The DES product liability story in America: The third generation litigation
William J. Curran · International Journal of Risk & Safety in Medicine · 1992
In the medical-injury field, issues of ethics and principles of law often overlap.In my own career spanning some 40 years, I have practiced and taught in each field and have contributed to American textbooks that have examined developments in each field.[1,2].In my judgement, the tragedy and drama of DES (diethylstilbestrol) played out over these same decades could be analyzed as a single-textbook, case study of medical ethics and law in action.The broad history of DES has been reviewed in this Journal before [3,4].The drug was marketed from the late 1940s by over 300 manufacturers in the U.S.A. and prescribed for millions of women during pregnancy as a miscarriage prevention.(The serious dangers of any form of drug-intervention during pregnancy had not yet sobered the enthusiasm of most practicing physicians in this expansive era before thalidomide shattered all illusions.)Early on, the complexities of the DES story began to sift out.It was soon evident that damage could and did often occur in the developing female fetus exposed to the drug in utero.Studies linked the drug to vaginal and cervical cancers and to serious malformations of the uterus, cervical and Fallopian tube deformities, and other abnormal cell and tissue problems.There was a marked increase in infertility, miscarriage and ectopic pregnancies.It was not until 1971, however, that diethylstilbestrol was removed from the American market.In litigation, the first ethical/legal controversy revolved around the manufacturer's obligations to the DES daughters.Why, asked opponents of recovery, should product liability (either for negligence or sales warranty) be extended to include persons not born at the time of the wrongdoing or exposure?In ethics, this is the subject matter of deontology, the study of moral duties.Most ethicists had little trouble supporting a duty by manufacturers (and attending physicians or obstetricians) to the daughters since the pregnancy was known at the time of exposure.Legal analysis was more complex, but the same conclusion was reached.In hotly contested judicial inquiries and scholarly reviews, it was determined that product liability should be imposed because the drug was being used for a pregnancy-related treatment objective and the developing fetus was within "the