By CHRISTOPHER RUGABER
Associated Press

WASHINGTON - The Supreme Court wrestled Tuesday with 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.

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.

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 that they broke more often than expected and contributed to at least five deaths.

The company's lawyer, Ted Olson, told the justices that makers of 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 pre-empts additional state regulation, Olson said, and that includes suits under state law.

Several justices, including Hon. Stephen Breyer and Hon. 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 Zieve, said that in many cases defects only become known after a device gets FDA approval and is on the market. Zieve argued that jury verdicts aren't the equivalent of additional state regulation and shouldn't be pre-empted.

Medtronic has said that Riegel's physician did not properly follow instructions for the product. But Zieve argued that the catheter's label was ambiguous and that Medtronic could have clarified it without having to go back to the FDA for

Breyer pressed Zieve on what design defects were alleged in the Riegel case, and Zieve seemingly struggled to approval. answer.

"The design claim in this case was not significantly developed," she said, in part because the case hasn't reached the discovery stage, when each side exchanges documents and other evidence.

Lower federal courts sided with Medtronic. It's possible that different juries could reach different conclusions about the same medical devices, the court said, "rendering it almost impossible" for a device to comply with both the conditions set by the FDA and the varying jury verdicts.

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 acknowledged. In addition, not all medical devices go through the FDA's extensive pre-market approval process, which Medtronic argues should adequately shield it from liability claims.

The Bush administration weighed in on behalf of Medtronic in a switch from the previous administration. In a similar case nine years ago, Clinton's solicitor general argued that the FDA's approval doesn't pre-empt product-liability suits.

The court is expected to decide the case by July. The case is Riegel v. Medtronic, 06-179.