Endo International Finalizes Settlement to Resolve 1,300 Testosterone Lawsuits Involving Testim, Other Hormone Replacement Drugs

Published on June 15, 2018 by Sandy Liebhard

Endo International PLC has finalized a settlement that will resolve all known testosterone lawsuits involving Testim and other male hormone replacement drugs marketed by its Endo Pharmaceuticals and Auxilium Pharmaceuticals subsidiary.

All of the lawsuits were filed on behalf of men who suffered heart attacks, blood clots, strokes, and other cardiovascular problems allegedly related to the use of testosterone replacement therapies.  The cases are pending in the U.S. District Court, Northern District of Illinois, where all such federally-filed claims were centralized in a multidistrict litigation for the purpose of coordinated pretrial proceedings.

According to an Endo International press release dated June 11th, the testosterone settlement does not involve any admission of wrongdoing or liability by the drug maker.

The judge overseeing the federal testosterone litigation has also issued a Case Management Order that requires, among other things, any future claimants, as well as existing plaintiffs electing not to participate in the settlement, to produce certain information within specified timeframes.  The order also allows for expedited discovery on claimants and dispositive motion practice on certain defenses. Further, it permits only limited discovery on Endo.

Details of the Endo testosterone settlement remain confidential.

 Testosterone Replacement and Cardiovascular Side Effects

Prescription testosterone replacement medications, including Axiron, AndroGel, and Testim, among others, 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 modify their prescribing information to note a possible increased risk of heart attacks and stroke. Several months later, the labels were updated yet again to include a general warning regarding a risk of venous thromboembolism, a dangerous type of venous blood clot that includes deep vein thrombosis and pulmonary embolism.

Plaintiffs who have filed testosterone lawsuits allege that the drugs’ manufacturers were aware of the cardiovascular risks associated with their products but failed to provide doctors and patients with appropriate warnings about these risks. Plaintiffs further charge that sales of these medications were driven by marketing claims that falsely characterized the low testosterone levels normally experienced by aging men as an “epidemic” and a “syndrome” called “Low-T” that required treatment.

Testosterone Settlements and Verdicts

Court documents indicate that nearly 6,000 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 settlement have not been disclosed.

The majority of testosterone lawsuits pending in Illinois involve AbbVie Inc.’s AndroGel testosterone gel. The first federal trial of an AndroGel lawsuit concluded in July 2017, with the jury ordering AbbVie to pay the plaintiff $150 million in punitive damages for false advertising. However, the verdict was overturned when the judge overseeing the litigation ordered a retrial.

That retrial concluded in March, when another Illinois jury awarded the plaintiff $3 million.

A second AndroGel lawsuit concluded in October 2017, with the jury awarding the plaintiff $140,000 in compensatory damages and $140 million in punitive damages.

AbbVie has prevailed in two bellwether trials, including a case that concluded on June 14th.


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