May 10, 2013 — Plaintiff Milton Tietz has been awarded more than $2.2 million in the first Humira histoplasmosis lawsuit to go to trial. The 12-member jury in Cook County, Illinois, found that Abbott Laboratories failed to adequately notify doctors about the risk of histoplasmosis, a life-threatening opportunistic fungal infection.
The lawsuit was filed on behalf of Delores Tietz, a woman who started taking Humira in October 2009 to treat rheumatoid arthritis. According to the complaint, within less than seven months, she developed a fever and chest pain. She spent weeks in the hospital as doctors struggled to diagnose her illness. Her family was told that she would probably die from the disease. It was finally determined that Humira was causing a life-threatening histoplasmosis fungal infection.
Histoplasmosis is a rare fungal infection that occurs when a person breathes spores of the Histoplasma capsulatum fungus, usually in areas with feces from birds or bats, such as caves or attics. The disease causes pneumonia-like symptoms.
Histoplasmosis infections very rarely occur in healthy people. However, they are more likely to occur in patients who are taking Humira (adalimumab). Humira, a tumor-necrosis factor blocker (TNF), treats diseases like arthritis and Crohn’s disease, which are caused by an over-reactive immune system, by lowering the body’s entire immune-system response. Not surprisingly, this increases the risk of infections like histoplasmosis, and also certain types of cancer.
The link between Humira and infections has been known for quite some time. Humira was first approved in 2003, and in 2006, the Journal of the American Medical Association published a study linking Humira to a doubled risk of pneumonia and tuberculosis.
It took the U.S. Food and Drug Administration (FDA) until 2008 to issue a Safety Communication linking Humira and histoplasmosis. It took Abbott Laboratories even longer to warn physicians. Abbott waited until May 2010 to warn doctors, which was more than 20 months after the FDA warning, and 10 days after Delores Tietz was hospitalized with a Humira-induced histoplasmosis infection.
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