Healthy Skepticism Library item: 6898

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Paytash CA.
The learned intermediary doctrine and patient package inserts: a balanced approach to preventing drug-related injury.
Stanford Law Rev 1999 May; 51:(5):1343-71

Abstract:

In this note, Catherine Paytash examines the validity of the learned intermediary doctrine as it is applied in the context of prescription drug therapy. She explores and analyzes the rationales advanced to support the rule and the criticisms that have been leveled against its application to prescription drugs. Paytash identifies two roles that the learned intermediary doctrine is intended to play in relation to prescription drugs: 1) a role that provides a reasonable and efficient legal system of warning about side effects and appropriate use, and 2) a role that encompasses a system for informing patients. Paytash concludes that the learned intermediary doctrine, though justified as a legal standard of liability for warnings provided by prescription drug manufacturers, is inadequate as a system for informing patients about the prescription medications they use. She proposes that the most efficient way of preventing prescription drug related injury is a hybrid solution comprised of the learned intermediary doctrine as the legal standard for liability for product warnings and an FDA-mandated system of patient package inserts as a supplemental means of providing prescription drug users with information.

Keywords:
Advertising/legislation & jurisprudence Consumer Participation Drug Labeling*/legislation & jurisprudence Duty to Warn/legislation & jurisprudence* Humans Legislation, Drug Liability, Legal Models, Theoretical Pharmaceutical Preparations/adverse effects* United States United States Food and Drug Administration