Androderm Settlement Agreement May Resolve 500 Testosterone Lawsuits

Actavis has reached a tentative agreement to settle about 500 Androderm lawsuits filed on behalf of men who allege the suffered a heart attack, stroke or other injury due to side effects of the testosterone patch.

The cases are part of a massive litigation over problems with testosterone replacement therapy drugs, which also includes claims against the makers of AndroGel, Axiron, Testim and others.

There are currently more 6,000 complaints pending in the federal court system that allege various drug makers failed to adequately warn users and the medical community about the health risks associated with testosterone drugs, which have been linked to an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, blood clots and other life-threatening health problems.

Given similar questions of fact and law presented in lawsuits filed throughout the federal court system, the testosterone lawsuits are currently centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL, or multidistrict litigation.

In the latest of a string of agreements reached by individual drug makers, Judge Kennelly issued a case management order (PDF) on June 29, which placed a stay on all Androderm claims against Actavis, after the parties informed the Court that a potential global settlement had been reached.

It is estimated that about 500 of the testosterone claims pending before Judge Kennelly involve Androderm. Actavis was acquired by Allergan Inc. in 2014. No details of the potential Androderm settlement have been released, but Judge Kennelly said suspending the cases is designed to allow the parties to devote their energy to finalizing the agreement.

The first federal “bellwether” trial over injuries caused by the use of Androderm is currently scheduled to begin on August 6, and Judge Kennelly indicates that trial date is not vacated at this time.

The Androderm settlement comes just two weeks after Auxilium Pharmaceuticals and its parent company, Endo International, announced that they had reached an agreement to resolve about 1,300 Testim lawsuits. In addition, late last year it was announced that Eli Lilly has agreed to settle all Axiron cases involving their testosterone gel.

While the three global settlements are expected to resolve more than one-third of the pending litigation, no agreements have been reported involving Androgel lawsuits, which account for the bulk of the filed cases, since that was the most widely used testosterone replacement therapy. AbbVie has continued to defend cases at trial, despite several large jury verdicts. A series of 19 Androgel trials are expected to begin later this year.