Insurance provider Humana Inc. is suing medical device company Medtronic Inc. for promoting its Infuse Bone Graft device for off-label uses. Humana alleges that Medtronic fooled the insurance provider into covering the costs of Infuse surgeries performed in ways that were not approved by the U.S. Food and Drug Administration (FDA).
The Infuse Bone Graft device was approved to help generate bone growth after spine surgery, but the company allegedly began promoting potentially unsafe methods of insertion, which could lead to severe side effects, including cancer, infections and male infertility. Medtronic is estimated to have made more than $1.3 billion from the device, much of which came from unapproved promotion of the device.
Medtronic has already been found to have illegally paid doctors to promote and use the device in patients, as well as ghost-writing literature claiming the device was safe and effective. The company is now facing multiple Infuse Bone Graft lawsuits alleging that the device caused severe complications. Potential Infuse side effects include excessive bone growth, swelling and death.