A federal judge ruled that Medtronic Inc. must face claims of fraud and negligence over its Infuse bone graft product. The judge refused to dismiss a substantial portion of the claims brought by a pair of Infuse lawsuits, alleging that the Infuse system has harmful side effects.

Plaintiffs Richard Eidson, Scott Bell and his wife April Bell filed Infuse bone graft lawsuits against Medtronic in 2013. Eidson brought the action “based on harmful effects he suffered after undergoing spinal surgery in which his surgeon used the same medical device produced by Defendants.”

In February 2005, Scott Bell underwent a spinal fusion operation in which his surgeon used Infuse for an unapproved purpose, also known as an off-label use. After his surgery, Bell reportedly experienced increased pain. On March 2, 2007, Scott was diagnosed with advanced bony overgrowth in the area of his spine targeted by the surgery.

The two Infuse lawsuits are related because they both involve the same product and similar questions of law. Both bone graft lawsuits allege that Medtronic “embarked on a vigorous campaign to promote off-label uses of Infuse by establishing consulting/royalty agreements with physicians who advocated off-label uses.”

The Infuse bone graft lawsuits also allege that Medtronic “funded studies and articles by opinion leaders that omitted mentions of the risks of off-label use or understated the incidence of adverse effects.” The company also “failed to report adverse events suffered by patients who used Infuse off-label to the FDA, and by April 2008 defendants had reported only 262 of an estimated 50,000-250,000 adverse events.”

With the allegations, Medtronic moved to dismiss both Infuse lawsuits, arguing that statute of limitations barred the lawsuit by the Bells. U.S. District Judge Lucy H. Koh disagreed with Medtronic. Koh also denied Medtronic’s request to toss fraud-based claims from both bone graft lawsuits.

“For example, plaintiffs allege defendants knowingly marketed Infuse in misleading ways, such as by paying kickbacks to ‘opinion leaders’ to directly advocate off-label use of Infuse to other spine surgeons without disclosing their financial relationship with defendants and bankrolling falsified medical studies and articles,” Koh wrote. “Accordingly, the court concludes that the state tort law duties underlying plaintiffs’ claims are not ‘different from, or in addition to’ federal requirements, which unquestionably ban fraudulent marketing.”

The judge also allowed claims for fraudulent misrepresentation/fraudulent inducement and negligent misrepresentation based on misleading off-label promotion.

Koh granted two of Medtronic’s motions, dismissing with prejudice failure-to-warn claims based on allegations of “overpromotion” and on deceptive off-label promotion.

These Infuse bone graft lawsuits are Richard Eidson v. Medtronic Inc. and Scott Bell and April Bell v. Medtronic Inc., Case Nos. 13-CV-02049 and 13-CV-01502, in the U.S. District Court for the Northern District of California, San Jose Division.