An Oklahoma woman has filed a testosterone treatment lawsuit against Eli Lilly & Co., claiming that Axiron was to blame for her husband’s death from cardiac arrest. Like similar cases filed over the past year, the lawsuit accuses Eli Lilly of failing to warn patients that Axiron could increase the risk for heart attacks, stroke and other cardiovascular problems.
According to the complaint, which is now pending in the federal testosterone multidistrict litigation underway in U.S. District Court, Northern District of Illinois, the woman’s husband used Axiron from May 2012 to January 2013. The topical medication was prescribed to treat “low T”, a condition the man believed he suffered from after viewing direct-to-consumer advertising created by Eli Lilly and other defendants. He died in March 2013, hours after suffering cardiac arrest, which the lawsuit attributes to Axiron.
Court records indicate that the Axiron lawsuit is one of more than 1,300 testosterone lawsuits pending in the Northern District of Illinois, where all federally-filed product liability claims involving the drugs’ alleged cardiovascular side effects have been consolidated for coordinated pretrial proceedings. A number of other low T treatments, including AndroGel and Testim, are also involved in the litigation.
The federal testosterone litigation was established last summer, after the U.S. Food & Drug Administration (FDA) announced that it was reviewing the cardiovascular risks potentially associated with prescription testosterone replacement treatments. In March, the agency announced that new information would be added to the products’ labels regarding their potential to increase the risk for heart attacks and stroke. The new labeling will also make it clear that Axiron and similar drugs are only approved to treat hypogonadism, a significant reduction in hormone levels related to an underlying illness or injury. The FDA noted that the drugs have not been proven to be safe and effective for relieving symptoms caused by age-related drops in testosterone.
Testosterone lawsuits seek compensation for medical bills and other financial, physical and emotional damages incurred due to plaintiffs’ alleged injuries. Among other thing, the drugs’ manufacturers are accused of engaging in “disease mongering” to induce men to seek treatment for low libido, fatigue and other symptoms common to aging men. The lawsuits contend that testosterone commercials attributed these issues to non-existent diseases, such as “Low T,” or “andropause.”