Public Health Law ppt

Public Health Law
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 Legislator’s 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
UNIVERSITY OF CALIFORNIA PRESS
Berkeley
.
Los Angeles
.
London
THE MILBANK MEMORIAL FUND
New York
Public Health Law
Power, Duty, Restraint
Revised and Expanded Second Edition
Lawrence O. Gostin
University of California Press, one of the most dis -
tinguished university presses in the United States,
enriches lives around the world by advancing scholar-
ship 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 Fund’s own publications, in reports

or books it publishes with other organizations, and in
articles it commissions for publication by other orga -
nizations, 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
©2008 by The Regents of the University of California
Library of Congress Cataloging-in-Publication Data
Gostin, Larry O. (Larry Ogalthorpe)
Public health law : power, duty, restraint / Lawrence
O. Gostin. — 2nd ed.
p. cm.
Includes bibliographical references and index.
isbn-13: 978-0-520-25376-6 (pbk. : alk. paper)
1. Public health laws—United States. I. Title.
KF3775.G67 2008
344.7304—dc22 2007004267
Manufactured in the United States of America
16 15 14 13 12 11 10 09 08
10987654321
The paper used in this publication meets the minimum
requirements of ansi/astm z39.48-1992 (r 1997)
(Permanence of Paper).
List of Illustrations xi
List of Tables xv

List of Boxes xvii
Foreword by Daniel M. Fox, Samuel L. Milbank,
and Carmen Hooker Odom xix
Preface to the Second Edition xxi
Acknowledgments xxix
part one
.
Conceptual Foundations of Public Health Law
1. A Theory and Definition of Public Health Law 3
Public Health Law: A Definition and Core Values 4
Public Health Statutes: Legal Foundations
of Public Health Agencies 23
Law as a Tool for the Public’s Health: Models
of Legal Intervention 28
The Legitimate Scope of Public Health and the Law 38
2. Public Health Regulation: A Systematic Evaluation 43
General Justifications for Public Health Regulation 47
Step 1: Is the Risk Significant? Risk Assessments 54
Contents
vi Contents
Step 2: Is the Regulation Effective? The “Means/Ends” Test 63
Step 3: Is the Regulation Cost-Effective? 64
Step 4: Is the Regulation the Least Restrictive Alternative?
Personal Burdens 68
Step 5: Is the Regulation Fair? Just Distribution of Benefits,
Burdens, and Costs 68
“Transparency”: A Principle of Good Public Health Governance 70
The “Precautionary Principle”: Acting under Conditions
of Scientific Uncertainty 72
part two

.
Law and the Public’s Health
3. Public Health Law in the Constitutional Design: Public Health
Powers and Duties 77
Constitutional Functions and Their Application to Public Health 77
The Negative Constitution: The Absence of Government’s Duty
to Protect Health and Safety 86
State and Local Power to Ensure the Conditions
for the Public’s Health: Salus Populi Est Suprema Lex 91
Federal Power to Safeguard the Public’s Health 98
New Federalism and the Public’s Health 109
4. Constitutional Limits on the Exercise of Public Health Powers:
Safeguarding Individual Rights and Freedoms 113
Public Health and the Bill of Rights: The Incorporation Doctrine 114
Jacobson v. Massachusetts: Police Power
and Civil Liberties in Tension 116
The Enduring Meaning of Jacobson 130
Public Health Powers in the Modern Constitutional Era 131
5. Public Health Governance: Direct Regulation for the Public’s
Health and Safety 147
A Brief History of Public Health Regulation 149
Public Health Agencies and the Rise of the Administrative State 153
Administrative Law: Powers and Limits of Executive Agencies 166
New Governance: Theory and Practice 171
Contents vii
6. Tort Law and the Public’s Health: Indirect Regulation 181
Major Theories of Tort Liability 183
Scientific Conundrums in Mass Tort Litigation: Epidemiology
in the Courtroom 196
The Public Health Value of Tort Litigation 202

“The Tobacco Wars”: A Case Study 204
Tort Litigation to Prevent Firearm Injuries: A Case Study 216
The Limitations of Tort Law: Social and Economic Costs 224
7. Global Health Law: Health in a Global Community 229
Globalization and the Spread of Infectious Disease,
Man-Made and Controllable 234
The Epidemiologic Transition from Infectious to Noncommunicable
Diseases: A Double Burden in Resource-Poor Countries 237
International Health Regulations: A Historic Development
in Global Governance 245
Framework Convention on Tobacco Control: Global Strategies
to Reduce Smoking 254
World Trade and World Health 258
Human Rights: Advancing Dignity, Justice, and Security in Health 270
part three
.
Public Health and Civil Liberties in Conflict
8. Surveillance and Public Health Research: Personal
Privacy and the “Right to Know” 287
Public Health Surveillance 290
Mandatory Reporting of Diseases and Other Health Conditions 295
Physician and Community Resistance to Notification Laws:
Case Studies on HIV and Diabetes Surveillance 297
Partner Notification: Contact Tracing, Duty to Warn,
and Right to Know 302
Public Health Research 307
Privacy, Confidentiality, and Security: Defining Concepts 315
Health Information Privacy: Ethical Underpinnings 319
Health Information Privacy: Legal Status 320
Toward a Model Public Health Information Privacy Law 327

viii Contents
9. Health, Communication, and Behavior: Freedom
of Expression 333
Two Antithetical Theories of Health Communication 334
Government Speech: Public Health Communications 336
When Government Speaks: A Constitutional Perspective 342
Commercial Speech 343
Compelled Commercial Speech: Health
and Safety Disclosure Requirements 361
Food Marketing to Children: A Case Study 365
10. Medical Countermeasures for Epidemic
Disease: Bodily Integrity 371
Compulsory Vaccination: Immunizing the Population
against Disease 376
Testing and Screening 395
A Case Study on HIV Screening: Public Health
and Civil Liberties in Conflict? 404
Compulsory Physical Examination and Medical Treatment 410
11. Public Health Strategies for Epidemic
Disease: Association, Travel, and Liberty 421
A Brief History of the Ancient Power of Quarantine 422
Isolation and Quarantine: Law, Ethics, and Public Policy 428
Community Containment Strategies 445
Pandemic Influenza: A Case Study on Medical
Countermeasures and Public Health Interventions 450
12. Economic Liberty and the Pursuit of Public Health 461
The Regulatory Tools of Public Health Agencies 463
Economic Liberty: Contracts, Property Uses, and “Takings” 473
The Normative Value of Economic Liberty 487
part four

.
The Future of the Public’s Health
13. Concluding Reflections on the Field 491
Public Health, Politics, and Money 492
Leadership and Jurisdiction 493
Contents ix
Legitimacy and Trust 495
Powers and Limits in Public Health: A Case Study
on Obesity and Chronic Disease 496
The Future of Public Health Law 513
Notes 515
Selected Bibliography 721
Table of Cases 741
Index 757
About the Author 768

photographs
1. The varied tasks of the Public Health Service in 1941 2
2. Cholera: The Broad Street pump 20
3. Public Health Service syphilis poster 33
4. Containment of infectious disease around military
training camps 42
5. Print showing an angel defending New York City against
the cholera epidemic 76
6. Public smallpox vaccinations in Jersey City 112
7. Cartoon deriding the dangerous state of mine safety
practices 146
8. Portraits of the great nineteenth-century public health
campaigners 154
9. Marine hospital in New Orleans 158

10. Billboard advertising Camel cigarettes in Times Square 180
11. Advertisement for a Colt handgun 217
12. South African protest demanding free access to HIV
drug therapy 228
13. Health communication campaign posters: Tuberculosis
and tobacco 235
14. Chronic starvation versus epidemic obesity:
Who’s to blame?
239
xi
Illustrations
xii Illustrations
15. Public Health Service campaign encouraging premarital
blood tests 286
16. The Tuskegee experiments: A scar on the history
of American public health research 315
17. Jackson Pollock photo and corresponding postage
stamp image with cigarette and smoke removed 332
18. Advertisement depicting doctors’ endorsement of Camel
cigarettes 344
19. Hippocrates explaining the importance of contagion
in a plague epidemic 370
20. The yellow fever epidemic of 1793 375
21. The long queue for smallpox vaccinations 385
22. Families visit quarantined officers 420
23. Sketches of the New York quarantine establishment 425
24. The threat of cholera at Ellis Island 427
25. Inspections of fruit in New York markets 460
26. Political cartoon criticizing the Kelo ruling 485
27. Increased attention to obesity 490

figures
1. The essential characteristics of public health law xxiii
2. Public health law: A definition and core values 5
3. The public health system 14
4. The mission of public health 26
5. The core functions of public health 27
6. Ten great public health achievements 30
7. Law as a tool for the public’s health: Seven models
of legal intervention 32
8. A guide to thinking about the determinants
of population health 40
9. Public health regulation: A stepwise evaluation 55
10. Public health risk assessment 57
11. Opportunity costs in risk regulation 67
12. Public health and federalism in the constitutional design 79
13. Separation of powers under the U.S. Constitution 84
14. Police power 93
15. Parens patriae power 97
16. Evaluating the constitutionality of public health policies:
Individual liberties versus public benefit 144
Illustrations xiii
17. The intersectoral public health system 148
18. Public health as a division of a superagency 162
19. Public health as a cabinet agency 163
20. The modern public health agency 167
21. The “negligence calculus”: Balancing risks, benefits,
and costs 187
22. Product liability theories 192
23. Admissibility of scientific evidence in the courtroom:
A timeline 200

24. “The tobacco wars”: A timeline 206
25. The transnational spread of infectious diseases 236
26. The World Health Organization 241
27. The International Health Regulations’ (IHR)
balancing dynamic 248
28. Decision instrument for the assessment and notification
of events that may constitute a public health emergency
of international concern 250
29. United Nations human rights bodies 272
30. Model State Public Health Privacy Act 328
31. Commercial speech: A definition 346
32. The constitutionalization of commercial speech 348
33. The Central Hudson test 350
34. Mandatory treatment: Balancing individual
and state interests 413
35. Regulatory tools of public health agencies 464
36. Economic liberties protected under the U.S. Constitution 474

1. Current and future public health challenges 31
2. Public health regulation: Trade-offs between public
benefit and private interests and rights 44
3. Federal constitutional powers to protect the public’s health 100
4. Public health and the Bill of Rights 115
5. U.S. Supreme Court decisions citing Jacobson v.
Massachusetts, 1905–2006 124
6. Negligence: The elements 184
7. Major intergovernmental organizations working on health 231
8. Major nongovernmental organizations (NGOs) working
on health 233
9. WTO agreements relevant to health 261

10. International Covenant on Civil and Political Rights
(ICCPR) 275
11. International Covenant on Economic, Social and
Cultural Rights (ICESCR) 276
12. Sources for the human right to health 279
13. Essential public health functions 288
14. The sciences and practices of public health: Definitions 289
15. Current data used to monitor health status 294
16. The nature of privacy: Defining relevant terms 317
17. The nature of personally identifiable information 319
xv
Tables
xvi Tables
18. Positive predictive value and prevalence 398
19. Isolation and quarantine: Application, benefits,
and challenges 433
20. Brief definitions of public health interventions
for an infectious disease outbreak 451
21. Public health strategies: Public benefits and private rights 452
22. Legal interventions to control overweight and obesity 505
1. The need for public health law reform 24
2. The aggregate health impact of repealing motorcycle
helmet laws 54
3. Federal preemption 80
4. Federalism: National, state, and local public health functions 81
5. The “right to bear arms” 117
6. The public/private distinction 119
7. The great nineteenth-century public health campaigners 152
8. The federal presence in public health 156
9. OSHA’s new governance strategies 174

10. Information as regulation: Zero trans fat Oreo cookies 177
11. Exemptions from strict liability for a design defect 194
12. Obesity litigation: Parallels to “Big Tobacco”? 213
13. Global governance for health 230
14. Sources of international law 243
15. WTO structure 262
16. The United Nations Human Rights Council 271
17. The right to the highest attainable standard of health 281
18. The Special Rapporteur on the Right to Health 282
19. Biosurveillance: NEDSS, BioSense, and syndromic
surveillance 291
20. Environmental public health tracking 293
21. Reporting requirements for out-of-state laboratories 296
xvii
Boxes
xviii Boxes
22. Diabetes: Medical explanation and prevalence 300
23. Ethics and trust in public health research 308
24. Ethics and regulation of human subject research 310
25. The nature of the privacy interest 317
26. Government suppression or disregard of science 340
27. Regulation of cigarette advertising 358
28. Conceptualizing the determinants of health and disease 373
29. Vaccines and the collective action problem 378
30. A summary of constitutional law and vaccination 384
31. Government vaccine initiatives 387
32. The national smallpox vaccination campaign 389
33. HIV screening: A global perspective 406
34. Mandatory HIV treatment 416
35. Severe Acute Respiratory Syndrome 430

36. Two model public health laws 438
37. CDC communicable disease regulations 440
38. Multistate practice: Telemedicine and disaster relief 465
39. Regulatory takings doctrine: Hardly a model of clarity 480
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 pol-
icy for health care and population health. The Fund has engaged in non-
partisan analysis, research, and communication about significant issues
in health policy since its inception in 1905.
Public Health Law: Power, Duty, Restraint was the third of what are
now nineteen California/Milbank Books on Health and the Public. The
publishing partnership between the Fund and the University of Califor-
nia Press encourages the synthesis and communication of findings from
research and experience, which could contribute to more effective health
policy.
Larry Gostin offers fresh information and analysis in every chapter of
this second edition. Perhaps most important, he describes increased at-
tention to the strengths and weaknesses of public health law as a result
of events since its initial publication.
The first edition appeared a year before the first of a series of chal-
lenges to public health, each of which has stimulated changes in law and
regulation as well as the allocation of new resources by government at
every level. These challenges include the events of September 11, 2001,
the twenty-two cases of anthrax in the next several months, the SARS
epidemic, the increased risk of a pandemic of avian flu, hurricanes Kat-
rina and Rita, and, as this edition went to press, news that public health
xix
Foreword
xx Foreword

regulations could not prevent a willful Atlanta lawyer with tuberculosis
from risking the health of people on several airplanes and two continents.
During the past seven years, moreover, the field of public health law
has expanded in size and scope. For the first time in over a century, public
health law is increasingly recognized as one of the professions of public
health, as essential as medicine, the laboratory sciences, and epidemiol-
ogy. This book has contributed to the growth of the field as a text in many
schools of law and public health and as the source of numerous citations
in articles and books.
Gostin has been a leader in studying, interpreting, and teaching public
health law—as well as in drafting it—for three decades. In writing and
then revising this book, he says, “I aspire to create a record of the field
of public health law at the turn of the millennium.” He has achieved that
aspiration.
Daniel M. Fox
President Emeritus
Carmen Hooker Odom
President
Samuel L. Milbank
Chairman
Good health is fundamentally important because it is essential to hap-
piness, livelihood, political participation, and many of the other elements
necessary for a life full of contentment and achievement. Certainly, health
is not the only important social value, and on occasion, public health as-
pirations have to yield to other values. Additionally, elected officials are
not obligated to spend inordinate amounts of tax dollars on a single public
good, such as health, when there are many competing political claims
for limited resources. Nevertheless, l think it is important that any book
purporting to examine carefully the interface between law and health
begin by emphasizing the powerful collective benefits afforded by en-

suring the conditions for a healthy population.
Libraries throughout the United States and other highly developed
countries are replete with books on the general subject of law and health.
Why then offer a book on public health law? The reason is that the vast
majority of these books are concerned principally with medicine and per-
sonal health care services—clinical decision making, delivery, organiza-
tion, and finance. Personal medical services are an important part of what
makes a community healthy. Yet medicine is only one contributor to
health, and probably a relatively small one at that. Virtually all national
health expenditures (excluding environmental funding) are devoted to
medical care; only a tiny fraction is allocated to population-based public
health initiatives. I am delighted to note, however, that since the last edi-
tion of this book, scholarly attention to the field of public health law has
xxi
Preface to the Second Edition
xxii Preface
surged. The modern interest in population health has focused on poten-
tially catastrophic threats to the public’s health, including bioterrorism
(e.g., anthrax and smallpox), emerging infectious diseases (e.g., SARS,
pandemic influenza), and chronic diseases caused by human behavior
(e.g., tobacco, high-calorie diet, and sedentary lifestyle). This extensively
revised second edition focuses on contemporary issues of great impor-
tance, including security, preparedness, obesity, and global health.
In this book, I offer a systematic definition and theory of public health
law. The definition is based on a broad notion of the government’s in-
herent responsibility to advance the population’s health and well-being:
Public health law is 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
(to identify, prevent, and ameliorate risks to health in the population), and

of the limitations on the power of the state to constrain for the common
good the autonomy, privacy, liberty, proprietary, or other legally protected
interests of individuals. The prime objective of public health law is to pursue
the highest possible level of physical and mental health in the population,
consistent with the values of social justice.
I explain why public health law is a coherent field, distinct from other
intellectual activities at the intersection of law and health. In particular,
I offer five characteristics that distinguish public health law from the vast
literature on law and medicine (see figure 1):
•
Government’s responsibility to advance the public’s health
•
Coercion and limits on state power
•
Government’s partners in the public health system
•
The population perspective
•
Communities and civic participation
•
The prevention orientation
•
Social justice
This book, therefore, is about the complex problems that arise when
government regulates to prevent injury and disease or to promote the
public’s health. The government possesses the authority and responsibil-
ity to persuade, create incentives, or even compel individuals and businesses
to conform to health and safety standards for the collective good. This
power and obligation forms the essence of what we call public health law.
In addition to offering a definition and theory, I examine the analyt-

Figure 1. The essential characteristics of public health law.
Preface xxiii
ical methods and tools of public health law, principally constitutional law,
which empowers government to act for the community’s health and lim-
its that power; statutory and administrative law, which provides the vast
regulatory structure at the federal, state, and local levels for responding
to health threats; tort law, which affords a civil remedy against individ-
uals and businesses whose unreasonably risky conduct causes injury or
disease; and international law, which guides and binds nation-states and
other entities in activities, relations, and transactions that transcend na-
tional borders.
Accordingly, much of the book discusses the extensive body of legal
doctrine that informs the field of public health law. A book on public
health law intended for a broad audience cannot consider all the nuances
and complexities of legal doctrine. For the sake of succinctness and clar-
ity, the text sometimes may imply that the law is more monolithic and
predictable than it really is. Subsequent chapters present some of the sub-
tleties of the law as applied to particular problems in public health. Nev-
ertheless, a much more careful examination of statutes, administrative
rules, and policies is essential in resolving specific legal problems facing
public health authorities.
I often return to two themes in this book: the trade-offs between public
goods and private rights, and the dilemma of whether to use coercive or
voluntary public health measures. As to the first theme, I emphasize the
collective goods that are achieved, or achievable, through legal and reg-
ulatory approaches. Seen in this way, the law is a potent tool for the re-
alization of healthier and safer populations. At the same time, I closely
examine the complexity of, and conundrums posed by, public health reg-
ulation. Though public health regulation is intended to achieve public
goods, it often does so at the expense of private rights and interests. Con-

sequently, in thinking about public health regulation, we have to take a
hard look at the trade-offs—between the common welfare, on the one
hand, and the personal burdens and economic interests of individuals
and businesses, on the other.
Characterizing these trade-offs between collective goods and individ-
ual rights is only one of several possible ways to conceptualize the prob-
lem. Another way would be to characterize the trade-off as between two
collective goods: the good of public health and the good of limited gov-
ern ment. After all, society gains a great deal of benefit from the protec-
tion of individual liberties through a constitutional system of limited gov-
ern mental interference. Still, an analysis of collective goods versus
individual rights captures at least one important way of thinking about
public health.
Another problem with characterizing public health law as a series of
trade-offs between private rights and public goods is that often the most
effective public health policy is to enhance private rights to attain public
goods. My friend the late Jonathan Mann was particularly eloquent in
urging the conclusion that public health and human rights are syner-
gistic; preserving and promoting individual rights most often advances
human well-being. Certainly, coercive policies may have unintended ef-
fects on group behaviors (e.g., driving people away from health care
services). Furthermore, antidiscrimination, privacy, and other legal safe-
guards have public health, as well as intrinsic, value. Nevertheless, some-
times public health officials confront hard choices between public goods
and private rights, and many of the chapters in this book explore these
complex choices.
The trade-offs between individual and population-based perspectives
lead to a second, related theme. Public health scholars and practitioners,
for as long as people have organized societies to defend their health and
security, have grappled with the decision of whether to use voluntary or

coercive approaches in achieving collective benefits. Is it always, or al-
xxiv Preface