A man from Virginia has filed a lawsuit alleging a topical testosterone gel caused him to have a pulmonary embolism.

Plaintiff Robert G. says he began using Axiron testosterone gel in December 2012. He says he kept using it until he suffered a pulmonary embolism in March 2014.

Robert claims the Axiron he used was the cause of his pulmonary embolism. He is now seeking damages from Eli Lilly and Co. and its related company Lilly USA, the alleged manufacturers of Axiron. Lilly administers Axiron under an exclusive license from Australian company Acrux, which originally developed the product.

Axiron is a brand of topical testosterone gel that’s applied under the arms. According to its approved FDA uses, Axiron is indicated for the treatment of hypogonadism, or failure of the testicles to produce a healthy amount of testosterone.

Robert’s Axion lawsuit will be part of a large group of similar lawsuits all being processed together in an Illinois court. As of December 2015, this multidistrict litigation contained almost 3,500 individual testosterone lawsuits against the makers of Axiron and several other testosterone replacement products.

Testosterone Gel Side Effects

Generally, plaintiffs in the testosterone MDL allege that they were not adequately warned about testosterone side effects before they chose to use a testosterone booster. These plaintiffs say testosterone gel put them at an unreasonable risk for suffering a spectrum of cardiovascular conditions such as stroke, heart attack, pulmonary embolism, heart failure, and deep vein thrombosis.

Plaintiffs allege that some testosterone gel manufacturers unlawfully promoted those products for uses other than those approved by the FDA – so-called “off-label” uses. Specifically, plaintiffs say some manufacturers promoted testosterone gel as a remedy for the symptoms of decreasing testosterone that come naturally with age – symptoms like mood disorders, poor concentration, lack of interest in sex, and loss of muscle mass or bone density.

Though these symptoms are not related to any bona fide medical condition, plaintiffs say some testosterone gel makers characterized them in marketing materials as a quasi-medical condition called “Low T.” In heavy direct-to-consumer advertising campaigns, some manufacturers encouraged men experiencing these symptoms to ask their doctors about using a testosterone booster to treat “Low T,” plaintiffs claim.

Lilly made a similar attempt to promote Axiron as a treatment for naturally decreasing testosterone levels, according to the plaintiffs. They say Lilly’s press release announcing its licensing deal with Acrux shows that Lilly intended to promote Axiron for off-label and “label expanding” uses. Plaintiffs assert that Lilly improperly expanded the indications for Axiron by depicting “Low T” as an acquired form of hypogonadism.

Lilly also directed its marketing efforts at physicians, allege plaintiffs. They say the company hosted events for physicians in which doctors would overstate the safety and efficacy of Axiron and offer favorable information about its off-label use.

By referring to the MDL’s master long form complaint, Robert is alleging that Axiron is defectively designed in a way that makes it unreasonably dangerous. He claims Eli Lilly exaggerated the drug’s benefits while understating its associated risks.

The Testosterone Gel Lawsuit   is Case No. 1:16-CV-02090 and is part of the Testosterone Product MDL In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545, in the U.S. District Court for the Northern District of Illinois.