McCarthy Tétrault LLP has defeated a proposed national class action commenced in Ontario against a healthcare company relating to the sale of a topical testosterone medication.

This decision is the first products liability in common law Canada to comprehensively address the standard of general causation in pharmaceutical cases since the landmark common issues trial decision of Justice Lax in Andersen v. St. Jude, Medical Inc., 2012 ONSC 3660. It is also the first pharmaceutical class action to be resolved by way of summary judgment prior to certification. For medical drug and device manufacturers, the case affirms the plaintiffs’ burden to prove general causation on a balance of probabilities and clarifies that general causation is a constituent element of most claims typically advanced in product liability cases. Absent proof of general causation, the class proceeding or putative class proceeding may be dismissed by way of summary judgment, even prior to certification.

The proposed national class was commenced on behalf of all Canadian men who were prescribed and used the drug 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 in June 2014. The plaintiffs alleged that the drug caused serious cardiovascular events including heart attack, stroke, thromboembolic events and death. In addition, the plaintiffs alleged that the drug was marketed 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 other specific, underlying medical conditions. The plaintiffs advanced claims in negligence (failure to warn, negligent design and pure economic loss), unjust enrichment 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 summary judgment motion and dismissed the action.

Justice Perell held that the case was appropriate for summary judgment, notwithstanding the complexity of the evidence and the volume of material filed, which consisted of more than 11,000 pages.

Justice Perell held that the plaintiffs failed to meet their onus of proving general causation. The plaintiffs had proven no more than a possibility that the drug might be a possible cause of serious cardiovascular events. They had thus failed to prove general causation on the balance of probabilities, which was fatal to all of the negligence claims, as causation is a constituent element of negligence. Justice Perell dismissed the plaintiffs’ claims in unjust enrichment and waiver of tort, rejecting the plaintiffs’ claims that the drug is a worthless, non-beneficial product and a dangerous one not worth the risk of being consumed. He held that the claims in unjust enrichment, waiver of tort and pure economic loss failed on both the facts and the law.