Court Says Medical Device Makers Immune From State Court Suits

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

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

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

Writing for the majority in the case (Riegel vs. Medtronic Inc.), Justice Antonin Scalia said permitting state juries to impose liability on the maker of an approved device "disrupts the federal scheme" under which the Food and Drug Administration has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use.

In a dissenting opinion, Justice Ruth Bader Ginsburg said that Congress did not intend such drastic limits on state court suits.

The decision dealt with a suit brought by Charles Riegel in New York state, who was injured in 1996 during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. Mr. Riegel died after the lawsuit was filed, and it was continued by his wife, Donna. The decision affirmed the dismissal of Ms. Riegel's lawsuit. The device was approved for use by the FDA in 1994.

But an official of an insurer involved in the niche business of insuring the product liability risk of medical device makers and life sciences companies said the decision in no way immunizes medical device manufacturers or the doctors who use the devices from potential liability.

"There are still plenty of avenues for financial redress on the part of injured patients," said Kevin Quinley, senior vice president of Medmarc, a risk specialty insurance company based in Chantilly, Va. "It does make one path more difficult for them, but there are other paths."

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

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

"This does not bring total immunity," added John Salvucci, a defense lawyer specializing in medical device and product liability cases at Cozen O'Connor in Philadelphia. "The underpinning rationale acknowledges that every device has both risks and benefits."

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

"Implementing preemption is in the public good, and the Supreme Court recognized that it is in the public interest to preserve preemption 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 and sole Senate sponsor of the 1976 law at the heart of the court decision.

"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," Mr. Kennedy said. He added, "Congress obviously needs to correct the court's decision."