The first trial in multidistrict litigation (MDL) involving testosterone replacement therapy (TRT) began June 5 in the U.S. District Court for Northern Illinois in Chicago. There are more than 7,000 claims pending against the manufacturers of testosterone treatments alleging they did not adequately warn users of potential cardiovascular side effects.
Testosterone replacement therapy is approved by the Food and Drug Administration (FDA) to treat hypogonadism, a condition in which the body does not produce enough of the male hormone. TRT is not designed to treat symptoms of age-related testosterone decline, but Plaintiffs allege drug companies marketed the products as a “fountain of youth” to treat conditions such as low libido, weight gain, and muscle loss. Such off-label use is not only ineffective, the lawsuits allege, but put men at increased risk for heart attacks, strokes, blood clots, and death.
Lawsuits name testosterone replacement therapy manufacturers including AbbVie, Besins, Eli Lily, and GlaxoSmithKline, and products such as AndroGel, Axiron, and Testim.
Seven cases in the class action have been singled out as bellwethers, with the first six involving AbbVie’s top-selling AndroGel. Those suing AbbVie claim the company even concocted a condition called “Low T” to lure men who did not need the treatment to ask for it by name. The seventh bellwether case is suing Besins.
In the first trial, which started June 5, plaintiff Jeffrey Konrad alleges his 2010 heart attack was linked to his use of AndroGel. He started using the testosterone gel 65 days before his heart attack.
The remaining bellwethers are scheduled through April 2018. The cases are consolidated under U.S. District Judge Matthew Kennelly.
Law 360 – AbbVie Confronts 1st Bellwether In Androgel MDL