Consumer Fraud Actions: The Applicability of the Learned Intermediary Doctrine

The learned intermediary doctrine has long been commonly used as a critical defense in personal injury pharmaceutical and medical device failure-to-warn claims. Under the established doctrine, recognized in nearly all states, a pharmaceutical or medical device manufacturer's duty to warn is fulfilled once it has educated the prescribing or implanting physician of the known risks and side effects associated with the product. See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 808 (E.D. Tex. 2002); Restatement (Third) of Torts: Prod. Liab. '6 (1998). The learned intermediary doctrine is premised on the principle that the physician has a 'duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product.' Ecke v. Parke, Davis & Co., 256 F.3d 1013, 1018 (10th Cir. 2001). The learned intermediary doctrine provides a powerful defense in defeating elements of failure-to-warn claims, such as duty and causation. There is no doubt the learned intermediary doctrine remains an effective tool in defeating pharmaceutical and medical device failure-to-warn claims.