Grumpiness, lack of energy and fatigue are often part of the natural process associated with diminished testosterone levels that all men experience with age. These symptoms are also used in marketing literature to sell “Low-T” drugs. Now, new research suggests that thousands of men were sold testosterone prescriptions that were not only unnecessary, but that also put them at risk for a 30% increased risk of heart attack, stroke and even death.

Drug makers, for many years, have aggressively marketed low testosterone treatment/testosterone replacement therapy (TRT) to men, but they failed to mention the risks associated with testosterone side effects. This failure to warn has lead to hundreds of testosterone product lawsuits filed by men who claim they suffered serious health complications caused by Low-T creams, gels, injections and patches. Plaintiff A. Gray is the most recent to file a testosterone lawsuit.

According to Gray’s testosterone lawsuit, he started using the testosterone gel product AndroGel in or around May 2011 to treat a reduced sex drive and low energy. After taking multiple doses, Gray suffered his first stroke in September 2011. He alleges the stroke was caused by testosterone side effects.

However, with no proper warning for him or his doctor of the risk of stroke from testosterone, Gray says he continued his T-Gel treatment. He suffered a second, more serious stroke in March 2013 that put him on life-support for more than three weeks. Before using AndroGel, Gray had no history of cardiac issues. Now, to this day, he still is not fully recovered, his AndroGel lawsuit alleges.

It wasn’t until the spring of 2014 that Gray’s wife allegedly saw a television commercial alerting viewers to the link between testosterone gels and heart attacks or stroke. Prior to this, the Grays had no idea of the risks of testosterone gel. Now the Grays are suing Abbvie and Abbott Labs, makers of Androgel, for producing, selling and marketing an allegedly dangerous product.

The couple is bringing claims are failure to warn, negligence, gross negligence, breach of implied and express warranty, fraud, negligent misrepresentation, intentional and negligent infliction of emotional distress, and loss of consortium.

The testosterone gel lawsuit is Gray v. Abbvie Inc., et al., Case No. 4:14-cv-00511-DPM, in the United States District Court for the Eastern District of Arkansas, Western Division.

Dangers of Testosterone Therapy

Testosterone therapy was originally approved to treat health related testosterone deficiencies, such as hypogonadism, (a condition of the sex glands wherein testosterone production is diminished or ceases). AndroGel 1% is one such treatment, originally approved in February 2000 for use by men who have “conditions associated with a deficiency or absence of endogenous testosterone.” However, today, many testosterone therapy prescriptions are now given for “lifestyle reasons.”

Aggressive marketing has made testosterone replacement therapy a multi-billion industry, and led healthy men to believe that they need these drugs; however, findings show that these men are putting themselves at unnecessary risk.

It’s been alleged that Low-T drugs cause medical problems, including life threatening cardiac events, strokes, and thrombolytic events. Moreover, these gels and creams carry health risks not only for the men using them, but also possibly for women and children who accidentally come into contact with it. Adverse event reports about T-Gels and TRT medications constantly come into being, which led to studies about the safety of the drugs.

TRT medications have been around since 2002, but for many of those years without warnings. The FDA issued black box warning for testosterone prescriptions didn’t happen until 2009. Already seven years out in the market, no one really took notice until two studies were published in 2013 and 2014.

The first study, published in November 2013 Journal of the American Medical Association (JAMA), proposed that side effects of low T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart conditions. It also pointed out that one quarter of men did not even have their testosterone levels tested before receiving a testosterone prescription.

The second study, reported in PLOSOne in January 2014, showed Low-T treatments could double the risk of heart attack in two groups of men: those over the age of 65 and younger men with heart disease.

The FDA, in response to the research, opened a testosterone therapy safety review on Jan. 31, 2014. Picked up by the press, the review brought public awareness of the risks of testosterone replacement therapies. This led to a jump in the number of testosterone gel lawsuits being filed, and more studies being undertaken. Most recently, the medical journal Urology published a study in February 2014 showcasing inconsistencies and inaccuracy with blood test screens for Low-T.