Abstract

The pre-emption doctrine as applied to food and drug law argues that manufacturers whose products gain Food and Drug Administration marketing approval are immune from tort liability in state court solely on the basis of their FDA approval. This pre-emption protection applies both to claims of direct damages caused by the product and as well as indirect damages claims.The recent 8-1 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. upheld the manufacturer’s contention that the pre-emption provision in the 1976 Medical Device Amendments of 1976 to the 1938 Federal Food, Drug and Cosmetic Act completely precluded civil damages suits by injured plaintiffs in state court. Justice Ginsburg was the lone dissenter.