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25 Anglo-Am. L. Rev. 286 (1996)
Causation and Drugs: The Legacy of Diethylstilbestrol

handle is hein.journals/comlwr25 and id is 300 raw text is: ANGLO-AMERICAN LAW REVIEW CAUSATION AND DRUGS: THE LEGACY OF DIETHYLSTILBESTROL By RICHARD GOLDBERG I. Introduction and Background One of the most controversial areas of product liability is that of establishing causation in drug-induced injury cases. Nowhere is this task more challenging than in the context of those drugs which may have an inherent propensity to harm successive generations. Diethylstilbestrol (DES), which was used as an oestrogenic hormone, is possibly the classic paradigm of the potential for generational drug-induced defects. The principal established adverse drug reaction associated with DES is that of second generation vaginal adenosis and vaginal clear cell adenocarcinoma. A causal link between DES and vaginal adenocarcinoma and adenosis has been established for over 20 years.1 The effect of DES on the second generation, ie, the daughters who were foetuses in utero when their mothers took the drug can be distinguished from third generation cases which have alleged that DES can cause reproductive abnormalities in the second generation, resulting in the premature birth of third generation children with physical disabilities, including cerebral palsy. There are also alleged cases of DES causing chromosomal damage to 1. Herbst, Ulfelder and Poskanzer, Adenocarcinoma of the Vagina. Association of Maternal Stilbestrol Therapy with Tumour Appearance in Young Women (1971) 284 N. Eng. J. Med. 878, 878, 879. Strict epidemiological analyses of data have pointed to shortcomings in such evidence: McFarlane, Feinstein and Horwitz, Diethylstilbestrol and Clear Cell Vaginal Carcinoma. Reappraisal of the Epidemiologic Evidence (1986) 81 Am. J. Med., 855-863. However, the McFarlane et al. study has been convincingly criticized in Buitendijk, Diethylstilbestrol and the next generation: a challenge tothe evidence? in Dukes and Beeley (eds.) Side Effects of Drugs Annual 12, (Amsterdam, New York and Oxford: Elsevier, 1988), pp.347-348.

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