Contaminated donor tissue gave Georgia patient tuberculosis, lawsuit says

A Calhoun woman contracted tuberculosis after contaminated human tissue was implanted in her spine during surgery, according to a lawsuit that she and her husband filed against the companies they say are responsible.

Tina and Steven Langford are seeking unspecified compensation from Elutia Inc., a Maryland-headquartered company that makes products for use in surgeries requiring bone grafting. The Langfords claim the “FiberCel Fiber Viable Bone Matrix” used in Tina Langford’s April 2021 spinal surgery contained human tissue from a donor with tuberculosis.

They’re also suing Tennessee-based DCI Donor Services Inc. and its subsidiary, New Mexico Donor Services, alleging those companies supplied the contaminated tissue used in the FiberCel.

“While the surgery was initially a success, (Tina Langford) soon began experiencing problems,” the lawsuit, filed Aug. 29 in a Georgia federal court, states. “(Tina Langford) was and is forced to undergo a grueling medical protocol to manage her TB diagnosis.”

Tuberculosis is a disease that usually affects the lungs, and which can be fatal if not treated properly, according to the U.S. Centers for Disease Control and Prevention.

Elutia, formerly known as Aziyo Biologics Inc., said it does not comment on ongoing litigation. DCI Donor Services did not immediately respond to questions about the Langfords’ case.

In June 2021, Aziyo Biologics recalled its FiberCel Fiber Viable Bone Matrix linked to a particular donor, after a hospital reported post-surgical infection in seven of the 23 patients who received the product. Four of those patients tested positive for tuberculosis, the U.S. Food and Drug Administration reported .

In their complaint, the Langfords said the contaminated FiberCel that was recalled in 2021 had been delivered to at least 20 states, including Georgia. They said Tina Langford was one of dozens of patients who received the contaminated FiberCel and subsequently tested positive for tuberculosis.

The donor whose tissue was used had “clear signs and symptoms” of an infection at the time of their death, the Langfords alleged.

In July 2023, Aziyo Biologics recalled all of its “viable bone matrix” products, after it learned that two patients had contracted tuberculosis after being treated with a product comprising tissue from a single donor. The CDC said the product was sent to 13 facilities in California, Louisiana, Michigan, New York, Oregon, Texas and Virginia, causing two deaths. In total, 36 people had surgery or dental procedures using the product, the CDC said .

At the time, Aziyo Biologics CEO and president Randy Mills said the company was “taking immediate action to safeguard patients.” It suspended shipments of all viable bone matrix products from all donors.

“The people of Aziyo care deeply about the patients we serve and will continue to work with the medical community, patients, and regulatory authorities as we gather additional information,” Mills said in a July 2023 news release .

Several national law firms have reported that eight patients died after receiving the contaminated FiberCel product in 2021. More than 100 patients were treated for tuberculosis in relation to the 2021 FiberCel recall, the CDC said.

Tina Langford’s surgery was at Floyd Medical Center in Rome, according to the lawsuit. It states that she was told in June 2021 that the FiberCel used in the surgery was tainted with tuberculosis.

Tina Langford has experienced significant side effects from the tuberculosis and associated treatments, “causing a cascade of sequential complications and injuries,” the complaint alleges.

The Langfords’ attorneys did not immediately respond to questions about the case.

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