Lawsuit Over AndroGel Blood Clots Filed Against AbbVie

A North Carolina man and his wife have filed a product liability lawsuit against the makers of AndroGel, alleging that side effects of the testosterone gel caused him to suffer a pulmonary embolism, deep vein thrombosis (DVT) and other blood clot injuries.  

The complaint (PDF) was filed against AbbVie in the U.S. District Court for the Northern District of Illinois on February 10, by Roger Gibby and his wife, Angela.

According to allegations raised in the AndroGel lawsuit, Gibby suffered blood clots in his lungs and legs in September, after receiving a prescription for the testosterone gel as a result of symptoms he attributed to low testosterone. Gibby indicates that he began using AndroGel after viewing AbbVie advertisements that encourage older men to use the testosterone replacement therapy if they are experiencing decreased sex drive, weight gain, depression or lack of energy.

The case joins a growing number of testosterone treatment lawsuits filed in recent weeks by men who allege AndroGel, Axiron, Testim and other similar products caused them to suffer a heart attack, stroke or sudden death.

Last month, the FDA launched an investigation into the potential testosterone therapy heart risks after two studies indicated that users may face an increased risk of cardiovascular events.

“AndroGel causes the hematocrit level to increase, thereby thickening the blood,” according to allegations raised in Gibby’s lawsuit over AndroGel. “This effect, if not monitored and controlled properly, can lead to life threatening cardiac events, strokes and thrombolytic events (including pulmonary embolism, deep vein thrombosis and other blood clots).”

The complaint accuses AbbVie of failing to adequately warn about the risk of AndroGel problems, as well as presenting claims for negligence, breach of warranty, fraud, misrepresentation, and loss of consortium on behalf of his wife. The couple seek both compensatory damages and punitive damages.

Testosterone Therapy Heart Problems

AndroGel is a prescription topical gel applied to the upper arms as a testosterone replacement therapy, which is designed for men suffering from testosterone deficiency caused by medical conditions such as hypogonadism. The testosterone treatment is the most widely used replacement therapy, with various other products sold as gels, patches, injections, implants and pills.

Amid aggressive direct-to-consumers advertisements, sales of AndroGel and other testosterone drugs has increased dramatically in recent years. Many critics have suggested that the market for these drugs was created by television advertisements that encourage men to seek prescription treatments for “low T” if they are suffering any number of common symptoms experienced by all men as they age. As a result, several studies have suggested that many men receiving AndroGel and other testosterone treatments have no real medical need for the drugs.

The first concerns about the potential health risks with testosterone treatments came in November 2013, when a study published in the Journal of the American Medical Association found that side effects of testosterone treatments were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by another study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.