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Medical Device Safety Act Would Restore Consumer Rights

Jun 27, 2008 | Parker Waichman Alonso LLP

A bill to overturn a Supreme Court ruling that protects the makers of defective medical devices from product liability lawsuits was introduced in the House of Representatives yesterday.  One of the bills sponsors, Rep. Frank Pallone, D-N.J, said in a statement that the Medical Device Safety Act of 2008 would reverse "an unfortunate Supreme Court decision that denied victims any legal recourse."

Sens. Edward Kennedy (D-Mass) and Patrick Leahy (D-Vt)  plan to introduce companion legislation in the Senate.

Drug makers and medical device manufacturers have been waging an aggressive campaign in the courts to obtain protection against product liability suits.  In February, medical device makers got their wish when the Supreme Court agreed with Medtronic Inc. and ruled that that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (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.

The Bush Administration recently  sided with drugmakers in another preemption case involving a Wyeth drug that is going before the High Court in the fall. It is expected that the Court will extend the preemption theory to pharmaceutical companies after it hears that case.