Litigation over Infuse bone graft continues to mount against Medtronic. Reuters reports that managed care company Humana Inc. filed a lawsuit on Friday in federal court in Tennessee alleging that Medtronic falsely represented the safety and effectiveness of Infuse. Humana also accused Medtronic of paying doctors to portray Infuse positively in published studies.
According to Reuters, Humana said in the suit that it paid for Infuse when it could have opted for less expensive and safer alternatives. When Infuse hit the market in 2002, it was touted as an innovative product that was an alternative to a traditional bone graft, which harvests bone from a patient’s own hip. Medtronic implemented a “sophisticated and deeply deceptive marketing strategy” to promote the use of Infuse while failing to warn about its risks. Medtronic denies the allegations.
There have been substantial safety concerns related to the off-label, or unapproved use, of Infuse. The product is only approved for a lower lumbar spinal fusion and some dental procedures. However, a Bloomberg report estimates that as much as 85 percent of Infuse procedures are off-label. In 2008, the U.S. Food and Drug Administration (FDA) found that using Infuse off-label in the cervical spine could lead to life-threatening complications, such as difficulty breathing and swelling of the neck and throat.
Independent researchers have found that Infuse does not work better than traditional bone grafts, and may carry additional risks, including a small increased risk of cancer.
The U.S. Senate and Department of Justice became investigating Infuse in 2011 due to allegations that Medtronic touted the product for off-label uses and hid the risks in its clinical trial data. The product because a subject of intense public scrutiny after the Spine Journal ran an entire issue criticizing Infuse. The group of spine experts who authored the issue pointed out that the researchers were paid tens of millions by Medtronic, and failed to mention side effects such as male sterility, cancer, infections, pain and bone dissolution.
In 2012, a report by the U.S. Senate Finance Committee found that Medtronic had paid millions in royalties and consulting fees to authors of the early studies promoting Infuse. The report also found that Medtronic employees had manipulated the studies.