Sens. Edward Kennedy, D-Mass., and Patrick Leahy, D-Vt., have introduced a bill with the intent to ensure that the Food, Drug and Cosmetic Act (FDCA) does not prevent individuals from suing medical devicemakers under state tort laws.
Kennedy and Leahy introduced the companion bill to the Medical Device Safety Act of 2008 H.R. 6381, which has 62 co-sponsors in the House.
Introduced in the House in June by Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif., the new companion bill seeks to reverse the Supreme Court’s decision in Riegel v. Medtronic, in which the court ruled eight to one that the express preemption provision of the federal FDCA preempts state-law claims seeking damages for injuries caused by devices with premarket approval.
Following the Riegel decision, Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee, threatened to create legislation to override the court, according to FDANews. He said that Congress never intended for FDA approval to give immunity to manufacturers from liability for injuries caused by faulty devices.
“The FDA used to be the gold standard, but the agency has come under scrutiny recently. If manufacturers are putting faulty devices on the market, they must be held accountable to the patients who use them, the way Congress always intended. I will continue to fight for legislation like this that puts the health and safety of Americans ahead of manufacturers’ interests,” said Sen. Barbara Mikulski, D-Md., a co-sponsor of the bill.
The device industry has warned that the bill would result in more lawsuits and ultimately higher healthcare costs. “If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices,” AdvaMed President and CEO Stephen Ubl said.