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district judge that Wildman’s warranty claim was preempted by federal law because it was differed from FDA requirements. Wildman appealed the ruling to the Fifth Circuit. Since 1976, the FDA had regulated the safety and effectiveness of medical devices, much they do with new drugs. Federal law also provides that no state may establish laws that are “different from, or addition to” FDA approval requirements — otherwise state tort laws would undermine the FDA’s central oversight role. But plaintiffs can beat preemption if they prove their state law claim is premised on a FDA regulation which is also known as a “parallel” claim because it enforce FDA regulations rather than undermine them. Wildman contended that the Medtronic device failed after a year and a half when Medtronic claimed in written marking material that their device had a life of nine years and that extensive and testing “give Medtronic the confidence that our device is reliable for nine years. To achieve this distinction, Medtronic rigorously verified and validated the many components that impact device longevity, not just the battery.” Medtronic argued that the FDA had approved their devices battery life for nine years and therefore Wildman’s state law claim should be preempted. But after examining the language in the Medtronic’s own marketing material, the Fifth Circuit agreed with Wildman that his state law warranty claim was a parallel claim and was not preempted in its Oct. 31 decision.
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