One such pharmaceutical — Androgel — is made by a company called AbbVie, a spinoff of Abbot Labs. The drug has been shown to address the problems associated with hypogonadism and that, together with the important nature of that condition has led to massive success of the drug. In 2010 the drug made $650 million in revenue, and by 2012 more than $1.2 billion, and perhaps as high as $2 billion according to the New York Times. AbbVie’s advertising of the drug also amounted to a whopping $80 million in 2012.
While the drug has exhibited certain benefits for those with hypogonadism, studies have also shown that use of the Androgel drug can increase the risk of heart disease, stroke, and death by as much as 30%. As a result of the allegedly negative effects of the Androgel product AbbVie has been hauled into court in a number of different lawsuits, many of which were filed in the Northern District of Illinois. Approximately 30 of those lawsuits were recently consolidated before the Hon. Matthew F. Kennelly as of March 14, 2014.
This is not the first time that AbbVie has been hauled into court over the Androgel product. In 2014, AbbVie was the subject of a U.S. Supreme Court case—FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013)—in which AbbVie was found to be potentially violated anti-trust law when it paid makers of products that compete with Androgel to delay the introduction of those products to the marketplace. Now, AbbVie is being sued on products liability grounds, namely that the product is contributing to harm to men that use the product and even to women that come into contact with the product. Among the claims being brought by the plaintiffs in these various cases are allegations that AbbVie failed to warn consumers about the potential risks of the drug though they were known at the time of distribution, and negligence in the creation of the product itself.
Those allegations are not entirely without merit. When Androgel’s maker—Unimed Pharmaceuticals—was going through Food and Drug Administration (FDA) Approval, it disclosed to the FDA the results of various studies that must be conducted as a condition precedent to market approval. Yet it is possible that AbbVie downplayed the risk of heart disease and other negative implications of the drug in order to obtain market approval and generate sales.
Now, the allegations are being weighed in federal court with the consolidations of these various lawsuits in the Northern District of Illinois. Procedurally, it remains to be seen whether additional cases from other districts will be consolidated into those proceedings in something akin to Multi-District Litigation. That may place additional pressure on AbbVie to settle the claims and avoid a finding of liability for the drug-maker, particularly in the wake of the negative outcome in FTC v. Actavis, Inc.
Have you or a loved one been adversely affected by Androgel or another Low-T supplement? If so, read this.