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Science in the courtroom. A new approach.

Judges, legislators, policymakers and often base decisions concerning health risks on evidence and testimony from scientists, physicians, and other experts. Unfortunately, the quality of this information can be questionable and its implications unclear. How are nonscientists to determine which expert presentations provide the strongest basis for law and policy? The controversy over the safety of silicone gel breast implants exemplifies what can go wrong when scientific data on health risks are inadequate and unclear. Since the 1980s, intense effort and immense sums of money have been devoted to resolving the question of whether women with silicone gel implants are more likely to develop connective tissue and autoimmune disorders such as lupus, rheumatoid arthritis, and "atypical connective tissue disease." Now, more than thirty years after implants entered the clinical setting and sixteen years after the Food and Drug Administration first notified implant manufacturers that safety data would be required, reasonably clear answers to this question are emerging. The emerging consensus is due in part to an innovative approach adopted by several courts handling litigation related to implant safety. The approach draws from two sources. In Daubert v. Merrell Dow Pharmaceuticals, Inc.,[1] the Supreme Court assigned to trial judges a gatekeeper role in determining whether scientific testimony is sufficiently reliable to be admitted into evidence. According to Daubert, judges evaluating the trustworthiness of scientific testimony are to consider several different factors, including whether the scientific claims a party seeks to introduce (1) can be and have been tested, (2) have undergone peer review and publication, and (3) are generally accepted in the scientific community. Judges also are to consider whether the techniques by which those claims were established have a known or potential error rate and are subject to professional standards. The Federal Rules of Evidence allow judges to obtain guidance on the admissibility of scientific evidence from independent scientific experts so that they need not rely solely on experts presented by the adversarial parties. Based on these rules, some federal judges handling breast implant litigation have asked independent scientists to evaluate research that addresses the possibility of a causal relationship between implants and connective tissue and immune disorders. The most influential assessment comes from a National Science Panel appointed in 1996 by Judge Samuel Pointer, who is coordinating pretrial proceedings for implant litigation in the federal courts. In December 1998 the panel concluded that research to date fails to supply evidence of a causal link between implants and connective tissue and immune disorders.[2] Expert Analysis The report is lengthy, systematic, and detailed, but nonetheless clearly written and comprehensible to the nonscientist--essential features of any document that will be used in a legal or policy context. Its four chapters review (1) silicone toxicity studies in animals, (2) studies of immune responses that could lead to health problems in implant recipients, (3) epidemiological data on the possible association between implants and the relevant disorders, and (4) the strength of the association between implants and symptoms that could be related to rheumatic or autoimmune disorders. Each chapter was approved by the whole panel but was primarily drafted by one of the panel's four experts, trained respectively in toxicology, immunology, epidemiology, and rheumatology. Attorneys for the plaintiffs and defendants were permitted to submit forty articles and other documents to each expert, but the panelists performed independent literature searches as well. Extensive references and appendices allow other scientists to evaluate the panel's conclusions. The panelists characterize their report as "an analysis of the most rigorous and relevant scientific information currently available. …