A Medical Device Daily

Two senators have followed the lead of House lawmakers and introduced a Senate counterpart of the Medical Device Safety Act of 2008 to ensure individuals are not prevented by the Food, Drug and Cosmetic Act (FDCA) from suing device makers under state tort laws.

Sens. Edward Kennedy (D-Massachusetts.) and Patrick Leahy (D-Vermont.) introduced the companion bill to H.R. 6381, which has 62 co-sponsors in the House, last month.

Introduced in the House in June by Reps. Frank Pallone (D-New Jersey) and Henry Waxman (D-California) (Medical Device Daily, April 3, 2008), the bill seeks to reverse the Supreme Court's decision in Reigel v. Medtronic, which confirmed preemption of state tort suits for FDA-approved medical devices.

Following the Riegel decision, Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee, threatened to create legislation to override the court. He said 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," Sen. Barbara Mikulski (D-Maryland), a co-sponsor of the bill, said.

The device industry warns 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," Advanced Medical Technology Association (Washington) President/CEO Stephen Ubl said in a statement.

No Comments