Hall Timothy S
Louis D. Brandeis School of Law at the University of Louisville, USA.
Seton Hall Law Rev. 2004;35(1):193-261.
For the past decade, the learned intermediary rule--the rule of tort law that provides that drug manufacturers may satisfy their duty to warn of a drug's dangers by warning the prescribing physician rather than the end user of the drug--has been the subject of vigorous academic debate. That debate has been largely moot, however, as the courts have proven reluctant to make significant inroads on the protection offered by the Rule to drug manufacturers. This Article proposes a new approach to the Rule. Part I discusses the history and overwhelming adoption of the Rule pursuant to the Restatement (Second) of Torts. Part II argues that changes in the health care delivery system have resulted in a legal system that introduces market distortions by effectively immunizing the pharmaceutical industry from the legal and social consequences of its own actions. Part III then sets forth a reconceptualization of the Rule, which preserves the Rule's benefits with respect to the drug industry, the health care system, and the goals of tort law, while also strengthening the protection the tort system offers to individuals injured by prescription drugs.
在过去十年里,学识渊博的中间人规则——侵权法中的一项规则,规定药品制造商可以通过警告开处方的医生而非药品的最终使用者来履行其对药品危险性进行警告的义务——一直是激烈学术辩论的主题。然而,由于法院已证明不愿对该规则给予药品制造商的保护进行重大突破,这场辩论在很大程度上已无实际意义。本文提出了一种针对该规则的新方法。第一部分讨论了该规则依据《侵权法重述(第二版)》的历史及广泛采用情况。第二部分认为,医疗保健提供系统的变化导致了一种法律体系,该体系通过有效免除制药行业自身行为的法律和社会后果而引入了市场扭曲。第三部分接着阐述了对该规则的重新概念化,既保留了该规则在药品行业、医疗保健系统以及侵权法目标方面的益处,同时也加强了侵权系统对因处方药而受伤的个人提供的保护。