AndroGel Lawsuit – Heart Attack & Stroke Risks

AndroGel is a type of testosterone replacement medication which may increase the risk for life-threatening side effects including heart attack, stroke, pulmonary embolism and clotting disorders. Drug maker AbbVie is facing thousands of AndroGel lawsuits filed by men or loved ones of those who took AndroGel and were exposed to additional risk due to aggressive marketing.

Testosterone Replacement Therapy (TRT) using testosterone gel.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.  

Increased risk of AndroGel may include:

  • Stroke
  • Heart attack
  • Blood clots
  • Pulmonary embolism
  • Deep vein thrombosis
  • Venous thromboembolism
  • Death

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.  

Many AndroGel lawsuits have been filed by men who were unaware of the serious consequences of choosing this method of low testosterone treatment.

FDA Investigations

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.

AndroGel Settlements

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 company counted one win when 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.  In this case, the jury decided that the death could have been a result of other medical conditions but two previous cases had been decided against AbbVie and resulted in awards of a total of $290 million for two plaintiffs who suffered heart attacks while using AndroGel.

Based on mixed results of AndroGel trials and similar trials of other testosterone replacement drugs, in September 2018, AbbVie announced they planned to settle thousands of AndroGel lawsuits for an undisclosed amount.  This move will set aside future trial dates which had been scheduled in federal court. Other manufacturers may also be close to offering settlements for similar testosterone treatment lawsuits but more may be expected.

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.