As of December 15, 2015, there were 3,481 lawsuits consolidated for pretrial proceedings in MDL 2545 (In Re: Testosterone Replacement Therapy Products Liability Litigation). That’s an additional 243 from the 3,238 that were consolidated as of November 16, 2015.
The lawsuits allege men were not adequately warned about the risk of serious testosterone side effects, including cardiac issues. Furthermore, some plaintiffs allege testosterone therapy was marketed to treat a condition called Low-T, which was in fact simply a natural part of aging.
One such lawsuit (case number 5:15-cv-02587) was filed by Timothy Wilkes and Pamela Wilkes against AbbVie Inc., concerning AndroGel, a testosterone gel. According to court documents, the defendants allegedly marketed AndroGel as being a safe and effective treatment for hypogonadism even though AndroGel is allegedly linked to life-threatening cardiac events. Plaintiffs accuse AbbVie of “disease mongering” to increase profits associated with testosterone therapy.
Included in the complaint are allegations that the defendants’ national education campaign included a “Low T Quiz,” specifically designed to be short and “somewhat sexy.” The man who allegedly wrote the quiz, Dr. John Morley, according to court documents, reportedly wrote the questionnaire - used by patients to determine whether or not they have Low T - in 20 minutes and called the questionnaire “not ideal.”
The marketing campaign apparently worked, resulting in around $1.4 billion in sales in one year, plaintiffs argue, even though in 2010 a New England Journal of Medicine study was reportedly discontinued after a high number of men in the testosterone group suffered side effects.
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Wilkes also argues in his lawsuit that not only is he put at risk of side effects but that secondary exposure to AndroGel can cause side effects including virilization in children, physical changes in women and fetal damages in pregnant women.
The lawsuit alleges the defendants knew or should have known about the risk of serious harm from using AndroGel and failed to provide an adequate warning to patients about the risk of serious side effects.