Although testosterone can be found in both men and women, its primary importance is as the key male sex hormone. In addition, testosterone is critical for regulating how the body produces red blood cells, develops muscle mass, and stores fat.
Testosterone can affect libido, energy level, mood, and weight maintenance. Testosterone naturally decreases with age, but even at younger ages, it can drop to low levels even in younger ages. This problem can lead to certain medical conditions, including infertility and hypogonadism (improper production of sex hormones).
There are significant problems that can develop if you have low testosterone. These include:
- Erectile dysfunction
- Lowered lean muscle mass
- Insomnia
- Low sex drive
- Hair loss
- Depression
- Fatigue
- Obesity
- Infertility
If you develop a serious medical condition due to low testosterone, your doctor may prescribe testosterone replacement therapy (TRT) (otherwise known as hormone replacement therapy) using artificial testosterone. The testosterone can be delivered orally, superficially (gels or patches), through the buccal system (applied to your upper gum or inner cheek), or through injections.
Testosterone products are considered a controlled substance and are, therefore, strictly regulated by state and federal laws. The U.S. Food and Drug Administration (FDA) has issued limited approval for using testosterone products by men with low-T, which certain medical conditions have caused.
How Safe is Testosterone Replacement Therapy?
There is no guarantee that any drug is safe, even if it has been rigorously researched and studied by its manufacturer and approved for use by the FDA.
Testosterone replacement therapy (TRT) does have side effects so a patient, in consultation with the treating doctor, should balance whether the benefits outweigh the potential for developing these side effects.
Some of the side effects complained about include:
- Acne
- Breast enlargement or pain
- Changes in the voice, including hoarseness or deepening
- Possible increased risk of heart attacks
- Mood swings
- Fatigue
- Difficulty with sleeping
- Blood clots
- Prostate cancer
- Stroke
- Death
What are the Responsibilities of Testosterone Manufacturers?
The FDA requires all drug manufacturers to place highly visible strict warning labeling on the outside of drug packages. They should indicate their approved medical applicabilities and caution users about potential side effects. These warnings are also intended to address the potential for abuse and dependency.
As an FDA schedule III drug (schedule III drugs are defined as drugs with a moderate to low potential for physical and psychological dependence), testosterone products should include labels that warn consumers and prescribers about possible association with increased risk of heart attacks and mental health problems in patients, such as hostility, depression, aggression, and other conditions.
Some of these labeling requirements arise out of a concern for secondary exposure (particularly in children) and the use of testosterone for non-medical related conditions, such as fatigue and lowered libido that are a natural part of growing older.
What are Some Examples Of Claims for Injuries Related to Testosterone Products?
There are reported medical risks associated with testosterone products, some of which are discussed above. An individual may be properly prescribed a testosterone product by a qualified medical professional and still develop some adverse reactions.
If you are injured while using a testosterone product, such as part of a TRT, you may allege various legal theories, including medical malpractice. A claim for medical malpractice may be filed against hospitals and medical personnel, such as doctors and nurses, for misdiagnosing the medical condition that caused you to be prescribed TRT in the first place or for failing to test for a medical condition before prescribing TRT. Additionally, you may assert that your doctor failed to adequately inform you of all the risks associated with the TRT.
You may also have a cause of action for product liability or strict liability relating to the manufacturers’ or distributors’ failure to provide adequate warning labels identifying the associated health risks, for asserting a medical use that was not approved, for utilizing misleading marketing, or for failing to include proper instructions for safe use.
Are there Lawsuits Against the Makers Of Testosterone Products?
Recent years have seen a significant increase in marketing by manufacturers touting the benefits of testosterone products for unapproved medical or off-label uses (age-related complaints, for example) or which exaggerate the positive effects of these products.
Testosterone lawsuits claim testosterone replacement drug manufacturers failed to warn of serious side effects. For example, in 2017, manufacturer Abbvie was ordered to pay $150 million in punitive damages. It also allegedly settled 4,200 AndroGel lawsuits in September 2018 but did not disclose the settlement amount.
Lawsuits filed in federal court have all made the same allegation: Manufacturers of testosterone products have put healthy men in danger by marketing the hormone to treat sexual dysfunction, age-related fatigue, and other symptoms beyond the use approved by the U.S. Food & Drug Administration. The FDA approved these drugs only for use in treating the medical condition known as hypogonadism, but manufacturers widely marketed the products for off-label use for a condition they allegedly invented and called “Low-T.”
These lawsuits accused manufacturers of marketing the products as safe and effective for this off-label use when, in fact, the products reportedly provide little or no benefit for men who do not have hypogonadism and can cause cardiovascular issues and even death. According to the litigation, ads for testosterone replacement products suggest decreased energy levels are caused by ‘Low-T” rather than by normal aging and other factors. Direct-to-consumer marketing quizzes set men up to believe that natural signs of aging instead point to testosterone deficiency and encourage them to seek replacement therapy with significant undisclosed risks.
Manufacturers face severe criticism for these and other marketing tactics. They created a $1.6 billion market for testosterone replacement drugs, and critics say they haven’t done nearly enough to inform consumers and doctors about potential risks.
Over 25,000 lawsuits have been filed against AbbVie Inc., Eli Lilly & Co., Pfizer Inc., Endo International, and other manufacturers. Cases involved popular products such as AndroGel and Depo-Testosterone. They claim men who used the drugs experienced side effects such as heart attacks, strokes, or blood clots called pulmonary embolism and deep vein thrombosis. Most of the injuries, except for death, had to occur within 90 days of using the product for a person to be able to sue. All indications suggest these lawsuits will continue against these and other manufacturers.
Many of the lawsuits were filed in state courts, then consolidated into class action suits (where a group of people who have suffered similar injuries takes on a large corporate defendant essentially as a single mass) and transferred to federal courts.
Should I Seek Legal Help If I Was Injured by Testosterone Therapy?
If you have been injured as a result of testosterone hormone therapy or taking a testosterone product, you may wish to consult a class action attorney to protect your rights (the type of lawyer depends on what went wrong and who was at fault). You may be able to pursue a claim on your behalf, or your loved ones may be able to pursue a claim because of your injuries.
