Learned-Intermediary Doctrine Law & Legal Definition


The learned intermediary doctrine is a principle of American personal injury law that provides that manufacturers of prescription drugs and medical devices discharge their duty of warning about a drug's potentially harmful effects by providing warnings to the prescribing physicians. The prescribing physician acts as a "learned intermediary" between manufacturer and consumer and has the primary responsibility of warning patients of the hazards of prescribed pharmaceutical products. The manufacturer's duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug's use. This special standard for prescription drugs is an exception to the Restatement's general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a "learned intermediary" between manufacturer and consumer. [Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. Tex. 1974)]