A Louisville, Ky., couple has filed a lawsuit against medical device company Medtronic and a local hospital because a spinal surgery left her with disabling complications, according to the Courier-Journal.
The woman had a bio-engineered bone-graft device called “Infuse” during a surgery in 2006. She was left with substantial nerve damage and mostly has to recline or lie flat leaving her husband to take care of her, the lawsuit claimed.
The couples’ attorney said he plans to file dozens of lawsuits on behalf of patients who have had similar complications from Infuse. He said he has met with about 40 people regarding Infuse and talked to hundreds.
The device contains “bone morphogenetic protein” and is placed as a liquid sponge in a cage. Surgeons place the cage between vertebrae, and as the liquid hardens, it becomes bone. In some cases, the bone grows outside the cage and causes disabling pain in the legs and backs.
The U.S. Food and Drug Administration approved Infuse for a specific surgery performed through the abdomen but not the type of surgery the woman underwent, according to her attorneys.
The lawsuit further claims the company downplayed the risks of serious side effects from the device and illegally promoted off-label use. The company did not comment for the story because of the pending litigation.