Pallone and Waxman to Offer Preemption Amendment

Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.) have drafted legislation to ensure federal law does not preempt state law when people harmed by medical devices sue devicemakers for liability.

The bill will be introduced next month, a spokesman for Pallone said.

The draft Medical Device Safety Act of 2008 was written because the lawmakers found the Supreme Court’s Feb. 20 decision in Riegel v. Medtronic “denies patients any legal recourse if they are a victim of a faulty medical device,” Pallone said.

The court held that the express preemption provision — section 360k of the Federal Food, Drug and Cosmetic Act (FDCA) — preempts state-law claims seeking damages for injuries caused by devices that have gone through the FDA’s premarket approval process.

The new law would amend the FDCA by adding the subsection “No Effect on Liability Under State Law,” which states, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”