Chicago, ILFollowing news that the US Food and Drug Administration (FDA) is investigating reports of testosterone side effects, testosterone lawsuits have reportedly been filed against Abbott Laboratories and AbbVie Inc. The lawsuits reported allege Abbott and AbbVie, makers of AndroGel testosterone replacement, hid the risks of testosterone side effects.
Bloomberg (2/5/14) reports that five lawsuits were filed against the companies. According to reports, the men are between the ages of 50 and 65, and all claim they suffered serious side effects as a result of using AndroGel. Among the alleged side effects were heart attacks, stroke and a mini-stroke.
According to court documents (filed in the case of Aurecchia v. AbbVie Inc., case number 1:14-cv-772), AbbVie and Abbott “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.”
The court documents argue that the defendants engaged in “disease mongering” by linking a variety of symptoms to low testosterone (“Low T”) - including listlessness, moodiness, and increased body fat - when those symptoms could be caused by a variety of things, including natural aging. The lawsuit notes that AndroGel’s sales increased to more than $1.37 billion per year due to the marketing campaign.
“Defendants coordinated a massive advertising campaign designed to convince men that they suffered from low testosterone,” the lawsuit filed by Kenneth Aurecchia alleges. That massive advertising campaign resulted in a situation where one-quarter of men who are prescribed testosterone have not had their testosterone levels tested prior to receiving that prescription, Aurecchia argues.
Among marketing materials for the “Low T” advertising campaign, the lawsuit argues, is a quiz that was allegedly created by a doctor who was instructed to not make the quiz too long and to make the quiz “somewhat sexy.” According to the court documents, the doctor who wrote the quiz, Dr. John Morley, said the quiz was “not ideal.”
Meanwhile, the lawsuit argues, studies suggest testosterone is linked to an increased risk of heart attacks and strokes. Those studies include a 2010 New England Journal of Medicine study that was discontinued after a high number of men in the testosterone group suffered adverse events, and a November 2013 JAMA (Journal of the American Medical Association) study that suggested testosterone therapy increased the risk of death, stroke and heart attack by approximately 30 percent.
In Aurecchia’s case, the lawsuit alleges that despite no previous history of cardiac events, after he began using AndroGel he suffered a myocardial infarction.
In January 2014, the FDA announced it was investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products. The investigation was undertaken following studies suggesting an increased risk of cardiovascular events possibly linked to these products. The FDA has only approved testosterone products for men whose testosterone levels are low “in conjunction with an associated medical condition.”
In addition to Aurrechia v. AbbVie, the other lawsuits filed are Benn v. AbbVie, 14-cv-0074; Gallager v. AbbVie Inc., 14-cv-00776; Marino v. AbbVie Inc., 14-cv-00777; and Myers v. AbbVie Inc., 14-cv-00780; US District Court, Northern District of Illinois.
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