CANADA Law and Practice Contributed by: Sylvie Rodrigue, Grant Worden, Nicole Mantini and Anne Merminod, Torys LLP
Learned Intermediary Doctrine Manufacturers of certain products ‒ particularly phar - maceuticals and medical devices ‒ may fulfil their duty to warn users of potential risks by properly inform - ing a “learned intermediary,” such as a prescribing physician or other qualified professional. Under this doctrine, the manufacturer’s obligation is to ensure that adequate warnings are given to the intermedi - ary, who then has the responsibility to convey the necessary information to the end user or patient. The courts expect that the intermediary will evaluate this information, weigh it against their medical knowledge and the patient’s personal circumstances, and then decide whether, how, and when to communicate the risk to the patient. If the manufacturer meets its duty to inform the learned intermediary, it may not be held liable for the intermediary’s failure to warn the ultimate consumer properly or completely. In the context of class actions, Canadian courts have generally deemed the learned intermediary doctrine a defence on the merits, limiting the manufacturer’s abil - ity to rely on adequate warnings provided to qualified professionals to defeat authorisation or certification. 2.13 The Impact of Regulatory Compliance on Product Liability Claims While adherence to regulatory obligations and stand - ards and regulatory approval or licensing of a prod - uct are significant factors that courts will consider, they do not provide immunity from liability; rather, they may serve as persuasive evidence that reason - able care was exercised. A plaintiff may defeat a defendant’s defence of regulatory compliance if the relevant standards set only a minimum threshold, or if the plaintiff can demonstrate that the product was nevertheless unsafe or that a higher standard of care was warranted. Ultimately, the courts assess whether compliance with the applicable standards was suffi - cient to discharge the defendant’s duty of care in the specific circumstances of the case. 2.14 Rules for Payment of Costs in Product Liability Claims Generally, in most jurisdictions in Canada, the prevail - ing party in a lawsuit is entitled to recover a portion of its legal costs from the losing party ‒ a principle known as the “loser pays” or “costs follow the event”
the plaintiff according to their degree of fault. The courts will assess the conduct of both parties, con - sidering whether the plaintiff failed to exercise reason - able care in using the product, ignored warnings, or misused the item in a foreseeable way. Intervening Causes This defence arises when a defendant argues that the loss or injury suffered by the plaintiff was not a direct result of any defect in the product or negligence by the defendant, but rather due to an independent and unforeseeable act or omission by a third party ‒ or even by the plaintiff themselves. In product liability actions, this intervening cause is sometimes biologi - cal or medical in nature. To succeed with this defence, the intervening act must break the chain of causation between the alleged defect and the harm suffered. Canadian courts consider several factors in assessing this argument, including whether the intervening act was reasonably foreseeable, whether it was truly inde- pendent of the defendant’s conduct, and whether it was the proximate cause of the injury. If the court finds that the intervening cause was significant enough to sever the causal link, the defendant may be wholly or partially absolved of liability. Product Misuse This defence arises when a product, although poten - tially defective, was not used in the manner intended or reasonably foreseeable by the manufacturer. If it can be demonstrated that the injury or loss result - ed primarily from the consumer’s unforeseeable or improper use of the product, rather than from any defect or failure in the product itself, the courts may limit or even eliminate the defendant’s liability. The burden generally falls on the defendant to prove that the misuse was the direct cause of harm and that such misuse was neither intended nor reasonably foresee- able during the course of normal or anticipated use. Canadian courts will also consider whether adequate warnings and instructions were provided with the product, as the absence of clear guidance may under - mine the misuse defence. Ultimately, the success of this defence depends on the specific facts of each case and the ability to show a clear break in causation between any alleged product defect and the resulting injury due to misuse.
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