Supreme Court sets pre-emption case date
This article was originally published in The Gray Sheet
Executive Summary
The U.S. Supreme Court will hear Riegel v. Medtronic on Dec. 4 in what could be the last word on the issue of federal PMA preemption. Charles and Donna Riegel sued Medtronic for alleged negligence in the design, testing, labeling and manufacturing of the Evergreen balloon catheter after the balloon burst while Mr. Riegel was undergoing an angioplasty procedure. The plaintiffs claim that Medtronic should be liable for resulting complications, while the company counters that the product was in compliance with FDA regulations for labeling, manufacturing and design, among other requirements, and thus is not vulnerable to state suits (1"The Gray Sheet" Oct. 8, 2007, p. 11)