The "Learned Intermediary": The Role of the Psychiatric Interventionist in Product Liability Lawsuits.

Abstract

Abstract: Malpractice lawsuits brought by patient-plaintiffs alleging damages from medications or medical devices may entangle both the prescriber and the biomedical manufacturer. In this scenario, the prescriber may be viewed as a defendant, or alternatively as a "learned intermediary" (LI) between the patient and biomedical company. Recent legal actions in the United States involving manufacturers of electroconvulsive therapy devices have invoked the principle of the LI in the arguments. The plaintiff argued that the manufacturer held a major responsibility for providing to device operators warnings which lack scientific basis. This commentary will describe the legal concepts of the LI, and we will argue that the prescriber's duty to the patient is to provide relevant warnings with a scientific grounding, based upon the sum total of the prescriber's education. The courts opined that the conveyance of benefit and risk information to the patient should reflect what is "known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available ." Himes v. Somatics, LLC, 16 Cal. 5th 209, 222, 549 P.3d 916, 923 (2024) (emphasis added).