Women in Clinical Trials: Are Sponsors Liable for Fetal Injury?
Journal of Law, Medicine and Ethics. 1993 Summer; 21(2): 217-230.
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 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 possiblity 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.
Autonomy; Birth Defects; Cells; Clinical Trials; Congenital Disorders; Consent; Drug Industry; Drugs; Ethics; Ethics Committees; Females; Fetuses; Germ Cells; Government; Government Regulation; Health; Hormones; Human Experimentation; Industry; Informed Consent; Injuries; Investigators; Law; Legal Aspects; Legal Liability; Legal Rights; Liability; Males; Mother Fetus Relationship; Prenatal Injuries; Regulation; Research; Research Ethics; Research Ethics Committees; Rights; Risks and Benefits; Selection of Subjects; State Interest; Toxicity; Women's Health;
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