The learned intermediary doctrine and patient package inserts: A balanced approach to preventing drug-related injury

In this note, Catherine Paytash examines the validity of the learned interm ediary doctrine as it is applied in the context of prescription drug therap y. She explores and analyzes the rationales advanced to support the rule an d the criticisms that have been leveled against its application to prescrip tion drugs. Paytash identifies two roles that the learned intermediary doct rine is intended to play in relation to prescription drugs; I) a role that provides a reasonable and efficient legal system of warning about side effe cts and appropriate use, and 2) a role that encompasses a system for inform ing patients. Paytash concludes that the learned intermediary doctrine, tho ugh justified as a legal standard of liability for warnings provided by pre scription drug manufacturers, is inadequate as a system for informing patie nts about the prescription medications they use. She proposes that the most efficient way of preventing prescription drug related injury is a hybrid s olution comprised of the learned intermediary doctrine as the legal standar d for liability for product warnings and an FDA-mandated system of patient package inserts as a supplemental means of providing prescription drug user s with information.