Medtronic Inc. has stated that it will pay out $22 million to settle about 1,000 lawsuits over its Infuse Bone Graft, and is reportedly setting aside an additional $140 million for complaints expected to be filed in the future. The announcement marks the latest chapter in a decade-long saga that’s come to symbolize how conflicts of interest in the medical community can affect patients. Infuse Bone Graft recipients have been diagnosed with cancer, ectopic bone growth, respiratory problems, nerve compression, retrograde ejaculation, urinary retention and other complications.
What’s the Problem?
The Medtronic Infuse Bone Graft includes bone morphogenetic protein (BMP-2), which was approved by the Food & Drug Administration in 2002 as an alternative to traditional spinal fusion surgery, which requires harvesting bone from the patient’s hip. The graft quickly soared to near blockbuster status, having been implanted in more than one million patients worldwide and reaching annual sales of approximately $800 million.
Shortly after the Infuse Bone Graft hit the market, several notable spine surgeons started co-authoring studies in reputable medical journals that failed to link the product to adverse health consequences including cancer, ectopic bone growth, and a complication that can lead to sterility in men. These studies later became the subject of investigative reports published in the Journal Sentinel/MedPage Today, as well as a rebuke by a group of reform-minded doctors in the Spine Journal in 2011.
In 2012, the U.S. Senate Committee investigated the issue and determined that Medtronic employees were secretly drafting and editing favorable articles about the Infuse Bone Graft, while the company paid out millions to surgeons who spoke positively about the product. According to the senate report, Medtronic’s manipulation of information about bone morphogenetic protein included overstating its benefits and downplaying potential risks. Over a period of 15 years, the company paid $210 million to a group of doctors and corporations.
In a May 2014 press release, Medtronic stated that it was paying out $22 million to resolve about 950 lawsuits over the Infuse Bone Graft. The company said approximately 750 cases filed on behalf of 1,200 people remain pending in various courthouses around the country. Most of these are still in early procedural stages.