Device Preemption Ruling Threatened by Draft Bill

Congress is turning up the heat on a preemption win for devicemakers as prominent lawmakers say they will soon introduce a bill to make the U.S. Supreme Court decision moot.

The court ruled earlier this year that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by devices with FDA premarket approval.

Bill sponsor Rep. Frank Pallone (D-N.J.) said the court’s decision ignores congressional intent and 30 years of experience in which “FDA regulation and tort liability have played complementary roles in protecting consumers from device risks.”

Lawmakers want to change that by amending the FDCA with the Medical Device Safety Act of 2008. It would add a subsection to the FDCA stating, “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.”

The legislation would apply to cases pending on the date of its enactment as well as claims for injuries sustained prior to its enactment. But cases dismissed on preemption grounds prior to its enactment could not be resurrected.

A spokesman for Pallone’s office said the bill would be introduced in the next several weeks.
 
The draft bill is available at www.fdanews.com/ext/files/FinalBill.pdf.