Posted Jun 26, 2007 04:23 pm CDT
The U.S. Supreme Court has agreed to decide whether federal regulatory approval of medical devices bars liability for injuries they cause.
The 2nd U.S. Circuit Court of Appeals upheld dismissal of the suit against Medtronic Inc., which had alleged its balloon catheter burst during an angioplasty, Associated Press reports. The decision is part of a growing consensus among appeals courts that the Food and Drug Administration’s pre-market approval process generally protects the companies, according to the wire service.
But the New York Times reports that appeals courts are not united on the pre-emption question. “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,” says the article by Stephen Labaton.
Both the Bush administration and Medtronic had urged the court to decline certiorari. The case is Riegel v. Medtronic, No. 06-179.