Medtronic (NYSE:MDT) last week told an appeals court that U.S. solicitor general Donald Verrilli got it wrong when he interpreted federal preemption rules in medical device product liability cases, as it fights the appeal of a preempted lawsuit filed over its Infuse bone graft product.
Patricia Caplinger sued Medtronic in June 2012 after a 2010 spinal fusion procedure allegedly using Infuse in an off-label manner led to excessive bone growth in her spine, according to court documents. By the fall of 2010 her symptoms had returned and grown worse, according to the documents, including a foot drop condition "allegedly resulting from exuberant bone growth caused by the use of the Infuse device."
"In December 2010, plaintiff’s drop foot condition caused a tear of the anterior cruciate ligament in her right knee, which required surgery in February 2011. Because of exuberant bone growth in plaintiff’s lumbar spine, revision surgery was required on September 9, 2011. Exuberant bone growth is continuing and will likely require a second revision surgery," according to court records.
Caplinger asserted claims for fraudulent misrepresentation and fraud in the inducement; constructive fraud; strict products liability – failure to warn; strict products liability – design defect; breach of express and implied warranty; negligence; and negligent misrepresentation, the records show.
The case was dismissd when an Oklahoma federal judge ruled that the lawsuit was preempted because her claims "seek to impose state-law requirements on the design, manufacture, or labeling of the Infuse device that are different from or in addition to the federal requirements imposed by the FDA," according to court documents. Caplinger appealed to the 10th Circuit, arguing that her failure to warn claims parallel federal statutes on failure-to-warn grounds.
Citing Verrilli’s brief in the pain pump case before the 9th Circuit Court of Appeals, Medtronic v. Stengel, Caplinger argued that "’FDA’s general labeling regulations governing adverse event reporting and labeling revision in light of new safety information’ are not preemptive," according to the documents.
Medtronic countered that Verrilli’s brief misinterpreted the precedents, according to court records.
"Caplinger’s reliance on the Ninth Circuit’s decision in Stengel – which endorsed a failure-to-warn claim based on a federal duty to report adverse events to the FDA – is misplaced. Caplinger waived any such claim. And while the Solicitor General erroneously believes that another type of failure-to-warn claim, one the Ninth Circuit held expressly preempted, could survive, he recognizes that the claim endorsed in Stengel might be expressly preempted, because the state duty to warn and the federal duty to report adverse events might not be ‘genuinely equivalent’ – as Medtronic argues," according to the documents [emphasis theirs]. "His position is wrong for the same reason Caplinger’s is wrong: It disregards the text of the statute, which preempts ‘any [state] requirement which is different from, or in addition to, any [federal] requirement … which relates to … safety or effectiveness.’ Because premarket approval established federal requirements ‘which relate to the safety or effectiveness’ of Infuse, Caplinger cannot impose any additional safety or effectiveness requirements through state law, regardless how she characterizes their ‘subject.’"
Medtronic has asked the Supreme Court to review the 9th Circuit’s decision against preemption in the Stengel case.