Testosterone Lawsuits Move Forward

Plaintiffs who have suffered heart attack, stroke or death, due to the use of testosterone supplements, will finally see their cases moving forward. U.S. District Judge Matthew F. Kennelly recently met with attorneys arguing the testosterone cases in order to discuss future case management strategies. The testosterone cases have been consolidated in a federal multidistrict litigation in the U.S. District Court for the Northern District of Illinois. Approximately 1,017 testosterone lawsuits are pending in this MDL; a sharp increase in the number of lawsuits was seen after the FDA announced an investigation into a number of cardiovascular events associated with testosterone supplements given to men with "Low-T."

Decline in Testosterone Levels a Normal Sign of Aging

Testosterone levels in men decrease naturally with age. In fact, testosterone levels among men decline by 1-3% per year after the age of thirty. This decline in testosterone levels is not the same as a diagnosis of hypogonadism which occurs when the sex glands produce little or no sex hormones. The FDA approved testosterone supplements only for use in the treatment of hypogonadism, however testosterone manufacturers have widely advertised the supplements as a cure-all for men who have such symptoms as:

  • A decrease in overall energy;
  • A decline in physical strength;
  • A decline in overall muscle mass;
  • A decrease in bone density;
  • A decrease in sexual desire;
  • An increase in belly fat, and
  • The occasional need for an afternoon nap.

Higher Risks of Stroke, Blood Clots, Heart Attack and Death for Testosterone Users

The hard-hitting advertisements directed at older men have sent thousands of these men to their doctors, begging for a prescription for testosterone supplements. Doctors, believing the supplements to be safe, have prescribed them off-label for many men. It is believed that significantly more than half of the men currently taking testosterone supplements do not have a diagnosis of hypogonadism.

Yet a study published in the Journal of American Medical Association in November, 2013, concluded men taking testosterone supplements had a 29% greater risk of suffering a stroke, heart attack, or death. Another study, published in August, 2013, saw a significant increase in blood clots among the men taking testosterone supplements. A testosterone clinical trial done in 2010 was halted early due to the extremely high number of study participants who experienced an adverse health event.

Over Five Million Prescriptions for Testosterone Supplements

Since 2001, the number of prescriptions for AndroGel and other testosterone supplements has more than quadrupled, reaching more than five million by 2013, including refills. After the FDA recommended further cardiovascular studies were necessary, a bit of a slow-down on testosterone prescriptions was seen. At the time the additional testosterone studies were recommended, the FDA also asked testosterone manufacturers to include labeling language stating there is no definitive proof that testosterone supplements reverse the common symptoms of aging.

No Black Box Warning for Testosterone Supplements

Public Citizen, a consumer "watchdog," asked the FDA to require a Black Box cardiovascular warning on all testosterone supplements, however the FDA denied that petition, claiming there was insufficient data at the time to warrant such a requirement. In 2014 and 2015, the number of testosterone lawsuits went from a handful to thousands. Specifically, the number of testosterone lawsuits in the Illinois MDL climbed from 282 as of January 2015 to 1,017 by February 2015.

Upcoming Testosterone Litigation

The vast majority (714) of these lawsuits have been brought against AbbVie, the manufacturer of AndroGel which currently corners approximately 60 percent of the testosterone supplement market. Two groups of cases are currently being prepared for trial. The first group contains six AndroGel lawsuits scheduled to begin between October 2016 and April 2017 (about one per month). The second group, a set of bellwether trials for other brands of testosterone supplements, is not expected to begin until late 2017.