Humira maker failed to warn of life-threatening infection risk

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Recent Cases: Drugs

August/September 2013, Volume 32, No. 4

Humira maker failed to warn of life-threatening infection risk 

In October 2009, Dolores Tietz’s physician prescribed Humira for rheumatoid arthritis. The drug suppresses the immune system by blocking the activity of TNF, a substance that can cause inflammation and lead to immune-system diseases such as rheumatoid arthritis and Crohn’s disease.

After taking Humira for several months, Tietz, 64, began suffering from chest pains, fever, and malaise. In May 2010, she hospitalized. After a two-week delay, doctors determined that she was suffering from disseminated histoplasmosis—a severe fungal infection that can cause multi-organ failure. Tietz suffered respiratory failure and fell into a coma. She remained hospitalized for several months and developed ICU polyneuropathy—a condition that occurs after extended periods in intensive care. The condition rendered Tietz paraplegic and unable to function. She underwent extensive inpatient rehabilitation and had to relearn how to walk, talk, and take care of herself. She now uses a wheelchair and requires assistance with many daily living activities. Her medical expenses totaled about $294,100.

Tietz died of a heart attack about three years after her diagnosis.

Tietz’s husband, on behalf of her estate, sued Abbott Laboratories, Humira’s manufacturer, alleging the company failed to adequately and timely warn that the drug poses a risk of fungal infections that could become life-threatening if unrecognized and untreated. The plaintiff asserted that at the time Tietz began taking the drug, the prescribing information contained a black box warning that described fungal infections as a possible risk. The plaintiff contended that the warning did not direct or otherwise inform physicians to have a “high index of suspicion” for histoplasmosis when treating a sick Humira patient. The plaintiff also alleged that Abbott failed to warn the larger medical community about the need to be vigilant for this very specific infection.

The plaintiff offered evidence that Abbott first became aware of the risk of drug-induced, unrecognized histoplasmosis during Humira’s early clinical trials in 2000. Abbott was also aware of a multitude of adverse event reports and patient deaths after the drug began sales in January 2003, leading up to September 2008, when the FDA issued an alert to Abbott and other manufacturers of TNF blockers about the risks of unrecognized, drug-induced histoplasmosis. Despite this, the plaintiff asserted, the company failed to alert treating physicians about the risk until May 2010—years after it first became aware of the risk, 20 months after the FDA alert, and 10 days after Tietz was hospitalized.

The defense argued that its warnings were adequate and that Tietz’s infection resulted from unrelated factors, including obesity, diabetes, rheumatoid arthritis, and her exposure to a chicken coop before becoming infected.

The jury awarded about $2.24 million, including about $800,000 for pain and suffering, $650,000 for loss of a normal life, $300,000 to Tietz’s husband for loss of society and services, about $294,100 for past medical expenses, and $200,000 for past disfigurement.

Abbott has filed motions for judgment n.o.v. or a new trial.

Citation: Tietz v. Abbott Labs., No. 12-L-002715 (Ill., Cook Co. Cir. May 9, 2013).

Plaintiff counsel: AAJ member Arnold Anderson Vickery, AAJ member Jim M. Perdue Jr., and Fred H. Shepherd, all of Houston; and AAJ member Gary D. McCallister, Chicago.

Plaintiff experts: Arnold L. Lentnek, infectious disease, New York City; and M. Eric Gershwin, rheumatology, Davis, Calif.

Defense expert: David W. Feigel Jr., new drug review/approval procedures, Tempe, Ariz.


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