Table Of ContentCASE STUDIES IN
FORENSIC EPIDEMIOLOGY
CASE STUDIES IN
FORENSIC EPIDEMIOLOGY
Sana Loue
Case Western Reserve University
Cleveland, Ohio
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Tous ceux dont la vie se passe á chercher la vérité savent bien que les images qu’ils en saisissent sont
nécessairement fugitives. Elles brillent un instant pour faire place à des clarets nouvelles et toujours
éblouissantes.Biendifférentedecelledel’artiste,l’oeuvredusavantestfatalementprovisoire.Ille
sait ets’enréjouit,puisque larapide vieillesse de ses livres estlapreuves même duprogrésdela
science.
H. Pirenne,quotedinG.Gérardy(1962). HenriPirenne,1862–1935. Brussels: Ministère
de l’education nationale et de la culture, Administration des services educatifs.
All those whose lives are spent searching for truth are well aware that the glimpses they catch of it
are necessarily fleeting, glittering for an instant only to make way for new and still more dazzling
insights. The scholar’s work, in marked contrast to the artist, is inevitably provisional. He knows this
and rejoices in it, for the rapid obsolescence of his books is the very proof of the progress of
scholarship.
J. Boswell (1980). Christianity, Social Tolerance, and Homosexuality: Gay People in
Western Europe from the Beginning of the Christian Era to the Fourteenth Century.
Chicago:University of Chicago (translating H. Pirenne, above).
Preface
Epidemiology has often been defined as the study of the distribution of
disease, together with the distribution of factors that may modify that risk
of disease. As such, epidemiology has often been reduced to a methodology
only, providing a mechanism for the study of disease that is somehow
removed, separate and apart from the populations that serve as its focus.
Epidemiology, however, is much more than that. The discipline pro-
vides a way of perceiving and knowing the world, and of relating to the com-
munities whose health and disease patterns we are trying to understand. As
such, its usefulness extends past the construction of questionnaires, the
detective work inherent in tracing the source of an infection or the analysis
of data. Rather, epidemiology serves as a point of reference and a linkage
between various domains of reality: in the courtroom, between a commu-
nity’s injuries and those alleged to be responsible for those violations;
between the community striving to effectuate changes to improve its health
and environment and the lawmakers and policymakers whose actions may
dictate or control the likelihood of that change; and between “mainstream”
populations and those who become or remain marginalized and stigmatized
due to disease or perceived disease.
Many epidemiologists may balk at this use of their profession, arguing
that, at best, it is an unnecessary foray from the protected, objective world
of science into the relatively subjective and highly charged world of public
affairs and legal wars. What this view ignores, however, is our own subjec-
tivity as epidemiologists, inherent in our everyday decisions relating to the
value of what it is we are to study, the relative importance of the research
questions that we wish to tackle. Those decisions are not merely a function
of calculating the monetary balance between monies to be expended and
costs saved through prevented cases of disease. We make, in many ways, the
value judgments that we profess to avoid.
This text focuses on various uses of epidemiology in the legal context,
as it is broadly defined. Chapter 1 focuses on forensic epidemiology as it is
usually conceived of. Concepts of causation in law and in epidemiology are
vii
viii Preface
explored, as are the mechanisms for determining causation. Chapters 2 and 3
expand the concepts discussed in chapter 1 by providing case studies of the
silicone breast implant litigation and of a lawsuit involving exposure to
E. coli. Chapters 4 through 6 continue with an examination of the uses of
epidemiology in the legislative and regulatory arenas by providing a foun-
dation, followed by a discussion of FDA action related to silicone breast
implants and tobacco.
Chapters 7 through 12 depart from what is often traditionally thought of
as the legal forum. These chapters focus on the use of epidemiology in the
context of community advocacy and social change. Readers may wonder at
the inclusion of such topics and their relation to law and epidemiology.
Community advocacy efforts often utilize legal mechanisms, among others,
to accomplish their aims. Epidemiology may be used as a basis for these
actions. Consider, for instance, the efforts of activists to establish needle
exchange programs, revisions in FDA drug approval processes, and the con-
trol of tobacco. As society changes, our perceptions of what is harmful or
healthful, normal or deviant, changes, as well as our knowledge and under-
standing evolve. We see this, for example, in our current reliance on “risk
behaviors,” in lieu of “risk groups,” to designate those individuals who are
at greater risk of contracting HIV infection, and in the evolution of attitudes
regarding the medical use of marijuana.
This text, above all else, challenges the reader to push the boundaries of
his or her thinking about what epidemiology is and how it is to be used to
make a contribution. The reader is asked to arrive at a more complete under-
standing of the populations with whom we work, the diseases that we inves-
tigate, and the systems that underlie and shape our endeavors.
Acknowledgments
The author gratefully acknowledges the helpful review and critique of ear-
lier versions of this manuscript by Dr. Siran Koroukian. Stephanie Stewart
and Gary W. Edmunds deserve praise and thanks for their time and diligence
in locating needed materials. Dr. Hal Morgenstern has generously permitted
the use of his diagrams illustrating the finer points of confounding. The
excerpts from various trials and depositions would not have been available
but for the interest and generosity of several attorneys and their law firms:
the law office of JerryMoberg in Euphrata, Washington, Jerome L. Skinner
of the Cincinnati, Ohio law firm of Waite, Schneider, Bayless, and Chesley,
and Dianna L. Pendleton. Mariclaire Cloutier, the editor of this volume,
deserves praise for her patience and support.
ix
Contents
1. Epidemiology in the Courtroom: Dissonant Goals,
Divergent Processes 1
Epidemiology and Law: Dissonant Goals 1
Epidemiology and Law: Divergent Processes 3
Causation in Epidemiology 3
Causation in Law 23
Epidemiological Causation Meets Legal Causation 36
Reconciling Law and Epidemiology 36
Epidemiology, Ethics, and Expert Witnesses 40
Discussion Questions 41
2. Case Study One: The Silicone Breast Implant Litigation 47
The History of Silicone Breast Implants 47
Epidemiological Findings and Legal Verdicts 50
The Events 50
TheExplanations: APost-Mortem 52
Discussion Questions 59
3. Case StudyTwo: TheE. Coli Investigation 63
The Epidemiology of E. Coli 63
The Facts 64
The Epidemiological Investigation 65
The Initial Investigation 65
The Case-Control Study 65
The Student Cohort Study 67
The Staff Cohort Study 67
Findings 67
Discovery 70
Plaintiffs’Case 70
xi
xii Contents
Defendant’sCase 71
The Trial 76
Plaintiffs’ Case 76
Defendant’s Case 77
Discussion Questions 79
4. Epidemiology, Legislation, andRulemaking 81
Legislatures 81
Legislative Authority 81
Formulating Legislation 82
Influencing Legislation 84
Administrative Agencies 86
Agency Authority 86
Oversight of Agency Activities and Administrative
Action 87
Agency Development of Rules 88
Challenging Agency Rules 93
Agency Action in the Face of Uncertainty 93
Influencing Agency Rulemaking 94
Discussion Questions 95
5. Case StudyThree: The FDA and Silicone BreastImplants 97
The FDA and the Regulation of Medical Devices 97
The FDA and Silicone Breast Implants 98
Assessing the FDA’s Actions 102
Discussion Questions 102
6. Case StudyFour: The Regulation ofTobacco 105
The FDA and the Regulation of Drugs 105
Tobacco and Its Effects 107
FDA Action and Tobacco 108
Discussion Questions 111
7. Law, Epidemiology, andCommunityOrganization
and Advocacy 115
Defining Advocacy 115
Stages of Development in Community Organization and Advocacy 115
Stage One: Assessing the Needs of the Community 116
Stage Two: Using Epidemiology for Research 118
Stage Three: Developing Strategies in Community
Organization and Advocacy 120
Epidemiology, Advocacy, and Ethics 125
Discussion Questions 126
Contents xiii
8. Case Study Five: Alcohol and Drunk Driving 129
Alcohol and Drunk Driving 129
The Physiological Effects of Alcohol 129
The Characterization of Alcohol Use 129
The Epidemiology of Driving-Related Injuries and Deaths 131
Mothers Against Drunk Drivers 131
The Claim to Moral Authority 132
Goals and Strategies 134
Organizational Characteristics 136
Discussion Questions 136
9. Case Study Six: Needle Exchange Programs 139
Defining Needle Exchange 139
Needle Exchange and Harm Reduction 139
Needle Exchange Programs: History and Examples 140
The Basis for Needle Exchange 143
Injection Drug Use: Behavior and Biology 143
The Impact of Substance Use and Abuse 144
HIV, AIDS, and Injection Drug Use 145
Hepatitis and Injection Drug Use 146
Public Policy and Needle Exchange 147
Community Activism and the Establishment of Needle Exchange
Programs 149
Discussion Questions 149
10. Epidemiology, Law, and Social Context 153
Deviance in Social Context 153
The Normative View of Deviance 154
The Social Audience Approach 156
Responses to Deviance 158
Deviance at the Juncture of Epidemiology and Law 161
Discussion Questions 163
11. Case Study Seven: Sex, Gender, and Sexuality 167
Defining Sex 167
Gender Identity and Gender Role 168
Sexual Orientation 169
Transsexuality and Transgenderism 171
Transsexuality 171
Transgenderism 172
Homosexuality, Science, and Changing Social Context 173
Homosexuality in Science and Medicine: Changing Views 173
Homosexuality, Science, and Civil Rights 174
Discussion Questions 178
