This comment will attempt to examine and evaluate the learned intermediary doctrine in light of the recent explosion in direct-to-consumer advertising of pharmaceutical products, focusing on an analysis of product liability principles, including comments from the proposed Restatement (Third) of Torts, as they apply to this subject. This comment will examine the potential ramification of FDA consumer advertising requirements, especially as they relate to potential additional exceptions to the learned intermediary doctrine. This analysis will support the conclusion that the learned intermediary doctrine remains functional and provides the consumer with the best available alternative to ensure the most appropriate use of safe and effective pharmaceuticals.
Michael C. Allen, Medicine Goes Madison Avenue: An Evaluation of the Effect of Direct-to-Consumer Pharmaceutical Advertising on the Learned Intermediary Doctrine, 20 Campbell L. Rev. 113 (1997).