AbbVie Inc., and Abbott Laboratories are trying to wiggle their way out of a massive multidistrict litigation (MDL) over side effects allegedly caused by testosterone replacement therapies by arguing to an Illinois federal judge that plaintiffs have not shown that use of testosterone supplements increases the risk of heart attacks or strokes.
Days earlier, the drug companies filed a separate summary judgment arguing that plaintiffs’ claims that they marketed testosterone treatments for unapproved uses was incorrect because Food and Drug Administration (FDA) officials had OK’d their marketing materials.
The motions for summary judgment were filed just months before the companies face the first bellwether trails over testosterone side effects. While lawsuits in the MDL target several testosterone manufacturers, AbbVie, maker of the top-selling AndroGel, faces the first wave of bellwethers.
Plaintiffs allege that the drug companies used aggressive marketing campaigns to lure in users who were not suitable for testosterone treatment by making up a condition they called “Low T.” The manufacturers claimed in the ads that testosterone therapy could treat symptoms of so-called Low T, such as low libido, weight gain, muscle loss and mood swings.
The ads resulted in skyrocketing sales of testosterone treatments, lining the pockets of the drug companies. In order to keep profits high, the consumers claim that drug companies did not fully disclose the health risks associated with use.
Testosterone replacement therapy is FDA approved to treat hypogonadism, a condition in which the male body produces too little of the hormone due to disease, injury or defect. It is not intended for age-related hypogonadism, as men’s testosterone levels naturally decline as they age.
Researchers have found that men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use. A second study found that men had a significant increased risk of heart attack and stroke in the first 90 days of use.