The University of California, Los Angeles has agreed to pay a combined $8.45 million to two patients who received Medtronic’s controversial Infuse bone graft product. These individuals filed lawsuits alleging that the product caused unwanted bone growth. They also claimed that the implanting surgeon had a conflict of interest because he allegedly received hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments.
Both patients allege that they were not informed about the risky procedures they were receiving, nor were they told that the product was being inserted into devices that had not been tested for safety, Star Tribune reports.
The term “off-label” refers to using a drug or medical device in a manner not approved by the U.S. Food and Drug Administration (FDA). Physicians are allowed to used products off-label as they see fit, but it is illegal for manufacturers to promote their products for unapproved uses; this is known as off-label marketing.
Medtronic has faced off-label marketing claims almost since Infuse was first marketed in 2002. The product has come under intense scrutiny in light of 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.
Medtronic has been under government investigations following allegations that it may have marketed Infuse off-label. Studies show that the product is used off-label 86 percent of the time.
UCLA agreed to pay $4.25 million to one plaintiff and $4.2 million to the other. The school said they agreed to settle so the it “could move forward with their ongoing commitment to excellence in patient care, research, education and community service.”
One of the plaintiffs received Infuse in the neck, where the FDA has warned it could lead to serious nerve and breathing problems. The lawsuit filed on his behalf alleges that Medtronic misbranded the cage device used to hold the product. Allegedly, Medtronic gained FDA approval by saying it would be used in the chest and lower spine, but the actual device is too small and the wrong shape to fit anywhere but the neck, the suit alleges. According to documents related to the plaintiff’s case, one of the device designers testified that 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.”