Lawsuits Filed against Testosterone Gel for Causing Heart Problems

AndroGel and other treatments for low testosterone became widely popular for men with issues involving sex drive, weight gain, and low energy. However, many of the men taking these treatments were not warned about the harmful side effects, such as the possibility of developing serious heart problems.

In February 2014, four men filed lawsuits against Abbott Labs and its subsidiary, AbbVie Inc, after the men suffered heart attacks and strokes. The lawsuits allege that Abbott Labs deceived the public about AndroGel, a gel which purports to treat low testosterone in men.

The four men, Micheal Gallagher, Steven Myers, Steve Marino, and Kenneth Aurecchia allege that Abbott Labs released statistics and celebrity endorsements about the positive effects of AndroGel while hiding known adverse health risks. The FDA had approved AndroGel for treatment of hypogonadism, a condition where men have lower testosterone than normal.

However, Abbott Labs sold their gel as a means of treating low energy, sex drive, and weight gain. The problem is that these symptoms are often caused by conditions other than hypogonadism, like the normal aging process. Even worse, many doctors admit that they never test their patient’s testosterone levels before prescribing AndroGel. AndroGel sales were $1.3 billion per year after Abbott Lab’s marketing campaign.

Increasing Danger to Public Health

Unfortunately for the plaintiffs in this lawsuit, their timing couldn’t be worse. Last year, the Supreme Court announced in a 5-4 decision that FDA regulations completely preempt state laws regarding warning labels on drugs. In other words, if there is a conflict between state law and the FDA, the FDA must win.

When would this come up? The FDA only requires that generic drug companies have the same warning labels as the brand name version. If the label needs to be changed, it is up to the FDA to approve the change. The Supreme Court believed that the FDA, which regulates the drug industry across the country, would have a better understanding of drug safety than juries.

The problem is that the FDA, like all government agencies, makes mistakes. AndroGel is an example. The FDA approved AndroGel for public use. Of course, AndroGel was approved for use treating hypogonadism, but as the case shows, drug companies can be overzealous in their advertising once their product enters the market. The Supreme Court’s decision could shield the subsidiary, AbbVie Inc, from all liability.

The decision wouldn’t shield the parent company, Abbott Labs, from liability. Suing Abbott Labs has its own problems. Abbott Labs could claim that misrepresentation is unintentional, the men didn’t rely on Abbott’s advertising, that Abbott Labs had no knowledge that the drugs could be harmful, or any number of other defenses. However, Abbott Labs might settle any lawsuit that comes their way. The drug company has settled lawsuits based on misrepresentation before.