U.S. Supreme Court
Scalia Deems Medical Device Liability ‘Extraordinary’
Posted Dec 5, 2007, 06:48 am CST
By Debra Cassens Weiss
Updated: Several justices wondered in U.S. Supreme Court oral arguments yesterday whether juries in product liability cases should be allowed to consider the safety of a medical device that has been approved by the government.
At issue in Riegel v. Medtronic is whether the tort claim is pre-empted by the Medical Device Amendments to the Food, Drug and Cosmetic Act, Law.com reports. The plaintiffs in the case, Charles Riegel and his wife, sued over a Medtronic balloon catheter that burst during Riegel’s angioplasty.
The Food and Drug Administration had given “premarket approval” to the catheter. The Bush administration argued in favor of pre-emption, the New York Times reports.
Antonin Scalia was among the justices who expressed concern about allowing juries to consider the safety of FDA-approved devices. "What's going on is simply one jury has decided that in its judgment, there was a safer device that should have been used; and because of the judgment of that one jury, the manufacturer is placed at risk in selling a device that scientists at the FDA have said is OK. I find that extraordinary," he said.
The Drug and Device Law blog says it is "cautiously optimistic" that the court will rule the product liability suit is pre-empted by federal law.
Updated at 1:30 PM to include Drug and Device Law blog prediction.