{"title":"Electroconvulsive Therapy, Manufacturers' Liability, and Learned Intermediaries.","authors":"Paul S Appelbaum","doi":"10.1176/appi.ps.20240518","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":20878,"journal":{"name":"Psychiatric services","volume":" ","pages":"appips20240518"},"PeriodicalIF":3.3000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psychiatric services","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1176/appi.ps.20240518","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍:
Psychiatric Services, established in 1950, is published monthly by the American Psychiatric Association. The peer-reviewed journal features research reports on issues related to the delivery of mental health services, especially for people with serious mental illness in community-based treatment programs. Long known as an interdisciplinary journal, Psychiatric Services recognizes that provision of high-quality care involves collaboration among a variety of professionals, frequently working as a team. Authors of research reports published in the journal include psychiatrists, psychologists, pharmacists, nurses, social workers, drug and alcohol treatment counselors, economists, policy analysts, and professionals in related systems such as criminal justice and welfare systems. In the mental health field, the current focus on patient-centered, recovery-oriented care and on dissemination of evidence-based practices is transforming service delivery systems at all levels. Research published in Psychiatric Services contributes to this transformation.