WILMINGTON, Del., June 28, 2021 /PRNewswire/ -- On June 23, 2021, Young Conaway filed five (5) separate complaints in Delaware's Superior Court claiming negligence against Aziyo Biologics, Inc. and Medtronic, Inc. on behalf of multiple clients affected by the bone putty product, FiberCel Fiber Viable Bone Matrix, thought to be contaminated with the bacteria that causes Tuberculosis ("TB").
Speaking on behalf of the plaintiffs, Personal Injury Section Chair Timothy Lengkeek stated, "Our clients have had to endure the stress caused by their original spinal surgery. Now they face the prospect of extensive antibiotic treatments and/or the need for additional surgical procedures due to this defective product. We look forward to discovering how this happened to multiple patients in this state."
The FDA's Urgent Voluntary Notification issued on June 2, 2021, in coordination with a voluntary recall by Aziyo Biologics, Inc., follows an investigation of a rare TB outbreak among more than 100 patients who may have been infected from a single FiberCel donor lot (Lot Number: NMDS210011). "We believe that there may be additional patients here in Delaware, as well as others across the country, who have been affected by this tainted product," said Mr. Lengkeek.
Federal and state health officials are recommending that patients who received FiberCel's Fiber Viable Bone Matrix product be tested and treated for TB even if they are not showing symptoms. TB is a bacterial disease caused by Mycobacterium tuberculosis. It usually affects the lungs, but can attack any part of the body, including the kidney, spine and brain. If the disease is not treated properly, or is drug resistant, it can be fatal.
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SOURCE Young Conaway Stargatt & Taylor, LLP