a restraining order; and
(II) The restrained person has been properly served with a copy of the
restraining order or the restrained person has received actual notice of the
existence and substance of such order.
(c) In making the probable cause determination described in paragraph (b) of this
subsection (3), a peace officer shall assume that the information received from
the registry is accurate. A peace officer shall enforce a valid restraining order
whether or not there is a record of the restraining order in the registry. (Colo.
Rev. Stat. 18-6-803.5[3] [emphases added]) . . .
We do not believe that these provisions of Colorado law truly made enforcement
of restraining orders mandatory. A well established tradition of police discretion has
long coexisted with apparently mandatory arrest statutes. . . .
Against that backdrop, a true mandate of police action would require some stronger indication from the Colorado Legislature than shall use every reasonable means
to enforce a restraining order (or even shall arrest . . . or . . . seek a warrant). . . .
It is hard to imagine that a Colorado peace officer would not have some discretion to
determine thatdespite probable cause to believe a restraining order has been violatedthe circumstances of the violation or the competing duties of that officer or his
agency counsel decisively against enforcement in a particular instance. The practical
necessity for discretion is particularly apparent in a case such as this one, where
the suspected violator is not actually present and his whereabouts are unknown. . . .
Respondent does not specify the precise means of enforcement that the Colorado
restraining-order statute assertedly mandated. . . . Such indeterminacy is not the
hallmark of a duty that is mandatory. Nor can someone be safely deemed entitled to
something when the identity of the alleged entitlement is vague. . . . After the warrant
is sought, it remains within the discretion of a judge whether to grant it, and after it is
granted, it remains within the discretion of the police whether and when to execute it.
Respondent would have been assured nothing but the seeking of a warrant. This is not
the sort of entitlement out of which a property interest is created. . . .
Even if the statute could be said to have made enforcement of restraining orders
mandatory because of the domestic-violence context of the underlying statute,
that would not necessarily mean that state law gave respondent an entitlement to
enforcement of the mandate. Making the actions of government employees obligatory can serve various legitimate ends other than the conferral of a benefit on a
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112 The Law and the Publics Health
specific class of people. The serving of public rather than private ends is the normal
course of the criminal law. . . .
Respondents alleged interest stems only from a States statutory schemefrom
a restraining order that was authorized by and tracked precisely the statute. . . . She
does not assert that she has any common-law or contractual entitlement to enforcement. If she was given a statutory entitlement, we would expect to see some indication of that in the statute itself. Although Colorados statute spoke of protected
person[s] such as respondent, it did so in connection with matters other than a right
to enforcement. . . . The protected persons express power to initiate civil contempt
proceedings contrasts tellingly with the mere ability to request initiation of criminal contempt proceedingsand even more dramatically with the complete silence
about any power to request (much less demand) that an arrest be made.
The creation of a personal entitlement to something as vague and novel as
enforcement of restraining orders cannot simply g[o] without saying. We conclude
that Colorado has not created such an entitlement.
Even if we were to think otherwise concerning the creation of an entitlement by
Colorado, it is by no means clear that an individual entitlement to enforcement of
a restraining order could constitute a property interest for purposes of the Due
Process Clause. Such a right would not, of course, resemble any traditional conception of property. Although that alone does not disqualify it from due process protection, . . . the right to have a restraining order enforced does not have some ascertainable monetary value, as even our [previous] cases have implicitly required.
Perhaps most radically, the alleged property interest here arises incidentally, not
out of some new species of government benefit or service, but out of a function that
government actors have always performedto wit, arresting people who they have
probable cause to believe have committed a criminal offense. . . .
We conclude, therefore, that respondent did not, for purposes of the Due Process
Clause, have a property interest in police enforcement of the restraining order
against her husband. . . .
In light of todays decision and that in DeShaney, the benefit that a third party
may receive from having someone else arrested for a crime generally does not trigger protections under the Due Process Clause, neither in its procedural nor in its
substantive manifestations. . . .
Justice STE VENS, with whom Justice GINSBURG joins, dissenting.
The central question in this case is . . . whether, as a matter of Colorado law,
respondent had a right to police assistance comparable to the right she would have
possessed to any other service the government or a private firm might have undertaken to provide. . . .
. . . The crucial point is that, under the statute, the police were required to provide
enforcement; they lacked the discretion to do nothing. The Court suggests that the
fact that enforcement may encompass different acts infects any entitlement to
enforcement with indeterminacy. But this objection is also unfounded. Our cases
have never required the object of an entitlement to be some mechanistic, unitary
thing. . . . The enforcement of a restraining order is not some amorphous, indeterminate thing. Under the statute, if the police have probable cause that a violation
has occurred, enforcement consists of either making an immediate arrest or seekPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Public Health Duties and Powers 113
ing a warrant and then executing an arresttraditional, well-defined tasks that law
enforcement officers perform every day. . . .
Police enforcement of a restraining order is a government service that is no
less concrete and no less valuable than other government services. . . . In this case,
Colorado law guaranteed the provision of a certain service, in certain defined circumstances, to a certain class of beneficiaries, and respondent reasonably relied on
that guarantee. . . .
Because respondent had a property interest in the enforcement of the restraining order, state officials could not deprive her of that interest without observing fair
procedures. . . . According to respondents complaint the process she was afforded
by the police constituted nothing more than a sham or a pretense.
Accordingly, I respectfully dissent.
III. State Police Powers: Protecting Health, Safety,
and Morals
I define police power in the Readers companion text as the inherent
authority of the state (and, through delegation, local government) to
enact laws and promulgate regulations to protect, preserve, and promote the health, safety, morals, and general welfare of the people. To
achieve these communal benefits, the state retains the power to restrict,
within federal and state constitutional limits, private interestspersonal interests in autonomy, privacy, association, and liberty as well as
economic interests in freedom to contract and uses of property.
Chief Justice John Marshall, in Gibbons v. Ogden, 22 U.S. 1, 87
(1824), was the first Supreme Court justice to refer to the police powers. Marshall conceived of state police powers as that immense mass
of legislation, which embraces every thing within the territory of a
State, not surrendered to the general government: all which can be most
advantageously exercised by the States themselves. Inspection laws,
quarantine laws, health laws of every description, as well as laws for
regulating the internal commerce of a State, and those which respect
turnpike roads, ferries, are component parts of this mass. Perhaps
the most famous explanation of the police power was the 1905 case of
Jacobson v. Massachusetts, excerpted in chapter 4.
Santiago Legarre, in a comprehensive article on the history of the police
powers (2007), suggests three different meanings of police power, each
favored in turn during different periods of American constitutional history: (1) a broad meaning, conveying the residual sovereignty of the states
or the powers inherent in every sovereignty; (2) a narrow meaning, conveying the states power to protect certain public goodsnamely, public
health, public safety, and public morals; and (3) a somewhat different
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114 The Law and the Publics Health
broad meaning, encompassing all great public needs, including economic
and social interests, such that the state may regulate for the publics
health, safety, morals, convenience, and general prosperity.
In the following reading, the University of Chicago historian
William J. Novak talks about the rich historical origins of the police
power. More important, he reminds us that early America, far from
illustrating laissez-faire philosophy, as is often assumed, was truly a
well-regulated society, and this regulation principally occurred at
the state and local levels.
Governance, Police, and American Liberal Mythology*
William J. Novak
She starts old, old, wrinkled and writhing in an old skin.
And there is a gradual sloughing off of the old skin,
towards a new youth. It is the myth of America.
D.H. Lawrence
A distinctive and powerful governmental tradition devoted in theory and practice to
the vision of a well-regulated society dominated United States social and economic
policymaking from 1787 to 1877. With deep and diverse roots in colonial, English, and
continental European customs, laws, and public practices, that tradition matured
into a full-fledged science of government by midcentury. At the heart of the wellregulated society was a plethora of bylaws, ordinances, statutes, and common law
restrictions regulating nearly every aspect of early American economy and society,
from Sunday observance to the carting of offal. These lawsthe work of mayors,
common councils, state legislators, town and county officers, and powerful state
and local judgescomprise a remarkable and previously neglected record of governmental aspiration and practice. Taken together they explode tenacious myths about
nineteenth-century government (or its absence) and demonstrate the pervasiveness of regulation in early American versions of the good society: regulations for
public safety and security (protecting the very existence of the population from
catastrophic enemies like fire and invasion); the construction of a public economy
(determining the rules by which the people would acquire and exchange food and
goods); the policing of public space (defining common rights in roads, rivers, and
public squares); all-important restraints on public morals (establishing the social
and cultural conditions of public order); and the open-ended regulatory powers
granted to public officials to guarantee public health (securing the populations
well-being, longevity, and productivity). Public regulationthe power of the state to
restrict individual liberty and property for the common welfarecolored all facets of
early American development. It was the central component of a reigning theory and
*From The Peoples Welfare: Law and Regulation in Nineteenth-Century America
by William J. Novak. Copyright 1996 by the University of North Carolina Press. Used
by permission of the publisher.
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Public Health Duties and Powers 115
practice of governance committed to the pursuit of the peoples welfare and happiness in a well-ordered society and polity.
These laws [are] what I collectively refer to as the well-regulated society. . . . To
the omnipresent and skeptical social-historical question, Were such laws enforced?,
the thousand cases examined here testify simply and unequivocally, yes. A second question is more interesting, more complicated, and more controversial: Why
is this governmental regulatory practice so invisible in our traditional accounts of
nineteenth-century American history? Why is it at all surprising to discover the pivotal role played by public law, regulation, order, discipline, and governance in early
American society? . . .
Americas nineteenth-century regulatory past remains something of a trade
secret. No comprehensive history of antebellum regulation exists, and the mention
of an American regulatory heritage prompts a familiar incredulity if not outright
denial. Why? The culprit is a set of four interrelated and surprisingly resilient myths
about nineteenth-century America challenged by this [essay]: the myth of statelessness, the myth of liberal individualism, the myth of the great transformation, and the
myth of American exceptionalism. . . .
[Ed.The author discusses these four myths.]
Together these four organizing myths constitute a master narrative of American
political development in which liberty against government serves as the fulcrum of
a constant and distinctively American liberal-constitutional tradition. The reigning
paradigms of American politics (self-interested liberalism), law (constitutionalism),
and economics (neoclassical market theory) conspire with this mythic historiography to produce a gross overemphasis on individual rights, constitutional limitations,
and the invisible hand; and a terminal neglect of the positive activities and public
responsibilities of American government over time. . . .
The well-regulated society confronts the myths of statelessness, individualism,
transformation, and exceptionalism with four distinguishing principles of positive
governance: public spirit, local self-government, civil liberty, and law. While very
much at odds with modern conceptions of the sovereign state and the rights-bearing
individual, these principles were the heart of the nineteenth-century vision of a wellregulated society.
Public Spirit
Salus populi (the peoples welfare) is . . . an abridgment of the influential common
law maxim salus populi suprema lex est (the welfare of the people is the supreme
law) and one of the fundamental ordering principles of the early American polity.
Nineteenth-century America was a public society in ways hard to imagine after the
invention of twentieth-century privacy. Its governance was predicated on the elemental assumption that public interest was superior to private interest. Government
and society were not created to protect preexisting private rights, but to further the
welfare of the whole people and community. . . .
Local Self-Government
Despite the jilting of the Articles of Confederation and the new supremacy clause
in the federal Constitution, nineteenth-century American governance remained
decidedly local. Towns, local courts, common councils, and state legislatures were
the basic institutions of governance, and they continued to function in ways not
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116 The Law and the Publics Health
unlike their colonial and European forebears. . . . Though its antidespotic thrust is
often mistaken for liberal individualism, local self-government conceived of liberty
and autonomy as collective attributesbadges of participation, things achieved in
common through social and political interaction with others. The independent lawmaking authority of local communities . . . was to be defended from usurpation by
despots, courtly mandarins, or other central powers. But within communities, individuals were expected to conform their behavior to local rules and expectations.
No community was deemed free without the power and right of members to govern
themselves, that is, to determine the rules under which the locality as a whole would
be organized and regulated. Such open-ended local regulatory power was simply a
necessary attribute of any truly popular sovereignty. . . .
Civil Liberty
Integral to local self-government was a unique conception of civil or regulated liberty. . . . Civil liberty consisted only in those freedoms consistent with the laws of the
land. Such liberty was never absolute, it always had to conform to the superior power
of self-governing communities to legislate and regulate in the public interest. From
time immemorial, as the common law saying went, this liberty was subject to local
bylaws for the promotion and maintenance of community order, comfort, safety,
health, and well-being. Freedom and regulation in this tradition were not viewed as
antithetical but as complementary and mutually reinforcing. . . .
Law
By definition, any history of early American government must also be a legal history. . . . As Thomas Paine (1945, 29) noted, In America the law is king. John Adams
famously added (invoking James Harrington) that this was a government of laws
(Paine 1945, 29). . . . But the content of the common legal tradition undergirding
the well-regulated society runs counter to some classic interpretations of American
bench and bar that emphasize solely devotion to private (usually economic) interests and hostility to government. The legal doctrines and practices guaranteeing the
rights of municipalities to regulate social and economic life were testaments to the
importance of nonconstitutional public law to the American polity. The nineteenth
century was not simply an age of private contract and public constitutional limitations. It was an epoch in which strong common law notions of public prerogatives and
the duties and obligations of government persisted amid a torrent of private adjudication and constitution writing. The rule of law, a distinctly public and social ideal
antedating both Lockean liberalism and Machiavellian civic humanism, dominated
most thinking about governance in the nineteenth century. . . .
Public spirit, local self-government, civil liberty, and common law were part of a
worldview decidedly different from our own and from the one we have imposed on an
unsuspecting past. Their reference point was the relationship of a citizen to a republic rather than an individual subject to a sovereign nation-state. But salus populi and
well-regulated governance entailed more than a particular legal-political worldview.
It was a governmental practice embedded in some of the most important public
policies and initiatives of the nineteenth century. In particular, the four principles
outlined here found clearest expression in countless nineteenth-century exertions
of what is known in legal parlance as state police power. . . .
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Public Health Duties and Powers 117
The state police power is one of the most enigmatic phenomena in American legal
and political history. To begin with, the phrase state police power is triply misleading. First, police power has little to do with our modern notion of a municipal police
force. Second, the triumph of this particular legal terminology was part of a late
nineteenth-century effort to rein in, constitutionalize, and centralize the disparate
powers of states and localities. Using the term to describe earlier developments thus
risks importing some anachronistic assumptions. Finally, despite being a state
power, the police power was usually exercised by local officials.
Generations of judges and scholars have suggested that, in fact, state police
power is undefinable. [The definitions proposed by early twentieth-century scholars] cover three essential components of police power: law, regulation, and peoples
welfare. Police power was the ability of a state or locality to enact and enforce public
laws regulating or even destroying private right, interest, liberty, or property for the
common good (i.e., for the public safety, comfort, welfare, morals, or health). Such
broad compass has led some to conclude that state police power was the essence of
governance, the hallmark of sovereignty and statecraft.
The American constitutional basis of state police power was the Tenth Amendment, reserving to the states all power not explicitly delegated or prohibited in the
Constitution. But more significant than this formal constitutional sanction were the
substantive roots of state regulatory power in early modern notions of police or
Polizei. . . . Police was a science and mode of governance where the polity assumed
control over, and became implicated in, the basic conduct of social life. . . . Police
aspirations also included enriching population and state, increasing agricultural
yields, minimizing threats to health and safety, promoting communication and commerce, and improving the overall quality of the peoples existence.
Such sweeping objectives required the intense regulation and public monitoring
of economy and society. Indeed the effect of police was a vast proliferation of regulatory intrusions into the remotest corners of public and private activity [including
religion, morals, health, travel, and labor]. No aspect of human intercourse remained
outside the purview of police science. . . .
The vast, largely unwritten history of American governance and police regulation
suggests that it is time to refocus attention on [a] . . . founding paradoxthe myth of
American liberty. For . . . the storied history of liberty in the United States, with its
vaunted rhetoric of unprecedented rights of property, contract, mobility, privacy,
and bodily integrity, was built directly upon a strong and consistent willingness to
employ the full, coercive, and regulatory powers of law and government. The public
conditions of private freedom remain the great problem of American governmental
and legal history.
IV. Federal Power to Safeguard
the Publics Health
The national government has only those powers expressly enumerated in the Constitution. For public health purposes, the foremost of
these are the power to tax and spend for the general welfare and the
power to regulate interstate commerce. These powers provide Congress
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118 The Law and the Publics Health
with independent authority to raise revenue for public health services
and to regulate, both directly and indirectly, private activities that
endanger the publics health. The Constitution also affords Congress
other powers important to public health. Congress has the power to
enforce the civil rights amendments (the Thirteenth, Fourteenth, and
Fifteenth Amendments); and it has the power to promote the Progress
of Science by securing for inventors the exclusive right to their discoveries through the granting of patents (Article I, section 8, clause 8). The
Constitution also grants the president authority to make treaties with
the Senates advice and consent, a power that has significance in global
health, as discussed in chapter 7.
The necessary and proper clause in Article I, section 8, of the
Constitution permits Congress to employ all means reasonably appropriate to achieve the objectives of enumerated national powers. Chief
Justice John Marshalls famous remark in McCulloch v. Maryland, 17
U.S. 316, 421 (1819), illustrates the potentially expansive powers of
Congress: Let the end be legitimate, let it be within the scope of the
constitution, and all means which are appropriate, which are plainly
adapted to that end, which are not prohibited, but consistent with the
letter and spirit of the constitution, are constitutional. This implied
powers doctrine has enabled the national government to expand into
public health regulation, traditionally a state-level responsibility. Federal
regulation now covers broad aspects of public health, such as air and
water quality, food and drug safety, pesticide production and sales, consumer product safety, occupational health and safety, and medical care.
A. The Power to Tax and Spendthe Power to Influence State and
Private Behavior
The power to tax and spend is found in the Constitutions phrase
Congress shall have Power To lay and collect Taxes, Duties, Imposts
and Excises, to pay the Debts and provide for the common Defence
and general Welfare of the United States (Article I, section 8, clause
1). The power to tax and spend enables the federal government to raise
revenue to provide for the good of the community, making possible
such services as health care for the poor, sanitation, and environmental
protection. Equally important, the taxing and spending power makes
it possible to regulate risk behavior and influence health-promoting
activities. Through its taxing powers, government can create incentives
to engage in beneficial activities (e.g., employer-sponsored health plans)
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Public Health Duties and Powers 119
or disincentives to engage in risk behaviors (e.g., smoking cigarettes).
Alternatively, by setting conditions on the granting of funds, the
United States can induce states to adopt federal regulatory standards.
The spending power has been challenged by states claiming that
when it is used inappropriately, the federal government coerces states
and violates state sovereignty. This issue came before the Supreme
Court in South Dakota v. Dole, which addressed the federal governments ability to encourage states to raise the minimum drinking age
by setting conditions on the receipt of federal highway funds. Dole
illustrates the Supreme Courts permissive view that government can
allocate resources on the condition that the recipient complies with
specified norms. Thus, the conditional spending power can be used to
achieve a public health objective.
South Dakota v. Dole*
Supreme Court of the United States
Decided June 23, 1987
Chief Justice REHNQUIST delivered the opinion of the Court.
[In South Dakota, persons nineteen years of age or older are permitted to purchase beer containing up to 3.2 percent alcohol. Title 23 U.S.C. 158 directs the
secretary of transportation to withhold federal highway funds from states that allow
persons under the age of twenty-one years to purchase and possess alcohol. The
State of South Dakota argues that 158 violates the constitutional limitations on
congressional spending power under Article I, section 8, clause 1 (tax-and-spend
power) of the Constitution and violates the Tenth Amendment (among other constitutional arguments).]
. . . Incident to [the tax-and-spend power], Congress may attach conditions on
the receipt of federal funds, and has repeatedly employed the power to further
broad policy objectives by conditioning receipt of federal moneys upon compliance
by the recipient with federal statutory and administrative directives. Fullilove v.
Klutznick, 448 U.S. 448, 474 (1980). . . . [Even those] objectives not thought to
be within Article Is enumerated legislative fields may nevertheless be attained
through the use of the spending power and the conditional grant of federal funds.
The spending power is of course not unlimited, but is instead subject to several
general restrictions articulated in our cases. The first of these limitations is derived
from the language of the Constitution itself: the exercise of the spending power must
be in pursuit of the general welfare. In considering whether a particular expenditure is intended to serve general public purposes, courts should defer substantially
to the judgment of Congress. Second, we have required that if Congress desires to
condition the States receipt of federal funds, it must do so unambiguously . . . ,
*483 U.S. 203 (1987).
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120 The Law and the Publics Health
enabl[ing] the States to exercise their choice knowingly, cognizant of the consequences of their participation. Pennhurst State School and Hospital v. Halderman,
451 U.S. 1, 17 (1981). Third, our cases have suggested (without significant elaboration) that conditions on federal grants might be illegitimate if they are unrelated to
the federal interest in particular national projects or programs. Massachusetts v.
United States, 435 U.S. 444, 461 (1978) (plurality opinion). . . .
South Dakota does not seriously claim that 158 is inconsistent with any of the
first three restrictions mentioned above. We can readily conclude that the provision is designed to serve the general welfare, especially in light of the fact that
the concept of welfare or the opposite is shaped by Congress. . . . Helvering v.
Davis, 301 U.S. 619, 645 (1937). Congress found that the differing drinking ages in
the States created particular incentives for young persons to combine their desire to
drink with their ability to drive, and that this interstate problem required a national
solution. The means it chose to address this dangerous situation were reasonably
calculated to advance the general welfare. The conditions upon which States receive
the funds, moreover, could not be more clearly stated by Congress. And the State
itself, rather than challenging the germaneness of the condition to federal purposes,
admits that it has never contended that the congressional action was . . . unrelated
to a national concern in the absence of the Twenty-first Amendment. Indeed, the
condition imposed by Congress is directly related to one of the main purposes for
which highway funds are expendedsafe interstate travel. This goal of the interstate
highway system had been frustrated by varying drinking ages among the States. A
Presidential commission appointed to study alcohol-related accidents and fatalities
on the Nations highways concluded that the lack of uniformity in the States drinking
ages created an incentive to drink and drive because young persons commut[e]
to border States where the drinking age is lower. By enacting 158, Congress conditioned the receipt of federal funds in a way reasonably calculated to address this
particular impediment to a purpose for which the funds are expended. . . .
We have also held that a perceived Tenth Amendment limitation on congressional regulation of state affairs did not concomitantly limit the range of conditions
legitimately placed on federal grants. . . . We think that . . . the [spending] power may
not be used to induce the States to engage in activities that would themselves be
unconstitutional. Thus, for example, a grant of federal funds conditioned on invidiously discriminatory state action or the infliction of cruel and unusual punishment
would be an illegitimate exercise of the Congresss broad spending power. But no
such claim can be or is made here. Were South Dakota to succumb to the blandishments offered by Congress and raise its drinking age to 21, the States action in so
doing would not violate the constitutional rights of anyone.
Our decisions have recognized that in some circumstances the financial inducement offered by Congress might be so coercive as to pass the point at which pressure turns into compulsion. Steward Machine Co. v. Davis, 301 U.S. 548, 590
(1937). Here, however, Congress has directed only that a State desiring to establish
a minimum drinking age lower than 21 lose a relatively small percentage of certain
federal highway funds. Petitioner contends that the coercive nature of this program
is evident from the degree of success it has achieved. We cannot conclude, however,
that a conditional grant of federal money of this sort is unconstitutional simply by
reason of its success in achieving the congressional objective.
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Public Health Duties and Powers 121
When we consider, for a moment, that all South Dakota would lose if she adheres
to her chosen course as to a suitable minimum drinking age is 5% of the funds otherwise obtainable under specified highway grant programs, the argument as to coercion is shown to be more rhetoric than fact. . . . Here Congress has offered relatively
mild encouragement to the States to enact higher minimum drinking ages than they
would otherwise choose. But the enactment of such laws remains the prerogative of
the States not merely in theory but in fact. Even if Congress might lack the power to
impose a national minimum drinking age directly, we conclude that encouragement
to state action found in 158 is a valid use of the spending power.
B. Controlling the Stream of Interstate Commercethe Power
to Regulate
The Commerce Clause, more than any other enumerated power, affords
Congress potent regulatory authority. Article I, section 8, clause 3,
states that [t]he Congress shall have the power . . . to regulate Commerce with foreign Nations, and among the several states, and with the
Indian Tribes. Since Franklin Delano Roosevelts New Deal era, the
Supreme Court has interpreted the Commerce Clause broadly, giving
Congress the ability to regulate almost any area of activity as long
as that activity has national effects. However, the Supreme Court has
begun to rethink the breadth of commerce power, shifting regulatory
authority back to the states for activities that are primarily intrastate.
In United States v. Lopez (excerpted next), the Court was faced with
a popular statute in which Congress had restricted gun possession in
school zones. Chief Justice William Rehnquists opinion does not question the importance of firearm control as a legitimate public health
function. Rather, he argues that controlling the mere possession of
guns in schools is outside the sphere of the federal commerce power.
United States v. Lopez*
Supreme Court of the United States
Decided April 26, 1995
Chief Justice REHNQUIST delivered the opinion of the Court.
In the Gun-Free School Zones Act of 1990, Congress made it a federal offense
for any individual knowingly to possess a firearm at a place that the individual
knows, or has reasonable cause to believe, is a school zone. 18 U.S.C. 922(q)(1)(A)
(1988 ed., Supp. V). The Act neither regulates a commercial activity nor contains a
requirement that the possession be connected in any way to interstate commerce.
*514 U.S. 549 (1995).
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122 The Law and the Publics Health
We hold that the Act exceeds the authority of Congress [t]o regulate Commerce . . .
among the several States. . . . U.S. Const., art. I, 8, cl. 3. . . .
. . . We have identified three broad categories of activity that Congress may
regulate under its commerce power. First, Congress may regulate the use of the
channels of interstate commerce. Second, Congress is empowered to regulate and
protect the instrumentalities of interstate commerce, or persons or things in interstate commerce, even though the threat may come only from intrastate activities.
Finally, Congresss commerce authority includes the power to regulate those activities having a substantial relation to interstate commerce, i.e., those activities that
substantially affect interstate commerce. . . .
Within this final category, admittedly, our case law has not been clear whether an
activity must affect or substantially affect interstate commerce in order to be
within Congresss power to regulate it under the Commerce Clause. We conclude, consistent with the great weight of our case law, that the proper test requires an analysis
of whether the regulated activity substantially affects interstate commerce.
We now turn to consider the power of Congress, in the light of this framework, to
enact 922(q). The first two categories of authority may be quickly disposed of:
922(q) is not a regulation of the use of the channels of interstate commerce, nor is it
an attempt to prohibit the interstate transportation of a commodity through the channels of commerce; nor can 922(q) be justified as a regulation by which Congress has
sought to protect an instrumentality of interstate commerce or a thing in interstate
commerce. Thus, if 922(q) is to be sustained, it must be under the third category as
a regulation of an activity that substantially affects interstate commerce. . . .
Section 922(q) is a criminal statute that by its terms has nothing to do with commerce or any sort of economic enterprise, however broadly one might define those
terms. Section 922(q) is not an essential part of a larger regulation of economic
activity, in which the regulatory scheme could be undercut unless the intrastate
activity were regulated. It cannot, therefore, be sustained under our cases upholding
regulations of activities that arise out of or are connected with a commercial transaction, which viewed in the aggregate, substantially affect interstate commerce.
Second, 922(q) contains no jurisdictional element which would ensure, through
case-by-case inquiry, that the firearm possession in question affects interstate
commerce. . . .
The Governments essential contention [is] that 922(q) is valid because possession of a firearm in a local school zone does indeed substantially affect interstate
commerce. The Government argues that possession of a firearm in a school zone
may result in violent crime and that violent crime can be expected to affect the
functioning of the national economy in two ways. First, the costs of violent crime
are substantial, and, through the mechanism of insurance, those costs are spread
throughout the population. Second, violent crime reduces the willingness of individuals to travel to areas within the country that are perceived to be unsafe. The
Government also argues that the presence of guns in schools poses a substantial
threat to the educational process by threatening the learning environment. A handicapped educational process, in turn, will result in a less productive citizenry. That, in
turn, would have an adverse effect on the Nations economic well-being. As a result,
the Government argues that Congress could rationally have concluded that 922(q)
substantially affects interstate commerce.
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Public Health Duties and Powers 123
. . . Under the Governments national productivity reasoning, Congress could
regulate any activity that it found was related to the economic productivity of individual citizens. . . . It is difficult to perceive any limitation on federal power, even in
areas such as criminal law enforcement or education where States historically have
been sovereign. Thus, if we were to accept the Governments arguments, we are
hard pressed to posit any activity by an individual that Congress is without power
to regulate. . . .
The possession of a gun in a local school zone is in no sense an economic activity
that might, through repetition elsewhere, substantially affect any sort of interstate
commerce. Respondent was a local student at a local school; there is no indication
that he had recently moved in interstate commerce, and there is no requirement that
his possession of the firearm [has] any concrete tie to interstate commerce.
To uphold the Governments contentions here, we would have to pile inference
upon inference in a manner that would bid fair to convert congressional authority under the Commerce Clause to a general police power of the sort retained by
the States. Admittedly, some of our prior cases have taken long steps down that
road, giving great deference to congressional action. The broad language in these
opinions has suggested the possibility of additional expansion, but we decline here
to proceed any further. To do so would require us to conclude that the Constitutions
enumeration of powers does not presuppose something not enumerated, and that
there never will be a distinction between what is truly national and what is truly
local. This we are unwilling to do.

In its 19992000 term, the Supreme Court revisited the Commerce
Clause in United States v. Morrison, 529 U.S. 598 (2000). At issue
was the private civil rights remedy created by the Violence against
Women Act of 1994, which allowed survivors to bring federal lawsuits
against perpetrators of gender-motivated crimes of violence. Congress
proclaimed that violence against women impairs womens ability to
work, harms businesses, and increases national health care costs. But
the Court, reiterating its arguments made in Lopez, found no national
effects of violence against women and struck down the law for exceeding Congresss authority under the Commerce Clause.
Lopez and Morrison suggest that the Supreme Court is fully prepared to narrow the scope of the federal commerce power to protect a
sphere of state sovereignty. In those cases, the effect was to strike down
progressive federal safety regulation relating to guns in schools and
violence against women. In Gonzales v. Raich, however, the Court said
that Lopez and Morrison should not be read too broadly. The Court
held that federal law enforcement authorities could criminally prosecute
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124 The Law and the Publics Health
dance with state law. Justice John Paul Stevens said that Congresss
authority to regulate interstate commerce includes the power to prohibit purely local cultivation and use of marijuana. He found striking
similarities between this case and Wickard v. Filburn, 317 U.S. 111
(1942), a case that upheld a federal prohibition on a farmer growing
wheat for his own consumption: Like the farmer in Wickard, respondents are cultivating, for home consumption, a fungible commodity for
which there is an established, albeit illegal, interstate market. The 63
decision in Raich revealed a fissure within the coalition on the Court
that over the past decade has curtailed federal power and safeguarded
state sovereignty.
Gonzales v. Raich*
Supreme Court of the United States
June 6, 2005
Justice STEVENS delivered the opinion of the Court.
. . . The question presented in this case is whether the power vested in Congress
by Article I, 8, of the Constitution [t]o make all Laws which shall be necessary
and proper for carrying into Execution its authority to regulate Commerce with
foreign Nations, and among the several States includes the power to prohibit the
local cultivation and use of marijuana in compliance with California law.
. . . In 1996, California voters passed Proposition 215, now codified as the Compassionate Use Act of 1996. The proposition was designed to ensure that seriously
ill residents of the State have access to marijuana for medical purposes, and to
encourage Federal and State Governments to take steps toward ensuring the
safe and affordable distribution of the drug to patients in need. The Act creates
an exemption from criminal prosecution for physicians, as well as for patients and
primary caregivers who possess or cultivate marijuana for medicinal purposes with
the recommendation or approval of a physician. . . .
Respondents Angel Raich and Diane Monson are California residents who suffer
from a variety of serious medical conditions and have sought to avail themselves of
medical marijuana pursuant to the terms of the Compassionate Use Act. . . .
On August 15, 2002, county deputy sheriffs and agents from the federal Drug
Enforcement Administration (DEA) came to Monsons home. After a thorough investigation, the county officials concluded that her use of marijuana was entirely lawful as a matter of California law. Nevertheless, after a 3-hour standoff, the federal
agents seized and destroyed all six of her cannabis plants. . . .
[Respondents brought an action against the attorney general. After the District
Court denied the respondents motion for a preliminary injunction, the Ninth Circuit
Court of Appeals reversed, finding that the federal Controlled Substances Act (CSA)
*545 U.S. 1 (2005).
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Public Health Duties and Powers 125
to be an unconstitutional exercise of Congress Commerce Clause Authority.] The
Court of Appeals distinguished prior Circuit cases upholding the CSA in the face of
Commerce Clause challenges by focusing on what it deemed to be the separate
and distinct class of activities at issue in this case: the intrastate, noncommercial
cultivation and possession of cannabis for personal medical purposes as recommended by a patients physician pursuant to valid California state law. [The Court
of Appeals distinguished this class of activities from the illicit drug market because
the marijuana does not enter the stream of commerce.]
The obvious importance of the case prompted our grant of certiorari. The case
is made difficult by respondents strong arguments that they will suffer irreparable
harm because, despite a congressional finding to the contrary, marijuana does have
valid therapeutic purposes. The question before us, however, is not whether it is wise
to enforce the statute in these circumstances; rather, it is whether Congress power
to regulate interstate markets for medicinal substances encompasses the portions
of those markets that are supplied with drugs produced and consumed locally. Wellsettled law controls our answer. The CSA is a valid exercise of federal power, even
as applied to the troubling facts of this case. We accordingly vacate the judgment of
the Court of Appeals. . . .
[Under the CSA, marijuana is listed as a Schedule I drug, characterized by a high
potential for abuse and a lack of any accepted medical use.] By classifying marijuana
as a Schedule I drug, as opposed to listing it on a lesser schedule, the manufacture,
distribution, or possession of marijuana became a criminal offense, with the sole
exception being use of the drug as part of a Food and Drug Administration preapproved research study. . . .
Respondents in this case do not dispute that passage of the CSA, as part of the
Comprehensive Drug Abuse Prevention and Control Act, was well within Congress
commerce power. Nor do they contend that any provision or section of the CSA
amounts to an unconstitutional exercise of congressional authority. Rather, respondents challenge is actually quite limited; they argue that the CSAs categorical
prohibition of the manufacture and possession of marijuana as applied to the intrastate manufacture and possession of marijuana for medical purposes pursuant to
California law exceeds Congress authority under the Commerce Clause. . . .
[There are] three general categories of regulation in which Congress is authorized
to engage under its commerce power. First, Congress can regulate the channels of
interstate commerce. Second, Congress has authority to regulate and protect the
instrumentalities of interstate commerce, and persons or things in interstate commerce. Third, Congress has the power to regulate activities that substantially affect
interstate commerce. Only the third category is implicated in the case at hand. . . .
[In Wickard v. Filburn, 317 U.S. 111 (1942), the Court upheld the Agricultural
Adjustment Act of 1938, a Depression-era law that sought to stabilize the grain supply
and prices by, among other things, prescribing how much wheat a farmer could grow.
The Court found that the act was a valid exercise of the Commerce Clause even where
it was applied to a farmer who was growing wheat for his personal use and not for sale
in the market:] That [the farmers] own contribution to the demand for wheat may
be trivial by itself is not enough to remove him from the scope of federal regulation
where, as here, his contribution, taken together with that of many others similarly
situated, is far from trivial. Wickard, 317 U.S., at 12728. Wickard thus establishes
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126 The Law and the Publics Health
that Congress can regulate purely intrastate activity that is not itself commercial,
in that it is not produced for sale, if it concludes that failure to regulate that class of
activity would undercut the regulation of the interstate market in that commodity.
The similarities between this case and Wickard are striking. Like the farmer in
Wickard, respondents are cultivating, for home consumption, a fungible commodity for which there is an established, albeit illegal, interstate market. Just as the
Agricultural Adjustment Act was designed to control the volume [of wheat] moving
in interstate and foreign commerce in order to avoid surpluses . . . and consequently
control the market price, a primary purpose of the CSA is to control the supply and
demand of controlled substances in both lawful and unlawful drug markets. In Wickard
we had no difficulty concluding that Congress had a rational basis for believing that,
when viewed in the aggregate, leaving home-consumed wheat outside the regulatory
scheme would have a substantial influence on price and market conditions. Here too,
Congress had a rational basis for concluding that leaving home-consumed marijuana
outside federal control would similarly affect price and market conditions. . . .
. . . We need not determine whether respondents activities, taken in the aggregate, substantially affect interstate commerce in fact, but only whether a rational
basis exists for so concluding. Given the enforcement difficulties that attend distinguishing between marijuana cultivated locally and marijuana grown elsewhere and
concerns about diversion into illicit channels, we have no difficulty concluding that
Congress had a rational basis for believing that failure to regulate the intrastate
manufacture and possession of marijuana would leave a gaping hole in the CSA.
Thus, as in Wickard when it enacted comprehensive legislation to regulate the interstate market in a fungible commodity, Congress was acting well within its authority
to make all Laws which shall be necessary and proper to regulate Commerce . . .
among the several States. U.S. Const., Art. I, 8. That the regulation ensnares
some purely intrastate activity is of no moment. As we have done many times before,
we refuse to excise individual components of that larger scheme.
To support their contrary submission, respondents rely heavily on two of our
more recent Commerce Clause cases. In their myopic focus, they overlook the larger
context of modern-era Commerce Clause jurisprudence preserved by those cases.
Moreover, even in the narrow prism of respondents creation, they read those cases
far too broadly.
Those two cases, of course, are Lopez and Morrison. As an initial matter, the
statutory challenges at issue in those cases were markedly different from the challenge respondents pursue in the case at hand. Here, respondents ask us to excise
individual applications of a concededly valid statutory scheme. In contrast, in both
Lopez and Morrison, the parties asserted that a particular statute or provision fell
outside Congress commerce power in its entirety. This distinction is pivotal for we
have often reiterated that [w]here the class of activities is regulated and that class
is within the reach of federal power, the courts have no power to excise, as trivial,
individual instances of the class. Perez v. United States, 402 U.S., 146, 154 (1971)
(emphasis deleted) (quoting Maryland v. Wirtz, 392 U.S., 183, 193 [1968]).
At issue in Lopez was the validity of the Gun-Free School Zones Act of 1990,
which was a brief, single-subject statute making it a crime for an individual to possess a gun in a school zone. The Act did not regulate any economic activity and
did not contain any requirement that the possession of a gun have any connection
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Public Health Duties and Powers 127
to past interstate activity or a predictable impact on future commercial activity.
Distinguishing our earlier cases holding that comprehensive regulatory statutes
may be validly applied to local conduct that does not, when viewed in isolation, have
a significant impact on interstate commerce, we held the statute invalid. . . .
The statutory scheme that the Government is defending in this litigation is at the
opposite end of the regulatory spectrum [from Lopez]. . . . The CSA . . . was a lengthy
and detailed statute creating a comprehensive framework for regulating the production, distribution, and possession of five classes of controlled substances. [It
established this closed regulatory system in order to accomplish Congresss main
objectivesconquering drug abuse and controlling the legitimate and illegitimate
traffic in controlled substances. Congress was particularly concerned with preventing the diversion of drugs from legitimate to illicit channels.]
[Similarly, the Courts holding in Morrison does not cast doubt on the validity of
such a comprehensive regulatory scheme. There the decision rested on the fact that
while gender-motivated crimes have an effect on interstate commerce, the statute
did not regulate economic activity.]
Unlike those at issue in Lopez and Morrison, the activities regulated by the CSA
are quintessentially economic. . . . The CSA is a statute that regulates the production, distribution, and consumption of commodities for which there is an established,
and lucrative, interstate market. Prohibiting the intrastate possession or manufacture of an article of commerce is a rational (and commonly utilized) means of
regulating commerce in that product. . . . Because the CSA is a statute that directly
regulates economic, commercial activity, our opinion in Morrison casts no doubt on
its constitutionality. . . .
Indeed, that the California exemptions will have a significant impact on both the
supply and demand sides of the market for marijuana is not just plausible as the
principal dissent concedes, it is readily apparent. The exemption for physicians provides them with an economic incentive to grant their patients permission to use the
drug. . . .
The exemption for cultivation by patients and caregivers can only increase the
supply of marijuana in the California market. The likelihood that all such production
will promptly terminate when patients recover or will precisely match the patients
medical needs during their convalescence seems remote; whereas the danger that
excesses will satisfy some of the admittedly enormous demand for recreational use
seems obvious. Moreover, that the national and international narcotics trade has
thrived in the face of vigorous criminal enforcement efforts suggests that no small
number of unscrupulous people will make use of the California exemptions to serve
their commercial ends whenever it is feasible to do so. . . .
So, from the separate and distinct class of activities identified by the Court of
Appeals (and adopted by the dissenters), we are left with the intrastate, noncommercial cultivation, possession and use of marijuana. Thus the case for the exemption comes down to the claim that a locally cultivated product that is used domestically rather than sold on the open market is not subject to federal regulation. Given
the findings in the CSA and the undisputed magnitude of the commercial market
for marijuana, our decisions in Wickard v. Filburn and the later cases endorsing its
reasoning foreclose that claim. . . .
[The judgment of the Court of Appeals is vacated.]
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128 The Law and the Publics Health
V. New Federalism and the Publics Health
As explained at the beginning of this chapter, public health functions
are carried out at multiple levels of government (federal, state, tribal,
and local). Some of the most significant, and politically controversial,
disputes occur when governments at each of these levels lay claim to
particular public health issues. In divisive areas such as gun control,
smoking, and the environment, the federal government may choose to
act. It is in this context that the Supreme Court may have to decide
whether national public health regulations invade a sphere of state
sovereignty.
New federalism is a principle of political change, spurred by conservative activism, that limits federal authority and returns power to
the states. New federalism has taken on significant political importance in public health in the contentious debates over which level of
government should set standards, as well as perform and pay for services. The Supreme Court altered the balance between the supremacy
of federal law and the separate sovereignty of the states in Lopez and
Morrison, but its decision in Raich may signal a retreat from strong
federalism.
This section discusses an additional constitutional issue in American
federalism: Congresss power to require state governments to implement federal standards. The Supreme Courts federalism jurisprudence
has extended beyond the Commerce Clause. The Court has held that
Congress cannot directly coerce states to comply with federal regulatory
standards, even when it is acting validly within the commerce power.
In New York v. United States (excerpted below), a federal program
regulating radioactive waste removal was held to be unconstitutional
because it commandeered state governments to implement federal
programs in violation of the Tenth Amendment. The Court held that
the federal government cannot coerce state legislatures to act according
to federal standards.
Five years after New York, in Printz v. United States, 521 U.S. 898
(1997), the Supreme Court used the same reasoning to strike down
provisions of the Brady Handgun Violence Prevention Act directing
state and local law enforcement officers to conduct background checks
on prospective handgun purchasers. Justice Scalia referred to the
dual sovereignty established by the Constitution that is the foundation of federalism. His opinion states that the Framers designed the
Constitution to allow federal regulation of the people, not the states.
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Public Health Duties and Powers 129
New York v. United States*
Supreme Court of the United States
Decided June 19, 1992
Justice OCONNO R delivered the opinion of the Court.
[In 1985, Congress enacted the Low Level Radioactive Waste Policy Amendments
Act of 1985 (the Act) amid fears that the nation would be left without any disposal
sites for low-level radioactive waste. The Act was intended to encourage states to
establish and operate disposal facilities for low-level radioactive waste over the next
several years, acting either by themselves or with other states in regional compacts.
The Act obligated states to provide for disposal of waste produced within each
states borders, and it provided three types of incentives to encourage compliance.
The first were monetary incentives, the second were access incentives, and the final
incentives were a take title provision. The take title provision mandates that if a
state is not able to provide for the disposal of waste generated within its borders,
it is obligated, upon request of the generator of the waste, to take possession of
that waste. Should the state fail to take possession, it will be liable for all damages incurred by the waste generator as a result. Petitioner, the State of New York,
claimed that the Act is inconsistent with the Tenth Amendment.]
These cases implicate one of our Nations newest problems of public policy and
perhaps our oldest question of constitutional law. The public policy issue involves
the disposal of radioactive waste. . . . The constitutional question is as old as the
Constitution: It consists of discerning the proper division of authority between the
Federal Government and the States. We conclude that while Congress has substantial power under the Constitution to encourage the States to provide for the disposal
of the radioactive waste generated within their borders, the Constitution does not
confer upon Congress the ability simply to compel the States to do so. We therefore find that only two of the Acts three provisions at issue are consistent with the
Constitutions allocation of power to the Federal Government. . . .
. . . If a power is delegated to Congress in the Constitution, the Tenth Amendment
expressly disclaims any reservation of that power to the States; if a power is an
attribute of state sovereignty reserved by the Tenth Amendment, it is necessarily a
power the Constitution has not conferred on Congress. . . .
. . . The Tenth Amendment confirms that the power of the Federal Government
is subject to limits that may, in a given instance, reserve power to the States. The
Tenth Amendment thus directs us to determine, as in this case, whether an incident
of state sovereignty is protected by a limitation on an Article I power. . . .
Petitioners do not contend that Congress lacks the power to regulate the disposal of low level radioactive waste. . . . Petitioners contend only that the Tenth
Amendment limits the power of Congress to regulate in the way it has chosen.
Rather than addressing the problem of waste disposal by directly regulating the
generators and disposers of waste, petitioners argue, Congress has impermissibly
directed the States to regulate in this field. . . .
*505 U.S. 144 (1992).
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130 The Law and the Publics Health
As an initial matter, Congress may not simply commandeer the legislative processes of the States by directly compelling them to enact and enforce a federal
regulatory program. Hodel v. Virginia Surface Mining & Reclamation Assn, Inc.,
452 U.S. 264, 288 (1981). . . . While Congress has substantial powers to govern the
Nation directly, including in areas of intimate concern to the States, the Constitution
has never been understood to confer upon Congress the ability to require the States
to govern according to Congresss instructions. . . .
In providing for a stronger central government, the Framers explicitly chose
a Constitution that confers upon Congress the power to regulate individuals, not
States. As we have seen, the Court has consistently respected this choice. We
have always understood that even where Congress has the authority under the
Constitution to pass laws requiring or prohibiting certain acts, it lacks the power
directly to compel the States to require or prohibit those acts.
This is not to say that Congress lacks the ability to encourage a State to regulate
in a particular way, or that Congress may not hold out incentives to the States as a
method of influencing a States policy choices. Our cases have identified a variety of
methods, short of outright coercion, by which Congress may urge a State to adopt
a legislative program consistent with federal interests. Two of these methods are of
particular relevance here.
First, under Congresss spending power, Congress may attach conditions on the
receipt of federal funds. South Dakota v. Dole, 483 U.S., 203, 206 (1987). Such
conditions must (among other requirements) bear some relationship to the purpose
of the federal spending; otherwise, of course, the spending power could render
academic the Constitutions other grants and limits of federal authority. Where the
recipient of federal funds is a State, as is not unusual today, the conditions attached
to the funds by Congress may influence a States legislative choices. . . .
Second, where Congress has the authority to regulate private activity under the
Commerce Clause, we have recognized Congresss power to offer States the choice
of regulating that activity according to federal standards or having state law preempted by federal regulation. . . .
By either of these methods, as by any other permissible method of encouraging
a State to conform to federal policy choices, the residents of the State retain the
ultimate decision as to whether or not the State will comply. If a States citizens view
federal policy as sufficiently contrary to local interests, they may elect to decline a
federal grant. If state residents would prefer their government to devote its attention and resources to problems other than those deemed important by Congress,
they may choose to have the Federal Government rather than the State bear the
expense of a federally mandated regulatory program, and they may continue to
supplement that program to the extent state law is not pre-empted. Where Congress
encourages state regulation rather than compelling it, state governments remain
responsive to the local electorates preferences; state officials remain accountable
to the people.
By contrast, where the Federal Government compels States to regulate, the
accountability of both state and federal officials is diminished. If the citizens of
New York, for example, do not consider that making provision for the disposal of
radioactive waste is in their best interest, they may elect state officials who share
their view. That view can always be pre-empted under the Supremacy Clause if it is
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Public Health Duties and Powers 131
contrary to the national view, but in such a case it is the Federal Government that
makes the decision in full view of the public, and it will be federal officials that suffer
the consequences if the decision turns out to be detrimental or unpopular. But where
the Federal Government directs the States to regulate, it may be state officials who
will bear the brunt of public disapproval, while the federal officials who devised the
regulatory program may remain insulated from the electoral ramifications of their
decision. Accountability is thus diminished when, due to federal coercion, elected
state officials cannot regulate in accordance with the views of the local electorate in
matters not pre-empted by federal regulation. . . .
[The Court upholds the first two sets of incentives under the commerce and
spending powers.] The take title provision is of a different character. This third
so-called incentive offers States, as an alternative to regulating pursuant to
Congresss direction, the option of taking title to and possession of the low level
radioactive waste generated within their borders and becoming liable for all damages waste generators suffer as a result of the States failure to do so promptly.
In this provision, Congress has crossed the line distinguishing encouragement
from coercion. . . . The take title provision offers state governments a choice of
either accepting ownership of waste or regulating according to the instructions of
Congress. . . .
Because an instruction to state governments to take title to waste, standing
alone, would be beyond the authority of Congress, and because a direct order to
regulate, standing alone, would also be beyond the authority of Congress, it follows that Congress lacks the power to offer the States a choice between the two.
Unlike the first two sets of incentives, the take title incentive does not represent
the conditional exercise of any congressional power enumerated in the Constitution.
In this provision, Congress has not held out the threat of exercising its spending
power or its commerce power; it has instead held out the threat, should the States
not regulate according to one federal instruction, of simply forcing the States to
submit to another federal instruction. A choice between two unconstitutionally coercive regulatory techniques is no choice at all. Either way, the Act commandeers
the legislative processes of the States by directly compelling them to enact and
enforce a federal regulatory program, Hodel, 452 U.S. at 288, an outcome that has
never been understood to lie within the authority conferred upon Congress by the
Constitution. . . .
The take title provision appears to be unique. No other federal statute has been
cited which offers a state government no option other than that of implementing
legislation enacted by Congress. Whether one views the take title provision as lying
outside Congresss enumerated powers, or as infringing upon the core of state sovereignty reserved by the Tenth Amendment, the provision is inconsistent with the
federal structure of our Government established by the Constitution. . . .
. . . Respondents . . . observe that public officials representing the State of New
York lent their support to the Acts enactment. . . . [and] then pose what appears
at first to be a troubling question: How can a federal statute be found an unconstitutional infringement of state sovereignty when state officials consented to the
statutes enactment?
The answer follows from an understanding of the fundamental purpose served
by our Governments federal structure. The Constitution does not protect the soverPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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132 The Law and the Publics Health
eignty of States for the benefit of the States or state governments as abstract political entities, or even for the benefit of the public officials governing the States. To the
contrary, the Constitution divides authority between federal and state governments
for the protection of individuals. . . .
State officials thus cannot consent to the enlargement of the powers of Congress
beyond those enumerated in the Constitution. Indeed, the facts of these cases raise
the possibility that powerful incentives might lead both federal and state officials to
view departures from the federal structure to be in their personal interests. Most
citizens recognize the need for radioactive waste disposal sites, but few want sites
near their homes. As a result, while it would be well within the authority of either
federal or state officials to choose where the disposal sites will be, it is likely to be
in the political interest of each individual official to avoid being held accountable to
the voters for the choice of location. If a federal official is faced with the alternatives of choosing a location or directing the States to do it, the official may well
prefer the latter, as a means of shifting responsibility for the eventual decision. If a
state official is faced with the same set of alternativeschoosing a location or having
Congress direct the choice of a locationthe state official may also prefer the latter,
as it may permit the avoidance of personal responsibility. The interests of public
officials thus may not coincide with the Constitutions intergovernmental allocation
of authority. Where state officials purport to submit to the direction of Congress in
this manner, federalism is hardly being advanced.

The readings in this chapter illustrate the complexity of constitutional
law in creating government powers and duties to preserve the publics
health and safety. Generally speaking, the Supreme Court sees few
affirmative obligations, but does permit wide-ranging powers to act
for the common good. The federal government possesses enumerated
powers that enable it to regulate in virtually all areas of public health.
The states retain the police powers that provide inherent authority to
safeguard the health, safety, and morals of the community. Perhaps
the most divisive issues in constitutional law involve matters of federalism. In recent years, the Court has shifted the balance of power,
denying the national government the authority to invade a sphere of
state sovereignty.
As a society, we have to seriously consider the competing claims of
the national and state governments in matters of public health. If the
states refuse to deal effectively with contentious public health issues
such as gun control, violence against women, or tobacco, will the
courts allow the federal government to intervene?
Another matter has preoccupied and divided the country every bit
as much as American federalism: the claim of government to act for the
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Public Health Duties and Powers 133
welfare of the population and the countervailing claim of individuals to
be free from government interference. The Constitution, of course, has
a great deal to say about the competing interests of communal goods
and individual rights. That is the topic of the next chapter.
Recommended Readings
American Federalism: The Antiregulatory Effects of
Federal Preemption
Parmet, Wendy E. 1992. Health care and the Constitution: Public health and
the role of the state in the Framing Era. Hastings Constitutional Law Quarterly 20: 267335. (Discusses the historical view of governments duty to
protect the population from epidemics)
Sharkey, Catherine M. 2007. Federalism in action: FDA regulatory preemption in pharmaceutical cases in state versus federal courts. Brooklyn Journal of Law and Policy 15: 101348. (Discusses the differing approaches of
state and federal courts in deciding whether the Federal Food, Drug, and
Cosmetic Act [FDCA] preempts state claims against pharmaceutical
companies)
The Negative Constitution: Governments Duty to Protect Health
and Safety
Seidman, Louis Michael, and Mark V. Tushnet. 1996. Remnants of Belief:
Contemporary Constitutional Issues. New York: Oxford Univ. Press.
(Argues that historically it has been the responsibility of the states to take
care of population health)
State Police Powers: Protecting Health, Safety, and Morals
Legarre, Santiago. 2007. The historical background of the police power. University of Pennsylvania Journal of Constitutional Law 9: 74596. (Explains
the meanings of the term police power and its historical usage as a broad
and narrow term)
Federal Power to Safeguard the Publics Health
Hodge, James G., Jr. 1997. Implementing modern public health goals through
government: An examination of new federalism and public health law. Journal of Contemporary Health Law and Policy 14: 93126. (Discusses the
impact of new federalism and its impact on public health)
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Photo 7. The scene is San Franciscos Chinatown at the turn of the twentieth
century. In 1900, the city quarantined a twelve-block area of that neighborhood, targeting Chinese homes and businesses for enforcement. In Jew Ho
v. Williamson, 103 F. 10 (C.C.N.D. Cal. 1900), the Circuit Court for the
Northern District of California held that selective enforcement of a valid
quarantine violated the constitutional guarantee of equal protection of the
laws. Reproduced by permission, Corbis, ca. 1900.
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135
Government has a long tradition of regulating for the communitys
welfare. Regulations target individuals (e.g., setting forth infectious
disease powers), professionals and institutions (e.g., requiring licenses),
and businesses (e.g., mandating inspections and safety standards).
The previous chapter emphasized the broad powers and duties of
government to safeguard the publics health. This chapter considers
the restraints on government power that protect individual interests in
autonomy, privacy, liberty, and property.
The cases and commentary in this chapter trace the evolution in
judicial thought on the balance between public health power and protection of individual rights. Public health jurisprudence is neither static
nor immune from political and social influences. Rather, judicial review
of public health interventions has changed over time with the varying
composition of the Supreme Court. These changes, moreover, often
reflect prevailing social and political thought. The Warren Courts
defense of personal freedom and nondiscrimination can be traced to
the civil rights movements for African Americans and women during
the 1960s. Decisions by the Rehnquist Court favoring federalism were
influenced by a predisposition toward states rights and against large
central government. And a pro-business, antiregulatory environment
appears to be shaping the Roberts Court.
Several different meanings may be attributed to constitutional
Four
Public Health and the
Protection of Individual Rights
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136 The Law and the Publics Health
adjudication (see figure 5). The primary role of the Constitution may
be seen as defending freedom, defending community and security, or
defending democratic institutions. It is possible to perceive the various
phases of Supreme Court decision making as in turn vindicating, or
repudiating, each of these values. But judges often reject these political
explanations, claiming simply that they objectively read the text and
history of the Constitution. In the eyes of these jurists, their primary
task is to discover the original intent of the Framers or to neutrally
construe the language of the Constitution.
The Constitutions primary purpose is often seen as the protection of
individual rights against excessive government interference. According
to this view, people are born free with inalienable rights to liberty and
property that can be impeded by the government only if the justification
is highly persuasive. This perspective restrains public health power. It
assumes that one valuefreedomought to prevail over other values,
DEFENSE OF
INDIVIDUAL FREEDOMS
DEFENSE OF
COMMUNITY AND SECURITY
DEFENSE OF
DEMOCRATIC INSTITUTIONS
Balance Individual
and Communal
Interests
Safeguards the community
interest in health and safety
Protects individual
rights and freedoms
Supports affirmative role of
legislative and executive
branches to regulate in the
interest of communal health
Figure 5. Constitutional functions.
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Public Health and the Protection of Individual Rights 137
including health and security, except in unusual cases. Courts that
adhere to this view scrutinize the exercise of public health powers more
closely. Public health officials, knowing that they are subject to intense
scrutiny, may be reluctant to use power aggressively. The result may be
firm protection of individual rights but diminished protection of the
communitys health and safety.
Others perceive the Constitutions primary purpose as the defense of
common goods. According to this view, the principal purpose of government is to safeguard communal interests in health and security, even
at the expense of individual interests. This perspective affords public
health officials the most extensive and flexible authority. It assumes that
the exercise of public health powers is legitimate unless they further an
insubstantial purpose or unjustifiably trample individual rights. Courts
that adhere to this view adopt a low level of constitutional scrutiny,
encouraging public health officials to employ a broad range of powers.
Finally, some perceive the Constitutions primary purpose as the
defense of democratic institutions. According to this view, the formulation and enforcement of policy are left largely to the political branches
of government. It assumes that public health powers involve highly
complex policy choices that are best made by lawmakers and agency
officials. Not only do these branches have greater policy expertise,
they are also politically accountable. If the electorate is displeased with
the decision of a legislator or public health official, the ballot box can
usually provide a remedy. If the public is displeased with a courts decision involving a constitutional principle, the electoral remedy is not
as clear. Courts that adhere to this view are deferential to legislatures
and executive agencies, giving them wide latitude in formulating and
executing public health policy (see box 2).
Whatever view one takes about judicial review, it is helpful to underscore the exceptional power of public health officials. Few actors in
the American system of government exercise such broad discretionary
powers and enjoy such a high level of respect and deference. This public
trust should vest a responsibility in public health officials to exercise
their powers wisely and justly.
This chapter contains two sectionsone focusing on early limits
on the exercise of police powers, and the other on modern limits. Both
are important, providing a sense of history and tradition as well as
articulating judicial principles on the rightful exercise of public health
authority.
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Box 2
Public health and democracy:
From Jacobson to Abigail Alliance
The courts have a long tradition of deferring to legislatures and agencies,
believing that elected officials have greater policy expertise and are democratically accountable to voters. Such deference is particularly common
when officials allocate scarce resources, such as access to experimental medicines. In the highly controversial case of Abigail Alliance v. Von
Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), cert. denied, 128 S. Ct. 1069
(2008), the United States Court of Appeals for the D.C. Circuit examined
whether terminally ill patients have a constitutional right to investigational
drugsthat is, drugs under study but not yet approved for public use by the
FDAregardless of the drugs potential lifesaving properties.
The case has been characterized as capturing a microcosm of contemporary health policy tensions, [raising] challenging issues regarding drug
safety at the limits of scientific knowledge, the role of markets vs regulators, medical care of terminally ill patients, individual rights vs protection
of public health, and the allocation of scarce resources (Jacobson and
Parmet 2007, 206). Initially, a panel of the circuit court concluded that
when no alternative government-approved treatment options exist, a terminally ill, mentally competent adult patient has a substantive due process
right of access to potentially lifesaving investigational drugs that have been
found, on the basis of Phase 1 trials, to be sufficiently safe for expanded
human trials (445 F.3d 470 [D.C. Cir. 2006]). The case was then reheard by
the entire circuit court, which vacated the panels decision, concluding that
terminal patients do not have a fundamental right to access such drugs. The
court, citing Jacobson v. Massachusetts, stressed the prerogatives of the
legislature and agency:
Although in the Alliances view the FDA has unjustly erred on the side
of safety in balancing the risks and benefits of experimental drugs,
this is not to say that the FDAs balance can never be changed. The
Alliances arguments about morality, quality of life, and acceptable
levels of medical risk are certainly ones that can be aired in the democratic branches, without injecting the courts into unknown questions
of science and medicine. Our Nations history and traditions have
consistently demonstrated that the democratic branches are better
suited to decide the proper balance between the uncertain risks and
benefits of medical technology, and are entitled to deference in doing
so. As the Supreme Court [held in Jacobson]: We must assume that,
when the statute in question was passed, the legislature . . . was not
unaware of these opposing theories, and was compelled, of necessity,
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Public Health and the Protection of Individual Rights 139
I. Early Twentieth-Century Limits on
the Police Power
This section on historical limits on police powers features two classic public health cases from the early twentieth century, Jacobson v.
Massachusetts and Jew Ho v. Williamson. The story of public health
law often begins with the refusal of Henning Jacobson to comply with
an early twentieth-century Cambridge, Massachusetts, ordinance
compelling smallpox vaccination. The resulting case is perhaps the
most important Supreme Court opinion in the history of American
public health law. In an article marking the centenary of Jacobson v.
Massachusetts, the public health lawyers and scholars Wendy Parmet,
Richard Goodman, and Amy Farber (2005, 65354) shed light on its
historical background:
By 1902, vaccination was well established in Massachusetts. Nevertheless,
smallpox remained a persistent visitor: in 1900, more than 100 cases were
reported in the state; in 1901, there were 773 cases and 97 deaths, and in
1902, 2,314 cases and 284 deaths.
In response, local public health officials resorted to a variety of
measures, many of which were scientifically sound but not all of which
were apt to inspire public trust. For example, on March 15, 1902, Boston
public health doctors, accompanied by guards, descended on the railroad
yards and forcibly vaccinated Italians, negroes and other employees.
In nearby Cambridge, a heated political battle brewed over the mayors
nominations for the board of health. It was in this contentious climate,
in which politicians and public health officials debated and vulnerable
groups were targeted, that [Reverend Henning] Jacobson and at least
three others . . . refused to be vaccinated and were prosecuted.
At the time, vaccination was highly regarded in the medical comto choose between them. It was not compelled to commit a matter
involving the public health and safety to the final decision of a court
or jury. It is no part of the function of a court or a jury to determine
which one of two modes was likely to be the most effective for the
protection of the public health against disease.
Consistent with that precedent, our holding today ensures that
this debate among the Alliance, the FDA, the scientific and medical
communities, and the public may continue through the democratic
process.
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140 The Law and the Publics Health
munity. Nevertheless, opposition to it was widespread and long-standing.
Antivaccinationism had many roots, including religious beliefs and
concern about civil liberties, as well as skepticism about medicine. . . .
. . . Born in Yllestad, Sweden, in 1856, Jacobson immigrated to the
United States in 1870. . . . Known as a charismatic preacher and a community leader, Jacobson practiced a form of pietism in which spirituality
was infused into everyday life. That pietism probably influenced his
resistance to vaccination. His status as an immigrant and as a member
of a minority religion may also have widened the gulf between him and
the Cambridge Board of Health. . . .
As we consider public health interventions today . . . we would do well
to recall Jacobson. Although much has changed in the past century, many
of the conflicts and tensions involved in the case remain unresolved. We
continue to debate the relationship between liberty and public health. Like
vaccination laws, isolation or quarantines imposed for communicable diseases and laws about reporting sexually transmitted diseases rely on the
state police power affirmed in Jacobson. Each such legal measure limits
the rights of individuals in the name of public health, and each is widely
accepted as an important tool by the public health community.
Jacobson v. Massachusetts*
Supreme Court of the United States
Decided February 20, 1905
Justice HARLAN delivered the opinion of the Court.
[The board of health of the City of Cambridge, pursuant to a Massachusetts statute, adopted an ordinance providing for mandatory vaccination for smallpox of all
city inhabitants over the age of twenty-one who had not been recently vaccinated.
The board passed the ordinance to address the growing prevalence of smallpox in
the city. The vaccinations were provided to the citizens free of charge. Under the
statute, those who did not comply would be subject to a fine of $5. Jacobson refused
to be vaccinated, and as a result, he was criminally charged. He alleged that the
statute was unconstitutional, arguing, among other things, that it violated the Due
Process, Equal Protection, and Privileges and Immunities clauses of the Fourteenth
Amendment.]
This case involves the validity, under the Constitution of the United States, of
certain provisions in the statutes of Massachusetts relating to vaccination. . . .
The authority of the state to enact this statute is to be referred to what is commonly called the police powera power which the state did not surrender when
becoming a member of the Union under the Constitution. Although this court has
refrained from any attempt to define the limits of that power, yet it has distinctly
recognized the authority of a state to enact quarantine laws and health laws of
every description Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 87 (1824); indeed, all
*197 U.S. 11 (1905).
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Public Health and the Protection of Individual Rights 141
laws that relate to matters completely within its territory and which do not by their
necessary operation affect the people of other states. According to settled principles, the police power of a state must be held to embrace, at least, such reasonable
regulations established directly by legislative enactment as will protect the public
health and the public safety. . . . The mode or manner in which those results are
to be accomplished is within the discretion of the state, subject, of course, so far
as Federal power is concerned, only to the condition that no rule prescribed by a
state, nor any regulation adopted by a local governmental agency acting under the
sanction of state legislation, shall contravene the Constitution of the United States,
nor infringe any right granted or secured by that instrument. A local enactment or
regulation, even if based on the acknowledged police powers of a state, must always
yield in case of conflict with the exercise by the general government of any power
it possesses under the Constitution, or with any right which that instrument gives
or secures.
We come, then, to inquire whether any right given or secured by the Constitution
is invaded by the statute as interpreted by the state court. The defendant insists
that his liberty is invaded when the state subjects him to fine or imprisonment for
neglecting or refusing to submit to vaccination; that a compulsory vaccination law
is unreasonable, arbitrary, and oppressive, and, therefore, hostile to the inherent
right of every freeman to care for his own body and health in such way as to him
seems best; and that the execution of such a law against one who objects to vaccination, no matter for what reason, is nothing short of an assault upon his person.
But the liberty secured by the Constitution of the United States to every person
within its jurisdiction does not import an absolute right in each person to be, at
all times and in all circumstances, wholly freed from restraint. There are manifold
restraints to which every person is necessarily subject for the common good. . . .
Real liberty for all could not exist under the operation of a principle which recognizes
the right of each individual person to use his own, whether in respect of his person
or his property, regardless of the injury that may be done to others. This court has
more than once recognized it as a fundamental principle that persons and property
are subjected to all kinds of restraints and burdens in order to secure the general
comfort, health, and prosperity of the state; of the perfect right of the legislature
to do which no question ever was, or upon acknowledged general principles ever
can be, made, so far as natural persons are concerned. Hannibal & St. J.R. Co. v.
Husen, 95 U.S. 465, 471 (1877). In Crowley v. Christensen, 137 U.S. 86, 89 (1890),
we said: The possession and enjoyment of all rights are subject to such reasonable
conditions as may be deemed by the governing authority of the country essential
to the safety, health, peace, good order, and morals of the community. Even liberty
itself, the greatest of all rights, is not unrestricted license to act according to ones
own will. It is only freedom from restraint under conditions essential to the equal
enjoyment of the same right by others. It is, then, liberty regulated by law. In the
Constitution of Massachusetts adopted in 1780 it was laid down as a fundamental
principle of the social compact that the whole people covenants with each citizen,
and each citizen with the whole people, that all shall be governed by certain laws
for the common good, and that government is instituted for the common good,
for the protection, safety, prosperity, and happiness of the people, and not for the
profit, honor, or private interests of any one man, family, or class of men. The good
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142 The Law and the Publics Health
and welfare of the commonwealth, of which the legislature is primarily the judge, is
the basis on which the police power rests in Massachusetts.
Applying these principles to the present case, it is to be observed that the legislature of Massachusetts required the inhabitants of a city or town to be vaccinated
only when, in the opinion of the board of health, that was necessary for the public health or the public safety. The authority to determine for all what ought to be
done in such an emergency must have been lodged somewhere or in some body;
and surely it was appropriate for the legislature to refer that question, in the first
instance, to a board of health composed of persons residing in the locality affected,
and appointed, presumably, because of their fitness to determine such questions.
To invest such a body with authority over such matters was not an unusual, nor
an unreasonable or arbitrary, requirement. Upon the principle of self-defense, of
paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members. It is to be observed that
when the regulation in question was adopted smallpox, according to the recitals in
the regulation adopted by the board of health, was prevalent to some extent in the
city of Cambridge, and the disease was increasing. If such was the situation,and
nothing is asserted or appears in the record to the contrary,if we are to attach any
value whatever to the knowledge which, it is safe to affirm, is common to all civilized
peoples touching smallpox and the methods most usually employed to eradicate that
disease, it cannot be adjudged that the present regulation of the board of health
was not necessary in order to protect the public health and secure the public safety.
Smallpox being prevalent and increasing at Cambridge, the court would usurp the
functions of another branch of government if it adjudged, as matter of law, that
the mode adopted under the sanction of the state, to protect the people at large
was arbitrary, and not justified by the necessities of the case. We say necessities of
the case, because it might be that an acknowledged power of a local community to
protect itself against an epidemic threatening the safety of all might be exercised in
particular circumstances and in reference to particular persons in such an arbitrary,
unreasonable manner, or might go so far beyond what was reasonably required
for the safety of the public, as to authorize or compel the courts to interfere for
the protection of such persons. . . . If the mode adopted by the commonwealth of
Massachusetts for the protection of its local communities against smallpox proved
to be distressing, inconvenient, or objectionable to some,if nothing more could be
reasonably affirmed of the statute in question,the answer is that it was the duty of
the constituted authorities primarily to keep in view the welfare, comfort, and safety
of the many, and not permit the interests of the many to be subordinated to the
wishes or convenience of the few. There is, of course, a sphere within which the individual may assert the supremacy of his own will, and rightfully dispute the authority
of any human government,especially of any free government existing under a written constitution, to interfere with the exercise of that will. But it is equally true that
in every well-ordered society charged with the duty of conserving the safety of its
members the rights of the individual in respect of his liberty may at times, under the
pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand. . . . The liberty
secured by the 14th Amendment, this court has said, consists, in part, in the right of
a person to live and work where he will (Allgeyer v. Louisiana, 165 U.S. 578 [1897]);
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Public Health and the Protection of Individual Rights 143
and yet he may be compelled, by force if need be, against his will and without regard
to his personal wishes or his pecuniary interests, or even his religious or political
convictions, to take his place in the ranks of the army of his country, and risk the
chance of being shot down in its defense. It is not, therefore, true that the power of
the public to guard itself against imminent danger depends in every case involving
the control of ones body upon his willingness to submit to reasonable regulations
established by the constituted authorities, under the sanction of the state, for the
purpose of protecting the public collectively against such danger.
It is said, however, that the statute, as interpreted by the state court, although
making an exception in favor of children certified by a registered physician to be
unfit subjects for vaccination, makes no exception in case of adults in like condition.
But this cannot be deemed a denial of the equal protection of the laws to adults;
for the statute is applicable equally to all in like condition, and there are obviously
reasons why regulations may be appropriate for adults which could not be safely
applied to persons of tender years.
Looking at the propositions embodied in the defendants rejected offers of proof,
it is clear that they are more formidable by their number than by their inherent value.
Those offers in the main seem to have had no purpose except to state the general
theory of those of the medical profession who attach little or no value to vaccination as a means of preventing the spread of smallpox, or who think that vaccination
causes other diseases of the body. What everybody knows the court must know,
and therefore the state court judicially knew, as this court knows, that an opposite
theory accords with the common belief, and is maintained by high medical authority.
We must assume that, when the statute in question was passed, the legislature of
Massachusetts was not unaware of these opposing theories, and was compelled,
of necessity, to choose between them. It was not compelled to commit a matter
involving the public health and safety to the final decision of a court or jury. It is no
part of the function of a court or a jury to determine which one of two modes was
likely to be the most effective for the protection of the public against disease. That
was for the legislative department to determine in the light of all the information it
had or could obtain. It could not properly abdicate its function to guard the public
health and safety. The state legislature proceeded upon the theory which recognized
vaccination as at least an effective, if not the best-known, way in which to meet and
suppress the evils of a smallpox epidemic that imperiled an entire population. Upon
what sound principles as to the relations existing between the different departments
of government can the court review this action of the legislature? If there is any such
power in the judiciary to review legislative action in respect of a matter affecting the
general welfare, it can only be when that which the legislature has done comes within
the rule that, if a statute purporting to have been enacted to protect the public
health, the public morals, or the public safety has no real or substantial relation to
those objects, or is, beyond all question, a plain, palpable invasion of rights secured
by the fundamental law, it is the duty of the courts to so adjudge, and thereby give
effect to the Constitution. Mugler v. Kansas, 123 U.S. 623 (1887).
Whatever may be thought of the expediency of this statute, it cannot be affirmed
to be, beyond question, in palpable conflict with the Constitution. Nor, in view of the
methods employed to stamp out the disease of smallpox, can anyone confidently
assert that the means prescribed by the state to that end has no real or substantial
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144 The Law and the Publics Health
relation to the protection of the public health and the public safety. Such an assertion would not be consistent with the experience of this and other countries whose
authorities have dealt with the disease of smallpox. And the principle of vaccination
as a means to prevent the spread of smallpox has been enforced in many states by
statutes making the vaccination of children a condition of their right to enter or
remain in public schools.
The latest case upon the subject of which we are aware is Viemester v. White, 72
N.E. 97 (N.Y. Ct. App. 1904), decided very recently by the court of appeals of New
York. That case involved the validity of a statute excluding from the public schools
all children who had not been vaccinated. One contention was that the statute and
the regulation adopted in exercise of its provisions was inconsistent with the rights,
privileges, and liberties of the citizen. The contention was overruled, the court saying, among other things: Smallpox is known of all to be a dangerous and contagious
disease. If vaccination strongly tends to prevent the transmission or spread of this
disease, it logically follows that children may be refused admission to the public
schools until they have been vaccinated. The appellant claims that vaccination does
not tend to prevent smallpox, but tends to bring about other diseases, and that it
does much harm, with no good. It must be conceded that some laymen, both learned
and unlearned, and some physicians of great skill and repute, do not believe that
vaccination is a preventive of smallpox. The common belief, however, is that it has a
decided tendency to prevent the spread of this fearful disease, and to render it less
dangerous to those who contract it. While not accepted by all, it is accepted by the
mass of the people, as well as by most members of the medical profession. It has
been general in our state, and in most civilized nations for generations. It is generally
accepted in theory, and generally applied in practice, both by the voluntary action of
the people, and in obedience to the command of law. Nearly every state in the Union
has statutes to encourage, or directly or indirectly to require, vaccination; and this
is true of most nations of Europe. . . . A common belief, like common knowledge, does
not require evidence to establish its existence, but may be acted upon without proof
by the legislature and the courts. . . . The fact that the belief is not universal is not
controlling, for there is scarcely any belief that is accepted by everyone. The possibility that the belief may be wrong, and that science may yet show it to be wrong,
is not conclusive; for the legislature has the right to pass laws which, according to
the common belief of the people, are adapted to prevent the spread of contagious
diseases. In a free country, where the government is by the people, through their
chosen representatives, practical legislation admits of no other standard of action,
for what the people believe is for the common welfare must be accepted as tending
to promote the common welfare, whether it does in fact or not. Any other basis would
conflict with the spirit of the Constitution, and would sanction measures opposed to
a Republican form of government. While we do not decide, and cannot decide, that
vaccination is a preventive of smallpox, we take judicial notice of the fact that this is
the common belief of the people of the state, and, with this fact as a foundation, we
hold that the statute in question is a health law, enacted in a reasonable and proper
exercise of the police power. 72 N.E. [at 9899].
Since, then, vaccination, as a means of protecting a community against smallpox,
finds strong support in the experience of this and other countries, no court, much
less a jury, is justified in disregarding the action of the legislature simply because
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Public Health and the Protection of Individual Rights 145
in its or their opinion that particular method wasperhaps, or possiblynot the best
either for children or adults.
Did the offers of proof made by the defendant present a case which entitled him,
while remaining in Cambridge, to claim exemption from the operation of the statute
and of the regulation adopted by the board of health? We have already said that his
rejected offers, in the main, only set forth the theory of those who had no faith in
vaccination as a means of preventing the spread of smallpox, or who thought that
vaccination, without benefitting the public, put in peril the health of the person vaccinated. But there were some offers which it is contended embodied distinct facts
that might properly have been considered. Let us see how this is.
The defendant offered to prove that vaccination quite often caused serious
and permanent injury to the health of the person vaccinated; that the operation
occasionally resulted in death; that it was impossible to tell in any particular
case what the results of vaccination would be, or whether it would injure the health
or result in death; that quite often ones blood is in a certain condition of impurity
when it is not prudent or safe to vaccinate him; that there is no practical test by
which to determine with any degree of certainty whether ones blood is in such
condition of impurity as to render vaccination necessarily unsafe or dangerous;
that vaccine matter is quite often impure and dangerous to be used, but whether
impure or not cannot be ascertained by any known practical test; that the defendant
refused to submit to vaccination for the reason that he had, when a child, been
caused great and extreme suffering for a long period by a disease produced by vaccination; and that he had witnessed a similar result of vaccination, not only in the
case of his son, but in the cases of others.
These offers, in effect, invited the court and jury to go over the whole ground
gone over by the legislature when it enacted the statute in question. The legislature
assumed that some children, by reason of their condition at the time, might not be fit
subjects of vaccination; and it is suggestedand we will not say without reasonthat
such is the case with some adults. But the defendant did not offer to prove that, by
reason of his then condition, he was in fact not a fit subject of vaccination at the time
he was informed of the requirement of the regulation adopted by the board of health.
It is entirely consistent with his offer of proof that, after reaching full age, he had
become, so far as medical skill could discover, and when informed of the regulation
of the board of health was, a fit subject of vaccination, and that the vaccine matter
to be used in his case was such as any medical practitioner of good standing would
regard as proper to be used. The matured opinions of medical men everywhere,
and the experience of mankind, as all must know, negative the suggestion that it is
not possible in any case to determine whether vaccination is safe. Was defendant
exempted from the operation of the statute simply because of his dread of the same
evil results experienced by him when a child, and which he had observed in the cases
of his son and other children? Could he reasonably claim such an exemption because
quite often, or occasionally, injury had resulted from vaccination, or because
it was impossible, in the opinion of some, by any practical test, to determine with
absolute certainty whether a particular person could be safely vaccinated?
It seems to the court that an affirmative answer to these questions would practically strip the legislative department of its function to care for the public health and
the public safety when endangered by epidemics of disease. Such an answer would
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146 The Law and the Publics Health
mean that compulsory vaccination could not, in any conceivable case, be legally
enforced in a community, even at the command of the legislature, however widespread the epidemic of smallpox, and however deep and universal was the belief of
the community and of its medical advisers that a system of general vaccination was
vital to the safety of all.
We are not prepared to hold that a minority, residing or remaining in any city or
town where smallpox is prevalent, and enjoying the general protection afforded by
an organized local government, may thus defy the will of its constituted authorities,
acting in good faith for all, under the legislative sanction of the state. If such be
the privilege of a minority, then a like privilege would belong to each individual of
the community, and the spectacle would be presented of the welfare and safety of
an entire population being subordinated to the notions of a single individual who
chooses to remain a part of that population. We are unwilling to hold it to be an
element in the liberty secured by the Constitution of the United States that one
person, or a minority of persons, residing in any community and enjoying the benefits of its local government, should have the power thus to dominate the majority
when supported in their action by the authority of the state. While this court should
guard with firmness every right appertaining to life, liberty, or property as secured
to the individual by the supreme law of the land, it is of the last importance that
it should not invade the domain of local authority except when it is plainly necessary to do so in order to enforce that law. The safety and the health of the people
of Massachusetts are, in the first instance, for that commonwealth to guard and
protect. They are matters that do not ordinarily concern the national government.
So far as they can be reached by any government, they depend, primarily, upon such
action as the state, in its wisdom, may take; and we do not perceive that this legislation has invaded any right secured by the Federal Constitution.
Before closing this opinion we deem it appropriate, in order to prevent misapprehension as to our views, to observeperhaps to repeat a thought already sufficiently
expressed, namelythat the police power of a state, whether exercised directly by
the legislature, or by a local body acting under its authority, may be exerted in such
circumstances, or by regulations so arbitrary and oppressive in particular cases, as
to justify the interference of the courts to prevent wrong and oppression. Extreme
cases can be readily suggested. Ordinarily such cases are not safe guides in the
administration of the law. It is easy, for instance, to suppose the case of an adult who
is embraced by the mere words of the act, but yet to subject whom to vaccination in
a particular condition of his health or body would be cruel and inhuman in the last
degree. We are not to be understood as holding that the statute was intended to be
applied to such a case, or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned. All
laws, this court has said, should receive a sensible construction. General terms
should be so limited in their application as not to lead to injustice, oppression, or
an absurd consequence. It will always, therefore, be presumed that the legislature
intended exceptions to its language which would avoid results of this character. The
reason of the law in such cases should prevail over its letter. United States v. Kirby,
74 U.S. 482 (1868). Until otherwise informed by the highest court of Massachusetts,
we are not inclined to hold that the statute establishes the absolute rule that an
adult must be vaccinated if it be apparent or can be shown with reasonable cerPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Public Health and the Protection of Individual Rights 147
tainty that he is not at the time a fit subject of vaccination, or that vaccination, by
reason of his then condition, would seriously impair his health, or probably cause his
death. No such case is here presented. It is the case of an adult who, for aught that
appears, was himself in perfect health and a fit subject of vaccination, and yet, while
remaining in the community, refused to obey the statute and the regulation adopted
in execution of its provisions for the protection of the public health and the public
safety, confessedly endangered by the presence of a dangerous disease.
We now decide only that the statute covers the present case, and that nothing
clearly appears that would justify this court in holding it to be unconstitutional and
inoperative in its application to the plaintiff in error.

Justice Harlans eloquent opinion in Jacobson rings with the values
of community and the common good. But beyond passively accepting
state legislative discretion in matters of public health, the Court makes
the first systematic statement of the constitutional limitations imposed
on public health officials. In Jacobson, the Court establishes four constitutional standards.
Public health necessityPublic health powers can be exercised
only when necessary to prevent an avoidable harm. Justice Harlan
insisted that police powers must be based on the necessities of
the case and cannot be exercised in an arbitrary, unreasonable
manner or go beyond what was reasonably required for the
safety of the public.
Reasonable meansThe methods used must be designed to
prevent or ameliorate a health threat. Even though the objective of the legislature may be valid and beneficent, the methods
adopted must have a real or substantial relation to protection
of the public health, and cannot be a plain, palpable invasion
of rights.
ProportionalityThe public health regulation may be unconstitutional if the burden imposed is wholly disproportionate to the
expected benefit. [T]he police power of a state, said Justice
Harlan, may be exerted in such circumstances, or by regulations so arbitrary and oppressive in particular cases, as to justify
the interference of the courts to prevent wrong and oppression.
Harm avoidanceThe control measure should not pose an
undue health risk to its subject. Justice Harlan emphasized that
Henning Jacobson was a fit subject for smallpox vaccinaPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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148 The Law and the Publics Health
tion, but asserted that requiring a person to be immunized who
would be harmed is cruel and inhuman in the last degree. If
there had been evidence that the vaccination would seriously
impair Jacobsons health, he might have prevailed in this historic
case. The courts have required safe and habitable environments for persons subject to isolation on the theory that public
health powers are designed to promote well-being, and not to
punish the individual. For example, in Kirk v. Wyman, 65 S.E.
387 (S.C. 1909) (excerpted in chapter 11), the South Carolina
Supreme Court found isolation in a pest house to be unconstitutional where even temporary isolation in such a place would
be a serious affliction and peril to an elderly lady, enfeebled by
disease.
During the same time period as Jacobson, the judiciary expressed its
displeasure with governmental action motivated by animus against an
ethnic group. In Yick Wo v. Hopkins, 118 U.S. 356 (1886), the Supreme
Court found unlawful discrimination when a San Francisco ordinance
prohibiting the washing of clothes in public laundries after 10 p.m.
was enforced only against Chinese owners. By 1900 public health
authorities were implementing a quarantine in San Francisco within a
twelve-block district known as Chinatown that housed a population of
12,000. Police, moreover, closed only businesses owned by nonwhite
persons. The quarantine was challenged in Jew Ho v. Williamson,
and a federal appellate court held it unconstitutional on the grounds
that it was unfair: the health authorities had acted with an evil eye
and an unequal hand. Jew Ho serves as a reminder that public health
measures can be motivated by prejudice and used as an instrument of
subjugation.
Jew Ho v. Williamson*
Circuit Court, Northern District of California
Decided June 15, 1900
Circuit Judge MORROW delivered the opinion of the court (orally).
[The board of health of San Francisco adopted a resolution authorizing the board
to quarantine twelve city blocks after nine people in the area died of bubonic plague.
*103 F. 10 (C.C.N.D. Cal. 1900).
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Public Health and the Protection of Individual Rights 149
The complainant, who resided within the limits of the quarantined district, alleged,
inter alia, that the resolution was enforced only against persons of Chinese race and
nationality, and not against persons of other races. Additionally, the complainant
alleged that there were not any cases of bubonic plague within the limits of the
quarantined district within the thirty days preceding the filing of this complaint.]
It is . . . contended that the acts of the defendants in establishing a quarantine
district in San Francisco are authorized by the general police power of the state,
intrusted to the city of San Francisco. . . .
. . . The question therefore arises as to whether or not the quarantine established
by the defendants in this case is reasonable, and whether it is necessary, under
the circumstances of this case. . . . This court will, of course, uphold any reasonable regulation that may be imposed for the purpose of protecting the people of the
city from the invasion of epidemic disease. In the presence of a great calamity, the
court will go to the greatest extent, and give the widest discretion, in construing the
regulations that may be adopted by the board of health or the board of supervisors.
But is the regulation in this case a reasonable one? Is it a proper regulation, directed
to accomplish the purpose that appears to have been in view? That is a question for
this court to determine. . . .
The purpose of quarantine and health laws and regulations with respect to contagious and infectious diseases is directed primarily to preventing the spread of
such diseases among the inhabitants of localities. In this respect these laws and
regulations come under the police power of the state, and may be enforced by quarantine and health officers, in the exercise of a large discretion, as circumstances
may require. . . . This is a system of quarantine that is well recognized in all communities, and is provided by the laws of the various states and municipalities: That,
when a contagious or infectious disease breaks out in a place, they quarantine the
house or houses first; the purpose being to restrict the disease to the smallest
number possible, and that it may not spread to other people in the same locality.
It must necessarily follow that, if a large section or a large territory is quarantined,
intercommunication of the people within that territory will rather tend to spread
the disease than to restrict it. . . . The quarantined district comprises 12 blocks. . . .
There are, I believe, 7 or 8 blocks in which it is claimed that deaths have occurred on
account of what is said to be this disease. In 2 or 3 blocks it has not appeared at all.
Yet this quarantine has been thrown around the entire district. The people therein
obtain their food and other supplies, and communicate freely with each other in all
their affairs. They are permitted to go from a place where it is said that the disease
has appeared, freely among the other 10,000 people in that district. It would necessarily follow that, if the disease is there, every facility has been offered by this species of quarantine to enlarge its sphere and increase its danger and its destructive
force. . . . The court cannot but see the practical question that is presented to it as
to the ineffectiveness of this method of quarantine against such a disease as this.
So, upon that ground, the court must hold that this quarantine is not a reasonable
regulation to accomplish the purposes sought. It is not in harmony with the declared
purpose of the board of health or of the board of supervisors.
But there is still another feature of this case that has been called to the attention
of the court, and that is its discriminating character; that is to say, it is said that this
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150 The Law and the Publics Health
quarantine discriminates against the Chinese population of this city, and in favor of
the people of other races. . . . The evidence here is clear that this is made to operate
against the Chinese population only, and the reason given for it is that the Chinese
may communicate the disease from one to the other. That explanation, in the judgment of the court, is not sufficient. It is, in effect, a discrimination, and it is the
discrimination that has been frequently called to the attention of the federal courts
where matters of this character have arisen with respect to Chinese. . . .
In the case at bar, assuming that the board of supervisors had just grounds
for quarantining the district which has been described, it seems that the board of
health, in executing the ordinance, left out certain persons, members of races other
than Chinese. This is precisely the point noticed by the supreme court of the United
States, namely, the administration of a law with an evil eye and an unequal hand.
Yick Wo v. Hopkins, 118 U.S. 356, 37374 (1886). Wherever the courts of the United
States have found such an administration of the law . . . [with] the purpose to enforce
it with an evil eye and an unequal hand, then it is the duty of the court to interpose,
and to declare the ordinance discriminating in its character, and void under the constitution of the United States. . . .
. . . This quarantine cannot be continued, by reason of the fact that it is unreasonable, unjust, and oppressive, and therefore contrary to the laws limiting the police
powers of the state and municipality in such matters; and, second, that it is discriminating in its character, and is contrary to the provisions of the fourteenth amendment of the constitution of the United States. The counsel for complainant will prepare an injunction, which shall, however, permit the board to maintain a quarantine
around such places as it may have reason to believe are infected by contagious or
infectious diseases, but that the general quarantine of the whole district must not
be continued, and that the people residing in that district, so far as they have been
restricted or limited in their persons and their business, have that limitation and
restraint removed.
II. Public Health Powers in the Modern
Constitutional Era
Broadly speaking, it is possible to identify two different kinds of
restraint on police powers. The first restraint is substantive in nature,
requiring government to provide a plausible explanation for its intrusion on individual interests. As the restriction of rights or liberties intensifies, the government must offer an increasingly strong justification.
The second type of restraint on police powers is procedural. Here
the Supreme Court requires government to provide a fair hearing
before depriving individuals of important liberty or property interests.
Police powers that affect important interestsfor example, a liberty
interest denied by quarantine or a property interest denied by confiscation of dangerous possessionsmay be exercised only with procedural
due process.
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Public Health and the Protection of Individual Rights 151
A. Substantive Rights: Levels of Scrutiny
The Supreme Court has developed a tiered approach to constitutional
law, according to which it adopts various levels of scrutiny depending
on the importance of the individual interests at stakestrict scrutiny,
intermediate scrutiny, or minimum rationality. City of Cleburne v.
Cleburne Living Center represents one of the Warren Courts clearest
articulations of this layered approach to constitutional adjudication.
City of Cleburne v. Cleburne Living Center*
Supreme Court of the United States
Decided July 1, 1985
Justice WHITE delivered the opinion of the Court.
A Texas city denied a special use permit for the operation of a group home for
the mentally retarded, acting pursuant to a municipal zoning ordinance requiring
permits for such homes. The Court of Appeals for the Fifth Circuit held that mental
retardation is a quasi-suspect classification and that the ordinance violated the
Equal Protection Clause because it did not substantially further an important governmental purpose. We hold that a lesser standard of scrutiny is appropriate, but
conclude that under that standard the ordinance is invalid as applied in this case. . . .
The Equal Protection Clause of the Fourteenth Amendment commands that no
State shall deny to any person within its jurisdiction the equal protection of the
laws, which is essentially a direction that all persons similarly situated should be
treated alike. Plyler v. Doe, 457 U.S. 202, 216 (1982). Section 5 of the Amendment
empowers Congress to enforce this mandate, but absent controlling congressional
direction, the courts have themselves devised standards for determining the validity
of state legislation or other official action that is challenged as denying equal protection. The general rule is that legislation is presumed to be valid and will be sustained if the classification drawn by the statute is rationally related to a legitimate
state interest. When social or economic legislation is at issue, the Equal Protection
Clause allows the States wide latitude, and the Constitution presumes that even
improvident decisions will eventually be rectified by the democratic processes.
The general rule gives way, however, when a statute classifies by race, alienage,
or national origin. These factors are so seldom relevant to the achievement of any
legitimate state interest that laws grounded in such considerations are deemed to
reflect prejudice and antipathya view that those in the burdened class are not as
worthy or deserving as others. For these reasons and because such discrimination is
unlikely to be soon rectified by legislative means, these laws are subjected to strict
scrutiny and will be sustained only if they are suitably tailored to serve a compelling
state interest. Similar oversight by the courts is due when state laws impinge on
personal rights protected by the Constitution.
*473 U.S. 432 (1985).
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152 The Law and the Publics Health
Legislative classifications based on gender also call for a heightened standard
of review. That factor generally provides no sensible ground for differential treatment. . . . Rather than resting on meaningful considerations, statutes distributing
benefits and burdens between the sexes in different ways very likely reflect outmoded notions of the relative capabilities of men and women. A gender classification fails unless it is substantially related to a sufficiently important governmental
interest. . . .
We have declined, however, to extend heightened review to differential treatment
based on age:
While the treatment of the aged in this Nation has not been wholly free of discrimination, such persons, unlike, say, those who have been discriminated against on
the basis of race or national origin, have not experienced a history of purposeful unequal treatment or been subjected to unique disabilities on the basis of
stereotyped characteristics not truly indicative of their abilities. Massachusetts
Board of Retirement v. Murgia, 427 U.S. 307, 313 (1976)
The lesson of Murgia is that where individuals in the group affected by a law have
distinguishing characteristics relevant to interests the State has the authority to
implement, the courts have been very reluctant, as they should be in our federal
system and with our respect for the separation of powers, to closely scrutinize legislative choices as to whether, how, and to what extent those interests should be
pursued. In such cases, the Equal Protection Clause requires only a rational means
to serve a legitimate end.
Against this background, we conclude for several reasons that the Court of
Appeals erred in holding mental retardation a quasi-suspect classification calling for
a more exacting standard of judicial review than is normally accorded economic and
social legislation. [The Court gives reasons for concluding that mental retardation
is not a quasi-suspect classification: Persons with mental retardation are a diverse
population, are materially different with less ability to cope, and have a certain level
of public and political support.] . . .
Doubtless, there have been and there will continue to be instances of discrimination against the retarded that are in fact invidious, and that are properly subject to
judicial correction under constitutional norms. But the appropriate method of reaching such instances is not to create a new quasi-suspect classification and subject
all governmental action based on that classification to more searching evaluation.
Rather, we should look to the likelihood that governmental action premised on a particular classification is valid as a general matter, not merely to the specifics of the
case before us. Because mental retardation is a characteristic that the government
may legitimately take into account in a wide range of decisions, and because both
State and Federal Governments have recently committed themselves to assisting
the retarded, we will not presume that any given legislative action, even one that
disadvantages retarded individuals, is rooted in considerations that the Constitution
will not tolerate.
Our refusal to recognize the retarded as a quasi-suspect class does not leave
them entirely unprotected from invidious discrimination. To withstand equal protection review, legislation that distinguishes between the mentally retarded and others
must be rationally related to a legitimate governmental purpose. This standard, we
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Public Health and the Protection of Individual Rights 153
believe, affords government the latitude necessary both to pursue policies designed
to assist the retarded in realizing their full potential, and to freely and efficiently
engage in activities that burden the retarded in what is essentially an incidental
manner. The State may not rely on a classification whose relationship to an asserted
goal is so attenuated as to render the distinction arbitrary or irrational. Furthermore,
some objectivessuch as a bare . . . desire to harm a politically unpopular group,
United States Dept. of Agriculture v. Moreno, 413 U.S. 528, 534 (1973)are not
legitimate state interests. Beyond that, the mentally retarded, like others, have and
retain their substantive constitutional rights in addition to the right to be treated
equally by the law. [The Court goes on to hold that although mental retardation is not
a classification deserving strict scrutiny, in this case denial of a zoning permit was
unreasonable and unconstitutional.]

Although most justices accept the constitutional standards expressed in
Cleburne, they are bitterly divided between alternative constitutional
visions, particularly in cases that involve privacy interests and sexual
and reproductive autonomy. Consider the stridently different judicial
perspectives in Lawrence v. Texas, 539 U.S. 558 (2003), and Gonzales
v. Carhart, 550 U.S. 124 (2007)both cases in which the Supreme
Court disregarded established judicial precedent.
Lawrence expressly overturned Bowers v. Hardwick, 478 U.S. 186
(1986), a Burger Court case upholding criminal penalties against two
men for having sex. Relying on a series of cases affording constitutional
protection to personal decisions relating to marriage, procreation, contraception, family relationships, child rearing, and education, Lawrence
struck down the penalties. Justice Anthony Kennedy, the swing vote on
the Court, said that the Texas statute criminalizing sexual conduct in
same-sex couples furthers no legitimate state interest which can justify
its intrusion into the personal and private life of the individual (539
U.S. at 578). Therefore, he concluded, gay couples have a due process
right to engage in consensual sexual activity in their home without government interference. Justice Sandra Day OConnor, who wrote separately, favored an approach based on the Equal Protection Clause, stating that a law branding one class of persons as criminal based solely
on the States moral disapproval . . . runs contrary to the values of the
Constitution and the Equal Protection Clause under any standard of
review (539 U.S. at 585). The majority of the Court, however, focused
on the protected conduct instead of the right to equal treatment, reasoning that homosexual couples would continue to be stigmatized as long
as consensual sexual acts could be criminalized under Bowers. DeclinPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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154 The Law and the Publics Health
ing to overturn Bowers, Kennedy wrote, would demean the lives of
homosexual persons (539 U.S. at 575).
Similarly, in Gonzales v. Carhart the Supreme Court changed course
from its precedent on reproductive freedom. In Roe v. Wade, 410 U.S.
113 (1973), and Planned Parenthood of Southeastern Pennsylvania
v. Casey, 505 U.S. 833 (1992), the Court established three principles
governing abortion jurisprudence: (1) prior to viability, the state may
not impose an undue burden on a womans right to choose to have
an abortion; (2) after viability, the state has the power to restrict abortion if the law contains an exception for pregnancies that endanger a
womans life or health; and (3) the state has legitimate interests from
the outset of the pregnancy in protecting the health of the woman and
the life of the fetus. Affirming these central holdings numerous times
since 1973, the Court stated clearly that the government has an obligation to protect the health of the woman.
In 2000, consistent with these rulings, the Court in Stenberg v.
Carhart, 530 U.S. 914 (2000), struck down a Nebraska statute criminalizing intact dilation and evacuation (a procedure termed by its critics partial birth abortion) because it did not contain an exception
for the preservation of a womans health. In unmistakable defiance
of the Courts decision, Congress enacted the Partial-Birth Abortion
Act of 2003, which banned the same procedure without allowing a
health exception. In doing so, Congress found that an intact dilation
and evacuation (D&E) is never necessarya statement that sharply
contradicts the American College of Obstetricians and Gynecologists
finding that the procedure is necessary and proper in certain cases.
By the time the act was challenged in the Supreme Court in 2007,
the Courts membership had significantly changed with the appointment of Chief Justice John Roberts and Associate Justice Samuel Alito.
In their confirmation hearings, both justices had pledge to respect
the precedents of Roe and Casey under principles of stare decisis (literally, to stand by things decided). Despite settled precedent, the
Supreme Court upheld the act. On one level, Gonzales v. Carhart does
not broadly restrict the practice of reproductive medicine because only
a small proportion of abortions use intact D&E. But on another level,
the decision is troubling because it undermines clinical freedom and
the physician/patient relationship (Drazen 2007), as well as calling into
question the legitimacy of a Court that departs from the principle of
stare decisis. In a stirring dissent, which she read aloud from the bench,
Justice Ruth Bader Ginsburg criticized the majority opinion:
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Public Health and the Protection of Individual Rights 155
The Act scarcely furthers [the states interest in preserving and promoting
fetal life]: The law saves not a single fetus from destruction, for it targets
only a method of performing abortion. . . .
Ultimately, the Court admits that moral concerns are at work,
concerns that could yield prohibitions on any abortion. Notably, the
concerns expressed are untethered to any ground genuinely serving the
Governments interest in preserving life. By allowing such concerns to
carry the day and case, overriding fundamental rights, the Court dishonors our precedent.
Revealing in this regard, the Court invokes an antiabortion shibboleth
for which it concededly has no reliable evidence: Women who have abortions come to regret their choices, and consequently suffer from [s]evere
depression and loss of esteem. Because of womens fragile emotional state
and because of the bond of love the mother has for her child, the Court
worries, doctors may withhold information about the nature of the intact
D & E procedure. The solution the Court approves, then, is not to require
doctors to inform women, accurately and adequately, of the different
procedures and their attendant risks. Instead, the Court deprives women
of the right to make an autonomous choice, even at the expense of their
safety.
In sum, the notion that the Partial-Birth Abortion Ban Act furthers any
legitimate governmental interest is, quite simply, irrational. The Courts
defense of the statute provides no saving explanation. In candor, the Act,
and the Courts defense of it, cannot be understood as anything other
than an effort to chip away at a right declared again and again by this
Courtand with increasing comprehension of its centrality to womens
lives. When a statute burdens constitutional rights and all that can be
said on its behalf is that it is the vehicle that legislators have chosen for
expressing their hostility to those rights, the burden is undue. Stenberg
v. Carhart, 530 U.S. 914, 952 (Ginsburg, J., concurring). (550 U.S. 124,
18091)
Beyond the equal protection and substantive due process rights contained in the Fifth and Fourteenth Amendments, the Constitution protects a number of other substantive rights and interests. For example,
the right of assembly, free speech, and religion (First Amendment);
the right to keep and bear arms (Second Amendment); the right to be
free from unreasonable searches and seizures (Fourth Amendment);
and the right to a speedy trial (Sixth Amendment) are all set forth in
the Constitution. At times, these substantive protections are at odds
with public health interests (see box 3). But the fact that a regulation
encroaches on a protected interest does not necessarily invalidate it.
Rather, the courts determine constitutionality by scrutinizing the interests involved under the appropriate standard of review.
In District of Columbia v. Heller, 554 U.S. 290 (2008), the Supreme
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156 The Law and the Publics Health
Courtagain divided along ideological lineswrestled with the
reaches of the Second Amendment right to keep and bear arms. At
issue in Heller is the constitutionality of the District of Columbias 1975
handgun law, which was credited with reducing gun homicides by 25
percent and gun suicides by 23 percent (Loftin et al. 1991). The justices
were sharply divided on two questions: Does the Second Amendment
protect a right of individuals to bear arms for purposes unconnected
with militia service? And, if it protects such a right, are the District of
Columbias restrictions on handgun registration and possession reasonable limitations on the right to keep and bear arms? The following
excerpt from the United States Law Week reviews the Courts opinion
in the case.
Box 3
Parental rights and contraceptive access for minors
Public health clinics operate in a political environment espousing two
values often in tensionensuring minors access to reproductive services
and respecting parental interests in knowing about, and even approving,
such services, including sexually transmitted disease (STD) treatment, contraception, and abortion. Some states have stepped in to expand minors
accessdistributing condoms and health information in the schools. Others
have contracted access by, for example, requiring health care professionals
to notify parents prior to providing reproductive services to minors. Both
approaches implicate competing constitutional interests: the minors right
to privacy, on the one hand, and the parents right to care for and guide
their children, on the other.
In Anspach v. Philadelphia Department of Public Health, 503 F.3d 256
(3d Cir. 2007), a city-operated health center provided morning after contraceptives to a sixteen-year-old minor, Melissa Anspach, at her request.
Her parents contended that the states action infringed on their parental
rights. The United States Court of Appeals for the Third Circuit analyzed
the nature and extent of parental rights, concluding that the state can
provide minors with reproductive health services in a noncoercive manner
without infringing on parental rights. Melissa Anspach herself also alleged
a constitutional violation, contending that because the state did not tell her
that the emergency contraceptives might act in a way that violates her religious beliefs concerning abortion, her right to free exercise of religion was
infringed. The court found that the clinics actions were constitutionally permissible because Anspach was not compelled to act contrary to her beliefs.
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Photo 8. Demonstrators react to two major Supreme Court decisions affecting
individual rights. At the top, protesters rally for and against limits on abortion outside the New Jersey statehouse six years after Roe v. Wade, 410 U.S.
113 (1973), legalized abortion in the United States. Below, supporters of gay
rights gather in Bostons Copley Square to celebrate the Supreme Court ruling
in Lawrence v. Texas, 539 U.S. 558 (2003), in which the Supreme Court
found sodomy laws to be unconstitutional. The sign in the photograph refers
to Justice Kennedys majority opinion, in which he wrote of same-sex couples
that the State cannot demean their existence or control their destiny by making their private sexual conduct a crime. Reproduced by permission. Top:
Bettman/Corbis, June 11, 1979. Bottom: Rick Friedman/Corbis, July 26,
2003.
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158 The Law and the Publics Health
Second Amendment Shields Individual Rights, Is Violated by
D.C.s Prohibition of Handguns*
Bureau of National Affairs, Inc.
The Second Amendment protects the individual right to have and use weapons for
self-defense, and the District of Columbias ban on handguns in the home violates
that right, the U.S. Supreme Court held . . . by a vote of 54.
This was the courts first comprehensive look at the amendment, which states
that a well regulated Militia, being necessary to the security of a free State, the right
of the people to keep and bear Arms, shall not be infringed. The court sided with the
two appeals courts that have construed it to confer an individual right, rather than a
collective right related to militia service as found by most appeals courts.
[Writing for the majority,] Justice Antonin Scalia said that the prefatory clauses
reference to the militia reflected concerns that the federal government not eliminate state militias, but does not limit the second, operative clauses recognition of
a pre-existing individual right to have and carry weapons. The amendment surely
elevates above all other interests the right of law-abiding, responsible citizens to use
arms in defense of hearth and home, he said. The D.C. laws are invalid because they
frustrate that core right, Scalia said.
A dissent [by Justice Stevens] charged that not a word in the constitutional
text even arguably supports the latter overwrought and novel construction of
the amendment. Another dissent [by Justice Breyer] argued that a handgun ban is
reasonable in a high-crime urban area, even assuming that the amendment protects
individual rights.
At issue were D.C. ordinances that, with certain exceptions, (1) bar registration
(and thus possession) of handguns, (2) prohibit carrying a handgun without a license
issued by the chief of police, and (3) require that lawfully owned firearms, such as
long guns, be kept unloaded and disassembled or bound by a trigger lock or similar
device unless they are located in a place of business or are being used for lawful
recreational activities. The plaintiff, who was denied a registration certificate for a
handgun that he wished to keep at home, charged that these ordinances violated
the Second Amendment to the extent that they bar use of functional firearms in
the home.
The district court dismissed the suit, ruling that the amendment, at most, protects an individuals right to bear arms for service in the militia. The D.C. Circuit,
agreeing with [an earlier ruling by] the Fifth Circuit, reversed. It found that the
amendment protects an individual right to possess firearms and that the citys total
ban on handguns, and the disassemble-or-lock requirement for lawful firearms, violated that right.
A Right of the People
Affirming, the Supreme Court said the Second Amendment is naturally divided into
two parts: its prefatory clause and its operative clause. The former does not limit
*Reproduced with permission from the United States Law Week 77, no. 1 (July 1,
2008): 101113. Copyright 2008 by the Bureau of National Affairs, Inc. (800-372-
1033). www.bna.com.
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Public Health and the Protection of Individual Rights 159
the latter grammatically, but rather announces a purpose. That purpose was to
prevent elimination of the militia, the court said. It explained that the amendments
proponents sought to prevent the federal governments enabling a select militia
or standing army to suppress political opponents as had occurred in 17th century
England via a disarming of the people. The term militia refers to all males physically capable of acting in concert for the common defense, rather than to the organized military units of the several states, the court said. And the phrase security
of a free state meant the security of a free polity, rather than the security of
each of the several states, thus torpedoing the theory of a D.C. Circuit dissenter who
reasoned that the amendment did not apply to the District of Columbia because it
is not a state.
The amendments operative clause significantly codifies a right of the people,
the court observed. This language resembles that in the First, Fourth, and Ninth
Amendments, which in each case protects individual, not collective, rights, it said.
Moreover, the people consistently refers to all members of the political community, rather than to a subset such as the militia, the court said. Reading the Second
Amendment as protecting only the right to keep and bear Arms in an organized
militia therefore fits poorly with the operative clauses description of the holder of
that right as the people, it reasoned.
The term arms was not limited to military weapons, the court said. Keep
arms was simply a common way of referring to possessing arms, for militiamen and
everyone else, it said. The term bear was not limited to military use of weapons,
but did signify confrontation, the court said. It thus concluded that the operative
clauses text guaranteed the individual right to possess and carry weapons in case
of confrontation. Being derived from the English Bill of Rights, it was clearly an
individual right, having nothing whatever to do with service in a militia, the court
said.
[Supreme Court Precedent] Harm onized
That interpretation is confirmed by analogous arms-bearing rights in contemporaneous state constitutions, which state courts construed to confer individual rights, the
court said. It also invoked post-ratification and 19th century commentary in support.
None of its precedents is to the contrary, the court said. In particular, United
States v. Miller, 307 U.S. 174 (1939), rejected a Second Amendment challenge by
defendants convicted of transporting an unregistered sawed-off shotgun, based
on that weapons lack of a reasonable relationship to the preservation or efficiency of a well regulated militia. If the Miller court had believed that the Second
Amendment protects only those serving in the militia, it would have been odd to
examine the character of the weapon rather than simply note that the two crooks
were not militiamen, the court here said. It thus read Miller to say only that the
Second Amendment does not protect those weapons not typically possessed by lawabiding citizens for lawful purposes, such as short-barreled shotguns.
Like most rights, the right secured by the Second Amendment is not unlimited,
the court cautioned. Thus, restrictions on carrying of concealed weapons, or on possession of weapons by felons or the mentally ill or in sensitive places such as schools
or government buildings, are not placed in doubt, it said. Nor are bans on carrying of
dangerous and unusual weapons. But the D.C. handgun ban and disassembly/lock
law strike at the inherent right of self-defense [that] has been central to the Second
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160 The Law and the Publics Health
Amendment right, and thus are invalid as to possession of those guns in the home,
it ruled. But it left the licensing requirement intact.
Dissenting, Justice John Paul Stevens, joined by Justices David H. Souter, Ruth
Bader Ginsburg, and Stephen G. Breyer, said that Miller recognized that the amendment protects the right to keep and bear arms for certain military purposes, but
that it does not curtail the Legislatures power to regulate the nonmilitary use and
ownership of weapons. He found nothing in the amendments text or history to
support an intent of the Framers to enshrine the common-law right of self-defense
in the Constitution. He cited a striking contrast of the Second Amendments terms
with contemporaneous provisions of the Vermont and Pennsylvania Constitutions
expressly recognizing individual rights.
Also dissenting, Breyer, joined by Stevens, Souter, and Ginsburg, said that a legislature could reasonably find that an urban handgun ban will advance goals of great
public importance, namely, saving lives, preventing injury, and reducing crime, and
thus the D.C. law falls within the zone that the Second Amendment leaves open to
regulation by legislatures.

The decision has important implications for public health authorities
working in violence prevention. The Court did recognize a significant
scope for gun control, suggesting that some reasonable limitation on
licensing or possession would be permitted. The Court also implied
that the right to personal possession did not extend to dangerous and
unusual weapons not typically used for self-defense or recreation,
such as machine guns. But the majority did not articulate the standard
of scrutiny that courts should use to evaluate the constitutionality of
gun laws. In his dissent, Justice Breyer criticized the majoritys failure
to set forth a constitutional standard and suggested that an interestbalancing inquiry be used. Justice Breyer would have upheld the
District of Columbia law because the city had a compelling interest in
curbing rampant gun violence, as demonstrated by the striking figures
on gun violence:
From 1993 to 1997, there were 180,533 firearm-related deaths in the
United States, an average of over 36,000 per year. Fifty-one percent were
suicides, 44% were homicides, 1% were legal interventions, 3% were
unintentional accidents, and 1% were of undetermined causes. . . .
The statistics are particularly striking in respect to children and adolescents. In over one in every eight firearm-related deaths in 1997, the victim
was someone under the age of 20. . . . More male teenagers die from
firearms than from all natural causes combined. . . .
Handguns are involved in a majority of firearm deaths and injuries in
the United States. . . . And among children under the age of 20, handguns
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Public Health and the Protection of Individual Rights 161
account for approximately 70% of all unintentional firearm-related injuries and deaths. In particular, 70% of all firearm-related teenage suicides
in 1996 involved a handgun. (128 S. Ct. at 2856)
While many state and municipal firearm laws appear to be permitted under Heller, categorical bans on handguns in cities such as
Chicago are in serious jeopardy. The National Rifle Association (NRA)
has recently filed lawsuits challenging firearm regulations around the
country. Gun advocates have even challenged Washington, D.C.s ban
on semiautomatic guns. Shortly after the Courts decision in Heller, the
New England Journal of Medicine published an editorial announcing,
The Supreme Court has launched the country on a risky epidemiologic
experiment (Drazen, Morrissey, and Curfman 2008, 517). The effects
of this experiment remain to be seen, as the courts continue to define
the legal standards for firearm laws and as jurisdictions struggle to
write laws that comply with Heller but protect the publics health.
B. Procedural Due Process
Hardly any state interest is higher than protecting its
citizenry from disease. Hardly any individual interest
is higher than the liberty interest of being free from
confinement. The consequences of error and abuse
are grave for both the state and the individual.
City of Newark v. J.S., 652 A.2d 265
(N.J. Super. Ct. Law Div. 1993)
The due process clause of the Fourteenth Amendment provides that no
state shall deprive any person of life, liberty, or property, without due
process of law. Police powers that implicate these important interests
in life, liberty, or property may be exercised only with procedural due
process. Once the court determines that the government must provide
procedural due process, the issue becomes What process is due?
that is, how elaborate must the procedures be to satisfy the due process
requirement? In Mathews v. Eldridge, 424 U.S. 319, 334 (1976), the
Court set the modern standard for fair procedures under the due process clause:
Due process is flexible and calls for such procedural protections as the
particular situation demands. Morrissey v. Brewer, 408 U.S. 471, 481
(1972). Accordingly, resolution of the issue whether the administrative
procedures provided . . . are constitutionally sufficient requires analysis
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162 The Law and the Publics Health
of the governmental and private interests that are affected. More precisely, . . . identification of the specific dictates of due process generally
requires consideration of three distinct factors: First, the private interest
that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the
probable value, if any, of additional or substitute procedural safeguards;
and finally, the Governments interest, including the function involved
and the fiscal and administrative burdens that the additional or substitute
procedural requirement would entail.
In Greene v. Edwards (excerpted next), the West Virginia Supreme
Court applied that standard in the public health context of isolation
for tuberculosis (TB), enumerating a list of procedural protections that
must be accorded to a person involuntarily confined under the states
Tuberculosis Control Act. Since Greene, the courts have continued to
define what the Constitution requires in terms of procedural protections for those whose liberty is constrained for public health purposes.
For example, a unanimous jury verdict and proof beyond a reasonable
doubt are not constitutionally required for civil commitment of a TB
patient (Ventura County Public Health Officer v. Adalberto M., 67
Cal. Rptr. 3d 277 [Cal. Ct. App. 2007]).
Greene v. Edward s*
Supreme Court of Appeals of West Virginia
Decided March 11, 1980
PER CURIAM:
William Arthur Greene . . . is involuntarily confined in Pinecrest Hospital under
an order of the Circuit Court of McDowell County entered pursuant to the terms of
the West Virginia Tuberculosis Control Act. He alleges, among other points, that the
Tuberculosis Control Act does not afford procedural due process because: (1) it fails
to guarantee the alleged tubercular person the right to counsel; (2) it fails to insure
that he may cross-examine, confront and present witnesses; and (3) it fails to require
that he be committed only upon clear, cogent and convincing proof. We agree. . . .
[The West Virginia Tuberculosis Control Act] provides in part:
If such practicing physician, public health officer, or chief medical officer having
under observation or care any person who is suffering from TB in a communicable
stage is of the opinion that the environmental conditions of such person are
not suitable for proper isolation or control by any type of local quarantine as
prescribed by the state health department, and that such person is unable or
unwilling to conduct himself and to live in such a manner as not to expose mem-
*263 S.E.2d 661 (W. Va. 1980).
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Public Health and the Protection of Individual Rights 163
bers of his family or household or other persons with whom he may be associated
to danger of infection, he shall report the facts to the department of health which
shall forthwith investigate or have investigated the circumstances alleged. If it
shall find that any such persons physical condition is a health menace to others,
the department of health shall petition the circuit court of the county in which
such person resides, or the judge thereof in vacation, alleging that such person
is afflicted with communicable TB and that such persons physical condition is a
health menace to others, and requesting an order of the court committing such
person to one of the state institutions. Upon receiving the petition, the court shall
fix a date for hearing thereof and notice of such petition and the time and place for
hearing thereof shall be served personally, at least seven days before the hearing,
upon the person who is afflicted with TB and alleged to be dangerous to the health
of others. If, upon such hearing, it shall appear that the complaint of the department of health is well founded, that such person is afflicted with communicable
TB, and that such person is a source of danger to others, the court shall commit
the individual to an institution maintained for the care and treatment of persons
afflicted with TB. . . . [ellipsis in the original]
It is evident from an examination of this statute that its purpose is to prevent a
person suffering from active communicable TB from becoming a danger to others.
A like rationale underlies our statute governing the involuntary commitment of a
mentally ill person.
In State ex rel. Hawks v. Lazaro, 202 S.E.2d 109 (W. Va. 1974), we examined
the procedural safeguards which must be extended to persons charged under our
statute governing the involuntary hospitalization of the mentally ill. We noted that
Article 3, Section 10 of the West Virginia Constitution and the Fifth Amendment
to the United States Constitution provide that no person shall be deprived of life,
liberty, or property without due process of law. . . .
We concluded that due process required that persons charged under [the West
Virginia statute governing involuntary commitment for the mentally ill] must be
afforded: (1) an adequate written notice detailing the grounds and underlying facts
on which commitment is sought; (2) the right to counsel; (3) the right to be present,
cross-examine, confront and present witnesses; (4) the standard of proof to warrant
commitment to be by clear, cogent and convincing evidence; and (5) the right to a
verbatim transcript of the proceeding for purposes of appeal.
Because the Tuberculosis Control Act and the Act for the Involuntary Hospitalization of the Mentally Ill have like rationales, and because involuntary commitment
for having communicable TB impinges upon the right to liberty, full and complete
liberty no less than involuntary commitment for being mentally ill, we conclude that
the procedural safeguards set forth in State ex rel. Hawks v. Lazaro, must, and do,
extend to persons charged under [the Tuberculosis Control Act]. . . .
We noted in State ex rel. Hawks v. Lazaro that where counsel is to be appointed
in proceedings for the involuntary hospitalization of the mentally ill, the law contemplates representation of the individual by the appointed guardian in the most
zealous, adversary fashion consistent with the Code of Professional Responsibility.
Since this decision, we have concluded that appointment of counsel immediately
prior to a trial in a criminal case is impermissible since it denies the defendant effective assistance of counsel. It is obvious that timely appointment and reasonable
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164 The Law and the Publics Health
opportunity for adequate preparation are prerequisites for fulfillment of appointed
counsels constitutionally assigned role in representing persons charged . . . with
having communicable TB.
In the case before us, counsel was not appointed for Mr. Greene until after the
commencement of the commitment hearing. Under the circumstances, counsel
could not have been properly prepared to defend Mr. Greene. For this reason, he
must be accorded a new hearing. . . .
[Mr. Greenes] discharge is hereby delayed for a period of thirty days during
which time the State may entertain further proceedings to be conducted in accordance with the principles expressed herein.

The government has considerable power to safeguard the health and
well-being of its citizens. However, this power has limits in a constitutional democracy. The state may regulate in the name of public health,
but it may not overreach. It may act on the basis of scientific evidence,
but not arbitrarily or with animus. From this point of view, society
seeks a reasonable balance between the common goods of public health
regulation and individual rights or freedoms. To ensure that we reach a
fair balance of interests, the Constitution requires government to have
a good reason for public health interventions. And when government
does intervene, the Constitution requires that individuals subject to
coercion receive a fair hearing.
Recommended Readings
Early Twentieth-Century Limits on the Police Power
Albert, Michael, Kristen Ostheimer, and Joel Breman. 2001. The last smallpox
epidemic in Boston and the vaccination controversy, 19011903. New England Journal of Medicine 344: 37579. (Sets forth the public health history
behind Jacobson, focusing on Bostons smallpox epidemic and the attendant
compulsory vaccination controversy)
Colgrove, James, and Ronald Bayer. 2005. Manifold restraints: Liberty, public
health, and the legacy of Jacobson v. Massachusetts. American Journal of
Public Health 95: 57176. (Reviews the historical tension between civil
rights and public health from Jacobson to today)
Gostin, Lawrence O. 2005. Jacobson v. Massachusetts at 100 years: Police
power and civil liberties in tension. American Journal of Public Health 95:
57681. (Provides a historical perspective on Justice Harlans opinion in
Jacobson and its enduring value)
Mariner, Wendy K., George J. Annas, and Leonard H. Glantz. 2005. Jacobson
v. Massachusetts: Its not your great-great-grandfathers public health law.
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Public Health and the Protection of Individual Rights 165
American Journal of Public Health 95: 58190. (Reviews Jacobson in light
of modern protections for civil liberties and human rights, positing that the
vigorous defense of individual rights aids public health by promoting public
trust and creating social solidarity)
Public Health Powers in the Modern Constitutional Era
Charo, R. Alta. 2007. The partial death of abortion rights. New England Journal of Medicine 356: 212528. (Details the Courts decision in Gonzales v.
Carhart and tracks state laws banning partial-birth abortion)
Dresser, Rebecca. 2007. Protecting women from their abortion choices. Hastings Center Report 37 (6): 1314. (Describes the Courts decision in Carhart and looks forward toward a case based on South Dakotas mandatory
disclosure approach to abortion)
Gostin, Lawrence O. 2007. Abortion politics: Clinical freedom, trust in the
judiciary, and the autonomy of women. JAMA 298: 156264. (Explains the
consequences of the Courts departure from precedents in Carhart)
. 2008. The right to bear arms: Constitutional law, politics, and public
health. JAMA 300: 157577. (Examines the Heller decision and its connection to public health)
Jacobson, Peter D., and Wendy E. Parmet. 2007. A new era of unapproved
drugs: The case of Abigail Alliance v. Von Eschenbach. JAMA 297: 2058.
(Describes the District of Columbia Circuit Court case holding that terminally ill patients do not have a fundamental right to access investigational
drugs found safe for expanded human trials but not approved for public use
by the FDA)
Rosenbaum, Sara, and Taylor Burke. 2003. Lawrence v. Texas: Implications
for public health policy and practice. Public Health Reports 118: 55961.
(Provides an examination of the public health implications of the Courts
decision in Lawrence striking down anti-sodomy laws)
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Photo 9. Employees of the Federal Meat Inspection Service inspect the internal organs of pigs in a 1950s meatpacking plant. The Meat Inspection Act,
passed in 1906 after Upton Sinclairs The Jungle described the unsanitary
conditions in such plants in gruesome detail, gives the federal government
the authority to perform these inspections. Reproduced by permission,
Hulton-Deutsch Collection/Corbis, ca. 1950s.
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167
The first two chapters in this part of the Reader explored the scope
and limits of the governments public health powers. In this chapter,
we examine how these powers are exercised. To achieve communal
health and safety, governments have formed specialized agencies,
usually in the executive branch. Local and federal agencies issue and
enforce regulations to ensure occupational health and safety; prevent
environmental degradation; and protect consumers from unsafe products, impure food and water, and ineffective or dangerous pharmaceuticals and medical devices. They license professionals, businesses,
and institutions to ensure adequate qualifications and standards, and
inspect premises and commercial establishments to identify unsanitary
conditions, unsafe environments, or impure products. (The contours of
agencies licensing and inspection powers will be examined in chapter
12.) Public health advocates see these agency activitiesand the regulatory state in generalas necessary to securing the publics health. A
well-regulated society generates communal benefits; it promotes health
and prevents injury and disease, fulfilling a central purpose of democratic government.
The legal status of the modern public health agency is highly
Fiv e
Public Health Governance
Direct Regulation for the Publics
Health and Safety
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168 The Law and the Publics Health
complex, informed by a vast body of administrative law. Administrative
law helps determine when public health agencies are acting openly,
fairly, and within the scope of their legislative mandates. Although the
modern public health agency resides within the executive branch of
government, it not only possesses executive power but may also issue
regulations, interpret statutes, and adjudicate disputes (see figure 6).
The lines between lawmaking, enforcement, and adjudication (inherent
in the doctrine of separation of powers) have become blurred with the
rise of the administrative state.
This chapter begins by exploring two fundamental questions: When
can an agency act? And when must an agency act? The first section
explores the former question, examining how courts decide whether
the legislature has granted an agency a specific power. The second
Courts
Public Health
Agencies
Interpret and
Enforce Statutes
Issue
Regulations
Adjudicate
Disputes
Delegates
authority
Legislature
Review
agency
action
E.g., abate nuisances,
issue licenses
E.g., set standards
for safe aand sanitary
foods, products, and
public premises
E.g., hear and resolve
disagreements
over licenses,
nuisance abatements,
and seizure of
contaminated food
Figure 6. Public health agency functions.
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Public Health Governance 169
section addresses the latter question, looking at when the courts will
compel an agency to regulate a significant health hazard; the hazards
in the illustrative cases are ethylene oxidea dangerous workplace
chemicaland greenhouse gas emissions linked to global climate
change. The third section undertakes a more fundamental inquiry into
the value of the regulatory state in protecting the publics health and
safety. The issue in this final section carries particular political significance because the debate over governments role in regulating businesses and individuals is highly charged in contemporary American
society.
I. Limits of Administrative Power: When Can an
Agency Act?
Legislatures are the policy-making arm of government and establish
public health agencies to carry out legislative policy. Consequently,
administrative agencies have only those powers that are delegated by
the legislature. In addition, there are limits as to what powers the legislature can lawfully delegate; some policy questions are assigned only
to the legislative branch (whose members are directly elected by and
accountable to the people) and cannot be handed over to executive
agencies. The judiciary reviews statutory grants of power to ensure that
agencies act within the scope of their authority and that the legislature
has not delegated purely legislative functions. The cases that follow
elucidate these two core administrative law doctrines.
A. Scope of Delegated Authority
When courts determine whether an agency action was within the scope
of its delegated authority, their central question is whether the legislature intended to grant the power exercised by the public health agency.
In examining this question, the judiciary often affords public health
agencies deference in decision making. If the agency asserts that it has
the delegated authority to act in a certain area, or the agency interprets
the authorizing statute in a certain way, the courts tend to defer (see
Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467
U.S. 837 [1984]).
The measure of deference to an agency administering its own statute
varies with the circumstances. The courts have looked to the degree of
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170 The Law and the Publics Health
care the agency took in arriving at its interpretations; its consistency,
formality of proceedings, and relative expertise; and the persuasiveness
of the agencys position (see United States v. Mead Corp., 533 U.S.
218, 227 [2001]).
There are at least three circumstances in which courts will not grant
agencies what is known as Chevron deference. In the first, the agency
has not been granted by Congress the power to interpret the statute;
in such cases, the agencys interpretation is entitled to respect only
to the extent that it is persuasive (see Skidmore v. Swift & Co., 323
U.S. 134 [1944]). In Gonzales v. Oregon (excerpted next), the attorney
general interpreted the scope of legitimate medical purpose under
the Controlled Substances Act so as to effectively criminalize the prescription of potentially lethal drug doses under the Oregon Death with
Dignity Act. The Supreme Court, however, declined to give the attorney general any deference.
In the second circumstance, discussed in Food and Drug Administration v. Brown & Williamson Tobacco Corp. (excerpted below),
Congress has directly spoken to the precise question at issue. Thus, if
Congress unambiguously specified its intent, the agency cannot form a
different judgment. Brown & Williamson dealt with the FDAs effort
to regulate tobacco in the 1990s: specifically, its attempt to prevent the
direct marketing of cigarettes to minors. The Supreme Court found
that Congress clearly intended to exclude tobacco from the FDAs jurisdiction, and thus the FDAs contrary interpretation was not entitled to
deference.
In the third circumstance, the agencys action raises significant constitutional questions. In Solid Waste Agency of Northern Cook County
v. United States Army Corps of Engineers, 531 U.S. 159 (2001), the
Supreme Court held that the Army Corps of Engineers exceeded its
authority under the Clean Water Act when it regulated waste disposal in intrastate waters. The Court said that when an administrative interpretation of a statute invokes the outer limits of Congresss
constitutional power, it is not entitled to Chevron deference. Concern
that agency action exceeds the limits of power granted by Congress is
heightened when the administrative interpretation alters the federalstate framework by permitting federal encroachment on a traditional
state power.
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Public Health Governance 171
Gonzales v. Oregon*
Supreme Court of the United States
Decided January 17, 2006
Justice KENNEDY delivered the opinion of the Court.
In 1994, Oregon became the first State to legalize assisted suicide when voters
approved a ballot measure enacting the Oregon Death With Dignity Act (ODWDA).
ODWDA . . . exempts from civil or criminal liability state-licensed physicians who . . .
dispense or prescribe a lethal dose of drugs upon the request of a terminally ill
patient. . . .
A November 9, 2001, Interpretive Rule issued by the [United States] Attorney
General . . . determines that using controlled substances to assist suicide is not a
legitimate medical practice and that dispensing or prescribing them for this purpose
is unlawful under the [Controlled Substances Act]. The Interpretive Rules validity
under the CSA is the issue before us. . . .
. . . A 1971 regulation promulgated by the Attorney General requires that every
prescription for a controlled substance be issued for a legitimate medical purpose
by an individual practitioner acting in the usual course of his professional practice. 21 CFR 1306.04(a) (2005). . . .
. . . To issue lawful prescriptions of [controlled substances], physicians must
obtain from the Attorney General a registration issued in accordance with the
rules and regulations promulgated by him. 21 U.S.C. 822(a)(2). The Attorney
General may deny, suspend, or revoke this registration if, as relevant here, the physicians registration would be inconsistent with the public interest. 824(a)(4);
822(a) (2). . . .
Executive actors often must interpret the enactments Congress has charged
them with enforcing and implementing. The parties before us are in sharp disagreement both as to the degree of deference we must accord the Interpretive Rules
substantive conclusions and whether the Rule is authorized by the statutory text at
all. . . . An administrative rule may receive substantial deference if it interprets the
issuing agencys own ambiguous regulation. An interpretation of an ambiguous statute may also receive substantial deference. Deference in accordance with Chevron,
however, is warranted only when it appears that Congress delegated authority to
the agency generally to make rules carrying the force of law, and that the agency
interpretation claiming deference was promulgated in the exercise of that authority. United States v. Mead Corp., 533 U.S. 218, 22627 (2001). Otherwise, the interpretation is entitled to respect only to the extent it has the power to persuade.
Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).
The Government first argues that the Interpretive Rule is an elaboration of one
of the Attorney Generals own regulations, which requires all prescriptions be issued
for a legitimate medical purpose by an individual practitioner acting in the usual
course of his professional practice. 21 CFR 1306.04 (2005). . . .
[The regulation] gives little or no instruction on a central issue in this case: Who
*546 U.S. 243 (2006).
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172 The Law and the Publics Health
decides whether a particular activity is in the course of professional practice or
done for a legitimate medical purpose? . . . An agency does not acquire special
authority to interpret its own words when, instead of using its expertise and experience to formulate a regulation, it has elected merely to paraphrase the statutory
language. . . .
. . . If a statute is ambiguous, judicial review of administrative rulemaking often
demands Chevron deference; and the rule is judged accordingly. All would agree,
we should think, that the statutory phrase legitimate medical purpose is a generality, susceptible to more precise definition and open to varying constructions,
and thus ambiguous in the relevant sense. Chevron deference, however, is not
accorded merely because the statute is ambiguous and an administrative official is
involved. . . .
. . . It is not enough that the terms public interest, public health and safety,
and Federal law are used in the part of the statute over which the Attorney General
has authority. The statutory terms public interest and public health do not call
on the Attorney General, or any other Executive official, to make an independent
assessment of the meaning of federal law. The Attorney General did not base the
Interpretive Rule on an application of . . . the public health and safety factor specifically. Even if he had, it is doubtful the Attorney General could cite the public
interest or public health to deregister a physician simply because he deemed
a controversial practice permitted by state law to have an illegitimate medical
purpose. . . .
. . . Since the Interpretive Rule was not promulgated pursuant to the Attorney
Generals authority, its interpretation of legitimate medical purpose does not
receive Chevron deference. Instead, it receives deference only [to the extent that
it is persuasive]. The weight of such a judgment in a particular case will depend
upon the thoroughness evident in its consideration, the validity of its reasoning, its
consistency with earlier and later pronouncements, and all those factors which give
it power to persuade, if lacking power to control. Skidmore, 323 U.S., at 140. The
deference here is tempered by the Attorney Generals lack of expertise in this area
and the apparent absence of any consultation with anyone outside the Department
of Justice who might aid in a reasoned judgment. . . . For the reasons given and
for further reasons set out below, we do not find the Attorney Generals opinion
persuasive. . . .
The judgment of the Court of Appeals is affirmed.
Food and Drug Administration v. Brown & Williamson
Tobacco Corp.*
Supreme Court of the United States
Decided March 21, 2000
Justice OCONNO R delivered the opinion of the Court.
[The Food and Drug Administration (FDA) has the power to regulate drugs and
*529 U.S. 120 (2000).
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Public Health Governance 173
medical devices to ensure they are safe and effective. Pursuant to this power,
the FDA claimed jurisdiction to regulate tobacco products as a nicotine delivery
device. The question for the Supreme Court was whether Congress intended to give
the agency the power to regulate.]
In 1996, the FDA, after having expressly disavowed any such authority since its
inception, asserted jurisdiction to regulate tobacco products. The FDA concluded
that nicotine is a drug within the meaning of the Food, Drug, and Cosmetic Act
(FDCA or Act), 21 U.S.C. 301 et seq., and that cigarettes and smokeless tobacco are
combination products that deliver nicotine to the body. Pursuant to this authority,
it promulgated regulations intended to reduce tobacco consumption among children and adolescents. The agency believed that, because most tobacco consumers
begin their use before reaching the age of 18, curbing tobacco use by minors could
substantially reduce the prevalence of addiction in future generations and thus the
incidence of tobacco-related death and disease.
Regardless of how serious the problem an administrative agency seeks to
address, however, it may not exercise its authority in a manner that is inconsistent
with the administrative structure that Congress enacted into law. ETSI Pipeline
Project v. Missouri, 484 U.S. 495, 517 (1998). And although agencies are generally
entitled to deference in the interpretation of statutes that they administer, a reviewing court, as well as the agency, must give effect to the unambiguously expressed
intent of Congress. Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.,
467 U.S. 837, 84243 (1984). In this case, we believe that Congress has clearly
precluded the FDA from asserting jurisdiction to regulate tobacco products. Such
authority is inconsistent with the intent that Congress has expressed in the FDCAs
overall regulatory scheme and in the tobacco-specific legislation that it has enacted
subsequent to the FDCA. . . .
The FDCA grants the FDA . . . the authority to regulate, among other items,
drugs and devices. See 21 U.S.C. 321(g)(h), 393 (1994 ed. & Supp. III). The Act
defines drug to include articles (other than food) intended to affect the structure
or any function of the body. Id. at 321(g)(1)(c). It defines device, in part, as
an instrument, apparatus, implement, machine, contrivance, . . . or other similar or
related article, including any component, part, or accessory, which is . . . intended
to affect the structure or any function of the body. Id. at 321(h). The Act also
grants the FDA the authority to regulate so-called combination products, which
constitute a combination of a drug, device, or biologic product. Id. at 353(g)(1).
The FDA has construed this provision as giving it the discretion to regulate combination products as drugs, as devices, or as both. . . .
The FDA determined that nicotine is a drug and that cigarettes and smokeless tobacco are drug delivery devices, and therefore it had jurisdiction under the
FDCA to regulate tobacco products as customarily marketedthat is, without manufacturer claims of therapeutic benefit. First, the FDA found that tobacco products
affect the structure or any function of the body because nicotine has significant
pharmacological effects. Fed. Reg. 44,418, 44,631 (1996). Specifically, nicotine
exerts psychoactive, or mood-altering, effects on the brain that cause and sustain
addiction, have both tranquilizing and stimulating effects, and control weight. Id. at
44,63144,632. Second, the FDA determined that these effects were intended
under the FDCA because they are so widely known and foreseeable that [they] may
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174 The Law and the Publics Health
be deemed to have been intended by the manufacturers, id. at 44,687; consumers
use tobacco products predominantly or nearly exclusively to obtain these effects,
id. at 44,807; and the statements, research, and actions of manufacturers revealed
that they have designed cigarettes to provide pharmacologically active doses of
nicotine to consumers, id. at 44,849. Finally, the agency concluded that cigarettes
and smokeless tobacco are combination products because, in addition to containing nicotine, they include device components that deliver a controlled amount of
nicotine to the body, id. at 45,20845,216.
Having resolved the jurisdictional question, the FDA next explained the policy
justifications for its regulations, detailing the deleterious health effects associated
with tobacco use. It found that tobacco consumption was the single leading cause
of preventable death in the United States. Id. at 44,398. . . . The agency also determined that the only way to reduce the amount of tobacco-related illness and mortality was to reduce the level of addiction, a goal that could be accomplished only by
preventing children and adolescents from starting to use tobacco. . . .
Based on these findings, the FDA promulgated regulations concerning tobacco
products promotion, labeling, and accessibility to children and adolescents. . . .
[The Court analyzes the FDAs assertion of authority to regulate tobacco
products, specifically the agencys construction of the statute, which is governed
by Chevron, 467 U.S. 837 (1984). Under Chevron, the Court determines whether
Congress has directly spoken (the expressed intent of Congress). If Congress has not
spoken, the Court must respect the agencys construction of the statute so long as it
is permissible. Such deference is justified because the responsibilities for assessing
the wisdom of such policy choices and resolving the struggle between competing
views of the public interest are not judicial ones, id. at 866, and because of the
agencys greater familiarity with the ever-changing facts and circumstances surrounding the subjects regulated.]
. . . We find that Congress has directly spoken to the issue here and precluded the
FDAs jurisdiction to regulate tobacco products.
Viewing the FDCA as a whole, it is evident that one of the Acts core objectives
is to ensure that any product regulated by the FDA is safe and effective for its
intended use. . . . The Act generally requires the FDA to prevent the marketing of
any drug or device where the potential for inflicting death or physical injury is not
offset by the possibility of therapeutic benefit. United States v. Rutherford, 442
U.S. 544, 556 (1979).
In its rulemaking proceeding, the FDA quite exhaustively documented that
tobacco products are unsafe, dangerous, and cause great pain and suffering
from illness. 61 Fed. Reg. 44,412 (1996). . . . These findings logically imply that, if
tobacco products were devices under the FDCA, the FDA would be required to
remove them from the market. . . .
Congress, however, has foreclosed the removal of tobacco products from the
market. A provision of the United States Code currently in force states that [t]he
marketing of tobacco constitutes one of the greatest basic industries of the United
States with ramifying activities which directly affect interstate and foreign commerce at every point, and stable conditions therein are necessary to the general
welfare. 7 U.S.C. 1311(a). More importantly, Congress has directly addressed the
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Public Health Governance 175
problem of tobacco and health through legislation on six occasions since 1965. . . .
Congress has stopped well short of ordering a ban. Instead, it has generally regulated the labeling and advertisement of tobacco products, expressly providing that
it is the policy of Congress that commerce and the national economy may be . . .
protected to the maximum extent consistent with [consumers] be[ing] adequately
informed about any adverse health effects. 15 U.S.C. 1331. . . . The collective
premise of these statutes is that cigarettes and smokeless tobacco will continue to
be sold in the United States. A ban of tobacco products by the FDA would therefore
plainly contradict congressional policy. . . .
Nonetheless, . . . the FDA found that, because of the high level of addiction among
tobacco users, a ban would likely be dangerous. 61 Fed. Reg. 44,413 (1996). In
particular, current tobacco users could suffer from extreme withdrawal, the health
care system and available pharmaceuticals might not be able to meet the treatment
demands of those suffering from withdrawal, and a black market offering cigarettes
even more dangerous than those currently sold illegally would likely develop. . . .
But the FDAs judgment that leaving tobacco products on the market is more
effective in achieving public health goals than a ban, id. at 44,398, is no substitute
for the specific safety determinations required by the FDCAs various operative
provisions. . . . In contrast, the FDAs conception of safety would allow the agency,
with respect to each provision of the FDCA that requires the agency to determine
a products safety or dangerousness, to compare the aggregate health effects
of alternative administrative actions. This is a qualitatively different inquiry. Thus,
although the FDA has concluded that a ban would be dangerous, it has not concluded that tobacco products are safe as that term is used throughout the Act. . . .
. . . To accommodate the FDAs conception of safety, however, one must read any
probable benefit to health to include the benefit to public health stemming from
adult consumers continued use of tobacco products, even though the reduction of
tobacco use is the raison dtre of the regulations. In other words, the FDA is forced
to contend that the very evil it seeks to combat is a benefit to health. This is
implausible. . . .
. . . What the FDA may not do is conclude that a drug or device cannot be used
safely for any therapeutic purpose and yet, at the same time, allow that product to
remain on the market. Such regulation is incompatible with the FDCAs core objective of ensuring that every drug or device is safe and effective.
Considering the FDCA as a whole, it is clear that Congress intended to exclude
tobacco products from the FDAs jurisdiction. A fundamental precept of the FDCA is
that any product regulated by the FDAbut not bannedmust be safe for its intended
use. . . . Consequently, if tobacco products were within the FDAs jurisdiction, the Act
would require the FDA to remove them from the market entirely. But a ban would
contradict Congresss clear intent as expressed in its more recent, tobacco-specific
legislation. The inescapable conclusion is that there is no room for tobacco products
within the FDCAs regulatory scheme. If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit.
In determining whether Congress has spoken directly to the FDAs authority to
regulate tobacco, we must also consider in greater detail the tobacco-specific legislation that Congress has enacted over the past 35 years. . . .
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176 The Law and the Publics Health
Congress has enacted six separate pieces of legislation since 1965 addressing
the problem of tobacco use and human health. Those statutes, among other things,
require that health warnings appear on all packages and in all print and outdoor
advertisements. . . .
In adopting each statute, Congress has acted against the backdrop of the FDAs
consistent and repeated statements that it lacked authority under the FDCA to regulate tobacco absent claims of therapeutic benefit by the manufacturer. In fact, on
several occasions over this period, and after the health consequences of tobacco use
and nicotines pharmacological effect had become well known, Congress considered
and rejected bills that would have granted the FDA such jurisdiction. Under these
circumstances, it is evident that Congresss tobacco-specific statutes have effectively ratified the FDAs long-held position that it lacks jurisdiction under the FDCA
to regulate tobacco products. Congress has created a distinct regulatory scheme
to address the problem of tobacco and health, and that scheme, as presently constructed, precludes any role for the FDA. . . .
Finally, our inquiry into whether Congress has directly spoken to the precise
question at issue is shaped, at least in some measure, by the nature of the question
presented. Deference under Chevron to an agencys construction of a statute . . . is
premised on the theory that a statutes ambiguity constitutes an implicit delegation
from Congress to the agency to fill in the statutory gaps. . . . Given this history and
the breadth of the authority that the FDA has asserted, we are obliged to defer not
to the agencys expansive construction of the statute, but to Congresss consistent
judgment to deny the FDA this power. . . .
By no means do we question the seriousness of the problem that the FDA has
sought to address. . . . Nonetheless, no matter . . . how likely the public is to hold the
Executive Branch politically accountable, an administrative agencys power to regulate in the public interest must always be grounded in a valid grant of authority from
Congress. . . . Reading the FDCA as a whole, as well as in conjunction with Congresss
subsequent tobacco-specific legislation, it is plain that Congress has not given the
FDA the authority that it seeks to exercise here.

To support its claim of jurisdiction, the FDA published voluminous
evidence indicating that the industry manipulated the nicotine content
of tobacco, designed cigarettes to deliver the drug to consumers, and
knew that nicotine was a highly addictive substance. The agency also
cited current statutes making it illegal to market cigarettes to children
and adolescents as it demonstrated that the industry had engaged in
a persistent campaign of advertising to young persons. Should the
Supreme Court have relied on these data to support the FDAs asserted
jurisdiction? And, from a policy perspective, has Congress shirked
its responsibility to safeguard the publics health? The Court made a
pointed reference to the fact that Congress has persistently acted to
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Public Health Governance 177
preclude a meaningful role for any administrative agency in making
policy on the subject of tobacco and health (529 U.S. at 156). Recently,
however, Congress has passed a major bill that expressly grants the
FDA jurisdiction to regulate tobacco products. On June 11, 2009, the
Family Smoking Prevention and Tobacco Control Act was enacted by
Congress, restoring the FDA authority that was invalidated in Brown
& Williamson.
B. Separation of Powers and Nondelegation
In Brown & Williamson, the Supreme Court was concerned only with
interpreting the statute granting the FDA regulatory power. The sole
issue for the Court was whether Congress intended to grant the FDA
jurisdiction to regulate tobacco products. Sometimes, however, even if
the legislature does intend to delegate broad authority to administrative agencies, the courts may prohibit such delegation on constitutional
grounds.
Conventionally, representative assemblies may not delegate legislative functions to the executive branch. According to the nondelegation doctrine, policy-making functions should be undertaken by the
legislative branch, on the theory that only representative assemblies are
politically accountable. Thus, if the legislature does intend to empower
an agency to issue rules, it must draw up clear guidelines. If the legislative grant of authority is so vague that the agency has no policy guidance, that delegation may be unconstitutional.
The nondelegation doctrine has rarely been used by the federal
courts to limit agency powers. In the 1935 case of A.L.A. Schechter
Poultry Corp. v. United States, 295 U.S. 495 (1935), the Supreme Court
invoked the doctrine to invalidate New Dealera regulations setting
maximum hours and minimum wages under the National Industrial
Recovery Act of 1933. However, since that time the Court has not
struck down a federal regulatory program on these grounds.
In 2001 the Supreme Court decided a much-anticipated case about
the allocation of authority in the modern administrative state. In
Whitman v. American Trucking Associations, Inc., 531 U.S. 457 (2001),
the Court refused to strike down the Environmental Protection Agency
(EPA) rules on air quality standards for ozone and particulate matter
(developed pursuant to the Clean Air Act) when they were challenged
on the basis of the nondelegation doctrine. Writing for the Court (531
U.S. at 472), Justice Antonin Scalia explained the doctrine as follows:
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178 The Law and the Publics Health
In a delegation challenge [at the federal level], the constitutional question
is whether the statute has delegated legislative power to the agency. Article
I 1 of the Constitution vests all legislative Powers herein granted . . .
in a Congress of the United States. This text permits no delegation of
those powers, and so we have repeatedly said that when Congress confers
decisionmaking authority upon agencies Congress must lay down by legislative act an intelligible principle to which the person or body authorized
to [act] is directed to conform.
Justice Scalia ruled that the Clean Air Acts delegation of authority to
the EPA to set national ambient air quality standards at a level requisite to protect public health was not an unconstitutional delegation
of power. It contained an intelligible principle for setting air quality
standards, and it was not necessary for the act to set precise upper
limits for pollutants.
Even if the courts do not rigidly apply the nondelegation doctrine,
they may use it as an aid to statutory construction, interpreting agency
authority narrowly if the grant of rule-making power is vague. Recall
the benzene case discussed in chapter 2, in which the Supreme Court
invalidated a federal agency rule that limited benzene in the workplace
to no more than one part per million parts of air. The Court reasoned
that the broad congressional delegation of power did not permit the
Occupational Safety and Health Administration (OSHA) to impose
health standards for exceptionally low risks with inordinately high
economic costs.
The nondelegation doctrine has received varying interpretations at
the state level; some jurisdictions liberally permit delegation of powers,
whereas others are more restrictive. In Boreali v. Axelrod, New Yorks
highest court found unconstitutional a health department prohibition
on smoking in public places because the legislature, not the health
department, should make these policy choices.
Boreali v. Axelrod*
New York Court of Appeals
Decided November 25, 1987
Judge TITONE delivered the opinion of the court.
We hold that the Public Health Council (PHC) overstepped the boundaries of its
lawfully delegated authority when it promulgated a comprehensive code to govern
*517 N.E.2d 1350 (N.Y. Ct. App. 1987).
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Public Health Governance 179
tobacco smoking in areas that are open to the public. While the Legislature has given
the Council broad authority to promulgate regulations on matters concerning the
public health, the scope of the Councils authority under its enabling statute must
be deemed limited by its role as an administrative, rather than a legislative, body. In
this instance, the Council usurped the latter role and thereby exceeded its legislative
mandate, when, following the Legislatures inability to reach an acceptable balance,
the Council weighed the concerns of nonsmokers, smokers, affected businesses and
the general public and, without any legislative guidance, reached its own conclusions
about the proper accommodation among those competing interests. . . .
The growing concern about the deleterious effects of tobacco smoking led our
State Legislature to enact a bill in 1975 restricting smoking in certain designated
areas, specifically, libraries, museums, theaters and public transportation facilities.
Efforts during the same year to adopt more expansive restrictions on smoking in
public areas were, however, unsuccessful. . . .
In late 1986, the PHC took action of its own. Purportedly acting pursuant to
the broad grant of authority contained in its enabling statute (Public Health Law
225[5][a]), the PHC published proposed rules, held public hearings and, in February
of 1987, promulgated the final set of regulations prohibiting smoking in a wide variety of indoor areas that are open to the public, including schools, hospitals, auditoriums, food markets, stores, banks, taxicabs and limousines. . . .
. . . The only dispute is whether the challenged restrictions were properly adopted
by an administrative agency acting under a general grant of authority and in the
face of the Legislatures apparent inability to establish its own broad policy on the
controversial problem of passive smoking. . . .
Section 225(5)(a) of the Public Health Law authorizes the PHC to deal with any
matters affecting the . . . public health. At the heart of the present case is the question of whether this broad grant of authority contravened the oft-recited principle
that the legislative branch of the government cannot cede its fundamental policymaking responsibility to an administrative agency. As a related matter, we must
also inquire whether, assuming the propriety of the Legislatures grant of authority,
the agency exceeded the permissible scope of its mandate by using it as a basis
for engaging in inherently legislative activities. While the separation of powers doctrine gives the Legislature considerable leeway in delegating its regulatory powers,
enactments conferring authority on administrative agencies in broad or general
terms must be interpreted in light of the limitations that the Constitution imposes.
However facially broad, a legislative grant of authority must be construed, whenever possible, so that it is no broader than that which the separation of powers doctrine permits. Even under the broadest and most open-ended of statutory mandates,
an administrative agency may not use its authority as a license to correct whatever
societal evils it perceives. Here, we cannot say that the broad enabling statute in
issue is itself an unconstitutional delegation of legislative authority. However, we
do conclude that the agency stretched that statute beyond its constitutionally valid
reach when it used the statute as a basis for drafting a code embodying its own
assessment of what public policy ought to be. . . .
A number of coalescing circumstances that are present in this case persuade
us that the difficult-to-define line between administrative rulemaking and legislative policy-making has been transgressed. While none of these circumstances,
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180 The Law and the Publics Health
standing alone, is sufficient to warrant the conclusion that the PHC has usurped
the Legislatures prerogative, all of these circumstances, when viewed in combination, paint a portrait of an agency that has improperly assumed for itself [a range
of actions] which characterizes the elected Legislatures role in our system of
government.
First, while generally acting to further the laudable goal of protecting nonsmokers from the harmful effects of passive smoking, the PHC has, in reality, constructed a regulatory scheme laden with exceptions based solely upon economic
and social concerns. . . . They demonstrate the agencys own effort to weigh the goal
of promoting health against its social cost and to reach a suitable compromise. . . .
Striking the proper balance among health concerns, cost and privacy interests,
however, is a uniquely legislative function. While it is true that many regulatory
decisions involve weighing economic and social concerns against the specific values
that the regulatory agency is mandated to promote, the agency in this case has not
been authorized to structure its decision making in a cost-benefit model and, in
fact, has not been given any legislative guidelines at all for determining how the
competing concerns of public health and economic cost are to be weighed. Thus,
[the agency] . . . was acting solely on [its] own ideas of sound public policy and was
therefore operating outside of its proper sphere of authority. Picone v. Commissioner
of Licenses, 149 N.E. 336 (N.Y. 1925). This conclusion is particularly compelling here,
where the focus is on administratively created exemptions rather than on rules that
promote the legislatively expressed goals, since exemptions ordinarily run counter
to such goals and, consequently, cannot be justified as simple implementations of
legislative values.
The second, and related, consideration is that in adopting the antismoking regulations challenged here the PHC did not merely fill in the details of broad legislation describing the over-all policies to be implemented. Instead, the PHC wrote on a
clean slate, creating its own comprehensive set of rules without benefit of legislative
guidance. . . .
A third indicator that the PHC exceeded the scope of the authority properly
delegated to it by the Legislature is the fact that the agency acted in an area in
which the Legislature had repeatedly triedand failedto reach agreement in the
face of substantial public debate and vigorous lobbying by a variety of interested
factions. . . .
In summary, we conclude that while Public Health Law 225(5)(a) is a valid
delegation of regulatory authority, it cannot be construed to encompass the policymaking activity at issue here without running afoul of the constitutional separation
of powers doctrine.

The decision in Boreali did not halt efforts to make public spaces in
New York State smoke-free. In 1995, the Smoke-Free Air Act came
into force in New York City. This local law, which banned smoking in
most restaurants, was expanded to cover the citys smaller restaurants
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Public Health Governance 181
and bars in 2003. In that same year, the New York legislature passed
the Clean Indoor Act, a comprehensive, statewide law that requires
almost all indoor workplaces and public places (e.g., restaurants, bars,
and other hospitality venues) to be smoke-free. Because these laws were
passed by the legislative branch of the city and state government, they
were not subjected to the nondelegation challenges at issue in Boreali.
II. Obligations of Administrative Agencies:
When Regulatory Action Must Be Taken
Agencies enjoy a relatively wide range of discretion in promulgating
and enforcing regulations under their authorizing statutes. Sometimes,
however, the legislature clearly instructs an agency to regulate a particular health hazard and, in such cases, the courts may compel the
agency to act to ameliorate that threat. Consider, for example, the
Occupational Safety and Health Act, which provides that the secretary
of labor shall issue an emergency occupational health standard when
workers are exposed to grave danger from exposure to substances
or agents determined to be toxic or physically harmful or from new
hazards, and such [an] emergency standard is necessary to protect
employees from such a danger (29 U.S.C. 655[c][1]). Under this provision, once the danger of exposure and the necessity of an emergency
standard are established, the secretary is obligated to act regardless of
other considerations.
Even when Congress has made an obligation to act clear (by using
words like shall), agencies, for political or other reasons, sometimes
act slowly or not at all. In such cases, litigation may be necessary to
enforce the legislatures mandate. At times, this process may span years
and may involve numerous court battles. David Vladeck (2006, 192
222), a public interest lawyer and scholar, recounts attempts to use
unreasonable delay litigation to force OSHA to set a more stringent
regulatory standard for ethylene oxide (EtO), a battle he describes as
the regulatory equivalent of hand-to-hand combat:
The filing of the petition [to ask OSHA to lower the acceptable occupation exposure level of EtO to a level consistent with new scientific
knowledge about the health harms of the chemicalincluding cancer and
spontaneous miscarriage] was the signal event that triggered seven years
of proceedings before OSHA, three trips to the federal courts resulting in
four published opinions, a contentious congressional hearing, and almost
to obstruct the rule-making by
the White Houses Office of Management and Budget. [The battle was
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182 The Law and the Publics Health
eventually successful, though the seven years of delay meant that many
workers continued to be exposed to unsafe levels of EtO.]
What conclusions can be drawn from the battle to regulate EtO?
Perhaps most important, hospital and health care workers are better
off with a full EtO standard in place. . . . Regulation can save lives and
prevent harm.
Unreasonable delay litigation, a novelty when we first sued, has
become a viable option in cases where agencies disregard their statutory
duties. . . . Courts understandably remain cautious about granting relief
in these cases to avoid upsetting an agencys prerogative to set priorities.
But, as the D.C. Circuit said in [Public Citizen Health Research Group
v. Brock, 823 F.2d 626 (D.C. Cir. 1987)], sometimes an agencys delay is
so protracted and so inexplicable that it becomes necessary for a court
to say that enough is enough and order an agency to take action by a
date-certain.
A decade ago, consumer organizations petitioned the EPA to regulate greenhouse gas emissions from motor vehicles. The Clean Air Act
(CAA) requires the EPA to set standards for vehicle emissions that
contribute to air pollution threatening public health. (See box 4, discussing the impact of climate change on human health, and figure 7.)
But the agency denied the petition in 2003, concluding that the act did
not grant it authority to regulate greenhouse gas emissions and that
such regulation would be unwise besides. In declining to act, the EPA
emphasized the Bush administrations efforts to reduce greenhouse
gas emissions through voluntary measures. The controversy reached
the Supreme Court, and in 2007 the Court decided Massachusetts v.
EPA (excerpted below). After the Court rejected the EPAs arguments,
President George W. Bush promised to issue regulations, but he did not
do so before leaving office. In April 2009, the Obama administration
began the process that might lead to the regulation of greenhouse gases
under the CAA.
Massachusetts v. EPA*
Supreme Court of the United States
Decided April 2, 2007
Justice STEVENS delivered the opinion of the Court.
On October 20, 1999, a group of 19 private organizations filed a rulemaking petition asking EPA to regulate greenhouse gas emissions from new motor vehicles
*549 U.S. 497 (2007).
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Public Health Governance 183
under . . . the Clean Air Act. Petitioners maintained . . . that greenhouse gas emissions have significantly accelerated climate change. . . . The petition further alleged
that climate change will have serious adverse effects on human health and the
environment. . . .
On September 8, 2003, EPA entered an order denying the rulemaking petition.
The agency gave two reasons for its decision: (1) that contrary to the opinions of its
former general counsels, the Clean Air Act does not authorize EPA to issue mandatory regulations to address global climate change; and (2) that even if the agency
had the authority to set greenhouse gas emission standards, it would be unwise to
do so at this time.
In concluding that it lacked statutory authority over greenhouse gases, EPA
observed that Congress was well aware of the global climate change issue when
it last comprehensively amended the [Clean Air Act] in 1990, yet it declined to
Box 4
Greenhouse gases and health
There is broad scientific agreement that greenhouse gas emissions resulting from human activity are changing the earths climate. From a public
health perspective, the key questions are, How will climate change affect
human health? And what can be done to minimize climate changes health
effects?
Although the precise impact is uncertain, there is little doubt that climate change will profoundly affect human health. Heat waves and extreme
weather events (e.g., floods and hurricanes) clearly cause excess mortality. Consider, for example, the 15,000 extra deaths in France during a
heat wave in August 2003. Infectious diseases will also take a large toll
in a warming world as the higher temperatures promote the proliferation
of microbessuch as salmonella and choleraand the insects that carry
vector-borne diseases, such as malaria and dengue fever. Safe drinking
water will become scarcer, as rising sea levels contribute to the salination of water supplies. Ecosystem changes and water scarcity will in turn
impair crop, livestock, and fisheries yields, leading to food shortages (see
figure 7). These impacts will contribute to larger social, economic, and
political disruptions, further complicating the relationship between climate
change and human health and security. As the epidemiologists Anthony
J. McMichael and Rosalie Woodruff (2004, 1417) note, Climate change is
not merely another addition to the list of environmental health hazards
each warranting separate epidemiologic study and risk management. It is
a complex global environmental hazard, with knock-on effects. . . . Hence
the overall risk to health is more than the aggregation of itemized disease
risks due to particular climatic factors.
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Microbial
contamination
pathways
Transmission
dynamics
Agro-ecosystems,
hydrology
Socioeconomics,
demographics
Heat waves
Extreme weather
Temperature
Precipitation
CLIMATE
CHANGE
REGIONAL
WEATHER
CHANGES
HEALTH EFFECTS
Temperature-related
illness and death
Extreme weatherrelated
health effects
Air pollutionrelated
health effects
Water- and food-borne
diseases
Vector- and rodent-borne
diseases
Effects of food and water
shortages
Mental, nutritional,
infections, and other related
health effects
Figure 7. Climate change and public health. Source: Adapted from World
Health Organization 2003a, 11, figure 3.1.
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Public Health Governance 185
adopt a proposed amendment establishing binding emissions limitations. 68 Fed.
Reg. 52926. Congress instead chose to authorize further investigation into climate
change. EPA further reasoned that Congress specially tailored solutions to global
atmospheric issues, id., at 52926in particular, its 1990 enactment of a comprehensive scheme to regulate pollutants that depleted the ozone layercounseled
against reading the general authorization of [the Clean Air Act] to confer regulatory
authority over greenhouse gases. . . .
Even assuming that it had authority over greenhouse gases, EPA explained in
detail why it would refuse to exercise that authority. The agency began by recognizing that the concentration of greenhouse gases has dramatically increased as a result
of human activities, and acknowledged the attendant increase in global surface air
temperatures. EPA nevertheless gave controlling importance to the NRC [National
Research Council] Reports statement that a causal link between the two cannot
be unequivocally established. Id., at 52930. Given that residual uncertainty, EPA
concluded that regulating greenhouse gas emissions would be unwise. . . .
. . . As we have repeated time and again, an agency has broad discretion to choose
how best to marshal its limited resources and personnel to carry out its delegated
responsibilities. That discretion is at its height when the agency decides not to bring
an enforcement action. . . . Some debate remains, however, as to the rigor with which
we review an agencys denial of a petition for rulemaking. . . .
EPA concluded in its denial of the petition for rulemaking that it lacked authority . . . to regulate new vehicle emissions because carbon dioxide is not an air pollutant as that term is defined in [the Clean Air Act]. In the alternative, it concluded
that even if it possessed authority, it would decline to do so because regulation
would conflict with other administration priorities. As discussed earlier, the Clean
Air Act expressly permits review of such an action. We therefore may reverse any
such action found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law. 42 U.S.C. 7607(d)(9).
. . . The first question is whether . . . the Clean Air Act authorizes EPA to regulate greenhouse gas emissions from new motor vehicles in the event that it forms a
judgment that such emissions contribute to climate change. We have little trouble
concluding that it does. In relevant part, [the Act] provides that EPA shall by regulation prescribe . . . standards applicable to the emission of any air pollutant from
any class or classes of new motor vehicles or new motor vehicle engines, which in
[the Administrators] judgment cause, or contribute to, air pollution which may reasonably be anticipated to endanger public health or welfare. 7521(a)(1). Because
EPA believes that Congress did not intend it to regulate substances that contribute
to climate change, the agency maintains that carbon dioxide is not an air pollutant
within the meaning of the provision.
The statutory text forecloses EPAs reading. The Clean Air Acts sweeping definition of air pollutant includes any air pollution agent or combination of such
agents, including any physical, chemical . . . substance or matter which is emitted
into or otherwise enters the ambient air. . . . 7602(g) (emphasis added). On its
face, the definition embraces all airborne compounds of whatever stripe, and underscores that intent through the repeated use of the word any. . . . The statute is
unambiguous. . . .
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186 The Law and the Publics Health
While the Congresses that drafted [the Clean Air Act] might not have appreciated the possibility that burning fossil fuels could lead to global warming, they did
understand that without regulatory flexibility, changing circumstances and scientific developments would soon render the Clean Air Act obsolete. The broad language . . . reflects an intentional effort to confer the flexibility necessary to forestall
such obsolescence. Because greenhouse gases fit well within the Clean Air Acts
capacious definition of air pollutant, we hold that EPA has the statutory authority
to regulate the emission of such gases from new motor vehicles.
The alternative basis for EPAs decisionthat even if it does have statutory
authority to regulate greenhouse gases, it would be unwise to do so at this time
rests on reasoning divorced from the statutory text. . . .
If EPA makes a finding of endangerment, the Clean Air Act requires the agency to
regulate emissions of the deleterious pollutant from new motor vehicles. . . . Under
the clear terms of the Clean Air Act, EPA can avoid taking further action only if
it determines that greenhouse gases do not contribute to climate change or if it
provides some reasonable explanation as to why it cannot or will not exercise its
discretion to determine whether they do. . . .
EPA has refused to comply with this clear statutory command. Instead, it has
offered a laundry list of reasons not to regulate. . . .
Although we have neither the expertise nor the authority to evaluate these policy
judgments, it is evident they have nothing to do with whether greenhouse gas emissions contribute to climate change. Still less do they amount to a reasoned justification for declining to form a scientific judgment. . . .
Nor can EPA avoid its statutory obligation by noting the uncertainty surrounding various features of climate change and concluding that it would therefore be
better not to regulate at this time. If the scientific uncertainty is so profound that it
precludes EPA from making a reasoned judgment as to whether greenhouse gases
contribute to global warming, EPA must say so. That EPA would prefer not to regulate greenhouse gases because of some residual uncertainty . . . is irrelevant. The
statutory question is whether sufficient information exists to make an endangerment finding.
In short, EPA has offered no reasoned explanation for its refusal to decide
whether greenhouse gases cause or contribute to climate change. Its action was
therefore arbitrary, capricious . . . or otherwise not in accordance with law. . . .
The judgment of the Court of Appeals is reversed, and the case is remanded for
further proceedings consistent with this opinion.
It is so ordered.
III. Deregulation and New Governance Theory
Questions concerning what agencies are legally able or obligated to
regulate are different from the underlying policy questions: What areas
of life should be regulated? How much regulation is desirable? And
how vigorously should regulations be enforced? Public health advocates see community-wide benefits to living in a well-regulated society;
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Public Health Governance 187
from a public health perspective, the regulatory state is a key element
in securing basic health and safety standards. But the free market and
laissez-faire economics are powerful values in American culture and
politics. Citizens sometimes see government regulation as creating
costly bureaucracies that tie up tax dollars and constrain economic
liberty. (Of course, when administrative agencies fail to fulfill their
mandateand when that inaction leads to highly visible food-borne
disease outbreaks, mining disasters, and unacceptably dangerous pharmaceuticalsthese objections typically lose their force.)
Market economists believe that regulation, if desirable at all, should
redress market failures rather than restrain free enterprise. They often
maintain that historical precedent supports the notion of minimal governmental intervention in the economy, asserting that the free enterprise system was the prevailing value in early America. The historian
William J. Novak (1993, 12) disputes this claim:
The relationship of law, state, and economy in America has been the
center of legal-historical research for almost 50 years now. But basic
assumptions about state regulation and economics have remained surprisingly static. First, regulation and the economy are seen as diametrical
opposites. Regulation is a contrived and public interference in a field
of invisible economic relations otherwise natural and private. Second,
American regulation is understood as a relatively recent invention. . . .
Through a historical reconstruction of 19th century notions of
public economy and the well-ordered market, I hope to establish the
predominance in theory and practice of an approach to economic life in
early America antithetical to the classical separation of market and state.
[Numerous] cases, statutes, and ordinances suggest that early Americans
understood the economy as simply another part of their well-regulated
society, intertwined with public safety, health, morals, and welfare and
subject to the same kinds of legal controls. Far from viewing the state and
the economy as adversarial, the notion of public economy was part of
a worldview slow to separate public and private, government and society.
It understood commerce, trade, and economics, like health and morals,
as fundamentally public in nature, created, shaped, and regulated by the
polity via public law.
Novak argues that economic regulation was deeply rooted in American
life and law throughout the preCivil War era. The pervasiveness of
regulation and the accompanying rationales steeped in a vision of a
well-regulated society call into question later descriptions of this
period as the golden age of market capitalism and individualism. (See
chapter 3, which excerpts Novaks historical discussion of the police
power and the regulatory state.)
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Photo 10.
Signs posted in a
Virginia store window
in 2007 announce safety recalls of childrens toys by
the Consumer Product
Safety Commission, which is
responsible for regulating such products.
The toys were
potentially contaminated with lead paint. Lead is a
potent neurotoxin that is especially dangerous for children. The series of recalls led Congress to pass legislation in July 2008 banning lead and other toxins in
childrens toys.
Reproduced by permission, Sonda
Dawes/
The
Image Works,
December 2007.
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Public Health Governance 189
In modern America, however, the regulatory state remains the subject of contention; a strong antigovernment movement favors deregulation, devolution, and privatization to dismantle the administrative
state. Others have advocated in favor of a hybrid system that falls
somewhere in the middle of the spectrum. They draw on the concept
of new governance, which recognizes the importance of nongovernmental stakeholders and their impact on society. The newer forms
of governance advocated under this theory tend to favor market- or
incentive-based regulation, negotiated rule making, self-regulation,
public disclosure, and other methods that aid the agency in coordinating decisions by affected parties rather than merely selecting the regulatory scheme that it prefers. Some new governance strategies might
be beneficial, achieving improved health and safety at a lower social
and economic cost than pure regulation, but it is unlikely that new
governance can or should replace traditional regulation for the publics
health. Instead, policy makers and regulators should apply the new or
traditional governance tools that are best suited to the task at hand.
While new governance and traditional regulation might complement
one another, many new governance strategies have been implemented to
the exclusion of effective traditional regulation. In the article excerpted
below, I describe the emerging Deregulatory State that has come to
prominence through preemption and privatization.
The Deregulatory State*
Lawrence O. Gostin
Public health can be achieved only through collective action. Individuals acting alone
cannot protect themselves from work hazards, unsafe or ineffective vaccines and
pharmaceuticals, impure food and water, a polluted environment, or epidemics. Only
a well-regulated society can secure the essential conditions for health. Yet in this
country, successive administrations have eroded health and safety protections. The
consequences include deaths in the mining industry, lead in toys, industrial solvents
in toothpaste, harmful bacteria in peanut butter and spinach, and unsafe and ineffective pharmaceuticals.
The Deregulatory State is a result of a conservative campaign that has created
and reinforced deep-seated concerns about overbearing government. The political
dialogue used to describe agency action is pejorative and effective: big government, centralized, top-down, and bureaucratic. This anti-government narra-
*Reprinted from Hastings Center Report 38, no. 2 (MarchApril 2008): 1011.
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190 The Law and the Publics Health
tive has set the terms of the debate about the role of government in protecting the
public from market excesses and failures.
The Deregulatory State takes many subtle forms, including self-policing, so that
industry discloses and corrects its own safety violations; incapacitating, so that
agencies are starved of expertise and resources; devolving, so that residual regulation is focused at the local level; preempting, so that the federal government denies
states the authority to protect their citizens; and privatizing, so that government
functions are conducted by for-profit or voluntary entities.
Regulatory Vacuums through Preemption
Congress has the power to preempt public health regulation at the state level, even
if the state is acting squarely within its police powers. Federal preemption may seem
like an arcane doctrine, but it has powerful consequences for the publics health
and safety. The Supreme Courts preemption decisions can effectively foreclose
meaningful state regulation and prevent people from turning to the courts for legal
redress. . . . From 2001 to 2006, Congress enacted twenty-seven statutes that preempt state health, safety, and environmental policies, demonstrating the potential
breadth of federal power to override state public health safeguards.
The Bush administration has vigorously advocated preemption to invalidate
state public health efforts in both amicus curiae briefs and preambles to agency
rules. On February 20, 2008, the Roberts Court handed the administration a victory in two major preemption cases. In Rowe v. New Hampshire Motor Transport
Association, the Court held that a federal transportation statute preempted
Maines laws designed to prevent minors from buying cigarettes on the Internet. In
Riegel v. Medtronic, Inc., the Court ruled that manufacturers are immune from tort
liability for medical devices . . . that received pre-market approval and meet Food
and Drug Administration specifications. . . . In effect, the executive and judicial
branches are dismantling a long-standing civil justice safety net for consumers
and patients who suffer from industry misconduct left unchecked by federal and
state regulations.
Outside the courtroom, multiple agencies charged with protecting public health,
safety, and the environment have systematically pushed for preemption through
administrative rulemaking. Federal agencies have inserted preemptory language
in preambles to rules governing everything from seatbelt placement and mattress
flammability to drug labeling and railroad safety. This troubling trend is made all the
more worrisome by the administrations failure to provide an opportunity for public
comment on the preemption language in rule preambles.
This sweeping preemption of state regulation and tort actions has created regulatory vacuums. Instead of advocating devolution or otherwise supporting state
authority to protect the publics health, the federal government has consistently
derailed state regulation. At the same time, it has dismantled federal safety standards, leaving a large regulatory abyss. . . .
Thus, the public remains unprotected prospectively because the federal government both declines to regulate and suppresses state efforts to do so. And the public
is unprotected retrospectively because of the Courts invalidation of state tort law.
In short, the public is left to fend for itself.
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Public Health Governance 191
Trusting the Private Sector
Privatization, understood broadly, is the governments abdication of responsibility
for health governance by assigning public functions to the private sector. It can happen directly, when the state contracts out governmental functions to industry (such
as in mental health care, prisons, or child welfare services). Or it can happen indirectly, when the state withdraws financial and political support for critical agency
functions, cooperates with industry in setting and enforcing standards, or simply
allows companies to self-regulate.
Agency Incapacity
Government can avoid stringent regulation simply by starving agencies of funds or
making them rely on industry largess for resources. The FDA offers a classic case
study of how the White House and Congress can weaken a once powerful agency.
The FDA is responsible for the safety of approximately 80 percent of food sold and
all human drugs, vaccines, and medical devices. . . . Yet Congress has steadily either
reduced funding or held it constant, even as the FDAs functions have expanded
vastly. . . . The FDAs resource shortfalls have resulted in inadequate inspections,
a dearth of scientists, inability to speed the development of new therapies, and
neglect of food and drug imports. For example, the FDA now carries out 78 percent
fewer food inspections than thirty-five years ago and inspects food manufacturers
on average only once every ten years. . . . The FDA is also hampered by the lack of
clear regulatory authority, organizational problems, and a scarcity of postapproval
data about drugs risks and benefits. Just as troubling, the FDAs major source
of funding for drug approvals is user fees from pharmaceutical companies, which
invites criticism about the agencys close relationship with industry.
Self-Policing
As part of the trend against state regulation, agencies have developed self-policing
programs that shift the burden of regulatory compliance from government to industry. The Occupational Safety and Health Administrations Voluntary Protection
Program exempts participating firms from routine inspection and eschews formal
adjudication. With the virtual nonenforcement of violations under this program,
industrys abysmal record of safety compliance is not surprising. OSHA has repeatedly failed to prosecute firms with a long history of safety violations, even in the
face of debilitating injuries and deaths caused by employer negligence. Similarly, the
Department of Veterans Affairs Medical Errors program asks hospitals to selfdisclose dangerous forms of malpractice, and the EPAs Greenlights recognizes
and rewards firms for self-disclosing and correcting safety violations. But industry
has only mild incentives to self-police, and researchers say they do so only if agencies increase inspections and compliance.
Self-Regulation
In an increasingly deregulated state, industry representatives, rather than government, have initiated much contemporary regulatory activity, [including] codes
of conduct, collaborative agreements, accreditation, information disclosure, and
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192 The Law and the Publics Health
ratings. . . . Perhaps the most prominent recent illustration of self-regulation is
the decision by food and beverage manufacturers to limit sales in schools and curb
advertising to children. But more often than not, self-regulation occurs in response
to pressure by government or advocacy groups. For example, the food and beverage
industries announced their schools and advertising policies shortly after the publication of Federal Trade Commission reports highlighting their deceptive practices
and the risks of obesity. Because they are not in a position to defend themselves and
their families, members of society need the protection of the state. If the government drastically reduces regulation and enforcement and leaves core government
duties to the private sector, current and future generations will suffer. Indeed, it
was in recognition of the palpable harms of the free market that health, safety, and
environmental regimes and civil justice systems emerged. They have evolved over
a long period to work synergistically in their protective effect; the whole system is
now under serious threat.
Recommended Readings
Limits of Administrative Power: When Can an Agency Act?
Gostin, Lawrence O. 2006. Physician-assisted suicide: A legitimate medical
practice? JAMA 296: 194143. (Argues that Gonzales v. Oregon affirms
the ability of states to regulate medical practice and that this ability may
promote the easing of end-of-life suffering)
Sunstein, Cass R. 2006. Chevron step zero. Virginia Law Review 92: 187
249. (Argues that the initial question of whether Chevron applies is overly
complex and must be simplified in order to broaden the Chevron tests use)
Obligations of Administrative Agencies: When Regulatory Action
Must Be Taken
McMichael, Anthony, and Rosalie Woodruff. 2004. Climate change and risk
to health: The risk is complex, and more than a sum of risks due to individual climatic factors. British Medical Journal 329: 141617. (Links climate
change and its effects on human health, and emphasizes the need for sustainable ways of living)
Vladeck, David C. 2006. Unreasonable delay, unreasonable intervention: The
battle to force regulation of ethylene oxide. In Administrative Law Stories,
ed. Peter L. Strauss, 191226. New York: Foundation Press. (Details the
seven-year battle to force OSHA to regulate ethylene oxide and describes
the legal strategy of unreasonable delay litigation)
Deregulation and New Governance Theory
Freeman, Jody. 2003. Public values in an era of privatization: Extending public
law norms through privatization. Harvard Law Review 116: 12851352.
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Public Health Governance 193
(Argues that privatization is not a shrinking of government but a way to
expand governments reach into traditionally private sectors of life)
Lobel, Orly. 2004. The renew deal: The fall of regulation and the rise of governance in contemporary legal thought. Minnesota Law Review 89: 262
390. (Argues that there is a sea change occurring in the legal field, as the
traditional regulatory model is shifting to a framework that is based on
governance)
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Photo 11. With a photograph of a wrecked Ford Explorer in the background, Ford Motor Company executives listen to testimony on Capitol
Hill in September 2000 as part of a House committee investigation of a
national recall of Firestone tires. The tires, which Ford installed on many
of its Explorers, had manufacturing defects. More than 140 individuals
were killed in auto accidents allegedly caused by the defective tires.
Reproduced by permission, Dennis Cook/AP/Wide World Photos,
September 6, 2000.
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195
The levers of public health regulation are often viewed as being in the
hands of legislatures and executive agencies. However, attorneys general and private citizens possess a powerful means of indirect regulation through the tort system. Tort litigation can be an effective method
for reducing the burden of injury and disease. The courts help redress
harms caused by pollution, toxic substances, unsafe pharmaceuticals
or vaccines, and defective or hazardous consumer products. Figure 8
provides an image of how tort law serves as a tool for reducing a variety of harms to the populations health.
The goals of tort law, though often imperfectly achieved, are frequently consistent with public health objectives. The tort system aims
to hold individuals and businesses accountable for their dangerous
activities, compensate persons who are harmed, deter unreasonably
hazardous conduct, and encourage innovation in product design, labeling, and advertising to reduce the risk of injury or disease. Civil litigation, therefore, can provide potent incentives for people and manufacturers to engage in safer, more socially conscious behavior.
Tort law can be an effective method of advancing the publics health,
Six
Tort Law and
the Publics Health
Indirect Regulation
When functioning well, a regulatory system prevents injury
and rewards innovation. But too often there are regulatory
gaps that jeopardize public safety. Since the founding of our
Republic, tort liability has filled those gaps.
David C. Vladeck, 2005
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196 The Law and the Publics Health
but like any form of regulation, it is not an absolute good. The tort
system imposes economic costs and personal burdens on individuals
and businesses, including transaction expenses (e.g., court costs and
attorneys fees) and monetary awards (both compensatory and punitive). Society may not be any the poorer if tort costs make it difficult
for dangerous, socially unproductive enterprises (e.g., the tobacco and
firearms industries) to operate within the market. However, tort costs
may be just as high for socially advantageous goods and services such
as vaccines, pharmaceuticals, and medical devices. In such cases, litigation may help ensure safety and efficacy, but it also risks hampering
development and production.
Tort litigation, moreover, can be seen as antidemocratic and unfair.
Critics argue that the political branches of government, not the judicial branch, should set health policy. Even though redress through
the courts is an important right in a constitutional democracy, some
observers do not believe that judges and juries should award substantial
punitive damages against manufacturers. Critics also claim that often
the chief beneficiaries of the tort system are a few plaintiffs and their
attorneys, rather than the entire population that has been harmed. For
example, some tobacco litigation has imposed substantial penalties on
Defective
Products
Misleading
Information
Environmental Hazards
Unsafe Vaccines and
Pharmaceuticals
Tort Law
Public
Health
Figure 8. Tort law as a tool in public health.
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Tort Law and the Publics Health 197
manufacturers but has disproportionately rewarded a relatively small
number of smokers and trial lawyers.
Litigation as a form of regulation, then, holds enormous potential
for improving the publics health, but also entails economic costs and
unjust distribution of benefits and burdens. As in any form of regulation, we balance the public goods resulting from civil litigation against
the burdens and inequities.
This chapter takes a look at tort litigation as a tool of public health.
(For those who are unfamiliar with the major theories of tort law, it will
be helpful to read chapter 6 in the companion text.) First, it discusses
tort law generally as a prevention strategy. Second, it explores the complex problems involving science and epidemiology in the courtroom.
The courts have long struggled to determine what types of scientific
evidence and proof should be admissible in public health litigation.
Finally, the chapter examines litigation against tobacco companies,
the fast-food industry, and medical device and pharmaceutical manufacturers. These cases may suggest new strategies and frameworks for
addressing other sets of public health issues. However, tort litigation
has its limitations as well; it may increase costs for consumers and may
stifle promising research and development.
I. Major Theories of Tort Litigation
This section provides a general overview of tort litigation for the publics health and highlights the unique role of the courts in public health
regulation. The fundamental questions are, how should public health
policy be constructed, and by which institutionsthe market, the
political system (i.e., the legislative and executive branches of government), or the courts? The two brief selections, by noted public health
lawyers, show the courts unique role in public health regulation and
discuss both the advantages and disadvantages of policy making by
the courts. As originally published, they use specific types of cases to
illustrate particular public health problems. Stephen P. Teret emphasizes air bag, cigarette, and firearm litigation; Wendy E. Parmet and
Richard A. Daynard explain a matrix of the forms of legal action used
in cases involving tobacco, firearms, and lead paint. Although those
illustrations are largely absent from the abridged versions below, this
chapter ends by providing updates on tobacco, firearm, and medical
device litigation.
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198 The Law and the Publics Health
Litigating for the Public Health*
Stephen P. Teret
Vector control has long been one of the basic tools of public health. When it was
learned that rodents, mosquitoes, and other living organisms transmitted to man the
etiologic agents for disease, the public health response was to control those vectors
of disease. Today, the vehicles for injury and disease are often manmade products,
frequently transmitting energy as the etiologic agent of injury. The public health
response should similarly be the control of these vehicles by use of the law. But
unlike rodents and mosquitoes, the modern day vehicles of injury and disease have
vested interests, lobbyists and political action committees that sometimes thwart
effective legislative and regulatory attempts to enhance the publics health. When
this happens, public health advocates have turned to the third branch of government, the judiciary, to seek relief from juries.
Product liability litigation is now being used as an effective tool for public
health advocacy. Its use is based on the premise that substantial settlements and
verdicts against the manufacturer of an unnecessarily dangerous product will
ultimately cause that manufacturer to invest in prevention rather than pay the
penalty for neglect. Manufacturers, responding to the negative effect which large
damage awards have on corporate profits and insurance premiums, have recalled
and redesigned formerly unsafe products, and have developed testing methods and
design strategies aimed at reducing the likelihood that a new product will injure its
user.
But product liability litigation, or the specter thereof, may also retard the introduction of innovative products that can be beneficial to the publics health. Some
manufacturers suggest that product liability exposure is great enough to warrant
the withdrawal of products from the market, even if on balance the benefit of the
product to the public clearly outweighs the risk of the product to an individual. . . .
Thus, product liability litigation can be seen as a double-edged sword, to be used as
a tool of public health under carefully chosen circumstances, when more conventional forms of advocacy have not proven fruitful. . . .
Cars, cigarettes and guns have presented sizable problems to the publics health.
Together, their annual death toll in the United States approaches half a million
people. The fact that each of these products may be susceptible to product liability
litigation is a reflection that jurors can find the hazards these products pose as
unacceptable. Cigarettes and guns can be seen as low-benefit, high-risk products.
Cars, although of great social benefit, are inadequately crashworthy with regard to
foreseeable risk.
The solution to liability exposure should be the marketing of safe products. For
some products, this may mean modification by the use of already existing devices
such as air bags. For other products such as cigarettes, it may mean the end of
manufacturing and marketing of the product altogether.
But instead of product changes, the perceived crisis of litigation has led many,
*Reprinted from American Journal of Public Health 76 (1986): 102729.
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Tort Law and the Publics Health 199
under the banner of tort reform, to propose limiting monetary recoveries for people
damaged from products. Some aspects of these proposals may have merit, particularly with regard to products which are now regulated. But for those products which
have been able to avoid meaningful regulation, largely due to the political strength
of lobbying groups, litigation represents the only de facto form of safety regulation. Limitation of the ability of injured and ill persons to seek compensation from
the manufacturers of guns and cigarettes, for example, would permit the continuing
damage these products cause to the publics health. The crisis involved with these
products is not litigation, but the terrible burden of death and disability caused by
these vehicles of injury and disease.
The New Public Health Litigation*
Wendy E. Parmet and Richard A. Daynard
One of the most remarkable developments of the last three decades has been the
increasing use of litigation as a public health tool. Although courts have long been
called on to review matters concerning public health, historically the courtroom was
seldom the forum of choice for public health enthusiasts. Instead, it was the place
where those who wished to resist public health regulation, be they milk producers,
bread makers, or parents who did not want their children to be vaccinated, went in
the hope of limiting the authority of public health agencies. Although such litigants
were usually not successful, public health had little to gain by the litigation. At best
the regulation might be upheld; at worst, the right of the individual or business to
refuse compliance might be proclaimed. The courtroom, in short, was a barrier that
public health authorities sometimes needed to pass through on their way to protecting the publics health.
In recent years, however, the tables have turned. Increasingly, individuals and
organizations concerned about public health have sought to use litigation to further
their goals. In other words, courts are now being used affirmatively in an effort to
make public health policy. Most notably, the tobacco control movement has pursued a litigation strategy, not simply to obtain compensation for tobaccos victims,
but also to achieve a reduction in tobacco use. Likewise, groups concerned about
gun violence have chosen to sue the gun industry. In similar fashion, the American
Public Health Association has urged the use of litigation to hold paint manufacturers
accountable for the injuries caused by lead paint. Litigation has also played a prominent role in the struggle to ensure access to health care for individuals infected with
HIV. . . .
Typology of Public Health Litigation
Courts have always played a role in public health enforcement. If a public health
agency ordered a warehouse with rotting food to close, the owner could go to court
and seek review of the order. Similarly, if a manufacturer wanted to resist a government regulation, it could challenge that regulation in court. In the process of
*Reprinted from Annual Review of Public Health 21 (2000): 43754.
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200 The Law and the Publics Health
deciding these cases, courts inevitably help delineate the nature and extent of public
health authority. . . .
What is different today is the increasing, and sometimes dominant, role played
by public health concerns. In [earlier] cases, individuals sought either to limit public
health authorities or to achieve monetary relief. The affirmative protection of the
publics health was not often one of the plaintiffs major goals. But in the wake of the
civil rights and other law reform movements, public health advocates have increasingly turned to the courts to achieve social change. . . .
The Literature
Much of the literature analyzing the success of reform litigation has focused on
litigation that [concerns] cases brought against governmental entities. One leading
scholar on the impact of law reform litigation, Rosenberg (1991), has concluded that
much of the constitutional reform litigation of the 1950s, 1960s, and 1970s, including
the litigation surrounding Brown v. Board of Education, resulted in far less change
than is generally believed. . . . Other scholars have suggested that reform litigation
may have an even more robust effect. The work of McCann (1992) is particularly relevant to a consideration of the impact of public health litigation. McCann believes that
Rosenberg has focused too heavily on the impact of judicial decisions themselves
rather than on the multidimensional process of litigation. From McCanns perspective, the focus must be not simply on court decisions and their direct impact but also
on the litigation process, which may have a constitutive impact and reshape perceptions of when and how particular values are realistically actionable (1992, 732).
Other scholars have considered the impact of product liability litigation, which
often touches on questions of public health. For the most part, these scholars have
used an economic perspective, asking whether such litigation is economically efficient, rather than whether it is capable of improving public health or influencing
the public health agenda. Nevertheless, although these scholars have disagreed
about the degree of deterrence achieved by product liability litigation, as well as its
efficiency as a deterrent or compensation system, they have generally found that it
creates some deterrent effect. . . .
[Ed.The authors discuss the effectiveness of tobacco litigation.]
Public Health Litigation and Democratic Theory
A commonly made and potent criticism of litigation-centered reform movements is
that they are fundamentally antidemocratic. If change is to occur in our laws, so the
criticism goes, it should occur via legislation enacted by democratically accountable
representatives. Situating policy development reform in the courts bypasses that
political accountability in favor of less accountable judges and juries.
In public health litigation, a further related criticism may be made. In our market
economy, individuals are presumed to have significant freedom as to what risks they
wish to incur. To the extent that public health policies seek to reduce risks beyond
the rate individuals would choose in the market, those policies may be described as
inherently paternalistic and contrary to the prevailing individualistic/market ethos.
When public health advocates seek to reduce those risks and achieve their aims not
through legislation but via judicial decrees, they become particularly vulnerable to
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Tort Law and the Publics Health 201
a charge of paternalism, for they may be seen as trying to force the public to accept
what neither it nor its representatives desire. . . .
Several responses may be made to the charge that public health litigation is both
antidemocratic and paternalistic. The first and narrowest is that litigation often
serves to further a democratically determined policy. Even if we concede that interference with the market should be the exception rather than the norm and that such
exceptions should be derived from politically accountable processes, a significant
role remains for litigation. Democratically enacted laws still require interpretation
and enforcement, and that often requires litigation. . . .
Another response to the antidemocratic critique recognizes that the judicial law
making that defines the common law has long been an accepted part of our democratic polity. Indeed many public health policies in place today result from an interactive dialog between courts and legislatures. For example, the doctrine of informed
consent for medical services originally emerged from litigation in which plaintiffs
asked courts to build on common-law doctrines of battery. . . .
A different response goes further to explain the use of litigation not only in
enforcing legislation but also in creating new public health policies. This response
questions the assumption that the legislative process itself is as democratic as the
antidemocratic critique assumes. As the Supreme Court recognized in the reapportionment cases of the 1960s, there are situations in which, absent judicial intervention, structural flaws in our political system prevent the popular will from being
enacted as legislation.
This situation has arisen with some public health issues, owing to campaign contributions by special interests. Because these contributions flow overwhelmingly to
incumbents, making credible challenges to their seats both difficult and rare, incumbents often refuse to enact serious campaign reform. What the special interests
exact in return for their money is a de facto veto over legislation adverse to their
interests. Contributions by the tobacco, gun, and health care industries are cases
in point. . . .
There is another way in which litigation may be able to force regulation onto the
legislative agenda, even if the affected special interest demurs. Litigation makes
compelling drama; lawsuits grab headlines, are regularly featured on talk shows,
and become part of ordinary conversation. Lawsuits can therefore thwart the desire
of the special interest to restrict discussion of issues involving it to the halls of
Congress, administrative agencies, and other venues where challenges to established ways of dealing with the issues are unlikely. Once the public and the media are
actively engaged in the issue, the political calculus, in Congress and elsewhere, may
change. In other words, litigation may be used not only to achieve judicially imposed
changes but also to change the political climate in which issues of public health are
debated.
At times, the information obtained via civil litigations discovery process may play
a critical role in disclosing information and educating the public about the nature and
causes of health risks, thus making the political process itself more informed. In her
study of tobacco litigation, Mather (1998) chronicles the vital role that litigationinduced discovery of tobacco industry documents played in shifting the attitudes of
both the public and policymakers about tobacco regulation. . . .
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202 The Law and the Publics Health
The Efficiency and Efficacy of Public Health Litigation
One of the fundamental goals of civil litigation is the prevention of socially undesirable activities. In public health litigation . . . a key goal is deterring the injury-causing
behavior of a private party. In terms of deterrence, product liability law seeks to
reduce the cost of product-related injuries, whereas the partially overlapping area
of toxic torts is intended to reduce the number and severity of illnesses caused by
toxic substances. Product liability and toxic tort laws reduce injuries and illnesses
by encouraging manufacturers and polluters either to make their products and byproducts safer or to make fewer of them. The encouragement comes from their fear
of having to pay large monetary damages if a jury decides they behaved irresponsibly (negligently, recklessly, fraudulently, etc.) in endangering the public. . . .
Some analysts of contemporary product liability law argue that, by awarding
judgments to injured consumers, tort law may actually increase injuries by making
the general public and potential plaintiffs less careful. It seems, however, extremely
unlikely that many would-be reckless or even negligent drivers (or other users of
consumer products) are deterred by the prospect that they or their estates may not
be able to recover damages for their physical injuries or deaths. More plausible is the
possibility that publicity surrounding product liability litigation may help educate
the public about the dangers of hazardous products. But even if consumers do not
change their behavior, product manufacturers are typically in a better position to
anticipate and internalize the costs of accidents than is the consumer who may be
harmed.
Other economic concerns arise from the significant transaction costs associated
with litigation. In pure dollar terms, there is little doubt that litigation can be expensive. A 1984 RAND Corporation study determined that 61 cents of every dollar spent
on the asbestos litigation went to lawyers fees and expenses. The tobacco litigation
has also been a costly affair. Estimates suggest that industry alone has spent at
least $600 million a year on lawyers fees. The multistate settlement reached by the
attorneys general will also result in the industrys paying $500 million per year in
attorneys fees to plaintiffs counsel for many years to come.
Several scholars have contended that the large transaction costs associated with
medical malpractice litigation undermine its efficiency as a method for compensating injured patients. The question of litigations efficiency as a compensation system, however, should not be confused with the question of whether the system can
achieve adequate deterrence or public health improvements. Indeed, to some extent,
the high costs of litigation can be assumed to abet public health goals because they
increase the cost of accidents and add incentives to reduce injurious activities. Of
course, this holds true only when the plaintiff or public health advocate can garner
sufficient resources to commence and continue the litigation. . . .
There is the paradoxical concern that the very power of litigation to achieve public health goals may lead lawyers and others to forget that lawyers are not, per se,
public health experts. The remedies lawyers seek and the settlements they agree
to may not always constitute the optimal solution from a public health perspective.
[Nevertheless,] public health litigation itself benefits immensely from the expertise
and support provided by public health authorities. To the extent that such litigation
is successful in the courtroom, it is often only because it has worked in harmony with
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Tort Law and the Publics Health 203
the policies of public health officials. The tobacco litigation would have been far less
effective than it has been were there no Surgeon Generals Reports.
Public Health Litigation and the Nature of Rights
In recent years legal theorists across the political spectrum have questioned our
cultures tendency to reduce issues of policy and politics to questions of legal
rights. While some of these concerns focus on the capacity of legal decisions to
actually effect change, an issue that has been considered previously, others focus
on the nature of legal reasoning and the contours of legal doctrine and ask whether
they are supportive or destructive of sound public policy and constructive political
changes. Several of these concerns appear particularly pertinent to public health
litigation. One set of issues relates to the strong preference in legal doctrine for
viewing rights, those interests that the law protects, as negative. To a large degree,
legal rights require that someone refrain from taking an action, rather than that
someone or something undertake an action. Tort law, for example, will generally not
hold an individual responsible for failing to come to the aid of another. . . .
Conclusion
Advocates for public health are increasingly going to court to advance their concerns. Such affirmative public health litigation faces formidable obstacles and
cannot always achieve its aims. Nevertheless, it may play a significant role in the
advancement of public health. Public health litigation may form a critical part of
a political struggle to achieve a public health agenda. It may also have a powerful deterrent effect on those individuals and organizations that create risks to the
public health. Finally, litigations articulation and recognition of individual rights can
serve as a necessary foundation for more fully protecting the public health.
II. Scientific Conundrums in Mass Tort Litigation:
Epidemiology in the Courtroom
Litigators using the court system as an instrument of public health
advocacy inevitably confront the vexing questions of proof and causation. As Tom Christoffel and Stephen P. Teret explain, problems of
proof and causation in mass tort litigation are materially different from
those in traditional tort actions, such as motor vehicle accidents. If
X hits Y, who then sustains an immediate injury, causality is readily
established by a witness who observes the event and a medical expert
who testifies that the harm resulted from the impact. But what if a
product (P) or activity (A) is associated with an increased rate of harm
(H) in the population? How difficult is it to marshal scientific proof
that A or P caused H?
A related question is the degree of proof needed to establish causality. If epidemiologists find an association between, say, exposure to a
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204 The Law and the Publics Health
toxic substance and an increased rate of cancer, how do we know that
the substance actually caused the harm about which the plaintiffs complain? Sometimes the causative agent of a plaintiffs condition can be
identified with near certainty, but it is impossible to link that agent to
a specific companys product. David Ozonoff (2005) poses a hypothetical that usefully illustrates this difficulty: consider a worker exposed
to asbestos insulation made by two companies, and assume that both
types were used interchangeably and both companies were aware of
the health risks of their product. Many years later, the worker develops mesothelioma, a cancer almost always caused by asbestos and thus
clearly caused by one of the companies products. But which one? When
causation is impossible to prove, which company should be liable?
Epidemiology and the Law : Courts and
Confidence Intervals*
Tom Christoffel and Stephen P. Teret
The law, wrote Oliver Wendell Holmes, Jr. (1881, 36), is forever adopting new principles from life at one end, and it always retains old ones from history at the other.
The common law (or case law), which was Holmess subject, is continually recreated as existing legal principles are applied or modified to fit new fact patterns. And
because the law deals with real-world facts, the legal system must keep appropriately abreast with new ways of seeing and understanding the world. This means that,
as science develops increasingly more sophisticated and precise means of measurement and analysis, the nations courts must struggle to decide how much legal
weight to afford the never-ending stream of new scientific insights and techniques.
Earlier in this century, courts had to decide whether polygraph readings and
paternity test results should be admitted as evidence in legal proceedings. Todays
legal controversies include the admissibility of such new types of scientific evidence
as DNA fingerprinting. In each case, the judicial concern is one of determining if a
particular area of science offers results that are valid and reliable enough to meet
accepted legal standards of proof.
Epidemiology provides another example of this interaction of law and science.
With the swine flu litigation of the early 1980s, epidemiological evidence began to
play an increasingly prominent role in helping courts determine whether a plaintiffs
disease or other harm was caused by some activity of the defendant. The increasing
judicial reliance on epidemiology is dramatic. . . .
The Basics of Tort Law
The main force driving the increased use of epidemiology in the courtroom has
been tort litigation. The law of torts determines when one person (or groups of per-
*Reprinted from American Journal of Public Health 81 (1991): 166166.
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Tort Law and the Publics Health 205
sons, or corporation or government) must pay compensation for civil, noncontractual wrongs caused to others. The injuries addressed by tort law include specific
types of intentionally inflicted wrongs (such as assault and battery, defamation,
and invasion of privacy), as well as injuries inflicted unintentionally through failure
to exercise the care that could be expected of an ordinarily prudent person [i.e.,
negligence]. . . .
For a claimant to succeed in a lawsuit alleging unintentional, negligent harm, four
requirements must be met. The plaintiff must prove that (1) the defendant owed the
plaintiff a duty to act in a particular way, (2) the defendant failed to fulfill that duty,
(3) the plaintiff suffered harm, and (4) the defendants breach of duty was the cause
of the plaintiffs harm. The plaintiff bears the burden of demonstrating the existence
of all four elements. This need not be proven beyond a reasonable doubt, as in criminal prosecutions, but simply by a preponderance of evidence. If the plaintiff fails to
prove any one of the four required elements by this criterion, the fact that the other
elements have been satisfied will not matter; the plaintiff will lose.
Toxic Torts
During most of this century, tort law was concerned predominantly with injuries for
which the cause-effect association was clear-cut: a car ran into a pedestrian, a shopper fell on a stores slippery floor, or a baby choked on a toy with small parts. The
injury and the facts surrounding it were evident. More recently, however, tort law has
been used to seek compensation for injuries in which causation is not provable by
mere eyewitness testimony regarding a specific causal event.
At the heart of such litigation has been a new and rapidly growing area of tort law,
usually labeled toxic torts but perhaps more appropriately referred to as massexposure or environmental-injury litigation. Exposure to asbestos, toxic waste,
radiation, and pharmaceuticals have led to large numbers of lawsuits in the past 15
years. In a sense, toxic torts could be viewed as one response to the harmful health
effects resulting from the careless or irresponsible use of modern technology.
The common element linking these various lawsuits is that some activity or product of the defendant is alleged to be associated with increased rates of a particular
type of harm, and the causal relationship between the exposure and the harm is not
amenable to eyewitness testimony. Some harmful agents that have been involved in
such lawsuits are dioxin, Agent Orange, low-level radiation, contaminated groundwater, lead paint chips, tampons leading to toxic shock syndrome, asbestos, diethylstilbestrol (DES), and various pharmaceuticals (including polio and flu vaccines as
well as Bendectin).
These noxious agents have several things in common: (1) all have been alleged
to cause harm to humans, (2) this harm has resulted in lawsuits, (3) the causal
connection between the agent and the specific harm has been the subject of some
specific controversy, and (4) this combination of factors has resulted in epidemiology and epidemiologists being brought into the courtroom. Whether the defendant
is selling a pharmaceutical product, is accused of contaminating groundwater, or
is responsible for the release of radioactive debris into the atmosphere, epidemiological evidence may be critical to showing that the defendants actions are causally
associated with the plaintiffs damage.
Toxic tort lawsuits do not differ fundamentally from the more familiar motor vehiPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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206 The Law and the Publics Health
cle injury and product liability lawsuits. There is a victim/plaintiff and an allegedly
culpable defendant. The harmful outcome was not sought by the plaintiff. Further,
in most cases, the injury was the result of exposure to some form of energy: kinetic,
chemical, thermal, electrical, or ionizing radiation. . . .
With toxic tort injuries . . . there is usually a latency period between exposure and
the development of noticeable harm. When harm becomes apparent decades after
a toxic exposure, the documentation of a cause-effect relationship must rely on
forms of proof that are new to the law. Greatly compounding this difficulty of proof
is that few harms are limited to unique single-cause, single-effect connections. Most
toxic tort harms can result from several causes, only one of which may involve the
defendant. And the plaintiff may have been exposed to more than one noxious agent
(e.g., tobacco and asbestos). Thus, it is not enough for toxic tort plaintiffs to show
that factor X is capable of causing harm Y. Plaintiffs must also demonstrate that it
is more likely than not that factor X caused their harm Y. The difficulty here is that,
even when it is possible to demonstrate that factor X is responsible for a significant
percentage of all cases of harm Y, it can rarely be proven that the harm Y suffered
by a particular individual, the plaintiff, was one of the cases caused by factor X. This
means that, even where it can be demonstrated that the defendant is responsible for
a significant number of the cases of a particular harm, no plaintiff can prove that he
or she is one of these particular cases.
A few harmful substances are closely associated with certain signature diseases,
such as DES and adenocarcinoma; in such cases, the disease is known to occur
rarely, if ever, absent the substance. But these cases are the exception. . . .
Reasonably Exclusive Factual Connection
The legal system has attempted to fit toxic torts into a standard tort framework, but
that has proven difficult to do. Even if it can be shown that a defendant is responsible
for a doubling or tripling of the number of cases of a particular disease or other
harm, it is hard for individual plaintiffs suffering from that harm to demonstrate
that theirs is one of the excess cases, rather than one of the cases that would have
occurred absent the defendant. . . .
Proving that the defendant had contributed a factor that is directly associated
with the type of harm suffered by the plaintiff does not complete the plaintiffs case
unless it can also be shown that the factor is both a necessary and sufficient cause
of such harm. If the direct association is one in which the defendants factor is (1) a
sufficient but not necessary cause, (2) a necessary but not sufficient cause, or even
(3) neither a necessary nor sufficientbut still a possiblecause, the problem for the
court is how to deal fairly with both plaintiff and defendant. . . .
What Does This Mean?
The expanding role of epidemiology in tort litigation serves to highlight an important
and interesting contrast between the nature of scientific proof and of legal proof.
Science is a matter of probabilities in a universe of randomness and uncertainty.
From the scientists point of view, . . . to demand certainty would be to misunderstand the nature of scientific knowledge. The legal system, on the other hand, seeks
finality in the resolution of disputes. Without such finality, the legal process would
be one of continual litigation and relitigation. For this reason, concepts of legal
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Tort Law and the Publics Health 207
causation have favored single-cause explanations. Tort law posits a direct chain of
causation, and a tort defendants conduct is held to be a cause of a particular event
if the event would not have occurred but for that conduct or if the conduct was a
substantial factor in bringing the event about. . . .
The job of the court is to come to the peaceful resolution of disputes. The court
does not have the luxury of awaiting further scientific studies to approach the truth;
it must come to a timely decision for the benefit of the litigants and the judicial system. Certainly the court would like its decision to be based on what it understands
to be the truth, but what the true facts are is often exactly what is being contested.
In the end, the court must act on uncertainties to resolve the dispute.
The idea of acting on uncertainty may cause discomfort to scientists, whose
discipline allows them to admit that they have not yet achieved a complete understanding of the truth and that further investigation is necessary. When the work of
scientists is being used as proof in courtfor example, the use of epidemiological
evidence in toxic tort casesscientists may complain that undue weight is being
attributed to inconclusive findings. The misperception, however, is in thinking that
the conclusion sought by the court is the same conclusion sought by the scientist.
The scientists conclusion is achieved when truth is illuminated, and the level of
certainty or proof required for this is very high. The courts conclusion is achieved
when the best decision, given the weight of the evidence, is made for that case and
the litigants dispute has been resolved in a socially acceptable fashion. For this, the
level of certainty need not be that of the scientist. . . .
Conclusion
Epidemiologists need to recognize the growing involvement of their profession in
complex tort litigation. . . . As a simple first step, epidemiology and the law should
become a standard part of health law courses. On a more complex level, if one or
two schools of public health established enough of a reputation in some of the areas
being confronted by the courts in toxic tort litigation, these institutions could serve
as valuable resource centers to the courts. Judges are free to pick court-appointed
experts, but in the toxic tort area they most often do not know where to turn. The
result is one of hired guns providing expertise for one or both sides of the litigation. . . . Whatever course is ultimately charted, it is clear that epidemiology and the
law will be working closely together for some time to come.

The problems of causation discussed by Christoffel and Teret can be
overcome only if the judge admits scientific evidence into the court
proceedings. It therefore becomes important to understand the criteria
used by the judiciary to permit its use. In Frye v. United States, 293
F. 1013 (D.C. Cir. 1923), a federal appeals court set a standard for the
admissibility of scientific evidence that lasted for more than seventy
years. Fryes general acceptance test permitted into evidence only a
well recognized scientific principle or discovery . . . sufficiently estabPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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208 The Law and the Publics Health
lished to have gained general acceptance in the particular field. Thus,
establishing a consensus within the scientific community was crucial to
the admission of expert testimony. In 1975 Congress enacted the Federal Rules of Evidence, which reflected a more liberal attitude toward
the admission of evidence: If scientific, technical or other specialized
knowledge will assist the trier of fact to understand the evidence . . . a
witness qualified as an expert . . . may testify. The Federal Rules favor
the admission of relevant testimony, relying on the adversarial process
to sort out strong from weak evidence.
After 1975, courts began to divide on whether the restrictive Frye
test, or the permissive Federal Rules test, governed admissibility. This
disagreement led to one of the most important Supreme Court cases
on the admissibility of scientific evidence, Daubert v. Merrell Dow
Pharmaceuticals, Inc.
Daubert v. Merrell Dow Pharma ceuticals, Inc.*
Supreme Court of the United States
Decided June 28, 1993
Justice BLACKMUN delivered the opinion of the Court.
[Petitioners, two minor children and their parents, alleged in their suit against
Merrell Dow Pharmaceuticals, Inc., (respondent) that the childrens serious birth
defects had been caused by the mothers prenatal ingestion of Bendectin, a prescription drug marketed by respondent. The district court found in favor of Merrell
Dow based on a well-credentialed experts affidavit concluding, upon reviewing
the extensive published scientific literature on the subject, that maternal use of
Bendectin has not been shown to be a risk factor for human birth defects. Although
petitioners had responded with the testimony of eight other well-credentialed
experts, who based their conclusion that Bendectin can cause birth defects on
animal studies, chemical structure analyses, and the unpublished reanalysis of
previously published human statistical studies, the court determined that this evidence did not meet the applicable general acceptance standard for the admission
of expert testimony. The Ninth Circuit Court of Appeals agreed and affirmed, citing
Frye for the rule that expert opinion based on a scientific technique is inadmissible
unless the technique is generally accepted as reliable in the relevant scientific
community.]
In this case we are called upon to determine the standard for admitting expert
scientific testimony in a federal trial. . . .
In the 70 years since its formulation in the Frye case, the general acceptance
test has been the dominant standard for determining the admissibility of novel sci-
*509 U.S. 579 (1993).
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Tort Law and the Publics Health 209
entific evidence at trial. Although under increasing attack of late, the rule continues
to be followed by a majority of courts, including the Ninth Circuit.
The Frye test has its origin in a short and citation-free 1923 decision concerning
the admissibility of evidence derived from a systolic blood pressure deception test,
a crude precursor to the polygraph machine. In what has become a famous (perhaps
infamous) passage, the then Court of Appeals for the District of Columbia described
the device and its operation and declared:
Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight
zone the evidential force of the principle must be recognized, and while courts will
go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be
sufficiently established to have gained general acceptance in the particular field
in which it belongs. Frye v. United States, 54 App. D.C. 46, 47 (1923) (emphasis
added). . . .
The merits of the Frye test have been much debated, and scholarship on its proper
scope and application is legion. Petitioners primary attack, however, is not on the
content but on the continuing authority of the rule. They contend that the Frye test
was superseded by the adoption of the Federal Rules of Evidence. We agree.
We interpret the legislatively enacted Federal Rules of Evidence as we would any
statute. Rule 402 provides the baseline: All relevant evidence is admissible. . . .
Relevant evidence is defined as that which has any tendency to make the existence of any fact that is of consequence to the determination of the action more
probable or less probable than it would be without the evidence. Rule 401. The
Rules basic standard of relevance thus is a liberal one. . . .
Here there is a specific Rule that speaks to the contested issue. Rule 702, governing expert testimony, provides:
If scientific, technical, or other specialized knowledge will assist the trier of fact to
understand the evidence or to determine a fact in issue, a witness qualified as an
expert by knowledge, skill, experience, training, or education, may testify thereto
in the form of an opinion or otherwise.
Nothing in the text of this Rule establishes general acceptance as an absolute
prerequisite to admissibility. Nor does respondent present any clear indication that
Rule 702 or the Rules as a whole were intended to incorporate a general acceptance standard. The drafting history makes no mention of Frye, and a rigid general
acceptance requirement would be at odds with the liberal thrust of the Federal
Rules. . . . Given the Rules permissive backdrop and their inclusion of a specific rule
on expert testimony that does not mention general acceptance, the assertion that
the Rules somehow assimilated Frye is unconvincing. Frye made general acceptance the exclusive test for admitting expert scientific testimony. That austere
standard, absent from, and incompatible with, the Federal Rules of Evidence, should
not be applied in federal trials.
That the Frye test was displaced by the Rules of Evidence does not mean, however, that the Rules themselves place no limits on the admissibility of purportedly
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210 The Law and the Publics Health
scientific evidence. Nor is the trial judge disabled from screening such evidence. To
the contrary, under the Rules the trial judge must ensure that any and all scientific
testimony or evidence admitted is not only relevant, but reliable.
The primary locus of this obligation is Rule 702, which clearly contemplates some
degree of regulation of the subjects and theories about which an expert may testify.
If scientific, technical, or other specialized knowledge will assist the trier of fact
to understand the evidence or to determine a fact in issue an expert may testify
thereto. (Emphasis added.) The subject of an experts testimony must be scientific . . . knowledge. The adjective scientific implies a grounding in the methods
and procedures of science. Similarly, the word knowledge connotes more than subjective belief or unsupported speculation. The term applies to any body of known
facts or to any body of ideas inferred from such facts or accepted as truths on good
grounds. (Websters 1986, 1252.) Of course, it would be unreasonable to conclude
that the subject of scientific testimony must be known to a certainty; arguably,
there are no certainties in science. But, in order to qualify as scientific knowledge,
an inference or assertion must be derived by the scientific method. Proposed testimony must be supported by appropriate validationi.e., good grounds, based
on what is known. In short, the requirement that an experts testimony pertain to
scientific knowledge establishes a standard of evidentiary reliability.
Rule 702 further requires that the evidence or testimony assist the trier of fact
to understand the evidence or to determine a fact in issue. This condition goes primarily to relevance, [which has been described as] . . . one of fit. Fit is not always
obvious, and scientific validity for one purpose is not necessarily scientific validity
for other, unrelated purposes. . . . Rule 702s helpfulness standard requires a valid
scientific connection to the pertinent inquiry as a precondition to admissibility.
That these requirements are embodied in Rule 702 is not surprising. Unlike an
ordinary witness, an expert is permitted wide latitude to offer opinions, including
those that are not based on firsthand knowledge or observation. Presumably, this
relaxation of the usual requirement of firsthand knowledge . . . is premised on an
assumption that the experts opinion will have a reliable basis in the knowledge and
experience of his discipline.
Faced with a proffer of expert scientific testimony, then, the trial judge must
determine at the outset, pursuant to Rule 104(a), whether the expert is proposing
to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. This entails a preliminary assessment of whether
the reasoning or methodology underlying the testimony is scientifically valid and
of whether that reasoning or methodology properly can be applied to the facts in
issue. We are confident that federal judges possess the capacity to undertake this
review. . . . Some general observations are appropriate.
Ordinarily, a key question to be answered in determining whether a theory or
technique is scientific knowledge that will assist the trier of fact will be whether it
can be (and has been) tested. . . .
Another pertinent consideration is whether the theory or technique has been
subjected to peer review and publication. . . . Submission to the scrutiny of the scientific community is a component of good science, in part because it increases
the likelihood that substantive flaws in methodology will be detected. The fact of
publication (or lack thereof) in a peer reviewed journal thus will be a relevant, though
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Tort Law and the Publics Health 211
not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.
Additionally, in the case of a particular scientific technique, the court ordinarily
should consider the known or potential rate of error, and the existence and maintenance of standards controlling the techniques operation.
Finally, general acceptance can yet have a bearing on the inquiry. A reliability
assessment does not require, although it does permit, explicit identification of a relevant scientific community and an express determination of a particular degree of
acceptance within that community. United States v. Downing, 753 F.2d 1224, 1238
(3d Cir. 1985). Widespread acceptance can be an important factor in ruling particular
evidence admissible, and a known technique which has been able to attract only
minimal support within the community, Downing, 753 F.2d, at 1238, may properly
be viewed with skepticism. . . .
We conclude by briefly addressing what appear to be two underlying concerns of
the parties and amici in this case. Respondent expresses apprehension that abandonment of general acceptance as the exclusive requirement for admission will
result in a free-for-all in which befuddled juries are confounded by absurd and
irrational pseudoscientific assertions. In this regard respondent seems to us to be
overly pessimistic about the capabilities of the jury and of the adversary system
generally. Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of
attacking shaky but admissible evidence. . . .
Petitioners and, to a greater extent, their amici . . . suggest that recognition of
a screening role for the judge that allows for the exclusion of invalid evidence will
sanction a stifling and repressive scientific orthodoxy and will be inimical to the
search for truth. It is true that open debate is an essential part of both legal and
scientific analyses. Yet there are important differences between the quest for truth
in the courtroom and the quest for truth in the laboratory. Scientific conclusions
are subject to perpetual revision. Law, on the other hand, must resolve disputes
finally and quickly. The scientific project is advanced by broad and wide-ranging
consideration of a multitude of hypotheses, for those that are incorrect will eventually be shown to be so, and that in itself is an advance. Conjectures that are probably
wrong are of little use, however, in the project of reaching a quick, final, and binding
legal judgmentoften of great consequenceabout a particular set of events in the
past. We recognize that, in practice, a gatekeeping role for the judge, no matter
how flexible, inevitably on occasion will prevent the jury from learning of authentic
insights and innovations. That, nevertheless, is the balance that is struck by Rules
of Evidence designed not for the exhaustive search for cosmic understanding but for
the particularized resolution of legal disputes. . . .
. . . The judgment of the Court of Appeals is vacated, and the case is remanded for
further proceedings consistent with this opinion.

The Supreme Court in Daubert left an important issue about admissibility unclearwhether the standards of reliability and relevancy apply
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212 The Law and the Publics Health
only to the experts methodology or also to her conclusions. In other
words, must the trial court blindly accept the anomalous conclusions
of an expert who relies on valid studies? In General Electric Co. v.
Joiner, 522 U.S. 136, 146 (1997), the Supreme Court held that the trial
court could critically examine whether the experts conclusions were
supported by the studies they cite: [C]onclusions and methodology
are not entirely distinct from one another. Trained experts commonly
extrapolate from existing data. But . . . a district court [is not required]
to admit opinion evidence which is connected to the existing data only
by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. Following Joiner, the Supreme Court in Kumho Tire Co., Ltd.
v. Carmichael, 526 U.S. 137 (1999), held that the Daubert factors apply
not only to scientific experts but to all experts, including engineers.
The Court reasoned that no clear line divides scientific knowledge from
technical or other specialized knowledge, and there is no convincing
need to make such distinctions.
The Supreme Court has progressively tightened the permissive ad –
missibility standard in the Federal Rules, giving trial judges considerable discretion to exclude both scientific methodologies and expert
opinions of all kinds that fail to meet tests of reliability and relevance.
The Court itself said that the law must make certain that an expert
employs in the courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field (Kumho,
526 U.S. at 152). But the major criticism of the Daubert framework
is that judges do not possess adequate knowledge or scientific background to effectively assess the validity of theories and data offered by
expert witnesses. Another criticism highlights the narrowing effect of
Daubert: the Supreme Court purported to open courtroom doors to
more types of scientific evidence, but the judges new role as gatekeeper
and the general guidelines offered have instead limited the evidence
allowed.
Has the Court reached the right balance with respect to the admissibility of scientific evidence? Some authors claim that judges permit
the introduction of scientifically unfounded evidence (so-called junk
science), with the result that businesses are held liable for harms they
did not create. Peter W. Huber, excerpted next, argues that trial lawyers have an incentive to introduce scientific evidence irrespective of
its rigor, medical experts are willing to testify for a fee, and juries are
prone to decide against defendants with deep pockets.
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Tort Law and the Publics Health 213
Galileos Revenge: Junk Science in the Courtroom*
Peter W. Huber
Ever wonder about Princess Dis recent affair with Elvis Presley? You can read all
about it on the front page of the supermarket tabloid. Elsewhere on the page appear
stories of bizarre accidents and fantastic misadventures. An impact with a cars
steering wheel causes lung cancer. Breast cancer is triggered by a fall from a streetcar, a slip in a grocery store, an exploding hot-water heater, a blow from an umbrella
handle, and a bump from a can of orange juice. Cancer is aggravated, if not actually
caused, by lifting a forty-pound box of cheese. Everybody knows, of course, that
such stories are fiction. Falls and bumps dont cause cancer.
Other stories tell how a spermicide used with most barrier contraceptives causes
birth defects. We know it doesnt. The whooping cough vaccine causes permanent
brain damage and death. Thats not true either. The swine flu vaccine caused serum
sickness. It didnt. A certain model of luxury car accelerates at random, even as
frantic drivers stand on the brakes. Not so. Incompetence by obstetricians is a leading cause of cerebral palsy. It isnt. The morning-sickness drug Bendectin caused an
epidemic of birth defects. It didnt. Trace environmental pollutants cause chemically induced AIDS. They dont.
How can anybody be absolutely, positively certain about these didnts, doesnts,
and donts? No one can. But the science that refutes these claims is about as solid
as science ever is.
And yet all of these bizarre and fantastic storiesElvis and Di exceptedare
drawn not from the tabloids but from legal reports. They are announced not in
smudgy, badly typed cult newsletters but in calf-bound case reports; endorsed not
by starry-robed astrologers but by black-robed judges; subscribed to not only by
quacks one step ahead of the authorities but by the authorities themselves. They
can be found on the dusty shelves of any major law library. The cancer-by-streetcar
cases are decades old, but the others are recent.
When they learn of these legal frolics, most members of the mainstream scientific
community are astounded, incredulous, and exasperated in about equal measure. . . .
Maverick scientists shunned by their reputable colleagues have been embraced by
lawyers. Eccentric theories that no respectable government agency would ever
fund are rewarded munificently by the courts. Batteries of meaningless, high-tech
tests that would amount to medical malpractice or insurance fraud if administered
in a clinic for treatment are administered in court with complete impunity by fringe
experts hired for litigation. The pursuit of truth, the whole truth, and nothing but the
truth has given way to reams of meaningless data, fearful speculation, and fantastic
conjecture. Courts resound with elaborate, systematized, jargon-filled, serioussounding deceptions that fully deserve the contemptuous label used by trial lawyers
themselves: junk science.
Junk science is the mirror image of real science, with much of the same form
but none of the same substance. There is the astronomer, on the one hand, and the
*Reprinted from Galileos Revenge: Junk Science in the Courtroom by permission of
Basic Books, a member of Perseus Books, L.L.C. 1991 by Peter W. Huber.
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214 The Law and the Publics Health
astrologist, on the other. The chemist is paired with the alchemist, the pharmacologist with the homeopathist. Take the serious sciences of allergy and immunology,
brush away the detail and rigor, and you have the junk science of clinical ecology.
The orthopedic surgeon is shadowed by the osteopath, the physical therapist by the
chiropractor, the mathematician by the numerologist and the cabalist. Cautious and
respectable surgeons are matched by some who cut and paste with gay abandon.
Further out on the surgical fringe are outright charlatans, well documented in the
credulous pulp press, who claim to operate with rusty knives but no anesthesia, who
prey on cancer patients so desperate they will believe a palmed chicken liver is really
a human tumor. Junk science cuts across chemistry and pharmacology, medicine
and engineering. It is a hodgepodge of biased data, spurious inference, and logical
legerdemain, patched together by researchers whose enthusiasm for discovery and
diagnosis far outstrips their skill. It is a catalog of every conceivable kind of error:
data dredging, wishful thinking, truculent dogmatism, and, now and again, outright
fraud.
On the legal side, junk science is matched by what might be called liability
science, a speculative theory that expects lawyers, judges, and juries to search
for causes at the far fringes of science and beyond. The legal establishment has
adjusted rules of evidence accordingly, so that almost any self-styled scientist, no
matter how strange or iconoclastic his views, will be welcome to testify in court. The
same scientific questions are litigated again and again, in one courtroom after the
next, so that error is almost inevitable.
Junk science is impelled through our courts by a mix of opportunity and incentive. Let-it-all-in legal theory creates the opportunity. The incentive is money: the
prospect that the Midas-like touch of a credulous jury will now and again transform
scientific dust into gold. Ironically, the laws tolerance for pseudoscientific speculation has been rationalized in the name of science itself. The open-minded traditions
of science demand that every claim be taken seriously, or at least thats what many
judges have reasoned. A still riper irony is that in aspiring to correct scientific and
medical error everywhere else, courts have become steadily more willing to tolerate
quackery on the witness stand.
Experienced lawyers now recognize that anything is possible in this kind of system. The most fantastic verdict recorded so far was worthy of a tabloid: with the
backing of expert testimony from a doctor and several police department officials,
a soothsayer who decided she had lost her psychic powers following a CAT scan persuaded a Philadelphia jury to award her $1 million in damages. The trial judge threw
out that verdict. But scientific frauds of similar character if lesser audacity are
attempted almost daily in our courts, and many succeed. Most involve real, down-toearth tragedies like birth defects, cancer, and car accidents. Many culminate in large
awards. As the now dimly remembered cancer-by-streetcar cases illustrate, junk
science is not an altogether new phenomenon in the courtroom. But its recent and
rapid rise is unprecedented in the history of American jurisprudence. Junk science
verdicts, once rare, are now common. Never before have so many lawyers grown
so wealthy peddling such ambitious reports of the science of things that arent so.
Yet among all the many refractory problems of our modern liability system, junk
science is the most insidious and the least noted. . . . If the operator of a streetcar is
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Tort Law and the Publics Health 215
to be blamed for cancer, serious science should be on hand to certify the connection.
But often it isnt. The rule of law has drifted away from the rule of fact.
What is to be done . . . about accidents in court: how [do you] stop legions of
case-hardened lawyers from attacking false causes, on behalf of false victims, on
the basis of what nobody but a lawyer and his pocket expert call science[?] . . .
No one would suggest that junk science should generally be banned or its practitioners silenced. Freedom of speech includes the freedom to say silly and false
things, even things that mislead, miseducate, or endanger. But our cherished freedom to say what we like on the front page of the National Enquirer need not imply the
freedom to say similar things from a witness box in the solemnity of a courtroom. . . .
It may be funny to see whimsical science in the astrology column next to the comics.
It is considerably less funny when something masquerading as science is taken seriously in court, less funny still when millions of dollars change hands on the strength
of arrant scientific nonsense, and not funny at all when such awards lead to the
disappearance of valuable and perhaps even life-saving products and services.
III. The Public Health Value of Tort Litigation
A. The Tobacco Wars: A Case Study
Recent lawsuits against the tobacco industry have important implications for the publics health, although opinion is divided on the nature
of their impact. Some, like Stephen Sugarman (2002), a law professor,
believe that the results are mixed and that the future success of these
suits remains uncertain. But others champion the potential benefits
of tobacco litigation. In the following excerpt, Jon S. Vernick, Lainie
Rutkow, and Stephen P. Teret discuss how cases against tobacco manufacturers benefit more than just successful plaintiffs; the larger public
also benefits when suits bring information about harmful industry
practices into the public eye.
Public Health Benefits of Recent Litigation aga inst
the Tobacco Industry*
Jon S. Vernick, Lainie Rutkow, and Stephen P. Teret
Litigation against the tobacco industry has met with mixed success. Between 1954
and 1994, private citizens filed more than 800 lawsuits against tobacco manufacturers. The tobacco companies achieved great success in court during this time by
*Reprinted from JAMA 298 (2007): 8689. Copyright 2007 American Medical
Association. All rights reserved.
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216 The Law and the Publics Health
challenging the science that tied smoking to negative health consequences, by arguing that smokers knew they were taking a risk when they smoked, and by suggesting
that smokers lifestyles, rather than smoking itself, contributed to their illnesses.
Only 2 courts found in favor of a private citizen, and both of these decisions were
subsequently reversed on appeal.
In the mid-1990s, however, the attorneys general of all 50 states sued several of
the major cigarette manufacturers to recoup health care and other costs incurred
by the states due to smoking-related illnesses. This litigation led to negotiations
between the 4 major tobacco companies and 46 states that resulted in the Master
Settlement Agreement (MSA) in 1997. The MSA required the states to drop any
pending litigation against the 4 companies in exchange for more than $200 billion
to be divided among the states. The MSA also included restrictions on the marketing
and advertising of tobacco products as well as provisions to limit advertising that
targeted youth. The public health benefits of the MSA have been a matter of some
controversy, however, as most states have failed to devote the majority of their
settlement to reducing tobacco consumption.
Recently, a new group of lawsuits has been brought against the industry, often
emphasizing the ways in which tobacco manufacturers have allegedly deceived consumers. Two influential cases decided in 2006 are emblematic of this latest wave of
lawsuitsEngle v. Liggett [945 So. 2d 1246 (Fla. 2006)] and United States v. Philip
Morris [449 F. Supp. 2d 1 (D.C. Cir. 2006)]. Both were widely reported as substantial
victories for the tobacco industry. But a closer examination of the decisions suggests that while they may have provided short-term victories for the industry, the
longer-term effects may well be a boon to public health. . . .
Engle v. Liggett
In May 1994, 6 individuals with smoking-related health conditions filed a lawsuit in
Florida that may significantly change tobacco litigation and how the tobacco industry does business. In this class action lawsuit against the major domestic cigarette
manufacturers, the named plaintiffs sought to represent all United States citizens
and residents, and their survivors, who have suffered, presently suffer or have died
from diseases and medical conditions caused by their addiction to cigarettes that
contain nicotine. The case proceeded as a class action lawsuit but the class was
limited to Florida smokers.
The plaintiffs argued that they were unable to stop smoking because they were
addicted to nicotine and, as a result, developed medical problems ranging from cancer and heart disease to colds and sore throats. They sought compensatory damages for the costs of the harm they had experienced and punitive damages to punish
what they argued was the industrys especially egregious conduct.
After a 2-year trial, the Engle jury concluded that the plaintiffs had proved that
cigarette smoking was addictive, that it caused numerous diseases, and that the
cigarette industrys conduct had given rise to liability for negligence, fraud, and
breach of the products warranty. The jury awarded the remaining 3 class representatives $12.7 million in compensatory damages, and the class as a whole $145 billion
in punitive damages. The cigarette manufacturers appealed the ruling.
On May 21, 2003, the Florida Court of Appeals reversed the trial courts decision
to allow the case to proceed as a class action lawsuit and overturned the damages
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Tort Law and the Publics Health 217
award [Liggett Group, Inc. v. Engle, 853 So. 2d 434 (Fla. Dist. Ct. App. 2003)]. The
plaintiffs subsequently appealed this decision to the Florida Supreme Court. In
December 2006, the Florida Supreme Court issued its landmark ruling, reinstating most of the jurys findings regarding causation and liability but overturning the
$145 billion punitive damages verdict. The court upheld the compensatory damages
verdict for 2 plaintiffs but decided that the third plaintiffs claim had not been filed
in time.
Most importantly, the Florida Supreme Court affirmed the trial courts ruling
that smoking cigarettes causes numerous diseases and health conditions, including:
aortic aneurysm, . . . cerebrovascular disease, . . . chronic obstructive pulmonary
disease, coronary heart disease, . . . complications of pregnancy, . . . peripheral vascular disease, and many forms of cancer. The court also agreed that the defendants placed cigarettes on the market that were defective and unreasonably dangerous, . . . [that] nicotine in cigarettes is addictive, . . . [that] the defendants agreed
to conceal or omit information regarding the health effects of cigarettes or their
addictive nature, . . . [that] all of the defendants sold or supplied cigarettes that were
defective, . . . and that all of the defendants were negligent [945 So. 2d at 1277].
Regarding punitive damages, the Florida Supreme Court concluded that the $145
billion award was excessive. Therefore, entitlement to punitive damages, if any, could
only be determined on a case-by-case basis in future individual lawsuits.
United States v. Philip Morris
In 1999, the US government brought a case against the tobacco industry alleging that the companies had, over several decades, repeatedly violated the federal
Racketeer Influenced and Corrupt Organizations (RICO) Act. The RICO Act applies
to businesses that conspire to and then impact interstate commerce through racketeering activities. The government argued that the tobacco companies engaged in a
conspiracy to deny well-established associations between smoking and multiple diseases, the association between second-hand smoke and lung cancer, and the addictive nature of nicotine. The government also alleged that cigarette manufacturers
falsely claimed that low-tar or light cigarettes are less harmful, intentionally
marketed tobacco products to persons younger than 21 years, and deliberately concealed evidence to prevent the public from learning about the dangers of smoking.
The government asked that the tobacco industry be prevented from using deceptive marketing practices, and sought the return of $289 billion in past profits that
the industry earned through its allegedly illegal, conspiratorial activities. However,
a 2005 ruling by a federal appeals court held that under the RICO Act only forwardlooking remedies could be imposed on the industry, such as prohibiting future deceptive marketing [396 F.3d 1190 (D.C. Cir. 2005)].
In August 2006, Federal District Court Judge Gladys Kessler issued a 1742-page
opinion in United States v. Philip Morris, concluding that the industry had indeed
violated the RICO Act [449 F. Supp. 2d 1 (D.D.C. 2006)]. The decision proclaims that
[f]rom at least 1953 until at least 2000, each and every one of [the defendant
tobacco companies] repeatedly, consistently, and vigorouslyand falselydenied the
existence of any adverse health effects from smoking. Moreover, they mounted a
coordinated, well-financed, sophisticated public relations campaign to attack and
distort the scientific evidence demonstrating the relationship between smoking and
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218 The Law and the Publics Health
disease, claiming that the link between the two was still an open question [id. at
208]. As in Engle, the Courts factual findings confirm that the tobacco industry
knew of nicotines addictive nature for decades but tobacco companies endeavored
to keep the extensive research and data they had accumulated out of the public
domain and out of the hands of the public health community by denying that such
data existed, by refusing to disclose it, and by shutting down or censoring laboratories and research projects which were investigating the mechanisms of nicotine
[id. at 307].
The Court used several remedies to punish the industry for its RICO violations,
including an injunction that prohibits tobacco companies from using deceptive brand
descriptors such as low tar and light. Tobacco companies also must issue statements
about the negative health effects of smoking through retail displays and print and
television media. In addition, the tobacco companies must disclose their marketing
data to the government. [Activities related to defrauding the public that take place
outside of the United States are not excludedsee United States v. Philip Morris
USA, Inc., 477 F. Supp. 2d 191, 197 (D.D.C. 2007).]
The tobacco companies immediately appealed the decision and on October 31,
2006, a federal appeals court granted a stay of Judge Kesslers decision pending
that appeal. [The D.C. Circuit subsequently affirmed most portions of the trial court
decision. United States v. Philip Morris, No. 06-5267 (D.C. Cir. 2009).]
Implications
When Engle was decided, national newspapers described the verdict as a major
legal victory, highly favorable to cigarette makers, and as lifting one of the biggest financial clouds over tobacco companies. Similarly, on the day the Philip Morris
verdict was announced, a Wall Street analyst was quoted as saying, Theres nothing
in this ruling that is going to hurt the profitability of the businesses.
Although neither Engle nor Philip Morris will immediately cost the tobacco industry billions of dollars in punitive damages or require the return of past profits, both
cases appear to represent a substantial future threat to the industry and a corresponding potential benefit for the publics health. As a result of Engle, individual
plaintiffs may now more successfully bring separate lawsuits against the cigarette
industry. At those individual trials, the plaintiffs will not have to prove that cigarette
smoking is addictive or that cigarettes cause cancer or other health problems. These
issues have already been established by Engle. Just as important, plaintiffs need
not reestablish the legal basis for liability because it will be presumed that the cigarette industry was negligent, engaged in fraud by concealment, and sold defective
products.
By thereby reducing the high cost of litigation against the tobacco industry,
Engle also should make such cases far more attractive for attorneys considering
representing sick plaintiffs or their survivors. In fact, major Florida law firms have
been actively soliciting clients since Engle. As a result, the tobacco industry may be
forced to defend thousands of Florida lawsuits without being able to use its usual
strategy of denying the health consequences of smoking or the addictive effects of
nicotine. . . .
Philip Morris also may have an important impact on industry conduct and upcomPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Tort Law and the Publics Health 219
ing litigation. The opinion presents detailed factual findings documenting decades
of illegal industry activity. In addition, the government can now use the tobacco
industrys marketing data to monitor the industrys attempts to target youth. If the
decision is upheld on appeal, cigarette makers will no longer be allowed to mislead
consumers that light or low-tar cigarettes are safe. Research has demonstrated that
so-called light cigarettes may encourage some persons to continue smoking but do
not lower nicotine and tar intake or reduce the risk of developing smoking-related
cancers. Even if Philip Morris is reversed on appeal, the opinion provides a roadmap
for future litigation based on industry fraud, conspiracy, and misrepresentation.
Despite this markedly improved litigation environment, however, the industry is
not without defenses. Each post-Engle Florida plaintiff will still have to prove that
cigarette smoking caused his or her own illness and the amount of damages he or
she experienced. In any individual lawsuit, the industry may try to demonstrate that
some other factor was the likely cause of the plaintiffs illness or that the plaintiff should bear some or all of the blame. The tobacco industry has a long-standing
policy of using procedural mechanisms to delay the litigation process, hoping that
plaintiffs will die, tire, or simply run out of resources.
It is difficult to predict the future effects of any lawsuit. But, Engle and Philip
Morris are in some respects significantly different from prior litigation efforts in that
they potentially presage, by their findings, the success of future litigation. This differs sharply from the MSA, which expressly repressed future litigation. Additionally,
Engle and Philip Morris may have other important effects. Publicity associated with
these and other recent lawsuits, and the information they have generated, may help
to further denormalize smoking and reduce the perceived legitimacy of the tobacco
industry. As a result, policymakers may be more willing to seek legislation regulating
the industry, such as the Family Smoking Prevention and Tobacco Control Act now
pending in Congress. Similarly, the public may be more willing to support restrictions
on smoking including efforts to ban smoking in indoor public places. In this changing
litigation and regulatory environment, Engle and Philip Morris can have a greater
public health impact than prior litigation.
Ultimately, the tobacco industry may experience an increased cost of doing business as a result of Engle, Philip Morris, and litigation and/or regulation likely to follow. Costs of litigation and regulation are generally passed on to consumers in the
form of higher prices. Research indicates that higher prices can result in less cigarette consumption, especially among more price-sensitive young people. Therefore,
if future lawsuits are more likely to be brought and to succeed as a result of Engle
and Philip Morris, some of the more than 400,000 smoking-related deaths in the
United States each year might be prevented.
B. Obesity
Litigation against the food industry draws on theories of liability
similar to those used in the tobacco lawsuits, giving hope that obesityrelated lawsuits might likewise engender certain public health benefits.
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220 The Law and the Publics Health
Tobacco litigation brought the harmful effects of smoking to the publics attention, and some believe it is possible that obesity lawsuits can
do the same.
It remains to be seen how successful these lawsuits will be in mirroring tobacco litigation and better protecting consumers. In approximately twenty-three states, the passage of what some call commonsense consumption laws has severely restricted obesity-related tort
litigation. The food and drink industry, using the rhetoric of personal
responsibility, continues to lobby strongly for the further adoption of
such laws, which generally ban claims arising out of weight gain,
obesity, a health condition associated with weight gain or obesity, or
other generally known condition allegedly caused by or allegedly likely
to result from long-term consumption of food (National Restaurant
Association 2006). In 2005, federal limitations on obesity-related tort
Photo 12. A potential buyer peruses the supply of handguns available at a
traveling gun show in Florida. Thirty to 40 percent of American firearms
sales take place privately or at gun shows, where private sellers do not have
to perform the otherwise-mandatory federal background checks on potential
gun purchasers. The two teens responsible for the 1999 Columbine massacre
in Littleton, Colorado, purchased the guns they used at a gun show.
Reproduced by permission, Robert Wallis/Corbis, April 9, 2005.
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Tort Law and the Publics Health 221
liability were considered, but the Personal Responsibility in Food Consumption Act of 2005, commonly known as the Cheeseburger Bill,
received no vote in the Senate after its passage in the House.
At the same time, some litigation has progressed. In 2003, two teenagers suffering from obesity and poor health made headlines when they
brought suit against McDonalds for false advertising and failure to
disclose health risks from eating the chains food. Their case, Pelman
v. McDonalds, was dismissed by the district court, but plaintiffs ap –
pealed. In 2005, the Second Circuit, in the opinion excerpted below,
Box 5
Firearms and tort litigation
The firearms industry was largely immunized from litigation with the 2005
passage of the Protection of Lawful Commerce in Arms Act (PLCAA). An
individual may no longer bring suit against gun sellers and manufacturers
for injuries from the unlawful use of a firearm, unless the suit falls under
one of six narrow exceptions. Before the PLCAA was enacted, four main
theories of liability were employed in firearm suits: manufacturing defects,
design defects, negligent entrustment, and public nuisance.
A recent firearm case, brought under a public nuisance theory, seemed
to have a chance of success. In New York City v. Beretta, the city sued
the firearms company under the third exception to the PLCAA, alleging
that the seller knowingly violated New Yorks criminal nuisance statute
by marketing guns to legitimate buyers while knowing that the guns would
be diverted to illegal markets and by failing to take reasonable steps to
inhibit the flow of guns into illegal markets. As a result, the city alleged,
thousands of guns manufactured or distributed by defendants were used
to commit crimes in the City of New York. However, in 2008 the Second
Circuit dismissed the claims, ruling that the citys case did not fit the PLCAA
exception, because the criminal nuisance law at issue was not adequately
applicable to the purchase and sale of firearms (New York City v. Beretta,
524 F.3d 384 [2d Cir. 2008]).
Although the use of tort law in firearms cases no longer seems to be a
viable strategy for preventing gun violence, the Beretta case provides an
interesting example of employing tort law to promote the publics health.
Other areas of litigation, such as obesity lawsuits, have taken up this challenge but their success remains to be seen, and legislation severely re –
stricting tort actions has been passed in a number of jurisdictions.
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222 The Law and the Publics Health
allowed the claims to go to trial. Regardless of how the plaintiffs fare
moving forward, it is unclear whether and to what extent their case
will serve as a model for future litigation.
Pelman v. McDonalds Corp. *
Court of Appeals for the Second Circuit
Decided January 25, 2005
Judge RAKOFF delivered the opinion of the court.
[P]laintiffs Ashley Pelman and Jazlen Bradley, by their respective parents, . . .
appeal from the dismissal of Counts IIII of their amended complaint [which allege] . . . that defendant McDonalds Corporation violated both 349 and 350 of
the New York General Business Law. . . .
Specifically, Count I alleges that the combined effect of McDonalds various
promotional representations during this period was to create the false impression
that its food products were nutritionally beneficial and part of a healthy lifestyle
if consumed daily. Count II alleges that McDonalds failed adequately to disclose
that its use of certain additives and the manner of its food processing rendered
certain of its foods substantially less healthy than represented. Count III alleges that
McDonalds deceptively represented that it would provide nutritional information to
its New York customers when in reality such information was not readily available at
a significant number of McDonalds outlets in New York visited by the plaintiffs and
others. The amended complaint further alleges that as a result of these deceptive
practices, plaintiffs, who ate at McDonalds three to five times a week throughout
the years in question, were led to believe[] that [McDonalds] foods were healthy
and wholesome, not as detrimental to their health as medical and scientific studies
have shown, . . . [and] of a beneficial nutritional value, and that they would not
have purchased and/or consumed the Defendants aforementioned products, in their
entirety, or on such frequency but for the aforementioned alleged representations
and campaigns. Finally, the amended complaint alleges that, as a result, plaintiffs
have developed obesity, diabetes, coronary heart disease, high blood pressure,
elevated cholesterol intake, related cancers, and/or other detrimental and adverse
health effects. . . . [brackets and ellipses in the original]
What is missing from the amended complaint, however, is any express allegation
that any plaintiff specifically relied to his/her detriment on any particular representation made in any particular McDonalds advertisement or promotional material. The district court concluded that, with one exception, the absence of such a
particularized allegation of reliance warranted dismissal of the claims under 350
of the New York General Business Law, which prohibits false advertising. As to the
exceptioninvolving McDonalds representations that its French fries and hash
browns are made with 100% vegetable oil and/or are cholesterol-freethe district
court found that, while the amended complaint might be read to allege implicit reliance by plaintiffs on such representations, the representations themselves were
*396 F.3d 508 (2d Cir. 2005).
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Tort Law and the Publics Health 223
objectively nonmisleading. [Plaintiffs do not challenge the dismissal of their claims
under 350.]
[Plaintiffs do, however,] challenge the district courts dismissal of the claims
under 349 of the New York General Business Law, which makes unlawful deceptive acts or practices in the conduct of any business, trade or commerce or in the
furnishing of any service in this state. Unlike a private action brought under 350,
a private action brought under 349 does not require proof of actual reliance.
Additionally, [because a claim of deceptive practices is not an allegation of fraud, an
action under 349] need only meet the bare-bones notice-pleading requirements of
[the Federal Rules of Civil Procedure].
Although the district court recognized that 349 does not require proof of reliance, the district court nonetheless dismissed the claims under 349 because it
concluded that plaintiffs have failed, however, to draw an adequate causal connection between their consumption of McDonalds food and their alleged injuries. 2003
WL 22052778 at *11 (S.D.N.Y. 2003). Thus, the district court found it fatal that the
complaint did not answer such questions as:
What else did the plaintiffs eat? How much did they exercise? Is there a family
history of the diseases which are alleged to have been caused by McDonalds
Photo 13. National fast-food chains KFC and Dunkin Donuts are prominently featured along this New York City sidewalk. The inexpensive, caloriedense food available at these and other fast-food outlets contributes to the
growing obesity problem in the United States. Both KFC and McDonalds
have been targeted by lawsuits stemming from the unhealthiness of their food.
Reproduced by permission, David M. Grossman/The Image Works.
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224 The Law and the Publics Health
products? Without this additional information, McDonalds does not have sufficient information to determine if its foods are the cause of plaintiffs obesity, or
if instead McDonalds foods are only a contributing factor. Id.
This, however, is the sort of information that is appropriately the subject of discovery, rather than what is required to satisfy the limited pleading requirements of [the
Federal Rules]. . . . So far as the 349 claims are concerned, the amended complaint
more than meets the requirements [of the Federal Rules of Civil Procedure].
Accordingly, the district courts dismissal of those portions of Counts IIII of the
amended complaint . . . is vacated, and the case is remanded for further proceedings
consistent with this opinion.
C. Medical Devices and Drugs: Preemption
Several recent and pending cases have dramatically altered the landscape of health-related tort litigation. Riegel v. Medtronic, 128 S. Ct.
999 (2008), and Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008)
(both discussed in chapter 3), took up the issue of preemption of lawsuits against medical device manufacturers and pharmaceutical companies. The Riegel decision has effectively barred plaintiffs from suing
for injuries caused by many medical devices approved by the Food and
Drug Administration. In Warner-Lambert, the Court broached the
narrow question of whether a traditional tort action for injuries from
an FDA-approved drug was preempted when state law required plaintiffs to first show fraud-on-the-FDA. The Court was evenly split on the
issue, leaving the Second Circuits decision intact. Wyeth v. Levine, 129
S. Ct. 1187 (2009), addressed the preemption question more broadly. In
Wyeth, the manufacturer faced a suit for failure to warn about the danger of using an IV push procedure for a particular antinausea drug.
The company asserted that it could not have warned more effectively,
because the federal Food, Drug, and Cosmetic Act (FDCA) forbids
changes to a drugs labeling without FDA approval. It also argued that
Congress intended drug safety determinations to be made by experts
at the FDA, not by a trial court. The Court disagreed, noting that the
FDCA permits a company to apply for a label change, and that it does
not have to wait for FDA approval to modify the labeling if it wishes
to add a warning. Further, the Court specifically noted that Congress
had the opportunity to add an express preemption provision when it
passed preemption language for medical devices, but chose not to do
so. Thus, while state law claims for failure-to-warn are preempted
for medical devices, they are still available for drugs. In the following
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Tort Law and the Publics Health 225
piece, I describe the role of tort litigation as a safety net for claims
when regulation has failed to protect the publics health and safety.
The Deregulatory Effects of Preempting Tort Litigation*
Lawrence O. Gostin
Charles Riegel underwent coronary angioplasty in 1996, shortly after sustaining a
myocardial infarction. Mr. Riegels physician inserted the Evergreen balloon catheter, a medical device approved by the US Food and Drug Administration (FDA), into
his patients coronary artery in an attempt to dilate the artery, but the catheter
ruptured. Mr. Riegel developed complete heart block, was placed on life support, and
underwent emergency coronary artery bypass graft surgery. He sued Medtronic, the
manufacturer of the device, alleging that the company was liable under New York
tort law in designing, testing, inspecting, labeling, and marketing the catheter. On
February 20, 2008, the Supreme Court held that the Medical Device Amendments
of 1976 (MDA) bars common law claims challenging the safety or effectiveness of a
medical device marketed in a form that received premarket approval from the FDA.
Riegel v. Medtronic Inc. [128 S. Ct. 999 (2008)] has broad implications for patient
safety because it removes all means of judicial recourse for most consumers injured
by defective medical devices.
The MDA and Preemption
The Federal Food, Drug, and Cosmetic Act (FDCA) has long required FDA approval for
the introduction of new drugs to the market, but historically states have regulated
medical devices. That changed with the enactment of the MDA in 1976 in light of the
proliferation of complex devices and high-profile failures. . . . The MDA imposes various levels of FDA oversight [and] expressly preempts any state requirement which
is different from, or in addition to MDA requirements and that relate to the safety
or effectiveness of the device. The Supreme Court interprets the MDAs preemption
in a manner substantially informed by FDA regulations, which state that preemption occurs only when the agency has established specific counterpart regulations
or other specific requirements applicable to that particular device. Justice Scalia,
writing for the Court in Riegel, found that the MDA preempts Mr. Riegels tort action
because the FDAs premarket approval process establishes specific safety requirements and that New Yorks common law claims impose different or additional
requirements. . . .
Riegel v. Medtronic Inc. leaves most injured patients without a remedy because
Congress has not authorized any federal products liability claims or any other type
of compensation mechanism, and the Supreme Court has eliminated almost all state
claims. . . . In effect, the Supreme Court is authorizing businesses to use federal
patient safety legislation as a shield against state tort law designed to safeguard
the publics health.
*Reprinted from JAMA 299 (2008): 231316. Copyright 2008 American Medical
Association. All rights reserved.
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226 The Law and the Publics Health
Congresss Intent and FDAs Political Reversal
Sponsors of the MDA protested that Congress never intended to bar state tort
actions. The overriding purpose of the legislation was to provide additional protection to consumers, not to withhold existing safeguards against defectively designed
or labeled devices. [Through the preemption provision] Congress sought merely to
ban states from implementing their own premarket approval processes, which many
states had enacted in response to public revulsion over the Dalkon Shield and other
high-profile medical device failures. If states imposed safety requirements that
conflicted with FDA rules, the resulting regulatory confusion would thwart national
policy. . . .
For 25 years, the FDA had held the view that Congress wanted federal approval
and tort liability to operate simultaneously, each providing a significant, yet distinct, layer of consumer protection (Porter 1997, 11). The FDA reversed its position
in 2004, an action that some charged was a political decision influenced by the White
House, intended to give the industry protection from tort litigation. The Courts
decision has the perverse effect of granting broad immunity to an entire industry
that, in the judgment of Congress, needed more stringent regulation (Medtronic v.
Lohr, 518 U.S. 470, 487 [1996]). . . .
The Incapacitation of an Agency
The Supreme Court characterized the FDA premarket approval process as rigorous, entailing an average of 1200 hours of review of a devices properties as well
as of manufacturing methods and research studies. But the courts confidence that
the agency has the expertise, resources, and information necessary to ensure the
safety of food, drugs, and medical devices is misplaced. The FDA is responsible for
the safety of approximately 80% of food sold and all human drugs, vaccines, and
medical devices. . . . Yet Congress has starved the agency of funds, even as the FDAs
functions have expanded vastly and public concern for the safety of foods, drugs,
and medical devices has increased. . . . These resource deficits have resulted in highprofile regulatory failures involving serious safety risks of recently approved . . .
anti-inflammatory drugs and type 2 diabetes medications. Litigation revealed that
manufacturers might have known about these risks but did not promptly inform the
FDA. The safety risks of medical devices may be higher than those for pharmaceuticals due to the more limited premarket testing of medical devices. In recent years,
manufacturers have recalled defibrillators, pacemakers, heart valves, hip and knee
prostheses, and heart pumps, all of which have exacted a serious toll on patients
who face the daunting prospect of removal and replacement surgery (Vladeck
2008, 997).
Furthermore, the premarket approval process can offer, at best, only a modest assurance of long-term safety. At the time of review, the FDA may not have all
the information or sufficient human resources needed to assess those data it does
have. More importantly, drugs and medical devices have not been widely tested in
the population, which can reveal deficiencies in safety and effectiveness that were
unknown at the time of approval. Because the agency is unable to require rigorous
postmarket surveillance and thereby provide critical ongoing oversight, patients are
left unprotected once a device enters the market. Ideally, the FDA would have the
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Tort Law and the Publics Health 227
power and resources to systematically review and monitor the safety and effectiveness of products over time. But the tort system is currently needed to fill the glaring
gaps in agency oversight. . . .
Tort Law as a Tool of Public Health
. . . In thinking about tort law as a tool of public health, it is important to emphasize
the role of litigation in preventing risk behavior and providing incentives for safer
products. State tort law provides a system of civil justice designed to compensate
patients, deter unreasonably hazardous conduct, and encourage innovation in product design, packaging, labeling, and advertising. Tort law, therefore, can be seen as
closing regulatory gaps in the FDA premarket approval process and providing some
much-needed postmarketing surveillance.
Certainly, tort litigation is imperfect, as it can increase industry costs, discourage
commercialization, or delay introduction of products onto the market. Nevertheless,
the tort system offers several clear benefits for patients and the health system. Tort
law assists patients who have been harmed by defective products, providing compensation for medical costs, pain, and disability. Currently there is no government
compensation program for patients injured by defective drugs or medical devices
similar to the childhood vaccine compensation system. Furthermore, tort law deters
industry negligence and deception and encourages disclosure and innovation to
improve product safety. Common law failure-to-warn claims, for example, create
incentives for companies to revise their labels in light of risks that were unknown
at the time of approval or risks that are greater than originally thought, thereby
alerting physicians and patients to potential hazards. If corporations know they are
immune from lawsuits, they may be less likely to conscientiously monitor a products safety, disclose health hazards, and promptly recall hazardous devices from
the market.
The tort system has another benefit that is not often fully recognizedthrough
the discovery process, it can compel corporations to disclose everything they know,
or reasonably should know, about the products safety and effectiveness. Tort
law, therefore, offers a backup system to uncover vital information about industry
practices, as it did so successfully with tobacco litigation. The discovery process
provides a feedback loop to the FDA, which in the past has changed its regulatory
decisions in light of information revealed in court. Litigation can thus be socially and
politically mobilizing by uncovering poor industry practices, drawing the attention
of the public and policy makers, and driving regulatory reform.
Fraud Committed on the FDA
From a common sense perspective, there are deep concerns about the positions
staked out by the FDA and the Supreme Court. Is it reasonable for a consumer
protection agency, with the concurrence of the nations highest court, to conclude
that injured patients should be effectively barred from recourse against companies
that aggressively market hazardous drugs or medical devices knowing the risks?
The public might express even greater skepticism if tort immunity were granted to
corporations that defraud the agency. But that may be precisely the position of the
Supreme Court, which permits a corporation to use FDA approval as a shield against
litigation even if it deceived the agency into granting that approval.
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228 The Law and the Publics Health
. . . Arguably, fraud should vitiate any protection the industry could gain from
FDA approval. Certainly, the FDA has the power to punish fraud against the agency,
but that still leaves injured patients without a remedy or compensation for their
injuries. In the post-Riegel world, moreover, lawsuits likely will be dismissed before
plaintiffs lawyers can use discovery to prove manufacturers deceived the FDA by
providing false information or withholding relevant information. The prospect of
less discovery is also concerning because the agency is increasingly reliant on the
industrys own data and analysis throughout the regulatory process. Notably, for
pharmaceuticals, the FDA already relies on industry user fees to fund the agencys
review.
In Warner-Lambert Co. v. Kent, announced weeks after Riegel, the Supreme
Court was asked to determine whether a state products liability statute that creates
a safe harbor from liability for FDA-approved drugs, but that carves out an exception for fraud, was also preempted. The Court was deadlocked in a 4-to-4 vote, which
does not create a precedent. The tied vote had the effect of upholding the Second
Circuit decision, allowing the suit to proceed because the tort claims depend primarily on traditional and preexisting tort sources, not at all on fraud-on-the-FDA
cause of action (Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 [2d Cir. 2006]).
Chief Justice Roberts did not participate in the Courts decision, leaving open the
possibility that if the issue comes back before the Court, it could be decided in favor
of preemption.
The Future of Tort Litigation
Following Riegel, the courts immediately began considering whether to dismiss
thousands of claims against medical device manufacturers, involving products ranging from heart valves, artificial hips, spinal disks, and defibrillators to drug-coated
heart stents and stimulators to control pain. To avoid dismissal, plaintiffs lawyers
will have to claim that a device was made improperly, in violation of FDA specificationsa so-called manufacturing as opposed to a design defect. Going forward, the
FDA reviews dozens, if not hundreds, of new devices annually, which could receive
protection against liability. The FDA is even more extensively involved in pharmaceutical approvals. If the courts were to grant drugs the same liability protections
offered to medical devices, it would have more systemic effects on the health care
system.
The MDA preempts state law that conflicts with federal safety requirements,
but the FDCA, which regulates pharmaceuticals, has no express preemption clause.
During its 20082009 term, the Supreme Court will hear Wyeth v. Levine, asking
whether the FDCA impliedly preempts state products liability claims against pharmaceutical manufacturers. . . .
The FDA is urging the Supreme Court to preempt stronger state regulation of
pharmaceuticals. If the FDAs view were to prevail, patients would have no safety net
in the likely event that the agency fails to detect and correct safety hazards. After
all, there are 11000 FDA-regulated drugs, with nearly 100 more approved each year,
making it virtually impossible to monitor comprehensively the performance of all
drugs on the market. . . .
In the end, the public is caught in a catch-22. At the same time the FDA is
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Tort Law and the Publics Health 229
widely perceived as ineffectual and the hazards of widely used drugs and devices
are revealed, the Supreme Court is making it more difficult for patients to discover
wrongdoing, even fraud, and to be fairly compensated for their avoidable injuries.
D. Limitations of Tort Law: Economic and Social Costs
Although tort litigation can benefit the publics health, legislation and
recent court decisions have limited the availability of this tool. Suits
against firearm manufacturers are largely preempted by the Protection
of Lawful Commerce in Arms Act (PLCAA), and a number of states
now have commonsense consumption laws that bar obesity lawsuits.
After the Riegel decision, it will be exceedingly difficult to bring medical device claims, though the Court allowed similar claims for pharmaceuticals to go forward in Wyeth.
While these and other limitations may thwart beneficial public
health litigation, some restrictions may be warranted to take into ac –
count litigations economic and social costs. The monetary damages
generated by tort litigation create a ripple effect, and improving safety
may increase production costs. This added cost is passed along to consumers, who must spend more to purchase the goods and services, or
to the employees, who may receive fewer benefits or lower wages, or
to both. If costs are high enough, funds for research and development
may be cut, and fewer new products or drugs will make it to market.
Of course, this is the desired result when the products concernedsuch
as tobacco and firearmsare inherently dangerous. But in other areas
(e.g., vaccines), such an outcome is potentially troubling.
Tort litigation provides injured plaintiffs with an avenue of recourse,
and may provide benefits to society as a whole. However, innovative
models have been proposed to maximize the public health benefits
of litigation and equitably balance the needs of injured plaintiffs and
societys broader interests. For example, the National Vaccine Injury
Compensation Program provides a no-fault alternative to traditional
tort litigation for certain individuals harmed by vaccinations. Another
suggestion, which is advocated by David Studdert, Michelle Mello, and
Troyen Brennan (2003), is to adopt a medical monitoring system, a
court-ordered program that would provide diagnostic tests for early
detection of illness in individuals exposed to potentially harmful drugs.
Both of these may be viable options to meet the twin goals of injury
compensation and improved public health.
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230 The Law and the Publics Health
Recommended Readings
Major Theories of Tort Litigation
Jacobson, Peter D., and Soheil Soliman. 2002. Litigation as public health policy: Theory or reality? Journal of Law, Medicine & Ethics 30: 22438.
(Discusses whether public health litigation has influenced policy and if litigation is a viable strategy for effecting policy change)
Vladeck, David C. 2005. Preemption and regulatory failure. Pepperdine Law
Review 33: 9597. (Discusses preemption and the role that the executive
and judiciary branches play in ensuring consumer safety)
Scientific Conundrums in Mass Tort Litigation:
Epidemiology in the Courtroom
Heinzerling, Lisa. 2006. Doubting Daubert. Journal of Law and Policy 14:
6583. (Argues that Daubert has effectively narrowed rather than expanded
the range of expert evidence allowed at trial)
Ozonoff, David. 2005. Legal causation and responsibility for causing harm.
American Journal of Public Health 95 (S1): S35S38. (Highlights the difficulty in determining causation)
The Public Health Value of Tort Litigation
Alderman, Jess, and Richard A. Daynard. 2006. Applying lessons from tobacco
litigation to obesity lawsuits. American Journal of Preventive Medicine 30:
8288. (Discusses the likelihood of tobacco litigation strategies being successfully employed in the context of obesity litigation)
Feldman, Eric A., and Ronald Bayer. 2004. Unfiltered: Conflicts over Tobacco
Policy and Public Health. Cambridge, MA: Harvard Univ. Press. (Provides
an overview and a comparison of tobacco policy in eight countries)
Gostin, Lawrence O. 2007. Law as a tool to facilitate healthier lifestyles and
prevent obesity. JAMA 297: 8790. (Explains how legal tools such as disclosure, taxation, and surveillance can be employed to combat obesity and
promote healthful eating)
Kessler, David A., and David C. Vladeck. 2008. A critical examination of the
FDAs efforts to preempt failure-to-warn claims. Georgetown Law Journal
96: 46195. (Argues that the FDAs push for preemption of failure-to-warn
claims threatens public health, because litigation can play an important role
in product safety)
Mello, Michelle, David Studdert, and Troyen A. Brennan. 2006. Obesitythe
new frontier of health law. New England Journal of Medicine 354: 2601
10. (Reviews the potential for a regulatory framework to combat obesity)
Rabin, Robert. 1992. A socio-legal history of the tobacco tort litigation. StanPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Tort Law and the Publics Health 231
ford Law Review 44: 85378. (Surveys the rise of tobacco lawsuits in the
late 1950s and the subsequent waves of litigation that have followed)
Studdert, David, Michelle Mello, and Troyen Brennan. 2003. Medical monitoring for pharmaceutical injuries. JAMA 289: 88994. (Proposes a medical
monitoring system as a method of addressing adverse health effects in tort
law claims)
Sugarman, Stephen. 2002. Mixed results from recent United States tobacco
litigation. Tort Law Review 10: 94126. Available at www.law.berkeley
.edu/faculty/sugarmans/#Tobacco. (Argues that the outcomes of recent
tobacco cases portend limited future success in this type of litigation)
Sugarman, Stephen, and Nirit Sandman. 2007. Fighting childhood obesity
through performance-based regulation of the food industry. Duke Law
Review 56: 140390. (Promotes performance-based regulation, similar to
the No Child Left Behind framework, for food and drink manufacturers
to help lower rates of obesity in children)
Vernick, Jon S., Jason W. Sapsin, Stephen P. Teret, and Julie Samia Mair. 2004.
How litigation can promote product safety. Journal of Law, Medicine &
Ethics 32: 55155. (Explores how litigation can serve the goal of reducing
product-related injuries)
Weeks, Elizabeth A. 2007. Beyond compensation: Using torts to promote public health. Journal of Health Care Law and Policy 10: 2759. (Examines the
overlap between the fields of tort law and public health, including theories
of tort law and product liability)
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Photo 14. Health workers prepare measles vaccines and vitamin
A supplements at a school in South Darfur, Sudan, as part of a 2004 vaccination
program launched by the WH
O, UNICE
F, and the
Sudanese Ministry
of Health.
The program aimed to vaccinate 2.26 million children against
measles and to supply children under the age of five with vitamin
A supplements. Reproduced by permission, Christine Nesbitt/africanpictures
.net/
The
Image Works, June 5, 2004.
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233
Scholars view public health law primarily as a domestic field of study.
And constitutional, statutory, administrative, and tort law affecting
the publics health undoubtedly is found mainly at the federal, state,
and local levels. But neither the legal system nor the health system operates in isolation. The forces of globalization heavily influence both,
propelling pathogens, and even behaviors and lifestyles, across national
frontiers. No state, acting alone, can ensure the conditions that will
guarantee the health of its population. This has always been true, but
never as obviously as in todays world. Travel and migration, dense
settlements in urban areas, crowding together of people and livestock,
trade in goods and services, and the dissemination of information and
ideas mean that, more than ever, health is a transnational concern
requiring effective global governance.
This chapter examines the contours of one of the most important
contemporary developments in public international law, an emerging
Sev en
Global Health Law
Health in a Global Community
Consider three children: one African, one south Asian,
and one European. At birth each, representing the average
for their [region], has life expectancy of less than 50 years.
The African and south Asian figures come from 1970,
the European figure from 1901. Over the past century,
life expectancy for the European child increased by about
30 years, and is still rising. Between 1970 and 2000, the
south Asian childs life expectancy rose by 13 years, whereas
for the child in sub-Saharan Africa, during the same period,
life expectancy rose by 4 months.
Michael Marmot, on behalf of the Commission on
Social Determinants of Health, 2007
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234 The Law and the Publics Health
field called global health law. The readings in this chapter expand
on each of the concepts in the following definition: Global health law
is a field that encompasses the legal norms, processes, and institutions
needed to create the conditions for people throughout the world to
attain the highest possible level of physical and mental health. The field
seeks to facilitate health-promoting behavior among the key actors that
significantly influence the publics health, including international organizations, governments, businesses, foundations, the media, and civil
society. The mechanisms of global health law should stimulate investment in research and development, mobilize resources, set priorities,
coordinate activities, monitor progress, create incentives, and enforce
standards. Study of the field should be guided by the overarching value
of social justice, which requires equitable distribution of health services, particularly to benefit the worlds poorest populations.
The domain of global health law is primarily concerned with (1)
formal sources of public international law, including, for example, treaties establishing the authority and responsibility of states for the health
of their populations and the duties of international cooperation, and
(2) formal subjects of international law, including states, individuals,
and public international organizations. However, to be an effective
global health governance strategy, global health law must evolve beyond
these traditional confines. It must foster more effective collective global
health action among governments, businesses, civil society, and other
actors. Accordingly, my definition of global health law is prescriptive as
well as descriptive: it sets out the sort of international legal framework
that is needed, but still unavailable, to empower the world community
to advance global health in accordance with the value of social justice.
Of course, like any legal system, international law tends to evolve slowly
in response to developments within the community that creates it and is
subject to it. Considerable change in the nature of international law has
taken place, for example, as a result of the recognition in the twentieth
century of universal human rights. Consequently, the evolution of international law envisioned in this concept of global health law is consistent
with the progressive, historical development of international law.
My definition of global health law captures five salient features:
namely, its missionensuring the essential conditions for the publics
health; its key participantsstates, international organizations, private and charitable organizations, and civil society; its sourcespublic
international law; its structureinnovative mechanisms for global
health governance; and its moral foundationsthe values of social
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Global Health Law 235
justice, which call for fair distribution of health benefits to the worlds
most impoverished and least healthy populations.
The mission of global health law is to ensure the conditions necessary for the highest possible level of physical and mental health worldwide. To make a difference for the worlds population, the international
community should focus on what I call basic survival needs (see the
final excerpt in this chapter). Basic survival needs focus attention on
the major determinants of healthin particular, functioning health
systems, sanitation, clean water, uncontaminated food, safe products
and services, and access to essential vaccines and pharmaceuticals. My
definition posits that legal norms, processes, and institutions can help
create the conditions in which people can be healthy.
The key participants in a system of global health governance are the
public and private sectors, together with civil society. National governments undoubtedly have, and will continue to have, primary authority
and responsibility for the health of their people. However, multiple nonstate actors increasingly affect the publics health nationally and internationally. Public international organizations such as the World Health
Organization (WHO), the United Nations Development Programme
(UNDP), UNICEF (the United Nations Childrens Fund), and the World
Bank set standards, issue guidance, provide technical assistance, and
make loans. Charitable organizations such as the Gates Foundation and
Clinton Global Initiative, together with public/private partnerships such
as the Global Fund to Fight AIDS , Tuberculosis and Malaria and the
International Finance Facility for Immunization, provide resources for
research and development, prevention, and treatment; nongovernmental organizations such as Mdecins Sans Frontires and Oxfam afford
services on the ground; media outlets such as CNN, the BBC, and Al
Jazeera influence public perceptions and behaviors; and civil society
organizations such as those working on AIDS , mental health, and disability rights offer support and campaign for health reforms.
This chapter proceeds in five sections; its length and the breadth
of its topics reflect the broad scope of law in a transnational context.
The selections first set forth the global dimensions of health, making
clear that globalization is a force that facilitates the spread of infectious
and chronic diseases across national borders. Second, the readings
examine the growing literature on global health governance, detailing
how international law, processes, and institutions can influence healthpromoting behavior by a diverse array of stakeholders. Here, the readings discuss the two most important legal instruments in international
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236 The Law and the Publics Health
public health law: the International Health Regulations (IHR) and the
Framework Convention on Tobacco Control (FCTC). The next sections
examine two bodies of international law that deeply influence global
healthhuman rights and trade law. Human rights law safeguards
civil and political rights, but also places duties on states to fulfill social,
cultural, and economic rights. The key socioeconomic right for our
purposes is the right to health. World trade law governs such important
areas as intellectual property (affecting products including vaccines,
pharmaceuticals, and medical devices), sanitary and phytosanitary
measures (affecting food), and trade in goods (including hazardous
products) and services (health care providers). The chapter concludes
with a discussion of the future of global health governance, where I
make a proposal for an innovative mechanism to facilitate global cooperationthe Framework Convention on Global Health.
I. The Global Dimensions of Health
Many millions of African children and adults die of
malnutrition, pneumonia, motor vehicle accidents
and other largely preventable, if not headlinegrabbing, conditions. One-fifth of all global deaths
from diarrhea occur in just three African countries
Congo, Ethiopia and Nigeriathat have relatively
low HIV prevalence. Yet this condition, which is not
particularly difficult to cure or prevent, gets scant
attention from the donors that invest nearly $1 billion
annually on AIDS programs in those countries.
Daniel Halperin, Harvard School of Public Health, 2008
A. Globalization and the Spread of Infectious Diseases:
Man-Made and Controllable
The causes of ill health are undeniably global in scope, and thus no
state or region acting in isolation can adequately ensure its populations
health. The forces of globalization allow infectious diseases to mutate
and spread across populations and boundaries. Global climate change
creates fertile conditions for the propagation of disease vectors and carriers, such as insects and rodents, and threatens the global food supply
(see box 4 and figure 7 in chapter 5). International commerce exposes
consumers to the risks of contaminated food, drugs, and consumer
products, as imports of toys, toothpaste, and vegetables illustrate.
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Global Health Law 237
Global marketing by tobacco companies and food industry conglomerates molds population preferences, fueling tobacco consumption and
modifying eating habits across cultures. Bioterrorism is also an omnipresent threat, as individuals and groups intent on political destabilization work to inflict harm on a global scale. These human activities, and
many more, have profound health consequences for people everywhere.
Members of the world community are interdependent, and they rely on
one another for health security.
In the first of a two-part JAMA series on global health, I explain
why the worlds rich should care about the poorest among us. Rich
states have a narrow self-interest in helping developing countries
because doing so can prevent the transnational spread of infectious
diseases; they have an enlightened self-interest because poor health
contributes to economic decline and political instability; and they have
an ethical obligation to ameliorate needless suffering because health is
a universal human aspiration and a basic human need.
Why Rich Countries Should Car e about the Worlds
Least Healthy People*
Lawrence O. Gostin
Why should rich countries care about the worlds least healthy people? . . . Rich
countries should care because global health serves their national interests, and
helping the most disadvantaged is ethically the right thing to do. If international
health assistance were structured in a way that was scalable (sufficient to meet
deep needs) and sustainable (to create enduring solutions), it would have a dramatic
influence on the life prospects of the worlds poorest populations.
National Interests in Global Health
Governments have no choice but to pay close attention to health hazards beyond their
borders. [No country can insulate itself from the health effects of people congregating and traveling, living in close proximity to animals, polluting the environment, and
relying on overtaxed health systems. The worlds communities are interdependent
and reliant on one another for health security.] More than 30 infectious diseases have
emerged during the last 2 to 3 decades, ranging from hemorrhagic fevers . . . to West
Nile virus and monkeypox. Vastly increased international trade in fruits, vegetables,
meats, and eggs has resulted in major outbreaks of food-borne infections. . . .
Beyond narrow self-interest, are there broader, enlightened interests in global
health? There is a strong case that a forward-looking foreign policy would seek to
redress extremely poor health in the worlds most impoverished regions. Epidemic
disease dampens tourism, trade, and commerce. . . . Animal diseases [have] severe
*Reprinted from JAMA 298 (2007): 8992. Copyright 2007 American Medical
Association. All rights reserved.
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238 The Law and the Publics Health
economic repercussions such as mass cullings of animals and trade bans. Massive
economic disruption would ensue from a pandemic of human influenza, with a projected loss of 3% to 6% in global gross domestic product.
In regions with extremely poor health, economic decline is almost inevitable. . . .
The World Bank estimates that AIDS has reduced gross domestic product nearly
20% in the most affected countries. AIDS, of course, is only 1 disease in countries
experiencing multiple epidemics, starvation and poverty, and regional conflicts.
Countries with extremely poor health become unreliable trading partners without the capacity to develop and export products and natural resources, pay for
essential vaccines and medicines, and repay debt. Countries with unhealthy populations require increased financial aid and humanitarian assistance. In short, a foreign
policy that seeks to ameliorate health threats in poor countries can benefit the public and private sectors in developed as well as developing countries.
[Poor health can also lead to security concerns.] In its most extreme form, poor
health can contribute to political instability, civil unrest, mass migrations, and
human rights abuses. . . . Politically unstable states require heightened diplomacy,
create political entanglements, and sometimes provoke military responses.
Diseases of poverty overwhelmingly are concentrated in sub-Saharan Africa,
and it is no surprise that many of these social and political problems occur in that
region. But much of Africa has weak political, military, and economic power, so it can
too easily be ignored. The same cannot be said about the burgeoning health crises
emerging in pivotal countries in Eurasia, such as China, India, and Russia.
Eurasia has more than 60% of the worlds inhabitants; one of the highest combined gross national products; and at least 4 massive armed forces with nuclear
capabilities. These countries are in the midst of a second wave of HIV/AIDS, with
prevalence rates increasing 20-fold in less than a decade. . . . Due to extreme health
hazards, Eurasia most likely will experience economic, political, and military decline.
Political instability in a region with such geostrategic importance will have major
international ramifications.
Governments, therefore, have powerful reasons based on narrow, as well as
enlightened, self-interest to ameliorate extreme health hazards beyond their borders. To their credit, . . . developed countries have increased annual global health
assistance, from $2 billion in 1990 to $12 billion in 2004. . . . This development assistance may appear substantial but is modest compared with the annual $1 trillion
spent globally on military expenditures and $300 billion on agricultural subsidies.
The increase in development assistance, moreover, is largely attributable to extensive resources devoted to a few high-profile problems, such as AIDS, pandemic
influenza, and the Asian tsunami. Even factoring in these new investments, most
Organisation for Economic Cooperation and Development [OECD] countries have not
come close to fulfilling their pledges to donate 0.7% of gross national income per
year. . . .
Profound Health Inequalities Are Unethical
Perhaps it does not, or should not, matter if global health serves the interests of
the richest countries. After all, there are powerful humanitarian reasons to help the
worlds least healthy people. But ethical arguments have failed to capture the full
attention of political leaders and the public.
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Global Health Law 239
. . . The global burden of disease is shouldered by the poor disproportionately,
such that health disparities across continents render a persons likelihood of survival drastically different based on where he or she is born. These inequalities have
become so extreme and the resultant effects on the poor so dire that health disparities have become a defining issue of modern society.
The current global distribution of disease has led to radically different health outcomes across the globe. Disparities in life expectancy among rich and poor countries
are vast. . . . Although life expectancy in the developed world increased throughout
the 20th century, it actually decreased in the least developed countries and in transitional states such as Russia. . . .
Human instinct suggests it is unjust for large populations to have such poor
prospects for good health and long life simply by happenstance of where they live.
Although almost everyone believes it is unfair that the poor live miserable and short
lives, there is little consensus about whether there is an ethical, let alone legal,
obligation to help the downtrodden. What do wealthier societies owe as a matter of
justice to the poor in other parts of the world?
Perhaps the strongest claim that health disparities are unethical is based on
what can be called a theory of human functioning. Health, among all other forms
of disadvantage, is special and foundational, in that its effects on human capacities
profoundly impact an individuals opportunities in the world. Health is necessary
for much of the joy, creativity, and productivity that a person derives from life. . . .
Perhaps not as obvious, health also is essential for the functioning of civil societies.
Without minimum levels of health, people cannot fully engage in social interactions,
participate in the political process, exercise rights of citizenship, generate wealth,
create art, and provide for the common security.
The capability to avoid starvation, preventable morbidity, and early mortality
is a quality that enriches human life. Depriving individuals of this capability strips
them of their freedom to pursue their lives as they wish. Under a theory of human
functioning, health deprivations are unethical because they unnecessarily reduce a
persons ability to function and the capacity for human agency.
But a theory of human functioning does not answer the more difficult question
about who has the corresponding obligation to do something about global inequalities. Even scholars who believe in just distribution of resources frame their claims
narrowly and rarely extend them to international obligations of justice. Their theories of justice are relational and apply to a fundamental social structure that
people share. States may owe their citizens basic health protection by reason of a
social compact. However, positing such a relationship among different countries and
regions is much more complex.
Increasingly, the global community is sharing a common social, political, and
economic structure. International law has established norms in areas ranging from
infectious diseases and tobacco use to access to essential vaccines and medicines. . . . Perhaps the international community is moving toward a global compact
on health in which wealthier countries have an ethical responsibility to serve other
countries according to their resources, and poorer countries have expectations to
receive help according to their needs.
Political leaders have . . . made numerous pledges of international development
assistance, including substantial commitments to the Millennium Development
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240 The Law and the Publics Health
Goals and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. As mentioned
above, many governments also have agreed to spend a certain proportion of their
gross national product on foreign assistance. These pledges appear sincere and very
specific. [In enacting the] Presidents Emergency Plan for AIDS Relief (PEPFAR),
the United States noted that it has the capacity to lead an international response
to global AIDS, and that in an age of miraculous medicines, no person should go
without treatment (U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act
of 2003, 22 U.S.C. 7601 [2003]). . . .
These promises to help others have moral force. Political leaders ought to follow through on their commitments. They appear to be made in good faith, and poor
countries rely on the promised assistance for the health and well-being of their
populations.
A Tipping Point
Politically and economically powerful countries should care about the worlds least
healthy people. It may be a matter of national interest, [or it] may be ethically the
right thing to do to avert an unfolding humanitarian catastrophe. Although no single
argument may be definitive in itself, the cumulative weight of the evidence is now
overwhelmingly persuasive. Whatever the reasons, perhaps global society is coming
to a tipping point where the status quo is no longer acceptable and it is time to take
bold action. Global health, like global climate change, may soon become a matter so
important to the worlds future that it demands international attention, and no state
can escape the responsibility to act.

Securing the basic health needs of the worlds poor requires more than
persuading key decision makers to prioritize global health spending:
while international health assistance is vital, foreign aid and charitable
giving do not by themselves improve global health. As Laurie Garrett
details, health interventions in resource-poor countries often fail to
improve and at times actually worsen public health outcomes. The
prevailing philanthropic approach to global health relies largely on disease-specific programs that reflect donor goals rather than local needs
and that lack long-term vision. This approach does little to address the
underlying factors contributing to the burden of disease in developing
countries. Furthermore, because donor funds are not aimed at supporting local solutions or local industries, they contribute to the poorer
nations continuing dependence on foreign aid. Garrett proposes that
the world health community address these shortcomings by focusing
on the most meaningful health outcomes that can be achieved by systemic improvements in the local public health infrastructurenamely,
increased maternal survival rates and improved overall life expectancy.
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Global Health Law 241
The Challenge of Global Health*
Laurie Garrett
Less than a decade ago, the biggest problem in global health seemed to be the lack
of resources available to combat the multiple scourges ravaging the worlds poor
and sick. Today, thanks to a recent extraordinary and unprecedented rise in public
and private giving, more money is being directed toward pressing heath challenges
than ever before. But because the efforts this money is paying for are largely uncoordinated and directed mostly at specific high-profile diseasesrather than at public
health in generalthere is a grave danger that the current age of generosity could
not only fall short of expectations but actually make things worse on the ground. . . .
[Improving global health requires much more than money.] It takes states,
health-care systems, and at least passable local infrastructure to improve public
health in the developing world. And because decades of neglect there have rendered
local hospitals, clinics, laboratories, medical schools, and health talent dangerously
deficient, much of the cash now flooding the field is leaking away without result. . . .
Few of the newly funded global health projects . . . have built-in methods of
assessing their efficacy or sustainability. Fewer still have . . . scaled up beyond
initial pilot stages. . . . Nearly all have been designed, managed, and executed by
residents of the wealthy world (albeit in cooperation with local personnel and agencies). . . . Virtually no provisions exist to allow the worlds poor to say what they
want, decide which projects serve their needs, or adopt local innovations. And
nearly all programs lack exit strategies or safeguards against the dependency of
local governments.
As a result, the health world is fast approaching a fork in the road. The years
ahead could witness spectacular improvements in the health of billions of people,
driven by a grand public and private effort[,] . . . or they could see poor societies
pushed into even deeper trouble, in yet another tale of well-intended foreign meddling gone awry. Which outcome will emerge depends on whether it is possible
to expand the developing worlds local talent pool of health workers, restore and
improve crumbling national and global health infrastructures, and devise effective
local and international systems for disease prevention and treatment. . . .
Pipe Dreams
. . . One problem is that not all the funds appropriated end up being spent effectively.
[Much of] current aid spending is trapped in bureaucracies and multilateral banks.
[A 2006 World Bank report estimated that about half of all funds donated for health
efforts in sub-Saharan Africa never reached clinics and hospitals because it went
to payments for ghost employees, padded prices, the siphoning off of drugs to the
black market, and the sale of counterfeit drugs.]
Another problem is the lack of coordination of donor activities. Improving global
health will take more funds than any single donor can provide, and oversight and
*Reprinted by permission of Foreign Affairs (86, 2007). Copyright (2007) by the
Council on Foreign Relations, Inc. www.ForeignAffairs.org.
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242 The Law and the Publics Health
guidance require the skills of the many, not the talents of a few compartmentalized
in the offices of various groups and agencies. In practice, moreover, donors often
function as competitors. . . .
This points to yet another problem, which is that aid is almost always stovepiped down narrow channels relating to a particular program or disease. From an
operational perspective, this means that a government may receive considerable
funds to support, for example, an [antiretroviral]-distribution program for mothers
and children living in the nations capital. But the same government may have no
financial capacity to support basic maternal and infant health programs, [leaving
mothers without] even the most rudimentary of obstetric and gynecological care or
infant immunizations.
Stovepiping tends to reflect the interests and concerns of the donors, not the
recipients. . . . Advocacy, the whims of foundations, and the particular concerns of
wealthy individuals and governments drive practically the entire global public health
effort. Today the top three killers in most poor countries are maternal death around
childbirth and pediatric respiratory and intestinal infections leading to death from
pulmonary failure or uncontrolled diarrhea. But few womens rights groups put safe
pregnancy near the top of their list of priorities, and there is no dysentery lobby or
celebrity attention given to coughing babies. . . .
[At the 2006 International AIDS Conference, former president Bill Clinton suggested that HIV/AIDS programs would help develop health infrastructure, facilitating
broad improvements in health. But this optimistic assessment has not played out.
Much of global HIV/AIDS funding goes to stand-alone programs, and, because of
HIV-related stigma, countries public health systems have frequently segregated
HIV/AIDS-related programs from general care.] Far from lifting all boats, as Clinton
claims, efforts to combat HIV/AIDS have so far managed to bring more money to the
field but have not always had much beneficial impact on public health outside their
own niche. . . .
Brain Drain
. . . Health professionals from poor countries worldwide are increasingly abandoning
their homes and their professions to take menial jobs in wealthy countries. Morale
is low all over the developing world, where doctors and nurses have the knowledge
to save lives but lack the tools. Where AIDS and drug-resistant TB now burn through
populations like forest fires, health-care workers say that the absence of medicines
and other supplies leaves them feeling more like hospice and mortuary workers than
healers.
Compounding the problem are the recruitment activities of Western NGOs [nongovernmental organizations] and OECD-supported programs inside poor countries,
which poach local talent. . . . PEPFAR-funded programs, UN agencies, other richcountry government agencies, and NGOs routinely augment the base salaries of
local staff with benefits such as housing and education subsidies, frequently bringing their employees effective wages to a hundred times what they could earn at
government-run clinics.
. . . Without tough guidelines or some sort of moral consensus among UN agencies, NGOs, and donors, it is hard to see what will slow the drain of talent from
already-stressed ministries of health. [The declining number of health care workers
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Global Health Law 243
is staggering: for example, in Zambia, only 50 of the 600 doctors trained over the
past 40 years remain today.]
Donor states need to find ways not only to solve the human resource crisis inside
poor countries but also to decrease their own dependency on foreign health-care
workers. In 2002, . . . the United Kingdom passed the Commonwealth Code of Practice for the International Recruitment of Health Workers, designed to encourage
increased domestic health-care training and eliminate recruitment in poor countries
without the full approval of host governments. British officials argue that although
the code has limited efficacy, it makes a contribution by setting out guidelines for
best practices regarding the recruitment and migration of health-care personnel. No
such code exists in the United States, in the EU [European Union] more generally, or
in Asiabut it should. . . .
. . . The personnel crisis in the developing world will not be dealt with until the
United States and other wealthy nations clean up their own houses. . . . All donor
programs in the developing world . . . should have built into their funding parameters
ample money to cover the training and salaries of enough new local health-care
personnel to carry out the projects in question, so that they do not drain talent from
other local needs in both the public and the private sectors.
Women and Children First
Instead of setting a hodgepodge of targets aimed at fighting single diseases, the
world health community should focus on achieving two basic goals: increased
maternal survival and increased overall life expectancy. Why? Because if these two
markers rise, it means a populations other health problems are also improving. And
if these two markers do not rise, improvements in disease-specific areas will ultimately mean little for a populations general health and well-being. . . .
Maternal mortality data is a very sensitive surrogate for the overall status of
health-care systems since pregnant women survive where safe, clean, round-theclock surgical facilities are staffed with well-trained personnel and supplied with
ample sterile equipment and antibiotics. If new mothers thrive, it means that the
health-care system is working, and the opposite is also true.
Life expectancy, meanwhile, is a good surrogate for child survival and essential
public health services. . . .
The OECD and [NGOs] should thus shift their targets, recognizing that vanquishing AIDS, TB, and malaria are best understood not simply as tasks in themselves but
also as essential components of these two larger goals. No health program should
be funded without considering whether it could, as managed, end up worsening the
targeted life expectancy and maternal health goals, no matter what its impacts on
the incidence or mortality rate of particular diseases. . . .
In the current framework, such as it is, improving global health means putting
nations on the dolea $20 billion annual charity program. But that must change.
Donors and those working on the ground must figure out how to build not only
effective local health infrastructures but also local industries, franchises, and other
profit centers that can sustain and thrive from increased health-related spending.
For the day will come in every country when the charity eases off and programs
collapse, and unless workable local institutions have already been established, little
will remain to show for all of the current frenzied activity.
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244 The Law and the Publics Health
B. The Epidemiologic Transition from Infectious to Chronic
Disease: A Double Burden on the Poor
It is not surprising that the spread of infectious diseases is a matter of
international concern. But it is less obvious why non-communicable
diseases (NCDs) have global dimensions. The world is experiencing an
epidemiological transition from infectious to chronic diseases, such
as cardiovascular diseases, cancers, respiratory conditions, and diabetes. The WHO estimates that NCDs now account for nearly 60 percent
of deaths, outstripping infectious diseases and injuries as the leading
cause of death and long-term disability worldwide.
In part, the shift toward NCDs is attributable to longer life expectancies and an aging population. As people live longer they are more
likely to develop debilitating NCDs. The epidemiologic shift to NCDs
is not explained solely by an aging population, however; it is at least
partially attributable to the process of globalization. Not only do
increased trade and travel contribute to the rapid transmission of infectious disease, but they also facilitate the dissemination of risk factors
for various NCDs. Roger S. Magnusson (2007), a leading global health
law scholar, explains the root causes for the epidemiological transition
from infectious to non-communicable diseases as follows:
[The shift in disease burden] reflects the rapid rise in behavioural risk
factors including smoking and high-sugar, high-fat diets. The nutrition
transition towards diets that are richer in saturated fats and poorer in
complex carbohydrates and dietary fibre, fruit and vegetables; the growth
of urban lifestyles involving less physical exertion; and the promotion and
rising consumption of tobacco and alcohol, have set the scene for lifestyle
epidemics to become the greatest health challenge of the 21st century.
While the proximate behavioural risk factors for non-communicable
diseases are well-known, the underlying environmental causes are both
complex and global in scale. Environmental factors underlying the
nutrition transition include the industrialization of food production, the
growth of sophisticated supply chain management on a global scale, the
expansion of market economies in developing countries, the growing
concentration of global food manufacturers as a result of mergers and
acquisitions, and the rapid growth of supermarkets in the developing
world. Rising incomes, price differentials favouring the cheap production
of energy-dense foods, growing urbanization and rapid growth in demand
for pre-prepared foods, are also key factors.
Historically, global health policy makers have distinguished between
diseases of poverty (acute infectious diseases) and diseases of affluence
(chronic NCDs). This distinction is declining in utility as the global
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Global Health Law 245
burden of disease shifts toward chronic diseases and as chronic disease
risk factors become increasingly prevalent in the developing world.
Some 80 percent of chronic disease deaths occur in low- and middleincome countries. The epidemiologic shift is particularly problematic
in developing countries, where the growing prevalence of NCDs is not
offset by a decline in communicable diseases, thereby creating a double
burden of disease that strains limited health resources.
Addressing the burden of NCDs in developing countries requires
concerted global action. As Derek Yach and colleagues (2004, 2617
18) observe, health policy interventions are integral to such efforts:
[In] the absence of policy actions, consumption of tobacco, alcohol,
and foods high in fat and sugar increases along with gross national
product, followed by associated increases in chronic diseases decades
later. . . . The global challenge policymakers face is how to implement
policies now that support continued economic development while
simultaneously reducing the rates of chronic diseases. Yet misconceptions regarding NCDs and the health burdens they create present a
fundamental barrier to policy action:
In developed countries, the relationship between socioeconomic inequalities and many chronic diseases and their risk factors are well described.
Although the disease burden is more variable in developing countries,
the poorest populations, particularly in rapidly growing cities, in many
cases already exhibit the highest risks for tobacco use, alcohol use, and
physical activity, with evidence emerging for obesity. This will lead to a
higher burden of chronic diseases over the long-term. Poverty also leads to
greater co-morbidity and decreased access to quality medical care. . . .
Many decision makers mistakenly believe that chronic diseases arise
only as a result of the irresponsibility of the individuals who contract
them, with the perception that smoking is a free choice with health
consequences. Yet age and uptake of smoking in developing countries
are showing a trend toward early teenage years, the stage of life when the
addictiveness of tobacco belies freedom of choice. Tobacco marketing is
often targeted specifically at children, alcohol advertisements shape young
peoples perceptions and encourage pro-drink attitudes, and food marketing works its way into the skin of children and adolescents. . . .
Chronic disease control is not necessarily expensive or ineffective.
For example, a recent review of tobacco control [programs] showed that
tobacco prevalence can be reduced cost-effectively in high-, middle-, and
low-income countries. Several clinical and public health interventions
have the potential to reduce the burden of disease from cardiovascular
disease, diabetes, and hypertension significantly and at low cost. . . .
The belief that scarce resources should not be used for chronic diseases
until infectious diseases are addressed is also fallacious. Several infectious agents cause cancers; tobacco increases deaths from tuberculosis in
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246 The Law and the Publics Health
already infected populations, and antiretroviral regimens in HIV-infected
patients increase the risk of heart disease. (Yach et al. 2004, 2620)
Abdallah S. Daar and colleagues (2007) have proposed strategies for
reducing the global burden of chronic NCDs as part of their grand
challenges series. They hope that focusing on twenty grand challenges for NCDs will galvanize health, science, and public policy communities to action. Appropriately, raising the political priority of NCDs
is identified as the first grand challenge to reducing chronic NCDs.
Daar and colleagues predict that with concerted action, the global community can avert at least 36 million premature deaths by 2015. Building
on the grand challenges approach, in 2008 the Oxford Health Alliance, a to chronic disease prevention, published
the Sydney Resolution, which is discussed in box 6.
Given current trends, it is particularly urgent for the global community to prioritize NCDs, undertake appropriate policy interventions,
and allocate sufficient resources. Without such action, we will soon live
in a world in which all major diseases are the diseases of the poor
(Ezzati et al. 2005, 3133).
II. International Public Health Law
The readings above make clear that international health assistance is
often chaotic and ineffective. The past decade has seen an explosion
of new philanthropists and service organizations engaging in global
health, joining a plethora of well-established state and United Nations
agencies. There is considerable confusion about how all the various
actors and their interventions fit together. Despite the propagation of
creative ideas and the influx of resources, there is no architecture of
global health. The global community needs effective methods of governing the diverse, fragmented activities on the ground. The WHO has
sought to meet this governance challenge by adopting two major international public health instrumentsthe IHR and the FCTC.
A. The International Health Regulations: A Historic Development
The World Health Assembly adopted the new IHR on May 23, 2005,
following a decade-long revision process. The severe acute respiratory
syndrome (SARS ) outbreaks in 2003 provided the major impetus for
a global consensus on the need for more coherent regulation of public
health hazards of international concern. In some ways, the IHR are
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Box 6
The Sydney Resolution:
Healthy people in healthy places on a healthy planet
At its 2008 summit, the Oxford Health Alliance, whose membership includes academics, activists, and health care providers, finalized the Sydney
Resolutiona global call to action on chronic diseases. The resolution, which
has been endorsed by the World Health Federation, aims to inspire diverse
stakeholders to take urgent action to halt the devastating global impact of
chronic diseases in ways that will promote economic and environmental
sustainability.
The resolution focuses on heart disease/stroke, diabetes, chronic lung
disease, and cancerfour preventable chronic diseases that account for 50
percent of the worlds deathsand their underlying causes: tobacco use,
physical inactivity, and poor diet. These preventable chronic diseases are
at epidemic proportions. They are increasingly affecting younger people and
cause physical disability, depression, and early death. There are immense
costs to society in lost productivity and increased use of health services.
The epidemic threatens economic stability in developed and developing
countries alike. In arguing for global action on chronic diseases, the Sydney
Resolution declares: There is a clear way forward. . . . The development of
how we live as societies, share opportunities, interact with the natural environment and how we design our cities, transport systems, food systems,
work places and housing will fundamentally determine future patterns of
health and disease. We need health services focused on prevention as well
as cures and we need our world free of tobacco. We must fundamentally
reshape our social and physical environments so that they are aligned with
eradicating this epidemic of chronic disease. Five core needs are enumerated in the resolutions call to action:
Healthy placesdesigning towns, cities, and rural areas that are
smoke-free, and where it is easy to walk, cycle, and play, with unpolluted open spaces and safe local areas that foster social interaction.
Healthy foodmaking healthy food affordable, and available to all.
Healthy businessengaging business in the agendas of promoting
healthy people, healthy places, and a healthy planet and making
good health good business.
Healthy public policyformulating comprehensive, innovative,
and joined-up legislation and social and economic policies that
promote health.
Healthy societiesaddressing equity and socioeconomic
disadvantage.
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248 The Law and the Publics Health
part of a long tradition of infectious disease regulation, with antecedents dating back to nineteenth-century European and Pan-American
treaties. But, more fundamentally, the revised IHR offer a powerful
new paradigm for global health governance. David Fidler and I describe
and analyze the revised IHR in the passage below.
The New International Health Regulations: An Historic
Development for International Law and Public Health*
David P. Fidler and Lawrence O. Gostin
The new International Health Regulations (IHR) appear at a moment when public
health, security, and democracy have become intertwined, addressed at the highest
levels of government. . . . This article analyzes the new IHR and their implications for
global health and security in the 21st century. . . .
Photo 15. Thousands of protesters march through the streets of Cape Town,
South Africa, in February 2003. Organized by South Africas Treatment
Action Campaign (TAC), the march called on that nations government to
expand funding for HIV treatment to the poor. TAC was successful in a legal
battle to require that the South African government develop a plan to provide
an HIV drug, nevirapine, to pregnant women to prevent mother-to-child
transmission of the virus. Reproduced by permission, Rodger Bosch/The
Image Works, February 14, 2003.
*Reprinted from Journal of Law, Medicine & Ethics 33 (2006): 8594. (Blackwell
Publishing).
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Global Health Law 249
The New IHR: An Imp ortant Development in Global Health Governance
. . . The purpose of the new IHR is to prevent, protect against, control and provide a
public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary
interference with international traffic and trade (International Health Regulations
2005, Article 2). The IHR seek to balance the states right to protect its peoples
health with obligations to take health-protecting actions in ways that do not unnecessarily interfere with international trade and travel. . . .
. . . The new IHR expand the scope of the IHRs application, incorporate international human rights principles, contain more demanding obligations for states
parties to conduct surveillance and response, and establish important new powers
for WHO. . . .
Scope of the New IHR: An All-Risks Approach
The old IHR applied only to a short list of infectious diseases whose spread was
historically associated with trade and travel (e.g., cholera, plague, and yellow fever).
The Regulations now encompass public health risks whatever their origin or source,
including: (1) naturally occurring infectious diseases . . . ; (2) the potential international spread of non-communicable diseases caused by chemical or radiological
agents in products moving in international commerce; and (3) suspected . . . releases
of biological, chemical, or radiological substances.
This all-risks approach embodies an important conceptual shift concerning
public healths role in the IHR. Trade calculations determined the old IHRs scope,
but risks to human health define the new IHRs scope. The result is a set of rules with
more public health legitimacy, flexibility, and adaptability. . . .
The New IHR and General Human Rights Principles
The new IHR proclaim that [t]he implementation of these Regulations shall be with
full respect for the dignity, human rights and fundamental freedoms of persons
(Article 3.1). . . . For a public health measure to restrict a civil and political right lawfully, the measure must (1) respond to a pressing public or social need; (2) pursue
a legitimate aim; (3) be proportionate to the legitimate aim; and (4) be no more
restrictive than is required to achieve the purpose sought by restricting the right.
The rights-restricting measure must also be implemented in a non-discriminatory
manner. Individuals deprived of liberty must be treated with humanity and respect
for the inherent dignity of the human person. . . .
The extent to which the new IHR incorporate human rights principles means that
international human rights law is relevant to the interpretation and implementation
of the new IHR. The Regulations incorporation of human rights will suffer, however,
if states parties do not integrate human rights thinking into the operation of their
respective public health systems. . . .
[The new IHR also include provisions related to informed consent and privacy.
Attention to these concerns represents an improvement over the former IHR, but
questions remain about protecting human rights when implementing the Regulations.]
National Public Health Capa cities: Surveillance and Response
The new IHR require states parties to develop, strengthen, and maintain core surveillance and response capacities. The old IHR had requirements for public health
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250 The Law and the Publics Health
capabilities only at points of entry and exit. The far-reaching provisions in the new
IHR shore up major weaknesses in global strategies created by inadequate national
surveillance and response capabilities. . . .
Although the new IHRs provisions on surveillance and response capacities recognize the critical need for capacity building, questions remain about the handling of
this issue. [The financial and technical resources needed for national capacity building may not be available, and the WHO suffers from resource constraints.] The new
IHR also contain no obligations on states parties to provide financial and technical
resources to support capacity building. . . .
Notification Obligations: Reporting Health Events to WHO
The new IHR require states parties to notify WHO of all events within their territories
that may constitute a public health emergency of international concern, defined as
an extraordinary event which is determined . . . (i) to constitute a public health risk
to other States through the international spread of disease and (ii) to potentially
require a coordinated international response (Article 1.1). A decision instrument
is used to guide states parties in determining whether a disease event may constitute a public health emergency of international concern.
In keeping with the new IHRs expanded scope, the notification obligations reflect
a radically different, and more demanding, approach to addressing the international
spread of disease. The notification provisions place a premium on states parties having sufficient surveillance capacities to detect disease incidents, assess them under
the decision instrument, and report disease events that may constitute public health
emergencies of international concern. [There is a serious question as to whether
many countries can develop the necessary surveillance capacities.]
Another problem looms for the new IHRs notification requirements. States parties often violated the old IHR by failing to report cases of diseases subject to the
Regulations because they feared other countries would implement economically
damaging trade or travel restrictions. [The new IHR contain information supply and
verification strategies to help combat this problem.]
Data and Verification Provisions: Unofficial Sources
of Information
The old IHR limited WHO to officially using information provided by states parties. . . . By contrast, the new IHR allow WHO to take into account reports from
sources other than notifications or consultations from or with governments and
to seek verification of such information from states parties in whose territories the
events are allegedly occurring (Articles 9.1 and 10.1). States parties must respond to
WHO verification requests. . . .
[Nongovernmental sources of information have been critical to the WHOs Global
Outbreak Alert and Response Network (GOARN). Access to nongovernmental information incentivizes compliance and transparency by states.]
Declaration and Recommendation Powers
The new IHR grant two other important powers to WHO that never appeared in the
old IHR. First, the new IHR accord WHO the authority to determine whether a disease
event constitutes a public emergency of international concern. States parties have
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Global Health Law 251
to notify disease events that may constitute such emergencies, but the DG [directorgeneral] determines if disease events are public health emergencies of international
concern. [Therefore,] a state partys refusal to cooperate does not bar WHO action.
Second, if the DG determines that a public health emergency of international
concern is occurring, then he or she shall issue non-binding, temporary recommendations to states parties on the most appropriate ways to respond. The DG may
also issue non-binding, standing recommendations on routine, periodic application
of health measures for specific, ongoing public health risks. . . . These powers allow
WHO to provide leadership on what health measures are appropriate from scientific
and public health perspectives and on the proper ways to balance health protection
with respect for human rights and acknowledgement of trade concerns.
Permissible Health Measures: Limits on National Public Health
Interventions
States parties to the new IHR are not legally bound to follow WHO temporary or
standing recommendations; but the new IHR contain binding limits on the types of
health measures states parties can take against public health risks. . . . Generally,
states parties cannot require an invasive medical examination, vaccination or other
prophylaxis as a condition of entry for any traveler; nor can a state party require
any health document for travelers other than those permitted by the new IHR or
recommended by WHO. . . .
The new IHR permit states parties to apply health measures that achieve the
same or greater level of health protection than WHO recommendations or that are
otherwise prohibited by the IHR. Such health measures must be based on scientific
principles, available scientific evidence, relevant guidance or advice from WHO, and
cannot be more restrictive of international traffic or more invasive or intrusive to
persons than reasonably available alternatives that would achieve the level of health
protection sought.
[The lack of enforcement mechanisms for these provisions may be problematic,
and the same noncompliance problems that plagued the old IHR may reemerge.]
The New IHR and the Future of Global Health Governance
The new IHR contain an international legal regime unprecedented in the history of the relationship between international law and public health. The revised
Regulations promise to become a centerpiece for global health governance in the
21st century. . . . The transformational nature of the new IHR creates a regime that
has the potential to contribute significantly to the general global governance mission
of improving national and international health. The Regulations provide a framework
that supports not only improved international cooperation on health but also the
strengthening of national health systems, producing more robust health governance
horizontally among states and vertically within them.
The new IHRs novelty should not, however, obscure hard realities facing its
future. WHO was systematically using non-governmental surveillance information
from GOARNs establishment in 1998, well before the IHR revision process was
completed; and this strategy would have continued whether or not the new IHR
had been adopted. More difficult issues arise with producing effective responses
to identified public health risks. For decades, WHO has issued recommendations on
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252 The Law and the Publics Health
many public health problems; but the mixed record of state compliance with WHO
guidance should temper enthusiasm for the new IHRs recommendation provisions.
The political controversies that surrounded WHOs more aggressive actions during SARS may deter WHO from taking similar actions under the new IHR. Laments
about the erosion of global and local public health capabilities suggest that WHOs
decades-long effort to improve health conditions in developing countries has also
met with only qualified success. The new IHR will not change this dynamic overnight,
particularly when the Regulations generate no fresh financial resources to support
capacity building. Compliance with international legal restrictions against the implementation of health measures that unnecessarily restrict trade or infringe on human
rights has not, in the past, been stellar, as illustrated by how non-compliance helped
destroy the old IHRs effectiveness. Whether the quantity and quality of compliance with the new IHRs rules on health measures are better will not depend on any
improved enforcement mechanism because the Regulations do not create one.
The new IHR are no magic bullet for global health problems. Previous transformations in international laws relationship with public health have, over time,
atrophied into insignificance. The history of the old IHR tells just such a story. . . .
Controversies and problems surrounding the threat of avian influenza also suggest
that the new IHR do not cut through the tangled knot of very hard political, economic, scientific, and public health choices governments must make to address this
public health emergency of international concern.
. . . Harvesting the new IHRs benefits for global health requires understanding
not only the difficulties this task faces but also the potential the Regulations represent. . . . The seminal achievement of the new IHR constitutes only the end of the
beginning. The hard work of making this transformative revision of global health
governance effective for individuals, states, and the international community now
begins.

As the preceding article discussed, for the first time in history, the
revised International Health Regulations permit an organized global
response within the rule of international law. The April 2009 outbreak
of a novel strain of influenza A (H1N1) offered the first test of its effectiveness. Although it remains to be seen how the continuing H1N1
outbreak will unfold, in box 7 I provide a brief, summary time line of
the initial stages of the outbreak as well as the corresponding actions
taken by the WHO.
B. The Framework Convention on Tobacco Control:
Global Strategies to Reduce Smoking
In the mid-twentieth century, the cigarette was a cultural icon in Western
societytobacco smoking was viewed as chic, promoted ubiquitously,
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Box 7
Outbreak of influenza A (H1N1): Time line (April 12June 11, 2009)
April 12 Outbreak of influenza-like illness in Veracruz, Mexico,
reported to WHO.
April 1517 U.S. CDC laboratories identify two cases of a novel strain
of A (H1N1) virus in southern California.
April 23 Novel strain of A (H1N1) virus infection confirmed in
several patients in Mexico.
April 25 In compliance with the International Health Regulations,
WHO convenes a meeting of the Emergency Committee,
composed of international experts in a variety of disciplines. Upon its advice, Director-General Margaret Chan
(WHO 2009c) declares the outbreak a public health
emergency of international concern (marking the first
time such a declaration had been made under the new
regulations).
April 27 According to its categorizations of pandemic phases
(WHO 2009a), WHO declares the situation at Pandemic
Phase 4, or sustained human-to-human transmission, in
Mexico.
April 29 After broad transmission is documented in the United
States, WHO raises alert to Pandemic Phase 5, which is
characterized by human-to-human spread of the virus
into at least two countries in the same WHO region.
June 11 All WHO regions reporting cases of novel strain A (H1N1);
WHO raises alert to Pandemic Phase 6, which is characterized by community-level outbreaks in at least one
other country in a different WHO region in addition to the
criteria defined in Phase 5. Designation indicates that a
global pandemic is under way.
source: Adapted from WHO 2009b.
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254 The Law and the Publics Health
and portrayed by sports and movie stars as an accoutrement of a good
life (Brandt 2007). By the close of the century, public and political perceptions had been transformed by revelations about the tobacco industrys knowledge of the risks of smoking and its intent to deceive. The
ensuing regulation and tort litigation in North America and western
Europe had a salutary effect, even if smoking remains a pressing public
health hazard. But in the twenty-first century, the tobacco industry has
quietly moved its locus of activity to lucrative emerging marketsthe
vast populations of Africa, Asia, eastern Europe, and Latin America.
Within these regions live some of the poorest, least educated, and sickest people on earth. Big Tobaccos new marketing strategy will cause
untold morbidity for the worlds most vulnerable populations (Gostin
2007b, Gostin 2007f).
The FCTC, the first convention negotiated under article 19 of
the WHO Constitution, was adopted in 2003 and entered into force
in 2005. Most countries have ratified the treaty, with three densely
populated countries conspicuously missingIndonesia, Russia, and the
United States. The FCTC Conference of Parties, representing 80 percent of the worlds population, set regulatory goals in Bangkok, Thailand, in July 2007. The conference established historic guidelines on
smoke-free environments, announced future guidelines on cross-border
advertising, and began work on the first FCTC protocol on illicit trade
in tobacco products.
In the following reading, Allyn L. Taylor and Douglas W. Bettcher
argue that the FCTC has the potential to be a global good for public
health, pointing to the demonstrated successes of other international
agreements in the area of global health, most of which address environmental issues. Taylor and Bettcher offer the development of the FCTC
as a model for the creation of global health agreements, emphasizing
the importance of an evidence-based approach in securing political
acceptance.
WHO Framework Convention on Tobacco Control:
A Global Good for Public Health*
Allyn L. Taylor and Douglas W. Bettcher
Cigarette smoking is one of the largest causes of preventable death worldwide and
the leading cause of premature death in industrialized countries. Currently, cigarette
*Reprinted from Bulletin of the World Health Organization 78 (2000): 92029.
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Global Health Law 255
smoking and other forms of tobacco consumption kill four million people per year,
with the majority of these deaths already occurring in developing nations. Moreover,
the epidemic of tobacco addiction, disease and death is continuing to shift rapidly to
the developing and transitional market countries. . . .
A significant contributor to the increased risk of tobacco-related diseases worldwide is the globalization of the tobacco epidemic through the successful efforts of
the tobacco industry to expand their global trade and to achieve market penetration in developing countries and transitional market economies. Major transnational tobacco companies targeted growing markets in Latin America in the 1960s,
the newly industrializing economies of Asia (Japan, the Republic of Korea, China
[Province of Taiwan], and Thailand) in the 1980s, andin the 1990s and currently
have moved into Africa, China, and eastern Europe, and are increasingly targeting
young persons and women. . . .
As the vector of the tobacco epidemic, the tobacco industry is well aware of the
characteristics of globalization and is attempting to manipulate globalization trends
in its favour. Recently released documents of the multinational tobacco industry
concretely indicate that the industry plans, develops and operates its markets
on a global scale (Yach 1999). For example, a careful review of tobacco industry
documents has shown that the industry looks towards the creation of new global
brands and a global smoker as one way of overcoming markets which have thus
far resisted the tobacco industrys onslaught. . . .
The dramatic increase in tobacco consumption in the last couple of decades portends public health and economic tragedy for nations worldwide in the 21st century.
Much of the potential calamity can be averted, however, through effective implementation of tobacco control strategies. In its recent report, Curbing the epidemic:
governments and the economics of tobacco control, the World Bank (1999) concluded that tobacco control is highly cost-effective as part of a basic public health
package in all countries. . . .
Since many, if not all, of the challenges of tobacco control are increasingly
transcending national boundaries, stemming the growth of the tobacco pandemic
requires global agreement and action. The globalization of the tobacco pandemic
restricts the capacity of countries to unilaterally control tobacco within their sovereign borders. All transnational tobacco control issuesincluding trade, smuggling,
advertising and sponsorship, prices and taxes, control of toxic substances, and
tobacco package design and labelling require multilateral cooperation and effective
action at the global level. If not attended to, these global aspects of tobacco control
can overwhelm the best national tobacco control strategies.
An International Evidence-Based Approach
The WHO Convention is being developed as a scientific, evidence-based approach
to global tobacco control, which has the potential to significantly advance national
and international efforts to curb the growth of the pandemic. [Ed.This article was
published before the FCTC was adopted and came into force.]
Evidence from other treaty-making processes shows that the institutions and
procedural mechanisms established by the WHO Convention can prompt timely consensus and action on cogent implementing protocols and, thus, contribute to the
implementation of the Convention and the advancement of the global public good of
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256 The Law and the Publics Health
international tobacco control. For example, environmental framework conventions
and protocols are often designed to encourage state parties to adopt implementing protocols by mandating regular and institutionalized meetings of the parties. In
the case of some framework conventions, the mandatory provisions for consultation
offer the prospect of a virtually continuous legislative enterprise (Handl 1992, 62).
Rapid implementation of the WHO Convention can also be encouraged by institutions and mechanisms that establish incentives for the parties, such as information,
technology, training, technical advice and assistance.
Of course, the effective international lawmaking experiences achieved at times
in the environmental areas may not accurately reflect WHOs potential to garner
broad support for the development and implementation of a Framework Convention
on Tobacco Control and related protocols. The extent to which international agreements are effectiveand under what conditionshas been a continuing source of
theoretical fascination and dispute among scholars of international relations and
international law. Although it is beyond the scope of this article to detail the factors that may contribute to the effective adoption and implementation of the WHO
Convention, it may be noted that tobacco control does share the characteristic of
scientific certainty which has galvanized effective international action in some
areas of environmental law. Like the hole in the ozone layer above Antarctica which
led to the conclusion of the Montreal Ozone Protocol, the health and economic consequences of tobacco consumption are empirically established. In addition, the use
of the framework convention protocol approach will allow countries to undertake
added substantive and/or institutional commitments as global consensus for concrete measures on tobacco control develops.
Framework Convention on Tobacco Control: A Global Public Good
As a rational, evidence-based approach, the WHO Convention holds the potential
of dramatically advancing global cooperation for tobacco control and can thus be
considered a potential intermediate public health good. The principles, norms and
standards ultimately codified in the Convention can legally establish global priorities for national action and multilateral cooperation on tobacco control. The institutions eventually established by the Convention, includingpotentiallya financial
mechanism, technical advice and assistance programmes, a mechanism to monitor
treaty compliance, and provisions for ongoing consultation of the parties, can help
contribute to the adoption of effective global tobacco control measures. Overall, by
providing an ongoing and institutionalized platform for multilateral consultations on
tobacco control, the WHO Convention may be able to promote adoption and implementation of effective tobacco control strategies worldwide.
WHO has the constitutional responsibility and the unique opportunity to propel
the development of a Framework Convention on Tobacco Control. Importantly, the
sheer process of negotiating and seeking its adoption can also be considered a public good. WHOs efforts to achieve global public support for an international regulatory framework for tobacco control may stimulate national policy change and thus
make a dramatic contribution to curtailing the spiraling pandemic well before global
consensus on cogent tobacco norms is secured.
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Global Health Law 257
III. Human Rights: Advancing Dignity, Justice,
and Security in Health
It is not necessary to recount the numerous charters
and declarations . . . to understand human rights. . . .
All persons are born free and equal in dignity and
rights. Everyone . . . is entitled to all the rights and
freedoms set forth in the international human rights
instruments without discrimination, such as the rights
to life, liberty, security of the person, privacy, health,
education, work, social security, and to marry and
found a family. Yet, violations of human rights are a
reality to be found in every corner of the globe.
Jose Ayala Lasso (former UN high commissioner for
human rights) and Peter Piot (former executive director
of UNAIDS ), 1997
The language of human rights is used in different ways, though usually
with a common core sense. Some mean by human rights a set of
entitlements and obligations under international law. Others apply the
term to a set of ethical standards that stress the paramount importance
of individuals. Still others use human rights language for its aspirational, or rhetorical, qualities.
Although all of these uses are important, I use the term primarily
to refer to a body of international law that arose in response to the
egregious affronts to peace and human dignity committed by the Nazis
during World War II. The main source of human rights law within the
United Nations system is the International Bill of Human Rights, composed of the Charter of the United Nations, the Universal Declaration
of Human Rights (UDHR), and two international covenants on human
rights. Human rights are also protected under regional systems, including those in the Americas, Europe, and Africa.
In its preamble, the United Nations Charter articulates the international communitys determination to reaffirm faith in fundamental
human rights, [and] in the dignity and worth of the human person.
The charter, as a binding treaty, requires member states to promote
universal respect for, and observance of, human rights and fundamental freedoms for all without distinction as to race, sex, language, or
religion (articles 5556).
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258 The Law and the Publics Health
The UDHR, adopted in 1948, built on the promise of the charter by
identifying specific rights and freedoms to which all human beings are
entitled. As a declaration of the UN General Assembly, the UDHR is
an expression of global consensus on the lasting importance of human
rights. It was the international communitys first attempt to establish
a common standard of achievement for all peoples and all nations in
the promotion and protection of human rights (preamble). The UDHR
has largely fulfilled the promise of its preamble, becoming the common standard for evaluating respect for human rights. Although it
was not promulgated to legally bind member states, the UDHRs key
provisions have so often been applied and accepted that they are now
widely considered to have attained the status of customary international law.
The adoption of the UDHR set the stage for a binding, treatybased scheme to promote and protect human rights. The International
Covenant on Civil and Political Rights (ICCPR) and the International
Covenant on Economic, Social, and Cultural Rights (ICESCR) were
adopted in 1966 and entered into force in 1976. Together, these covenants convert the UDHRs expression of human rights and freedoms
into a set of legal obligations incumbent on states parties. The United
States has ratified the ICCPR but not the ICESCR. The rights contained
in the ICCPR are principally negative or defensive in character, affording individuals a sphere of protection from government restraint. These
rights, which are to be respected without discrimination, include the
right to life, liberty, and security of person; the prohibition of slavery,
torture, and cruel, inhuman, or degrading treatment; the right to an
effective judicial remedy; the prohibition of arbitrary arrest, detention,
and exile; freedom from arbitrary interference with privacy, family,
or home life; freedom of movement; freedom of conscience, religion,
expression, and association; and the right to participate in government.
The UDHR characterizes economic, social, and cultural rights as
indispensable for [a persons] dignity and the development of his personality (article 22). To oversimplify somewhat, the ICESCR forms
the foundation for positive rights, that is, those requiring affirmative
duties of the state to provide services. Such positive rights include the
right to social security, the right to education, the right to work, the
right to receive equal pay for equal work and to remuneration ensuring
an existence worthy of human dignity, and the right to share in the
cultural life of the community and to share in scientific advancement
and its benefits (articles 2227). Article 12 of the ICESCR requires
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Global Health Law 259
governments to recognize the right of everyone to the highest attainable standard of physical and mental health. Article 25 of the UDHR
also expressly recognizes that everyone has the right to a standard of
living adequate for the health and well-being of himself and his family,
including . . . medical care and necessary social services. The article
further specifies the right to social security and support in times of
need.
Human rights law follows a set of internationally agreed-on rules
specified in the text of treaties and other instruments, is informed by
precedent, and is interpreted by tribunals and commissions. International human rights law seldom provides easy answers; rather, the
field struggles to define and enforce human rights in the context of the
legitimate powers of governments and the needs of communities.
This section begins with a classic exposition of the relationship
between health and human rights by Jonathan M. Mann and colleagues.
Manns work is seminal, forming the basis for modern scholarship and
advocacy in the field. Above all, he made an early plea for greater clarity of thought about the meaning of the international right to health.
The UN Committee on Economic, Social, and Cultural Rights has
responded by publishing General Comment 14 on the right to health,
excerpted below. The General Assembly subsequently appointed a special rapporteur, who has also published influential guidance.
Health and Human Rights*
Jonathan M. Mann et al.
Health and human rights have rarely been linked in an explicit manner. With few
exceptions, notably involving access to health care, discussions about health have
not included human rights considerations. Similarly, except when obvious damage
to health is the primary manifestation of a human rights abuse, such as with torture,
health perspectives have been generally absent from human rights discourse.
[Despite the gap that exists between health and human rights, both are] powerful, modern approaches to defining and advancing human well-being. Attention to
the intersection of health and human rights may provide practical benefits to those
engaged in health or human rights work, may help reorient thinking about major
global health challenges, and may contribute to broadening human rights thinking
and practice. However, meaningful dialogue about interactions between health and
human rights requires a common ground. To this end, following a brief overview of
selected features of modern health and human rights, this article proposes a provi-
*Reprinted from Health and Human Rights 1 (1994): 623.
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260 The Law and the Publics Health
sional, mutually accessible framework for structuring discussions about research,
promoting cross-disciplinary education, and exploring the potential for health and
human rights collaboration. . . .
A Provisional Fram ework: Linkages between Health and Human Rights
The goal of linking health and human rights is to contribute to advancing human
well-being beyond what could be achieved through an isolated health- or human
rightsbased approach. This [article] proposes a three-part framework for considering linkages between health and human rights; all are interconnected, and each has
substantial practical consequences. . . .
The First Relationship: The Impa ct of Health Policies, Program s, and
Practices on Human Rights
Around the world, health care is provided through many diverse public and private
mechanisms. However, the responsibilities of public health are carried out in large
measure through policies and programs promulgated, implemented, and enforced
by, or with support from, the state. Therefore, this first linkage may be best explored
by considering the impact of public health policies, programs, and practices on
human rights.
The three central functions of public health are: assessing health needs and problems; developing policies designed to address priority health issues; and assuring
programs to implement strategic health goals. Potential benefits to and burdens on
human rights may occur in the pursuit of each of these major areas of public health
responsibility.
For example, assessment involves collection of data on important health problems in a population. However, data are not collected on all possible health problems,
nor does the selection of which issues to assess occur in a societal vacuum. Thus,
a states failure to recognize or acknowledge health problems that preferentially
affect a marginalized or stigmatized group may violate the right to nondiscrimination by leading to neglect of necessary services, and in so doing, may adversely
affect the realization of other rights, including the right to security in the event
of . . . sickness [or] disability or to the special care and assistance to which mothers and children are entitled (UDHR, art. 25).
Once decisions about which problems to assess have been made, the methodology of data collection may create additional human rights burdens. Collecting
[health] information from individuals . . . can clearly burden rights to security of
person (associated with the concept of informed consent) and of arbitrary interference with privacy. [In addition, the methods used might compromise the right of
nondiscrimination. For example, information gathered by a telephone survey, which
excludes households without telephones (usually associated with lower socioeconomic status), might produce a skewed assessment and biased programs or policies.] Also, personal health status or health behavior information (such as sexual
orientation or history of drug use) has the potential for misuse by the state, whether
directly or if it is made available to others, resulting in grievous harm to individuals
and violations of many rights. . . .
The second major task of public health is to develop policies to prevent and control
priority health problems. Important burdens on human rights may arise in the policy
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Global Health Law 261
development process. For example, if a government refuses to disclose the scientific basis of health policy or permit debate on its merits, or in other ways refuses
to inform and involve the public in policy development, the rights to seek, receive
and impart information and ideas . . . regardless of frontiers (UDHR, art. 19) and to
take part in the government . . . directly or through freely chosen representatives
(UDHR, art. 21) may be violated. Then, prioritization of health issues may result in
discrimination against individuals, as when the major health problems of a population
of a specific sex, race, religion, or language are systematically given lower priority. . . .
The third core function of public health, to assure services capable of realizing
policy goals, is also closely linked with the right to nondiscrimination. When health
and social services do not take logistic, financial, and sociocultural barriers to their
access and enjoyment into account, intentional or unintentional discrimination may
readily occur. . . .
It is essential to recognize that in seeking to fulfill each of its core functions and
responsibilities, public health may burden human rights. In the past, when restrictions on human rights were recognized, they were often simply justified as necessary to protect public health. Indeed, public health has a long tradition, anchored in
the history of infectious disease control, of limiting the rights of the few for the
good of the many. . . .
Unfortunately, public health decisions to restrict human rights have frequently
been made in an uncritical, unsystematic, and unscientific manner. Therefore, the
prevailing assumption that public health, as articulated through specific policies and
programs, is an unalloyed public good that does not require consideration of human
rights norms must be challenged. For the present, it may be useful to adopt the
maxim that health policies and programs should be considered discriminatory and
burdensome on human rights until proven otherwise. . . .
The idea that human rights and public health must inevitably conflict is increasingly tempered with awareness of their complementarity. [New approaches in
the HIV/AIDS context incorporate public health and human rights goals, and such
approaches are possible elsewhere.] At present, an effort to identify human rights
burdens created by public health policies, programs, and practices, followed by
negotiation toward an optimal balance whenever public health and human rights
goals appear to conflict, is a necessary minimum. An approach to realizing health
objectives that simultaneously promotesor at least respectsrights and dignity is
clearly desirable.
The Second Relationship: Health Impa cts Resulting from Violations of
Human Rights
Health impacts are obvious and inherent in the popular understanding of certain
severe human rights violations, such as torture, imprisonment under inhumane conditions, summary execution, and disappearances. . . .
However, health impacts of rights violations go beyond these issues in at least
two ways. First, the duration and extent of health impacts resulting from severe
abuses of rights and dignity [such as torture] remain generally underappreciated. [In
addition, torture broadly influences mental and social well-being; it] is often used as
a political tool to discourage people from meaningful participation in or resistance
to government.
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262 The Law and the Publics Health
Second, and beyond these serious problems, it is increasingly evident that violations of many more, if not all, human rights have negative effects on health. For
example, the right to information may be violated when cigarettes are marketed
without . . . information regarding the harmful health effects of tobacco smoking [or
when governments withhold] valid scientific health information about contraception
or measures (e.g., condoms) to prevent infection with a fatal virus (HIV). . . .
A related, yet even more complex problem involves the potential health impact
associated with violating individual and collective dignity. The UDHR considers dignity, along with rights, to be inherent, inalienable, and universal. While important
dignity-related health impacts may include such problems as the poor health status
of many indigenous peoples, a coherent vocabulary and framework to characterize dignity and different forms of dignity violations are lacking. A taxonomy and an
epidemiology of violations of dignity may uncover an enormous field of previously
suspected, yet thus far unnamed and therefore undocumented damage to physical,
mental, and social well-being.
Assessment of rights violations health impacts is in its infancy. Progress will
require: a more sophisticated capacity to document and assess rights violations;
[and] the application of medical, social science, and public health methodologies to
identify and assess effects on physical, mental, and social well-being. . . .
The Third Relationship: Health and Human Rights
Exploring an Inextricable Linkage
The proposal that promoting and protecting human rights is inextricably linked to
the challenge of promoting and protecting health derives in part from recognition
that health and human rights are complementary approaches to the central problem
of defining and advancing human well-being. This fundamental connection leads
beyond the single, albeit broad mention of health in the UDHR (art. 25) and the
specific health-related responsibilities of states listed in Article 12 of the ICESC R. . . .
Modern concepts of health recognize that underlying conditions establish the
foundation for realizing physical, mental, and social well-being. Given the importance of these conditions, it is remarkable how little priority has been given within
health research to their precise identification and understanding of their modes of
action, relative importance, and possible interactions.
The most widely accepted analysis focuses on socioeconomic status; the positive
relationship between higher socioeconomic status and better health status is well
documented. Yet this analysis has . . . important limitations [in that it does not fully
explain some persistent health disparities].
A second problem lies in the definition of poverty and its relationship to health
status. Clearly, poverty may have different health meanings; for example, distinctions between the health-related meaning of absolute poverty and relative poverty
have been proposed.
A third, practical difficulty is that the socioeconomic paradigm creates an overwhelming challenge with which health workers are neither trained nor equipped to
deal. Therefore, the identification of socioeconomic status as the essential conditions for good health paradoxically may encourage complacency, apathy, and even
policy and programmatic paralysis. . . .
Experience with the global epidemic of HIV/AIDS suggests a further analytic
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Global Health Law 263
approach, using a rights analysis. For example, married, monogamous women in
East Africa have been documented to be infected with HIV. Although these women
know about HIV and condoms are accessible in the marketplace, their risk factor is
their inability to control their husbands sexual behavior or to refuse unprotected or
unwanted sexual intercourse. Refusal may result in physical harm, or in divorce, the
equivalent of social and economic death for the woman. Therefore, womens vulnerability to HIV is now recognized to be integrally connected with discrimination and
unequal rights, involving property, marriage, divorce, and inheritance. The success
of condom promotion for HIV prevention in this population is inherently limited in the
absence of legal and societal changes which, by promoting and protecting womens
rights, would strengthen their ability to negotiate sexual practice and protect themselves from HIV infection.
More broadly, the evolving HIV/AIDS pandemic has shown a consistent pattern
through which discrimination, marginalization, stigmatization, and, more generally,
a lack of respect for the human rights and dignity of individuals and groups heighten
their vulnerability to becoming exposed to HIV. In this regard, HIV/AIDS may be illustrative of a more general phenomenon in which individual and population vulnerability to disease, disability, and premature death is linked to the status of respect
for human rights and dignity. . . .
. . . The concept of an inextricable relationship between health and human rights
also has enormous potential practical consequences. For example, health professionals could consider using the International Bill of Human Rights as a coherent
guide for assessing health status of individuals or populations; the extent to which
human rights are realized may represent a better and more comprehensive index of
well-being than traditional health status indicators. . . .
From the perspective of human rights, health experts and expertise may contribute usefully to societal recognition of the benefits and costs associated with realizing, or failing to respect, human rights and dignity. . . . Collaboration with health
experts can help give voice to the pervasive and serious impact on health associated
with lack of respect for rights and dignity. In addition, the right to health can be
developed and made meaningful only through dialogue between health and human
rights disciplines. Finally, the importance of health as a precondition for the capacity
to realize and enjoy human rights and dignity must be appreciated. . . . People who
are healthy may be best equipped to participate fully and benefit optimally from the
protections and opportunities inherent in the International Bill of Human Rights.
The Right to the Highest Attainable Standard of Health*
United Nations Committee on Economic, Social, and Cultural Rights
Health is a fundamental human right indispensable for the exercise of other human
rights. . . . The right to health is closely related to and dependent upon the realization of other human rights . . . including the rights to food, housing, work, education,
human dignity, life, non-discrimination, equality, the prohibition against torture,
*Reprinted from General Comment 14, CESCR, E/C.12/2000/4 (Nov. 8, 2000).
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264 The Law and the Publics Health
privacy, access to information, and the freedoms of association, assembly and
movement. . . .
The right to health is not to be understood as a right to be healthy. The right to
health contains both freedoms and entitlements. The freedoms include the right
to control ones health and body, including sexual and reproductive freedom, and
the right to be free from interference, such as the right to be free from torture,
non-consensual medical treatment and experimentation. By contrast, the entitlements include the right to a system of health protection which provides equality of
opportunity for people to enjoy the highest attainable level of health.
The notion of the highest attainable standard of health . . . takes into account
both the individuals biological and socio-economic preconditions and a States
available resources. . . . The right to health must be understood as a right to the
enjoyment of a variety of facilities, goods, services and conditions necessary for the
realization of the highest attainable standard of health. . . .
The Committee interprets the right to health . . . as an inclusive right extending
not only to timely and appropriate health care but also to the underlying determinants of health, such as access to safe and potable water and adequate sanitation,
an adequate supply of safe food, nutrition and housing, healthy occupational and
environmental conditions, and access to health-related education and information,
including on sexual and reproductive health. . . .
Photo 16. A Kenyan mother and child sit on the edge of a bed covered with
a bed net. Insecticide-treated bed nets are frequently distributed in countries
where malaria is endemic. In Kenya, as many as half of all outpatient visits are
related to malaria. In some areas, each resident may receive between 150 and
300 infective mosquito bites per year. Bed nets, when used consistently and
correctly, are an effective way of preventing nighttime bites. Reproduced by
permission, Wendy Stone/Corbis, 2004.
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Global Health Law 265
The right to health . . . contains the following interrelated and essential elements . . . :
Availability
Functioning public health and health-care facilities, goods and services, as well as
programmes, have to be available in sufficient quantity within the State party. The
precise nature of the facilities, goods and services will vary, [but they include] the
underlying determinants of health, such as safe and potable drinking water and
adequate sanitation facilities, hospitals, clinics and other health-related buildings,
trained medical and professional personnel receiving domestically competitive salaries, and essential drugs. . . .
Accessibility
Health facilities, goods and services have to be accessible to everyone without discrimination, within the jurisdiction of the State party. Accessibility has four overlapping dimensions: [(1) non-discriminationhealth facilities, goods and services
must be accessible to all without discrimination on any of the prohibited grounds;
(2) physical accessibilitythey must be within safe physical reach for all sections of
the population; (3) economic accessibilitythey must be affordable to all; and (4)
information accessibilitypeople should have the right to seek, receive, and impart
information and ideas concerning health issues, while retaining the right to have
personal health data treated with confidentiality].
Acceptability
All health facilities, goods and services must be respectful of medical ethics and
culturally appropriate . . . , as well as being designed to respect confidentiality and
improve the health status of those concerned.
Quality . . .
Health facilities, goods and services must also be scientifically and medically appropriate and of good quality. This requires, inter alia, skilled medical personnel, scientifically approved and unexpired drugs and hospital equipment, safe and potable
water, and adequate sanitation.
Non-discrimination and Equal Treatment
. . . The Covenant proscribes any discrimination in access to health care and underlying determinants of health, as well as to means and entitlements for their procurement, on the grounds of race, colour, sex, language, religion, political or other
opinion, national or social origin, property, birth, physical or mental disability, health
status (including HIV/AIDS), sexual orientation and civil, political, social or other
status. . . . States have a special obligation to provide those who do not have sufficient means with the necessary health insurance and health-care facilities, and to
prevent any discrimination on internationally prohibited grounds in the provision of
health care and health services. . . .
Limitations
Issues of public health are sometimes used by States as grounds for limiting the
exercise of other fundamental rights. . . . Such restrictions must be in accordance
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266 The Law and the Publics Health
with the law, including international human rights standards, compatible with the
nature of the rights protected by the Covenant, in the interest of legitimate aims
pursued, and strictly necessary for the promotion of the general welfare in a democratic society. . . . Limitations must be proportional, i.e. the least restrictive alternative must be adopted where several types of limitations are available. Even where
such limitations on grounds of protecting public health are basically permitted, they
should be of limited duration and subject to review.
Legal Obligations
While the Covenant provides for progressive realization and acknowledges the constraints due to the limits of available resources, it also imposes on States parties
various obligations which are of immediate effect. States parties have immediate
obligations in relation to the right to health, such as the guarantee that the right
will be exercised without discrimination of any kind and the obligation to take [deliberate, concrete, and targeted] steps towards the full realization . . . of the right to
health. . . .
. . . There is a strong presumption that retrogressive measures taken in relation
to the right to health are not permissible. If any deliberately retrogressive measures
are taken, the State party has the burden of proving that they have been introduced
after the most careful consideration of all alternatives and that they are duly justified by reference to the totality of the rights provided for in the Covenant in the
context of the full use of the State partys maximum available resources.
The right to health, like all human rights, imposes three types or levels of obligations on States parties: the obligations to respect, protect and fulfil. In turn, the
obligation to fulfil contains obligations to facilitate, provide and promote. The obligation to respect requires States to refrain from interfering directly or indirectly
with the enjoyment of the right to health. The obligation to protect requires States
to take measures that prevent third parties from interfering with article 12 guarantees. Finally, the obligation to fulfil requires States to adopt appropriate legislative,
administrative, budgetary, judicial, promotional and other measures towards the full
realization of the right to health.
International Obligations
States parties have to respect the enjoyment of the right to health in other countries,
and to prevent third parties from violating the right in other countries. . . . Depending
on the availability of resources, States should facilitate access to essential health
facilities, goods and services in other countries, wherever possible and provide the
necessary aid when required. States parties should ensure that the right to health is
given due attention in international agreements and . . . ensure that their actions as
members of international organizations take due account of the right to health. . . .
Violations
In determining which actions or omissions amount to a violation of the right to
health, it is important to distinguish the inability from the unwillingness of a State
party to comply with its obligations. . . .
Violations of the right to health can occur through the direct action of States
or other entities insufficiently regulated by States. The adoption of any retrogresPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Global Health Law 267
sive measures incompatible with the core obligations . . . constitutes a violation of
the right to health. Violations through acts of commission include the formal repeal
or suspension of legislation necessary for the continued enjoyment of the right to
health or the adoption of legislation or policies which are manifestly incompatible
with pre-existing domestic or international legal obligations in relation to the right
to health.
Violations of the right to health can also occur through . . . acts of omission,
[which] include the failure to take appropriate steps towards the full realization of
everyones right to [health], the failure to have a national policy on occupational
safety and health as well as occupational health services, and the failure to enforce
relevant laws. [If resource constraints render it impossible for a State to comply
fully with its Covenant obligations, it has the burden of showing that every effort
has nevertheless been made to use all available resources at its disposal in order to
satisfy, as a matter of priority, these obligations.]
Violations of the Obligation to Respect
Violations of the obligation to respect are those State actions, policies or laws that
contravene the standards set out in article 12 of the Covenant and are likely to result
in bodily harm, unnecessary morbidity and preventable mortality. [Examples include
denying groups access to health facilities, goods, and services through de jure or de
facto discrimination and deliberately withholding information vital to health protection or treatment.]
Violations of the Obligation to Protect
Violations of the obligation to protect follow from the failure of a State to take all
necessary measures to safeguard persons within their jurisdiction from infringements of the right to health by third parties. [Examples include failures to protect
consumers and workers from unhealthy goods and practices; to discourage the production, marketing, and consumption of tobacco; to protect women against violence
or prosecute perpetrators; and to enforce environmental laws.]
Violations of the Obligation to Fulfil
Violations of the obligation to fulfil occur through the failure of States parties to
take all necessary steps to ensure the realization of the right to health. [Examples
include failures to adopt an appropriate national health policy, to provide sufficient
public resources for securing the right to health, to monitor realization of the right
to health by identifying indicators and benchmarks, and to take measures to reduce
inequitable distribution of health facilities, goods, and services.]
IV. World Trade and World Health
The very idea of international trade is politically contentious. From a
nationalist or populist perspective, trade is responsible for social ills,
such as domestic unemployment (outsourcing); unfair/unsafe labor
practices abroad (child labor); tainted food, drugs, and consumer
goods (unregulated foreign markets); international health care worker
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268 The Law and the Publics Health
migration (brain drain from developing to developed countries); and
exorbitant prices for essential medicines (access to antiretroviral drugs
for the worlds poor). From a free market perspective, trade brings
innovations in science, increased employment, and greater wealth to
all trading partners.
The truth probably lies somewhere between these two extremes.
Certainly, to the extent that trade has expanded economies, it has done
so primarily in already wealthy countries and has had less benefit, if
any, in low-income countries. It has also made it more difficult for
the worlds poor to gain access to essential medicines, because large
corporations rely on laws protecting intellectual property rights to keep
prices high. Nonetheless, trade has the potential to improve health and
human well-being. As the WHO and the World Trade Organization
(WTO) Secretariats 2002 joint report on trade law and public health
notes, there is a positive link between freer trade and economic
growth, which can lead to reduced poverty and higher standards of
living, including better health (23).
Whether and how trades potential to positively affect global health
can be harnessed depends in part on the structure and rules of the
international trade system. Since it was created at the conclusion of the
Uruguay Round of Multilateral Trade Negotiations in 1995, the World
Trade Organization has taken its place at the center of our international
trade system. The WTO consists of 151 member states. Each WTO
member state is bound by treaties governing trade in goods (the most
important being the General Agreement on Tariffs and Trade [GATT]
and the Agreement on Sanitary and Phytosanitary Measures [SPS]),
trade in services (the General Agreement on Trade in Services [GATS]),
and intellectual property protections (the Agreement on Trade-Related
Aspects of Intellectual Property Rights [TRIPS]).
The highest governing body of the WTO is the Ministerial Council,
which is composed of high-level representatives from each member
state. Although the Ministerial Council meets infrequentlytypically
every two yearsit plays a key role in developing WTO trade policy.
For example, the 2001 Ministerial Conference in Doha, Qatar, which
called for flexibilities in access to essential medicines for the poor,
has provided health and human rights advocates with a valuable tool
for improving global access to HIV/AIDS treatments. Lower-level
representatives of WTO states parties also participate in WTO governance through the General Council and specialized councils. The most
notable aspect of the WTOs structure is its well-developed and bindPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Global Health Law 269
ing dispute settlement system. The dispute settlement process begins
with a consultation period, which focuses on negotiation, and then
proceeds to a kind of trial before panels of trade experts. A panel decision can be appealed to the Appellate Body, a standing body of seven
members. Unless WTO member states unanimously vote to overturn it,
the decision of the Appellate Body is final and binding.
A cursory examination of the WTOs record on health reveals a
troubling trend. When health issues have come before the WTOs dispute settlement organs, countries defending their health-related policies
have repeatedly lost. From the 1990 Thailand cigarettes case, which
found Thailands import ban on cigarettes to be unnecessarily restrictive on trade, to the 2007 Brazil tires case (discussed further below),
which found Brazils health-based import ban on tires to have been
applied in a way that constituted arbitrary or unjustified discrimination between countries, the resolution of trade disputes appears to have
largely favored free trade over health interests.
This story of trade and health is incomplete, however. In the following article, M. Gregg Bloche and Elizabeth R. Jungman contend
that a closer examination of WTO rules and jurisprudence reveals that
the WTO in fact treats health as an interpretive principle and accords
heightened deference to national health policies.
Health Policy and the WTO*
M. Gregg Bloche and Elizabeth R. Jungman
The WTO framers paid little heed to health policy. Over the past several years,
however, politics and the AIDS pandemic have pushed health to center stage as a
trade issue. The WTO has responded with heightened deference to national authority
when member states health polices conflict with other values protected by trade
agreements.
On their face, the principal WTO agreements bearing on health are frustratingly
vague in their approach to the task of balancing protection for health against other
trade-related concerns. [For example, the TRIPS agreement] contains language that
might be read to allow poor countries to elide patents on lifesaving medicines. But
TRIPS says little about the prerequisites or procedures for invoking its ambiguous
exceptions to patent protection.
Despite this absence of clear direction, the WTO system . . . has come to treat
protection for health as a de facto interpretive principle when disputes arise over
the meaning of trade agreements. To be sure, such a principle is nowhere stated in
*Reprinted from Journal of Law, Medicine & Ethics 31 (2003): 52945. (Blackwell
Publishing).
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270 The Law and the Publics Health
WTO associated treaties, declarations, or jurisprudence; nor is health even mentioned as a purpose in the preambles to the major WTO agreements. Yet the special
weight accorded to health in WTO decision-making is evident across a broad range
of trade issues. . . .
Health and the Law of the GATT
. . . Article XX(b) of the GATT. . . allows member states to take actions that restrict
trade and that are otherwise proscribed by the GATT if they are necessary to
protect human . . . life or health. Read in conjunction with the WTO standard for
reviewing such actionsthe requirement that dispute settlement panels make an
objective assessment of relevant facts and lawthis provision appears to permit
close scrutiny, by panels and the Appellate Body, of claims of health necessity made
to support trade restrictions.
Outside the health context, the Appellate Body has invoked the objective
assessment standard to support robust scrutiny of member states trade remedies
and restraints. . . .
In sharp contrast, the Appellate Body has been highly deferential to member
states trade restrictions in the GATT Article XX(b) context. Although it has construed the objective assessment standard to require that restrictions purportedly
necessary to protect human . . . life or health be based on some scientific evidence
of health risk, it has held that such restrictions need not rest on majority scientific
opinion. In its 2001 decision upholding a French import ban on asbestos-containing
products, the Appellate Body stated that a member may rely, in good faith, on scientific sources which . . . may represent a divergent, but qualified and respected,
opinion (WTO 2001, para. 155). Some have seen this deference to member states
discretion in the face of scientific uncertainty as a step toward WTO adoption of
international environmental laws precautionary principle. Alternatively, this deference follows from treatment of protection for health as an interpretive principle,
calling for less onerous standards of proof and review for trade restraints when
health is at stake.
Indeed, [in its asbestos opinion, the Appellate Body] announced that WTO members have a right to determine the level of protection of health that they consider
appropriate in a given situation (WTO 2001, para. 168). Frances decision to reduce
the risk of new, asbestos-related health risks to zero by barring the manufacture,
domestic sale, and import of asbestos-containing products was within this right, the
tribunal held. [Allowing national regulators to set a zero-risk goal and to bar imports
accordingly constitutes exceptional deference to member states health policies.]
[The asbestos decision contrasts with the Thailand tobacco opiniona pre-WTO
decision on the requirement that a measure under Article XX(b) be necessary. In
that case, a GATT panel found that Thailands discriminatory taxes on imported cigarettes were proscribed because they failed to meet the necessity test. Thailand, supported by the WHO, argued that enabling foreign competition in the tobacco market
would overwhelm the governments antismoking message and boost the incidence
of smoking. The panel, however, found that nondiscriminatory taxes on both domestic and foreign cigarettes could achieve the health goals in a more GATT-friendly
fashion.]
Whatever the merits of this controversial, pre-WTO ruling, the Appellate Body
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Global Health Law 271
signaled in its asbestos opinion that member states now have wide latitude to
specify health policies that rule out less restrictive alternatives. In response to the
exporting countrys claim that France could stop the spread of asbestos-related
risks through a less restrictive policy of controlled use of asbestos-containing
construction materials, rather than resorting to an outright ban, the Appellate Body
said Frances chosen level of health protectionno asbestos-related riskprecluded any alternative to an outright ban. The countervailing health risks posed by
substitute, non-asbestos building materials were of no moment, from this perspective, since France had specified its health policy more narrowly, as the elimination
of asbestos related risks.
. . . The Asbestos opinions discussion of the Article XX(b) necessity test is striking for its emphasis on the high weight to be given to health, in comparison with other
goals. The more vital or important the ends at issue, the easier it [is] to accept
as necessary measures designed to achieve those ends. And health, the opinion
holds, is both vital and important in the highest degree (WTO 2001, para. 172).
Health Risks from Food: The SPS Agreement
In 1998, the Appellate Body ruled that the European Communities import ban on
beef from hormone-fed cattle violated the WTO agreement governing member
states food and agricultural safety regulations. Supporters and critics of this decision agree on its landmark importance as a statement of WTO law governing regulation of food safety. Activists opposed to giving cows growth-promoting hormones
condemned the ruling, as did many who worry about the ebb of national authority
over food safety more generally. . . .
The EC lost the hormones case on narrow grounds. Applying language in the
relevant WTO treaty, the SPS Agreement, requiring regulators to act based on
a risk assessment, the Appellate Body found that the EC failed to conduct a risk
assessment to evaluate its claim that poor control over hormone doses given to
animals gives rise to health hazards for humans. Had the EC done such a risk assessment and found dangers of this kind, it could have counted the risk of poor control
over hormone administration, the Appellate Body said. This risk, by itself, could have
justified the ECs import ban.
Other language in the hormones opinion strongly supports member states discretion to regulate food and agriculture related health risks. . . . The Appellate Body
rejected the proposition that the SPS risk assessment provision requires a showing
of a threshold level of risk to justify trade-restricting regulation. The Appellate Body
also held that risk assessment can count concerns not reducible to quantitative
analysis by laboratory methods. This allows national regulators to weigh subjective factors that influence both the perception and reality of risk. Beyond this, the
Appellate Body read the precautionary principle into the SPS provision authorizing countries to regulate where relevant scientific evidence is insufficient. . . .
In addition, the opinion states that regulators need not show they in fact took into
account the risk assessment data and conclusions presented to a WTO panel. This
enables member states to present state-of-the-art scientific data when defending
their regulations in dispute resolution proceedings, and it eases the administrative
(and financial) burden on governments concerned about crafting regulations to survive WTO scrutiny.
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272 The Law and the Publics Health
Moreover, the opinion treated the SPS mandate that regulation be based on a
risk assessment as requiring only a rational relationship between the regulatory
measure and the risk assessment. . . . The Appellate Body allowed for the possibility
of divergent scientific opinion from qualified and respected sources. Such opinion [properly supported] could suffice to establish the requisite rational relationship between a risk assessment and a regulation. . . .
To sum up, [the] hormones decision requires that there be some empirical substance to claims of health risk if they are to pass muster in the dispute settlement
process: subjective perceptions and popular fears are not by themselves enough.
But once this low empirical barrier is crossed, emerging SPS jurisprudence protects
health to a remarkable degree, through a policy of exceptional deference to member
states assessments of and responses to health risk.
Intellectual Property and Lifesaving Medicines
Nowhere have perceptions of conflict between the WTO system and protection for
health been as strong as in the area of trade in lifesaving medications. The AIDS
pandemic in sub-Saharan Africa has made WTO treatment of drug companies intellectual property rights into one of the most visible and poignant international issues
of our time. . . .
. . . It is widely held that the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) makes it more difficult for generic drug makers and grey
market importers to undercut patent protected prices [for medicines] by exploiting
permissive intellectual property law in poor countries. . . .
The Appellate Body has not yet opined on member states flexibility, under
TRIPS, to issue compulsory licenses, permit parallel importing, or import generic
drugs manufactured elsewhere. Conflict over these issues has played out within the
WTOs political organs. To a remarkable degree, this political process has responded
to the desperate medical needs of sub-Saharan Africa and other impoverished
regions. In the face of opposition from the pharmaceutical industry and industrialized nations, the WTOs highest governing body, the Ministerial Conference, issued a
pronouncement in November 2001 declaring that members have a right to protect
public health, . . . to promote access to medicines for all, and to use, to the full,
the provisions in the TRIPS Agreement, which provide flexibility for this purpose.
This ministerial pronouncement, generally referred to as the Doha Declaration,
cleared a path for parallel importingacquisition of patent-protected drugs at lower
prices through arbitrageby construing TRIPS to allow members to make their own
rules for exhaustion of patent rights. It also construed the rather convoluted TRIPS
provision on compulsory licensing, or use without authorization of the right holder,
to grant countries several, overlapping right[s] [allowing countries greater latitude to use patented products in public health crises]. The Doha Declarations use of
rights language to construe the TRIPS provision on compulsory licensing contrasts
with the provision itself, which is framed as a list of constraints on members authority to issue compulsory licenses. . . .
[To be effective in facilitating access to essential medications, compulsory licensing rules must allow countries to export generic versions of patent-protected drugs
to countries that lack generic pharmaceutical industries. The Doha Declaration
instructed the TRIPS governing body to find an expeditious solution to this probPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Global Health Law 273
lem. The resulting 2003 implementation agreement] authorizes individual member
states to decide which health problems merit compulsory licenses for export. Critics
have expressed concern that the agreements safeguards against illicit diversion of
drugs . . . could slow poor countries efforts to make legitimate use of its provisions
to save lives. . . .
[Nonetheless, the] Doha Declaration and implementation agreement . . . reduced
the TRIPS threat to member states health promotion efforts by construing ambiguous treaty terms in health-friendly fashion. There will be debate over Dohas legal
authority, its implications for particular manufacturing and importing scenarios, and
whether it should be seen as changing or merely clarifying WTO members legal obligations. But the Declarations broad affirmation of members right to protect public
health and to use, to the full, the TRIPS Agreements flexibility for this purpose
is consonant with the larger picture we have sketched in this article, of an emerging
WTO norm that treats health as reason for special deference to national authority.
Conclusion: Health as an Interpretive Principle
. . . There is a case to be made for an interpretive principle of protection for health
that takes the form of heightened deference to member states health policies
instead of an affirmative transnational duty.
This case rests on the intensely subjective, highly variable nature of peoples
beliefs about [risks, which] are shaped by our character styles, values and culture,
and personal and social experience. These influences tend to be local phenomena. . . .
Health policies that fail to take account of these influences risk breaking too sharply
with peoples subjective needs. And public decision-making mechanisms that fail
to offer opportunities for community control, or at least engagement, tend to raise
peoples anxieties about the risk-benefit judgments reached. Thus health politics
is peculiarly local. . . . National, let alone transnational, efforts to systematize and
rationalize health policies encounter skepticism and resistance. . . .
One might object that parochial resistance to these rationalizing efforts should
not be treated as a challenge to their legitimacy, since these efforts are our best
chance to maximize the welfare of the whole. But the more removed these efforts
are from democratic oversight, the more tenuous are their claims to political legitimacy in both theory and practice. . . . WTO deference to national health policy is
responsive to this challenge. It serves as a steam valve for domestic anxieties about
globalization while incorporating protection for health as an interpretive principle.
Protection of health as an interpretive principle, rather than an internationally
justiciable right, allows room for national variations in resource availability, perceptions of risk, and balancing between health and other goals. . . .
No WTO organ has explicitly embraced the premise of an international human
right to health. For some proponents of such a right, this has been disheartening. Yet
the WTOs tacit endorsement of protection for health as an interpretive principle,
effected through heightened deference to national health policies, has done as much
to establish health as a value in international law as have actions by international
bodies more directly focused on health. Indeed, the WTO has arguably done more. Its
judicial and ministerial pronouncements have created state practice, through both
their legal force and member countries compliance with them. The WTO has thereby
become a prime mover of customary as well as treaty-based international health
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274 The Law and the Publics Health
law. It has recognized a soft, non-justiciable right to health in all but name. Member
states, NGOs, and others concerned about the place of health in transnational law
should press WTO institutions to make this recognition explicit.

A recent case decided by the WTOs Appellate Body illustrates both
the promise and the shortcomings of WTO jurisprudence on trade and
health. In 2006, the European Commission challenged Brazils ban on
the importation of retreaded tires, arguing that it was disguised trade
protectionism. Brazil, however, justified its import restrictions on the
grounds of environmental and human health, arguing that incinerating tires releases toxic gases and contaminates the soil, water, and
air. Mosquitoes also use the tires as breeding grounds, facilitating the
transmission of dengue fever, yellow fever, and malaria. In Brazil
Measures Affecting Imports of Retreaded Tyres, decided in December
2007, the Appellate Body deferred extensively to Brazil in analyzing
the underlying health matters; but in the end, it found the health-based
import ban to be an unjustified restriction on trade.
The Appellate Body recognized Brazils sovereign interest in determining whether the ban on retreaded tires was necessary for health reasons, hinting at its use of health as an interpretive principle. Consider
the following passage from its report (WTO 2007, 8283):
The issue of whether [Brazils] Import Ban [on retreaded tires] is necessary
within the meaning of Article XX(b) of the GATT 1994 . . . illustrates the
tensions that may exist between, on the one hand, international trade and,
on the other hand, public health and environmental concerns arising from
the handling of waste generated by a product at the end of its useful life.
In this respect, the fundamental principle is the right that WTO Members
have to determine the level of protection that they consider appropriate
in a given context. Another key element of the analysis of the necessity
of a measure under Article XX(b) is the contribution it brings to the
achievement of its objective. A contribution exists when there is a genuine
relationship of ends and means between the objective pursued and the
measure at issue. To be characterized as necessary, a measure does not
have to be indispensable. However, its contribution to the achievement
of the objective must be material, not merely marginal or insignificant,
especially if the measure at issue is as trade restrictive as an import ban.
Thus, the contribution of the measure has to be weighed against its trade
restrictiveness, taking into account the importance of the interests or the
values underlying the objective pursued by it. As a key component of a
comprehensive policy aimed to reduce the risks arising from the accumulation of waste tyres, the Import Ban produces such a material contribuPublic Health Law and Ethics : A Reader, edited by Lawrence O. Gostin, University of California Press, 2010. ProQuest Ebook
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Global Health Law 275
tion to the realization of its objective. [We] consider that this attribution
is sufficient to conclude that the Import Ban is necessary, in the absence of
reasonably available alternatives. . . .
Accordingly, we uphold the Panels finding that the Import Ban can be
considered necessary to protect human, animal or plant life or health.
While the Appellate Bodys analysis of Brazils import ban significantly
favors the value of health regulations, the ultimate resolution of the
case was not in Brazils favor. The Appellate Body found that because
Brazil, in practice, allowed retreaded tires to be imported from other
countries and permitted some used tires to be imported for retreading
in Brazil, the operation of the import ban actually served to favor trade
from certain countries over others and to favor the domestic retreaded
tire industry. Therefore the health regulation was, in practice, arbitrarily and unjustifiably discriminating between countries and serving
to protect domestic industry from international competition.
Interestingly, the Appellate Bodys decision does not prohibit Brazils
import ban. Rather, Brazil can comply with the ruling either by abandoning the import ban or by expanding the ban to operate without
exceptions, making it function with more coherence and with a stronger basis in science. Such a development would both improve health
and abandon needless favoritism in trade. As the prominent trade law
scholars Michael J. Trebilcock and Robert Howse (2005) note, health
and environmental concerns are often used as justifications for trade
policies that are in fact optimized more to enhance protectionism than
to improve health or the environment. Ensuring that health regulations
are informed more by science than by protectionist impulses not only
would guarantee that the resulting regulations are consistent with the
WTO system but would also generate better health outcomes. Such an
ideal outcome, however, assumes that we live in a world where policy
decisions can be made without the distorting influence of economic
protectionism. In reality, the WTOs rules may make adopting and
implementing health regulations more difficult; without protectionist
incentives to sweeten the deal, it may not be possible to mobilize the
political will required to address certain health problems.
V. The Future of Global Health Governance
This chapter defined the term global health law and discussed the
forces of globalization that present health hazards throughout the
world. The readings explained the need for an architecture of global
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276 The Law and the Publics Health
health, examining the strengths and weaknesses of existing international law. The chapter concludes here with a proposal for an innovative
mechanism for global health governancethe Framework Convention
on Global Health.
Meeting the Survival Needs of the Worlds Least Healthy
People: A Proposed Model for Global Health Governance*
Lawrence O. Gostin
International health assistance is provided in an ineffective way that does not
enhance the capability for human functioning. Most funding is driven by emotional,
high-visibility events, including large-scale natural disasters such as the Asian
tsunami; diseases that capture the publics imagination such as the human immunodeficiency virus and AIDS; or diseases with the potential for rapid global transmission such as hemorrhagic fever, severe acute respiratory syndrome, or pandemic
influenza. These funding streams skew priorities and divert resources from building
stable local systems to meet everyday health needs. . . .
Basic Survival Needs
What is truly needed, and what richer countries instinctively (although not always
adequately) do for their own citizens, is to meet what can be called basic survival
needs. Basic survival needs include sanitation and sewage, pest control, clean
air and water, diet and nutrition, tobacco reduction, essential medicines and vaccines, and well-functioning health systems. Survival needs are laid out in the United
Nations Millennium Development Goals, which call for major improvements in
maternal and child health, and the prevention of AIDS, malaria, and other diseases.
Meeting everyday survival needs may lack the glamour of high-technology medicine
or dramatic rescue, but what they lack in excitement they gain in their potential
impact on health, precisely because they deal with the major causes of common
disease and disability across the globe. Mobilizing the public and private sectors to
meet basic survival needs, comparable to a Marshall Plan, could radically transform
prospects for improving health among the worlds poorest populations.
. . . Vast human benefits would accrue from highly cost-effective interventions.
For instance, vaccine-preventable diseases are virtually extinct in developed countries but still account for millions of deaths annually in poorer regions. Basic sanitation and water systems would vastly improve global health at minimal cost, such as
clean water kits costing as little as $3. An insecticide-treated bed net, which costs
roughly $5, is highly effective in reducing malaria, river blindness, elephantiasis,
and other insectborne diseases among children. But only about 1 in 7 children in
Africa sleep under a bed net, and only 3% of children in sub-Saharan Africa use a net
impregnated with insecticide.
The single most important way to ensure basic survival is to build enduring
*Reprinted from JAMA 298 (2007): 22528. Copyright 2007 American Medical
Association. All rights reserved.
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Global Health Law 277
health systems in all countries. Health systems include public health agencies with
the capacity to identify, prevent, and ameliorate health risks in the populationdisease surveillance, laboratories, data systems, and a competent workforce. They also
include primary health care, bringing basic medical services (eg, maternal and child
health, family planning, and medical treatment) as close as possible to where people
live and work. Primary care promotes individual and community self-reliance and
participation in the planning, organization, operation, and control of health services,
making fullest use of local and national resources. What poor countries need is to
gain the capacity to provide essential health services.
Proposal for a Fram ework Convention on Global Health
If meeting basic survival needs can truly make a difference for the worlds population, and if this solution is preferable to other paths, can international law structure
legal obligations accordingly? Extant health governance has been lamentably deficient, and a fresh approach is badly needed.
The World Health Organization [WHO] Constitution grants the agency formidable
powers, but its potential has never been realized. In 60 years of existence, WHO
has enacted only 1 significant regulation (the IHR) and 1 treaty (the FCTC ). There
is, however, a much larger body of international law that powerfully affects global
health in areas ranging from food safety, arms control, and the environment to trade
and human rights. The WHO should be a leader in creating, or at least influencing,
this body of international law, but that has not happened. The agency has shied
away from rulemaking because it has seen itself principally as a scientific, technical
agency.
As a result, social activists increasingly have turned to the language of human
rights to articulate their aspirations for global health. But recasting the problem of
extremely poor health as a human rights violation does not help. The legal obligation to protect the publics health falls primarily on each state (ie, nation-state), but
poor countries lack the capacity to do so. Although the International Covenant on
Economic, Social, and Cultural Rights posits that all states have duties to cooperate,
there are no specific requirements for assisting other countries.
If law is to play a constructive role, new models will be required. One model would
be a Framework Convention on Global Health (FCGH). An FCGH is a global health
governance scheme that incorporates a bottom-up strategy that strives to do the
following: build capacity, so that all countries have enduring and effective health
systems; set priorities, so that international assistance is directed to meeting basic
survival needs; engage stakeholders, so that a wide variety of state and nonstate
participants can contribute their resources and expertise; coordinate activities, so
that programs among the proliferating number of participants operating around the
world are harmonized; and evaluate and monitor progress, to ensure that goals are
met and promises kept.
The framework convention-protocol approach refers to a process of incremental regime development. In the initial stage, participating states would negotiate
and agree to the framework instrument, which would establish broad principles for
global health governance. In subsequent stages, specific protocols would be developed to achieve the objectives set forth in the original framework. These protocols,
organized by key components of the global health strategy, would create more
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278 The Law and the Publics Health
detailed legal norms, structures, and processes. The framework convention-protocol
approach has considerable flexibility, allowing participating states to decide the
level of specificity that is politically feasible now, saving more complex or contentious issues to be built in later protocols.
The framework convention-protocol approach is becoming an essential strategy
of powerful transnational social movements to safeguard health and the environment. [Models for global health governance include the Framework Convention on
Tobacco Control as well as environmental treaties like the United Nations Framework
Convention on Climate Change.]
An FCGH would represent a historical shift in global health, with broadly imagined global governance. The initial framework would establish the key modalities,
with a strategy for subsequent protocols on each of the most important governance
parameters. . . .
The framework convention-protocol approach has a number of advantages. The
incremental nature of the governance strategy allows the international community
to focus on a problem in a stepwise manner, avoiding potential political bottlenecks
over contentious elements. The process of creating international norms and institutions also provides an ongoing and structured forum for states and stakeholders to
develop a shared humanitarian instinct on global health. A high-profile forum for
normative discussion can help educate and persuade participating states, and influence public opinion, in favor of decisive action. And it can create internal pressure
for governments and others to actively participate in the framework dialogue. The
creation of such a normative community, therefore, may be an essential element
of building an international consensus. The imperatives of global health cannot be
framed just as a series of isolated problems in far-off places, but rather as a common
concern of humankind.
This approach, however, will not be a panacea and cannot easily circumvent many
of the seemingly intractable problems of global health governance including the
domination of economically and politically powerful countries; the deep resistance
to creating obligations to expend, or transfer, wealth; the lack of trust in international legal regimes; and the vocal concerns about the integrity and competency of
governments in many of the poorest regions.
But given the dismal nature of extant global health governance, an FCGH is a
risk worth taking. It will, at a minimum, identify the genuinely important problems in
global health: targeting the major determinants of health, prioritizing and coordinating currently fragmented activities, and engaging a broad range of stakeholders.
It also will provide a needed forum to raise visibility for one of the most pressing
problems facing humankind.
Fair Terms of International Cooperation on Global Health
[A collective international effort is needed to tackle the complex problems of global
health.] If all states and stakeholders voluntarily accepted fair terms of cooperation
through an FCGH, then [they] could dramatically improve life prospects for millions
of people. But it would do more than that. Cooperative action for global health,
like action to address global warming, benefits everyone by diminishing collective
vulnerabilities.
The alternative to fair terms of cooperation through an FCGH is that everyone
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Global Health Law 279
would be worse off, particularly those who have compounding disadvantages. Absent
a binding commitment to help, rich states might find it politically or economically
easier to withhold their fair share of global health assistance, hoping that others
will take up the slack. Major outbreaks of infectious disease, including extensively
drug-resistant forms, would become increasingly more likely. . . .
If the global community does not accept fair terms of cooperation on global
health soon, there is every reason to believe that affluent states, philanthropists,
and celebrities simply will move on to another cause. When they do, the vicious cycle
of poverty and endemic disease among the worlds least healthy people will continue
unabated. That is a consequence that no one should be willing to tolerate.
Recommended Reading
The Global Dimensions of Health
Cohen, Jon. 2006. The new world of global health. Science 311: 16267. (Discusses the wave of new global philanthropy and its drawbacks and
challenges)
Commission on Social Determinants of Health. 2008. Closing the Gap in a
Generation: Health Equity through Action on the Social Determinants of
Health. Geneva: World Health Organization. (Final report of the Commission on Social Determinants of Health; states that the toxic combination of
bad policies, economics, and politics is, in large measure, responsible for the
fact that a majority of people in the world do not enjoy the good health that
is biologically possible)
Daar, Abdallah S., et al. 2007. Grand challenges in chronic non-communicable
diseases. Nature 450: 49496. (Identifies barriers to solving problems of
global non-communicable diseases)
Ezzati, Majid, et al. 2005. Rethinking the diseases of affluence paradigm:
Global patterns of nutritional risks in relation to economic development.
Public Library of Science Medicine 2: 40411. (Posits that cardiovascular
disease and other so-called diseases of affluence are likely to dramatically
affect the worlds poor as well)
Heinzerling, Lisa. 2008. Climate change, human health, and the post-precautionary principle. Georgetown Law Journal 96: 44560. (Suggests two
ways of reframing public discourse on climate change: to think of climate
change as a public health threat and to stop using the precautionary
principle).
Kaul, Inge, Isabelle Grunberg, and Marc A. Stern. 1999. Defining global public
goods. Global Public Goods, 220. Oxford: Oxford Scholarship Online
Monographs. (Provides a useful typology of global public goods)
Magnusson, Roger S. 2007. Non-communicable diseases and global health
governance: Enhancing global processes to improve health development.
Globalization & Health 3 (2). (Examines the impact of WHO, World Bank,
and UN policies on the development of a global framework for addressing
non-communicable diseases)
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280 The Law and the Publics Health
Taylor, Allyn L. 2004. Governing the globalization of public health. Journal of
Law, Medicine & Ethics 32: 500508. (Explains how globalization has created the need for a global health infrastructure)
World Health Organization. 2003. World Health Report. Geneva: World
Health Organization. (Reports on challenges to increasing health investment and on global health challenges and solutions)
Yach, Derek, Corinna Hawkes, C. Linn Gould, and Karen J. Hofman. 2004.
The global burden of chronic diseases: Overcoming impediments to prevention and control. JAMA 291: 261622. (Discusses potential policy solutions
for improving the global response to chronic diseases)
International Public Health Law
Fidler, David P. 2004. SARS: Governance and the Globalization of Disease.
New York: Palgrave Macmillan. (Recounts the outbreak, explains the implications for global health governance, and makes recommendations for dealing with new infectious diseases such as SARS )
Gostin, Lawrence O., and Allyn L. Taylor. 2008. Global health law: A definition and grand challenges. Public Health Ethics 1 (1): 5363. (Proposes a
definition of global health law and a road map for its future)
Roemer, Ruth, Allyn Taylor, and Jean Lariviere. 2005. Origins of the WHO
Framework Convention on Tobacco Control. American Journal of Public
Health 95: 93638. (Outlines the history of the Framework Convention and
its adoption by the WHO)
Human Rights: Advancing Dignity, Justice, and Security in Health
Gruskin, Sofia, ed. 2005. Perspectives on Health and Human Rights. New
York: Routledge. (Contains readings and materials on health and human
rights)
Mann, Jonathan M. 1997. Medicine and public health, ethics, and human
rights. Hastings Center Report 27 (3): 613. (Discusses the relationship and
inextricable links between these disciplines)
World Trade and World Health
Sapsin, Jason W., Theresa M. Thompson, Lesley Stone, and Katherine E.
DeLand. 2003. International trade, law, and public health advocacy. Journal of Law, Medicine & Ethics 31: 54656. (Examines trades effect on
public health)
Trebilcock, Michael J., and Robert Howse. 2005. The Regulation of International Trade. 3d ed. New York: Routledge. (A textbook; provides analysis of
the rules and organizations that shape international trade)
United Nations Commission on Human Rights, Economic and Social Council.
2004. Economic, Social and Cultural Rights: The Right of Everyone to the
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Global Health Law 281
Highest Attainable Level of Physical and Mental Health. Report of the Special Rapporteur, Paul Hunt. Addendum: Mission to the World Trade Or –
ganization. UN Doc. E/CN.4/2004/49/Add.1. www.unhchr.ch/Huridocda/
Huridoca.nsf/e06a5300f90fa0238025668700518ca4/5860d7d863239d82c1
256e660056432a/$FILE/G0411390.pdf. (Provides an accessible introduction to technical issues that lie at the intersection of trade and the right to
health)
The Future of Global Health Governance
Gostin, Lawrence O. 2008. Meeting basic survival needs of the worlds least
healthy people: Toward a framework convention on global health. Georgetown Law Journal 96: 33192. (Provides a more detailed examination of
the core deficiencies in global health assistance and the proposal for the
Framework Convention on Global Health)
Hollis, Aidan, and Thomas Pogge. 2008. The Health Impact Fund: Making
New Medicines Accessible for All. www.yale.edu/macmillan/igh/hif_book
.pdf. (Discusses the current inequitable distribution of medicines; provides a
solution in the form of the Health Impact Fund)
Silberschmidt, Gaudenz, Don Matheson, and Ilona Kickbusch. 2008. Creating
a Committee C of the World Health Assembly. Lancet 371: 148386. (Proposes the creation of a Committee C within the World Health Assembly that
would serve as a forum for debate of major health initiatives by other key
players in the global health arena)
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Part Three
Public Health and
Civil Liberties in Conflict
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Photo 17. A young woman receives a free diabetes screening at a Texas community center. In much of the country, diabetes rates are alarmingly high.
The rising incidence of type II diabetes is linked to the increasing prevalence
of obesity. In 2005, New York Citys health commissioner, Thomas Frieden,
proposed a controversial diabetes surveillance program similar to those typically used for infectious diseases. Reproduced by permission, Marjorie
Kamys Cotera/Daemmrich Photography/The Image Works.
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285
To achieve collective benefits, public health officials systematically collect, store, use, and disseminate vast amounts of personal information,
commonly in electronic form. Public health officials monitor health
status to identify health problems, diagnose and investigate health
hazards, conduct research to understand health problems and find
innovative solutions, and disseminate information intended to inform,
educate, and empower people in matters related to their health. The
data that they collect provide the basic infrastructure necessary to
effect many of the common goods of community health. These data
are also often personally identifiable and sensitive. Data may reveal
information about a persons lifestyle (e.g., sexual orientation), health
status (e.g., mental illness, breast cancer, HIV), behaviors (e.g., unsafe
sex or needle sharing), and genetics (e.g., family health history).
Society faces hard choices in balancing individual interests in privacy and the collective benefits produced by public health data collection. This chapter explores that tension. The opening section describes
public health surveillance from historical and contemporary perspectives, focusing on salient illustrations of health monitoring for infectious diseases (e.g., HIV/AIDS ) and chronic diseases (e.g., diabetes).
Second, the chapter examines legal and ethical aspects of particular
public health practices, with deep historical roots in American public
health: the reporting of injuries and diseases to state health departments and partner notification. Third, the chapter explores the diffiEight
Surveillance and
Public Health Research
Privacy and the Right to Know
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286 Public Health and Civil Liberties in Conflict
cult, but highly important, distinctions between public health research
and practice. Finally, the chapter looks at the right to privacy, which
has gained recognition under the Constitution as well as under federal
and state statutes. This final section also presents a model public health
privacy statute that seeks to reconcile the collective benefits of surveillance with individual interests in privacy.
I. Surveillance: An Essential Public Health
Activity, Ethical and Rights-Based Concerns
The population faces numerous health threats, such as contaminated
food and water, emerging infections, bioterrorism, and chronic diseases caused by unhealthy lifestyles. Public health agencies cannot
avert these threats unless they have a system of early detection and
continuous health monitoring. In the absence of a strong public health
information infrastructure, communities remain vulnerable to diseases
and injuries, particularly those that are novel or not well understood.
Surveillance is a fundamental public health activity that yields essential
information about patterns of morbidity and mortality in populations.
It has also been the source of considerable ethical debate, generated by
concerns about pr