University of Missouri-Kansas City School of Law, USA.
Duke Law J. 2011 Feb;60(5):1123-91.
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.
在过去的二十年中,法院一直裁定,品牌处方药的制造商不能对服用其产品仿制药的人所遭受的伤害承担责任。这意味着因服用仿制药而受伤的患者可能根本无法获得任何补救措施,因为在许多情况下,仿制药制造商都会以其没有生产任何患者的医生所依赖的信息为借口来逃避责任。这是一个令人困惑的困境。仿制药制造商生产了原告所服用的产品,品牌药制造商生产了患者的医生所看到的所有信息,即使每个制造商都有疏忽行为,也不能对他们其中任何一个制造商追究责任。加州上诉法院最近做出了一项令人震惊的裁决,即品牌药制造商可能要对服用其产品仿制药的原告承担责任。对此决定的反应是压倒性的负面。评论员谴责该决定是近年来任何法院做出的最糟糕的裁决之一。全国各地的法官都驳回了这一决定,认为这是对该问题的强烈司法共识的一种误导性偏离。尽管该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代表了法院首次正确审查了这一问题。此外,本文还指出了加州法院推理中的一些弱点,并提出了一个分析品牌药和仿制药制造商责任的新的一般框架。