Medtronic Inc. and other medical device makers got a gift from the US Supreme Court yesterday, after it ruled that Food & Drug Administration (FDA) pre-market approval of a medical device shields companies from state product liability lawsuits. While the Supreme Court ruling will nullify some medical device product liability lawsuits currently making their way through state courts, it is unclear how great an affect it will really have, because most medical devices on the market today went through a different approval process than the one at issue in this case.
According to The New York Times, the Supreme Court’s decision was one sought by the Bush Administration, which since 2004 has been trying to reverse longstanding federal policy that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law. In the case considered by the Supreme Court, Medtronic 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. 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 sole dissenter on the court, Justice Ruth Bader Ginsberg, clearly disagreed. In her dissent, the Justice wrote that court had misread Congress’s intent in adding the pre-emption clause to the law. All Congress intended when it wrote the law was to prevent individual states from imposing their own premarket approval process on new medical devices, Justice Ginsberg argued.
Several lawmakers quickly voiced their disapproval of the Supreme Court’s decision and promised quick action to reverse it. “The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Rep. Henry Waxman (D-Calif) told The New York Times. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
It’s not clear how many current state medical device lawsuits might be barred as a result of this ruling, 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, 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.
But the Bush Administration is still not finished with the pre-emption issue. According to The New York Times, next Monday, the Supreme Court will hear another FDA. pre-emption case, Warner-Lambert Co. v. Kent. The issue in that case is whether a state lawsuit can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the FDA during the approval process. The Bush Administration has taken the side of drug makers in that case. The Administration is also arguing in Wyeth vs. Levine – a case the Supreme Court is taking up next term – that, in the case of FDA approved drugs, a shield exists against state product liability lawsuits even though the Food, Drug and Cosmetic Act of 1938 does not contain a pre-emption clause.
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