Main Menu

New Product Liability Lawsuit Filed Against Medical Device Companies Over FiberCel Bone Graft Infections

News & Media Mentions

May 15, 2024

Morris James is actively involved in a newly filed product liability lawsuit alleging that a defective bone graft product, FiberCel, led to a tuberculosis (TB) infection in patients. The lawsuit was filed by Mark and Wanda Swartz in the Maryland Circuit Court for Prince George’s County. The Swartzes claim that the contaminated FiberCel bone graft product, manufactured by several healthcare device providers, caused them to contract TB following their bone grafting procedures in March 2021.

The legal action, first reported by, involves representation from attorneys at Morris James, Saltz Mongeluzzi Bendesky, and Bertram & Murphy.

The lawsuit asserts that the defendants, including Medtronic, Elutia, and Spinalgraft Technologies, failed to adequately test the FiberCel "Fiber Viable Bone Matrix" for contamination, leading to TB infections. The Swartzes are seeking compensatory, special, and punitive damages for what they describe as "wanton, willful, fraudulent, and reckless acts" by the companies.

In June 2021, the FDA issued an urgent recall of a specific donor lot of FiberCel due to reports of TB infections following surgical implantation. The recall came after patients, including the Swartzes, contracted TB from contaminated human tissue. The complaint details the Swartzes' suffering from symptoms such as neck and joint pain, weakness, fatigue, and anxiety, which required extensive medical treatment.

According to the Centers for Disease Control and Prevention, "136 units within the product lot in question were implanted into 113 patients in 20 states. Of the 113, the CDC has identified at least 72 patients who have exhibited clinical or diagnostic findings consistent with tuberculosis infection".

Lawrence Cohan of Saltz Mongeluzzi revealed that the firm anticipates filing approximately 20 additional lawsuits related to postsurgical infections caused by FiberCel. The litigation highlights significant concerns within the medical community about the safety and testing of such medical products. Common symptoms of active tuberculosis disease include cough, chest pain, and coughing up blood.

Medtronic, one of the named defendants, stated, "Medtronic has great sympathy for patients who were impacted by the unfortunate situation. As a former distributor for Elutia/Azyio, Medtronic did not manufacture, produce, or design FiberCel and was not involved in donor screenings. Medtronic will continue to defend our company, and we are hopeful Elutia will resolve the litigation amicably with impacted patients."

Morris James remains dedicated to advocating for those affected by medical product failures and will continue to provide updates as new developments arise in this significant case. Contact us immediately if you recently underwent spinal surgery and have since been diagnosed with tuberculosis or been contacted by health agencies in connection with tainted bone graft material. We are helping victims of this recall nationwide.

Click here (Subscription Required).

Back to Page