Talks for a global settlement have begun between pharmaceutical giant AbbVie and plaintiffs in the thousands of testosterone lawsuits related to the company’s flagship testosterone replacement therapy medication, AndroGel. If a settlement agreement is reached, it would bring an end to the multidistrict litigation (MDL) that has been in progress since 2014. Other defendants, including Endo Pharmaceuticals and Allergen, announced settlements earlier this year for their products Testim and AndroDerm, respectively.
What is Testosterone Therapy?
Testosterone therapy is used to treat low testosterone levels, Low-T, caused by physical problems that reduce the production of testosterone in men. Low-T can cause emotional problems, such as depression, as well as fatigue and a lowered sex drive. Testosterone products like AndroGel help raise a man’s testosterone levels to reduce these symptoms.
Recent studies have found a connection between the use of testosterone replacement therapies and dangerous medical conditions, including heart attacks, blood clots and strokes. Due to these complications, thousands of lawsuits have been filed against various manufacturers, with cases against AbbVie’s AndroGel accounting for more than half of the lawsuits filed in federal courts.
Why Are People Suing?
The testosterone lawsuits against AbbVie claim that AndroGel caused serious medical problems, and the company failed to warn patients and doctors of the health risks. Plaintiffs further allege that AbbVie used marketing campaigns to promote testosterone treatment for off-label uses of the medication, including for lowered testosterone levels due to aging, for which it wasn’t approved by the U.S. Food and Drug Administration (FDA).
A study in the Journal of the American Medical Association found that testosterone testing and the use of testosterone therapy increased between 2009 and 2013, and the majority of prescriptions dispensed were for AndroGel. The study claims that the rise in testing is linked to a rise in television ads promoting testosterone therapy products and encouraging men to have their testosterone levels tested.
In 2015, the FDA required label changes to all testosterone therapy medications to clarify the approved uses of the medications and warn of an increased risk of heart attacks and strokes when using them. The FDA also required that new trials be conducted to ensure the medications’ safety.
The Legal Battle over Testosterone
Over the past year, AbbVie has gone to court in six bellwether trials and won four of them. In the other two cases, the jury found for the plaintiffs and agreed that AndroGel was to blame for their heart attacks and awarded large amounts. Both verdicts have since been overturned and retrials were required. In the first retrial, the jury again found for the plaintiff but awarded only $3.2 million in damages, far less than the $150 awarded previously. The second retrial is still pending. Earlier this year, Judge Matthew F. Kennelly announced that he and 11 other judges would try 20 of the pending testosterone cases against AbbVie between October 2018 and March 2019.
On September 10, in the wake of AbbVie’s testosterone settlement announcement, Judge Matthew Kennelly ordered a stay on all further proceedings while the parties discuss a potential global settlement. The parties are required to regularly report on the settlement talks as they work towards a resolution. All deadlines are currently suspended, and if a settlement agreement is reached, it should resolve all outstanding cases.
In addition to the testosterone therapy lawsuits they’ve been battling, AbbVie has also been at the center of an antitrust case for AndroGel alongside partner Besins Healthcare Inc. In this case, they were accused of using anti-competitive tactics to delay generic competition for AndroGel to keep the price high. They were ordered to pay $448 million to consumers who were overcharged for AndroGel in early August. AbbVie has since filed an appeal to the court’s decision.
AbbVie Testosterone Lawsuit Settlement Potential
AbbVie is the last defendant to work on a settlement offer in the testosterone therapy MDL. On June 12, Endo Pharmaceuticals announced it had set aside $200 million to settle 1,300 pending testosterone lawsuits. And in July, Allergan reached a settlement agreement for 500 Androderm lawsuits, though the amount hasn’t yet been disclosed. While AbbVie faces a higher number of cases to settle than the other companies, there’s no guarantee they will offer comparable settlement amounts.
If you or a loved one has used testosterone replacement therapy and suffered severe side effects, you may be eligible for compensation. Contact an attorney today for a free case review.