Physicians' liability for adverse drug reactions

Although the Food and Drug Administration's spontaneous reporting system for adverse drug reactions has been collecting reports since 1960, the number of adverse drug reactions reported is low. One of the perceived deterrents to reporting adverse drug reactions is physicians' fear of involvement in litigation. We discuss the basis for physicians' liability and review the standard of care concept regarding physicians' liability associated with adverse drug reactions. Examination of the elements of a professional negligence case and "informed consent" shows what physicians can do to avoid malpractice related to adverse drug reactions.