Abstract

Calls for the inclusion of women in clinical trials raise the obvious question: why have sponsors excluded them? The answer most often given is one tragically evocative word: Thalidomide. The tragedies of the children born with seal limbs because their mothers took this over-the-counter sleeping pill and cure for morning sickness showed that, contrary to previous perceptions, the placenta could not be depended upon to filter out toxins before they reached the fetus. The specter of birth defects spawned sponsors’ fears of a variety of catastrophes which contributed to closing the doors of clinical trials for women.This paper will not argue that the possibility of birth defects arising from the ingestion of an experimental drug does not exist. Sadly, scientists do not yet have the ability to predict which drugs will cause birth defects. Rather, it will argue that case law does not provide a basis for sponsor liability when a woman gives informed consent and the regulations governing clinical trials are followed.