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 to 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
Because 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.
What Is Testosterone Replacement Therapy?
In recent years, testosterone replacement therapy has become increasingly popular. This type of treatment aims to increase and stabilize testosterone levels in those suffering from low testosterone. In men, low testosterone levels are associated with a loss of traditional male characteristics, such as muscle tone, sexual drive, and male hair patterns. By increasing the male hormones responsible for such characteristics, testosterone therapy aims to treat these conditions.
The replacement therapies may also be used for low testosterone in women as an overall hormone replacement therapy. In addition to cancer treatments and fertility clinics, testosterone replacement therapy may also be useful in other settings.
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 are a natural part of aging. 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.
How Does Testosterone Replacement Therapy work?
In most cases, testosterone drugs are administered as part of testosterone replacement therapy. These drugs can either be injected or taken orally. Topical creams and gels such as AndroGel have also become fairly popular. Numerous testosterone drug products are available, which may be prescribed by a doctor.
Drugs are usually administered cyclically over a period of time until the person’s hormone levels return to normal. This process can take several months.
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 number 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 include a damage award that reimburses the victim for their injuries and other expenses.
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 due to 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 with low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for treating 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.”
What Types of Injuries and Side Effects Can Result from Testosterone Therapy?
The Food and Drug Administration (FDA) issued a warning regarding testosterone drugs and testosterone therapy treatments in 2014. Among the risks and side effects noted in the warning were:
- Heart attacks
- Strokes
- Circulation problems and blood clots
- Cardiovascular disease in general
Another danger of testosterone therapy is that the drugs can cause the body to shut down its testosterone production. The person’s testosterone levels may be ideal during the treatment. As a result of dependence on testosterone drugs, once the treatment stops, the person’s body is no longer able to produce testosterone at suitable levels. This has led to an increase in the number of personal injury lawsuits filed concerning testosterone products and treatments.
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 to treat 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. 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 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 make men 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.
Should I Hire a Lawyer?
Low testosterone treatments can result in injuries and other losses. Testosterone replacement therapy carries various risks. You may wish to hire a class action lawyer if you’ve undergone testosterone therapy and have received injuries in connection with the treatment. A lawyer can investigate your situation to see if you have a claim. In addition, your lawyer will be able to assist you in filing your case and will be able to represent you during the trial process.
