Testosterone Litigation On the Rise

About 5,000 lawsuits have been filed against manufacturers of Testosterone Replacement Therapy (TRT) drugs in a multidistrict litigation docket in Illinois. Multidistrict litigation dockets (MDLs) are special federal procedures designed to speed up the process of handling complex cases, such as these TRT drug cases.

These lawsuits were filed by men who have suffered various injuries, including heart attack, stroke, pulmonary embolism, and deep vein thrombosis, stemming from the use of TRTs like Androgel, Axiron, and Fortesta. The lawsuits claim that these drugs were deliberately marketed to aging men through aggressive and fraudulent marketing campaigns that failed to disclose the possible serious risks.

Pharmaceutical companies face allegations that they invented low testosterone syndrome in order to create a demand for their products. Testosterone products were approved by the FDA originally to treat medically low testosterone levels; however, the FDA has stated that testosterone products should not be used in men who are experiencing reduced testosterone due to aging-an expected event in life. According to the FDA, the rise in sales of these drugs suggests that TRTs are being marketed and used for off-label purposes by men with no medical need.

In response to research done and an investigation by the FDA in 2014, the FDA directed manufacturers to conduct additional research and required the drug makers to warn patients that the products may increase their risk of heart attacks and strokes. Find out more here.