Update: Chicago Jury Orders AbbVie to Pay $150 Million Over AndroGel Side Effects
July 27, 2017 – AbbVie Inc. must pay $150 million to an Oregon man who accused the company of failing to warn about the safety risks of AndroGel, a federal jury in Chicago has decided. The jury took the unusual step of awarding Plaintiff Jesse Mitchell $150 million in punitive damages, meant to punish AbbVie, but nothing in compensatory damages for his personal injuries.
AndroGel Linked to 30% Increased Risk of Heart Attack, Stroke, and Death
An alarming recent study has revealed that men who use prescription testosterone replacement products, including AndroGel, are at a 30% increased risk of heart attack, stroke or death during the first 90 days of treatment. The study was published in November 2013 in the Journal of the American Medical Association.
In addition, a study published in PLOS One looked at the rate of heart attacks in the first 90 days of treatment for men aged 65 and older, and found a doubled risk of heart attack. For men under 65 who had heart disease, the risk of heart attack tripled.
According to Dr. Francisco Lopez-Jimenez, a Cardiologist at the Mayo Clinic who was interviewed by USA Today:
“That’s equivalent to smoking one or two packs of cigarettes a day, or having sky-high cholesterol.”
What is AndroGel?
AndroGel is a topical testosterone gel product manufactured by AbbVie, Inc. (formerly part of Abbott Laboratories). It comes in 1% and 1.62% concentrations, and was initially approved in 2000. The U.S. Food and Drug Administration (FDA) has approved AndroGel to treat hypogonadism (low testosterone) in conjunction with a serious medical condition (missing testicles, chemotherapy side effects, disorders of the hypothalamus or pituitary, etc.).
How Can AndroGel Cause Blood Clots?
AndroGel contains testosterone, a male hormone that can potentially increase the risk of blood clots in several ways:
- Increasing production of red blood cells
- Making blood thicker
- Elevating blood pressure
- Reducing levels of HDL (“good”) cholesterol
- Increasing circulating estrogens, a risk-factor for heart disease
Blood clots from AndroGel tend to form inside veins in the lower leg, in a condition called deep vein thrombosis (DVT). These blood clots can grow extremely large, obstruct circulation, or break off and get trapped in vital organs. One of the most common complications is pulmonary embolism (blood clots in the lungs), but blood clots can also cause heart attack, stroke, and death.
AndroGel and “Low T”
Annual prescriptions for testosterone have increased five-fold between 2000 to 2011. Of the 5.3 million prescriptions written in 2011 alone, approximately two-thirds were for AndroGel. In 2012, the industry generated $2 billion.
The rapid rise of AndroGel is likely due to an aggressive “disease awareness campaign” aimed at convincing middle-aged men to ask their doctor if they have low testosterone. According to AbbVie, you might have “Low T” if you feel “sad or grumpy,” have deteriorating performance at work or in sports, erectile dysfunction, or are “falling asleep at dinner.”
The problem is that these symptoms are very common and vague, and not necessarily caused by hypogonadism, the medical condition AndroGel was approved to treat. Federal law prohibits drug companies from marketing products for “off-label” uses. In addition, recent studies indicate that only 50% of men on testosterone therapy actually have hypogonadism, and 25% received a prescription without ever having a blood test.
AndroGel Side Effects
- Blood clots
- Deep Vein Thrombosis (DVT)
- Pulmonary embolism
- Heart attack
- Cardiac arrhythmia
- Male breast growth (gynecomastia)
- Prostate cancer
- Testicular shrinkage
- Fertility problems due to decreased sperm production
First AndroGel Bellwether Ends in Mistrial
June 19, 2017 – The first attempt to hold AbbVie Inc. responsible for the side effects alleged from AndroGel has ended in a mistrial after the lead plaintiff’s attorney suffered from heart problems. Court documents indicate that the man was hospitalized with heart complications on June 10 and underwent an unspecified procedure, but has since been released and is now recovering back home.
Testosterone Supplements may be Addictive, FDA Warns
January 18, 2017 – The FDA has approved class-wide label changes for all prescription testosterone boosters regarding a risk of abuse and dependence associated with use of the medications. The new warnings alert prescribers that some patients may abuse testosterone supplements, and that adverse outcomes may result. FDA reminds users that prescription testosterone therapy is approved only for men “who have low testosterone due to certain medical conditions.”
Do I have an AndroGel Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AndroGel lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free AndroGel Lawsuit Evaluation: Again, if you or a loved one was injured by side effects of AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing an AndroGel lawsuit, and we can help.