Although testosterone can be found in both men and women, it is the key male sex hormone important for regulating how the body produces red blood cells, develops muscle mass and stores fat.

Testosterone can also affect libido, energy level, weight maintenance, and mood. Testosterone naturally decreases with age but it can drop to low levels that lead to certain medical conditions, including infertility and hypogonadism.

If you develop a serious enough medical condition as a result of low testosterone (sometimes referred to as low-T), your doctor may prescribe testosterone replacement therapy (otherwise known as hormone replacement therapy) using artificial testosterone delivered orally, superficially (gels or patches) 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 the use of testosterone products by men with low-T which has been caused by certain medical conditions.

How Safe is Testosterone Replacement Therapy?

There is no absolute guarantees that any drug is safe, even if it has been rigorously researched and studied by its manufacturer and then approved for use by the FDA.

Testosterone replacement therapy (TRT) does have side effects which is why 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 possible increased risk of heart attacks, blood clots, prostate cancer, stroke or even death.

What are the Responsibilities of Testosterone Manufacturers?

The FDA requires strict warning labeling on the outside of drug packages to clearly indicate their approved medical applicabilities and to caution users about potential side effects. These warnings are also intended to address the potential for abuse and dependency.

Specifically, as a FDA schedule III drug, 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 and the use of testosterone for non-medical related conditions, such as low libido and fatigue that are a natural part of the aging process.

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 stated above. An individual may be prescribed a testosterone product by a medical professional and still develop some of these risks.

If you are injured while using a testosterone product, such as part of a TRT, you may allege a variety of 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?

Recall that testosterone products for use in TRT are approved for a low-T related medical condition. However, recent years have seen a significant increase in the 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.

These injuries have resulted in lawsuits against a few of the makers of testosterone products from plaintiffs who have suffered heart attacks, deaths and other injuries. All indications suggest these lawsuits will continue against these and other makers.  

The lawsuits allege various legal theories under state and federal law, which include many of the same legal theories that have been identified earlier in this article.

Additionally, these lawsuits number in the thousands, which have led to many being consolidated into class action suits and transferred to federal courts. As well, a good proportion of these suits already have resulted in settlements against the makers while others are still proceeding to trial.

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 with a personal injury and medical malpractice attorney to protect your rights. You may be able to pursue a claim on your behalf or your loved ones may also be able to pursue a claim because of your injuries.