AndroGel Lawsuit
AndroGel has been linked to serious and life-threatening complications in generally healthy men. Some of the side effects of AndroGel include heart attack, strokes, pulmonary embolisms, and deep vein thrombosis (“DVT”).
What is AndroGel?
AndroGel box and packaging
AndroGel is a topical testosterone gel prescribed to men who suffer from testosterone deficiency. It is used as a testosterone replacement therapy and contains androgens, (male sex hormones) to help combat low levels of testosterone. Some men suffer from primary or secondary hypogonadism, which is where the body does not produce adequate amounts of the hormone to regulate normal bodily function.
Side effects of AndroGel
- Heart attack
- Stroke
- Blood clot
- Pulmonary embolism
- Transient ischemic attacks
- Sudden death
What is TRT?
Testosterone replacement therapy (TRT) has been a lucrative business for manufacturers of the androgen gels and patches. The industry alone has made billions of dollars on these products. Aggressive marketing conducted by the manufacturers have targeted middle-age men, who naturally lose testosterone as they age, to increase their interest in TRT products.
Serious cardiovascular complications
The Journal of the American Medical Association (JAMA) published their findings from a study in November 2013 that testosterone supplements caused significant health complications. Researchers at the Veteran Affairs Eastern Colorado Healthcare System discovered that cardiovascular complications were among 25.7% of those using TRT products. 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 announced 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.”
AbbVie Lawsuits
Multiple lawsuits accuse AbbVie and other makers of testosterone replacement medicines of hiding or downplaying their products’ risk for blood clots and violating federal law with aggressive marketing campaigns. AndroGel has been tied to fatal heart attacks in at least four cases.
In July 2017, a jury awarded $150 million in punitive damages stemming from the Plaintiff’s claim that the makers of AndroGel 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.
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, stroke and death.
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.”
Even after countless lawsuits and negative publicity on their testosterone products, Toni Haubert, an AbbVie spokesperson, issued a statement saying, “We believe our disease education and marketing of AndroGel have adhered strictly to FDA-approved uses and are in full compliance with applicable standards.”