Drug-Eluting Stents Protected by Preemption, Judge Rules

Citing the preemption provision in the Federal Food, Drug and Cosmetic Act, Louisiana Judge Tom Stagg dismissed a case against Boston Scientific involving its Class III Taxus drug-eluting stent. “The district court’s decision in this case is a significant one for the device industry because it expressly extends the principle of federal preemption to a drug-device combination product for which the ‘primary mode of action’ is that of a Class III device,” James Cohen, an attorney at Buchanan Ingersoll Rooney, said. The ruling in McQuiston v. Boston Scientific Corp. mirrors a Minnesota decision in June involving a drug-eluting stent produced by Johnson & Johnson subsidiary Cordis.
Devices & Diagnostics Letter