Thursday, February 19, 2009

Wisconsin Supreme Court Rules Product Liability Claim Against Device Manufacturer is Preempted

Any time a manufacturer of an FDA approved device modifies that device in a way that affects its safety or effectiveness, the manufacturer must go through a Pre Market Approval (PMA) "supplement". One interesting question is whether the filing of a supplemental PMA is enough to preempt claims against the manufacturer in state court. In Blunt v. Medtronic, Inc., ___ N.W.2d ___, 2009 WL 367768, at *7-11 (Wis. Feb. 17, 2009), the Wisconsin Supreme Court says it is. Here is a post, in full, from the Products Liability Professors Blog by J. David Prince on this case: The Wisconsin Supreme Court ruled yesterday that state law tort claims against the manufacturer of an FDA-approved medical device are preempted. In Blunt v. Medtronic, 2009 WL 367768 (Wis., 2-17-09), the Wisconsin court concluded that the U.S. Supreme Court's ruling last year in Riegel v. Medtronic, 128 S.Ct. 999 (2008) governed in this case as well. Joseph Blunt had a Medtronic pacemaker implanted in 2004 to keep his heart from failing. Based on its own laboratory testing, Medtronic warned the following year that the devices' batteries might fail in one out of 10,000 patients. Blunt then chose to have the device removed. Medtronic became aware of the problem two years before it issued the warning. The manufacturer submitted to the FDA a supplemental application reflecting design changes aimed at eliminating the battery problem. The FDA approved these changes but did not order the device with its original design recalled nor did it withdraw its 2002 approval of the original design. During all of this time, Medtronic continued to market and sell the device with its original design. Riegel says that a device-specific pre-market approval of a Class III device by the Food & Drug Administration constitutes a federal requirement that preempts any different or additional state law requirements. The Wisconsin court concluded that the specific device implanted in Mr. Blunt, manufactured according to its original design, had been determined to be safe and effective after a rigourous pre-market review by the FDA. It is in precisely that situation that the federal agency's approval preempts state law, including common law, claims. Two Justices concurred but criticized both Riegel and the FDA's process for assuring the safety of medical devices.

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