A Ray City, Ga. couple is suing drug makers Eli Lilly, Pfizer and Pharmacia & Upjohn Co. alleging that their testosterone replacement therapy drugs caused the husband to suffer multiple strokes.

Plaintiff Kenneth D. began taking Eli Lilly’s Axiron – a testosterone gel applied to the underarms — in September 2011. Two months later he suffered a stroke, according to the testosterone product lawsuit.

In December 2012, Kenneth started on Depo-Testosterone, which is injected into the buttock muscle. On Feb. 28, 2013, he suffered another stroke. He had a third stroke on Aug. 31, 2014.

His testosterone product lawsuit states that Kenneth’s injuries were the direct result of his use of testosterone products and further alleges that had he and physicians known the true risks associated with the use of testosterone products, including Axiron and Depo-Testosterone, Kenneth would not have used them or he would have known to get adequate monitoring for their side effects.

What is Testosterone Replacement Therapy?

Testosterone is a primary hormone responsible for the normal growth and development of the male sex organs, and maintenance of secondary sex characteristics. The hormone plays a role in sperm production, fat distribution, maintenance of muscle strength and mass, and sex drive.

Testosterone levels naturally begin declining in men after age 30 and can fluctuate based on a number of factors including sleep, time of day and medications ingested. The normal decline in testosterone, also known as low-t, does not constitute a medical condition.

Using testosterone replacement therapy drugs for low testosterone or low-t, has become wildly popular in recent years. Drug companies have engaged in direct to consumer marketing of their low-t products for the treatment of erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

Those general symptoms are often a result of aging, weight gain, or lifestyle, rather than conditions associated with hypogonadism, a medical term for diminished function of the gonads.

Each year, U.S. doctors write 5.3 million prescriptions for low-t treatments. In addition to injections, testosterone replacement therapy drugs like Axiron, Androgel and Testim, come in gels, creams, patches and pills.

Testosterone Product Lawsuits

Kenneth, along with hundreds of other men, have filed testosterone product lawsuits which similarly allege that low-t drugs cause heart attacks, strokes, deep vein thrombosis (blood clots deep in the body), pulmonary embolism (when pulmonary arteries in the lungs become blocked), or other severe testosterone side effects that were not disclosed on testosterone product labels and warnings.

Plaintiffs accuse drug manufacturers of misrepresenting that low-t replacement therapy drugs are safe and effective when they cause serious medical problems, including life threatening cardiac events, strokes, and thromboembolic events. They also allege that the marketing campaigns are designed to convince men that they suffer from low-t, when the decline in testosterone is a natural result of aging.

More than 200 testosterone product lawsuits have been consolidated into a low-t drug MDL or multidistrict litigation.

Kenneth’s testosterone product lawsuit states that Axiron and Depo-Testosterone can “cause an increase in hematocrit and estradiol in adult males, resulting in thickened blood, the development of blood clots, and heart damage.” These effects, if not monitored and controlled properly, can lead to life threatening cardiac events, strokes and thromboembolic events, including but not limited to deep vein thrombosis, pulmonary embolism, transient ischemic attacks, ischemic stroke, and numerous types of cardiovascular injuries.

The Testosterone Product Lawsuit is Case No. 1:15-cv-01668, U.S. District Court for the Northern District of Illinois, Eastern Division.