Supreme Court To Weigh Limits On Cases Involving Medical Devices

WASHINGTON, June 25 — Setting the stage for a confrontation between the states and manufacturers, the Supreme Court said on Monday that it would hear an appeal raising the issue of whether the makers of medical equipment approved by the federal government may be sued under state law by patients injured by those devices.

Although the appeal will most likely turn on the Supreme Court’s interpretation of the 1976 medical devices amendments to the Food, Drug and Cosmetic Act, the case is part of a broader debate in Washington over the extent to which the Bush administration and Congress may preclude the states from imposing consumer regulations that are more stringent than the federal government’s.

Federal agencies under the control of Bush administration appointees have sought to adopt regulations covering matters as diverse as auto safety and medicine labeling to preclude active state prosecutors and trial lawyers from bringing lawsuits that would impose higher safety standards.

An array of agencies, including the Food and Drug Administration, the National Highway Traffic Safety Administration and the Consumer Product Safety Commission, have proposed or adopted rules that would make it more difficult for consumers to bring lawsuits under state laws that are more favorable to victims than are federal regulations.

Critics of the Bush administration say that the approach strips consumers of valuable state protections. Supporters say the federal effort to pre-empt the states sets uniform national standards and discourages overzealous state prosecutors.

In the case before the Supreme Court, both the Bush administration and the defendant company, Medtronic, had urged the justices to reject the appeal of a patient who was injured when a balloon catheter it made ruptured during an angioplasty in 1996.

The patient, Charles R. Riegel, and his wife, Donna, sued Medtronic for a variety of state tort law violations, including negligent design and breach of warranty. The company maintained that Mr. Riegel’s surgeon should not have used the balloon catheter because of Mr. Riegel’s condition and that the surgeon used the device in a manner inconsistent with its labeling.

Both a Federal District Court and a Federal Appeals Court in New York dismissed most of the Riegels’ claims. Those courts concluded that because the F.D.A. had approved the balloon catheter after a rigorous review and before it went to market, injured patients could not file claims against Medtronic under state law. The medical devices amendment forbids a state from adopting any requirement “which is different from, or in addition to, any requirement” in federal law.

Federal courts around the nation have taken different views of whether that provision bars state law damage claims against medical devices approved by the F.D.A. The issue has so confounded the courts that three appeals courts reviewing the same medical device made by the same company have reached two different conclusions about whether patients could bring a lawsuit.

Lawyers involved in the Medtronic case say they expect the court to hear from manufacturers and business groups in support of Medtronic, as well as from states and consumer organizations on behalf of the patient who was injured. The case, Riegel v. Medtronic, No. 06-179, is expected to be heard by the court in the fall.

A group of similar cases involving drugs is moving through the courts.

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