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Session Slot: Monday, 10:30 - 12:20

Estimated Audience Size: 200

AudioVisual Request: Not sure

Session Title: Issues Arising in the Use of Epidemiologic Studies as Evidence in Legal and Regulatory Decision-Making

Theme Session: YES

Applied Session: Yes

Session Organizer: D'Agostino Jr., Ralph Wake Forest University School of Medicine

Address: Dept of Public Health Science/ Biostatistics Medical Center Blvd. Winston-Salem, NC 27157-1063

Phone: (910) 716-9410

Fax: (910) 716-5425


Session Organizer: Gastwirth, Joseph L. George Washington University

Address: Department of Statistics 2201 G St. NW Washington, D.C. 20052

Phone: (202) 994-6548


Session Timing: 110 minutes total (Sorry about format):

Opening Remarks by Chair - 5 or 0 minutes First Speaker - 30 minutes (or 25) Second Speaker - 30 minutes Third Speaker - 30 minutes Discussant - 10 minutes (or none) Floor Discusion - 10 minutes (or 5 or 15)

Session Chair: Reynolds, Gladys H. Centers for Disease Control and Prevention

Address: 1600 Clifton Rd., NE Atlanta, GA 30333

Phone: (404)639-7224

Fax: (404)639-7039


1. Casual Inference in Legal Context

Loue, Sana,   Case Western University

Address: Dept of Epidemiology and Biostatistics Ohio

Abstract: This presentation first discusses the differing purposes of law and epidemiology. It next focuses on the elements required to establish causation in a tort case and briefly summarizes the various legal mechanisms that can be sued to establish or refute causation. These legal criteria are compared to epidemiological principles and methods used in the process of causal inference. The presentation concludes with a brief discussion of the role of expert witnesses, such as epidemiologists and biostatiticians, in litigation.

2. What Does It Mean To Estimate The Causal Effects Of Smoking

Rubin, Donald B.,   Harvard University

Address: Dept of Statistics One Oxford St. Cambridge, MA 02138

Phone: (617)495-5498

Fax: (617) 496-8057


Abstract: Most believe that smoking is a major ``cause'' of certain disease such as lung cancer. Current litigation, however, concerns the health-care costs ``caused by smoking'', in particular, those costs caused by the (alleged) misconduct of the tobacco industry starting roughly a quarter century ago. What does it mean to try to estimate these effects? And what does it mean to try to estimate the causal effects on health-care costs of ``the existence of smoking'' ignoring any issues of misconduct? In what ways are these different questions?

3. Some Suggestions for Reconciling the Values of Statistical Science With the Goals and Needs of the Legal and Regulatory Processes

Gastwirth, Joseph L.,   George Washington University

Address: Department of Statistics 2201 G St. NW Washington, D.C. 20052

Phone: (202) 994-6548


Abstract: In principle, science is an ongoing search for the truth. Hence, scientific knowledge is contingent in the sense that any theory is subject to falsification if and when predictions logically derived from it are not borne out in an appropriate experiment. The legal system, on the other hand, is a process for resolving disputes in a reasonably prompt, fair and socially acceptable manner. Epidemiologic studies are used in product liability cases which are filed after a harm has occurred. Most states have statues of limitations requiring plaintiffs to file a claim within a pre-set time after the harm occurred or after it was discovered by them. Regardless of the state of scientific knowledge at the end of the limitations period, if plaintiffs have not filed suit, they are precluded from receiving compensation no matter how strongly subsequent studies demonstrate a causal relationship between the product in question and the harm. Similarly, a manufacturer's liability, especially on their duty to warn users of a potential hazard, depends on the state of knowledge available at the time it made and sold the product. Unlike the open-ended nature of scientific investigation, courts need to reach a decision based on the evidence available at the time of the trial. Data from two cases illustrates the point that a change in the view point of the scientific community due to the developments subsequent to a trial does not necessarily imply that the original legal decisions were wrong. Similarly, government officials must decide whether to recall a product or issue a warning based on the available information, knowing that the public may be exposed to a potential harm during the time it takes for new studies to be conducted. After a brief review of the studies that lead to the warning campaign that eventually reduced the incidence of Reye's syndrome by over 80%, suggestions for balancing the trade-off between maximal scientific knowledge and the need to protect the public will be given.

4. The Impact of Daubert v. Merrell Dow Pharmaceuticals on the Admissibility of Statistical-Influential Evidence of Causation.

Green, Michael,   Univeristy of Iowa

Address: Law School Iowa City, Iowa

Abstract: The legal system has long relied on expert witnesses to provide opinion about causal phenomena that are not subject to other readily available proof. One of the most significant areas where this occurs is when a person with disease claims that is was caused by a toxic agent. Even before the revolutionary asbestos litigation began in the mid- 1970's, experts and statistical evidence had been employed in cases involving exposure to the svine-flu vaccine and to radiation.

As toxic substance litigation grew, increasing concern was raised about the quality of expert testimony. The adversary system tends to pressure even honest experts to state their conclusions more surely to omit qualifications that might enhance the validity of their opinion, and to draw tenuous inferences. Physicians were sometimes permitted to testify about causation based on clinical experience, which in some cases was no more than a part hoc ergo propter hoc rationale.

The United States Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals in 1993 imposed significant limits on the admission of expert scientific opinion. The methodology and the reasoning of the expert are to be examined by the court for scientific validity. Unless the trial judge decides that the expert's opinion passes this threshold test, the expert's testimony may not be admitted in court.

The precise scope and impact of the Court's opinion on the admissibility of expert testimony about causation in toxic substance cases remains unclear and controversial. This paper will examine the ambiguity created by the Daubert case and the way in which lower courts are resolving that ambiguity.

List of speakers who are nonmembers: Michael Green

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Next: asa.epid.02 Up: ASA Epidemiology (2) Previous: ASA Epidemiology (2)
David Scott