Sandoz Canada Inc. and several other pharmaceutical companies recently defeated a certification application and obtained summary dismissal of a proposed pharmaceutical product liability class action, successfully arguing that the plaintiff's claims of alleged increased risk of contracting cancer should be summarily dismissed because there is no basis in evidence or law to support such claims. Peter Pliszka, Andrew Borrell, and Zohaib Maladwala of Fasken represented Sandoz in securing this result.

The putative class proceeding was issued against numerous pharmaceutical companies that make or distribute ranitidine, a histamine H2-receptor, in heartburn medication. The plaintiff alleged that ranitidine could, over time and under certain conditions, transform into N-nitrosodimethylamine ("NDMA"), which the plaintiff alleged was carcinogenic. The plaintiff's Notice of Civil Claim included claims for increased risk of harm and potential future harm.

Sandoz, alongside other defendants, argued that the plaintiff's claim was fatally flawed both factually and legally because there was no scientific evidence that NDMA is carcinogenic in humans, and the plaintiff sought damages not for any actual harm suffered, but rather for an alleged increased risk of possible future harm.

In reasons reported at Dussiaume v. Sandoz Canada Inc., 2023 BCSC 795, Justice Wilkinson agreed with Sandoz and the other defendants, and dismissed the plaintiff's certification motion and granted the defendants' summary judgment motion. The judge found that there was no evidence to support the plaintiff's factual allegation that NDMA is carcinogenic in humans. Thus, Justice Wilkinson held that there was no basis for the claim that, even if any ranitidine contained NDMA, it would present a risk of cancer. The judge also applied well-settled caselaw — including Atlantic Lottery Corp. Inc. v. Babstock, 2020 SCC 19 — to reject the plaintiff's various claims of damages. In Babstock, the Supreme Court confirmed that "there is no right to be free from the prospect of damage; there is only a right not to suffer damage [...]."1 As Justice Wilkinson observed, this "important limitation" on negligence claims has been applied across Canada, including in pharmaceutical product liability class actions.2

In particular, Justice Wilkinson relied on Palmer v. Teva Canada Ltd., 2022 ONSC 4690, a recent decision of Justice Perell in which Fasken also represented Sandoz, in successfully defeating another motion for certification of a proposed class action. Drawing on Palmer and Babstock, Justice Wilkinson found that the plaintiff's claims were "similarly flawed", writing that "[f]uture harms that might — or might not — occur are not compensable. The conduct of a defendant in negligence is only wrong to the extent that it causes an actual materialized loss."3

The plaintiff's foundational failure to plead compensable loss was also fatal to his claim for "medical monitoring" — i.e., the cost of monitoring to provide early detection of any adverse health effects. Justice Wilkinson referred to as a helpful authority a case where a plaintiff was found to have tried to "short circuit the negligence analysis by presuming that the defendant's conduct had caused a physical injury that warranted such monitoring."4

The plaintiff in Dussiaume also alleged psychological injury — for example, psychological injury occasioned by "learning about" the alleged adverse effects of ranitidine. However, Justice Wilkinson found that such claims were essentially derivative of the plaintiff's doomed claims for alleged risk of harm and potential future harm. "Just as claims for increased risks of physical harm are not compensable, claims for worries about increased risk of physical harm are also not compensable," wrote Justice Wilkinson. Similarly, "It follows that if the risk of a potential future physical harm is not compensable, neither is a harm one step removed [...]."5 Further, Justice Wilkinson concluded that any claims for psychological injury must fail because they did not rise above "ordinary annoyances, anxieties, and fears that people living in society must deal with,"6 and they were not "reasonably foreseeable", meaning that there was "no basis in material fact or evidence to support the reason" for psychological injury in this case.7

Dussiaume is a welcome decision for current and prospective defendants in product liability class actions. It confirms that our courts will apply well-established principles about evidence and requisite elements of causes of action to prevent plaintiffs' lawyers from pursuing class actions that are founded upon speculation of possible future harms for which there is no basis in fact.

Nevertheless, based on experience, we anticipate that the plaintiffs' bar will continue to make creative attempts to try to circumvent these established principles to assert claims against defendant manufacturers and distributors. If you would like to discuss any questions, thoughts and strategies about guarding against such claims, please contact the authors.


1. At para. 33.

2. Dussiaume at para. 50.

3. At para. 54.

4. At paras. 79-80, following Dow Chemical Company v. Ring, Sr., 2010 NLCA 20.

5. At paras. 71-72.

6. At para. 103.

7. At para. 106.

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