Testosterone Lawsuit

Testosterone treatment manufacturers have been accused of inappropriately and aggressively marketing Low-T testosterone therapy which may have caused serious injury in some men. Thousands of testosterone lawsuits have been filed against multiple drug manufacturers due to risk of heart attack, stroke, blood clots and other life-threatening side effects.

Quick Summary
Testosterone Lawsuits

Many men who took testosterone for Low-T were never tested to find out if they actually had lower than normal hormone levels or were simply experiencing normal signs of aging. Despite not having an official medical condition, men were prescribed testosterone drugs and may have suffered severe complications as a result.

Many are taking legal action against the makers of these testosterone products and have filed testosterone lawsuits. Manufacturers of Androgel, Androderm, Testim, Testopel, Axiron and other testosterone products have faced more than 25,000 testosterone lawsuits.

Testosterone Complications

Research has shown risks related to testosterone therapy and other “low T” treatments are common and include:

  • Blood Clots
  • Myocardial infarction (MI) or heart attack
  • Cerebrovascular accident (CVA) or stroke
  • Pulmonary embolism (PE)
  • Deep vein thrombosis (DVT)
  • Venous thromboembolism (VTE)
  • Death

Lawsuits for these complications are still being filed and some companies are in the process of settling thousands of testosterone lawsuits including Endo Pharmaceuticals, Allergan, Eli Lilly, and AbbVie.

Testosterone replacement medications are generally approved to treat low testosterone levels caused by hypogonadism, where testosterone is not secreted in normal amounts. However, the drug industry cleverly and aggressively marketed testosterone therapy to men for symptoms of “Low-T”. Low-T is not a diagnosis but is a marketing term, coined to describe symptoms such as fatigue, low sex drive, and loss of muscle tone. Many of these men may have suffered severe complications as a result of testosterone replacement therapy.

More than 25,000 lawsuits have been filed against manufacturers of testosterone products due to side effects which were life-threatening or fatal. Testosterone products and their manufacturers which may be facing lawsuits include:

  • AndroGel – Produced by AbbVie
  • Androderm – Produced by Actavis, Inc. (formerly Watson Pharmaceuticals), division of Allergan
  • Axiron – Produced by Eli Lilly and Company
  • Testim and Testopel – Produced by Auxillium/Endo Pharmaceuticals with GlaxoSmithKline
  • Bio-T-Gel – Produced by Teva Pharmaceuticals
  • Depo-Testosterone – Produced by Pharmacia & Upjohn Company, later Pfizer
  • Fortesta – Produced by Auxillium/Endo Pharmaceuticals, Inc.
  • Striant – Produced by Columbia Laboratories and later Auxillium/Endo Pharmaceuticals

FDA Issues Safety Announcement Regarding Testosterone Therapy

Issues with testosterone therapy were identified when publication of two studies in PLOS ONE and the Journal of the American Medical Association (JAMA) revealed a potential link between testosterone therapy and an increased risk for heart health problems. Following the publication, the Food and Drug Administration issued a safety warning in 2014 regarding use of these drugs, and announced it plans to investigate claims of increased risk which showed a two to three-fold risk of cardiovascular events.

In mid-2014, the FDA issued a second safety alert regarding an increased risk of blood clotting events such as deep vein thrombosis and venous thromboembolism which can cause fatal events including heart attack, stroke, and pulmonary embolism. The announcement included the requirement of changes to labeling of testosterone products to warn prescribers of blood clotting risks. In mid-2015, the agency again required additional warning information be added, this time regarding the risk of heart attack and other cardiovascular events.

Testosterone Marketing

Much of the concern over testosterone therapy is because of the rate at which the drugs had been prescribed and lack of medical need. Data suggests that nearly 43 percent of men who were given testosterone prescriptions actually had normal levels of testosterone based on their age and many men were never tested for low hormone levels.

Men experience a natural decline in testosterone levels as they age, contributing to loss of sex drive, decreased muscle tone and lack of energy. Drug companies that make testosterone supplements have been accused of preying on these men and going as far as to create a condition – low T – to convince them they need medication. This marketing tactic may have exposed men to unnecessary risks – some of which were debilitating or even fatal.

Side Effects of Testosterone Therapy

Though many of the side effects linked to testosterone therapy are mild, some are severe and can be deadly. There is also evidence testosterone therapy can worsen pre-existing conditions. Use of testosterone has been linked to:

  • Blood clots, including deep vein thrombosis and pulmonary embolism
  • Congestive heart failure
  • Heart disease
  • Heart attack
  • Stroke
  • Death

Testosterone Therapy Lawsuits

Thousands of lawsuits have been filed against testosterone manufacturers for injuries caused by their products. These lawsuits have accused the companies of:

  • Misleading marketing tactics
  • Understating risks
  • Failure to warn of risks

Federal testosterone lawsuits have been consolidated into multidistrict litigation (MDL 2545) in the Northern District of Illinois. It is a highly complex litigation case involving a number of companies and products. A few of the cases, known as “bellwether” cases have already gone to trial, prompting some companies to offer settlements for testosterone cases against their products.

Though some cases have been dismissed and all of the manufacturers have denied fault, some companies may be in the process of settling many of their lawsuits for testosterone products. Notable testosterone settlements that have been offered or are under consideration include:

  • AndroGel – Produced by AbbVie
  • Androderm – Produced by Actavis, Inc. (formerly Watson Pharmaceuticals), a division of Allergan
  • Axiron – Produced by Eli Lilly and Company
  • Testim and Testopel – Produced by Auxillium/Endo Pharmaceuticals in cooperation with GlaxoSmithKline

Though no amounts for settlement offers have been disclosed, past medical injury cases have reached into the $ thousands or even $ millions. Each case is unique and must be considered separately, but men or loved ones of those who used testosterone therapy and experienced serious effects such as heart attack, stroke, or pulmonary embolism may have a right to compensation and should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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