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Court of Appeal Cuts Off Speculative Product Liability Claims

May 22, 2025

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Written By Thomas Feore and Ana Nizharadze

In 2024, Ontario’s highest court affirmed the principle that a certifiable tort claim requires a plaintiff to provide some basis in fact for a present, materialized injury that is “sufficiently serious.” A legally compensable injury is required—a mere risk of harm will simply not suffice.

In Palmer v Teva Canada Ltd, 2024 ONCA 220 (Palmer), the plaintiffs claimed damages arising from their ingestion and/or purchase of drug products containing nitrosamines—potentially carcinogenic compounds that create no present symptoms, but that may marginally increase future risk of cancer.

Largely affirming the lower court’s decision, the Court held that the plaintiffs’ claims for mental and economic injury were not certifiable to (a) in the case of mental injury, because the alleged mental injuries were not serious and prolonged and were not a foreseeable result of learning that one might have ingested nitrosamines, and (b) in the case of economic injury, because ingestion of nitrosamines presented no imminent harm. The decision is instructive for any personal injury action in which plaintiffs lacking a materialized physical injury pursue claims for mental injury or economic loss in the form of potential future medical costs.

The Palmer Decision

The plaintiffs, on behalf of the putative class members—individuals who had ingested or purchased the defendants’ Valsartan products—argued that these products increased their risk of certain cancers, since the defendants’ allegedly negligent manufacturing introduced potentially carcinogenic nitrosamine impurities. The defendants voluntarily recalled the contaminated lots of Valsartan. Recognizing that nitrosamines in these Valsartan products may marginally increase cancer risk, Health Canada issued numerous notices associated with the recalls, advising patients to continue taking their medication unless their physician or pharmacist directed otherwise.

The plaintiffs did not seek damages for bodily injury, since none of them had been diagnosed with cancer. Rather, the plaintiffs sought damages for mental distress from learning of their allegedly increased risk of developing cancer in the future, as described in Health Canada notices regarding the defendants’ product recalls. The plaintiffs also sought to recover potential future medical costs, including monitoring for cancer.

The Court of Appeal’s Analysis

The plaintiffs made three arguments on appeal, namely that the lower court

  1. failed to consider that ingesting nitrosamines in Valsartan caused the plaintiffs to suffer "genotoxic injury" (that is, changes to their “internal bodily composition at a cellular or molecular level”),
  2. wrongly concluded the plaintiffs’ alleged mental distress was not compensable, and that present mental distress based on the apprehension of an increased risk of developing disease in the future cannot ground a viable claim, and
  3. erred in requiring (and not finding) an “imminent” threat of physical harm as a pre-condition to recover future medical monitoring costs and other alleged economic loss.

The Court of Appeal rejected these arguments.

1. Physical Injury Must Be Real and “Perceptible”

Regarding “genotoxicity”, the plaintiffs alleged that supposed “molecular changes” in their cells “caused by negligent exposure to a toxin” constituted an actualized physical injury. As the Court of Appeal observed, however, these supposed “changes” did not occasion any symptoms—and therefore no compensable present harm. As the Court reiterated, a “physical change with no perceptible effect” upon one’s health is not compensable in negligence.

2. Present Psychological Harm Based on Future Risk Could be Compensable, But Must Be Particularized, Significant and Reasonably Foreseeable

The Court of Appeal held that there could, in theory, be a cause of action for present psychological harm occasioned by learning of exposure to an increased risk of future disease: “[p]sychological distress caused by even a speculative concern of an increased risk is still [present] harm.”

However, such harm must be “serious and prolonged” and rise above the “ordinary annoyances, anxieties and fears” of living in society as the Supreme Court outlined in both Mustapha v Culligan of Canada Ltd., 2008 SCC 27, and Saadati v Moorhead, 2017 SCC 28. The psychological harm must be a reasonably foreseeable consequence of learning about the exposure, in a person of ordinary fortitude.

To this end, the Court of Appeal clarified that a plaintiff is required to particularize the alleged psychological harm in its pleading. A bare pleading of the legal test—that the alleged mental distress is “serious and prolonged” etc.—is not enough. Furthermore, the Court of Appeal found that for a person of ordinary fortitude, the notices issued by Health Canada would “assuage concern” more than they would prompt any “serious and prolonged” mental distress.

3. Imminent Underlying Harm is Required to Recover Pure Economic Loss

The Court of Appeal clarified that, to recover for pure economic loss, “imminent harm” must be so imminent as to be equivalent to present injury. It held that, without some indication that the defendants’ Valsartan products presented an “imminent” harm, pure economic losses in the form of future medical costs were not compensable. Since Valsartan presented no imminent harm, the Court of Appeal refused to certify this claim.

The Court’s rationale echoes the Ontario Superior Court’s decision in Rego v Bayerische Motoren Werke AG, 2023 ONSC 5244 (Rego), in which the motion judge observed that the role of “imminent harm” is to “analogiz[e]” the costs of any “anticipatory repairs” to “physical injury to the plaintiff’s person or property.” In Rego—which decision has been appealed to the Court of Appeal for Ontario—the motion judge substantially narrowed the putative class of vehicle owners to solely those who either (a) incurred repair costs for actual damage caused by the defective engine at issue, or (b) incurred repair costs to avert an imminent breakdown in the engine.

Looking Forward

The Court of Appeal’s decision in Palmer brings welcome coherence and clarity to the oft-discussed requirement that putative class actions based in tort claims require a present, materialized injury. The decision represents a definitive rebuke by an appellate court of efforts to circumvent this requirement in what are, at their core, speculative product liability claims based on potential personal injuries.

This decision (and the forthcoming decision from the Court of Appeal in Rego) may deter plaintiffs from bringing such speculative claims in the future.

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