坏药:处方药,先发制人,和潜在的无过错修复。

Amalea Smirniotopoulos
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引用次数: 0

摘要

几十年来,联邦对药品和医疗器械的监管与各州的侵权索赔携手合作,以保护美国公众的健康和安全。现在,一种抢占的新趋势危及了这一计划。近年来,最高法院越来越尊重行政机关关于其优先购买权的主张,并在越来越多的案件中发现了优先购买权。在这一过程中,最高法院优先考虑了医疗器械伤害索赔,并将药品损害索赔置于不稳定的地位。取消针对药物和器械危害的普通法索赔将给FDA的监管计划留下漏洞,危及美国人的健康和安全。它还将阻止普通美国人为他们的伤害寻求赔偿——即使是那些由制造商渎职造成的伤害。本文建议国会为药品和医疗器械制定一个无过错赔偿计划,以弥补这些差距。这样的方案既可行,又在政治上可行,既能满足制造商、侵权改革家、患者和原告律师的要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix.

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.

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