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June 22, 1984

The Diethylstilbestrol Dilemma: Who Should Pay?

Author Affiliations

From the Office of the General Counsel, American Medical Association. For further information and reprints, write to Office of the General Counsel, American Medical Association, 535 Dearborn St, Chicago, IL 60610.

JAMA. 1984;251(24):3228-3229. doi:10.1001/jama.1984.03340480020019

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DIETHYLSTILBESTROL is one of the "toxic time bombs" recently discovered to be responsible for diseases that do not manifest themselves until many years after exposure.

In 1947, the Food and Drug Administration allowed manufacturers to recommend diethylstilbestrol for the prevention of miscarriages. In 1971, investigations reported an increased risk of a rare form of vaginal cancer, clear-cell adenocarcinomas, in the daughters of women who had taken diethylstilbestrol (N Engl J Med 1971;284:878-881), and the FDA thereafter required diethylstilbestrol labeling to state that the drug was contraindicated for use to prevent miscarriage. It is estimated that during the more than 20 years that diethylstilbestrol was marketed for the prevention of miscarriages, more than 200 companies distributed the drug (Downey and Gulley, Theories of Recovery for DES Damage: Is Tort Liability the Answer?, 4 J Legal Med 167, 180 n 63), and that between 500,000 and 2 million pregnant women took the