A growing number of individuals throughout the United States are pursuing product liability lawsuits over problems following Medtronic Infuse bone graft procedures, with one recent complaint filed on behalf of nearly 100 plaintiffs who all allege they suffered severe injuries and complications from excessive growth of bone around the spine.
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.
According to allegations raised in the mounting number of Medtronic Infuse bone graft lawsuits filed nationwide, off-label use of the device in the cervical spine, such as through a non-anterior approach or involving fusions at multiple levels, increases the risk of severe and potentially life-threatening complications associated with the bone overgrowth, which may damage nerves or compress the airway.
One of the latest Medtronic Infuse complaints was filed in the 22nd Circuit Court in St. Louis, Missouri on October 1. The lawsuit involves 98 different plaintiffs who claim they suffered a number of different injuries, including uncontrolled bone growth, nerve damage, airway compression and breathing difficulties. The lawsuit claims that the injuries occurred because Medtronic failed to tell doctors and patients of the risks and then encouraged the use of Infuse in ways that were dangerous and against the recommendations of the FDA.
Preemption Challenges Over Off-Label Use
Medtronic has attempted to defend the cases filed in courts nationwide by arguing that the product liability lawsuits should be preempted by federal law, since the FDA approved Infuse BMP as safe and effective.
The manufacturer argues that the controversial Supreme Court decision in Riegel v. Medtronic, which involved another medical device, should protect them from liability for design defects because such claims would conflict with federal regulations regarding the approval of medical devices in the United States.
Plaintiffs in most of the cases allege that they suffered Infuse-related complications because Medtronic illegally promoted the bone graft product for uses that were not specifically approved by FDA or determined to be safe and effective. 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 a 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.
In late August, Illinois state court Judge Eileen Mary Brewer rejected an attempt by Medtronic to have a lawsuit pending in Cook County Circuit Court dismissed, finding that the FDA did not apply device-specific requirements on Medtronic for the off-label use and that state court claims are not prevented from providing damages for claims based on a violation of FDA regulations.
In contrast, a Minnesota state court judge granted Medtronic’s motion to dismiss dozens of cases early last month, finding that the plaintiffs could not sue the device maker over injuries caused by Medtronic Infuse because the FDA had approved the product. Judge Laurie Miller found that Medtronic was not under legal obligation to warn of adverse effects involving off-label usage, but has allowed plaintiffs to refile their cases with more specific allegations of fraud involving the promotion of the device for non-approved uses.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on Infuse complications in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published, which encouraged the off-label use of Infuse.