A new plaintiff from Indiana is one of many who continue to join the ongoing multidistrict litigation over testosterone replacement therapy.

Plaintiff Terry H. says he was prescribed AndroGel, a medication used for testosterone replacement therapy, in August 2008. He claims he used it regularly until May 2011, when he suffered a heart attack. He now attributes that heart attack to his AndroGel testosterone therapy.

Terry’s testosterone gel lawsuit will be added to the multidistrict litigation, or MDL, now pending before Judge Matthew F. Kennelley in a Chicago federal court. This MDL is a consolidation of several testosterone lawsuits into a single court so that issues common to all the claims can be resolved efficiently and consistently. Like a class action lawsuit, the MDL is a procedural device commonly used in large-scale products liability litigation.

The current testosterone medication MDL has been ongoing since June 2014, when the federal Judicial Panel on Multidistrict Litigation consolidated the first few testosterone lawsuits. Plaintiffs such as Terry accuse AbbVie and Abbot of running a multi-million dollar promotional campaign intended to promote AndroGel as a lifestyle drug to treat symptoms unrelated to any actual medical condition.

The campaign identified certain symptoms common to the normal aging process as symptoms of a phenomenon called “Low T.” The campaign spurred men to ask their doctor about using AndroGel to treat symptoms such as low energy and decreased sex drive. One plaintiffs’ attorney described this campaign as promoting AndroGel as a lifestyle drug to treat a “contrived condition,” while simultaneously exposing men to an increased risk of stroke or heart attack.

The FDA’s Testosterone Warning

In March 2015, the FDA warned that FDA-approved testosterone products are approved only to treat low testosterone levels associated with a bona fide medical condition. For example, some real medical conditions that require testosterone replacement therapy include hypogonadism related to disorders of the testicles, pituitary gland, or brain, or damage resulting from chemotherapy or infection. The agency emphasized that the benefits and safety of testosterone replacement therapy have not been evaluated in the context of treating low testosterone that occurs naturally due to aging.

In the same announcement, the FDA also required manufacturers to add a warning about the possible increased risk of heart attack and stroke in patients undergoing testosterone replacement therapy.

Terry’s testosterone gel lawsuit names AbbVie Inc. and its parent company Abbott Laboratories as defendants. When Abbott spun off AbbVie in January 2013, AbbVie gained control over AndroGel. Eli Lilly & Co. makes a similar testosterone product called Axiron.

The Androgel lawsuit raises claims for strict liability based on design defect and failure to warn, negligence, negligent misrepresentation, breach of warranty, fraud, redhibition (a civil action available under Louisiana law, similar to lemon laws in common law jurisdictions), violation of consumer protection laws, and unjust enrichment. Terry also seeks an award of punitive damages.

Terry’s Testosterone Gel Lawsuit is Case no. 1:15-CV-04432, in the U.S. District Court for the Northern District of Illinois.

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.