Medtronic Injury Case Before the Supreme Court Will Impact Fate of Defective Medical Device Lawsuits

January 17, 2008, by Michael A. DeMayo

Medical device manufacturer Medtronic wants the U.S. Supreme Court to rule that medical device makers are exempt from products liability lawsuits, if a device that caused the injury is FDA approved.

The specific case, Riegel v. Medtronic, stems from a personal injury lawsuit filed by the family of Charles Riegel, a man whose Medtronic-manufactured balloon catheter burst while he was undergoing a medical procedure to clear his arteries.

In the lawsuit against Medtronics, Riegel cited negligent design and labeling and manufacturing issues. The catheter was FDA approved. The lawsuit was thrown out at both the U.S. District Court level and the US Court of Appeals level before arriving at the Supreme Court.

Medtronics claims that amendments to the Food, Drug, and Cosmetic Act say that FDA-approved medical devices are preempted from product liability lawsuits in state civil courts. The amendments, however, do not say that federal standards are preempted by state common law claims. This, however, is what Medtronics is claiming and the Bush Administration supports with the device maker’s assertion.

If the Supreme Court decides that Medtronics is right, anyone injured by a defective medical device won’t be able to file a personal injury claim or lawsuit.

Last December, Medtronics agreed to pay $114 million to settle 2,682 products liability lawsuits by people who had used the company’s Marquis implanted cardiac defibrillators. A battery problem had caused some of the defibrillators, implanted in patients at risk of heart attacks, to fail. ICD’s had to be surgically replaced in 11,000 patients.

Last year, Medtronic announced an international recall of heart-defibrillator wires, which were fracturing at a rapid rate. Some 235,000 people have these wires implanted in their chests.

If you have been injured or suffered health problems or have had to undergo a medical procedure because of a defective medical device, you should contact our North Carolina or South Carolina products liability law firm immediately.

Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices, NewsInferno, January 3, 2008

Medtronic to Pay $114 Million In Settling Heart-Device Suits, The Wall Street Journal, December 21, 2007

Related Web Resources:

Riegel v. Medtronic, Supreme Court Docket



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