TIPP CITY, Ohio — Attorneys for an Ohio woman who said she was left with "serious injuries" after receiving a unit of a recalled bone repair product filed a lawsuit against the product's manufacturer and distributors.
In the complaint, which was filed in the Montgomery County Court of Common Pleas on Thursday, Michelle Weethee's attorneys allege the FiberCel she received during a spinal surgery in March was "defective" because it was contaminated with the bacterium that causes tuberculosis.
Weethee tested positive for tuberculosis on June 7.
The complaint also alleges FiberCel's manufacturer, Aziyo Biologics, Inc., and distributors, including Medtronic, Inc., SpinalGraft Technologies, LLC, and Venture Medical, LLC, were negligent because they should have known their "failure to exercise reasonable care" would "result in injury to patients."
News 5 reached out to Aziyo Biologics, Inc.. In an email, a spokesperson wrote, "We do not have a comment at this time."
Aziyo voluntarily recalled 154 units of FiberCel on June 2. The CDC said 113 units were implanted into 113 patients in 18 states. The CDC said eight of those patients have since died. Their deaths remain under investigation.
"I feel like this is on the company, and they dropped the ball," Weethee said during an interview with News 5.
Weethee underwent spinal surgery on March 24 at a hospital in Dayton, Ohio. The lawsuit says Weethee initially "did well" after the surgery. However, on May 10, "the skin on her lower back split open, revealing a wound that was failing to heal internally."
Despite surgeries, medications and the placement of a wound vac, Weethee's attorney told News 5 her wound is still not healing properly. Her attorney also said Weethee feels fatigued, nausea, and has joint pain, among other side effects and symptoms.
"The back pain that I initially had before my surgery is gone, but it’s been replaced with… a different type of pain," Weethee said. "Pain from a wound that won’t heal.”
The CDC and FDA said they are investigating how the recalled FiberCel units became contaminated with the bacterium that causes TB.