Makers of testosterone replacement products have come under fire in recent years for misleading advertising, pushing the drug for patients who don’t need it, and for possibly causing or increasing the risk of heart attacks in men using testosterone. Now, after a big win against AndroGel maker AbbVie, a judge has tossed out a $150 million jury-awarded settlement, citing an inconsistent verdict and the need for a new trial.
Problems with AndroGel and Other Testosterone Supplements
Testosterone is a natural hormone that declines in men as they age. Although this is natural, in some men low testosterone is a real health problem, called hypogonadism. It can cause uncomfortable symptoms that can be corrected with a testosterone supplement. Several companies make a testosterone supplement, including AbbVie which makes AndroGel, a topical supplement.
While testosterone can help some men, it does come with some risks and side effects. The potential side effects include skin irritation, mood swings, and prostate enlargement. There is also evidence that using supplemental testosterone increases the risk of blood clots, heart attack, and stroke.
Lawsuit and Verdict against AbbVie
The risks and side effects may be considered within the realm of safety for a prescribed drug, but some of the manufacturers have been accused of misleading people about those risks. In the present case, the plaintiff, Jesse Mitchell, accused the company of misrepresenting the risks of using AndroGel. Mitchell suffered a heart attack while using the product. He had been using AndroGel for five years and did recover from the heart attack.
In the trial the jury awarded Mitchell punitive damages of $150 million but no compensatory damages. The jury found that the company was not liable for his heart attack but that it did misrepresent the risks and falsely marketed AndroGel. The verdict was one of thousands that AbbVie has faced and currently faces over damages caused by AndroGel.
A U.S. district judge, Matthew Kennelly, has since overturned that verdict and its substantial punitive damages. Kennelly stated that the verdict of the jury was inconsistent and incompatible. He stated that there was a serious conflict between the fact that the jury found AbbVie to have been guilty of false marketing and not awarding the plaintiff any compensatory damages.
As a result of the conflicted verdict the judge threw it out entirely, nulling the $150 million punitive damages, and ordering a new trial. Other similar trials have ended with jury verdicts finding that AbbVie was both guilty of false marketing and liable for plaintiffs’ heart attacks. These other trials resulted in both punitive and compensatory damages. Whether the new Mitchell case will end similarly remains to be seen. In some cases against other companies, such as Endo International, juries have found that the maker of testosterone was not liable for a patient’s heart attack or stroke.
While the ultimate result of this trial and thousands of others over supplemental testosterone remain to be determined, people may continue to suffer from the results of misrepresentation of the product by pharmaceutical companies. As with many drugs, there are risks of using supplemental testosterone, but companies need to be held accountable for failing to adequately warn patient and doctors of the severity of those risks.