The Mensing Conundrum: Litigating Generic Drug Injuries in California

Richard E. Custin, Michelle O'Connor-Ratcliff, R. Ratcliff
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Abstract

As long as there have been prescription drugs, people have suffered injuries caused by those drugs. While a perfect level of safety is just not possible, state tort laws have long provided protection to injured drug consumers and incentive to drug manufacturers to improve and maintain the safety of their products. However, the United States Supreme Court has recently revealed an alarming gap in this supposed consumer protection and safety incentive scheme. A series of cases now reveals that some state claims of injury resulting from a prescription drug are not preempted by federal law if the drug is a brand name, but are preempted if the drug is a generic. This incongruity in federal law may leave a consumer injured by a generic drug without a viable civil remedy. Consumers are likely to be completely unaware of the protections they are giving up when they accept a cheaper, generic prescription, leaving them at a significant legal disadvantage. Generic drugs continue to capture an increased market share of prescriptions, so the number of consumers affected by federal preemption will grow. This article will provide a brief history of generic drugs, outline the recent United States Supreme Court cases that have revealed the consumer protection problem related to generics, and address potential solutions for litigating generic prescription drug injury claims in California.
月经难题:在加州诉讼仿制药伤害
只要有处方药,人们就会遭受这些药物造成的伤害。虽然完美的安全水平是不可能的,但长期以来,州侵权法为受伤的药品消费者提供了保护,并激励药品制造商改善和维持其产品的安全性。然而,美国最高法院最近揭露了这个所谓的消费者保护和安全激励计划中令人震惊的漏洞。现在的一系列案例表明,一些州对处方药造成的伤害的索赔,如果药物是品牌,则不受联邦法律的优先考虑,但如果药物是仿制药,则优先考虑。联邦法律中的这种不协调可能使消费者受到仿制药的伤害而没有可行的民事救济。消费者很可能完全没有意识到,当他们接受更便宜的非专利处方时,他们正在放弃保护,这使他们在法律上处于明显的劣势。仿制药继续占据越来越多的处方市场份额,因此受联邦优先购买权影响的消费者数量将会增加。本文将简要介绍仿制药的历史,概述最近美国最高法院的案件,这些案件揭示了与仿制药有关的消费者保护问题,并讨论了在加利福尼亚州诉讼仿制药处方药伤害索赔的潜在解决方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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