AbbVie, Inc. has entered discussions to settle federal testosterone lawsuits filed on behalf of men who claim to have suffered heart attacks, strokes, and blood clots due to their use of AndroGel.
The AndroGel settlement talks were disclosed in an Order issued on September 10th in the U.S. District Court, Northern District of Illinois, which stayed proceedings in all pending cases to allow the parties time to complete their discussions.
AndroGel is a testosterone replacement therapy indicated to treat hypogonadism, or low testosterone levels related to an underlying medical condition, injury, or illness.
In March 2015, the U.S. Food & Drug Administration (FDA) ordered testosterone manufacturers to update their label warnings with information about an increased risk of heart attack and stroke. The agency also voiced concern that the drugs were being over-prescribed to men who merely suffered from age-related testosterone depletion and directed that their labels also clearly state that testosterone replacement therapy had never been proven safe or effective for this purpose.
Several months later, the drugs’ prescribing information was updated yet again to include a general warning regarding a risk of venous thromboembolism, a dangerous type of venous blood clot that includes deep vein thrombosis and pulmonary embolism.
The federal testosterone litigation was established in the Northern District of Illinois in 2014 to allow all federally-filed testosterone lawsuits to undergo coordinated discovery and other pretrial proceedings. At its peak, the litigation included more than 25,000 filings, the largest number of which involved AndroGel.
Plaintiffs pursuing testosterone lawsuits claim that AbbVie and other defendants failed to warn doctors and patients about the cardiovascular risks allegedly associated with their products. They further charge that sales of the medications were driven by deceptive marketing claims that falsely characterized the low testosterone levels normally experienced by aging men as an “epidemic” and a “syndrome” called “Low-T” that required treatment.
The litigation’s first AndroGel trial concluded in July 2017, when AbbVie was ordered to pay the plaintiff $150 million in punitive damages for false advertising. However, the verdict was overturned when the judge overseeing the litigation ordered a retrial. That retrial concluded in March, when another Illinois jury awarded the plaintiff $3.2 million.
The second bellwether trial of an AndroGel lawsuit resulted in a $140 million verdict. However, that verdict was overturned last month, when another retrial was ordered.
Juries have ruled for AbbVie in the remaining 4 AndroGel bellwether trials.
According to the Cook County Record, AbbVie is the only testosterone defendant remaining in the federal litigation.
Just last month, Allergan finalized an agreement to resolve all claims involving AndroDerm.
A settlement involving Testim and other testosterone products marketed by Endo Pharmaceuticals and Auxilium Pharmaceuticals was finalized in June, while Eli Lilly & Co. agreed to settle Axiron lawsuits in January.
Details of the testosterone settlements announced thus far are confidential and none of the drug makers have admitted liability for plaintiffs’ injuries.