Practice Tip: The Learned Intermediary Doctrine

For more than a half-century ' a virtual lifetime in American law ' pharmaceutical and medical device manufacturers have benefited from the learned intermediary doctrine as a defense in product liability cases alleging a failure to warn of a product's risks. The doctrine remains a strong and viable defense to this day. The learned intermediary doctrine, in recognition of the existence of the unique relationship between prescriber/physician and patient/consumer, provides that manufacturers of prescription drugs and medical devices can be held liable for failing to warn of the risks of a device or drug only when the manufacturer fails to warn the health care provider of risks attendant to a specific device or drug. In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 803 (E.D. Tex. 2002); Restatement (Third) of Torts: Prod. Liab. '6(d) cmt. a (1998). Thus, unlike all other manufacturers, a manufacturer of pharmaceuticals and medical devices need not warn the consumer directly. The doctrine is based on the well-accepted principle that a patient's prescribing physician is in the best ' and the unique ' position to educate the patient of the risks presented by a drug or device, given the patient's specific medical condition and therapeutic needs.