First Testosterone Gel Trial to Begin in June

May 31st, 2017

The first of seven multidistrict litigation (MDL) trials involving testosterone therapy gel products begins on June 5, 2017 in the U.S District Court for the Northern District of Illinois.  About 7,000 individual cases have been filed in this MDL. The Plaintiffs allege that over a dozen pharmaceutical companies unethically and aggressively marketed testosterone replacement therapy drugs to treat symptoms of normal male aging. AbbVie Inc. and Abbott Laboratories face most of the claims in the upcoming trials, primarily involving the popular product AndroGel. The pharmaceutical company faces accusations of creating and marketing a condition known as “Low T” to create a need for treatment using AndroGel.  This was done, however, without regard for the known dangers of the product.

The U.S. Food and Drug Administration (FDA) approves testosterone therapy products to treat a medical condition known as hypogonadism, which is the inability of the human body to produce sufficient amounts of testosterone. Diagnosis of this disease requires a blood test and is rare. AbbVie, however, used a marketing campaign that focused on using AndroGel to combat low energy levels, weight gain, and low libido, symptoms that frequently occur in men as they age, unrelated to hypogonadism. The FDA rejected the company’s repeated requests for approval to recommend use of the product for age-related dips in testosterone. As an end run around the FDA, AbbVie provided patients with self-diagnostic tests that relied on answers to simple questions, instead of the comprehensive blood work required to accurately prescribe testosterone gel as a treatment for hypogonadism.

Not only did AbbVie deceive thousands of men into thinking that they had a treatable condition that required the use of their drug, they also failed to adequately warn medical professionals and consumers about the dangers of using AndroGel. In 2014, the National Institute of Health (NIH) completed a study on the records of 55,000 men who had used testosterone therapy. The study showed that the use of testosterone therapy to treat “Low T” in men over the age of 65 doubled the relative risk of heart attack, and more than doubled the risk of heart attack and stroke in men under 65 with a history of heart disease. Other risks associated with use of the product included blood clots, prostate cancer, reduced sperm count, gynecomastia, edema, and high cholesterol. Plaintiffs claim that they were not adequately warned of these dangerous side effects.

The plaintiff in the first MDL trial alleges that he suffered a heart attack just two months after he began his AndroGel treatment. The trial, which begins in just 10 days, is forecasted to last about three weeks and will be followed by six other trials in the coming months. Our experienced lawyers fight for individuals who have been harmed by defective products. If you or a loved one has suffered a heart attack, blood clot, or stroke after testosterone therapy, the attorneys at the Yost Legal Group will investigate your claim. For a free consultation, please call us at 1-800-YOSTLAW. At The Yost Legal Group, there is no fee or expense unless you recover.