Jeffrey Konrad, a traffic consultant in Tennessee, started taking AbbVie’s heavily advertised testosterone drug AndroGel in 2010 and suffered a heart attack shortly thereafter. Now he’s one of 4,100 men suing the company over allegations that AndroGel caused their cardiovascular problems—and he’s the first to offer testimony in a class action case that started Monday in a U.S. District Court in Illinois.
The suit was filed against six sets of testosterone makers, including Endo and Eli Lilly, but AbbVie was chosen to face trial first. The court drama comes at a time when the company is facing declining sales of its key products, including AndroGel, and the threat of biosimilar competition to its top-selling Humira.
Sales of AndroGel soared past $1.1 billion in 2012 but fell off a cliff over the next few years, after the FDA slapped additional warnings on the testosterone salve and the patients’ lawsuits emerged. AndroGel sales came in at just $675 million last year.
The master complaint against AbbVie and the other companies, weighing in at a whopping 129 pages, boils down to one key claim: Testosterone is approved to treat hypogonadism, a serious medical condition that causes levels of the hormone to drop precipitously, but makers of the drugs heavily marketed them to aging men to treat an “invented” disease called Low T, the suit alleges. As a result, otherwise healthy men sought out treatment and ended up facing the risk of cardiovascular side effects.
In an e-mailed statement, an AbbVie spokeswoman said prescription testosterone should only be prescribed after a thorough medical exam. "AbbVie is committed to our patients with hypogonadism due to certain medical conditions and we believe our disease education and marketing of AndroGel have adhered strictly to FDA-approved uses and are in full compliance with applicable standards," she said.
The suit contends that AbbVie “created a robust and previously nonexistent market” for AndroGel with an $80 million marketing campaign. As part of that campaign, the company launched several websites that encouraged men to take the “Is it Low T” quiz, which asked such questions as “are you falling asleep after dinner?” the master complaint notes. AbbVie, it reads, “marketed and sold testosterone as a lifestyle drug meant to make men feel younger and increase libido.”
The FDA did try to warn men about the risks of testosterone. In 2015, the agency ordered that testosterone makers revise the labels on their products to reflect the proper use of the hormone and the increased risk of cardiovascular side effects. The agency upped its scrutiny of the drug after the Journal of the American Medical Association (JAMA) published a study in 2013 that reported a 29% increase in rates of heart attack, stroke and death among testosterone users.
Konrad said in court filings obtained by Bloomberg that had he known about the risks, he would not have taken AndroGel. AbbVie responded with filings stating the company made no safety representations to Konrad or his doctors. A lawyer for AbbVie said in his opening comments that the company didn’t engage in misconduct and that Konrad’s doctors couldn’t confirm a link between AndroGel and his heart attack. “The FDA set the rules of the marketplace and we followed those rules,” he said, as quoted by Bloomberg.
The start of the AndroGel court proceedings is a thorn in the side of AbbVie, which is facing a host of challenges to some of its biggest blockbusters. Sales of its top-selling arthritis remedy Humira did jump 23% year-over-year in the first quarter to $2.7 billion, but the company is facing biosimilar competition overseas that’s hampering its growth, and biosimilars are on their way in the U.S. Meanwhile, sales of its hepatitis C combo Viekira Pak fell 36% to $263 million during the quarter, as AbbVie struggles to compete for market share against Gilead Sciences’ Harvoni.
The plaintiffs in the testosterone lawsuit are seeking compensation for injuries they believe were caused by AndroGel and other versions of the hormone. Carl Tobias, professor of product liability law at the University of Richmond, predicted in an interview with Bloomberg that AbbVie will use the Konrad case and other early AndroGel proceedings to figure out how to settle the suit. That would certainly be a logical strategy for a company dealing with more pressing challenges.