Photographer: Daniel Acker/Bloomberg

AbbVie Ordered to Pay $150 Million Damages in ‘Low-T’ Trial

  • $150 million verdict is first over Low-T testosterone booster
  • Oregon man blamed 2012 cardiac arrest on company’s AndroGel

AbbVie Inc. was ordered to pay $150 million to an Oregon man who accused the drugmaker of hiding the heart-attack risks of its AndroGel testosterone booster, but the company’s first trial loss probably won’t stand because jurors awarded no compensation for injuries.

AbbVie misled Jesse Mitchell and his doctor about AndroGel’s propensity for causing blood clots, which can lead to fatal heart attacks, a federal court jury in Chicago concluded Monday. Mitchell, a 54-year-old laundry manager, suffered a heart attack in 2012 after taking AndroGel for four years.

In an unusual outcome, the panel awarded Mitchell nothing on his claim for compensatory damages from the heart attack, including his hospital bills as well as pain and suffering. But the 11-member jury still socked AbbVie with $150 million in punitive damages over the finding that company officials made fraudulent misrepresentations about the product’s safety profile. 

The punishment award probably will be overturned because the U.S. Supreme Court has said such awards should be based on actual damages to be reasonable, said Neil Vidmar, a Duke University law professor who has taught about punitive damages.

"I think it’s a strong message they sent in terms of AbbVie’s conduct,” Troy Rafferty, Mitchell’s lawyer, said after the verdict.

Since Mitchell wasn’t awarded any compensation for his injuries, AbbVie contends AndroGel didn’t cause him any damage, according to Adelle Infante, a spokeswoman for the company.
“We expect the punitive damage award will not stand,” she said in an email.

Shares Fell

Shares fell about 1 percent on news of the verdict, closing at $73.91 Monday.

Sales of AndroGel, once one of the company’s top-selling products, have plummeted since regulators called for tougher warning labels. The gel generated $675 million in sales last year, compared with a high of more than $1.1 billion in 2012, according to data compiled by Bloomberg. AbbVie officials have steadfastly maintained the testosterone booster didn’t cause a higher rate of blood clots.

The suits, consolidated before U.S. District Judge Matthew Kennelly, accuse AbbVie and other makers of testosterone-replacement medicines of hiding or downplaying their products’ clot risk and violating federal law with aggressive marketing campaigns. AndroGel has been tied to fatal heart attacks in at least four cases.

AbbVie has been specifically targeted for allegedly launching an $80 million marketing campaign in 2012 to promote AndroGel for a condition known as “Low T,” or low testosterone. Television ads promised immediate benefits for men suffering from low energy and lack of sexual drive, according to court filings.

The U.S. Food and Drug Administration approved the drug in 2011 only for men who suffer from hypogonadism, a severe loss of testosterone, rather than the natural decline of the hormone through aging. Regulators moved to strengthen safety warnings after a study suggested testosterone-replacement medicines increased the risks of heart attacks and strokes by almost 30 percent.

AbbVie ignored studies that showed higher incidents of cardiac problems related to AndroGel and has refused to do its own research into the claims, Rafferty told told jurors in closing arguments last week.

Benefits, Risks

“AbbVie didn’t prove whether AndroGel is effective for symptoms of aging or whether the benefits outweigh the risks," Rafferty said. It also marketed the drug for symptoms of aging without federal regulators’ permission to do so, he added.

AbbVie’s lawyer countered in his closing argument that Mitchell’s heart attack was caused by other factors, such as his weight, high cholesterol and a history of smoking since the age of 16. “His risk was elevated because of his choices; to not lose weight or quit smoking," said David Bernick, one of the company’s lawyers. “Heart attack is a problem waiting to happen.’’

Jurors ruled for AbbVie on Mitchell’s claims for negligence and strict liability, but found AbbVie’s conduct was responsible for his heart attack in connection with the fraudulent representation claim, according to court filings.

The panel also found Abbott Laboratories responsible for Mitchell’s heart attack. AbbVie, based in North Chicago, Illinois, was spun off in 2013 from Abbott, and a spokesman for that drugmaker said in the past that all liability for AndroGel suits lies with AbbVie.

The case is Mitchell v. AbbVie Inc., 14-cv-9178, U.S. District Court, Northern District of Illinois (Chicago).

— With assistance by Michelle Cortez

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