Will preemption rescue Medtronic from InFuse lawsuits?

October 24, 2013 by Brad Perriello

The preemption doctrine could save Medtronic from the raft of lawsuits it's facing over alleged off-label promotion of its InFuse bone putty.

Will preemption rescue Medtronic from InFuse lawsuits?

Medtronic (NYSE:MDT) could avoid a major headache if the courts continue to allow the doctrine of preemption in product liability lawsuits filed over its InFuse bone-growth protein, according to Fish & Richardson principal José Sierra.

The InFuse bone growth protein has been on the U.S. market since 2002, when the FDA approved the product for anterior use in the lower spine. Lawsuits have accused Medtronic of illegally marketing the device for use in the neck and in posterior lumbar procedures.

But those suits face an uphill battle if recent cases are anything to go by, Sierra wrote in Lexology.

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"A majority of plaintiffs seeking damages based on off-label promotion of Medtronic's InFuse bone graft system have been stopped in their tracks following several recent federal court decisions holding that such challenges were barred on preemption grounds. Indeed, with the exception of 2 district court cases out of the 9th Circuit, these preemption rulings not only underscore the limits of off-label promotion arguments in medical device cases, but also show that courts remain skeptical about whether off-label promotion is illegal under federal law," he wrote, citing the Caplinger v. Medtronic case in the U.S. District Court for Western Oklahoma in which the judge found that the plaintiff's off-label claims failed to trump federal preemption.