Federal lawsuit filed for surgery
A Delaware law firm has filed a federal lawsuit over surgical patients contracted tuberculosis from the FiberCel bone graft device.
Plaintiffs from four states, including one in Delaware, have joined lawsuits against manufacturer Aziyo and distributor Medtronic for personal injury allegedly sustained by tuberculosis-contaminated FiberCel.
Keith Donovan, an attorney for Wilmington-based Morris James, which is co-presenting the cases with Philadelphia-based Saltz Mongeluzzi and Bendesky, said he expected many more people with infected bone grafts to present. He said, to his knowledge, more than 100 people had received tuberculosis-infected transplants.
FiberCel is made from human cadaver tissue; It is designed to be like natural tissue and is used as a bone cavity filler in orthopedic and spinal surgery. Aziyo, the maker of FiberCel, is based in Wilmington, while distributor Medtronic is based in Minneapolis. Aziyo developed the product and Medtronic sold it. The product is marketed for use in orthopedic and reconstructive bone grafting procedures, an operation that uses transplanted bone to repair damaged or diseased bones.
On June 2, the U.S. Food and Drug Administration issued an urgent recall of FiberCel after Aziyo received reports of patients testing positive for tuberculosis and postoperative infections in patients with spinal surgery. Donovan said that one of Aziyo’s carcasses was diagnosed with tuberculosis, a bacterial infection that can appear in any part of the body, although most of the time it affects the lungs. Symptoms include cough, weight loss, or fever, and the disease can be fatal.
Donovan said the recalled batch contained 154 units of infected FiberCel that were shipped in 20 states. According to legal records, Aziyo has admitted that at least one hospital reported post-operative infections in seven out of 23 patients infected with FiberCel.
Donovan said the first lawsuit was filed by Richard Williams, an existing client who had undergone cervical fusion with an infected graft. Donovan said Williams later started showing symptoms of tuberculosis.
Although he doesn’t know what kind of tests Aziyo did on the body that turned out to be infected, Donovan said the product was harvested, frozen, and then sold to hospitals. Other clients include Deborah Rice, a Florida woman who tested positive for tuberculosis following spinal surgery in March. Customers include Jean Georges, a Newark man who contracted tuberculosis after back surgery; According to lawyers for Morris James, Georges had to undergo a second operation to remove and replace spinal fluid.
His attorney Matthew Fogg said, “There is no doubt that Mr. Georges contracted tuberculosis as a direct result of the contaminated, recalled Aziyo FiberCel implant used in his surgery. His life has been hell on earth and he is filing a lawsuit to ensure that those responsible for his pain and suffering are held fully accountable. “
Donovan said at the time that Morris James had 12 customers in five states and more are in the pipeline. He said more than money, these customers want to know how this could happen and want to make sure it doesn’t happen again. Although the litigation is still in the very early stages, Donovan believes the cases will not move to a class action lawsuit, given the difficulties arising from the widespread jurisdiction and lengthy class certification process.
“We expect more of this across the country,” he said.