BLOOMFIELD, Indiana — The widow of a patient who said her husband died after receiving a contaminated bone repair product wants product manufacturers and government regulators to do more to protect patients from deadly and contagious communicable diseases. Georgia Flinn's husband of 44 years, Greg, 73, died on May 23 after receiving FiberCel that was voluntarily recalled by its manufacturer, Aziyo Biologics, according to a lawsuit filed by her attorneys.
"I want to give a voice to my husband's death," she said. "I want people to realize companies are accountable and need to test, and that we are the victims. They need to go a step further than just the basic requirements, and they need to do all they can to protect the recipient of the product."
Tuberculosis, a bacterial disease that most commonly attacks the lungs, can become contagious and is deadly if left untreated, according to Dr. Charles Bark, Medical Director, TB Clinic, The MetroHealth System.
The diagnosis
Flinn said her husband was an active outdoorsman who loved to hike, bike, and play with his grandchildren.
"He loved the outdoors," she said. "He loved God, family and country." Flinn said her husband of 44 years "was just a very good, gentle person."
Flinn said back issues had slowed down her husband. “He just couldn’t walk very well anymore. He couldn’t ride bikes. He couldn’t do much because the back hurt him so much." Hoping for relief, she said he underwent a spinal fusion at IU Health Bloomington Hospital in April.
“The incision looked great," she said. "After about two days, he just didn’t feel good.” She said her husband had a fever, chills, and lost his appetite.
She said his health kept deteriorating. Eventually, he was admitted back into the hospital, where doctors delivered a diagnosis no one expected.
"They said ‘We have to tell you your husband has contracted tuberculosis.' And we all jumped back and said ‘How did he get tuberculosis'?" she said.
The diagnosis also came too late to treat Flinn for TB. He died on May 23.
“After 44 years, you are kind of connected at the hip,” she said. "I don’t have the person I want to talk to. I don’t have anybody to share my highs and lows and to hear about them. I can’t talk to him anymore."
A few weeks after his death, Flinn said her husband's surgeon told her Greg likely contracted tuberculosis from contaminated FiberCel used during his surgery.
"I just don't understand how that happens,” she said.
The recall
The U.S. Food and Drug Administration (FDA) announced the recall on June 2 one donor lot of FiberCel product. Aziyo Biologics voluntarily recalled 154 containers. The CDC said the containers were shipped to 37 facilities in 20 states between March 1 and April 2.
Here are the states where the CDC says patients received the contaminated product:
18 States impacted by TB outbreak: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Oregon, South Dakota and Virginia
2 States pulled the product before it was implanted in any surgical patients: Texas and Washington
The CDC said there are 113 affected patients and eight deaths, including Flinn, linked to the single contaminated lot of FiberCel, a bone putty made from the cells of cadavers.
The FDA requires human tissue used for products like FiberCel to be tested for several communicable diseases, including hepatitis, HIV and syphilis, but not tuberculosis, according to a spokesperson.
The allegations
More than a dozen lawsuits filed in Indiana allege a contaminated bone product is to blame for a deadly tuberculosis outbreak in the state. Carmel law firm Wagner Reese filed a wrongful death lawsuit on behalf of Greg Flinn, as well as 11 other lawsuits. The lawsuit names FiberCel’s manufacturer, seller and distributor, and alleges their product was defective, “unreasonably dangerous,” and that its labeling failed to contain a warning about the risk of tuberculosis infection.
“It's a big problem,” said Tim Karns, an attorney with Wagner Reese. “Unfortunately this product somehow made it through the manufacturing process with a deadly communicable disease in it, and has been distributed throughout the state and nationwide."
"No information has been provided by Aziyo that they tested for tuberculosis,” Karns said. “Their methods and processes were inadequate and lead to Gregory Flinn's death and the sickness of numerous individuals across the country."
Bark said testing cadaver tissue for tuberculosis could help minimize the risk of contamination. "When you look at it under a microscope, TB has certain patterns you might see and also staining features, and the other option would be a molecular test like a DNA test that would look for it in the tissue," Bark said.
The Ohio investigation
An Ohio Department of Health spokesperson confirmed one of the deaths occurred in Ohio, but would not reveal where the patient received surgery over privacy concerns. Six Ohioans "underwent procedures with the affected lot," according to ODH.
An ODH spokesperson said five units of the affected lot of FiberCel were received by three Ohio healthcare facilities, including:
- Mayfield Spine Surgery Center (Cincinnati)
- Miami Valley Hospital North (Dayton)
- Western Reserve Hospital, LLC (Cuyahoga Falls)
The Ohio Department of Health (ODH) said it is "working with the CDC, local tuberculosis (TB) control units, and affected healthcare facilities to investigate and respond to the TB outbreak associated with a contaminated bone allograft material (FiberCel)."
The responses
Mark Bosko, VP Marketing and Public Relations, Western Reserve Hospital sent the following statement: "Western Reserve Hospital was notified by the device manufacturer of the recall. Upon notification of the recall, the Ohio Department of Health took the lead on recommendations and investigation and we worked to identify one (1) patient with which the device was utilized approximately one month prior to the recall notice. Due to HIPAA regulations and patient confidentiality, no further details concerning this specific matter may be shared."
The Mayfield Spine Surgery Center sent the following statement: “We cannot speak to a specific situation, however we take patient safety very seriously, and are committed to providing the highest level of quality care and experience for our patients."
Miami Valley Hospital North did not respond to News 5's voicemail or email requests for an interview.
The wound that won't heal
Michelle Weethee said she is one of the six Ohio patients who received the recalled FiberCel. She tested positive for TB and is undergoing treatment.
She had spinal surgery in March at Miami Valley Hospital North after suffering for years from back pain. "The back pain that I initially had before my surgery is gone," she said. "But it’s been replaced with a different type of pain. Pain from a wound that won’t heal."
RELATED: Her spinal surgery was a success. Then she tested positive for tuberculosis
A few weeks after the operation, Weethee was at work when her wound split open. “All of a sudden, I felt a pop," she said. "That was the first sign that there was something wrong." The wound created a gaping hole in her back.
Inside, infection raged out of control. Then, her doctors received a call from the CDC, she said, informing her she was one of the patients who was implanted with recalled FiberCel. Weethee said she tested positive for TB.
Despite taking 12 pills a day to treat the infection, undergoing three surgeries, and having a wound vac attached for periods of time, Weethee's attorney said the infection is still not getting better.
Along with the TB infection, she must endure side effects from the medications, which she has to take for up to a year — maybe longer. "The antibiotic is pretty rough," she said. She said she experiences nausea, vomiting, fatigue, sore joints, and has little appetite.
"My whole life right now centers around me being sick," she said. “It breaks my heart that this is what my life has come to."
Bark said TB cases are "not common" in the U.S., but still occur "on a regular basis." He said there are about 30 cases a year in Cuyahoga County.
Bark said it is estimated there are as many as 13 million Americans infected with TB but who do not have symptoms. He said there are close to 9,000 cases diagnosed each year.
Prior to COVID-19, TB was the leading cause of death among infectious diseases around the globe.
"TB is still a major problem throughout the world. It’s really an ongoing global pandemic with 11 million or 10 million cases every year," he said.
Aziyo Biologics, Inc. statement
News 5 has made multiple requests for an interview with Aziyo Biologics. A spokesperson declined our requests, but sent News 5 the following statement:
“Ensuring patient health and safety is our highest priority at Aziyo Biologics, Inc. We are fully committed to determine the medical root cause of these adverse events. We will be fully transparent through this process and continue to cooperate with both the FDA and the CDC in an ongoing investigation to understand whether there is any causal relationship between the post-surgical infections and the FiberCel single donor lot used.
"We have reviewed our procedure for screening donors and producing this product and have not identified any deviations from our established protocols, which are based on industry standards and government requirements.
"We are evaluating adjustments to our donor screening and testing methodology and process to broaden detection of disease beyond existing industry standards.
"Our culture is built on the principle of continuous improvement in the safety, efficacy and quality of our products.”
When asked where the infected tissue was procured and whether it was tested for tuberculosis, the spokesperson responded, "The company does not have any further comment at this time."
