November 16, 2017 / 9:30 PM / in a month

Endo unit cleared of liability in first testosterone replacement trial

NEW YORK (Reuters) - A federal jury in Chicago said on Thursday that Endo International’s Auxilium unit was not responsible for the heart attack a man suffered while using the company’s testosterone replacement drug Testim.

The verdict was a victory for the drugmaker in its first trial over allegations it defectively designed Testim, a skin gel, and negligently misrepresented its risks.

Matthew Maletta, Endo’s chief legal officer, said in a statement that Testim was safe and Endo would continue to vigorously defend against similar claims.

Endo and its subsidiaries face some 1,290 other Testim lawsuits in state and federal courts across the country, the company’s latest regulatory filing in November showed.

The case is part of a larger litigation at the Illinois court. Some 6,000 plaintiffs allege that a range of defendants, such as AbbVie Inc, Pfizer, Inc, Endo Pharmaceuticals, Inc and GlaxoSmithKline, had failed to warn of cardiovascular risks from their testosterone drugs.

AbbVie is the only other company that has faced trials over its testosterone replacement drug AndroGel. It lost both those trials.

Trials against the other manufacturers are due in 2018.

Thursday’s verdict involved Steve Holtsclaw of Tennessee, who had been using Testim for more than half a year to treat chronic fatigue. He suffered a heart attack in July 2014 and was hospitalized twice, but has since recovered.

Lawyers for Holtsclaw did not immediately respond to a request for comment.

Holtsclaw alleged Endo misrepresented Testim’s risks when marketing it to his physician, pushing him to prescribe the gel for off-label uses, including chronic fatigue.

Auxilium, which Endo acquired in 2014, in court papers rejected all allegations. It said Holtsclaw had been unable to prove that Testim caused his heart attack, citing his “numerous medical conditions that put him at risk for cardiovascular disease.”

Auxilium also said Testim complied with U.S. Food and Drug Administration regulations at the time and was safe and effective when prescribed as approved in 2002.

The FDA has generally approved testosterone replacement products for men with low or no testosterone due to medical conditions such as a genetic failure of the testicles.

In 2014, the FDA convened an advisory committee to consider the adverse cardiovascular outcomes associated with testosterone replacement therapy.

On the committee’s recommendation, the FDA in May 2015 required all prescription testosterone manufacturers to warn about cardiovascular risk on their drug labels.

Reporting by Tina Bellon; Editing by Richard Chang

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