Supreme Court Shields Medical-Device Makers

Scalia wrote that devices such as Medtronic's catheter are subjected to nearly a year of study. Because they are designed to be used on people with the most serious medical conditions, Scalia wrote, they can carry great risks for patients and thus the FDA plays an important role in weighing the benefits against the potential costs.

Allowing juries to award damages when something goes wrong, Scalia wrote, would be unfair. A jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court," Scalia wrote. Patients "would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations."

But Ginsburg, in her dissent, wrote that she doubted Congress meant to foreclose consumers injured by FDA-approved devices that "nevertheless prove unsafe.

"The MDA's failure to create any federal compensatory remedy for such consumers further suggests that Congress did not intend broadly to preempt state common-law suits grounded on allegations independent of FDA requirements."

The decision upset some Democrats on Capitol Hill.

"The Supreme Court's decision strips consumers of the rights they've had for decades," said Rep. Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. "This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

The American Association for Justice, a group of trial lawyers, said in a statement attributed to chief executive Jon Haber that the decision "limits the rights of people to receive justice through the legal system when they are injured by the negligence or misconduct of others."

But, like Sharkey, the association pointed out that the decision was narrowly tailored to apply only to Class III medical devices -- those that have received the highest level of FDA scrutiny.

And Scalia's opinion said the law "does not prevent a state from providing a damages remedy for claims premised on a violation of FDA regulations.''

Scalia also noted that the preemption clause passed by Congress refers to medical devices approved by the FDA, not drugs, leaving that question for another day.