Medtronic faces about 1,000 product liability lawsuits involving problems with the Infuse bone graft device, where plaintiffs allege that they experienced complications associated with bone overgrowth after the device was implanted in their spines during procedures that were not approved by the FDA.
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.
On March 3, Medtronic released a report for the third quarter of fiscal year 2014 (PDF) indicating that more than 1,000 people have presented claims against the company in state and federal courts nationwide, and the number of complaints is expected to continue to grow significantly.
According to allegations raised in the Medtronic Infuse bone graft lawsuits, plaintiffs have suffered severe never damage, airway comprssion and other complications associated with uncontrollable bone growth after the device was used off-label, such as in the cervical spine, at multiple levels or through a non-anterior approach.
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.
Medtronic has been accused of withholding important safety information about the risks associated with off-label uses, resulting in an argument by plaintiffs that 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.