There are now over 2,000 federal claims involving Androgel, Testim, Axiron and other alleged testosterone injury lawsuits caused by side effects of low testosterone drugs.
Since June 2014, all federal testosterone drug injury and product liability lawsuits have been consolidated as part of a multidistrict litigation (MDL), with the cases centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.
MDL consolidation is common in pharmaceutical and medical device litigation to streamline and fast track the trial process.
Over 2,000 Testosterone Federal Lawsuits
According to the U.S. Judicial Panel on Multidistrict Litigation, there are currently at least 1,975 product liability lawsuits pending before Judge Kennelly involving testosterone replacement therapy. Most of the complaints filed to date have been brought against AbbVie over their Androgel treatment, which is the most popular testosterone replacement therapy.
FDA Testosterone Blood Clot Warnings
Federal drug regulators have ordered of AndroGel, Testim, Axiron, Depo-Testosterone and other “Low T” drug manufacturers to add new warnings about the link between blood clots and testosterone replacement therapy, including an increased risk of deep vein thrombosis (DVT) or pulmonary embolism.
On June 19, 2014, the FDA announced that additional information about the risk of blood clots will be added to testosterone drug labels, indicating that the medications may cause venous thromboembolism (VTE).
The statement comes as the FDA continues to investigate the potential link between testosterone and heart problems, following earlier medical studies that noted that men using the “Low T” drugs may face an increased risk of heart attacks, strokes and death.
What are Testosterone Induced Blood Clots?
Venous thromboembolism are blood clots that occur in the veins, clots in the legs are known as deep vein thrombosis (DVT). When the blood clots break off and move to the heart and lungs, this is known as a pulmonary embolism, which can be fatal.
The FDA warning highlights that these blood clots appear to be a different problem than those that may be causing testosterone users to suffer heart attacks and strokes.
Common Testosterone Allegations and Injuries
All the plaintiffs voice similar allegations, that inadequate warnings were provided about the increased risk of heart attack, stroke, deep vein thrombosis, pulmonary embolism or other catastrophic cardiovascular injury after the use of testosterone drugs.
Furthermore, the lawsuits allege that the drug manufacturers recklessly marketed the hormonal medications to men who were experiencing normal age related reduction in testosterone levels, which do not require medical treatment.
Bellwether Testosterone Trials
A representative group of Androgel injury cases are being prepared for early trial dates. AbbVie is the manufacturer of Androgel and is the most popular gel product involved in the litigation. Six Androgel bellwether trials have been scheduled to take place in 2016 and into 2017, where AbbVie will be the only defendant.
The cases are to be divided into two categories: those involving blood clots from testosterone therapy, such as thromboembolism and deep vein thrombosis injuries; and testosterone heart attack claims.
By October 31, the plaintiffs and defendants are expected to select eight AndroGel cases dealing with thromboembolism injuries and eight cardiovascular injury cases for bellwether discovery.
By March 1, 2016, the court expects to choose three thromboembolism cases and three heart attack cases to go to trial. Individual trial dates for the three thromboembolism cases have been scheduled to begin October 31, 2016, December 5, 2016 and January 9, 2017.
The three cases involving cardiovascular injuries are scheduled to begin on February 13, 2017, March 20, 2017 and April 24, 2017.
A second group of bellwether trials are expected involving lawsuits pending against other manufacturers, which would likely not begin until the second half of 2017.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.