Spine patient sues over tainted bone graft

Tina and Steven Langford have filed a lawsuit against Elutia, formerly known as Aziyo Biologics, after Tina contracted tuberculosis from a product used during her spine surgery in April 2021. The couple alleges that the FiberCel Fiber Viable Bone Matrix contained human tissue from an infected donor, leading to Tina’s severe health complications. This lawsuit adds to a growing list of legal challenges for Elutia regarding FiberCel, particularly after a June 2021 FDA recall spurred by reports of tuberculosis and infections linked to the bone grafts, including a similar case filed by a North Carolina couple just months prior.[1]

I feel a little behind the times because where did this all start? Especially in 2021, with this year being 2024. (Granted, there was this whole….THING happening in 2021….)

Let’s start from the beginning…

On May 25, 2021, a Delaware acute care hospital alerted the Delaware Division of Public Health (DPH) about seven patients who developed tuberculosis after spinal surgeries performed in March and April, all linked to a single lot of bone allograft material (referred to as product A). The DPH notified the CDC, prompting a field investigation, which began on June 2. Investigators examined medical records, interviewed patients, and assessed potential exposure risks during the surgery and subsequent patient care. Of the 23 patients who received the affected product, 19 showed symptoms of tuberculosis, with many requiring hospitalization and additional surgical procedures. Tragically, one patient died weeks post-surgery. [2]

On June 2, 2021, Aziyo Biologics, Inc. initiated a voluntary recall of the FiberCel Fiber Viable Bone Matrix, specifically Donor Lot Number NMDS210011, due to safety concerns following a complaint from a hospital. The company issued an Urgent Notification Letter instructing customers to inspect their inventory, quarantine any remaining products from the affected lot, and notify any further distributors.[3]

By June 25, 19 patients exhibited signs of tuberculosis in their spines or chests, with many requiring hospitalization and additional surgical procedures. Tragically, one patient died weeks post-surgery. [2]

In a “Nationwide Tuberculosis Outbreak in the USA Linked to a Bone Graft Product: An Outbreak Report” published in Aug 2022, the following findings were presented:

• Bone was sourced from a deceased donor and processed into 154 bone allograft units containing live cells.
• These units were distributed to 37 hospitals and ambulatory centers in 20 U.S. states between March 1 and April 2, 2021.
• 136 units (88%) were implanted in 113 patients across 18 states, some patients receiving multiple units.
• A voluntary recall of the lot occurred between June 2 and 7, 2021. Of the remaining 18 units, eight were tested for M. tuberculosis and ten were returned to the manufacturer.
• 7 of 113 recipients died before outbreak detection, and 1 died the day after notification of tuberculosis (TB) exposure.
• 105 recipients (93%) were notified of TB exposure by June 15, 2021; 8 had begun treatment before outbreak detection, and the remaining 97 began treatment by June 21.
• The donor was an 80-year-old man with a history of travel to countries with high TB incidence, but had no known history of TB or exposure.
• The donor’s death was attributed to cardiogenic shock following cardiac arrest, not TB.
• The donor’s bones were processed into a product containing demineralized cortical and cancellous bone, tested for bacteria and fungi, but not for M. tuberculosis.
• Among 113 recipients, 77% had microbiological or imaging evidence of TB disease, mostly at the surgical site (73%) with 25% showing dissemination.
• Common symptoms included surgical site pain (74%), neurological symptoms (39%), and pulmonary symptoms (33%).
• M. tuberculosis was detected in all eight recalled product units and matched with samples from 53 recipients. The strain was genetically unique and had not been previously identified in the U.S.
• No drug resistance was found, and first-line TB treatment was effective.
• One additional case of TB was reported in November 2021 from a patient who received a non-recalled product lot, with the investigation ongoing by July 2022.[4]

In late August 2023, the Centers for Disease Control and Prevention (CDC) reported a second death linked to tainted FiberCel Fiber Viable Bone Matrix. [5]

As of today, (although I have not been able to confirm in any sources outside of Law Firm websites) six more patients who received this lot died. Bringing the alleged total deaths to 8. [6]

Then it happened again?

In January, the CDC released a report about a “Second Nationwide Tuberculosis Outbreak Caused by Bone Allografts Containing Live Cells”, here’s what they had to say:

• July 7, 2023: CDC was notified of a meningitis case 5 weeks after spinal fusion surgery using a bone allograft product containing live cells; Mycobacterium tuberculosis (TB) was detected in the cerebrospinal fluid.
• July 11, 2023: Another case involved a persistent surgical site infection after a laminectomy using a similar product, where TB was confirmed. Clinicians reported similarities to the 2021 TB outbreak.

Key Findings:

• The donor was U.S.-born with no TB risk factors. A chest radiograph showed signs of pneumonia and a lung nodule before death, which was attributed to sepsis.
• By July 14, 36 patients had received units from the implicated product lot. Five patients were diagnosed with TB, two of whom died. At least 10 others showed TB-compatible symptoms.
• Whole-genome sequencing confirmed the bone allograft as the source of TB transmission, with a close genetic match among samples from patients and the unused product.

In response to the outbreak, all recipients are being treated as a precaution, even if they haven’t shown symptoms, to prevent more severe health outcomes. Early detection and timely treatment have proven crucial in minimizing complications. Meanwhile, lawmakers are pushing the FDA to strengthen regulations on tissue transplants, advocating for better screening and the use of culture-based testing to detect TB more reliably than current nucleic acid methods.[7]

References

[1] Behm, C. (2024, October 17). Spine patient sues over tainted bone graft: 5 notes. Becker’s Spine Review. https://www.beckersspine.com/biologics/60862-spine-patient-sues-over-tainted-bone-graft-5-notes.html?origin=SpineE&utm_source=SpineE&utm_medium=email&utm_content=newsletter&oly_enc_id=3879F1010134A1X

[2] Li, R., Wilson, W. W., Schwartz, N. G., Hernandez-Romieu, A. C., Glowicz, J., Hanlin, E., Taylor, M., Pelkey, H., Briody, C. A., Gireesh, L., Eskander, M., Lingenfelter, K., Althomsons, S. P., Stewart, R. J., Free, R., Annambhotla, P., Basavaraju, S. V., Wortham, J. M., Morris, S. B., . . . Drees, M. (2021). Notes from the Field:Tuberculosis Outbreak Linked to a Contaminated Bone Graft Product Used in Spinal Surgery — Delaware, March–June 2021. MMWR Morbidity and Mortality Weekly Report, 70(36), 1261–1263. https://doi.org/10.15585/mmwr.mm7036a4

[3] Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011. (2021, June 2). FDA. https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/urgent-voluntary-notification-fibercel-fiber-viable-bone-matrix-fibercel-lot-number-nmds210011#:~:text=Aziyo%20will%20provide%20prepaid%20shipping,calling%20888%2D869%2D2435.

[4] Schwartz NG, Hernandez-Romieu AC, Annambhotla P, Filardo TD, Althomsons SP, Free RJ, Li R, Wilson WW, Deutsch-Feldman M, Drees M, Hanlin E, White K, Lehman KA, Thacker TC, Brubaker SA, Clark B, Basavaraju SV, Benowitz I, Burton Glowicz J, Cowan LS, Starks AM, Bamrah Morris S, LoBue P, Stewart RJ, Wortham JM, Haddad MB; Bone Allograft Tuberculosis Investigators. Nationwide tuberculosis outbreak in the USA linked to a bone graft product: an outbreak report. Lancet Infect Dis. 2022 Nov;22(11):1617-1625. doi: 10.1016/S1473-3099(22)00425-X. Epub 2022 Aug 4. PMID: 35934016; PMCID: PMC9605268. https://pmc.ncbi.nlm.nih.gov/articles/PMC9605268/

[5] Second patient dies from CDC-identified outbreak of TB cases linked to viable bone matrix. (2023, August 25). American Dental Association. https://adanews.ada.org/ada-news/2023/august/second-patient-dies-from-cdc-identified-outbreak-of-tb-cases-linked-to-viable-bone-matrix/#:~:text=The%20product%20is%20FiberCel%20Fiber,cases%20associated%20with%20that%20material.

[6] FiberCel Bone Graft Injury Tuberculosis Attorneys & Lawyers Delaware (DE). (2024, August 28). Morris James LLP. https://www.morrisjames.com/service/mass-torts-litigation/fibercel/#:~:text=Based%20on%20information%20from%20the,directed%20to%20appropriate%20medical%20treatment.

[7] Wortham, J. M., Haddad, M. B., Stewart, R. J., Annambhotla, P., Basavaraju, S. V., Nabity, S. A., Griffin, I. S., McDonald, E., Beshearse, E. M., Grossman, M. K., Schildknecht, K. R., Calvet, H. M., Keh, C. E., Percak, J. M., Coloma, M., Shaw, T., Davidson, P. J., Smith, S. R., Dickson, R. P., . . . LoBue, P. A. (2024). Second nationwide tuberculosis outbreak caused by bone allografts containing live cells — United States, 2023. MMWR Morbidity and Mortality Weekly Report, 72(5253), 1385–1389. https://doi.org/10.15585/mmwr.mm725253a1