Abbvie Pharmaceuticals was ordered to pay out $150 million by a federal court in Illinois for misrepresenting their drug, AndroGel. The medication is meant to treat low testosterone (Low-T) in middle age and older men.
The jury found that Abbvie created a false narrative around the condition, going as far as essentially making it up, in order to profit off of the ignorance of their customers. However, the company was not found guilty of causing adverse effects, like the heart attack the plaintiff had while taking to drug. They verdict was made up of only punitive damages and not compensatory damages.
AndroGel and other Low-T drugs can be taken in many forms, including:
- Gel (as the name would imply)
AndroGel is only approved for treating hypogonadism, which is condition that causes the body to produce lower-than-normal levels of testosterone. Over the years, it has made Low-T synonymous with aging, meaning any man can potentially take these drugs. In this sense, the condition being treated is made up in most situations.
Abbvie has done this in several ways. One way is simply having doctors not check the patient for hypogonadism; they may not even be aware of the requirement. Hypogonadism can be found through a routine blood test. ¼ of all AndroGel users never had the test done, and ½ of those taking the drug were not diagnosed with it in the first place.
Another example would be Abbvie’s website, which contains a self-diagnosis test with overly broad questions, like “Are you tired?” or “Are you grumpy?” These questions could apply to nearly everyone. Yet, the website will suggest that the test taker should pursue testosterone treatment. This greatly expands their customer base.
Although the recent verdict did not find Abbvie guilty of causing the man’s heart attack, they still have a long, unsound relationship with the FDA. AndroGel was found to increase the chance of heart attack or stroke in their otherwise healthy patients, and they found it doubled the chance in those taking the drug with a heart condition.
These findings are even more startling, given the fact that the effects were studied only three months into therapy. As a result, the FDA ordered Abbvie to place warnings for heart attack and stroke on their label in March, 2015. The manufacturer was urged to put a warning for an increased risk of blood clots after the correlation was found in a study, too.
The recent verdict was issued for what is known as a bellwether trial. This is a trial used to assess the likelihood of the verdict for the class action suit and gives the two sides the option to settle. There are currently 6,000 plaintiffs in the class action consolidated in Chicago. Abbvie will likely appeal the decision, but the verdict should give them a bleak outlook for minimizing exposure in future cases.