Fibercel Lawsuit Over Tuberculosis from Contaminated Bone Graft Removed to Federal Court

A Virgina man diagnosed with tuberculosis has filed a lawsuit against Fibercel manufacturers, claiming he was infected after receiving a contaminated bone graft product, which was later linked to more than 100 illnesses nationwide.

The complaint (PDF) was brought by William Wilcox in Loudoun County Court in Virginia in March 2023, but was removed to federal court (PDF) earlier this month by the defendants, which include Aziyo Biologics, Inc., Medtronic Sofamor Danke U.S.A., SpinalGraft Technologies, LLC, DCI Donor Services, Inc. and New Mexico Donor Services.

FiberCel is a fiber-based bone repair product, which is engineered to maintain characteristics of natural tissue for bone grafts, or alone as a bone void filler. It contains preserved living cells from donors to facilitate bone repair and healing in recipients, and is used during various spine and orthopedic procedures.

The lawsuit comes nearly two years after the U.S. Centers for Disease Control and Prevention (CDC) warned about a tuberculosis outbreak in June 2021, which affected more than 100 people who underwent surgery involving FiberCel Bone Matrix tissue products.

The CDC warning instructed more than 100 patients who received FiberCel Bone Matrix tissue products for spinal surgery or fracture repairs to be screened for tuberculosis, warning that a certain lot of the product which came from a single donor may have been contaminated with Mycobacterium tuberculosis.

The CDC investigation was announced following a FiberCel Fiber Viable Bone Matrix recall issued by the U.S. Food and Drug Administration (FDA) on June 2, 2021, and the agency concluded that a total of 113 patients were infected with tuberculosis due to tainted FiberCel tissue products, 16 of whom were hospitalized as a result. Wilcox says he was one of them.

FiberCel Tuberculosis Lawsuit

In his original complaint, Wilcox indicates he underwent spinal surgery in March 2021, which included bone grafting with FiberCel. He was notified in June that he may have been exposed to tuberculosis, and later tested positive for a tuberculosis infection.

“Plaintiff’s tuberculosis was caused by the contaminated and recalled FiberCel used in his operation,” the lawsuit states. “As a direct and proximate result of the implantation of contaminated FiberCel, Plaintiff was forced to undergo two revision surgeries in an attempt to mitigate the damage done by the contaminated FiberCel.”

The Fibercel lawsuit indicates Wilcox had to undergo a “grueling” medical protocol to manage his tuberculosis, and will require medical monitoring in the future in order to keep tabs on his health and the possible return of the condition.

Wilcox argues he never would have suffered these damages if the manufacturer had done its duty and made certain its products were free from contamination.

The case has been moved to the U.S. District Court for the Eastern District of Virginia, where Senior U.S. District Judge Anthony J. Trenga issued a court order (PDF) on May 17, scheduling a pretrial conference for June 7 before a magistrate judge.

Judge Trenga ordered the parties to confer before the conference to consider the claims, defenses, the potential for a trial and the likelihood of a prompt settlement agreement. The order calls for discovery to be completed by September 15, and a pretrial conference to be held on September 21.

Wilcox’s lawsuit is one of several complaints filed in the wake of the CDC warning and tuberculosis outbreak, most of which appear to have been removed from state courts to federal courts within the last few weeks.

Tuberculosis Health Risks

Tuberculosis is caused by the Mycobacterium tuberculosis bacteria, which spreads through the air when a person with TB in their lungs or throat coughs, sneezes, or talks. The infections are of such concern they need to be reported to the local or state health department tuberculosis program.

While most people infected with TB do not show symptoms, symptoms can include chest pain, breathing complications, chronic coughing, fatigue, chills, loss of appetite, shortness of breath and swollen lymph nodes. Treatment of the infection often involves an extended course of antibiotics.