AbbVie Inc. fabricated a condition called Low T to lure men without hypogonadism to use its testosterone replacement therapy AndroGel but didn’t tell them that using the hormone treatment could put them at risk of life threatening heart attacks, attorneys for an AndroGel user who nearly died told an Illinois federal jury.
The case of Jesse Mitchell versus AbbVie is the second bellwether to go to trial among thousands lodged against AbbVie and other testosterone treatment manufacturers. The first ended in a mistrial when the plaintiff’s lead attorney fell ill. That trial was rescheduled for September.
Those suing the drug companies claim that the testosterone makers ignored warnings from the Food and Drug Administration (FDA) not to promote the use of testosterone for men with natural drops in testosterone. Testosterone therapy is indicated only for men with hypogonadism, a condition in which a man does not produce enough testosterone due to injury or disease. Only about 150,000 men suffer from the condition. Marketing a prescription drug for a purpose for which it is not approved is illegal.
But AbbVie saw bigger profits for its hormone drug by promoting the treatment for so-called Low T through aggressive direct-to-consumer advertising, telling men that testosterone use could boost low libido and help improve mood, lawsuits allege. The gamble paid off, resulting in surging sales for testosterone treatments. That is, until the FDA ordered tighter prescribing language on the labels.
Meanwhile, studies began to show that there were steep risks for men who used testosterone therapy. The medication was linked to an increased risk of heart attacks, strokes, blood clots and death.
Mitchell claims that he went to his doctor in 2007 complaining of depression and fatigue. He was prescribed AndroGel, which he took off and on for five years before suffering a near-fatal heart attack. Two years later, he and his wife, Kimberly, sued AbbVie, claiming they were never warned that use of the company’s AndroGel carried cardiovascular risks.