Fortesta Lawsuit

What is Fortesta?

10 mg Fortesta Pump Bottle

Fortesta is manufactured by Pharbil Waltrop GmbH and disributed by industry giant, Endo Pharmaceuticals. It is a topical androgen gel that is applied to the front and inside area of the thighs. Fortesta is used to treat disorders in males such as sexual dysfunction, primary or secondary hypogonadism (a severe loss of testosterone) and other ailments that require the use of testosterone replacement therapy (TRT).

Side effects of Fortesta:

• Heart attack
• Stroke
• Blood clot
• Pulmonary embolism (PE)
• Deep vein thrombosis (DVT)
• Venous thromboembolism (VTE)
• Transient ischemic attacks
• Brain damage
• Sudden death

Certain drug manufacturers led a successful, albeit misleading, advertising campaign encouraging men to boost their “T-levels” for increased energy and a stronger libido. Although it is unclear if low levels of energy and a dismal sex drive can be supplemented with testosterone, it is clear that the manufacturers have preyed on men’s insecurities in these areas in order to make a profit. Environmental factors, such as stress and sexual arousal, can cause a fluctuation in testosterone levels.

Studies show an increased risk of cardiovascular complications

The Journal of the American Medical Association (JAMA) published their findings from a study in November 2013 that testosterone supplements caused a significant increase in cardiovascular complications. Researchers discovered that stroke, heart attack and sudden death, were among 25.7% of TRT candidates versus 19.9% of those who did not participate in the treatment. Within a year and a half, researchers determined that 23 participants suffered heart attacks, 33 had strokes and 67 died from participating in testosterone supplementation.

Public Awareness Campaigns

Consumer advocacy groups, such as Public Citizen, perform content-awareness campaigns so consumers can make informed decisions. In a 2014 press release, Public Citizen wrote that studies conducted by the drug companies showed no increased risk of cardiovascular complications from using TRT products. However, in multiple outside studies, there was a significant increased risk in cardiovascular complications from using TRT products.

According to Public Citizen, “More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta.”

Updates from the FDA

The Food and Drug Administration issued a press release in 2015 that required manufacturers of testosterone products to change their labeling to indicate that use of testosterone products carries an increased risk of heart attack and stroke.

Also mentioned in the press release was the acknowledgement that testosterone replacement therapy has been used to treat conditions other than what it was initially made for. “[The] FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.”

Litigation Update

A number of lawsuits have been filed against the manufacturers of testosterone products for hiding or downplaying their products’ risk for blood clots, heart attack and stroke. In July 2017, a jury awarded $150 million in punitive damages stemming from the Plaintiff’s claim that the makers of AndroGel, a different TRT product, fraudulently mismarketed the drug to consumers. Later that fall, a different jury found AndroGel caused the Plaintiff to suffer a heart attack and awarded the man $140,000 in compensatory damages and $140 Million in punitive damages.

Fortesta Lawsuit