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US Supreme Court Could Protect Medical Equipment Manufacturers from Law Suits

by Gopalan on  June 27, 2007 at 2:11 PM Medico Legal News   - G J E 4
US Supreme Court Could Protect Medical Equipment Manufacturers from Law Suits
From abortion to consumer rights, the conservatives-dominated US Supreme Court seems set to leave its mark, whatever could be the ultimate fate of President George W. Bush.
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It said on Monday that that it would hear an appeal raising the issue of whether the medical equipment manufacturers approved by the federal government may be sued under state law by patients injured by those devices.

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At the end of the case, the federal government could win a ruling by which it could simply prohibit states from imposing more stringent consumer regulations than what it lays down.

True to his undisguised bias for the industry, Bush has been tacitly encouraging various federal agencies to adopt regulations that would preclude active state prosecutors and trial lawyers from bringing lawsuits that could result in higher safety standards for a variety of products and processes.

Agencies like the Food and Drug Administration (FDA), 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 FDA 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 FDA.

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.

Significantly, a group of similar cases involving drugs is also moving through the courts.

Source: Medindia
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