Lawsuits against AbbieVie, Inc. – the maker of Androgel – and four other pharmaceutical companies making testosterone replacement therapy drugs have been centralized into a multi district litigation court (MDL) in Illinois. Some 3,500 product liability cases are filed in the federal court system for claims against makers of the “Low-T replacement therapy.” Plaintiffs include both testosterone therapy users and insurance companies.
Low T Replacement Therapy
Several forms of testosterone replacement therapy remain on the market. They include oral agents, injectable agents, and topical delivery, typically creams. AndroGel is a topical agent that was approved by the FDA in 2011. It is one of the most popular products designed to treat low testosterone levels. Androgel is primarily prescribed to men who fail to produce sufficient amounts of testosterone themselves. The gel, a blend of synthetic testosterone and alcohol, is applied to the skin once a day. It can cost some $500 per month.
Testosterone Therapy Problems
After testosterone therapy products had been on the market for roughly two years, more and more doctors began to discuss the dangerous side effects. Older men were using Low T therapy to regain youth, boost energy, increase sex drive – reasons for which it was not ostensibly designed. The largest risks associated with testosterone supplementation include an increase in cardiovascular problems such as heart attacks and strokes. Other risks include prostate cancer, larger red blood cells, reduced sperm count, gynecomastia (breast growth), edema, sleep apnea, high cholesterol.
Androgel / Abbott Lawsuits
Five men aged 50-63 sued Abbott Laboratories and AbbVie, Inc. in 2014 in the U.S District Court for the Northern District of Illinois. They alleged their injuries were caused by AndroGel. Two of the plaintiffs suffered heart attacks, two suffered strokes; all said Androgel caused the problem, and that Abbott and AbbVie failed to warn them about the risks associated with AndroGel. Their petition said the companies knew or should have known about the risks posed by testosterone therapy. Their complaint charges that the company downplayed the known health risks and deceived consumers. Testosterone marketing included testimonials from professional athletes the same ages as the ad-target group.
Studies show Significant Risks
The founder of Public Citizen’s Health Research group, Dr. Sidney Wolfe, published a piece in the British Medical Journal regarding testosterone therapy. Dr. Wolfe said his research uncovered 27 studies done on testosterone drug safety. The thirteen studies funded by drug companies showed no increased heart risks, but fourteen studies funded independently showed a significant increase in heart risks.
NIH: Testosterone doubles Heart Attack Risk
The National Institutes of Health funded an epidemiologic study based on the records of 55,000 men who had taken testosterone. The NIH found that for men over 65 the relative risk of heart attacks from Low T thereapy for three months doubled the risk they had the year before using testosterone; and the therapy more than doubled the heart attack and stroke risk for men under 65 who had a history of heart disease.
Insurance Companies sue Low T Product Makers
Insurance companies in the MDL allege the defendants created testosterone replacement therapy products to treat a fictitious disease called ‘Andropause.’ The insurance companies claim ‘symptoms’ of the ‘disease’ are only facts of the male aging process; they are therefore non existent or medically unnecessary. The insurers also claim violations of Racketeer Influenced and Corrupt Organizations (RICO) Act. They say Androgel was aggressively marketed despite being ineffective as well as dangerous.
Androgel Testosterone MDL
Defendants for the trial cases seek to set deadlines for complete fact discovery and expert discovery from July 2016 to February 2017. They want deadline for Daubert motions (re: expert witnesses) set from September 2016 to September 2017. Plaintiffs argue that these dates represent significant delays that would needlessly slow the MDL progression. Plaintiffs wish to try these cases as soon as possible.