Endo International will pay $200 million to settle 1,300 lawsuits over Testim. The company disclosed the deal June 12, 2018. The agreement is to resolve “all known” testosterone lawsuits against the company.
Testim is a testosterone therapy drug. Endo’s subsidiary Auxilium manufactures Testim. GlaxoSmithKline co-promotes the drug.
Endo announced in February it would seek a deal.
About 900 of the Testim lawsuits are part of a multidistrict litigation. MDLs combine several similar lawsuits to save time and money in court. A federal panel combined the lawsuits in an Illinois federal court.
The testosterone MDL includes more than 6,000 testosterone lawsuits against Endo, Eli Lilly and AbbVie. The companies manufacture different testosterone therapy products.
The outcome of early trials in an MDL can lead both sides to shape settlements. These trials are known as bellwether trials.
Lilly settled 400 Axiron lawsuits earlier this year. AbbVie lost two testosterone lawsuits over its AndroGel product. The verdicts totaled $143 million. AbbVie faces more bellwether trials in the MDL.
Testosterone lawsuits blame Endo and other testosterone makers for cardiovascular injuries. Some men reported heart attacks and strokes after beginning Testim. Others cited deep vein thrombosis and pulmonary embolism. Widows of men on testosterone drugs filed lawsuits for their husbands’ sudden deaths.
People suing Endo and other manufacturers claim the companies over-sold their drugs’ benefits in ads. And that the companies ignored testosterone side effects.
The FDA approved testosterone therapy only for treating hypogonadism. It’s a medical condition in which a man’s body fails to make enough testosterone.
But lawsuits claim manufacturers pushed “off label” uses of the drugs. They accuse companies of promoting testosterone therapy as treatment for flagging male sex drives. Plaintiffs say the companies also promoted the drugs as treatment for normal aging conditions.
The lawsuits allege testosterone drugs offered little benefit for the off-label uses. But the medicine raised the risks of deadly side effects.
Endo won its first bellwether trial in late 2017. But the company immediately pursued a settlement with all the people who sued.
Endo set $200 million aside for the deal late last year. The move puts the rest of its bellwether trials on hold.
The company noted the money it set aside in federal financial filings. It said the $200 million would be cheaper than fighting future lawsuits in court.
The company faced stiff financial pressure to settle. FiercePharma reported that Endo has lost most of its market value in recent years. It also faces hundreds of lawsuits from cities and counties over the opioid crisis.
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