A federal jury in Chicago stated that Endo International plc – Ordinary Shares (NASDAQ:ENDP)’s Auxilium segment was not accountable for the heart attack a person suffered while using the firm’s testosterone replacement drug Testim. The judgement was a win for the drugmaker in its initial trial over allegations it defectively developed Testim, a skin gel, and carelessly misrepresented its risks.
Matthew Maletta, the Chief Legal Officer of Endo, expressed that Testim was safe and company would continue to dynamically defend against similar allegations. The company and its subsidiaries face around 1,290 other Testim cases in federal and state courts across the nation, the firm’s latest regulatory submission in November showed. The litigation is part of a larger lawsuit at the Illinois court. Around 6,000 plaintiffs claim that a range of defendants had failed to caution of cardiovascular risks from their testosterone medications.
AbbVie is the only other firm that has faced litigations over its testosterone replacement medication AndroGel. It lost both those cases. Hearings against the other makers are due in 2018. The recent verdict involved Steve Holtsclaw, who had been on Testim for over half a year to cure chronic fatigue. He got a heart attack in 2014 and was hospitalized twice.
Holtsclaw alleged that Endo International misrepresented Testim’s hazards when marketing it to his doctor, pushing him to advise the gel for off-label applications, including chronic fatigue. Auxilium, which company bought in 2014, in court papers rejected all claims. It stated Holtsclaw failed to prove that Testim was the reason for his heart attack, stating his various medical ailments that put him at risk for cardiovascular ailment.
Auxilium also stated Testim complied with U.S. FDA guidelines at the time and was effective and safe when prescribed as permitted in 2002. The FDA has generally permitted testosterone replacement offerings for men with no or low testosterone due to medical problems like genetic failure of the testicles.