Electroconvulsive Therapy, Manufacturers' Liability, and Learned Intermediaries

Psychiatr Serv. 2024 Nov 19:appips20240518. doi: 10.1176/appi.ps.20240518. Online ahead of print.

Abstract

Manufacturers of drugs or devices that are prescribed by physicians are protected by the "learned intermediary rule" from having to disclose risks directly to patients. Instead, they must inform physicians of these risks. But when a company fails to disclose a known risk, how can a patient gain compensation for any resulting harm? The California Supreme Court considered this question in a case involving alleged memory impairment from electroconvulsive therapy. By broadening the ways by which plaintiffs can demonstrate that the absence of a warning caused their injury, the court made it easier for patients to recover compensation for the consequences.

Keywords: Compensation; Electroconvulsive therapy (ECT); Law and psychiatry; Learned intermediary rule; Medical harm.