Marketing for Off-Label Use Draws Testosterone Lawsuit

Kevin H. of Colorado is suing AbbVie and Abbott Laboratories, makers of AndroGel, over the side effects he allegedly experienced while using that medication.

Kevin reportedly suffered two separate deep vein thromboses after using AndroGel prescribed by his physician. He now claims AbbVie failed to properly address AndroGel’s dangerous testosterone side effects in its labeling and marketing. He also claims AbbVie’s marketing for AndroGel improperly promoted use of that drug beyond what was medically indicated.

AndroGel and Testosterone Side Effects

AndroGel is a topical ointment used for testosterone replacement therapy. The FDA approved AndroGel in February 2000 as a treatment for hypogonadism, a reduction or cessation of testosterone production associated with particular medical conditions such as genetic problems or chemotherapy. As a pharmaceutical commodity, AndroGel has been very successful. Recent sales have exceeded $1 billion per year.

However, some patients experience certain negative testosterone side effects. It tends to thicken the blood and increase the risk of clotting, which itself can lead to hypertension, heart disease (including myocardial infarction), deep vein thrombosis, pulmonary embolism, and stroke. Certain inherited traits can also increase a patient’s risk of excessive blood clotting. Kevin’s complaint states that AndroGel’s labeling does not adequately warn consumers or physicians about the risks of these testosterone side effects.

AbbVie’s Aggressive Marketing

In addition to his claim of failure to warn, Kevin alleges that AbbVie improperly marketed AndroGel for off-label use. An off-label use is any use other than that for which the FDA approved the drug, and pharmaceutical companies are not allowed to promote a drug for such uses. The FDA did not approve AndroGel as a treatment for free-standing low testosterone, which occurs naturally in healthy persons.

Nevertheless, AbbVie promoted the idea of low testosterone levels as a disease, with AndroGel as the treatment. Their “disease awareness” marketing campaign encouraged consumers to ask their doctors about AndroGel as a treatment for symptoms such as listlessness, moodiness, increased body fat, erectile dysfunction, decreased sex drive, and decreased ability to play sports – all of which can be associated with aging or changes in lifestyle rather than low testosterone. The FDA and the Journal of the American Medical Association have publicly called out AbbVie and other companies for improperly marketing their testosterone medications for off-label use.

Kevin’s testosterone lawsuit is based in part on his and his physician’s reliance on AbbVie’s AndroGel marketing. He claims the defendants’ actions constitute failure to warn, negligence, breach of warranty, fraud, negligent misrepresentation, and design defect. He seeks compensation for all harm resulting from his AndroGel complications, including emotional distress and social consequences.  He also seeks punitive damages and costs of the litigation, including attorney’s fees.

Kevin’s testosterone lawsuit is currently pending in the U.S. District Court for the Northern District of Illinois. Hundreds of other testosterone lawsuits are also pending against various pharmaceutical companies.

The AndroGel Lawsuit is Case No. 14-cv-08222, in the U.S. District Court for the Northern District of Illinois.