VOL. 122 | NO. 118 | Tuesday, June 26, 2007
U.S. Supreme Court to Consider Lawsuit Against Medtronic
WASHINGTON (AP) - The U.S. Supreme Court on Monday agreed to consider whether federal regulatory approval of medical devices shields manufacturers from most product liability lawsuits in state courts.
The decision could upend a growing consensus in the federal appeals courts that the Food and Drug Administration's regulation of the devices - particularly the agency's stringent pre-marketing approval process - generally does protect the companies from lawsuits.
The justices ignored the advice of the Bush administration, which agreed with a federal appeals court and recommended last month that the court turn down the case. The Clinton administration had taken the opposite position - that liability lawsuits could proceed - in a similar case nine years ago.
In the dispute before the justices, a New York couple, Charles and Donna Riegel, sued Medtronic Inc. when its Evergreen balloon catheter burst during Charles Riegel's angioplasty. The balloon catheter is used to open patients' clogged arteries.
The 2nd U.S. Circuit Court of Appeals in New York last year upheld a lower court ruling that dismissed the suit. The appeals court noted that medical device manufacturers cannot alter their products, once on the market, without FDA approval.
As a result, a jury verdict deeming a product unsafe would put companies in a difficult position, the appeals court said. It is possible that different juries could reach different conclusions about the same medical devices, the court said, "thus rendering it almost impossible" for a device to comply with both the conditions set by the FDA and the varying jury verdicts.
The case won't be heard until the court's next term, which begins in October.
The case is Riegel v. Medtronic, (06-179).
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