Endo Pharmaceuticals, its Auxilium subsidiary and GlaxoSmithKline have agreed to settle roughly 1,300 testosterone lawsuits filed on behalf of men who allegedly suffered heart attacks, strokes and blood clots due to their use of Testim and other hormone-boosting drugs.
On Friday, the federal judge overseeing the massive testosterone litigation currently underway in the U.S. District Court, Northern District of Illinois, issued a 45-day stay for all cases pending against the three defendants, so that the details of the still-undisclosed settlement could be finalized.
“The parties are negotiating the terms of a potential settlement, subject to certain contingencies and conditions,” a spokesperson for Endo and Auxilium told Bloomberg News via an emailed statement. “The settlement will not involve any admission of wrongdoing or liability.’’
A Testim lawsuit slated to go to trial on April 6th has been removed from the Court’s schedule.
Prescription testosterone medications such as Axiron, AndroGel and Testim are only approved to treat hypogonadism, or low testosterone secondary to an injury or medical condition. They have not been proven safe and effective for men who experience decreasing testosterone levels merely due to aging.
In March 2015, the U.S. Food & Drug Administration (FDA) ordered testosterone manufacturers to update their product labels with information regarding an increased risk of heart attacks and stroke. Several months later, the labels were modified yet again to include a general warning regarding a risk of venous thromboembolism, venous blood clots that include deep vein thrombosis and pulmonary embolism.
Plaintiffs involved in the federal testosterone litigation claim that the drugs’ makers were aware of the cardiovascular risks associated with their products and failed to properly warn doctors and patients about these potentially deadly side effects. Plaintiffs further charge that sales of Testim and other testosterone treatments were driven by marketing claims that falsely characterized low testosterone levels normally experienced by aging men as an “epidemic” and a “syndrome” called “Low-T” that required treatment.
Court documents indicate that more than 6,200 testosterone lawsuits have been centralized in the Northern District of Illinois.
In January, Eli Lilly & Co., announced it had agreed to settle all Axiron lawsuits pending in the proceeding. Details of the Axiron settlements have not been disclosed.
The bulk of the litigation consists of claims involving AbbVie Inc.’s AndroGel testosterone gel. The first federal trial of an AndroGel lawsuit concluded in July, with the jury ordering AbbVie to pay the plaintiff $150 million in punitive damages for false advertising. However, a new trial was recently ordered in that case.
A second AndroGel lawsuit concluded in October, with the jury awarding the plaintiff $140,000 in compensatory damages and $140 million in punitive damages.