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WASHINGTON - Supreme Court justices wrestled yesterday with the question of how much protection federally approved medical devices should have from product-liability lawsuits.
In the case before the court, medical-device maker Medtronic Inc. is fighting a lawsuit by the widow of a New York man who suffered life-threatening injuries when a Medtronic balloon catheter burst during an angioplasty in 1996. The balloon catheter is used to open patients' clogged arteries.
The woman, Donna Riegel, alleged defects in the design, manufacture, and labeling of the product, among other claims. Her husband, Charles Riegel, died in 2004 from unrelated causes.
The stakes are high for medical-device companies, as product-liability suits can be expensive. Guidant, now owned by Boston Scientific Corp., agreed last month to pay up to $240 million to settle thousands of heart patients' legal claims involving potentially faulty defibrillators.
Medtronic also has run into trouble with its defibrillators, recalling its Sprint Fidelis defibrillation wires in October, after discovering they broke more often than expected and contributed to at least five deaths.
The company's lawyer, Ted Olson, told the justices that a product in compliance with the FDA shouldn't be found liable for negligence by a jury in a state tort lawsuit.
"The FDA is the right place for these decisions," he said.
Federal law regulating medical devices preempts additional state regulation, Olson said, and that includes lawsuits under state law.
Several justices, including Stephen Breyer and Antonin Scalia, appeared to agree that juries shouldn't second-guess the FDA.
If a jury rules against a company like Medtronic, that "manufacturer is placed at risk in selling a device that scientists at the FDA have said is OK," Scalia said. "I find that extraordinary."
But Riegel's lawyer, Allison M. Zieve, said that in many cases defects only become known after a device gets FDA approval and is on the market.
Medtronic has said that Riegel's physician did not properly follow instructions for the product.
If the Supreme Court rules for Medtronic, it wouldn't necessarily bar all suits. Lawsuits alleging that a product wasn't designed or manufactured as specified when it was approved by the FDA could still proceed, Olson said.
The court is expected to decide the case by July.
© Copyright 2007 Globe Newspaper Company.
