Plaintiffs have a tough time suing medical device companies for state law breach of warranty claims because they are often preempted by federal law.
But Austin attorney Jeff Meyerson beat those odds when he recently convinced the U.S. Court of Appeals for the Fifth Circuit to reverse a preemption of his client’s warranty case against the manufacturer of an electronic pain relieving device because it was “parallel’’ to federal requirements imposed by the U.S. Food and Drug Administration (FDA).
The background to his win in Wildman v. Medtronic is as follows, according to the court opinion.
The lawsuit begun with Ray Wildman’s filing of a state law warranty claim against Medtronic alleging the neurostimulator device it produced that was implanted in his back to relieve pain did not last as long as the company promised.
Wildman suffered an infection that required surgery and caused him to miss months of work, so he sued the Medtronic for breach of warranty in a Texas state court. But the company removed the case the federal court and had it dismissed after convincing a U.S. 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.
“Medtronic is telling consumers why its product is superior. When the statement says nine years, it means the many components — in its word, ‘not just the battery’ — are guaranteed to last that long,” Judge Gregg Costa wrote in the decision.
“It cannot have it both ways by claiming that as an advantage over competitors in the marketplace and now contending that only the battery life matters,” Costa wrote.
Costa concluded that Medtronic’s marketing statement went beyond what the FDA evaluated in its approval process, reversing the district court’s preemption decision. “Medtronic may make such representations, but it faces state law liability if they are proven false,” Costa wrote, noting Wildman is still a long way from proving his case because it’s still in the pleading stages.
The ruling was huge for Meyerson. Not only does he represent Wildman on appeal, he’s also filed other similar breach of warranty cases against Medtronic in Arizona and Minnesota — all of which Medtronic claims are preempted by federal law.
“This is a very good opinion for us,” Meyerson said. “The floors of courthouse are littered with federal preemptions that Medtronic has filed,” Meyerson added, some of which he’s beaten, some he hasn’t.
“And it’s very frustrating to my clients when they can’t bring a case. They pay $20,000 for the device itself, it’s like a car,’’ Meyerson added, noting the recent Fifth Circuit is the first time an appellate court has weighed in on one of his clients cases.
David Lehn, a Washington D.C. lawyer who represents Medtronic on appeal, did not return a call for comment.
Meyerson adds that he wants Medtronic to honor their word his clients that their device will last nine years and make his clients whole when they don’t.
“The reason I really care about these cases is because of what they’ve done to convince these people to get these devices — and not take action when they fail,” Meyerson said. “We want them to do us right, and instead what we’re getting is a lot of litigation.”