Department of Psychiatry, Columbia University, USA.
Psychiatr Serv. 2011 Apr;62(4):347-9. doi: 10.1176/ps.62.4.pss6204_0347.
When can pharmaceutical companies be held liable for failure to disclose medication risks--such as the link between selective serotonin reuptake inhibitors and suicidality of young people? The companies have claimed that Food and Drug Administration approval of labeling information, required by federal law, should preempt liability in state courts. Thus injured patients would either be left without recourse or be compelled to sue the clinicians who prescribed the medication. A recent U.S. Supreme Court decision, however, rejected the preemption defense and opened the door to patients' suits that seek compensation. This column explores the application of this new approach and its implications for the mental health professions.
制药公司何时会因未能披露药物风险（如选择性 5-羟色胺再摄取抑制剂与年轻人自杀的关联性）而承担责任？这些公司声称，根据联邦法律要求，食品和药物管理局批准标签信息应先于州法院的责任。因此，受伤的患者要么没有追索权，要么被迫起诉开出处方的临床医生。然而，美国最高法院最近的一项裁决驳回了这种先占抗辩，并为寻求赔偿的患者诉讼打开了大门。本专栏探讨了这种新方法的应用及其对精神卫生专业的影响。
