Auxilium Pharmaceuticals Inc., maker of the testosterone replacement therapy Testim, escaped a verdict in the first bellwether trial blaming Testim for a man’s heart attack. This marks the first victory in multidistrict litigation (MDL) over testosterone side effects that names several testosterone manufacturers.
The first two bellwether trials were against AbbVie Inc., makers of AndroGel, and resulted in combined $290 million in verdicts.
The seven-day trial focused on the case of Steve Holtsclaw, who claimed he was prescribed Testim after complaining to his doctor about chronic fatigue. Months after treatment, Holtsclaw suffered a heart attack. He since learned that studies linked testosterone replacement therapies to cardiovascular risks including heart attacks, strokes, blood clots and death.
His attorneys argued that Testim is not indicated as a treatment for chronic fatigue. The drug is intended for men with hypogonadism, a condition in which men do not produce enough of the male hormone. Drug companies promoted it as a treatment for the symptoms of so-called Low T, a condition they claimed caused symptoms such as fatigue, muscle loss and weight gain.
Holtsclaw’s lawsuit accused Auxilium of strict liability, negligence, intentional misrepresentation and misrepresentation by concealment against the company. The jury deliberated four hours before rejecting all counts and awarding no compensatory or punitive damages.
Holtsclaw’s case is one of more than 6,000 in the multidistrict litigation naming several manufacturers of testosterone replacement therapies.