Allergan has finalized a settlement that will end hundreds of lawsuits related to the company’s Androderm testosterone product, according to court documents. The lawsuits claim that the testosterone replacement drug caused serious injuries, with more than 500 people suing Allergan.
Actavis, the company that originally manufactured the product, has also been named in some of the lawsuits. Allergan purchased the company in 2015.
According to the Illinois federal court document, dated July 26, 2018, both parties have agreed not to disclose details of the settlement. A filing in June announced that a tentative settlement was in the works.
The lawsuits claimed that users of Androderm suffered serious side effects, including stroke, heart attack and death. The lawsuit accuses the companies of marketing its drug for off-label uses that were not approved by the U.S. Food and Drug Administration (FDA).
Androderm was approved by the FDA to treat hypogonadism, a condition in which the body is unable to produce enough hormones. According to the lawsuits, the companies would market the drug as a way to boost male sex drive or slow the signs of aging.
The FDA previously cautioned against using testosterone replacement drugs to treat age-related low testosterone. It also required manufacturers to add warnings related to the potential risk of heart attack and stroke.
More than 25,000 testosterone lawsuits have been filed in recent years. Nearly 6,000 were pending in the Androderm Illinois MDL.
Six lawsuits related to AndroGel have already gone to trial, with two of the cases ending in verdicts of $140 million and $150 million. Both verdicts were overturned. A second trial reduced the verdict to $3.2 million. The next four trials ended in AbbVie’s favor.
Last month, Endo International agreed to a $200 million tentative settlement that affected 1,300 Testim lawsuits.
Allergan was slated to face a trial on August 6. The trial has been canceled in light of the settlement announcement.