A recent Supreme Court decision may put an end to Medtronic, Inc., and other device makers, from using the legal strategy of preemption in their litigation. Medtronic has long sought to have courts nationwide ensure that it is not sued over federal preemption on all claims that involve devices that had received premarket approval (PMA) by the U.S. Food and Drug Administration (FDA)
The lawsuit involved was brought by a now-deceased man who allegedly became a paraplegic after undergoing surgery in which pain medication was infused into his spine. In this case, Medtronic was accused of neglecting to advise federal regulators about previous issues with its SynchroMed EL pump and catheter. The High Court denied a request to review the Court of Appeal’s ruling in the case involving Medtronic and preemption and found that the claims were not preempted by the FDA’s medical device oversight.
Earlier Supreme Court decisions interpreted federal law concerning medical device approval as limiting the types of lawsuits that may be brought; however, a ruling in 2008 found that device makers may not be subject to “additional requirements under state product liability law,” Bloomberg News reported. This means that individuals may sue under state rules deemed to be “parallel” to federal requirements. This most recent lawsuit, according to the Court of Appeals in San Francisco, found that the failure-to-warn claims were not preempted by the FDA’s supervision of medical devices and, therefore, met the requirements and is now able to proceed.
Medtronic appears to have been seeking to resolve a gap in its litigation strategy, which involves the numerous preemption motions nationwide. This appears to have been done to ensure the medical device maker would avoid the views of the Solicitor General of the United States. These views were specifically sought by the Supreme Court prior to its denying review.
Although Medtronic had been using the preemption argument in a number of courts, the strategy has been met with minimal success. Also, mounting lawsuits rejected the review of applicable state law and statutes, including three Circuit Courts of Appeal, in addition to the most recent review.
If the FDA has not specifically provided for a medical device to be preempted, it is not; general specifications are insufficient. If a device does have specific preemption from the FDA, state court actions may be maintained if device makers seek redress for state claims that parallel, but do not seek to change, federal requirements.
In another example, Medtronic and Stryker attempted to have a lawsuit dismissed over their bone protein products and involved the off-label marketing of Stryker’s OP-1 Putty used with its Calstrux bone filler and Medtronic’s Infuse bone graft. In another case, Medtronic sought reconsideration of a ruling involving Infuse. In both cases, the justices ruled that preemption did not apply.
Many experts hope that the Supreme Court’s recent denial may prompt Medtronic to stop weighing down the courts with trivialpreemption motions that have no legal basis.