Number of Lawsuits in Testosterone MDL Near 300January 7, 2015 — Nearly 300 lawsuits involving testosterone are now pending in the U.S. District Court for the Northern District of Illinois, with two new cases transferred into the centralized litigation on Monday.

Plaintiffs in 295 lawsuits accuse several manufacturers of testosterone replacement products, such as Axiron, of failing to adequately warn about the potential risk of strokes, heart attacks, blood clots, and other life-threatening side effects.

For example, a lawsuit was filed in October 2014 on behalf of James A. Foley, a 70 year-old man from Minnesota who started taking Axiron in April 2011. In October 2012, he was hospitalized with deep vein thrombosis (DVT) and a pulmonary embolism (PE) — essentially, a blood clot grew in his legs and traveled to his lungs.

Foley says he never would have used Axiron if the manufacturer had clearly warned about its risks.

Axiron and other testosterone replacement products have come under scrutiny in recent years, with several studies raising concern about cardiovascular side effects.

One study, published in 2010 by the New England Journal of Medicine, had to be stopped prematurely when patients who were already in poor health had more cardiovascular events if they also used testosterone.

In November 2013, the Journal of the American Medical Association (JAMA) published a study linking testosterone therapy with an increased risk of heart attack and stroke.

Another study, published in PLoS One in January 2014, also found higher rates of heart attacks in men over 65 on testosterone. Soon after this study was published, the FDA launched an investigation.

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