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"Medical Device Safety Act" Seeks to Overturn Supreme Court Ruling on Defective Device Lawsuits

Mar 26, 2008 | Parker Waichman Alonso LLP

Lawmakers in Congress are getting closer to passing legislation that would overturn a Supreme Court decision that barred people injured by defective medical devices from suing in state courts if the device was approved by the Food & Drug Administration (FDA).  Two members of the House of Representatives say they are drafting a bill to overturn the decision that should be ready sometime next month.

In the case considered by the Supreme Court, Medtronic Inc, the maker of the faulty Sprint Fidelis Defibrillator Lead and other defective devices,  had argued  that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts.  That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.  Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Eight members of the Supreme Court agreed with Medtronic.  In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device.  Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

But U.S. Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif. disagree with the Supreme Court's interpretation, and want to clarify the law in broader terms.  To that end, they plan to introduce the " Medical Device Safety Act" that would state that existing federal law governing medical device approvals does not "modify or otherwise affect" lawsuits brought in state courts. As it stands now, the bill would apply to any civil action pending or filed on or after the date of enactment. A spokeswoman for Pallone told the Pioneer Press that  the bill is expected to be introduced shortly after Congressional leaders return from break Monday.

It’s not clear how many current state medical device lawsuits might be barred if the Supreme Court's ruling is allowed to stand, but it does not ban all of them.  According to The New York Times, most medical devices now available reached the market through a different process than covered by the decision, under which the FDA found them to be “substantially equivalent” to those marketed before the 1976 law took effect. The Supreme Court ruled in 1996 that this approval process does not pre-empt state damage suits against manufacturers. The decision also does not ban state lawsuits against medical devices that are not manufactured according to FDA specifications, and lawsuits can still be brought under state laws that mirror federal laws.