As part of a settlement, Minneapolis-based MedTronic has agreed to pay $22 million to plaintiffs in an estimated 950 lawsuits filed over its Infuse bone growth product, but does not admit to any wrongdoing. An additional 750 cases brought by 1,200 plaintiffs are pending and more claims are expected to be brought.
Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein found in the body. Use of the protein causes bone growth in specific areas of the spine. The FDA approved its use in 2002 as an alternative to conventional spinal fusion. However, approval was limited to treat degenerative disc disease, open fractures of the tibia, sinus augmentation, and localized alveolar ridge augmentation.
Worldwide, more than one million people have received an Infuse implant. Plaintiffs allege Medtronic promoted Infuse to spinal surgeons for off-label uses that caused patient injuries. 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. Over the last 15 years, Medtronic reportedly has paid $210 million in royalties and other payments to a group of 13 doctors and two corporations linked to doctors to promote the off-label use of Infuse.
Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein found in the body. Use of the protein causes bone growth in specific areas of the spine. The FDA approved its use in 2002 as an alternative to conventional spinal fusion. However, approval was limited to treat degenerative disc disease, open fractures of the tibia, sinus augmentation, and localized alveolar ridge augmentation.
Worldwide, more than one million people have received an Infuse implant. Plaintiffs allege Medtronic promoted Infuse to spinal surgeons for off-label uses that caused patient injuries. 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. Over the last 15 years, Medtronic reportedly has paid $210 million in royalties and other payments to a group of 13 doctors and two corporations linked to doctors to promote the off-label use of Infuse.
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