AndroGel Stroke Lawsuit Filed Over Testosterone Gel Side Effects

A New York man has joined the growing number of men throughout the United States who are pursuing a product liability lawsuit against AbbVie, Inc. over AndroGel, alleging that side effects of the testosterone gel caused him to suffer a stroke that has permanently changed his way of life.  

The complaint (PDF) was filed by Gary White on March 10, in the U.S. District Court for the Northern District of Illinois. White indicates that he used AndroGel testosterone for only about five months before a suffered a cerebrovascular accident in May 2011, more commonly known as a stroke.

White was 56 when he was first prescribed AndroGel, indicating that he had no history of heart disease and was in good health, leading an active lifestyle. According to allegations raised in the lawsuit, as a result of the AndroGel stroke, White now must undergo regular monitoring, alter his diet and take medications to prevent further injury.

The case joins a growing number of AndroGel lawsuits and other testosterone treatment lawsuits being pursued by men who allege the popular drugs increase the risk of strokes, heart attacks, blood clots and sudden death.

All of the complaints raise similar allegations that the drug makers failed to adequately research the medications or warn about the cardiac risks with testosterone replacement therapy (TRT). Plaintiffs claim that AbbVie and manufacturers of other testosterone gels, patches and injections promoted the products in a way that encouraged use of the drugs among men who had no medical need for the treatments.

Suggesting that men should seek treatment for “Low T” if they experience general symptoms like fatigue or decreased libido as they age, critics have suggested that the drug makers were “disease mongering,” creating a market for the medications that has extended well beyond the approved use to treat testosterone deficiencies caused by medical conditions, such as hypogonadism.

“The marketing program sought to create the image and belief by consumers and physicians that low testosterone affected a large number of men in the United States and that the use of AndroGel is safe for human use,” the lawsuit filed by White states, “even though Defendants knew these to be false, and even though Defendants had no reasonable grounds to believe them to be true.”

White accuses AbbVie of failure to warn, negligence, breach of warranty, fraud, and negligent misrepresentation, seeking both compensatory and punitive damages.

Testosterone Side Effects

This lawsuit comes amid increasing concerns about the link between testosterone therapy and heart problems.

In November 2013, a study published in the Journal of the American Medical Association found that side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by another study released in late January by the medical journal PLOSOne, 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. The FDA investigation was announced just days later.

In response to the findings, the FDA launched a safety review of AndroGel and other testosterone replacement therapy on January 31. The consumer watchdog group Public Citizen has filed a petition with the FDA, urging the agency to add a black box warning to all testosterone drugs warning men about the potential risk of stroke and heart attacks.