Androderm Lawsuit
Androderm is a testosterone replacement medication that has been linked to serious and life-threatening conditions in males. Androderm has been linked to heart attack, strokes, pulmonary embolisms, and deep vein thrombosis (“DVT”).
What is Androderm?
Packaging and Box of 4 mg Androderm
Androderm is manufactured either as a transdermal patch or gel and prescribed to men to increase testosterone levels. 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 Androderm:
- Heart attack
- Stroke
- Blood clot
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Transient ischemic attacks
- Brain damage
- Sudden death
What is testosterone replacement therapy (TRT)?
The manufacturers of testosterone supplementation products have been under scrutiny for marketing to men who experience testosterone loss due to the natural loss of the hormone as they age.
Testosterone replacement therapy (TRT) was a lucrative business for manufacturers of the androgen gels and patches such as Androderm. Aggressive marketing conducted by manufacturers targeted middle-age men to increase their naturally declining “T-levels” to increase their sex drive and energy levels. However, it is unclear if TRT is helpful in creating a better quality of life when stacked against dangerous side effects of Androderm.
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.
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.”
Litigation Update
Multiple lawsuits accuse the makers of testosterone replacement medicines of hiding or downplaying their products’ risk for blood clots, heart attack and stroke, and violating federal law with aggressive marketing campaigns. 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.