A couple has filed a lawsuit against biotech company Elutia, formerly known as Aziyo Biologics, alleging that one member of the couple contracted tuberculosis from a spine implant.
The lawsuit, filed Aug. 20 in a federal court, alleges that Elutia did not take proper steps during the research, testing, design, development, manufacture, tissue recovery, production, inspection, labeling, advertisement, marketing, promotion, sale and distribution of the FiberCel implant.
The FiberCel Fiber Viable Bone Matrix product is made from processed human tissue consisting of cancellous bone particles with preserved living cells. While it is rigorously screened and tested, the FiberCel used in Carl Halsey's surgery was manufactured using contaminated human tissue recovered from a single donor, according to the lawsuit.
It was discovered that the single donor had a tuberculosis infection prior to his death and had clear signs and symptoms at the time of his death of an infectious etiology that were not appropriately recognized by Aziyo, according to the lawsuit.
On June 2, 2021, the FDA issued an urgent voluntary recall of FiberCel, specifically three products. Aziyo initiated the voluntary recall in response to reports of patients testing positive for tuberculosis and postsurgical infections following the surgical implantation of FiberCel as part of an orthopedic or spinal procedure.
Mr. Halsey underwent spinal surgery March 23, 2021, in Greenville, N.C. The FiberCel product contained no adequate warning to his physician of the danger that he could contract tuberculosis if a FiberCel product was used during the surgery, according to the lawsuit.
While the surgery was successful, Mr. Halsey began experiencing problems afterward. On June 8, 2021, the physician who performed the spine procedure notified Mr. Halsey he may have been exposed to tuberculosis. He subsequently tested positive for TB, according to the lawsuit.
Mr. Halsey was forced to undergo a medical protocol to manage his tuberculosis diagnosis and will require continued medical monitoring to monitor his health, the lawsuit said.
Mr. Halsey and his wife, Julia Halsey, are suing Elutia for injuries, harm, damages, and economic and non-economic losses in an amount to be determined in the future in excess of $75,000.
Elutia did not respond to Becker's request for comment. This story will be updated if more information becomes available.