Testosterone lawsuits filed as part of the multidistrict litigation (MDL) in an Illinois federal court have now surpassed 2,700, according to the MDL web page.

The MDL was established in June 2014 in the U.S. District Court for the Northern District of Illinois, and initially included eight separate testosterone lawsuits.

Plaintiffs who have filed testosterone product lawsuits in the MDL claim that testosterone replacement therapy companies like AbbVie manufactured and sold products that led men taking them to suffer serious health problems including stroke, heart attack, and death.

Testosterone MDL Status

U.S. District Judge Matthew Kennelly, who is overseeing the federal AndroGel litigation, has issued a case management order mandating that AbbVie produce documents on safety information and clinical trials regarding AndroGel.

In a separate case management order, Judge Kennelly also updated the process for plaintiffs to request a waiver of service for newly filed complaints.

AndroGel Bellwether Trials

In 2014 and 2015, the testosterone litigation increased rapidly from only a few dozen AndroGel complaints filed throughout the federal and state court systems to several thousand cases involving various different low-t drugs.

By far, most of the lawsuits filed have been brought against AbbVie, the makers of AndroGel, which is the most widely used and heavily marketed testosterone replacement therapy.

As part of the coordinated pretrial proceedings in the low-t MDL, two groups of cases are being prepared for early trial dates. The first involves lawsuits over AndroGel brought against AbbVie, which will result in a series of six bellwether trials scheduled to begin about one-per-month between October 2016 and April 2017.

Trials involving the second bellwether group, for lawsuits over other low-t drugs, are not expected to begin until late 2017.

While the outcomes of these test trials are not binding on other cases, they may help facilitate eventual testosterone settlement agreements.

Testosterone Product Safety Concerns

Testosterone therapy companies gross billions of dollars annually, and it is estimated that over two million men use low-t products each year. Despite their popularity, however, testosterone therapy products have been shown to pose significant health risks to those who use them.

Several studies have linked low-t therapy to heightened risk of cardiovascular problems. A study from November 2013 associated testosterone therapy products with increased rates of heart attack, stroke, and death. Another study published in 2014 analyzed the risk of myocardial infarction in over 55 thousand low-t drug patients. The results of the study showed an increased risk of myocardial infarction in all men using testosterone therapy, especially in users 65 years and older.

The U.S. Food and Drug Administration (FDA) has acknowledged the literature on the risks of low-t therapy. In January 2014, the agency issued a Drug Safety Communication alerting doctors and patients to a potential link between testosterone therapy products and cardiovascular problems.

Later that year, the FDA began requiring that all testosterone therapy products on the market carry a warning about the risks of low-t products.

Testosterone Therapy Lawsuits

Testosterone replacement therapy is intended to help regulate hormone levels in men with medically low testosterone. The U.S. Food and Drug Administration (FDA) has stated that testosterone products should not be used in men who are experiencing reduced testosterone due to aging.

However, many men who have filed testosterone therapy lawsuits claim that products like AndroGel and Testim were deliberately marketed toward aging men. Additionally, testosterone lawsuits allege that manufacturers failed to adequately test their products’ safety, and in some cases concealed or downplayed the cardiovascular risks of testosterone therapy.

The Testosterone Products MDL is In re: Testosterone Replacement Therapy Product Liability Litigation, MDL No. 2545, in the U.S. District Court for the Northern District of Illinois.