In June 2014, the FDA added a general warning to all testosterone products about the risk of blood clots in the veins, also known as VTE. In March 2015, the FDA also required drug-makers to add warnings about a possible increased risk of heart attacks and strokes.
Over 2,000 lawsuits involving blood clots, heart attacks, strokes, and other side effects of testosterone have been filed in a consolidated federal litigation.
The lawsuits have been centralized under Judge Matthew F. Kennelly in the U.S. District Court for the Northern District of Illinois, In Re: Testosterone Replacement Therapy Products Liability Litigation (MDL No. 2545).
According to statistics (PDF) issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on July 15, a total of 2,001 lawsuits have been filed since the litigation was created just over a year ago, with at least 1,975 still pending.
All of the lawsuits accuse drug-makers of failing to adequately warn that men may suffer a deadly heart attack, stroke, deep vein thrombosis, pulmonary embolism, or other severe injury. Lawsuits also accuse drug-makers of recklessly marketing testosterone to men who were experiencing “Low T” as a natural part of aging — not hypogonadism, which is the only medical condition testosterone is FDA-approved to treat.
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