Informed Consent in the Prescription Drug Context: The Special Case

Evaluation of the general doctrine of informed consent is the starting point for determining whether, and how, the doctrine might apply to prescription drug therapy. This article demonstrates that, unlike the decision to undergo surgery (the more typical informed consent situation), the process of prescribing drugs contains numerous considerations, many of which are inherent in and unique to prescription drug therapy. The presence of these considerations dictates that courts accord even greater significance to the need for patient participation in prescription drug therapy than that accorded in the more typical consent to surgery situation. Moreover, in light of the many unique considerations involved, courts need to examine their ready deference to physicians\u27 autonomy, which results in total exclusion of patient participation and the abrogation of patients\u27 rights of self-determination and bodily integrity. This article argues that when the physician prescribes drug therapy, the only reasonable guarantee of a patient\u27s right of bodily integrity and self-determination is for courts to apply a subjective, individual-patient standard of disclosure in conjunction with a presumption of proximate cause. Finally, the article proposes a duty/disclosure scheme that alters the objective-patient model of informed consent to accommodate the unique aspects of prescription drug therapy and to give full force and effect to the patient\u27s rights