Complaints against AbbieVie, Inc. and four other pharmaceutical companies regarding testosterone replacement therapy have been centralized as an MDL for pretrial proceedings in Illinois. There are nearly 3,500 product liability cases in the federal court system involving claims against the replacement therapy. There are two distinct groups of plaintiffs; consumers and insurance companies.
There are several forms of testosterone replacement therapy including oral agents, injectable agents, and topical delivery. AndroGel, a topical agent, was approved by the FDA in 2011. It is one of the most used medical products to treat low testosterone levels. The gel is mostly prescribed to men whose bodies fail to produce sufficient amounts of the male hormone. Made with synthetic testosterone and alcohol mixed into a gel, the product is applied to the skin once a day. Moreover, it can cost up to $500 a month.
Within two years on the market, however, doctors became increasingly vocal about the dangerous side effects on older men using the prescriptions to regain youth, boost energy, and increase sex drive, instead of for its intended purpose. The biggest risks associated with using testosterone include an increase in cardiovascular issues like heart attacks and strokes. Other risks include prostate cancer, larger red blood cells, reduced sperm count, edema, gynecomastia, sleep apnea, and also high cholesterol.
In 2014, five men ranging from age 50-63, sued Abbott Laboratories and AbbVie, Inc. in the U.S District Court for the Northern District of Illinois alleging injuries caused by AndroGel. After two of the plaintiffs suffered heart attacks and two suffered strokes which they attributed to the use of the gel, they alleged the companies failed to warn consumers about the risks associated with AndroGel and knew or should have known about the risks posed by therapy. The complaint alleges the company downplayed the known health risks. Additionally, they deceived consumers through positive marketing, including testimonials from retired professional athletes.
Doctor Sidney Wolfe is the founder of Public Citizen’s Health Research group. Wolfe released an article in the British Medical Journal regarding the effects of testosterone therapy. According to Wolfe’s research there are about twenty seven studies available on the safety of testosterone drugs; thirteen of those studies were funded by drug companies and showed no increased heart risks. The other fourteen studies, however, which were funded independently, collectively showed a significant increase in heart risks.
The National Institutes of Health funded an epidemiologic study based on the records of 55,000 men who had been prescribed testosterone. They found that in all men aged 65, the relative risk of heart attacks after using the drug for three months was twice the risk as it was in the year before beginning use. It was also more than twice the risk in those men under 65 with a history of heart disease.
The insurance companies involved in the MDL allege the defendants created testosterone replacement products to treat a made up disease called Andropause. They claim the symptoms of the disease are essentially symptoms of the male aging process. The problem is therefore non existent and medically unnecessary. Furthermore the insurers claim violations of Racketeer Influenced and Corrupt Organizations Act. They are alleging Androgel was aggressively marketed despite being not only ineffective, but dangerous.
For trial cases, the defendants seek to have deadlines for complete fact discovery and expert discovery from July 2016 to February 2017 and the deadline for Daubert motions from September 2016 to September 2017. Plaintiffs argue, however, that these are significant delays that would needlessly delay the progression of the MDL.