More than 1,340 angry men who tried testosterone supplementation to treat their “Low T”—and who believe they were harmed as a result—have joined a collection of lawsuits pending in the U.S. District Court in the Northern District of Illinois against seven companies involved in the marketing of the hormone. Now what?
A hint of what’s to come could emerge April 21, when the court overseeing the cases is scheduled to hold a conference on the progress of discovery efforts. All of the men involved in the suits believe they suffered heart attacks, strokes, or other health problems after taking testosterone, and as of now, the first case is scheduled to go to trial in the fall of 2016.
The legal actions can’t move fast enough for men like Bob Cripe of Kansas City and Daniel Lang of Dayton, Ohio, both plaintiffs in the testosterone cases. Cripe alleges he suffered a spinal stroke at age 46, a week after being diagnosed with Low T and starting treatment with AndroGel, made by
Ron Johnson, the lawyer representing Cripe, predicts the cases against AbbVie, Endo, and the others will set a precedent in pharmaceutical litigation, even though this is far from the first time drug companies have been sued over alleged side effects. What makes these cases different, he contends, is that testosterone drugs were heavily marketed for a condition that the FDA hasn’t even recognized as a disease, let alone approved any product to treat. In other words, he says, the millions of dollars the companies spent on direct-to-consumer (DTC) ads urging men to talk to their doctors about Low T was off-label marketing to a greater extreme than anything the industry has seen before.
“I’ve seen drugs with inadequate warnings or side effects that they should have disclosed and didn’t. But what I haven’t seen before is companies inventing a fake disease,” says Ron Johnson, a partner at Schachter, Hendy & Johnson in Fort Wright, KY, and co-lead counsel on the testosterone cases. “Bob talks about having borderline Low T but there’s no such thing as that. It was made up in marketing departments of drug companies. I’ve never seen this level of disease mongering.”
Spokespeople for AbbVie and Endo declined to comment, citing the ongoing litigation. A spokeswoman for AbbVie added, “If a patient has questions or concerns about his treatment regimen, he should speak with his healthcare professional.”
Although the consolidated suit against testosterone makers is a massive 128 pages, the major complaint can be summed up in one sentence: Testosterone is only FDA-approved to treat hypogonadism, a drastic hormonal decline caused by injury or disease, and by marketing it beyond that use, the suits allege, the companies endangered healthy men.
For example, the suit alleges that AbbVie initially estimated that hypogonadism affects about a million men, but shortly after AndroGel was approved in 2000, the company announced that the market had grown to at least four million potential patients. By 2003, the complaint says, that number was 20 million. “These numbers did not, and could not represent, the number of men with the conditions for which AndroGel is indicated, which are believed to be substantially smaller,” the complaint reads.
The suit proceeds to describe several aggressive marketing tactics allegedly practiced by testosterone makers. It alleges, for example, that Endo had a $13 million marketing budget for Fortesta in 2013, 70% of which it spent detailing physicians about Low T. The complaint describes an ad in Urology Times that showed a man’s thighs with two drops of Fortesta on them, accompanied by the text “When his pair needs some help, this pair could raise his T.” Endo also provided free blood testing to men in some states who completed an online questionnaire about Low T, the suit alleges.
Then there were those direct-to-consumer ads, many of which attributed a bunch of symptoms associated with aging—fatigue, loss of libido, and more—to Low T. Print and TV advertising for AndroGel began shortly after the 2000 FDA approval of the product and grew from there. The company spent $75.6 million on DTC marketing for AndroGel in 2012, and $67.9 million in 2013, according to data from market-researcher Kantar Media. (Spending dipped last year, as the FDA began reviewing reports of cardiovascular side effects associated with testosterone.)
Plaintiff Cripe, who works in financial services, says the ads were tantalizing. “There were a lot of commercials on at the time about looking younger, feeling younger, and yeah, that was a partial reason I went to see the doctor,” Cripe says. “When I thought I could just rub this gel on myself and have all this vitality, it seemed like a no-brainer. I was all in.”
Fellow plaintiff Lang, a retired
The FDA has already made some of the changes that lawyers representing testosterone patients hoped would come out of the suits, Johnson says. In March, the agency ordered that labels be revised to clarify what the proper use of testosterone is, and to include the increased risk of cardiovascular events. The FDA is also requiring testosterone makers to conduct clinical trials to better define those risks.
“I’m very hopeful the FDA changes will change prescribing habits,” Johnson says. “From this point forward, [the lawsuits] are all about getting compensation for these men.”
After about eight months of therapy, Lang says he has finally recovered from his embolisms. Cripe has adjusted to life in a wheelchair and testified before the FDA about his experience with testosterone. They both hope their participation in the litigation will lead to changes in how the pharmaceutical industry markets products directly to consumers.
“I guess everyone wants to be better, but I was pretty good” without testosterone, Cripe says. “If there’s a possibility someone could end up paralyzed the rest of their life or dead, the risk should only be taken by people who desperately need testosterone to live an ordinary life. I hope changes are made so this doesn’t happen to someone like me in the future.”
Also on Forbes:
