AndroGel is a topical gel containing testosterone which is approved to treat low testosterone levels caused by hypogonadism. AndroGel, along with other forms of testosterone replacement therapy, was heavily marketed for “Low-T”, a non-medical condition which had symptoms that may have been attributed to normal aging. Many men who used AndroGel for Low-T were never tested for low testosterone and may have been placed at unnecessary risk for serious complications such as:
Axiron may have increased the risk for:
- Heart attack
- Blood clots
- Pulmonary embolism
AndroGel’s manufacturer, AbbVie, has faced thousands of AndroGel lawsuits filed by men or loved ones of those who suffered serious side effects after using the medication.
Men who suffered serious side effects or family members of those who died after using testosterone replacement medications like AndroGel, have filed thousands of lawsuits against AbbVie and other manufacturers. AndroGel lawsuits were part of large multidistrict litigation (MDL) case and in September of 2018, after losing two bellwether liability lawsuits resulting in a $150 million and separate $140 million judgement, AbbVie agreed to settle about 4,200 AndroGel lawsuits for undisclosed amounts.
Though most of the near 25,000 testosterone replacement lawsuits have been settled, some may still remain in court systems.
AndroGel, manufactured by AbbVie, is the most common of the many prescription products developed for use as daily testosterone replacement therapy. It is also involved in a number of testosterone therapy lawsuits filed by AndroGel users who claim their injuries were caused by the drug.
AndroGel users and their loved ones allege that the drug manufacturer, AbbVie did not adequately warn of the possible side effects of its use. AndroGel is approved to treat low testosterone levels that are caused by a medical condition known as hypogonadism. It is not approved to treat symptoms of testosterone decline that are related to normal aging.
Like other testosterone replacement products, AndroGel was marketed with great focus on benefits for relief of symptoms of “Low-T”. Low-T is not an actual medical diagnosis but is a marketing term which was used to encourage men to take testosterone. In fact, only two percent of men undergoing testosterone therapy suffer from insufficient levels of this hormone and most men were never tested for low testosterone levels.
Increased risk of AndroGel may include:
- Heart attack
- Blood clots
- Pulmonary embolism
- Deep vein thrombosis
- Venous thromboembolism
Many AndroGel lawsuits have been filed by men who were unaware of the serious consequences of choosing this method of low testosterone treatment.
AndroGel FDA Warnings
In January 2014, the U.S. Food and Drug Administration announced its investigation of AndroGel and other testosterone treatments for men both under and over the age of 65. The investigation was prompted by the results of two large studies which showed that the heart attack risk may be two to three times higher when using testosterone and that the risk was highest in the months just after starting the medication.
In July of 2014, the FDA issued a separate warning statement about increased risk of deep vein thrombosis and venous thromboembolism which may be caused by testosterone-related changes to blood clotting mechanisms. The FDA required at this time that the warning be included in prescribing information for AndroGel and other testosterone medications. In 2015, the agency completed their heart attack investigation and required that labeling also include warnings about heart attack, stroke and other cardiovascular events which may cause death.
Shortly after the FDA’s first announcement, men began filing AndroGel lawsuits for heart attack, stroke, and other life-threatening complications of testosterone treatment. Thousands of men followed suit and AbbVie has faced over 4,200 AndroGel lawsuits in federal court, along with others in state and local courts.
The first case to go to trial was decided in favor of AbbVie, against the plaintiff who had claimed that AndroGel caused a man’s pulmonary embolism but the jury decided that the death could have been a result of other medical condition. Other early cases were decided against AbbVie and resulted in awards of a total of $290 million for two plaintiffs who suffered heart attacks while using AndroGel. Out of six early AndroGel lawsuits, AbbVie lost four of those cases.
Based on mixed results of AndroGel trials and similar trials of other testosterone replacement drugs, in September 2018, AbbVie announced plans to settle thousands of AndroGel lawsuits for undisclosed amounts. In the same time period, other manufacturers also settled thousands of testosterone lawsuits.
Though most AndroGel lawsuits have been settled, men or loved ones of those who suffered a heart attack, stroke, pulmonary embolism, or other debilitating event while using AndroGel, should seek legal advice. Past lawsuits have provided compensation for medical costs, lost wages, pain and suffering and in some cases, punitive damages against companies who knew of the dangers of a treatment but continued to market a product without adequate warnings.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.