Gregory J. Wartman

Another Federal District Court Rules That FDA Labeling Regulations Preempt Some State Law Tort Claims
Gregory J. Wartman, April 10, 2008
A federal district court in Oklahoma recently ruled that a plaintiff's state law failure to warn claims against a prescription drug manufacturer are preempted by FDA regulations because FDA had considered and expressly rejected the plaintiff's proposed additional warning.

U.S. Supreme Court Rules Most State Law Tort Claims against Premarket Approved Medical Devices Preempted
Mark Carlisle Levy, Gregory J. Wartman, April 10, 2008
On February 20, 2008, the United States Supreme Court ruled that the 1976 Medical Device Amendments to the federal Food, Drug and Cosmetic Act preempts common law tort claims challenging the safety and effectiveness of a medical device approved by the premarket approval process.