Product News and Recalls

First Testim Trial Ends with Decision in Favor of Drugmaker

testim trial sides with drugmakerTestim maker Endo International’s Auxilium unit emerged victorious in the first trial over whether its testosterone therapy drug caused a heart attack in a patient.

The Tennessee plaintiff had been prescribed Testim for what he described as chronic fatigue and had been applying the testosterone gel to himself for over 6 months. In July 2014, he suffered a heart attack and was subsequently hospitalized twice. His recovery since then has been described as full.

The case was based on the plaintiff’s allegations that Testim had been marketed improperly and that his use of the drug to combat fatigue was off-label. He claimed that Endo was misrepresenting the risks associated with taking Testim and that the gel had been designed improperly.

The company countered every claim in the plaintiff’s case and blamed his heart attack on what it describes as his “numerous medical conditions that put him at risk for cardiovascular disease.”

In the end, the jury agreed and cleared Endo of any liability in the man’s heart attack. Endo’s chief legal officer followed up on the verdict by issuing a statement reiterating the safety of their product and the company’s commitment to defending itself against similar claims.

Those claims are numerous. Some 1,290 Testim lawsuits have been filed in state and federal courts across the country. They are actually part of a larger litigation involving 6,000 plaintiffs and most testosterone therapy manufacturers including Endo Pharmaceuticals, Inc, AbbVie Inc,, and Eli Lilly. All cases involve some form of a failure to warn claim over the cardiovascular risks of testosterone therapy.

Of those, AbbVie is the only other company whose testosterone treatment has faced trial in court. Two cases over the cardiovascular effects of AndroGel resulted in decisions of $140 million and $150 million in favor of the plaintiffs; both of whom alleged that the treatments were responsible for their heart attacks.

All prescription testosterone drug makers have been federally mandated to include information regarding the cardiovascular risks of their products since May of 2015.