AndroGel lawsuits - Absence of causation dispositive in product liability

Date Closed

February 14, 2017

Lead Office



60.00 Million CAD

In November of 2016 McCarthy Tétrault LLP successfully defended a proposed national class action commenced in Ontario against Abbott Products Laboratories, Limited, Abbott Products Inc., Abbott Products Canada Inc. (collectively, “Abbott”) and AbbVie Products LLC (“AbbVie”) relating to the sale of AndroGel, a topical testosterone medication. The proposed national class was on behalf of all Canadian men who were prescribed and used AndroGel in Canada from 2002 onward (the date of Health Canada marketing approval) and their spouses or other dependents entitled to advance derivative claims under provincial legislation. The court granted Abbott's motion for summary judgment, declaring that association is not enough to meet the standard for causation required in negligence cases.

The plaintiffs alleged that AndroGel caused serious cardiovascular events including heart attack, stroke, thromboembolic events and death. In addition, the plaintiffs alleged that AndroGel was marketed by Abbott for off-label uses relating to age-related testosterone deficiency and that the risks of treatment outweighed the benefits for patients with “lowT” due to age but without underlying medical conditions (i.e. for patients without what the FDA has recently described as “classical hypogonadism.”) The plaintiffs advanced claims in negligence (failure to warn and negligent design), unjust enrichment, pure economic loss and waiver of tort.
The Defendants moved for summary judgment prior to certification. The summary judgment motion was heard for over six days before Justice Perell, with reasons released on November 23, 2016. Justice Perell granted the Defendants’ summary judgment motion and dismissed the action.
Justice Perell held that the plaintiffs failed to meet their onus of proving general causation. While not deciding whether Abbott had breached the standard of care in warning physicians and the public, Justice Perell concluded that “the trend of the evidence, which showed compliance with regulatory standards, tended to favour Abbott” and that in any event, the absence of general causation was dispositive of the negligence claims. Justice Perell held that the plaintiffs’ claims in unjust enrichment, pure economic loss and waiver of tort failed on both the facts and the law. Notably, he rejected the arguments that AndroGel was being prescribed by doctors “off-label” and that it was a useless product.

Abbott and AbbVie were represented by Neil Finkelstein, Brandon Kain, Byron Shaw and Breanna Needham.