A Chicago jury returned a $2.2 million verdict against Abbott Laboratories and AbbVie Inc. in a lawsuit brought by a man who alleged his wife suffered a life-threatening fungal infection as a result of taking the arthritis drug Humira (adalimumab).
According to Law360, Delores Tietz nearly died in May 2010 of a widespread histoplasmosis fungal infection. Milton Tietz’s suit alleged that if Abbott had adequately warned of the risk of unrecognized histoplasmosis for Humira users, doctors could have diagnosed his wife’s infection faster.
Throughout the trial, Abbott’s attorneys argued the Humira label had warned of the risk of serious infections since the drug entered the market in late 2002 and that, in addition to label warnings, the information was available through websites and the Physicians Desk Reference.
The company said it could not send a warning letter to doctors without the approval of the U.S. Food and Drug Administration (FDA). Abbott did send a letter on May 17, 2010, as part of the risk evaluation and mitigation strategy directed by the FDA in 2008, Law360 reports. Delores Tietz had entered the hospital earlier that month.
The 2008 FDA directive also required an updated label for Humira, which took effect in December 2008.
Milton Tietz’s attorneys argued that Abbott knew about the risk for unrecognized, widespread histoplasmosis infections in Humira patients well before the 2008 FDA alert and company officials were aware of several histoplasmosis-related deaths in Humira patients before 2008.
Though Abbott’s attorneys argued that the black box warning on the Humira label contained sufficient information, jurors nonetheless decided in the plaintiff’s favor on the negligence claim. Delores Tietz died earlier this year; her death was not at issue in the suit, Law360 reports.