A Texas man has filed a product liability lawsuit against the makers of AndroGel, a testosterone gel used to treat low testosterone levels in men, alleging that the product is unsafe and potentially deadly.

Plaintiff Steven Myers alleges in the AndroGel lawsuit that AbbVie Inc. “misrepresented that AndroGel is a safe and effective treatment for hypogonadism or low testosterone, when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.”

Myers’ AndroGel lawsuit was filed on Feb. 4, 2014. According to his testosterone gel complaint, the company “engaged in aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for AndroGel. Further, Defendants engaged in an aggressive unbranded ‘disease awareness’ campaign to alert men that they might be suffering from low T.” Myers cites these tactics, including a low T quiz, as a major driving force behind the sales of testosterone gel.

“As a result of this ‘disease mongering,’ as termed by Dr. Adriene Fugh-Berman of Georgetown University Medical Center, diagnoses of Low T have increased exponentially,” Myers says in the testosterone gel lawsuit. “This has directly related to AndroGel’s sales increasing to over $1.37 billion per year. However, consumers of AndroGel were misled as to the drug’s safety and efficacy, and as a result have suffered injuries including life-threatening cardiac events, strokes, and thrombolytic events.”

While Myers claims that testosterone gels can be dangerous and even lethal, he survived his experience with the product. Myers notes the history of the company’s campaign in his lawsuit.

“Since the Food and Drug Administration (FDA) approved AndroGel, Defendants have also sought to convince primary care physicians that low testosterone levels are widely under-diagnosed, and that conditions associated with normal aging could be caused by low testosterone levels,” the testosterone gel lawsuit says. “While running its disease awareness campaign, Defendants promote their product AndroGel as an easy to use topical testosterone replacement therapy. Defendants contrast their product’s at-home topical application with less convenient prescription testosterone injections, which require frequent doctor visits.”

Myers considers himself one of the many men who were lured by the marketing campaigns for AndroGel.

“Plaintiff Steven Myers was 61 years of age when he was prescribed and used AndroGel for symptoms he attributed to low testosterone after viewing Defendants’ advertisements,” the AndroGel lawsuit says. “The AndroGel he consumed caused physical and emotional impairment which affected his personal and professional life. These impairments included, but were not limited to myocardial infarction. Prior to using AndroGel Plaintiff had no history of these cardiac events.”

There was evidence of this potential testosterone gel side effect previously, Myers asserts in his testosterone gel lawsuit. “In November of 2013, a JAMA [Journal of the American Medical Association] study was released entitled Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels which indicated that testosterone therapy raised the risk of death, heart attack and stroke by about 30%.”

In addition to other research linking testosterone gel with complications, “AndroGel has been linked to several severe and life changing medical disorders in both users and those who come into physical contact with users or the unwashed clothes of someone who applied AndroGel. Patients taking AndroGel may experience enlarged prostates and increased serum prostate-specific antigen levels.”

Those who are around the testosterone gel, but don’t necessarily use it (such as a spouse or partner) might even experience secondary side effects.

Myers claims that, “Defendants’ marketing strategy beginning in 2000 has been to aggressively market and sell their products by misleading potential users about the prevalence and symptoms of low testosterone and by failing to protect users from serious dangers that Defendants knew or should have known to result from use of its products.”

Preparing for the Road Ahead

Many men like Myers see joining a class action lawsuit or filing their own individual product liability lawsuit as a quick and fair way to get a resolution following their AndroGel side effects. He says, “AbbVie’s advertising program, sought to create the image and belief by consumers and their physicians that the use of AndroGel was a safe method of alleviating their symptoms, had few side effects and would not interfere with their daily lives, even though Defendants knew or should have known these to be false, and even though the Defendants had no reasonable grounds to believe them to be true.”

Patients depend on the information provided by drugmakers to make the best decisions for themselves.

According to Myers, “Defendants purposefully downplayed, understated and outright ignored the health hazards and risks associated with using AndroGel. Defendants deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes, and manipulating hypogonadism statistics to suggest widespread disease prevalence, while downplaying known adverse and serious health effects.”

He’s suing AbbVie for failure to warn, negligence, breach of warranty, fraud, negligent misrepresentation, and punitive damages.

The AndroGel lawsuit is Steven Myers v. AbbVie Inc., et al., Case No.: 1:14-cv-780, in the U.S. District Court for the Northern District of Illinois, Eastern Division.