WASHINGTON--Consumers injured by medical devices approved byfederal regulators cannot file product liability suits against themakers in state courts, the U.S. Supreme Court ruled yesterday.

In a 8-1 decision, the court ruled that manufacturers of medicaldevices are not liable for personal injuries under a 1976 law aslong as the Food and Drug Administration approved the device beforeit was marketed and it meets the agency's specifications.

These devices include heart valves, implantable defibrillatorsor breast implants, for example.

Writing for the majority in the case (Riegel vs. MedtronicInc.), Justice Antonin Scalia said permitting state juries toimpose liability on the maker of an approved device "disrupts thefederal scheme" under which the Food and Drug Administration hasthe responsibility for evaluating the risks and benefits of a newdevice and assuring that it is safe and effective for its intendeduse.

In a dissenting opinion, Justice Ruth Bader Ginsburg said thatCongress did not intend such drastic limits on state courtsuits.

The decision dealt with a suit brought by Charles Riegel in NewYork state, who was injured in 1996 during an angioplasty when aballoon catheter burst while being inserted to dilate a coronaryartery. Mr. Riegel died after the lawsuit was filed, and it wascontinued by his wife, Donna. The decision affirmed the dismissalof Ms. Riegel's lawsuit. The device was approved for use by the FDAin 1994.

But an official of an insurer involved in the niche business ofinsuring the product liability risk of medical device makers andlife sciences companies said the decision in no way immunizesmedical device manufacturers or the doctors who use the devicesfrom potential liability.

"There are still plenty of avenues for financial redress on thepart of injured patients," said Kevin Quinley, senior vicepresident of Medmarc, a risk specialty insurance company based inChantilly, Va. "It does make one path more difficult for them, butthere are other paths."

"There is not a lot of stripping away here," he added.

Specifically, Mr. Quinley said, the decision does not rule outlawsuits claiming that a device was made improperly, in violationof FDA specifications. "Cases may also be brought under state lawsthat mirror federal rules, as opposed to supplementing them," Mr.Quinlan said.

"This does not bring total immunity," added John Salvucci, adefense lawyer specializing in medical device and product liabilitycases at Cozen O'Connor in Philadelphia. "The underpinningrationale acknowledges that every device has both risks andbenefits."

"The FDA weighs those risks and benefits and makes the decisionthat is in the best interest of the public," he said. "If thedecision permits the marketing of the device, that does not meanthat all risks have been eliminated; it merely accepts that thebenefits outweigh the risks.

"Implementing preemption is in the public good, and the SupremeCourt recognized that it is in the public interest to preservepreemption in its decision,:" Mr. Salvucci added.

Reacting to the decision was Sen. Edward Kennedy, D-Mass.,chairman of the Health, Education, Labor and Pensions Committee andsole Senate sponsor of the 1976 law at the heart of the courtdecision.

"In enacting legislation on medical devices, Congress neverintended that FDA approval would give blanket immunity tomanufacturers from liability for injuries caused by faultydevices," Mr. Kennedy said. He added, "Congress obviously needs tocorrect the court's decision."