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Endo Faces Product Liability Lawsuit over Fortesta Testosterone Gel

May 13, 2014

Endo Pharmaceuticals and Prostrakan Group PLC are being sued over their testosterone-boosting Fortesta gel, Law 360 reports. The product liability suit, which is reportedly the first to be filed in Philadelphia Court of Common Pleas against Prostrakan, alleges that the testosterone gel caused one Georgia resident, Demetric Taylor, to have a heart attack. Taylor and his wife allege in the suit that Fortesta is an unnecessary drug that is marketed for a condition that does not truly exist. Taylor’s suit is just one of several that have been filed in light of emerging evidence linking testosterone drugs to heart risks.

According to the lawsuit, Endo and Prostrakan marketed Fortesta as a drug that would help treat low testosterone. Taylor alleges that he and his doctor relied on the companies’ claim that low testosterone was a medical condition. “Defendants’ advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the ‘symptoms’ of low testosterone,” the lawsuit stated. “These ‘symptoms’ include listlessness, increased body fat and moodiness — all general symptoms that are often a result of aging, weight gain or lifestyle, rather than low testosterone.”

Taylor’s suit also claims that Endo and Prostrakan knew about the dangers associated with Fortesta, but failed to notify users and healthcare professionals about these risks.

There have been several testosterone product liability lawsuits filed, Law360 reports. This includes suits against Auxilium Pharmaceuticals Inc.’s drug Testim and Abbott Laboratories and AbbeVie's AndroGel.

Concerns about testosterone drugs have been on the rise due to research linking testosterone therapy to an increased risk of heart attack and stroke. In light of these findings, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are investigating the heart risks of testosterone drugs.

Testosterone is the hormone largely responsible for the development of male characteristics. The FDA has only approved testosterone drugs for men who produce low levels of testosterone due to a medical condition known as hypogonadism. This condition is associated with fatigue, depression, as well as loss of sex drive, bone, muscle, and facial and pubic hair.

In recent years, drug makers have spent millions on marketing testosterone drugs for low testosterone, or “Low-T”. In 2013, $107.3 million was spent on Low-T ads, compared to $14.3 million in 2011. This has drawn criticism from medical experts, including those at Consumer Reports, who believe that the benefits of testosterone drugs are exaggerated while the risks are minimized.

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