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Endo Pharmaceuticals and Auxilium Pharmaceuticals confirmed this week that a global agreement has been reached to settle all testosterone drug lawsuits filed over heart attacks, strokes and other injuries linked to their Testim gel product.
In a press release issued on Monday, the parent company Endo International PLC announced an agreement that is expected to resolve about 1,300 product liability lawsuits filed by individuals nationwide. Details about terms of the testosterone drug settlement still have not been released.
The cases are part of a massive litigation, which includes more than 6,000 complaints brought against various drug makers for failing to warn users and the medical community about the potential side effects of 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. In addition to cases over Testim, claims have also been filed agains the makers of Androgel, Axiron, Androderm and other drugs.
Given similar questions of fact and law presented in lawsuits filed throughout the federal court system, the testosterone litigation is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL, or multidistrict litigation.
The possibility of the settlement was first announced in February, when parties entered into a Memorandum of Understanding regarding a global Testim settlement.
According to the recent announcement, a master agreement has been executed which is designed to allow for the resolution of all known claims against the company. Endo will make a one-time deposit into a qualified settlement fund if certain customary conditions are met, such as thresholds for plaintiff participation.
In addition, the agreement also came with a case management order, which establishes certain evidence requirements future claimants and those who chose not to participate in the settlement. It also allows expedited and limits discovery for future claims.
“We believe the master settlement agreement allowing for resolution of all known testosterone replacement therapy product liability claims against Endo marks another important achievement for the Company to deliver on its multiyear turnaround strategy,” Endo’s Chief Legal Officer and Executive Vice President, Matthew J. Maletta, said in the press release. “We expect the master settlement agreement and case management order will collectively assist claimants to move forward with their lives and permit Endo to move forward with an even greater focus on its core business priorities.”
Auxilium developed Testim gel in 2002, for treatment among men with a deficiency or absence of testosterone, and entered into a co-marketing agreement for the drug with GlaxoSmithKline in 2012. Endo Pharmaceuticals completed an acquisition of Auxilium Pharmaceuticals in January 2015, in a deal valued at $2.6 billion.
The agreement to settle all Testim cases came after an Axiron settlement reached by Eli Lilly to resolve all lawsuits involving their competing testosterone gel. However, the terms of neither deal have been disclosed yet.
While the two global settlements are expected to resolve about one-third of the pending litigation, no agreements have been reported involving Androgel lawsuits, which involve claims against AbbVie for injuries associated with their market-leading testosterone gel product.