On March 9, 2021, John Dukes, a resident of New Paris, Ohio, underwent a L4-L5 spinal fusion surgery and had a calcified cyst surgically removed at Reid Hospital in Richmond, Indiana. Although these are serious procedures, hundreds of thousands of patients successfully undergo similar surgeries in the United States each year. Unfortunately, following his surgery, John tested positive for tuberculosis. This infection is believed to have resulted from FiberCel Fiber Viable Bone Matrix (“FiberCel”), a bone repair product primarily used in bone grafting procedures associated with orthopedic and spinal surgeries.
FiberCel was designed, manufactured, and sold by Aziyo Biologics, Inc. (“Aziyo”), a corporation headquartered in Silver Spring, Maryland. Aziyo makes FiberCel from human cellular and tissue-based products that are harvested from a human cadaver or “donor.”
Aziyo represents that each “donor” cadaver is screened and tested by Aziyo’s Medical Director or physician designee. Aziyo further claims that said screening and testing includes “[c]ommunicable disease testing performed by a laboratory registered with [The Food and Drug Administration “FDA”] to perform such testing on human specimens … and [the donor] was found to be negative or non-reactive for” HIV, hepatitis B, hepatitis C, and syphilis. However, Aziyo does not expressly warn patients, physicians, or the medical community at large that FiberCel could transmit tuberculosis.
Aziyo manufactures FiberCel at its facility located in Richmond, California. On October 8, 2019, Aziyo announced that it had signed an exclusive, multi-year distribution agreement with Medtronic, whereby Aziyo would manufacture and supply FiberCel to Medtronic for distribution in the U.S. orthopedic market. SpinalGraft Technologies, LLC (“SpinalGraft”), a subsidiary of Medtronic, is responsible for distributing FiberCel in the U.S. In, turn, Medtronic and/or SpinalGraft have contractually retrained Rapp Medical Systems, LLC (“Rapp”) to sell and distribute FiberCel in Indiana.
On June 2, 2021, Aziyo announced a voluntary recall pertaining to a single donor lot of FiberCel. The recall was instituted after Aziyo learned of post-surgical infections in patients treated with FiberCel, including some patients who tested positive for tuberculosis. The recalled lot consisted of 154 units of FiberCel derived from a single donor, which were shipped to facilities in 20 different states, including Indiana.
Today, Wagner Reese, LLP and DeLaney & DeLaney LLC filed a lawsuit in Marion County, Indiana, on behalf of John Dukes and Kimberly Smith, John’s wife, to hold Aziyo, Medtronic, SpinalGraft, and Rapp responsible for the substantial and permanent harm they have inflicted on the Dukes Family. Since being implanted with the FiberCel product, John’s spine and blood have become severely infected with the Mycobacterium tuberculosis bacterium. Although John is currently on several medications to treat this condition, John remains in constant fear that this disease could spread to his lungs, kidneys, heart, and/or liver and prove fatal.
John is currently required to take several prescription medications on a daily basis. John must take these medications in the presence of a representative of the Indiana State Department of Health in order to ensure that he does not miss a dose, become contagious, and pose a threat to the public health. Accordingly, this incident has wholly eroded John’s privacy and rendered him a pariah among his friends and family.
When asked why he elected to initiate legal action, John stated that he “want[s] to recover the costs associated with his hospital bills and future medical care and hopefully prevent this situation from happening to others.” Kimberly, in turn, wants to make certain that the “defendants are held accountable for the harm they have caused John and his family.”
Unfortunately, the Dukes family are not the only individuals that were exposed to the contaminated FiberCel product. Wagner Reese and Delaney & Delaney currently represent six (6) additional patients who tested positive for tuberculosis after receiving FiberCel in a spinal surgery. One of these patients has now died. The firms anticipate filing additional lawsuits for these claims over the next several days.