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允许对 FDA 批准的药物和设备提起产品责任诉讼有助于提高患者安全性。

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

机构信息

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Clin Pharmacol Ther. 2010 Jun;87(6):645-7. doi: 10.1038/clpt.2009.213.

DOI:10.1038/clpt.2009.213
PMID:20485322
Abstract

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

摘要

2008 年和 2009 年,最高法院审查了这样一个问题,即因危险处方药或医疗设备而受伤的患者是否可以对制药商和设备制造商提起侵权诉讼。法院裁定,对设备制造商的诉讼被排除在外,而对制药商的诉讼则没有。产品责任诉讼的威胁通过鼓励制造商对其产品已知的不良反应提供更明确的警告,从而促进了患者安全。

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