For the second time, a jury found in favor of plaintiff Jesse Mitchell, who sued drugmaker AbbVie, alleging its testosterone replacement therapy AndroGel led to his heart attack. He was awarded more than $3 million, including $200,000 in compensatory damages and $3 million in punitive damages. The verdict was announced March 26.
Mitchell had already won against AbbVie last summer, when a jury awarded him $150 million in punitive damages, finding the company misrepresented the testosterone products. At the crux of the argument are claims that the testosterone makers ignored warnings from the Food and Drug Administration (FDA) not to promote the use of testosterone for men with natural drops in testosterone.
Testosterone therapy is indicated only for men with hypogonadism, a condition in which a man does not produce enough testosterone due to injury or disease. Only about 150,000 men suffer from the condition. Marketing a prescription drug for a purpose for which it is not approved is illegal. Despite this, the company aggressively marketed the drug for the off-label treatment of a made-up condition they called Low T.
In the first trial, the jury awarded no compensatory damages, finding the medication did not cause the heart attack. As a result, U.S. District Judge Matthew Kennelly ordered a new trial, saying that the jury’s verdict was “logically incompatible” because the company was not found liable in the case. In December, he ordered a new trial.
Mitchell claimed that he went to his doctor in 2007 complaining of depression and fatigue. He was prescribed AndroGel, which he took off and on for five years before suffering a near-fatal heart attack. Two years later, he and his wife, Kimberly, sued AbbVie, claiming they were never warned that use of the company’s AndroGel carried cardiovascular risks.
The Mitchell retrial was the fourth bellwether trial for AbbVie in multidistrict litigation (MDL) that involves several testosterone therapy replacement manufacturers. The lawsuits claim the manufacturers promoted TRT as a “fountain of youth” for older men, and did not adequately warn of cardiovascular risks with the drug.
The case is Mitchell et al. v. AbbVie Inc. et al., case number 1:14-cv-09178, and the MDL is In re: Testosterone Replacement Therapy Products Liability Litigation, case number 2545, both in the U.S. District Court for the Northern District of Illinois.