Life Science Compliance Update

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August 07, 2017

AbbVie Found Liable for Misrepresentation in AndroGel Case

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In July 2017, a Chicago jury found AbbVie Inc. guilty of fraudulently misrepresenting the risks of its testosterone replacement drug AndroGel. The federal jury ordered the company to pay $150 million in punitive damages.

Allegations

The verdict comes in a case where Jesse Mitchell blamed the drug for a heart attack he had in 2012 after four years of taking AndroGel. Mitchell, who used AndroGel from 2008 to 2012, alleged that AbbVie knew or should have known the drug could cause cardiovascular disease, strokes and other serious injuries, but failed to adequately warn consumers and doctors. He was 49 at the time of his heart attack.

He took the drug during an active advertising campaign warning consumers about "low T." The company marketed the drug to consumers despite its "dangerous side effects" even though there were "safer alternative methods of treating loss of energy, libido erectile dysfunction, depression, loss of muscle mass and other conditions AndroGel's advertising claims are caused by low testosterone," Mitchell alleged in court documents.

The company had argued in court documents that Mitchell had other risk factors that could have caused his heart attack, such as a history of smoking, high blood pressure and high cholesterol, among other things.

Jury Decision

The jury did note that AbbVie was not negligent or strictly liable for the heart attack Mitchell suffered after taking AndroGel, but that nonetheless, AbbVie falsely marketed the drug. The jury, however, found in favor of AbbVie on allegations that AndroGel lacked adequate warnings or instructions, making it unreasonably dangerous, as well as allegations that the company was negligent.

Mitchell also sought compensatory damages for his injuries and losses. It is interesting that the jury determined that AndroGel did not cause any damage, but nonetheless awarded punitive damages.

The decision is the first in a series of test cases that are aimed at helping plaintiffs (and the makers of AndroGel) gauge the range of damages so they can craft a legal strategy and settlement options going forward. The verdict – in response to a lawsuit filed by Jesse Mitchell and his wife in 2014 – is the first in response to more than 6,000 pending lawsuits that have been consolidated in federal court in Chicago.

Statements and Analysis

"The jury found that AndroGel did not cause any damage," AbbVie said in a statement. The company said that it did not expect the punitive damage award to stand, without providing further details.

Carl Tobias, a law professor at the University of Richmond, said the jury's decision to award punitive damages without granting compensatory damages was "extremely unusual."

"Usually you can't recover punitive damages without having any compensatory damages," Tobias said. Even still, he believes that, "The fact that a jury awarded punitive damages may encourage plaintiffs and their lawyers to bring on more cases and pursue them even more aggressively."

Even with the likelihood of AbbVie appealing, it is still newsworthy as the settlement is likely to have an impact on the outstanding cases with similar fact patterns.

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