Medtronic Inc. and Kentucky hospital are facing lawsuit alleging that spinal surgery with the company’s Infuse bone graft product left a woman total disabled. The plaintiff alleges that she received the Infuse bone graft during an “unconsented, off-label surgery” at Louisville’s Norton Hospital is 2006, and as a result, suffered permanent nerve damage.
According to a report from the Louisville Courier-Journal, the woman’s lawsuit alleges that in certain patients and procedures, Infuse causes uncontrolled bone growth on or near the spinal cord and spinal nerves.
“When spinal nerves are compressed … a patient can experience … extreme and debilitating pain in the legs and back, which is precisely what happened to plaintiff,” the lawsuit says.
The woman’s attorney told the Courier-Journal that said she now must recline or lie flat most of the time and depend on her husband for help with such simple things as tying her shoes and shaving her legs. The complaint accuses Medtronic of downplaying the serious risks associated with Infuse, and actively and illegally promoting off-label uses.
Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body that promotes bone growth. The graft only approved for use in single-level anterior lumbar fusion. However, while doctors can use an FDA-approved product in anyway they see fit, but manufacturers are legally barred from promoting those uses.
In 2008, the U.S. Food & Drug Administration (FDA) warned that Infuse and similar products had caused serious and potentially life-threatening problems when they were used off-label in cervical spine (neck) surgeries. Despite such dangers, it is believed that 85% of the procedures using Infuse are off-label.