TmAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE

Mass tort litigation is a relatively new and controversial development in American law. Causation issues, which are often problematic in these cases, were particularly troublesome in the recent breast implant litigation. In Science on Trial, Marcia Angell provides an engaging introduction to the regulation of and litigation over silicone breast implants in the United States. She addresses three broad areas: the factual history of the controversy, including the relevant epidemiology; tort law and its failings, especially with regard to causation determination; and the relationship between scientists and the public. The book provides an interesting overview of the topic, although it is probably too basic to be of practical use to those already well versed in it. Thumbnail descriptions of the relevant people, cases, and more dubious scientific studies enliven Angell's account of the controversy. Her descriptions of epidemiology and medical research are particularly clear and wellwritten. In the early chapters of the book, Angell describes breast implants and their use. The first known attempt to enlarge a woman's breasts (using fat from a benign tumor on the woman's back) occurred in 1895 (p. 35). Subsequent techniques made use of petroleum jelly, beeswax, vegetable oils, and most commonly, paraffin or silicone injected directly into the breast (pp. 35-36). The use of breast implants did not become common in the United States until the 1970s (p. 33-34), however, after the introduction of silicone breast implants. These implants, consisting generally of a "rubbery silicone envelope containing silicone gel" (p. 39), were first introduced in 1962 (13. 39). Silicone, which is widely used for medical devices (e.g., artificial joints and needle lubrications), was a logical choice for implant manufactme since it is stable, resists bacterial contamination, and is well tolerated by the body (p. 36). Between 1979 and 1992 (when silicone breast implants were bannedZ by the Food and Drug Administration ("FDA")), 100,000 to