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Mass tort litigation expert Richard Nagareda discusses implications of Riegel v. Medtronic
Release Date: Feb 26, 2008
Listen to mass tort litigation expert Richard Nagareda’s discussion of Riegel v. Medtronic
After suffering serious injury when a catheter burst while he was undergoing an angioplasty procedure, Charles Riegel sued the catheter's manufacturer, Medtronic, Inc.
Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received full-scale premarket approval from the Food and Drug Administration. The trial court agreed and dismissed the case.
Riegel appealed the case, ultimately to the Supreme Court. The question before the Court was whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.
On Feb. 20, the Court ruled 8 to 1 today in favor of Medtronic, a decision that reaffirms that full-scale FDA premarket approval for medical devices – a process that involves extensive information disclosure by the manufacturer to the FDA and that is designed to position the FDA to balance patient benefits and risks – appropriately preempts state tort lawsuits to challenge the design or labeling of devices approved through that process. The Court ruled that Congress has granted the FDA the exclusive authority to assess the proper balance in its pre-market review of the device.
This decision was the Court’s first ruling that addressed the legal effect of FDA’s full-scale premarket device approval on tort lawsuits.
