The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Georgia resident Demetric Taylor recently filed a testosterone replacement therapy lawsuit against Endo Pharmaceuticals and Prostrakan Group PLC, makers of the testosterone-boosting gel, Fortesta. Taylor claims that the drug led to his unexpected heart attack.

The case was filed on May 12, 2014, in the Philadelphia Court of Common Pleas—the first to be filed in that court, though a number of other similar cases are pending in federal court in the Eastern District of Pennsylvania.

Plaintiff Claims Defendants Over-Promoted Fortesta

On January 31, 2014, the FDA announced a new investigation into the safety of testosterone therapy drugs. They stated they had been monitoring the risks, and decided to reassess the medications based on the publication of two separate studies that had suggested men taking the drugs were at an increased risk of heart attack and stroke.

Taylor claims that the defendants were misleading in their advertisements of Fortesta, encouraging men with symptoms like fatigue, weight gain and moodiness to ask their doctors about testosterone therapy. The FDA, however, approved the drug to treat only men with true low-testosterone levels caused by a medical condition.

The symptoms listed in Fortesta advertisements could be attributed to a number of other conditions, including aging or lifestyle, yet Taylor alleges the company’s marketing claims encourage men without medical conditions to ask for prescriptions anyway.

Taylor further claims that the defendants failed to provide adequate warnings about the risks, such as those for heart attack and stroke.

Studies Show Men without Low T Taking Testosterone

The FDA first approved Fortesta at the end of 2010 for the treatment of hypogonadism, which is a medical condition in which the body doesn’t produce enough testosterone. The product comes in a clear, colorless and odorless gel with a two percent concentration of testosterone that’s applied directly to the front and inner thighs.

“A small amount of gel applied each day may be all that’s needed to help raise your T,” the company states on its website. They also claim that a healthcare provider will test potential patients before prescribing the drug.

A recent study, however, shows that this “testing” is not always taking place. Researchers looked at data for over 400,000 men who had all received a prescription for the drug and found that overall, testosterone supplementation had increased, adding: “Substantial use is seen in men without recent testing and in U.S. men with normal levels.” They warned that physicians should consider the “medical necessity” of testosterone before writing out a prescription.

Comments are closed.

Of Interest