A rare outbreak of tuberculosis among dozens of surgical patients — some of them at hospitals in northern Virginia — is under investigation by federal health authorities, including the Centers for Disease Control and Prevention. The CDC suspects the infections may be tied to a malleable bone putty used in spinal and other orthopedic procedures.
The substance includes human cells harvested from cadavers, according to Aziyo Biologics Inc., a regenerative medicine company that has voluntarily recalled 154 containers of its FiberCel product.
Patrick Malone & Associates represents patients infected with tuberculosis apparently from this FiberCel bone putty product. Our firm is actively investigating what happened to determine the legal liability of everyone involved and to see where the breakdowns occurred in the checks and balances intended to keep medical products safe.
The CDC says the apparently contaminated FiberCel supplies were shipped frozen to 37 facilities in 20 states between March 3 and April 2, with 136 of the containers and the product in them getting implanted into 113 patients, the Washington Post reported. Eight patients died after their procedures, but the cause of death is still being determined. The newspaper reported this:
“[P]ublic health officials are recommending that the remaining patients who received these bone repair products be treated for tuberculosis even if they are not showing symptoms. Health-care providers are contacting 105 patients who used this product and all but four are being treated for the disease, the CDC said in a statement …States were able to sequester 18 of the affected products to prevent additional surgeries, the CDC said. The agency is investigating the outbreak with state health departments, the Food and Drug Administration and the companies that manufactured and distributed the product.”
TB infection is a serious complication, the newspaper reported, noting:
“Tuberculosis is caused by a bacterium, Mycobacterium tuberculosis [see photo above]. It usually affects the lungs, but can attack any part of the body, including the kidney, spine and brain. Not everyone infected becomes sick, but if not treated properly, the disease can be fatal. Typical treatment for TB that is not drug-resistant is a six-month course of antibiotics.”
The company that makes FiberCel, including by processing harvested human tissue, has said it did not test these materials for TB. Such materials typically do undergo examination for “HIV, hepatitis C, and other infections that are more commonly spread” in patient implants, the newspaper reported.
Infections involving bone products, however, are unusual, and experts told the Washington Post that a case similar to this outbreak, affecting bone grafts, had not occurred since 1953.
Health officials learned of the TB outbreak after hospitals, particularly those in Indiana and Delaware, complained of problems involving their surgical patients. Another cluster of patients may have been infected at Inova Loudoun Hospital in Leesburg, Virginia.
The Washington Post reported that TB is notorious as an infection because the disease can be dormant for periods, only to flare up and cause serious issues for patients:
“About 80% of TB cases that occur in the United States happen when bacteria that have been living quietly in a person’s body reactivate and cause disease. Many people who have a latent tuberculosis infection never develop the disease. For people with weakened immune systems, especially those with HIV infection, the risk of developing tuberculosis is much higher than for people with normal immune systems. Someone with an active TB infection may have symptoms that include a bad cough that lasts three weeks or longer, pain in the chest, coughing up blood, weakness or fatigue, weight loss, lack of appetite, fever and chills, and night sweats. The United States reported nearly 9,000 cases of tuberculosis in 2019. Up to 13 million people in the United States are estimated to be living with latent TB infection, according to the CDC.”
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by defective and dangerous products, especially of the medical kind. Any medical product containing human material must be tested rigorously to make sure it is safe before being used in patients. Clearly that didn’t happen here, and this must be remedied — including, if appropriate, through lawsuits in the civil justice system.
As medicine makes technological advances, patients should never become inadvertent or casual experimental subjects. They must receive their fundamental right to informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom.
Makers and suppliers of medical devices products cannot let patients assume unfair and uninformed risks, including, say, for items or substances extracted or derived from human tissue. We lived through the costly horrors of virus-tainted blood, plasma, and other bodily products during the HIV-AIDS crisis. Consumers have been subject to scares about impure prescription drugs and supplements. Big Pharma is learning the cost of its keeping hidden what it knew about cancer-causing asbestos and its inclusion in baby powders.
We have much work to do to ensure the safety and wholesomeness of everything that Big Pharma and medical device makers want to put on and in on bodies, especially as pills and products.