Abbvie hit with enormous and unusual verdict for misrepresenting AndroGel Risks.

Lauraann Wood reported on this surprising and highly unusual verdict in the Chicago Daily Law Bulletin last week. Mr. Jessie Mitchell, an Oregon resident, filed suit against Illinois pharmaceutical company Abbvie alleging that Abbvie purposely downplayed the serious side effects and health risks posed associated with Androgel – a testosterone replacement therapy for men.

By way of background, the United States Food and Drug Administration[“FDA”] approved Androgel in 2000 to treat men suffering from hypogonadism – difficulty or inability to produce testosterone. At that time there were approximately 5 million men suffering from hypogonadism.

Mitchell alleged that after the FDA approval, Abbvie coordinated a massive advertising campaign to market Androgel and convince men they suffered from low testosterone or “Low T”. Abbvie, as part of the campaign, came up with an online “Is it Low T?” quiz and encouraged consumers to take the quiz. But Mitchell alleged the “quiz” wasn’t particularly authoritative. First, Mitchell alleged that the quiz was created by a doctor in exchange for a $40,000 grant. Mitchell further alleged the doctor came up with some of the questions while occupying a bathroom stall, writing the questions on toilet paper. He then had his assistant type them the next day. The doctor later admitted that he had “…no trouble calling it a crappy questionnaire.” Wood’s article didn’t address whether that testimony was heard by the jury. If it was heard in open court, it had to be devastating.

And some of the questions on the quiz – example: “Are you sad and/or grumpy?” were simply too vague to elicit any meaningful information or point to Low T. But the campaign, according to Mitchell, created a previously non-existent market for the drug. By 2003, just three years after approval, 20 million men were taken Androgel.

Mitchell alleged that while Abbvie had successfully created a previously non-existent market – it failed to properly warn consumers about Androgel’s downsides – which include an enormously increased risk of heart attack in certain patients. Mitchell himself suffered a serious heart attack in 2012. Additionally, in 2009, the FDA issued a warning that children who were secondarily exposed to Androgel could suffer serious health consequences.

Mitchell had sued for compensatory damages arising out of his heart attack and punitive damages for Abbvie’s misrepresentation of the risks associated with Androgel. But the jury did not award Mitchell any compensatory damages for that claim. Abbvie lawyers were likely happy about that. But that happiness was short-lived. Because the jury did award damages to Mitchell on his fraud claim.

The jurors awarded $150 MILLION dollars to Mitchell to punish Abbvie for misrepresenting the health risks. Congratulations to Troy Rafferty of Pensacola, Florida who represented Mitchell. Not easy to take on a pharmaceutical giant on a fraud claim and win. Well done.