The Litigation Counsellor®

Hot Litigation Topic: Pliva v. Mensing

Written by Counsel Financial | Sep 26, 2011 9:16:49 PM

Justice Thomas writing for the Supreme Court held that Federal labeling laws preempt state law, and that generic drug manufacturers cannot be held liable under state law actions for failure to warn. Because generic drug manufacturers are required by the FDA to use the EXACT same labels as the brand name manufacturers it would be "impossible" for the generic drug manufacturers to comply with the Federal duty of sameness, and to have used a stronger warning label, as required by state law. The opinion was followed by a strong dissent written by Justice Sotomayor. She argued that since generic drug manufacturers can "take steps" to convince the FDA to increase the labeling requirements (which this Defendant has not done) there was only a "possibility of impossibility". The decision basically holds that generic drug manufacturers have no liability for the inadequacy of their labels, regardless of the steps they take to make them safer, because the FDA tells them their labels must match those of their brand name counterparts.