Giorgi-Guarnieri Deborah
DGG Medical, Inc., Newport News, VA.
Focus (Am Psychiatr Publ). 2019 Oct;17(4):372-379. doi: 10.1176/appi.focus.20190024. Epub 2019 Nov 6.
Malpractice claims frequently focus on the clinician's prescription of medications. Claims may arise in many environments: inpatient units, outpatient offices, prisons, journal articles, pharmaceutical talks, and clinical trials of new medications. The basis of the claim may be product liability, informed consent, deliberate indifference, violation of the Federal Food, Drug, and Cosmetic Act, or academic malpractice. All malpractice claims include a duty, a breach of duty, causation, and damages. The duty and breach of duty may be obvious, but causation can vary considerably in malpractice claims. Perhaps the damages are most apparent when the patient has suffered side effects. This article explores clinician liability for the use of antidepressants from the clinical trial to the removal from the market.
医疗事故索赔常常聚焦于临床医生的用药处方。索赔可能出现在许多环境中:住院病房、门诊办公室、监狱、期刊文章、药品讲座以及新药临床试验。索赔的依据可能是产品责任、知情同意、故意漠视、违反《联邦食品、药品和化妆品法案》或学术失范行为。所有医疗事故索赔都包括义务、义务的违反、因果关系和损害赔偿。义务和义务的违反可能很明显,但在医疗事故索赔中因果关系差异很大。当患者出现副作用时,损害赔偿可能最为明显。本文探讨了从临床试验到药品退市期间临床医生使用抗抑郁药的责任。