For hundreds of years, explorers have searched in vain for the mythical Fountain of Youth. Now, according to the drug manufacturer, this wonder cure is available from their doctors in a convenient gel format. While AndroGel is highly effective in treating hypogonadism, a rare condition, many doctors prescribe it to help older men look and feel younger. There is almost no evidence that the testosterone supplement does these things, and plenty of evidence that AndroGel, which is known to be a dangerous drug, causes serious side effects.
AbbVie originally developed AndroGel, a topical testosterone supplement, to treat hypogonadism in men. This condition, which is characterized by extremely low testosterone levels of less than 300 nanograms per blood deciliter, affects hundreds of thousands of people, causing physical symptoms like erectile dysfunction and infertility.
When the Food and Drug Administration approved the drug, it approved AndroGel for general sale and not for a specific purpose. So, like many other drug and device manufacturers, AbbVie began looking for additional customers, to offset the massive costs involved in developing a drug like AndroGel. Moreover, Congress recently shortened the drug exclusivity length, so cheaper generics are available faster and the original manufacturer has even less time to show a healthy profit on a given drug.
Starting around 2013, AbbVie and other testosterone supplement makers began an aggressive multimillion-dollar marketing campaign targeted at middle-aged men, largely with television ads during football games. The push worked, as studies show that testosterone supplement prescriptions increased markedly in the marketing campaign areas.
These commercials claimed that testosterone supplements were effective treatments for lethargy, sexual dysfunction, weight gain, low self-confidence, mild depression, and other symptoms commonly associated with middle age. These claims were an extension of the scientific evidence that AndroGel was an effective anti-hypogonadism drug, but they had little additional factual basis.
Top scientists have connected AndroGel with heart disease and other serious side effects.
In 2009, as evidence about the testosterone supplement-heart disease link continued to mount, the FDA ordered AbbVie and Endo Pharmaceuticals (the makers of Testim, another popular testosterone supplement) to warn customers about the risk of heart disease. Later, in 2013, the FDA considered limiting AndroGel prescriptions to hypogonadism only, an announcement that triggered a precipitous drop in sales. But despite this announcement, the introduction of generic alternatives, and an ongoing Federal Trade Commission lawsuit which accuses the company of bribing competitors to delay their introduction of generic testosterone supplements, analysts still expect AndroGel and other name-brand supplements to gross over $5 billion a year for the foreseeable future.
AndroGel Side Effects
For decades, researchers have theorized that genetic differences between men and women explain the difference in heart disease rates between the two sexes. Recently, these efforts have focused on testosterone, hormones which both sexes have but most men possess in abundance.
Initially, researchers discovered that men over 65 who took testosterone supplements developed unhealthy plaque levels, a thick, waxy substance that hardens arteries and restricts oxygen flow. Not long thereafter, other scientists concluded that younger men also faced a significantly higher risk of coronary artery disease. In fact, one 2010 safety study was cancelled after a test subject had a heart attack which may have been linked to testosterone supplement use.
Serious AndroGel side effects are not limited to just cardiac episodes. Some other common adverse health issues include:
- Blood Clots: The same substance that clogs arteries may also cause blood clots to be much thicker than normal, causing DVT (deep vein thrombosis). If these embolisms migrate to the brain, which they often do, they may cause a stroke.
- Prostate Cancer: Both human and animal studies have established a link between unnaturally high testosterone levels and prostate cancer, especially among men who already had an elevated risk for this disease.
- Sleep Apnea: In many ways, the body is like a string of Christmas lights, because if one part is off, other parts may also be affected. That’s probably the reason for the correlation between testosterone supplements and sleep apnea, a serious condition that causes daytime fatigue, making it dangerous to drive a car and operate other heavy equipment.
Other possible side effects include hormonal imbalances in men that possibly lead to infertility and unintentional exposure to pets, children, and women.
Your Claim for Damages
AbbVie and other drug manufacturers have a legal duty to only sell products that are safe and effective, and AndroGel arguably falls short in both these areas.
If victim/plaintiffs establish that the drug was defectively designed or manufactured, the drug maker is strictly liable for damages. Many drugs suffer from design defects because the drug makers know about health and safety risks but either suppress or ignore these risks in order to maximize their own profits. Errors can also occur in the manufacturing or delivery process, as some drug makers look to cut corners wherever possible.
According to Paul Napoli a leading bad drug attorney, “With Androgel, the risk is not worth the reward. There have been countless lawsuits paid by AbbVie.”
Furthermore, as mentioned earlier, there is little evidence, other than anecdotal stories, that testosterone supplements effectively treat anything other than hypogonadism.
The dangerous side effects associated with AndroGel often trigger large medical bills for emergency surgeries and ongoing care, which is why victims are usually eligible for significant compensation for their economic losses. As the medical bills and lost wages only tell part of the story, victims may also receive money for their pain and suffering and other noneconomic damages.
Moreover, due to AbbVie’s wrongful conduct in ignoring known health risks to pursue profits, many juries also award significant punitive damages. This money is available if there is clear and convincing evidence of reckless conduct or intentional neglect. In some cases, a punitive damages cap may apply.