Interpreting the Supreme Court's Medical Device Decision

The ruling gives the FDA the final word, but legal experts say it's not as extensive as it appears.


Members of the U.S. Supreme Court.

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On the face of it, the Supreme Court's decision this week to shield medical device makers from lawsuits appeared to be a big win for business—and a possible sign of hard times to come for consumers. In an 8-to-1 decision, the justices ruled against a New York man, Charles Riegel, who died after a balloon catheter made by Medtronic burst after being inserted during an angioplasty in 1996. Riegel's wife sued, but the court sided with the company, saying states don't have the right to impose liability on medical device makers so long as the devices have been approved by the FDA.

Consumer advocates were outraged, viewing the decision as the first blow struck by an increasingly pro-business court. The ruling, after all, effectively makes the FDA—an agency that has struggled recently in its monitoring role—the final word on medical devices: If the agency gives a product its approval, consumers harmed by a device may have limited legal recourse. Democrats on Capitol Hill are beside themselves. "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," Sen. Ted Kennedy said in a statement. "Congress obviously needs to correct the court's decision."

Legal scholars, though, insist that the ruling may not be as extensive as it appears, and, more important, has no real application beyond medical devices. The justices didn't actually have that much room to maneuver, experts say: They were bound by a federal law passed in 1976 that defined the FDA's "premarket" approval process for medical devices—and included a specific clause preventing state law from pre-empting it. "They interpreted it relatively broadly, but their interpretation wasn't that weird," says Jonathan Varat, a law professor at UCLA. "That's why eight of them voted for it." The pre-emption clause, he points out, was inserted to prevent confusion: After the FDA has approved a device, Congress doesn't want states forcing companies to tinker with their products. The statute reflects this, disallowing states from imposing "any requirement" on devices.

The justices' reasoning may not have been overflowing with empathy, but it does seem to hold up. Victims of malfunctioning devices who file suit against a company rely on common law torts to bring their cases—effectively invoking state law, Varat says, to force companies to change their products. In his majority opinion, Justice Antonin Scalia wrote that state tort law, because it requires companies to account for possible lawsuits, qualifies as an unacceptable new requirement. "If you don't comply with state law, you're going to be subject to liability," says Varat, "The lawyer's going to say 'Do it, or you're going to get sued.' That sounds like imposing a requirement to me."

Health policy experts agree that the justices really didn't have much wiggle room this time. Though some of them appeared more willing than others to support a decision that effectively reduces court damage awards—a pet peeve of the Bush administration—if a valid federal law conflicts with a state law, the state law has to give way. "It made it easy for the justices to say there's a case for pre-emption," says Joy Wilson, health policy director at the National Conference of State Legislatures.

So just how pro-business—and anti-supersize jury awards—is the new Roberts court? Experts say the real test will come this fall, when the court takes up another case, Wyeth v. Levine. That case, which involves a woman whose arm was amputated after a drug gave her gangrene, involves a pharmaceutical company, not a medical device maker. There is no specific federal pre-emption in statutes governing drug companies, so the justices may have more room to decide for themselves whether the company can be held liable for causing harm.

Experts aren't sure which way the justices will fall, but few expect the majority to side so strongly with business. "That to me, would be a fairly big leap, and quite different," says Wilson.