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The Testosterone Therapy Litigation

What is the Testosterone Replacement Therapy Product Liability Litigation About?

Doctors prescribe testosterone replacement therapy drugs, medications and treatments to treat low testosterone in millions of men in the U.S. each year, with annual sales exceeding $2 billion. These products may be in the form of injection, gel, implant, patch or pill. Some of the more common treatments for low testosterone are or have been Androderm, AndroGel, Android, Androxy, Axiron, Bio-T Gel, Delatestryl, Depo-Testosterone, Fortesta, Methitest, Striant, Testim and Testopel.

Men experience low testosterone levels from either a disease known as hypogonadism, in which the body is unable to produce normal amounts of testosterone, or merely be due to normal aging, where testosterone levels start gradually declining after men reach the age of 30. Common symptoms of low testosterone levels include muscle loss, lower strength, fatigue, depression, low libido, erectile dysfunction, infertility, osteporosis or hair loss. Although the U.S. Food and Drug Administration (FDA) approved testosterone replacement therapy products only to treat hypogonadism, men seek to use these products for non-medical reasons including increasing physical development and performance or counteracting the natural aging process.

After several studies linking testosterone replacement therapy products to increased risks of stroke, heart attack or death, the FDA issued several drug safety communications warning of the dangers of testosterone replacement therapy products, particularly for uses other than hypogonadism. Further, the FDA required manufacturers of all approved prescription testosterone products to (i) change their labeling to clarify the approved uses of testosterone therapy products and add information about a possible increased risk of heart attacks and strokes associated with testosterone use, and (ii) conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products.

Many users of testosterone replacement therapy products have filed federal lawsuits across the United States against pharmaceutical manufacturers seeking damages for serious injuries, alleging that the manufacturers (i) recklessly marketed testosterone products in misleading advertisements which created a "disease" ("Low T") based upon general symptoms and natural issues, causing otherwise healthy men to seek dangerous prescription medications, and (ii) failed to adequately research and warn the public of the risks of testosterone therapy products.

In June 2014, many of the lawsuits were consolidated into a multidistrict litigation (MDL) in Illinois federal court to resolve common issues among the cases (In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545). Preliminary bellwether trials to test jury reaction to lawsuits representative of the MDL plaintiff pool are scheduled to go to trial starting in late 2016.

We presently represent clients in the Testosterone Replacement Therapy Products Liability Litigation MDL. If you or a family member have taken testosterone therapy replacement drugs, medications or treatments (with or without experiencing side effects or related conditions), you and/or your family member may be entitled to money damages.

Please call (212) 203-7710 or visit us here for an initial consultation and case evaluation.

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