Another patient injury lawsuit is set to proceed against Medtronic (NYSE:MDT) and it’s problematic Infuse bone-growth protein after an Arizona district judge ruled that federal preemption doesn’t apply in a case accusing the company of off-label marketing, a relatively new tactic that is proving somewhat successful for patients waging battles against medical device makers.
Arizona District Court Judge G. Murray Snow denied, in large part, Medtronic’s attempts to dismiss a patient’s lawsuit accusing the company of liability for injuries allegedly caused by treatment with Infuse during a lumbar fusion procedure.
Medtronic had asked Judge Snow to toss the case on the grounds that the product was protected by federal preemption, which has protected many medical device makers by effectively squashing liability lawsuits against products approved by the FDA. The Arizona court ruled that the case did not fall under traditional preemption because the plaintiff had accused Medtronic of promoting the FDA-approved Infuse product for use in procedures that were not cleared by the federal agency.
The effect of preemption "vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not be reviewed by the FDA but has been promoted by the manufacturer," the court wrote. "Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device."
Plaintiff Dr. Cristina Ramirez claims that Medtronic failed to warn the FDA of known issues with Infuse, including bone overgrowth that could occur when the product was used in posterior procedures, a use that was not reviewed or cleared by the FDA but which Ramirez claims was "aggressively promoted" by Medtronic. Such off-label uses comprised about 90% of Infuse’s 2011 revenue, according to the complaint.
Medtronic is fighting similar battles in courts across the country. A Minnesota judge ruled earlier this month that federal preemption laws effectively blocked a patient injury lawsuit over Infuse, even as an Illinois judge ruled to allow a very similar lawsuit to proceed against the medical device giant.
All eyes are on the Infuse lawsuits as patients and personal injury lawyers look for a chink in the preemption armor that has since 2008 armored many companies against litigation.
In 2008 the U.S. Supreme Court ruled that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval. The decision has helped block lawsuits against many medtech companies, including some Infuse complaints, but the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.
Some lawyers are seeing early success with pinning medical device lawsuits on allegations of off-label marketing, a tactic that helped both the Illinois and the new Arizona lawsuits to proceed to trial. Thus far decisions in lower courts and gone both ways, and the case is likely to land Medtronic back in the Supreme Court.