Ruling on Devices Could Signal ‘Big Win’ for Drugmakers

A U.S. Supreme Court ruling in favor of federal preemption in Riegel v. Medtronic is a “big win” for manufacturers and paves the way for similar rulings in two upcoming drug preemption cases, one expert says.

Wednesday’s 8–1 decision limits devicemakers’ liability under state laws for products with the FDA’s premarket approval (PMA) and demolishes long-standing arguments from plaintiffs opposing preemption, James Beck, counsel with Philadelphia law firm Dechert’s product liability group, said. The firm did not represent either party in the case.

The court ruled that the express preemption provision of the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by devices with PMA.

Next week, the court will hear arguments in Warner-Lambert v. Kent on whether state law is preempted to the extent it requires a court to determine as a prerequisite to awarding tort damages whether a drug manufacturer committed fraud on the FDA.

The court also has agreed to hear a second drug preemption case, Levine v. Wyeth, in which it will decide whether the FDA’s authority to regulate labeling of a Wyeth drug preempts Vermont state law for product liability. No date has been set for that hearing.

Drug and device preemption cases differ because devices are subject to an express preemption provision in the FDCA whereas the law only implies preemption for drug cases. In the Riegel decision, however, Beck notes that much of the court’s description of the PMA process strongly resembles the FDA approval process for new drug applications.