There is a great deal of tension between women's groups, supported by the Food and Drug Administration (FDA), that felt it critically important for women of childbearing age to participate in investigational studies, and pharmaceutical companies' legal departments that (as most lawyers do) want to minimize any product liability risk. This paper provides clinicians with some background as to why lawyers are so concerned about these studies, and suggests to lawyers why they should not be so worried if the company proceeds properly. The perspective is that of a trial lawyer who has defended claims that a demonstrably safe drug, Bendectin, causes birth defects.
