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Still More Lawsuits Added to Testosterone MDL

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Chicago, ILThe number of testosterone lawsuits consolidated for pretrial proceedings continues to increase and is now pushing 2,000. That means that in the past four months, more than 500 testosterone side effects lawsuits have been added to the multidistrict litigation, with more possibly on the way. Patients who have filed testosterone lawsuits allege they were not warned about the risks associated with testosterone therapy.

According to MDL records, as of July 15, 2015, there are 1,975 lawsuits consolidated before Judge Matthew F. Kennelly in MDL 2545 (In Re: Testosterone Replacement Therapy Products Liability Litigation). That’s more than 200 lawsuits added since June 15, when there were 1,768 lawsuits in the MDL. Consolidation in an MDL is not a comment on the merits of the lawsuit, simply an acknowledgement that the lawsuits share similar questions of fact and are more efficiently dealt with for pretrial proceedings as a group.

Testosterone lawsuits filed allege patients suffered heart attacks or strokes as a result of using testosterone therapy. Some critics also take issue with the fact that testosterone is approved for certain uses, but not to treat a condition marketed as “Low T,” a condition not recognized by the US Food and Drug Administration (FDA). Symptoms of “Low T” reportedly mirror the natural effects of aging.

In March 2015, the FDA issued a warning that the labels of certain testosterone products were being changed to warn about the increased risk of heart attack and stroke, and to show the approved uses for testosterone. When it made the announcement, the FDA addressed concerns about testosterone use in treating symptoms linked to aging, noting that the benefits and safety of testosterone for such uses have not been established.

Additionally, the FDA warned about a “possible increased cardiovascular risk associated with testosterone use.”

The FDA did note that studies reported conflicting findings, with some suggesting an increased risk of heart attack, stroke or death, while others found no such link. Testosterone manufacturers have been told by the FDA to conduct a clinical trial to determine the risk of heart attack and stroke in patients who use testosterone therapy.

Patients using testosterone should seek medical help if they suffer chest pain, shortness of breath, slurred speech or weakness on one side of the body.


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