Green William
Food Drug Law J. 2013;68(2):115-35, i.
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.
1992年，美国食品药品监督管理局（FDA）批准了可注射的避孕药物甲羟孕酮避孕针（Depo - Provera），条件是其制造商要针对骨质疏松风险开展批准后研究。2004年，该机构修订了该药物的标签，加入了关于骨质疏松风险的黑框警告。本文将分析FDA对甲羟孕酮避孕针的批准及标签修订过程：该机构对优普强公司（Upjohn）新药申请的受理情况、其生育与孕产妇健康咨询委员会对人体临床研究的审查及批准建议、对甲羟孕酮避孕针的上市批准，以及2004年的药物标签修订。接着，本文将分析2004年后那些声称因使用该药物而受伤的女性提起的产品责任诉讼。在这些案件中，没有一起能成功抵御制造商的简易判决动议，因为这些女性无法通过专家和医生的证据证实，FDA批准的标签不足以让她们的医生了解骨质疏松风险，不足以告知她们的医生骨质疏松风险，即不充分的警告导致了她们的骨质疏松或骨质减少，以及这些是可获赔偿的伤害。因此，制造商得以利用FDA的标签、州产品责任法和知悉中介原则来避免承担责任。结论部分将思考这些产品责任案件给其他使用过甲羟孕酮避孕针并出现骨密度流失的女性带来的教训。
