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Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

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Managed care company Humana has sued Medtronic Inc., accusing the company of falsely representing its Infuse bone growth device as safe and effective in spinal fusion surgeries.

Humana filed the lawsuit in federal court in Tennessee on Friday. The complaint alleges that Medtronic paid for academic literature that fraudulently portrayed Infuse as safe and effective for off-label uses. According to court documents, Humana said that Medtronic engaged in a “sophisticated and deeply deceptive marketing strategy” designed to expand the market for Infuse, by urging and compensating spine surgeons to use the device by over-emphasizing its benefits and downplaying its serious risks, Reuters reported.

Medtronic insists that physicians are compensated for intellectual property rights and for providing legitimate and documented consulting services to the company. The medical device maker also says that Infuse’s label has reflected its risks from the time the U.S. Food and Drug Administration (FDA) approved it in 2002, according to Reuters.

Independent reviews prompted by spine experts and U.S. lawmakers, however, raised questions about the safety of Infuse, which was once hailed as a major advance in spinal fusion surgery. The product, which contains a genetically engineered protein known as recombinant human bone morphogenetic protein 2, offered an alternative to painful bone harvesting from other body parts to perform a bone graft, Reuters reported.

Three years ago, the U.S. Senate and Department of Justice began investigating unapproved uses of Infuse and safety information mislaid from Infuse’s clinical trial data. The product also came under fire after the Spine Journal ran an entire issue criticizing the bone growth product in June 2011, alleging that physicians who were paid tens of millions of dollars by Medtronic failed to report serious complications including male sterility, increased risk of cancer, infections, and pain and bone dissolution, according to Reuters.

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