The Food and Drug Administration (FDA) repeatedly rejected Auxilium Pharmaceuticals Inc.’s requests to expand the indication of its testosterone replacement therapy Testim to include age-related drops in testosterone, yet the drug company continued to market its product for age-related symptoms, attorneys for Steve Holtsclaw said during opening arguments. As a result, Holtsclaw trusted the product was safe, but realized the error of his ways when he suffered a heart attack seven months after starting the hormone therapy.
Holtsclaw’s lawsuit is the first bellwether to reach trial against Auxilium in a multidistrict litigation that names numerous manufacturers of testosterone treatments. Two trials involving AbbVie Inc.’s AndroGel resulted in a total judgment of about $300 million against the drug company. Testosterone manufacturers named in the MDL are accused of misleading consumers about the safe use of testosterone replacement therapy, and failing to warn about the increased cardiovascular risk. Studies have linked testosterone use to an increased risk of heart attacks, strokes and blood clots.
Testosterone treatments are only approved to treat hypogonadism, a reduction of the male hormone in men caused by injuries or genetic disorders. It is not intended for age-related drops in testosterone, yet drug companies have heavily marketed the product for this use.
Holtsclaw was prescribed Testim to treat chronic fatigue. Blood tests revealed he had low-normal testosterone levels for his age. But, his lawsuit states, Testim is not approved to treat fatigue, yet Auxilium allegedly included the symptom among a cluster of symptoms for which the company said Testim could treat. This is despite the FDA refusing to allow testosterone replacement therapies for such use.
Holtsclaw filed his lawsuit against Auxilium in 2015 alleging strict liability, negligence, intentional misrepresentation and misrepresentation by concealment. The lawsuit also names Endo Pharmaceuticals Inc., which acquired Auxilium in 2015. Endo got out of the lawsuit after winning a summary judgment before the trial began.