Androgel Therapy Lawsuits
Prescription testosterone, often prescribed in the form of a gel under the brand name Androgel, is used to boost subpar levels of the hormone. There are currently about 6500 testosterone cases pending in federal multidistrict litigation (MDL). A series of bellwether trials are expected to begin this summer, the first of which is scheduled for June 2017. According to the plaintiffs in these cases, Androgel and other testosterone supplements caused user to suffer heart attacks, strokes, deep vein thrombosis, pulmonary embolism, and other injuries.
In early 2014, the US FDA issued a safety announcement concerning the potential risks associated with testosterone therapy. The announcement came as a result of two medical studies indicating higher risks for patients beginning their first three months of testosterone therapy treatment. The FDA stated it would conduct further investigations to learn more.
Both of the medical studies that triggered the FDA announcement evaluated statistical data linking the use of testosterone therapy to an increased risk of myocardial infarction, also known as heart attack. Research showed the greatest risk to occur within 90 days of the initial treatment, with a two to three times increased the chance of heart attack in users over the age of 65 and under 65 if they already had heart disease. The risk for men over 65 was suspected in the past, but this was these were the first studies that addressed the risk for men under the age of 65.
Researchers involved in the study encouraged all men to use caution when it comes to testosterone therapy products.
Testosterone Therapy Widely Prescribed, Even When Inappropriate
There was also evidence that men undergoing treatment were not even adequate candidates for testosterone therapy and did not suffer from decreased levels of the hormone. More than 40 percent of those receiving testosterone therapy showed levels within the normal range and were using the medication to reduce the natural effects of aging, which include muscle loss, and decreases in bone density and libido.
The only FDA-approved use of testosterone therapy is for treating hypogonadism, a condition that is known to reduce testosterone. Hypogonadism occurs when the testicles do not produce enough testosterone. This can happen due to a variety of factors, including:
- Klinefelter syndrome
- Undescended testicles
- Mumps orchitis
- Injury to the testicles
- Cancer treatment
Very few men have received diagnoses of the condition, compared to the number of prescriptions written for testosterone treatment. There is evidence these products are being used to treat low testosterone (low-T) caused by other factors, including nothing more than the natural effects of aging.
Legal Action against Testosterone Therapy Manufacturers
Since the study data was made public, at least five men have come forward with reports concerning their injuries related to testosterone therapy use. They were the first to take legal action against the manufacturers of AndroGel and other testosterone therapy medications, and more men are expected to follow, based on the more than five million prescriptions issued in the United States for testosterone therapy.
In these lawsuits, men allege the manufacturers of AndroGel and various testosterone therapy products downplayed the risks and led doctors and users to believe the treatments were completely safe or with only minor hazards. The companies are also accused of using misleading marketing that implied the products were suitable for treating conditions other than hypogonadism (a disease that leads to severely depleted testosterone levels).
Testosterone therapy is only approved by the FDA for treating hypogonadism, so while the drugs can be prescribed legally by doctors for treating reduced testosterone levels due to other causes, they cannot be marketed in this manner.
Several other brand name testosterone therapy products in addition to AndroGel have been named in the lawsuits. Anyone who has used a testosterone therapy product and experienced side effects as a result, especially if those side effects related to hearing health, is encouraged to seek legal counsel. It is possible you might be entitled to compensation based on your experience with AndroGel or any other testosterone therapy product.