Commercials depicting men as moody, tired, and less sexually interested surfaced during the past 10 years, with the advertised solution being treatment for low testosterone. As a result, sales of testosterone therapy pills, patches, injections, and creams increased to 432 million prescriptions, up from 208 million, in just a few years, creating a $1.6 billion industry for drug manufacturers in the process.
The FDA has approved such medically-monitored treatment for men with low testosterone, also known as hypogonadism. However, men taking these medications, including AndroGel, put themselves at risk for such side effects as strokes, heart attacks, high blood pressure, blood clots, kidney and liver issues, and even death.
If the benefits outweigh the risks for certain men, why have AndroGel and similar low-testosterone therapy products been under fire? As a recent mass tort lawsuit now pending in the U.S. District Court of Illinois shows, illegal off-label usage and aggressive marketing tactics put a large group of men at risk – patients that may not have needed low testosterone therapy but did experience a heart attack or stroke and other physical and emotional issues potentially related to AndroGel.
Doctors have prescribed AndroGel, a cream available in one-percent and 1.62-percent options, for daily low testosterone therapy. The product manufactured by AbbVie, formerly part of About Laboratories, is applied directly to skin and arms to boost hormone levels. However, because this method results in secondary exposure, the FDA required a black box warning as of 2009.
In November 2013, a study published in the Journal of the American Medical Association found that men using AndroGel were 30 times more likely to have a heart attack or stroke during a three-year period when compared to men with low testosterone levels not on supplements. 3,000 individuals, 60 years of age on average, participated; most had high blood pressure, unhealthy cholesterol, or diabetes, but all had clear, unblocked arteries.
Results showed that men without coronary artery disease using AndroGel were just as likely to experience a stroke, heart attack, or death as subjects with the condition. Since the study’s publication, the FDA began an investigation as of January 2014 into these risks associated with approved testosterone products.
Nevertheless, the FDA has gone after drug companies marketing AndroGel and other low-testosterone supplements for off-label uses – an illegal practice – over the past 15 years. The FDA warned AbbVie in 2000 about claiming the drug fights the natural aging process.
Three years later, a lawsuit filed against Solvay Pharmaceuticals cited False Claims Act violations, alleging off-label promotion resulted in pharmacies filing millions of dollars of false claims with government health plans. As well, the drug manufacturer allegedly gave kickbacks to doctors promoting its low-testosterone supplements for off-label uses and, in the process, aimed to increase sales by 36.5 percent, according to a leaked document.
With more recent claims, AbbVie’s marketing campaign claimed men naturally experiencing testosterone loss could build muscle mass, strengthen bone density, and improve sex drive; as a result, sales increased to $1.37 billion per year.
However, men given AndroGel were not always thoroughly tested to determine if they, in fact, suffered from testosterone loss not related to aging. Rather, the “Is It Low T?” quiz had been used.
AndroGel makes just one low-testosterone therapy treatment. Several others in cream, patch, pill, and injection forms exist on the market, including Androderm, Axiom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, and Testim. For now, the pending mass tort case is pursuing only AndroGel and manufacturers AbbVie and Abbott Laboratories for off-label marketing and understating side effects.
Mass Tort Lawsuit
On February 4, 2014, five lawsuits were filed against AbbVie and Abbott Laboratories, alleging the manufacturers concealed information about side effects and misled medical professionals by claiming AndroGel effectively treats hypogonadism.
As well, court documents show the plaintiff accuses the defendant of “disease mongering,” such as associating natural aging symptoms, such as listlessness and moodiness, with low testosterone and pushing this therapy, when safer, alternative treatments could have been used.
Plaintiffs are now seeking compensation for past and future medical expenses, emotional distress, and loss of earnings and are pursuing punitive damages.
Although this mass tort lawsuit specifically targets AndroGel, other low-testosterone therapy treatments are associated with the same side effects. Were you put at risk by false advertisements claiming you needed a testosterone supplement to fight the natural aging process, only to be prescribed without thorough testing? Did AndroGel or a similar supplement cause you to experience a heart attack or stroke, when your health was otherwise in good standing? Aggressive advertisement and off-label usage has put thousands, if not millions, of men at risk, and if you think you have a claim, Trantolo & Trantolo’s experienced mass tort attorneys are here to help.