Supreme Court To Hear Medtronic Pre-emption Case, Despite Irregularities
This article was originally published in The Gray Sheet
Executive Summary
The U.S. Supreme Court reaffirmed Oct. 1 that it will hear a case against Medtronic this session that could settle the long-standing issue of whether FDA premarket approval protects device manufacturers from liability in patient lawsuits
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Supreme Court sets pre-emption case date
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)
Supreme Court sets pre-emption case date
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)
Supreme Court To Judge Protective Power Of PMA Approval In State Suits
The U.S. Supreme Court on June 25 agreed to consider whether device manufacturers are protected by FDA premarket approval in state product liability cases