That changed after the U.S. Food and Drug Administration in 2014 announced it was investigating the health risks associated with FDA-approved testosterone products after two new studies raised concerns. The next year, the agency required label changes to clarify the approved uses and to warn of possible increased risk of heart attacks and strokes with testosterone use.
Last year, AndroGel sales totaled $577 million, down nearly 15 percent from 2016, and the company anticipates a further slide to $475 million in 2018, according to its recent earnings call.
Nolte, who sued AbbVie in 2014, sought damages to cover $160,000 in medical bills he said were connected to his experience with AndroGel. At his trial, his attorneys asked the jury to consider awarding up to $10 million for pain and suffering.
During closing arguments, Nolte's attorneys highlighted the company's marketing culture and its internal discussions about expanding screening for low-T so it could meet sales goals. The company's actions were "not just negligence but willful, wanton conduct," Keith Mitnik, one of Nolte's attorneys, told jurors. Older men like Nolte with other health problems are "exactly who they shouldn't have been giving (AndroGel) to," he said.
But AbbVie's lawyers spotlighted multiple risk factors in Nolte's health history that could have contributed to his pulmonary embolism, including a genetic clotting disorder called Factor V Leiden, his decision to discontinue use of anticoagulants and a previous pulmonary embolism he'd suffered the year before, after undergoing coronary bypass surgery. The central question, they emphasized, was whether AndroGel caused his embolism.
"He made choices that impacted his health in multiple ways," Jim Hurst, an attorney for AbbVie, said during closing arguments. "Hold him responsible for his own choices."
As Nolte sat beside his wife in the Chicago courtroom, the jury returned a verdict in favor of AbbVie, clearing it of all claims. Nolte's lawyers did not make him available for an interview.
The recent decision in the Nolte case veered from the split verdicts in AbbVie's prior two bellwether cases, which did not blame the drug for causing the men's heart attacks but did punish AbbVie for misleading marketing. The judge overturned the first verdict, saying it was "logically incompatible" for the jury to award $150 million in punitive damages but nothing in compensatory damages. In the second verdict, the jury awarded $140 million in punitive damages and $140,000 in compensatory damages.
Those outcomes suggested "the jury is upset with the conduct or the morals of marketing by the drug company and not so much by the drug's safety factor," said Colin Gainer, a partner in the Chicago health care practice at law firm SmithAmundsen, who is not involved in the AndroGel litigation.
In addition to AbbVie, companies targeted by the testosterone lawsuits include Eli Lilly and Endo International. Indianapolis-based Eli Lilly, maker of Axiron, reached a global settlement in the hundreds of lawsuits against it before its first bellwether trial began.
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