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Patients aren’t the only ones suing Medtronic over problems with their Infuse bone graft device. Managed care company Humana Inc is also suing the company for falsely representing its product as safe and effective in spinal fusion surgeries.
The suit alleges that Medtronic paid for academic literature that fraudulently said the product was safe and effective for several off-label uses. Humana often paid for the more expensive procedure over traditional bone grafts because of the strength of this literature.
The suit claims that Medtronic used a “sophisticated and deeply deceptive marketing strategy” to expand the market for the device through paying surgeons to use the product and encouraging them by overstating the benefits.
Yet Medtronic says the risks were well known and were in FDA labeling since the approval of the device in 2002. They say that the compensation to physicians was for their intellectual property rights and for consulting services. Independent reviews of the product say that Infuse works as well as traditional bone grafts but may not be as safe. Spine Journal ran an entire issue criticizing the device in June 2011 after its own investigation.
If you have experienced sterility, cancer, infections, pain, or bone dissolution from the implantation of an Infuse device, you need to seek compensation. John Foy can help you get the compensation you need.
