FDA,避孕药上市批准和产品责任诉讼:Depo-Provera和骨质疏松的风险。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2013-01-01
William Green
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引用次数: 0

摘要

1992年,FDA批准了一种注射避孕药Depo-Provera,条件是其制造商在批准后进行骨质疏松症风险的研究。然后在2004年,该机构修改了该药的标签,包括一个关于骨质疏松风险的黑盒子警告。本文将分析FDA的Depo-Provera批准和标签修订过程:该机构对Upjohn新药申请的接受,其生育和孕产妇健康咨询委员会对人体临床研究和批准建议的审查,Depo-Provera的上市批准,以及2004年药品标签修订。然后,本文将分析2004年后由声称因使用该药而受伤的妇女提起的产品责任诉讼。没有一个案例在制造商的简易判决动议中幸存下来,因为这些女性无法通过专家和医生的证据证明fda批准的标签不足以告知她们的医生骨质疏松症的风险,不充分的警告导致了骨质疏松症或骨质减少,并且这些伤害是可以赔偿的。因此,制造商已经能够使用FDA标签、国家产品责任法和学习中介原则来避免责任。结论将考虑这些产品责任案件的教训,为其他妇女谁接受了Depo-Provera和骨密度损失。
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The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.

The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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