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.