Testosterone Therapy Lawsuit Information
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed November 20, 2023
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Testosterone plays a vital role in a variety of bodily functions. It's an essential hormone for men. It controls sexual development during puberty. It also helps maintain bone density, fat distribution, muscle mass, and sperm production. A male person with low T-levels may have issues with these processes.
Starting at around 30, men begin to experience a decline in testosterone production. The effects of this decline are often not noticeable until after age 40. Men with low testosterone levels complain of low energy, trouble concentrating, and a reduced sex drive. Testosterone replacement therapy (TRT) offers the opportunity to boost testosterone levels artificially.
Men who undergo testosterone replacement therapy may face adverse side effects. These include an increased risk of heart attack, stroke, and death. The Food and Drug Administration (FDA) looked into the link between testosterone products and cardiovascular problems.
This article discusses testosterone replacement therapy (TRT). It also talks about the health risks of TRT and the rising number of testosterone lawsuits.
Testosterone Replacement Therapy
Testosterone replacement therapy can help some men. People with abnormally low testosterone levels (hypogonadism) may use TRT to achieve normal testosterone levels.
Reduced testosterone production is often the result of genetic factors. Sometimes, chemotherapy and radiation can temporarily suppress the natural production of testosterone. Men who experience severe testicular injuries may also use testosterone replacement therapy.
Some Men Use Testosterone Products Instead
As they grow older, many men take prescription testosterone products as a health supplement. The testosterone supplement market has been booming in recent years. Americans spend billions on men's testosterone products each year.
Some of the more common testosterone-related products include:
- Creams
- Gels
- Injections
- Gums
- Implants
Aggressive advertising campaigns have fueled much of this growth.
Types of Testosterone Replacement Therapy
There are several ways a patient can receive TRT. Usually, your healthcare provider will prescribe whichever method you're most comfortable with. They'll also try to prescribe a therapy that's the least expensive. For example, oral testosterone tablets are costly, and they pose the most significant health risks. Your urologist will likely try other methods before they resort to oral medications.
The different types of testosterone replacement therapy include:
- Androderm: This is a testosterone patch you wear daily. It gradually releases testosterone into your body through the skin. The hormone then enters your bloodstream. The goal is for your T levels to increase to the point where you reach maintenance therapy slowly. The risks of using the patch are that it may cause heart attack, stroke, and blood clots.
- Injectable testosterone: A lot of patients prefer injectables because you only need to get a shot once every 10 weeks. Side effects of injecting testosterone include reduced energy levels, libido, and mood. You may also experience tenderness in your breasts if you use this method.
- Topical: Testosterone creams and testosterone gels are pretty popular among men with low testosterone levels. There are fewer serious side effects with topical application. You must be careful not to touch children and pregnant women while the cream or gel is on your hand. It can be dangerous for both groups.
- Intranasal: This involves small testosterone patches you place inside your nostril three times per day. Some people avoid intranasal treatment because it can cause headaches, nosebleeds, runny nose, and nasal discomfort.
- Implants (Pellets): Your doctor will inject small pellets of testosterone into your hip or buttocks. You'll need to undergo this therapy every three to six months, depending on your testosterone levels. This appears to be the safest method of TRT.
- Cheek (buccal patch): This method requires placing small patches inside your cheek against your upper teeth at least twice daily. Some of the side effects of the buccal patches are that they cause headaches and can cause gum or mouth sores.
Who Can Undergo TRT?
According to the American Urological Association, patients must undergo blood tests before their doctor prescribes them TRT. If the tests show low testosterone levels, the doctor will look to see if you have any other symptoms of hypogonadism.
Some of the ancillary symptoms of hypogonadism include the following:
- Breast growth and tenderness
- Sexual dysfunction
- Fatigue
- Low sex drive
Once you're diagnosed with this disorder, your doctor will discuss your options. They'll also help you explore the benefits and risks of each type of testosterone replacement therapy.
Risk of Heart Attack and Stroke
By 2014, testosterone replacement therapy ran into serious roadblocks. On Jan. 31, 2014, the FDA announced it was investigating whether testosterone products increase the risk of heart attack, stroke, and death in patients.
As a result of its investigation, it required manufacturers to include warnings on their labels to clarify the approved uses of these medications. All prescription testosterone products must have this warning.
The FDA's investigation was a response to the results of two studies that found an association between testosterone replacement therapy and cardiovascular disease. A study published in January 2014 concluded that older men and younger men with pre-existing heart disease who received testosterone replacement therapy faced a substantially increased risk of heart attack.
A second study published in March 2014 found that men taking testosterone experienced an increased risk of adverse outcomes.
A recent study published in the New England Journal of Medicine found there is not a significant difference in the incidence of heart attack and stroke between those men undergoing TRT and members of a placebo group. But, questions remain following the study. The study did confirm that there were higher incidence rates of acute kidney disease, pulmonary embolism, cardiovascular events, and atrial fibrillation in those participants who received oral TRT.
Testosterone Replacement Therapy Lawsuits
Several testosterone replacement therapy patients sued one of the manufacturers of testosterone therapy products, Abbott Laboratories, for injuries allegedly caused by their product, AndroGel. The plaintiffs in the AndroGel lawsuits argued that the company's testosterone treatments caused them to suffer heart attacks and strokes.
The plaintiffs also alleged that Abbott Laboratories hid the danger of heart attacks and strokes from consumers. Similar testosterone replacement therapy lawsuits are pending against other manufacturers.
To date, TRT patients have sued pharmaceutical companies for injuries caused by their testosterone replacement therapy products. These companies include the following:
- AbbVie (a spin-off corporation of Abbott Laboratories)
- Endo Pharmaceuticals (Endo International)
- GlaxoSmithKline
- Actavis
- Eli Lilly and Company
The allegations in the testosterone therapy lawsuits range from failure to warn consumers about the dangers of their testosterone products to breach of warranty. The specific claims made against the defendants named above include:
- Drugmakers failed to warn patients and urologists of the potential risks of their testosterone products
- Negligence
- Design defects
- False marketing efforts (off-label use)
- Breach of express and implied warranties
If you became sick after undergoing TRT, your product liability attorney may be able to sue the drug manufacturer.
State of Testosterone Replacement Therapy Litigation
The courts have gotten thousands of TRT lawsuits to date. The pharmaceutical companies settled some outstanding claims for more than $2 billion. Thousands of cases are still pending.
The federal courts combined the remaining cases in a multidistrict litigation matter. Litigation continues. Judge Matthew F. Kennelly in the Northern District of Illinois presides over MDL 2545 In Re: Testosterone Replacement Therapy Products Liability Litigation.
What Adverse Side Effects Do Plaintiffs Allege in the Testosterone Replacement Therapy Litigation?
The lawsuits against the pharmaceutical companies allege that the defendants' testosterone products caused significant injuries and even death in patients.
The specific adverse reactions cited in the plaintiffs' lawsuits include:
- Blood clots
- Stroke
- Pulmonary embolism
- Heart disease
- Prostate cancer
In the earlier TRT lawsuits, plaintiffs also alleged that the treatment caused deep vein thrombosis. A recent study confirmed no causal relationship between the two.
Filing a Testosterone Replacement Therapy Lawsuit? Get Legal Help
Treating a stroke, heart attack, or other cardiac event is often difficult and expensive. When a loved one dies from a cardiac event, the surviving family members end up with a lot of medical bills.
A product liability lawsuit allows patients and their loved ones to get compensation for:
- Medical costs
- Lost wages
- Pain and suffering
Consider meeting with a product liability attorney today to learn more about bringing a testosterone replacement therapy lawsuit. Call and schedule your free case evaluation with a personal injury lawyer today.
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