BLOOMFIELD — A Bloomfield widow is pushing for change after her losing her husband of 44 years to tuberculosis.
Greg Flinn, 73, died on May 23 after receiving a contaminated bone repair product during a back surgery at IU Health Bloomington Hospital, court records allege.
His widow, Georgia Flinn of Greene County, wants manufacturers to do additional testing on bone repair products before using them on people.
“I want people to realize companies are accountable and need to test, and that we are the victims,” Georgia said.
Tuberculosis is caused by a bacterium that can attack the lungs, the spine and other parts of the body and can be deadly.
More than a dozen lawsuits filed in Indiana allege a contaminated bone product is to blame for a deadly tuberculosis outbreak in our state.
At the age of 73, Greg was still active— hiking, playing with his grandkids, and biking with his wife.
“He loved the outdoors,” Georgia said. “He was a very gentle person. He loved God, family and country."
Greg started having back issues, and in April went in for a spinal fusion at IU Health Bloomington Hospital.
Within days of his back surgery, Greg felt sick.
"He didn't want to eat, and he had headache and chills,” Georgia said.
Greg went back into the hospital where doctors gave Georgia unexpected news.
"They said ‘We have to tell you your husband has contracted tuberculosis’ and we all jumped back and said ‘how did he get tuberculosis?’" Georgia said.
It was too late to treat tuberculosis, and Greg died on May 23.
“We were married for over 44 years and after 44 years, you are kind of connected at the hip,” Georgia said. “The house is vacant. He's not coming home and there's just no one to talk to."
After his death, Georgia said his surgeon informed them Greg likely contracted tuberculosis from a contaminated bone repair product used in spine and orthopedic procedures, FiberCel, which is derived from cadavers.
"I just don't understand how that happens,” Georgia said.
The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration are investigating.
FiberCel’s website shows it is manufactured by Aziyo Biologics and sold through Medtronic.
The CDC tells WRTV Investigates 18 states have been impacted by this tuberculosis outbreak: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Oregon, South Dakota and Virginia.
Texas and Washington received the product, but pulled it before it was implanted in any surgical patients.
Eight people who received the contaminated product have died, according to the CDC.
Two of those deaths happened in Indiana, according to the Indiana State Department of Health.
Indiana state health officials are investigating a link between at least 30 cases of tuberculosis and one particular donor lot of FiberCel.
Records show the impacted bone repair product was used at the following facilities:
- Lutheran Hospital in Fort Wayne
- St. Joseph Regional Medical Center in Mishawaka
- Reid Health in Richmond
- IU Health Methodist in Indianapolis
- IU Health Bloomington
- Eskenazi in Indianapolis
- Memorial Hospital in South Bend
- Surgicare in Bloomington
These facilities used the product before the FDA announced a voluntary recall on June 2 of one donor lot of FiberCel product.
Carmel law firm Wagner Reese has filed a wrongful death lawsuit on behalf of Greg Flinn, as well as 11 other lawsuits.
They’re suing FiberCel’s manufacturer, seller and distributor alleging their product was defective, “unreasonably dangerous,” and that its labeling had no warning about the risk of tuberculosis infection.
“It's a big problem,” attorney Tim Karns with Wagner Reese said. “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."
IU Health is not a party to the Flinn wrongful death lawsuit and was not able to provide comment.
The FDA requires companies to test for HIV, Hepatitis, Syphilis, and other “relevant communicable diseases.”
"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."
Infectious disease Dr. Charles Bark said testing cadaver tissue for tuberculosis would 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.
Georgia hopes her husband’s death pushes product manufacturers to test specifically for tuberculosis, and for the government to update its regulations.
"I want to give a voice to my husband's death,” Georgia said. “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."
WRTV Investigates asked the FDA if they plan to require any additional testing.
“FDA continues to work closely with the Centers for Disease Control and Prevention (CDC) and the company to investigate the situation,” the FDA said in a statement. “We recommend contacting the company directly for additional information about the product and the recall.”
We reached out to FiberCel’s manufacturer regarding whether they have plans to do additional testing on their products, and they have yet to respond.
In June, the company provided the following statement:
"We cannot comment on pending legal matters. Aziyo continues to work with the FDA and the CDC and is committed to a thorough, timely, and transparent investigation. Aziyo’s June 22 8-K filing with the SEC here provides updated information on the status of this investigation and notification of patients who were treated with the product lot."
"Consistent with the company’s commitment to patient safety, Medtronic fully supports Aziyo’s decision to issue a voluntary recall of the affected lot of FiberCel Viable Bone Matrix (VBM), which was manufactured by Aziyo Biologics and shipped directly to healthcare providers. As the exclusive distributor of Aziyo’s FiberCel VBM, Medtronic is working closely with Aziyo and the Centers for Disease Control and Prevention (CDC) to notify all customers who may have received product from the affected lot that is subject to this voluntary recall. Medtronic is also working with Aziyo and the CDC to ensure that healthcare providers and patients have the necessary guidance to manage care and treatment of impacted patients, and to establish a patient support program. In keeping with its commitment to patient safety, Medtronic has suspended all distribution of Aziyo’s FiberCel VBM until completion of the CDC investigation with Aziyo."
CDC is working with health departments to respond to a tuberculosis (TB) cluster in spinal surgery patients in several states. These surgical procedures all used a single product lot of FiberCel, a bone allograft, manufactured by Aziyo Biologics and distributed by Medtronic (FiberCel lot NMDS210011). On June 2, the manufacturer proactively issued a voluntary nationwide recall of the single lot of FiberCel linked to these patients.
The manufacturer reported that 154 units of the FiberCel product, from a single donor, were shipped to 37 facilities in 20 states from March 1 to April 2. At present, there is no indication that other units of FiberCel are affected by this situation. All facilities and states have been contacted and all unused units have been sequestered.
Here is more information about the patients and sequestered units as of June 21, 2021:
- Healthcare providers contacted 105 patients who had surgery using this product lot to evaluate and treat them for TB disease
- All surgical patients exposed to this product lot are now on treatment for TB disease.
- Eight states were able to sequester 18 units, preventing additional surgeries using the affected lot.
CDC recommends that all patients who received this product lot immediately begin full treatment for TB disease, even if they do not have any symptoms. CDC’s recommendation is based on the risk of localized TB disease in areas involved in surgery, in the spine or other bones, and in other parts of the body. CDC is also providing guidance to healthcare facilities to prevent transmission of TB between patients and protect healthcare personnel who may have exposed during patient surgery and patient care, including environmental services personnel and decontamination reprocessing personnel.
TB is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs but can also attack any part of the body such as the kidney, spine, and brain. TB can cause severe health problems and death if untreated.
CDC is working with partners, including the U.S. Food and Drug Administration (FDA), to determine how the TB contamination may have happened. At this point, the available evidence suggests that TB was transmitted through the product. The risk of TB transmission through bone grafts has been rare, with only one case report available in the published literature (from 1953).
CDC, state and local health departments, hospitals and surgical centers in the affected states, and FDA are working together to prevent further patient harm and determine if additional measures can be taken to prevent similar outbreaks in the future.
If you have questions about patients or healthcare facilities in a particular state, please call that state’s health department.
"The Indiana Department of Health is working with local health departments and providers to investigate individuals across the state who received a bone repair product that has been linked to tuberculosis infections across the United States. All affected individuals have been notified and appropriate public health actions have been taken. Tuberculosis cases must be reported to the local health department within 24 hours per Indiana’s Communicable Disease Rule. There are 30 cases reported because according to the CDC, anyone who received the product is considered a case. An outbreak is an increase in the expected number of TB cases, but this is a unique situation and not a typical tuberculosis outbreak. Historical tuberculosis data may be found here."