Two Medtronic Infuse Plaintiffs Obtain $8.45 Million in SettlementsAug 10, 2016
Two individuals who filed lawsuits over Medtronic's controversial Infuse bone graft product will receive a combined total of $8.45 million in settlements. Each of their lawsuits alleged that they were not informed about the risky procedures involving Infuse, which were allegedly being performed on them by a UCLA with financial ties to Medtronic. Allegedly, they were never told that the Infuse was being used in a way that had never been tested or validated by the U.S. Food and Drug Administration (FDA).
Both lawsuits claimed that the surgeon had a conflict of interest because he allegedly received hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments. UCLA agreed to pay $4.25 million to one plaintiff and $4.2 million to the other. The school said it agreed to settle so it "could move forward with their ongoing commitment to excellence in patient care, research, education and community service."
In both cases, plaintiffs claimed that they suffered unwanted bone growth because Infuse was used off-label. Off-label use is when a drug or a medical device is used in a manner not approved by the FDA. Physicians are allowed to use products off-label if they believe it will benefit patients. However, manufacturers are prohibited from marketing their products for unapproved uses.
Infuse was approved by the FDA in 2002. For nearly the entire time the bone graft product has been on the market, Medtronic has faced allegations of injuries from off-label use. According to Star Tribune, studies indicate that Infuse is used off-label in 86 percent of procedures.
One of the plaintiffs also alleged that Medtronic misbranded Infuse. According to the lawsuit, the company marketed the cage device used to hold Infuse for the chest and lower spine and gained FDA approval in this manner. Allegedly, however, the device is too small and the wrong shape to fit anywhere but the cervical spine, or neck. The plaintiff in the lawsuit claimed that the injuries stemmed from using Infuse off-label in the neck.
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.
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.
Infuse stirred controversy 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, sparking questions about the integrity of data promoting Infuse.