Allograft Litigation Moved Up to Federal Court

A number of lawsuits in the ongoing FiberCel allograft litigation have been removed to federal court, including a recent case filed by William Wilcox.

Wilcox claims that during his 2021 spinal surgery, the FiberCel used was contaminated with tuberculosis. This he asserts led to his development of tuberculosis and need for medical care.

In his complaint he claims that “as a direct and proximate result of the implantation of contaminated FiberCel, Plaintiff [Wilcox] was forced to undergo two revision surgeries in an attempt to mitigate the damage done by the contaminated FiberCel.” He further argues that “as a direct and proximate result of the implantation of contaminated FiberCel, Plaintiff [Wilcox] was forced to undergo a grueling medical protocol to manage his TB [tuberculosis] diagnosis.”

According to court documents, FiberCel is a “human tissue allograft consisting of cryopreserved cancellous and corticocancellous bone matrix that is aseptically processed to preserve native factors that support bone repair.” It “can be used in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.”

In 2021, Aziyo Biologics (based in Silver Springs, Maryland) announced a voluntary recall for a donor lot FiberCel Variable Bone Matrix consisting of 154 units of FiberCel. All of the units had been derived from a single donor and had been shipped to 20 states.

According to court documents, Aziyo Biologics admits that “after it learned of post-surgical infections in patients treated with FiberCel, including some patients who tested positive for tuberculosis, Aziyo issued notice of the voluntary recall to hospitals that received FiberCel from the voluntarily recalled lot.”

Wilcox initially filed his lawsuit in the Circuit Court of Loudoun County, Virginia. His complaint listed the following as defendants: Aziyo Biologics, Inc.; Medtronic Sofamor Danek USA, Inc.; SpinalGraft Technologies, LLC; DCI Donor Services, Inc.; and New Mexico Donor Services.

According to court documents, the FiberCel at issue was processed by Aziyo and distributed by SpinalGraft Technologies, a wholly owned subsidiary of Medtronic Sofamor Danek. Additionally, New Mexico Donor Services, one of DCI Donor Service’s tissue recovery facilities, “recovered and provided the subject human donor tissue to Aziyo.”

The litigation is ongoing. According to the court’s most recent scheduling order in the matter, discovery should be completed by September 15, 2023.

Wilcox is not the only patient suing the companies following the recall. Since 2021, patients have been alleging harm and even death related to the contaminated FiberCel. For OTW’s original coverage of the litigation and recall, see “Wrongful Death Suit Hits Aziyo Over TB-Tainted Implant” and “Bone Graft Product Recalled Over TB Contamination Fears.”