No lawsuits over devices if FDA approved, says USSC

Rob Luke Feb. 28, 2008, 7:20am

Justice Antonin Scalia

WASHINGTON, D.C. -- Plaintiffs cannot sue the makers of a medical device that cause harm if the device has been approved by the federal regulator, the U.S. Supreme Court (USSC) ruled last week.

The ruling was widely viewed as a victory for business defendants and a blow to consumers in medical-malpractice and similar cases.

In Riegel v. Medtronic (docket# 06-179) the USSC upheld by an 8-1 margin a Second Circuit Court of Appeals ruling that the states cannot impose liability on the manufacturers of medical devices approved by the Federal Drug Administration (FDA). The case was brought by the widow of a man who died in 1996 after a Medtronic catheter burst while being inserted.

"State requirements are pre-empted under the [federal Medical Devices Amendment] only to the extent that they are 'different from, or in addition to' the requirements imposed by federal law," wrote Justice Antonin Scalia in the opinion.

"The District Court interpreted the claims here to assert that Medtronic's device violated state tort law notwithstanding compliance with the relevant federal requirements."

In dissent, Justice Ruth Bader Ginsburg disagreed with the majority that the MDA's pre-emption clause prevented common-law challenges to FDA-approved devices. "The constriction of state authority ordered today was not mandated by Congress and is at odds with the MDA's central purpose: to protect consumer safety," she wrote.

Some legal experts, however, said consumer-advocate outrage over the decision may have been overblown, considering it is probably restricted to medical devices only. They also note that when a valid federal law conflicts with a state one, the state law must give way.

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