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Medtronic has agreed to pay about $22 million to settle about 950 Infuse BMP lawsuits filed on behalf of individuals nationwide who have experienced problems after receiving the bone graft product.
The settlement was announced in a press release issued on May 6, but does not include an admission of guilt and still leaves an estimated 750 cases unresolved.
Estimates suggest that litigation costs, including all Medtronic Infuse settlements, will ultimately cost the company between $120 and $140 million. Whether those remaining cases will proceed to trial or be settled later is unknown.
Medtronic Infuse is a newer type of bio-engineered bone graft product that has been promoted as an alternative to traditional spinal fusions, where bone is harvested from another area of the body or used from a cadaver.
The FDA approved Infuse recombinant human bone morphogenetic protein (rhBMP-2) for limited use during spinal fusion procedures where the lumbar spine is approached through the front and the product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae. However, Medtronic has been accused of illegally promoting the device for non-approved uses, with a vast majority of sales for Infuse involving applications that were never approved by the FDA.
In March 2014, Medtronic indicated that the number of lawsuits over Infuse are likely to continue to grow significantly, and the manufacturer has indicated that it intends to defend its product in court.
The settlement announcement came just days after the California Supreme Court granted the company’s petition to review a decision by a lower court that determined that Medtronic Infuse lawsuits were not preempted by federal law.
“This agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by Medtronic,” the company stated. “The company continues to stand behind INFUSE Bone Graft, which has been utilized in more than one million patients since it was approved more than ten years ago, and will vigorously defend the product and company actions in the remaining cases.”
Medtronic has tried repeatedly to have the cases dismissed, arguing that the product liability lawsuits should be pre-empted by federal law because the Infuse device was approved by the FDA. The manufacturer has argued that the controversial Supreme Court decision in Riegel v. Medtronic should be applied to protect them from design defect claims, but plaintiffs claim that the company loses that protection because it illegally marketed Infuse for uses not approved by the FDA.
According to allegations raised by plaintiffs in the Medtronic Infuse lawsuits, since the manufacturer has withheld important safety information about the risks associated with off-label uses, the claims should therefore not be subject to the Supreme Court decision that state-law product liability claims involving approved medical devices are preempted by federal law.
A federal judge rejected the company’s pre-emption argument in August, allowing some cases to proceed. However, unlike many similar litigation, the Medtronic Infuse lawsuits have not been centralized in federal court, which means each case is going through pretrial proceedings individually, increasing the chances of contradictory rulings by different judges.
The company has appealed that decision to the U.S. Supreme Court. The California Supreme Court says it will not make a decision on Medtronic Infuse cases until the federal high court does. However, it is unclear at this time whether those appeals will continue if settlements are reached to resolve the cases.