A New Jersey federal judge has thrown out a suit alleging a heart medication made by Eon Labs Inc. and Sandoz Inc. led to injuries and deaths due to off-label use, saying the plaintiffs’ claims are preempted by federal law.
U.S. District Judge Madeline Cox Arleo dismissed a suit led by Noah Medford against the companies over the drug Amiodarone, a generic form of the heart drug Cordarone, as Medford has not identified state law that parallels the U.S. Food, Drug and Cosmetic Act or U.S. Food and Drug Administration regulations.
The 277 plaintiffs allege that they, or their family members, died or were injured after receiving Amiodarone after being diagnosed with atrial fibrillation.Neither the drug nor its name brand version were approved by the FDA for treatment of atrial fibrillation, but rather as a “last resort” drug for recurrent, life-threatening ventricular fibrillation and ventricular tachycardia.
Medford alleges that Cordarone’s maker, Wyeth Pharmaceuticals, deliberately marketed Cordarone’s use as a “first-line” therapy for atrial fibrillation, and that Eon and Sandoz, as makers of the generic version, piggybacked off this marketing to sell their own drugs for the same uses. Wyeth is not a party in the suit.
The claims center on three theories: that Eon and Sandoz failed to provide medication guides, that they wrongly promoted off-label uses of Amiodarone, and that they failed to report adverse events to the FDA.
Judge Arleo found that each of these claims were preempted by federal law, saying that the claims stem from alleged violations of FDA regulations and the FDCA, but that Medford hasn’t identified parallel state law that allows him to pursue his claims.