CHICAGO — AbbVie notched a win 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 that the drugmaker was not to blame for the pulmonary embolism suffered by an 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 federal court in Chicago, where AbbVie is based, to clear the company 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 federal court — the epicenter of litigation involving testosterone drugs — suggests that it is too soon to tell whether 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.
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.
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 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 U.S. District Judge Matthew Kennelly in the Northern District of Illinois, 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 that low levels of the hormone could be to blame for a lack of libido and flagging energy levels, according to a trial transcript.
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 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, trailing only blockbuster rheumatoid arthritis treatment Humira among AbbVie drugs, according to the company’s regulatory filings.
That changed in 2014, when the Food and Drug Administration 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 slide to $475 million in 2018, according to its recent earnings call.
Alexia Elejalde-Ruiz is a Chicago Tribune writer.