Supreme Court may prohibit lawsuits for FDA-approved devices

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Dec. 4—Medtronic and other medical-device makers today will attempt to obtain protection from multimillion-dollar product liability lawsuits in a case before the U.S. Supreme Court.

The Supreme Court justices will hear Riegel v. Medtronic, on whether patients can file product-liability lawsuits over devices cleared for sale by the FDA’s approval process.

Previously, a federal appeals court barred a suit from a New York man who claimed he suffered permanent injury when a Medtronic heart catheter burst during an angioplasty. The lower court's approach would undercut thousands of lawsuits, and such a ruling might also shield the Minneapolis-based Medtronic from suits over its withdrawn Fidelis defibrillator wires, according to Bloomberg.

Edward E. Angwin, a lawyer from Birmingham, Ala., who is suing the New Brunswick, N.J.-based Johnson & Johnson over its Duragesic pain-killing patch, told Bloomberg that there is “significant concern that the court's ruling may alter the landscape and make it either impossible or difficult to bring these claims.”