Also known as: learned intermediary · learned intermediary doctrine
Written by attorneys · grounded in primary & secondary sources — see below
A doctrine under which a prescription drug or medical device manufacturer satisfies its duty to warn by providing adequate information about risks to the prescribing physician rather than directly to the patient. The physician's independent medical judgment in selecting and prescribing the product breaks the causal chain between the manufacturer and the patient unless the warnings to the physician were inadequate or misleading. To establish causation a plaintiff must show that an adequate warning to the physician would have changed the prescribing decision.
Lena Lawson received a prescription for a blood-pressure medication manufactured by Lakewood Manufacturing. The company had sent the prescribing physician a detailed letter describing the risk of stroke that later materialized. When Lawson sued the manufacturer for failure to warn, the court held that the adequate disclosure to her physician insulated the company from liability because the physician's independent judgment broke the causal chain.
Lucy Liu's physician prescribed a new antidepressant made by Lone Peak Energy after reviewing the company's package insert that listed the known side effects. Liu later suffered an adverse reaction and sued the manufacturer for failing to warn her directly. The court dismissed the claim because the manufacturer's duty to warn ran solely to the physician who evaluated the risks and benefits for her individual case.
Select any source to read its text and confirm it supports the definition.
Lars Lindstrom underwent surgery that included implantation of a medical device produced by Lumen Capital. The device carried a risk of infection that the company had disclosed to the surgeon. Lindstrom sued the manufacturer claiming the warning was inadequate, but he offered only general evidence that physicians knew of infection risks. The court granted summary judgment because generalized awareness could not prove that a better warning would have altered the surgeon's prescribing decision.
Yes. Florida courts and the Eleventh Circuit have applied the doctrine to medical device manufacturers, holding that the duty to warn runs to the prescribing physician rather than the patient.
Supporting sources
A plaintiff must show that an adequate warning to the physician would have altered the physician's prescribing decision. Generalized evidence that physicians were already aware of the risk is insufficient.
Supporting sources
The physician stands in the best position to evaluate a patient's needs and to assess the risks and benefits of a particular course of treatment, so an adequate warning to the physician satisfies the manufacturer's duty.
Supporting sources
…instructions on ways to safely use the product to avoid injury. Carole A. Cheney, Comment: Not Just for Doctors: Applying the Learned Intermediary Doctrine to the Relationship Between Chemical Manufacturers, Industrial Employers, and Employees , 85 Nw. U.L. Rev. 562, 566 (1991). See Hodder v. Goodyear Tire & Rubber Co. , 426 N.W.2d 826, 834…