Steve Holtsclaw’s heart attack in 2014 weighs on his mind daily. He’s more emotional now, and constantly wonders, “How much longer have I got?” the 62-year-old man told an Illinois federal jury during the first bellwether trial in a multidistrict litigation (MDL) involving cardiovascular risks with Auxilium Pharmaceuticals Inc.’s testosterone replacement therapy Testim.
Holtsclaw was prescribed Testim in 2013 after complaining to his doctor about chronic fatigue. A blood test showed his testosterone levels were low. Months later, Holtsclaw suffered a heart attack. He received two stents and was put on several medications to help prevent a second heart attack. He was also taken off Testim.
Holtsclaw sued Auxilium in 2015 because he believes the company’s testosterone treatment caused him to suffer a heart attack.
The multidistrict litigation, which consolidated thousands of cases in Illinois federal court, names several manufacturers of testosterone replacement therapies. The first two bellwether trials involved AbbVie’s AndroGel, and resulted in two multimillion verdicts against the drug company – one for $150 million and the other for $140 million.
The lawsuits against Auxilium, AbbVie and the other drug companies claim that the testosterone manufacturers promoted their products to men to treat symptoms of normal signs of aging – a use that is not approved by the Food and Drug Administration (FDA) because it has not been shown to be safe or effective for this use. Meanwhile, studies began to emerge showing that testosterone use – especially in older men – increased their risk of heart attacks, strokes, blood clots and death.
Testosterone treatments are only FDA approved to treat men who do not produce enough of the male hormone due to injury, defect or disease.