Low testosterone is a condition that affects portions of the male population. The condition has to do with low counts of the hormone testosterone and is linked mainly with men. Low testosterone is linked with various other medical issues, including:
- Low energy levels
- Hair loss
- Weight gain
- Decrease in sexual activity
- Various other symptoms
On account of these connections, many different products and methods are attempting to increase testosterone levels, especially in males. In many cases, low testosterone drugs are prescribed or suggested to persons seeking to improve their testosterone levels.
How Are Low Testosterone Drugs Administered? Are There Any Health Concerns?
Testosterone drugs don’t work by directly administering testosterone to the patient. Instead, these drugs usually involve effects on the precursors that produce and process testosterone in the human body (such as Andostenedione). These types of drugs are often administered through methods like:
- Topical testosterone creams or gel (such as Androgel)
Drugs that affect or enhance testosterone production can also lead to side effects. These can include high blood pressure, various heart issues, nausea, vomiting, headache, and other symptoms.
Are There Any Legal Concerns?
Testosterone lawsuits claim that testosterone replacement drug manufacturers failed to warn of serious side effects. Many lawsuits named Abbvie’s testosterone drug called Androgel. In 2017, Abbvie was ordered to pay $150 million in punitive damages. The company settled 4,200 Androgel lawsuits the next year, but the settlement amounts were not disclosed.
At the height of testosterone litigation, more than 25,000 lawsuits had been filed against Abbvie, Eli Lilly & Co., Pfizer, Endo International, and other manufacturers. The cases typically involved products like Androgel and Depo-Testosterone.
Men’s testosterone lawsuits typically claim that they experienced side effects such as heart attacks, strokes, blood clots, pulmonary embolism, and deep vein thrombosis after using the drugs. Most injuries occurred within 90 days of using the product.
Because of the large numbers of manufacturers and cases, the U.S. Judicial Panel on Multidistrict Litigation created a testosterone multidistrict litigation.
In addition to the health risks associated with testosterone drugs, there are also different types of legal issues that can arise. For instance, injuries sustained from low testosterone can result in lawsuits involving:
Legal remedies can consist of a damage award that reimburses the victim for their injuries and other expenses.
What Are Common Injuries and Side Effects of Testosterone Therapy?
Studies have linked testosterone replacement products to increased risks of cardiovascular events in men. Studies show that men over the age of 65 who use prescription testosterone therapy products have twice the risk of a heart attack within the first three months of taking the products.
Studies also show that senior males who use testosterone replacement products are 30% more likely to suffer from a heart attack, stroke, or death when compared to other senior males who do not use the drugs.
Serious side effects associated with testosterone replacement products include:
- Increased risk of prostate cancer
- Worsening symptoms of an enlarged prostate
- Lower sperm count
- Enlarged and painful breasts
- Difficulty breathing during sleep
- Increased risk of deep vein thrombosis (blood clots in a deep vein) in the legs
Have Any Testosterone Replacement Products Been Recalled?
Although recalls for testosterone replacement products are not common, the FDA has issued a safety announcement warning the public that testosterone therapy products are not approved for treating low testosterone as a result of aging. The FDA also requires that manufacturers of low testosterone products warn about the increased risk of heart attacks and stroke.
The FDA stated the following as part of its mandate: “The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”
Why Are Testosterone Replacement Therapy Products Used?
Testosterone therapy drugs are approved to treat hypogonadism, a condition occurring in men where the sex organs produce little or no testosterone. Natural testosterone production plays a significant role in male characteristics such as mood and sex drive. Men who experience low testosterone man experience fatigue, low libido, and depression.
As men age, dips in testosterone levels are a natural part of the aging process. Testosterone therapy drugs were not approved to treat natural aging processes. Men experience a gradual decrease in testosterone levels starting around age 30. By age 45, nearly 40% of all men have lost some of their testosterone.
What Are Common Accusations Against Manufacturers?
Lawsuits for low testosterone drugs filed in federal court typically have the same allegation. The lawsuits usually claim that manufacturers of low testosterone products put healthy men in danger by marketing the hormone to treat sexual dysfunction, age-related fatigue, and other symptoms that go beyond the use approved by the U.S. Food & Drug Administration.
The FDA has approved low testosterone drugs for use in treating a medical condition called hypogonadism. Still, drugmakers often market the products for off-label use for a condition they call low testosterone.
Lawsuits have accused makers of testosterone products of marketing the products as safe and effective for off-label use. In fact, the products reportedly provide little or no benefit for men without hypogonadism. The lawsuits also claim the drugs can cause cardiovascular issues and death.
How is Low Testosterone Marketed?
According to several lawsuits, testosterone ads suggest decreased energy levels are caused by low testosterone rather than aging or any other contributing factors. Websites and television ads show middle-aged men longing to rejoin sporting activities and asking men if they’ve lost their sense of energy. Direct-to-consumer marketing quizzes often set men up to believe that natural signs of aging point to a testosterone deficiency and encourage them to seek testosterone replacement therapy.
Testosterone product manufacturers face criticism for these tactics and for creating a $1.6 billion market for replacement drugs. Lawsuits claim that testosterone product manufacturers haven’t done enough to inform consumers and doctors about potential risks and side effects. The lawsuits also claim that misleading marketing tactics unnecessarily expose people to the serious side effects of hormone treatments despite multiple warnings from the FDA regarding risks to men, women, and children.
Do I Need a Lawyer for Help with Low Testosterone Drug Lawsuits?
Injuries and other losses can result from low testosterone treatments. You may wish to hire a personal injury attorney to file a lawsuit involving testosterone drug treatments. Your attorney can help you file your claim and represent you in court if you need to file for damages.