Crystal Stevens, of Louisville, Kentucky, and her husband Eric have filed a lawsuit in Jefferson Circuit Court against Medtronic and Norton Hospital alleging that the Infuse bone graft has caused permanent and disabling complications.
According to the lawsuit, Stevens received the Infuse bone graft in 2006, and has since suffered substantial nerve damage from Infuse bone overgrowth, the Courier Journal reports. An attorney for Stevens says that she is most always confined to a flat or recline position, and is unable to do the most basic things.
Medtronic’s Infuse bone graft device was approved by the FDA for a specific type of spine surgery, and not the type of surgical procedure that Stevens underwent. The lawsuit claims that Medtronic “actively and illegally” promoted the bone graft device for off-label uses while downplaying the risks.
Steven’s attorney says that dozens of lawsuits will soon be filed against Medtronic by his office.