Twerski Aaron D
Brooklyn Law School, Brooklyn, New York.
Am Univ Law Rev. 2018;68(1):281-304.
For over half a century, courts and commentators have disagreed as to the standards governing liability for drug design cases. In the last several years, the United States Supreme Court decided two cases that will have a profound effect on whether drug design defect cases, in general, are federally preempted. In PLIVA v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, the Court preempted product liability actions for failure to warn and design defect against the manufacturers of generic drugs that met the FDA standard for the brand name drug. In these cases, the Court made wide-ranging statements that are applicable to brand name drugs as well. This Essay finds the Bartlett Court erred in having read New Hampshire law too narrowly. At the same time, the Court's reasoning has opened a debate as to the scope of federal preemption for brand name drugs. This Essay argues that the sweeping language in these two cases leads to the conclusion that common law drug design cases involving brand name drugs will fall prey to federal preemption.
半个多世纪以来,法院和评论家们对于药物设计案件的责任判定标准一直存在分歧。在过去几年里,美国最高法院判决了两起案件,这两起案件将对药物设计缺陷案件总体上是否被联邦法律优先适用产生深远影响。在“普利瓦诉门辛案”(PLIVA v. Mensing)和“互助制药公司诉巴特利特案”(Mutual Pharmaceutical Co. v. Bartlett)中,最高法院判定,对于符合FDA品牌药标准的仿制药制造商,因未提供警示和设计缺陷而引发的产品责任诉讼不成立。在这些案件中,最高法院还做出了一些广泛适用的声明,这些声明同样适用于品牌药。本文认为,巴特利特案的法院在对新罕布什尔州法律的解读上过于狭隘,因而出现了错误。与此同时,法院的推理引发了一场关于联邦法律对品牌药优先适用范围的辩论。本文认为,这两起案件中的笼统措辞导致了这样一个结论:涉及品牌药的普通法药物设计案件将沦为联邦法律优先适用的牺牲品。