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Torts Keyed to Franklin
Riegel v. Medtronic, Inc.
Citation:552 U.S. 312, 128 S. Ct. 999, 169 L.Ed.2d 892 (2008)
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Several thousand tort claims followed the marketing and sale of the Dalkon Shield intrauterine device, which was linked to serious infections, several deaths, and a large number of pregnancies. In response, several states adopted regulatory measures requiring premarket approval of medical devices. Congress swept back state obligations and imposed a regime of detailed federal oversight via the MDA.
The MDA includes an express preemption provision that gave the FDA almost total oversight for medical devices. Once a device receives premarket approval, the MDA subjects the devices to reporting requirements and forbids a manufacturer to make any changes in the product without FDA approval that would affect the safety or effectiveness of the medical device.
Under the MDA, Class III devices receive the most stringent federal oversight. This class includes devices that support or sustain human life and are of substantial importance to prevent impairment of human health, such as replacement heart valves and pacemaker pulse generators.
Medtronic’s Evergreen Balloon Catheter is a Class III device that received FDA premarket approval in 1994.
Riegel went into surgery for a heart attack that was caused by a blocked artery. During the procedure, Riegel’s doctor inserted Medtronic’s catheter, though the labeling of the catheter warned that it should not be used for patients with conditions like Riegel. Additionally, Riegel’s doctor inflated the catheter higher than the maximum pressure recommended by the catheter’s label. The catheter burst, causing Riegel to develop a heart block, be placed on life support, and undergo an emergency coronary bypass surgery.
Riegel and his wife sued Medtronic, alleging that its catheter was designed, labeled, and manufactured in a manner that violated New York common lawand that these defects caused Riegel to suffer severe and permanent injuries.
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