A Texas man who suffered a stroke while on testosterone replacement therapy has filed a testosterone lawsuit in Illinois federal court.

Plaintiffs George and Nelva S. are suing 10 of the 22 named defendants in the multidistrict litigation over testosterone replacement therapy. George says he used AndroGel and Testim testosterone replacement products between June and November 2013. In July 2013, he suffered a stroke. He now attributes that stroke to the AndroGel and Testim he was using during that period. His wife Nelva is bringing her own claim for loss of consortium.

Testosterone Product Litigation

George and Nelva’s testosterone lawsuit is just one of over 1,800 such claims in the testosterone multidistrict litigation pending in the U.S. District Court for the Northern District of Illinois.

This multidistrict litigation is a consolidation of individual testosterone lawsuits that share common issues. When a large number of such claims are filed at roughly the same time, as is common with large-scale pharmaceutical products liability cases, the federal court system sometimes consolidates those claims into a single multidistrict litigation (or MDL) in a single court.

Besides AndroGel and Testim, other testosterone products implicated in the MDL include:

• Axiron
• Depo-Testosterone
• Androderm
• Testopel
• Fortesta
• Striant
• Delatestryl

These testosterone products have generated significant revenue for their manufacturers. AndroGel was the second-biggest seller for its manufacturer AbbVie in 2014, with sales reaching $934 million. There were 2.3 million patients who received a prescription for testosterone in 2013, almost twice as many as prescribed three years earlier.

Generally, the claims over testosterone products arise out of their tendency of to cause certain harmful cardiovascular side effects. Studies have linked testosterone replacement therapy to an increased risk of serious cardiovascular complications, including heart attack, stroke, and sometimes death. One study published in November 2013 indicated that testosterone products could increase the risk of these complications by as much as 29 percent. Another study found nearly double the risk of heart attack in men age 65 and older.

FDA Takes Action On Testosterone Products

In March 2015, the FDA issued a Drug Safety Communication mandating new labeling requirements for testosterone products. The new labels include a warning about the potential risk of heart attack or stroke associated with testosterone products.

The new labeling also clarifies that these drugs are indicated only where low testosterone is attributable to “disorders of the testicles, pituitary gland or brain that cause a condition called hypogonadism.” The agency said it was aware that testosterone products have recently been used to remedy symptoms of low testosterone that occurs naturally with aging and is not associated with any actual medical condition. The benefits and safety of that type of testosterone treatment have yet to be determined, the agency said.

In the same communication, the FDA announced that it would require manufacturers of testosterone products to conduct a clinical trial to investigate the incidence of heart attack and stroke among users of testosterone products.

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