Five lawsuits were filed recently against Abbott Laboratories Inc. and AbbVie Inc. It was alleged in each case that the companies downplayed the stroke and heart attack risks associated with testosterone replacement treatment AndroGel. The lawsuits, filed in Illinois federal court last month, came days after the U.S. Food and Drug Administration (FDA) began investigating the treatment. It’s alleged in the lawsuits that the two drugmakers have engaged in an extensive advertising campaign about low testosterone (Low T), telling consumers that the natural effects of aging in men, such as listlessness and weight gain, were actually symptoms of the condition that could be treated with their products. The complaints each allege:
What consumers received, however, were not safe drugs, but a product which causes life-threatening problems, including strokes and heart attacks.
The suits came four days after the FDA announced it was investigating possible increased risks of stroke, heart attack and death in men using testosterone replacement therapies such as AndroGel. The agency pointed to two recent research articles that found elevated cardiovascular risks in men using testosterone replacement products. The Plaintiffs referenced the same articles in their complaints.
One study, published in November 2013 in the Journal of the American Medical Association, described a 30 percent rise in such risks in a comparison of thousands of patients. The second study, published last month in the journal PLOS ONE, found that risks of heart attack doubled in men older than 65 who were using testosterone replacement. It was alleged that Abbott and AbbVie “purposefully downplayed, understated and outright ignored” AndroGel’s risks in their marketing campaign. Three of the plaintiffs suffered heart attacks after taking AndroGel, one suffered a stroke, and another suffered a so-called ministroke, according to the complaints. The Pplaintiffs are bringing claims for:
The five Plaintiffs in their complaints seek punitive and other damages. Abbott has marketed AndroGel since 2010. In January 2013 Abbott created AbbVie as a spin-off company for its proprietary pharmaceutical business, including AndroGel. AbbVie defended the safety of AndroGel in a statement, saying its efforts to educate the public about low testosterone follow the FDA’s guidance. In its defense, Abbott said:
AndroGel has more than 10 years of clinical, safety, published and post-marketing data, with known therapeutic risks well documented in the prescribing label.
The plaintiffs in these five cases are represented by David Ratner and David Sirotkin, lawyers with Morelli Ratner, a firm with offices in New York City, and by Trent B. Miracle, who is with the Alton, Ill.-based firm Simmons Browder Gianaris Angelides & Barnerd. It will be very interesting to see how these cases develop as they go through the system. We will continue to monitor them.
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