Two plaintiffs will receive a combined total of $8.45 million to settle allegations that they suffered injuries associated with using Medtronic Infuse in ways not approved by the U.S. Food and Drug Administration. Both lawsuits allege that they were not informed about the off-label procedures. The plaintiffs also allege that they were never informed that the UCLA surgeon had financial ties to Medtronic.
The FDA approved Infuse, a bone graft product, in 2002. Infuse drew media attention following reports that company-funded studies failed to mention a number of complications. In June 2011, a group of researchers brought light to this issue in The Spine Journal, raising questions about the integrity of data promoting Infuse.
Both lawsuits allege injuries from using Infuse off-label, or in a manner not approved by the FDA. Physicians have the right to use a product off-label if they believe it is the best option for the patient, but it is illegal for companies to market their products for unapproved uses. The plaintiffs allege that they were never informed about the off-label risks or the surgeon’s conflict of interest. The suits allege he received hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments.
Medtronic has faced allegations of injuries from off-label nearly the entire time Infuse has been on the market. According to Star Tribune, studies indicate that Infuse is used off-label in 86 percent of procedures. In 2008, the FDA warned that use of Infuse in the cervical spine could lead to life-threatening complications, including nerve damage and breathing problems.
One of the plaintiffs who received Infuse in the cervical spine also alleged that Medtronic misbranded Infuse. The suit alleges that Infuse was approved because Medtronic marketed it for use in the chest and lower spine, when in reality the device is too small and the wrong shape to fit anywhere but the cervical spine, or neck. The plaintiff in the lawsuit alleged that the injuries stemmed from using Infuse off-label in the neck. Medtronic says the surgeon was not paid to use Infuse in the surgery and was not a consultant at the time.
The plaintiff’s case includes a testimony from one of the device designers, who said he intended it for use in the neck. Additionally, attorneys revealed an email from a Medtronic employee telling UCLA officials that “because of its small size many surgeons prefer to use it in the cervical spine.” Medtronic says that the surgeon was not paid for using Infuse during this procedure and was not a consultant at that time.
UCLA has agreed to settle one lawsuit for $4.25 million and the other for $4.2 million. The institution said it agreed to the settlement so it could “could move forward with their ongoing commitment to excellence in patient care, research, education and community service.”