Pharmaceutical

AbbVie faces fourth testosterone side effects trial

androgel pump 435x435 AbbVie faces fourth testosterone side effects trialAbbVie Inc. will continue to use deceptive practices to market its testosterone replacement therapy AndroGel unless it is sent a firm message and faces financial pressure, say attorneys for a man who blames his heart attack on the drug. The jury in the fourth bellwether trial against AbbVie in a multidistrict litigation heard testimony alleging testosterone manufacturers did not adequately warn of cardiovascular risks with their testosterone treatments.

Jesse Mitchell’s case was the first to go to trial and accuse AbbVie of failing to warn that AndroGel could increase the risk of heart attacks, strokes and blood clots, some of which could be fatal. His trial ended with a jury award of $150 million in punitive damages for Mitchell’s claims of strict liability and negligence.

But the jury awarded no compensatory damages, finding that the testosterone treatment was not the cause of Mitchell’s injury. U.S. District Judge Matthew Kennelly ultimately vacated the first verdict and ordered a new trial after concluding that jurors were likely confused about how causation fit into each of Mitchell’s claims.

Not only did Mitchell blame AndroGel for his heart attack, he also blamed AndroGel for aggressively marketing the drug for an off-label use, a condition called Low T. He said AbbVie claimed that AndroGel could relieve Low T “symptoms” in older men such as low libido, weight gain and mood swings.

Testosterone treatments are only indicated for hypogonadism, a condition in which men do not produce enough of the male hormone due to injury, defect or disease. It is not intended for age-related hypogonadism.

AbbVie’s aggressive marketing pushed the testosterone treatment market from a $50 million industry in 2000 to a $1 billion one in 2010. Meanwhile, the company failed to conduct studies to determine whether the drug was putting men at increased risk for cardiovascular problems.

Mitchell’s attorneys asked the jury to award Mitchell more than $130,000 to cover his medical expenses, and punitive damages of more than $1 million so that the company would be penalized for its wrongdoing. AbbVie is worth $5.1 billion.

Source: Law360