$22 Million Settlement Reached for Some Medtronic Infuse Bone Graft Lawsuits

San Francisco, CAMedtronic, 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’s Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein that is naturally released by the body. Use of the Bone Morphogenetic Protein initiates bone growth in specific areas of the spine, giving surgeons some control over where the bone re-growth occurs. The US Food and Drug Administration (FDA) approved its use in 2002, as an alternative to conventional spinal fusion. However, the FDA approval was for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. Specifically, the agency approved the Infuse Bone Graft to treat degenerative disc disease and open fractures on the tibia. The FDA also approved Medtronic Infuse Bone Graft for use in sinus augmentation and localized alveolar ridge augmentation. Infuse attained sales of approximately $800 million annually and, so far, more than one million people have undergone an Infuse implant worldwide.

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.

"It certainly seemed to many of us to be promotion in a medical or scientific sense," said Eugene Carragee, MD, the Stanford University spine surgeon who headed the 2011 Spine Journal review of Infuse. "Whether that is promotion legally is unclear." (Medpage Today)

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.

Complications linked with the Medtronic bone graft include swelling of the airways, which can cause difficulty breathing, speaking and swallowing. Medtronic Infuse has also been linked to retrograde ejaculation which can lead to male sterility.