Last week the U.S. Food and Drug Administration (FDA) voted to place new limitations on the testosterone drug industry, calling for stronger labels for men who primarily take the hormone known as Low-T for increased energy and libido. Although the FDA is not required to follow this panel’s report, it most probably will in light of the increased number of lawsuits against manufacturers of testosterone products. The FDA may not want to act on this, but will find itself on the wrong side of history if they continue to do nothing.
Testosterone is a male hormone that helps with bone density, sex drive, muscle mass and strength, fat distribution, production of red blood cells, and sperm production. It appeals to men looking to be a little better, a little younger, and in helping to slow down the aging process. Doctors can prescribe a form of testosterone therapy treatment in the form of a gel, patch, injection or pellet.
There are many lawsuits being filed against manufacturers of these testosterone products, alleging that in recent years studies have linked testosterone therapies to serious cardiac issues, such as heart attack or stroke.
As we have previously posted on our blog, a study in PLOS One found that men aged 65 and older had double the risk of suffering a heart attack after filling a prescription for testosterone therapy treatment. Younger men involved in the study had three times the risk of suffering a heart attack if they had a family history of heart disease.
The results of these studies prompted an announcement by the FDA on January 31, 2014 that they would investigate the risk of heart attack, stroke and death among men taking the FDA-approved testosterone therapy treatments. Why has so much time elapsed since the FDA announced they were ‘investigating the risk of heart attack and death in men taking FDA-approved testosterone products?”
Plaintiffs assert that if the manufacturers properly disclosed the risks associated with the testosterone treatments, they would not have used the drug at all, severely limited the dose and length of use or would have closely monitored the degree to which the drugs were adversely affecting their health. The lawsuits include causes of action for strict product liability, negligence, breach of implied and express warranties, fraud, and negligent misrepresentation and seek punitive damages against manufacturers. Lawsuits in the Low T cases filed in federal court have been consolidated before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.
If you or a loved one has been injured as a result of taking a Low-T product, you should contact an experienced attorney before your rights expire. For a free consultation, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) to discuss your options.