On July 24th, AbbVie Inc. was ordered to pay $150 million in punitive damages to plaintiff Jesse Mitchell of Oregon, who claimed that the company failed to adequately warn patients of the increased risk of heart attack associated with use of its AndroGel brand testosterone booster.
The jury in Chicago elected to award the Plaintiff no compensatory damages for the heart attack he suffered after taking AndroGel for four years, with the entirety of the $150 million dollar award being granted in the form of punitive damages.
The jury’s finding for punitive damages stemmed from their finding that the company had misrepresented the danger posed to patients who used AndroGel. The verdict is the first of more than 6,000 related lawsuits that have been consolidated in federal court in Chicago.
Sales of AndroGel, which cleared more than $1 billion in 2013, began to fall after the FDA announced it would begin investigating the drug for an increased risk of heart attacks and strokes in previously healthy men who used the testosterone replacement therapy. In June of 2014, the FDA mandated that labels on testosterone replacement drugs carry warnings of the risk of blood clots.
AbbVie has become a prime target for litigation claiming that the company misrepresented the risks of its testosterone replacement therapy after it launched an ad campaign that promoted its use for “Low-T,” and outlined how the drug could increase energy and sexual drive.
However, due to the fact that the award was for punitive damages only, it is likely that it will be overturned. According to Bloomberg, the U.S. Supreme Court has said that punitive awards should be based on material damages suffered by plaintiffs to be considered reasonable.
Mixed Data on Potential Harm
While the FDA’s medication guide on AndroGel lists blood clots in the legs and lungs, as well as a possible increase in the risk of a heart attack or stroke, as potential risks of the medication, there seems to be some remaining debate on the medication’s dangers.
A joint study by UCLA and the National Institutes of Health published in 2014 found that the risks of a heart attacked increased two fold for men under 65 with a previous history of heart disease shortly after beginning testosterone replacement therapy.
However, another study conducted on the records of 44,335 patients at Kaiser Permanente medical centers in California found that 10.2% of male patients who were not given testosterone replacement therapy had a heart attack or stroke during the study’s 3 year observation period, versus 8.2% for patients who were given testosterone replacement.