July 29, 2013 Articles

Inside the Learned Intermediary Doctrine

By Chris A. Johnson, Alicia J. Donahue, and Paula Sarti

Generally, product manufacturers have a duty to warn consumers directly of all material, foreseeable risks associated with the use of their product. Restatement (Third) of Torts: Prods. Liab. § 2(c) (1998). However, many courts have recognized an exception in situations in which the product is recommended or prescribed to the consumer by a learned third party, such as a physician. That exception is called the learned intermediary doctrine. Restatement (Third) of Torts: Prods. Liab. § 6 cmt. d (1998).

The doctrine is important to drug manufacturers because it allows them to discharge their duty to warn consumers about their products by informing the learned intermediary, commonly the prescribing physician, of all material risks associated with their use. Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996). The prescribing physician is ultimately responsible for directly informing the patient about the potential benefits and risks of using the medication. Restatement (Third) of Torts: Prods. Liab. § 6 cmt. b (1998) Thus, prescription drug manufacturers' duty to warn consumers flows through the patients' prescribing physicians, not directly to consumers.

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