AbbVie notched a win late last month in its ongoing battle against thousands of lawsuits that claim AndroGel, a once-blockbuster drug marketed to treat low testosterone in men, causes heart attacks, strokes and other injuries.
A jury decided the North Chicago-based drugmaker was not to blame for the pulmonary embolism suffered by a 72-year-old Arizona retiree who started using AndroGel after seeing TV advertisements promoting testosterone therapy as a fix for fatigue and low sex drive. It marked the first verdict in Chicago federal court to clear AbbVie of any wrongdoing.
The win for AbbVie comes a few months after two separate juries in the same federal courtroom awarded huge punitive damages – $150 million and $140 million – to two men who suffered heart attacks while taking AndroGel, a prescription gel men apply daily to their upper arms and chest. But inconsistencies in the first verdict led the judge to overturn it and order a new trial, scheduled to start in early March. He is considering AbbVie's request he do the same with the second.
The mix of verdicts unfolding in Chicago federal court – the epicenter of mass litigation involving multiple testosterone drugs – suggests it is too soon to tell if the scales are tipping in favor of the drugmakers or the thousands of men who blame them for encouraging them to take drugs they believe caused them harm.
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AndroGel, the market leader, hit the market in 2000, when it was approved by the FDA to treat a condition called hypogonadism, which is testosterone deficiency resulting from genetic defect, illness or trauma.
But for several years, drug companies promoted the off-label use of testosterone therapy to combat age-related frustrations including fatigue, low sex drive and increased body fat, symptoms of what it termed "low-T."
The lawsuits allege that companies' efforts to grow the market led them to target older men without properly warning of the risk of complications.
AbbVie has owned AndroGel for only part of the drug's history. Abbott International acquired AndroGel in 2010, and AbbVie was spun off from the company three years later.
"We will keep having (trials) in the foreseeable future and in increasing numbers," said Ron Johnson, co-lead counsel for the men, plus some of their wives, with cases in federal court. Three more trials are set for May, June and July.
"We are very confident," Johnson said.
AbbVie did not respond to multiple requests seeking comment.
Men across the country have filed nearly 7,000 lawsuits claiming injury from various testosterone replacement drugs, 4,500 of them involving AbbVie's AndroGel.
The lawsuits, filed in district courts across the country, have been consolidated before Judge Matthew Kennelly in Chicago federal court, who last year began hearing bellwether cases that are intended to be representative of the larger group and provide guideposts for whether the drug companies should settle the rest and what the value of the settlements should be. Three of the four federal bellwether trials completed so far have involved AbbVie.
Meanwhile, more than 200 additional testosterone drug cases await judgment in Cook County Circuit Court, many involving Illinois plaintiffs with lawsuits against AbbVie. The one test case tried so far, involving a 66-year-old man who suffered a heart attack while taking AndroGel, resulted in a verdict in favor of AbbVie, but the man's attorneys are seeking a new trial that will allow them to present evidence on the internal decision-making behind the company's sales tactics. That evidence was not permitted in the initial trial.
Advertisements by AbbVie and other companies substantially increased testosterone testing and use of testosterone treatments between 2009 and 2013, according to a study published last year in the Journal of the American Medical Association. More than 4.8 million prescriptions for testosterone gels and creams were dispensed in 2012, up 40 percent from 2009, according to IQVIA, a health data research company. The lion's share – more than 3 million – were for AndroGel.
Bob Nolte, the Arizona retiree who recently lost his case against AbbVie after a three-week trial, was prescribed AndroGel in the summer of 2012 after getting a testosterone test at his doctor's office. He asked for the test after seeing TV commercials suggesting "low-T" could be to blame for low libido and low energy, according to a transcript of his testimony.
Two months after he started applying the gel, Nolte, 72 at the time, experienced chest pain he described as "10 out of 10" and went the hospital, where he was told he had multiple blood clots in both lungs.
The event "very much changed my mobility," he said in his testimony, making it difficult for him to walk, and he was advised he would have to take blood thinners for the rest of his life.
"It was terribly bad at first. I had two shoe sizes larger, walking with a walker," said Nolte, who was president and CEO of the health services group at the nonprofit Volunteers of America, and later ran a computer consulting firm, before retiring. "I'm kind of happy with my recovery, but it was no fun at all."
AndroGel sales soared to a peak of $1.15 billion in 2012, and it was AbbVie's second most-lucrative drug behind Humira, which treats rheumatoid arthritis, according to the company's regulatory filings.
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.