Lawsuit filed on behalf of Indiana man alleges negligence
The number of patients reporting tuberculosis symptoms after surgeries involving recalled human tissue has spiked above 70 in the nation and to 30 in Indiana, with at least two suspected cases in Monroe County.
Federal health officials are investigating at least 72 cases in which patients have developed post-surgical tuberculosis symptoms, according to a filing with the Securities and Exchange Commission from Aziyo Biologics. Aziyo is the Silver Spring, Maryland-based manufacturer of the bone repair product FiberCel, which was recalled June 2.
The Indiana State Health Department has told The Herald-Times that it was investigating at least 30 cases in 19 Indiana counties. A spokeswoman for the department said that due to privacy concerns, the department cannot disclose which counties are affected unless they have had five or more cases.
A Bedford man told The Herald-Times last week that he contracted TB from a device used during a back surgery in early April at Indiana University Health Bloomington Hospital. The man requested his name not be used because he feared retaliation from health care providers.
The cases have prompted at least three lawsuits, including one filed by Indianapolis law firm Wagner Reese, which is alleging that negligence by Aziyo and its distributors caused a tuberculosis infection in John Wayne Dukes, an Ohio man who underwent back surgery in Richmond, Indiana.
Dukes underwent spine fusion and cyst removal surgery on March 9 at Reid Hospital in Richmond. According to the lawsuit, the surgery involved the recalled FiberCel product, and Dukes “continued to experience substantial joint pain in his spine and extreme fatigue.”
After Aziyo recalled the product, Dukes’ surgeon, Dr. Hon Vien, notified Dukes, who tested positive for tuberculosis on June 7.
“I was totally shocked … and very angry,” Dukes told The Herald-Times on Wednesday.
Dukes said he was told the surgery would include screws and plates, and that he did not know it would involve any transplanted tissue.
Dukes said he now has to take 11 medications every morning — 4,500 mg total — while Ohio health officials are observing him via video call.
“They are concerned that it may become contagious,” he said.
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Dukes, 55, works with his wife to supply furniture to military bases and offices, but he said he has not been able to work because he still suffers from fatigue and back pain, which he suspects is a result of the infection.
He also criticized health officials for failing to provide even basic information about the illness or the medications he is required to take. Dukes said he had to look up a lot of the information online.
Some of the medications have caused painful blisters on his hands and neck, he said.
And, Dukes said, he worries about potential long-term effects of the TB infection. Every day, he said, he looks up new symptoms and potential complications.
So far, he said, he has not been given a long-term prognosis.
“They haven’t told me anything that far out,” Dukes said.
Lawsuit alleges negligence
The lawsuit, filed by Wagner Reese Monday in Marion Superior Court, alleges that as a result of the negligence by Aziyo and its distributors, Dukes “has suffered damages including serious personal injury and illness, pain and suffering, past and future medical costs and expenses, past and future medical monitoring, loss of past and future income, impaired earning capacity, inconvenience, and loss of enjoyment, quality of life, and diminished life expectancy.”
“While Aziyo warns that ‘current technologies may not preclude the transmission of infectious agents or diseases, including hepatitis and HIV,’ it does not expressly warn users, consumers, physicians or the medical community at large that FiberCel could transmit tuberculosis,” the suit alleges.
The suit requests unspecified compensatory damages. At least one other lawsuit has been filed, in Delaware.
An Aziyo spokeswoman told The Herald-Times via email that the company does not comment on pending litigation.
“We continue to work with the FDA and the CDC and we are committed to a thorough, timely and transparent investigation,” she said.
Since announcing the recall, the company’s shares have fallen 21%, wiping out more than $27 million in shareholder value.
TB is a potentially fatal bacterial disease that usually attacks the lungs but also can attack other parts of the body, including the kidneys, spine and brain. The U.S. reported nearly 9,000 TB cases in 2019. The year before, the nation recorded 542 TB deaths, according to the U.S. Centers for Disease Control and Prevention.
More:For centuries, scientists sought a tuberculosis cure. A Passaic man found it in the dirt.
State law requires that TB cases be reported to local health departments within 72 hours — though information from the CDC indicates that TB “is usually not infectious.”
A state health department spokeswoman told The Herald-Times last week that it was investigating at least 30 suspected TB cases, but would not answer questions about required state testing protocols for transplant tissue or whether any protocols did not work or were not followed.
This article was first published in The Herald-Times.
