Pharmaceutical

AndroGel marketing materials cannot be barred from next trial

androgel pump 435x435 AndroGel marketing materials cannot be barred from next trialAbbVie Inc., failed to convince an Illinois federal judge to block jurors from seeing its marketing materials for its testosterone replacement therapy AndroGel in the next bellwether trial in a mulstidistrict litigation (MDL), according to Law360. The drug company’s aggressive marketing practices were the damning evidence in the first testosterone side effects trial to reach verdict in the MDL, costing AbbVie $150 million in punitive damages to a couple who sued the company over cardiovascular risks.

U.S. District Judge Matthew F. Kennelly denied AbbVie’s motion for reconsideration on his ruling and punished the company by docking 30 minutes of trial time at the next bellwether, scheduled to start Sept. 18.

The first verdict involved the case of Jesse Mitchell, who blamed AndroGel – which he took off and on for years – for his heart attack, posting studies that showed use of testosterone treatment increased the risk of heart attacks, strokes and blood clots. The jury wasn’t swayed by this notion, finding that Mitchell’s other health issues could have contributed to his heart attack. But the jury did find substance with Mitchell’s other claim that the company’s ads were misleading and awarded Mitchell and his wife $150 million in punitive damages.

AbbVie had allegedly promoted AndroGel for a made-up condition, Low T, which was purported to cause symptoms such as low libido, mood swings and weight gain. The drug company vigorously promoted the drug through direct-to-consumer advertisements, which Mitchell said prompted him to ask his doctor if he was a candidate for the drug.

Testosterone replacement products are only approved for hypogonadism, a condition in which men do not produce enough of the male hormone due to injury, disease or defect.

AbbVie’s aggressive marketing campaign resulted in skyrocketing sales, which have slowed since the Food and Drug Administration (FDA) required AbbVie and other testosterone manufacturers to specify on the drugs’ labels that the medication is only for men with diagnosed hypogonadism.

AbbVie and other testosterone manufacturers face more than 6,000 lawsuits in the MDL over testosterone side effects.

Sources:
Law360
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