Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

IF 1.8 2区 社会学 Q1 LAW Duke Law Journal Pub Date : 2011-02-01
Allen Rostron
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Abstract

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

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公平处方:品牌药和仿制药生产商侵权责任的新途径。
在过去的二十年里,法院一直裁定,名牌处方药的制造商对那些服用仿制药的人所遭受的伤害不承担责任。这意味着,受仿制药伤害的病人可能根本得不到补救,因为在许多情况下,仿制药制造商会以它没有提供病人的医生所依赖的任何信息为理由逃避责任。这是一个令人困惑的困境。原告收到的产品是仿制药制造商生产的,而病人的医生看到的所有信息都是名牌制造商提供的,即使每个制造商都有过失,也不能被追究责任。加州上诉法院最近发布了一项令人震惊的裁决,它得出结论,名牌药品制造商可能会对原告承担责任,因为原告服用了其产品的仿制药。对这一决定的反应是压倒性的负面。评论人士谴责这一裁决是近年来法院做出的最糟糕的裁决之一。全国各地的法官都认为这是一种误入歧途的偏差,偏离了在这个问题上达成的强有力的司法共识。尽管这一决定受到了严厉的批评,但本文认为,加州法院的裁决实际上是法院首次对这一问题进行适当审查。此外,本文还指出了加州法院推理中的一些不足之处,并提出了一种新的通用框架来分析品牌药和仿制药制造商的责任。
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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来源期刊
CiteScore
1.90
自引率
0.00%
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0
期刊介绍: The first issue of what was to become the Duke Law Journal was published in March 1951 as the Duke Bar Journal. Created to provide a medium for student expression, the Duke Bar Journal consisted entirely of student-written and student-edited work until 1953, when it began publishing faculty contributions. To reflect the inclusion of faculty scholarship, the Duke Bar Journal became the Duke Law Journal in 1957. In 1969, the Journal published its inaugural Administrative Law Symposium issue, a tradition that continues today. Volume 1 of the Duke Bar Journal spanned two issues and 259 pages. In 1959, the Journal grew to four issues and 649 pages, growing again in 1970 to six issues and 1263 pages. Today, the Duke Law Journal publishes eight issues per volume. Our staff is committed to the purpose set forth in our constitution: to publish legal writing of superior quality. We seek to publish a collection of outstanding scholarship from established legal writers, up-and-coming authors, and our own student editors.
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