First U.S. Lawsuit Filed Against Aziyo Biologics, Inc. And Medtronic, Inc. On Behalf Of Delaware Patient Infected With Tuberculosis After Receiving Tainted Surgical Bone Graft Product During Spinal Fusion

Jun 22, 2021 10:48 AM ET

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A retired career corrections officer, who contracted tuberculosis (TB) during a spinal fusion operation, today filed the first lawsuit against Delaware biotechnology company Aziyo, Inc., that recently recalled its TB-tainted FiberCel Viable Bone Matrix (VBM) used to promote bone grafts in nearly two dozen orthopedic surgeries at Christiana Care Hospital, and possibly many more across the United States. The filing in the Delaware Superior Court was jointly announced by plaintiff's attorneys from Saltz Mongeluzzi & Bendesky P.C. and Morris James, LLP.  Besides Aziyo, Medtronic, Inc., the regenerative medical product's exclusive distributor, was named as a defendant.


Lawrence R. Cohan, who heads Saltz Mongeluzzi's mass tort and toxic tort practices, and Keith E. Donovan, Managing Partner at Morris James, said the complaint (Richard Williams v. Aziyo, Inc. et al., Filing Delaware Superior Court, New Castle County, C.A. No.: N21C-06-166 EMD) includes claims for unspecified compensatory and punitive damages in seeking justice for plaintiff Richard Williams, 74, of Bear, Delaware, who is being treated with antibiotics for his TB infection resulting from the implantation of a tainted bone graft product while he recovers from what should have been an uncomplicated operation at Christiana Care Hospital. As part of the procedure, his medical team relied on Aziyo's proprietary product developed from allograft bone. Surgeons learned only after his surgery on Aril 13, 2021- and before the June 2nd product recall - that their patient was infected with TB. It is a communicable disease that can be fatal.


"We believe our client and likely others were infected with tuberculosis due to the contaminated surgical bone product which should have been fully tested to ensure it was disease-free and suitable for implantation," said Mr. Cohan, a nationally recognized medical product liability trial lawyer. "Our team looks forward to the start of intensive pre-trial discovery and through the justice system ultimately holding accountable all those responsible for permitting this contaminated product to reach hospitals, surgeons and their unsuspecting patients." Mr. Cohan was Plaintiffs' Lead Counsel in the massive, nationwide Human Tissue MDL involving thousands of cases over several years.


Mr. Donovan, whose firm is headquartered in Wilmington, Delaware and filed the complaint, stated, "Our courageous client, who so looked forward to a speedy post-operative recovery and resuming his wonderful, active retirement, was instead shocked to learn of his TB diagnosis and that he urgently required "revision surgery" last week to remove the contaminated bone-repair product and perform a second spinal surgery using unadulterated material. A dedicated former public employee, he wants us to do everything possible to ensure that what happened to him can never happen again, to any patient, anywhere. We anticipate filing similar actions on behalf of other TB-infected surgical patients in the near future." Attorneys Susan D'Alonzo Ament, Matthew R. FoggKevin G. Healy, and Michael G. Owen at Morris James and attorney Joshua C. Cohan at Saltz Mongeluzzi are also engaged in Mr. Williams' representation.


Aziyo's voluntary product recall, issued through the U.S. Food and Drug Administration (FDA), referred to "post-surgical infection in seven of the 23 patients that have received FiberCel from this Donor Lot. Four of these patients have tested positive for Tuberculosis." Aziyo claims that lot consists of 154 units all derived from a single donor. Tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis. It usually attacks the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain.


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