Last month, a Georgia testosterone therapy lawsuit was filed against synthetic hormone manufacturers Prostrakan Group PLC and Endo Pharmaceuticals. The plaintiff alleges he suffered a sudden myocardial infarction (heart attack) after using a testosterone booster topical gel solution called Fortesta.
On January 31, 2014, the U.S. Food and Drug Administration (FDA) announced its launch of a new investigation into the potential health risks posed by testosterone therapy products. Current FDA regulations required manufacturers to affix package label warnings about possible red blood cell count elevation and venous blood clot formation.
The FDA also recently implemented new regulations that mandate package label warnings to advise patients and healthcare practitioners of the potential health hazards that may result from using synthetic hormonal replacements such as Androgel, Testim and the Fortesta gel at issue in the pending Georgia testosterone therapy lawsuit. The recently revised FDA rules expand those requirements to include explicit language that conveys the risk of venous blood clots developing in users with normal red blood cell counts. That decision was reportedly prompted by the release of two clinical study findings that showed male patients who use such drugs have up to three times the incidence of developing cardiovascular problems.
Marketing Deception Alleged in Georgia Testosterone Therapy Lawsuit
A major point of contention in the Georgia testosterone therapy lawsuit is false advertising. More specifically, the plaintiff claims that Fortesta ads deliberately mislead men who suffer from chronic fatigue, obesity and mood swings into consulting a physician about testosterone replacement, when these conditions could be for any number of other reasons including age or stress.
The official Fortesta website displays the prominent slogan “A small amount of gel applied each day may be all that’s needed to help raise your T.” Other featured content reportedly implies that Fortesta is appropriate for many lifestyle and age-related health problems and that healthcare providers always test patients before prescribing the drug. Recently published research results have revealed that doctors frequently fail to conduct such tests to confirm “medical necessity” for testosterone replacement therapy, however.
Injured? Seek Help Today
According to widely publicized statistics, millions of male patients all over the world have made testosterone supplements a multi-billion-dollar product. For instance, about 3 million AndroGel prescriptions were written during 2012 alone. Gross aggregate sales volume for all testosterone boosters like Axiron, Textim, AndroGel, Fortesta and others was more than $2 billion that same year.
If you or someone you love has taken a prescribed testosterone therapy like Fortesta or Androgel, consider contacting the Georgia Injury Attorney Group. We are here to help you understand your options if you have been injured. We can also help you determine if you have a case, and connect you with an affiliated lawyer, all at no cost to you. Contact us today to learn more.