Healthy Skepticism Library item: 9322

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

Young AL, Rave NL.
Product liability considerations in prescription drug labeling
Drug Inf J 1993; 27:(3):915-920

Abstract:

Current doctrines for holding manufacturers of pharmaceuticals liable for failing to adequately warn of potential adverse effects are reviewed, basic concepts for product liability are explained, and current cases that address which adverse effects require warnings and to whom the warnings must be given are reviewed. The interactions between compliance with Food and Drug Administration regulations and potential civil liability are also examined.