Medtronic Agrees $22M Infuse Bone Graft Settlement

San Francisco, CA: Medtronic, the maker of a spinal bone graft product called Infuse Bone Graft, has said it will pay $22 million to settle about 1,000 lawsuits stemming from claims of adverse health outcomes related to the product and claims that the manufacturer illegally promoted the Medtronic bone product for off-label uses. Medtronic is also reportedly preparing a further $140 million to settle an even larger number of anticipated claims.

Medtronic allegedly encouraged physicians to use its Infuse bone stimulator off-label in the cervical spine, which helped generate sales of more than $3 billion for the manufacturer. As of September of 2008, about 680,000 units of Infuse Bone Grafts had been used in the US, according to Medtronic. According to a report by the Senate committee investigating the product, the company's undisclosed manipulation of information through the medical literature included overstating its benefits and downplaying concerns about serious complications. According to MedPage Today, during the past 15 years, Medtronic has paid $210 million in royalties and other payments to a group of 13 doctors and two corporations linked to doctors. Many of the lawsuits claim that it was by paying spinal surgeons the company was able to promote the off-label use of Infuse.

According to a press release Medtronic issued Tuesday, the $22 million will resolve the claims of some 950 people. A further 750 cases brought by 1,200 people are pending across the use, and there could be another 2,600 claims yet to be brought.

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Published on May-9-14