According to the Judicial Panel on Multidistrict Litigation, as of November 16, 2015 there were 3,238 lawsuits consolidated in MDL 2545 (In Re: Testosterone Replacement Therapy Products Liability Litigation) before US District Judge Matthew Kennelly. That’s up more than 700 from the 2,477 lawsuits consolidated in the MDL as of September 15, 2015.
Testosterone therapy is approved by the US Food and Drug Administration (FDA) to treat low testosterone levels that are linked to certain medical conditions, including testicular disorders, pituitary gland disorders or hypogonadism. Lawsuits allege, however, that some makers of testosterone therapies marketed the therapies to treat low testosterone even when it was associated with the natural process of aging.
In March 2015, the FDA issued a drug safety communication about testosterone therapy, warning that testosterone therapy was potentially linked to an increased risk of heart attacks and strokes. That warning was based on a review of published studies, some of which suggested an increased risk of heart attack, stroke or death linked to testosterone treatment, although not all studies came to the same conclusion.
“FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the FDA noted. “The benefits and safety of this use have not been established.”
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Testosterone makers have been told to conduct clinical trials to determine the risk of heart attack and stroke. Patients who are taking testosterone therapy should be on alert for symptoms of cardiovascular problems, including chest pain, shortness of breath and slurred speech.
Although the testosterone lawsuits continue to increase in number, Judge Kennelly did dismiss claims linked to state law in the multidistrict litigation. According to Cook County Record (11/11/15), the state law claims were dismissed after Kennelly found they were preempted by federal law.