October 25, 2012 – The U.S. Senate Committee on Finance published a report today accusing medical device manufacturer Medtronic Inc. of editing health journal articles and giving kickbacks to physicians who conducted company-sponsored studies of its Infuse Bone Graft product. According to the report, Medtronic’s role in editing the articles was not disclosed by the company, and that by law, “Medical journals should ensure industry role contributions be fully disclosed.” The senate inquiry began in June last year, after rumors flew about surgeons being paid by Medtronic to omit complications associated with the Infuse.
Medtronic Infuse Bone Graft Lawsuit Update 12/10/12: A medical malpractice lawsuit has been filed on behalf of a Pennsylvania man who allegedly experienced severe side effects after undergoing a spinal fusion procedure where the Medtronic Infuse BMP was used as an alternative to a traditional bone graft. The complaint alleges that the design of the Medtronic Infuse, as well as a lack of proper medical care by the surgeon, caused the plaintiff to suffer permanent injuries following the surgery. Click here to learn more.
What’s the problem?
In addition to secretly editing numerous health journal articles, the Senate Committee on Finance is accusing Medtronic of deceptively marketing Infuse, a synthetic protien used in spinal surgery, as a superior technique to bone grafts from the pelvis, and of paying out approximately $210 million in royalties and ‘consulting fees’ to doctors who conducted company sponsored studies over a period of nearly 15 years.
In an issue of the Spine Journal that was published a week after the senate inquiry, it was reported that 13 studies of Infuse that were sponsored by Medtronic found absolutely no adverse events associated with the product. The Committee report was published after members reviewed over 5,000 documents related to the Infuse safety trials.
First approved by the U.S. Food & Drug Administration (FDA) for spinal surgery in 2002, the Medtronic Infuse Bone Graft generated sales of approximately $800 million in the fiscal year 2011.