Law360 (April 23, 2008, 12:00 AM EDT) -- Yes, probably more than you realize. On Feb. 20, 2008, in Riegel v. Medtronic Inc., the U.S. Supreme Court found that common law tort claims challenging the safety and effectiveness of devices that require premarket approval (PMA) under the Medical Device Amendments of 1976 (MDA) are preempted by federal law.
This case does not apply to devices that are marked under a premarket notification, also known as a §510(k) devices.
After Riegel v. Medtronic Inc., §510(k) device manufacturers continue to be vulnerable to state law tort...
Does Riegel V. Medtronic Affect You?
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