Pharmaceutical

Axiron side effects trial dates set

Axiron Axiron side effects trial dates set Two cases among more than 6,000 lawsuits waged against Eli Lilly and Co. over testosterone side effects have been selected by the U.S. District Court for the Northern District of Illinois to serve as bellwether trials in the Testosterone Replacement Therapy Product Liability multidistrict litigation (MDL).

U.S. District Judge Matthew K. Kennelly selected the case of Tracy Garner and the case of John Debroka Jr. to serve as bellwethers. Garner claims to have had a heart attack after initiating testosterone therapy with Lilly’s Axiron. Debroka alleges he developed deep vein thrombosis, a blood clot deep in the veins, after taking Axiron.

The lawsuits against Lilly and other testosterone manufacturers include injuries such as heart attacks, strokes, deep vein thrombosis, and pulmonary embolism (blood clot in the lung), some of which have been fatal.

The lawsuits claim the drug companies created a condition called Low T and heavily marketed testosterone treatments to reverse symptoms such as low libido and weight gain. The ads resulted in huge profits for testosterone manufacturers. But those suing the drug companies say those profits came with serious risks to consumers.

In January 2014, the Food and Drug Administration (FDA) announced it was investigating reports of cardiovascular events including deaths in men who had been treated with FDA-approved testosterone therapy. In March 2015, the agency issued a safety communication warning them that the products are not intended for age-related drops in the male hormone. Manufacturers were also required to add new warnings about the risk of heart attacks and strokes with use of the drugs.

Other testosterone manufacturers named in the testosterone MDL include Endo Pharmaceuticals, Actavis Inc., Auxilium Pharmaceuticals Inc., Pfizer, and Pharmacia. The first several trials target AbbVie Inc., maker of the top selling AndroGel testosterone replacement treatment.

Source: Mass Tort Nexus