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AbbVie faces another product liability lawsuit over the failure to warn about the heart risks from AndroGel, with a Georgia man claiming that he suffered three heart attacks as a result of the popular testosterone gel.
The complaint (PDF) was filed by 49 year old Kimberly Dula on March 12, in the U.S. District Court for the Northern District of Illinois. The case joins a growing number of Androgel lawsuits filed in courts throughout the country in recent months, raising similar allegations about the drug maker’s failure to warn about the risk of heart attacks, strokes, blood clots and wrongful death.
Dula indicates in the lawsuit that began using AndroGel testosterone in November 2011, for treatment of symptoms he attributed to “low testosterone.” He states that he started using the testosterone gel after seeing advertisements for the medication, which encourage men to ask their doctors about prescription treatments for “low T” if they experience a variety of symptoms common to all men as they age, such as decreased energy levels, diminished sex drive and weight gain.
According to allegations raised in the complaint, Dula claims that he suffered the first of three mycardial infarctions on January 8, 2013. However, because he was unaware that the medication may be contributing to his heart risks, he eventually suffered two more heart attacks. It was not until February 2014 that he learned about the link between AndroGel and heart attacks.
Testosterone Health Concerns
In January 2014, a study was published in the medical journal PLOSOne, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions. The FDA investigation was announced just days later.
This research was a follow up to a November 2013 study published in the Journal of the American Medical Association that suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.
In response to the findings, the FDA launched a safety review of AndroGel and other testosterone replacement therapy on January 31, leading to multiple media reports about the potential risk and lawyers advertising for potential claims.
Dula claims that AbbVie and their parent company Abbott Laboratories knew or should have known about the potential AndroGel heart attack side effects, yet withheld information from consumers and the medical community.
The lawsuit claims that if the manufacturer had provided adequate warnings about the potential heart risks, Dula may not have used AndroGel or any testosterone replacement therapy.
All of the complaints involve similar allegations that the manufacturers essentially created the “disease” of low testosterone among men, blaming everything from fatigue to grumpiness on “Low T.” However, originally, the testosterone drugs were approved by the FDA to treat medically discernable low testosterone levels caused by a medical condition, such as hypogonadism. The condition was at first estimated to affect only about a million men in the U.S., but now the pharmaceutical industry estimates a 20 million man market for testosterone drugs.
“Defendants purposefully downplayed, understated and outright ignored the health hazards and risks associated with using AndroGel,” Dula claims in his lawsuit. “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.”