An Oregon man who alleges AndroGel caused his heart attack has been awarded $150 million in punitive damages, after a federal jury found that AbbVie, Inc. engaged in false advertising when it marketed the popular testosterone treatment.
The plaintiff was not awarded any compensatory damages, as the jury concluded that the testosterone gel was not responsible for the heart attack he suffered in 2012.
The verdict came Monday in the U.S. District Court, Northern District of Illinois, where more than 6,000 testosterone lawsuits are pending against the makers of AndroGel and other prescription testosterone drugs. All of the plaintiffs involved in the litigation allege that AbbVie and other defendants failed to warn that testosterone-replacement therapy could increase a man’s risk for heart attacks, stroke, and other life-threatening cardiac complications. They further claim that the drug companies misrepresented their products as effective treatments for a non-existent disorder dubbed “andropause” or “low T,” which supposedly causes low libido, fatigue, and other symptoms that are merely typical of the male aging process.
In awarding plaintiff Jessie Mitchell $150 million in punitive damages, the jury selected for the litigation’s first bellwether trial found that AbbVie made fraudulent misrepresentations regarding the benefits and risks associated with AndroGel. However, the panel rejected Mitchell’s claims of strict liability and negligence, denying Mitchell compensatory damages.
Punitive damages are awarded by juries to punish wrongful conduct. However, it is unusual for a jury to assess a punitive award in the absence of compensatory damages. It’s highly likely that AbbVie will appeal the verdict. Still, some experts believe the case could spell trouble for testosterone defendants.
“The fact that a jury awarded punitive damages may encourage plaintiffs and their lawyers to bring on more cases and pursue them even more aggressively.” Carl Tobias, a law professor at the University of Richmond who specializes in products liability litigation, told Reuters.
In March 2015, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of AndroGel and other testosterone treatments to update their product labels with information about their possible association with a heightened risk of heart attacks and stroke. The FDA also mandated that the labels clearly state that testosterone-replacement therapy is only approved to treat hypogonadism, a significant reduction in hormone levels related to an underlying illness or injury, and had not been proven safe and effective for relieving symptoms caused by age-related drops in testosterone.
In 2015, the FDA announced that the labeling for prescription testosterone treatments would be updated with a general warning in regarding a risk of venous thromboembolism, venous blood clots that include deep vein thrombosis and pulmonary embolism.