Reimagining the Learned Intermediary Rule for the New Pharmaceutical Marketplace

Abstract

For the past decade, the learned intermediary rule - the rule of law that provides that drug manufacturers may satisfy theur 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 conseqences 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.

Keywords: tort, learned intermediary, products liability, health law, FDA, food & drug law

JEL Classification: K13, K32