The judicial panel on multidistrict litigation (JPML) has created an MDL to hear product liability lawsuits filed against the makers of prescription low testosterone products. Lawsuits involving testosterone replacement therapy (TRT) will be consolidated in the Northern District of Illinois with Judge Matthew F. Kennelly presiding over pretrial proceedings in the Chicago courtroom. This reduces the cost of discovery and allows for consistency in pretrial rulings.
Popular testosterone products are AndroGel, made by Abbvie and Abbott Laboratories. Other brands include Axiron (Lilly) and Androderm (Watson). Thousands of product liability lawsuits predicted to be filed content that makers hid the dangers of the testosterone products from consumers.
The plaintiffs suffered heart attack, strokes, mini-strokes, deep vein thrombosis, pulmonary embolism and deaths. And $80 million dollar marketing campaign began in 2012 and sold AndroGel as a lifestyle decision to treat “Low T.” AndroGel received FDA approval in 2000, making it the treatment for men feeling stressed out by the burdens of midlife. Testosterone manufacturers also pushed men to self-diagnosis providing a checklist to compare symptoms. A simple blood test will reveal if a man has seriously low levels of testosterone and the Endocrine Society provides clinical guidelines for testosterone use.
The first cases were filed in January 2014 after the FDA said it would begin to investigate the safety of these therapies in light of the growing numbers of adverse event reports it was receiving. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition such as hypogonadism. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. Consumer groups want a black-box warning on the products, the highest risk warning that can appear on a product short of a recall.
Public Citizen petitioned the FDA in February of this year asking it to add a black box warning about the increased risk of heart attack and cardiovascular events following the use of testosterone-containing drugs. Public Citizen reports there were more than 400,000 prescriptions filled in the U.S. in December 2013, just one month and 5 million filled in 2013. The $2 billion a year industry last year is expected to top $5.8 billion in sales by 2018.