A California couple is suing AbbVie Inc. and Abbott Laboratories, the makers of AndroGel testosterone gel, alleging that it caused the husband to suffer a stroke.

Plaintiffs Frank and Doris H.’s testosterone gel lawsuit is just one among more than a thousand similar claims that have been grouped together into a single multidistrict litigation in federal court in Chicago.

This MDL is meant to consolidate all claims in the federal court system related to testosterone gel side effects.

According to the testosterone lawsuit, Frank began using AndroGel around June 2013 on the advice of his doctor. He suffered a stroke a couple months later, which he says resulted in “motor, cognitive and other physical injuries and limitations.” The plaintiffs allege Frank’s stroke and its residuals were caused by AndroGel.

About Testosterone Multidistrict Litigation

The MDL was initiated in June of 2014 by an order of the federal Judicial Panel on Multidistrict Litigation consolidating existing testosterone product lawsuits into a single court.

Since then, new plaintiffs like Frank and Doris have joined the MDL by filing their claims using a short-form complaint issued by the court. This short-form complaint refers to a master long-form complaint that lays out the plaintiffs’ full and general allegations.

Generally, plaintiffs in the MDL allege that the manufacturers of testosterone products, like AndroGel, failed to properly warn patients and doctors about certain dangers associated with those products.

Plaintiffs cite studies that show with testosterone replacement therapy come increased risks of cardiovascular injuries like heart attack, blood clots, or stroke.

Plaintiffs also allege that manufacturers improperly promoted their testosterone replacement products by touting them as a treatment for a condition they called low-T, or low testosterone.

While the FDA has approved testosterone replacement therapy as a treatment for low testosterone levels associated with certain particular medical conditions, the products are not approved to treat the decrease in testosterone that occurs naturally with age. Manufacturers are legally prevented from promoting their products for any use other than those approved by the FDA.

Plaintiffs say the manufacturers of these drugs improperly marketed them for off-label use as “lifestyle drugs” used to change naturally-occurring symptoms of aging, thereby unreasonably increasing the risk of testosterone side effects for persons who had no actual medical condition that could benefit from testosterone replacement therapy.

Frank and Doris’s AndroGel claims are based on legal theories of defective design, failure to warn, negligence, misrepresentation, breach of implied warranty, fraud, loss of consortium, and violation of consumer protection laws, and violation of California’s Legal Remedies Act.

Other claims available for plaintiffs and listed on the MDL’s short form complaint include breach of express warranty, redhibition ( a type of defective products claim available under Louisiana’s civil code), unjust enrichment, wrongful death, and survival action.

Frank and Doris’s individual Testosterone Gel Lawsuit is Case No. 1:15-CV-07121 and the Testosterone Product 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.

A select group of cases in the Testosterone Product MDL will be the first to go to trial between October 2016 and April 2017. These “bellwether” cases will be used to gauge how particular claims and evidence play out at trial.