Testosterone is a naturally occurring hormone produced in the human body. This hormone is mainly produced in the testicles of men and is responsible for sperm production, a man’s sex drive, and building muscle and bone mass. Testosterone production tends to naturally decrease as men age. As a result, men can experience various symptoms if testosterone levels decrease below a normal range. Low testosterone, also called low T or hypogonadism, can often be mistaken as a natural part of aging. Typical symptoms include low sex drive, difficulty achieving erection, low semen volume, hair loss, fatigue and lack of energy, loss of muscle mass, increase in body fat, decrease in bone mass, and mood changes. Common treatment for symptomatic low T is testosterone replacement therapy. This treatment helps many men with clinically proven low levels of testosterone to feel “normal” again, i.e. normal sex drive, able to maintain erection, etc. However, drug manufacturers have participated in aggressive direct-to-consumer advertising urging men to seek treatment for low testosterone when they likely do not need it. In these cases, the risks of the treatment typically far outweigh the benefits.
Although testosterone replacement therapy has been shown to reduce the symptoms of low T, there have also been many reported side effects that can be life threatening. Recently, studies have shown data that suggests some patients taking testosterone supplements delivered as a gel, patch, injection, implant or pill may face an increased risk of cardiovascular problems. A November 2013 study in the Journal of the American Medical Association (JAMA) suggested that men with certain preexisting heart issues may be up to 29 percent more likely to die, suffer a heart attack or stroke while taking some form of testosterone supplements. This is not the first study that has shown evidence linking increased cardiovascular risks and testosterone treatments. In 2009, a study funded by the National Institute of Health examined 200 older men with a high incidence of heart disease. The men who were also receiving testosterone therapy were found to have a significant spike in the rate of heart attacks. Researchers decided to cancel the study early due to these findings. A January 2014 study by PLoS One, a medical journal, found that men over the age of 65 and younger men with pre-existing heart disease might actually face a two-fold increase of risk of heart attacks associated with testosterone treatments. Collectively, these studies prompted the FDA to issue a drug safety communication in March 2015 revealing that new warning labels will be added to low testosterone drugs regarding the possible increased risk of cardiovascular complications. The warnings would also reiterate that the drugs should only be used to treat clinically proven hypogonadism.
Due to the link between higher risk of heart problems with testosterone treatment, many lawsuits have been filed against drug manufacturers for failing to warn customers of the potential heart risks. Most of the lawsuits are against the makers of Androgel, AndroDerm, Axiron and Testim. The lawsuits claim that the makers of these drugs cared more about the profits they made and disregarded the health and safety of their customers. Specifically, allegations claim that the makers failed to sufficiently research the link between increased cardiovascular problems and their drugs, irresponsibly advertised the drugs and encouraged healthy men to take the medications for general symptoms experienced naturally as men age, and failing to warn patients of the already studied link between heart risk and testosterone treatments. Ron Johnson, lead counsel on the testosterone cases, notes that these drugs were advertised for an ailment that is not even recognized by the FDA. It seems to be a combination of drug makers marketing too aggressively and failing to warn consumers, as well as doctors being too eager to write prescriptions when pressured by their patients. Although there are many similar allegations, no settlements have been agreed upon. The testosterone litigation is still in its early stages, but in total there is expected to be several thousand cases filed in state and federal courts across the nation.
If you believe you have a a Low Testosterone claim ans would like to speak to an attorney about your legal remedies, give the drug injury lawyers at Altman and Altman LLP a call for a free case consultation. 617-492-3000.
“9 Warning Signs of Low Testosterone.” Healthline. N.p., n.d. Web. 11 July 2016.
“Androgel Testosterone Settlements.” Saiontz Kirk PA YouHaveALawyercom. N.p., n.d. Web. 12 July 2016.
“Lawyers for Heart Attacks, Strokes, Wrongful Death.” YouHaveALawyer.com. N.p., n.d. Web. 12 July 2016.
Weintraub, Arlene. Forbes. Forbes Magazine, 6 Apr. 2015. Web. 12 July 2016.