A Chicago jury has ordered Abbott Laboratories to pay out $2.24 million in damages for a fungal infection from Humira, in the first case over the popular arthritis drug to go to trial in the country.
The verdict came in a Humira lawsuit brought by Milton Tietz on behalf of his wife, Delores Tietz, who was diagnosed with a histoplasmosis fungal infection in May 2010, which nearly killed her.
Tietz alleged that the fungal infection diagnosis took months because Abbott Laboratories failed to warn doctors about the risk of problem. His wife died last year, of an unrelated heart attack
Following trial in Cook County Circuit Court, the jury found that Abbott was negligent and ordered the drug maker to pay $2,244,063.20 in damages. However, the jury did not agree that the drug was a defective product.
Humira (adalimumab) is a tumor necrosis factor blocker, also known as TNF blocker, which was approved by the FDA in 2003 for treatment of rheumatoid arthritis. It later gained approval for treatment of psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis, which was previously called juvenile rheumatoid arthritis. The drug pulled in sales of $6.5 billion in 2010.
In September 2008, the FDA issued a warning to health care professionals that Humira and other TNF blockers, including Humira, Enbrel, Remicade and Cimzia, carried the risk of fungal infections, including histoplasmosis, blastomycosis and coccidioidmycosis. Some of those infections could be life-threatening, the agency warned.
According to the Humira lawsuit brought by Tietz and others, Abbott waited more than a year to place a black box warning on Humira about the risk of infections and to send out a letter to doctors alerting them to the problem.