Tracy Garner was intrigued by advertisements for testosterone replacement therapy to boost sex drive and improve muscle mass in men with “Low T.” He asked is doctor about the hormone therapy, and in March 2013, Garner was prescribed Eli Lilly and Co.’s Axiron. A few days later, he had a heart attack.
Garner is one of about 6,000 men suing manufacturers of testosterone replacement therapy, alleging the drug companies engaged in aggressive marketing of a prescription drug for off-label use – the treatment of so-called Low T, according to Law360. Testosterone treatments are intended for men with hypogonadism, a condition in which the body does not produce enough of the male hormone due to injury or disease. It is not intended for the natural drop in testosterone men experience as they age.
Garner filed his lawsuit in 2015 after learning that studies dating back decades have linked testosterone therapy to an increased risk of cardiovascular events including heart attacks, strokes, blood clots and death. Garner claims Eli Lilly and Co. was aware of these risks but failed to warn doctors or their patients.
Garner’s case was one of two cases selected by U.S. District Judge Matthew F. Kennelly to serve as a bellwether in the testosterone side effects multidistrict litigation against manufacturers of the male hormone. Garner’s case, along with that of John DeBroka Jr.’s, were selected to be the first tried against Eli Lilly and Co. DeBroka’s case alleges he suffered deep vein thrombosis within a month after taking Axiron in late 2013.
About 6,000 cases are pending in the MDL, 4,200 of which name AbbVie’s top selling AndroGel. Judge Kennelly has already selected about a half dozen AndroGel cases to serve as bellwethers, the first of which ended in a mistrial earlier this month after the plaintiff’s lead attorney fell ill. That trial is rescheduled for September. AbbVie faces the second bellwether next month.