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Torts - Negligence - Duty to Warn

. Price v. Lundbeck

In Price v. Lundbeck (Div Court, 2023) the Divisional Court considered (and dismissed) an appeal of a denial of a class action certification, here in a tort ('duty to warn') pharmaceutical case:
[2] For the reasons set out below, this appeal is dismissed. The Class Proceedings Judge applied the correct legal principles, and his expertise, and denied certification.


[19] The Class Proceedings Judge employed the legal principles for certification, including that there was no preliminary review of the merits of the claim. The plaintiffs only had to show “some basis in fact” for each of the certification criteria other than the requirement that the pleadings disclose a cause of action. And “some basis in fact” is a low evidentiary standard. The court could not resolve conflicting facts and evidence at the certification stage or opine on the merits of the plaintiffs’ claim.


[20] The Class Proceedings Judge noted the court’s important gate-keeping function, as underscored by the Supreme Court of Canada in Pro‑Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57, [2013] 3 S.C.R. 477.

[21] In Pro-Sys, at para. 103, the Supreme Court emphasized “the importance of certification as a meaningful screening device.” Further, the Court held, at para. 104, that there is “limited utility in attempting to define “some basis in fact” in the abstract. Each case must be decided on its own facts. There must be sufficient facts to satisfy the [judge] that the conditions for certification have been met to a degree that should allow the matter to proceed on a class basis without foundering at the merits stage”.

[22] The Class Proceedings Judge reviewed the applicable law on the commonality requirement, which had been approved of in the first Divisional Court decision. Among other principles, to meet the common issue criterion, the proposed issue had to be a “substantial ingredient” of each class member’s class and not be semantically manufactured by overgeneralizing.

[23] As he cited from Rumley v. British Columbia, 2001 SCC 69, [2001] 3 S.C.R. 184, at para. 29: “It would not serve the ends of either fairness or efficiency to certify an action on the basis of issues that are common only when stated in the most general terms. Inevitably such an action would ultimately break down into individual proceedings.”

[24] The Class Proceedings Judge considered the first step of the proposed common issue: “Is or may Celexa® be teratogenic?” He found a lack of the needed commonality. The requirement that the proposed common issue advance the litigation in a meaningful way was not met. He found that even if the proposed common issue that Celexa® “is or may be” teratogenic was decided in the plaintiffs’ favour, no class member’s case would be advanced because each claim, to be successful, would have to show that it caused the specific congenital malformation experienced in that instance.

[25] The Class Proceedings Judge considered other pharmaceutical cases relied on by the plaintiffs, but in those cases, the courts narrowed the common issue to a specific defect before certifying: Bartram (Litigation guardian of) v. GlaxoSmithKline Inc., 2012 BCSC 1804, aff’d 2013 BCCA 462, Miller v. Merck Frosst Canada Ltd., 2013 BCSC 544, aff’d, 2015 BCCA 353, leave to appeal refused, [2015] S.C.C.A. No. 431. He found that the option of narrowing the issue was not available to the court. There were hundreds of potential congenital malformations. The proposed common issue seized on superficial commonality, as cautioned against in Rumley.

[26] The Class Proceedings Judge also considered the second step of the proposed common issue, regarding the duty to warn, in view of the leading case of Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 and other authorities including Adam v. Ledesma-Cadhit, 2021 ONCA 828, leave to appeal refused, [2022] S.C.C.A. No. 13. He followed Hollis, under which a duty to warn must arise from specific risks, which must also be material. In turn, the risk is relevant to the other issues surrounding the duty to warn, including whether a defendant ought to have reasonably foreseen that the plaintiff might suffer a loss, the question of what warning would be found sufficient, and the question of whether or not the plaintiff would have declined the drug.

[27] The Class Proceedings Judge found as follows, paras. 155, 159-60:
There are hundreds of congenital malformations, some of which might be material and others which may not. The patient receiving a general warning of teratogenicity from a doctor would have no basis to assess the specific risk and make an informed decision as to whether to take Celexa® to help protect both the mother and the baby from potential risks arising from depression, or to choose not to do so. This informed consent is the raison d’être of the duty to warn, and it could not be effected under the [second step in the proposed common issue].


“Teratogenicity” is not the harm suffered, but instead a term that relates to the possibility of hundreds of congenital malformations, only some of which (if any) might have been reasonably foreseeable. If it were found that the defendants ought to have known that citalopram is a teratogen because it can cause clubfoot, it may not have been the case that the defendants ought to have known (or known at the same time) that citalopram is a teratogen because it can cause craniosynostosis. The etiologies and evolving epidemiological data differ for each congenital malformation.

The reasonable foreseeability of any particular congenital malformation would require analysis of the etiology for each such malformation, which will vary. Not every congenital malformation would be, or could have been, reasonably foreseeable based on the etiology and epidemiological studies available at a particular time. Consequently, there could be no commonality under the proposed terms of the [second step in the proposed common issue].
[28] The Class Proceedings Judge concluded that to establish a duty to warn, there would need to be a specific material risk. In contrast, the duty to warn step of the proposed common issue was based on general causation – whether Celexa® “is or may be teratogenic”. He found that the duty to warn step could not stand on its own terms, separate from the first step.

[29] The Class Proceedings Judge therefore concluded that the plaintiffs had not met the low threshold to show some basis in fact that either step was a common issue that should be certified under s. 5(1)(c) of the Act. Although this was sufficient to dismiss the certification motion, he went on to consider the other issues.

[30] On the preferrable procedure requirement in s. 5(1)(d) of the Act, the Class Proceedings Judge stated the applicable legal principles, including as set out by Strathy C.J.O. in Amyotrophic Lateral Sclerosis Society of Essex County v. Windsor (City), 2015 ONCA 572, 387 D.L.R. (4th) 603. At para. 62, Strathy C.J.O. noted that “it is not enough for the plaintiffs to establish that there is no other procedure which is preferable to a class proceeding. The court must also be satisfied that a class proceeding would be fair, efficient and manageable.”

[31] The Class Proceedings Judge followed the Supreme Court of Canada decision in Hollick v. Toronto (City), 2001 SCC 68, [2001] 3 S.C.R. 158. In Hollick, at paras. 29-31, McLachlin C.J. held that even though the Act requires only that a class action be the preferrable procedure for the resolution of the common issues, the question of preferability “must take into account the importance of the common issues in relation to the claims as a whole”.

[32] As with the claim in Hollick, the Class Proceedings Judge found that even if the proposed common issues were found to advance the litigation (which he did not find), any such advance would be peripheral and minor. The individual issues would overwhelm any benefit. He also considered the proposed litigation plan, concluding as follows, at para. 211:
The present case lacks a workable way forward. It will break down into potentially thousands of individual trials, all with every liability and damages issue to be proven, including general causation of the particular congenital malformation, since the class does not purport to certify such an issue.
. Burr v. Tecumseh Products of Canada Limited

In Burr v. Tecumseh Products of Canada Limited (Ont CA, 2023) the Court of Appeal considered the negligence duty to warn:
2. No duty to warn the Burr-Callisters

[83] As noted by the Supreme Court in Hollis v. Down Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634, at paras. 20-29, the principles governing the duty to warn include the following:
i. There is a duty to warn of dangers inherent in the use of a product;

ii. The duty is ongoing and continues after the product is delivered;

iii. Warnings must be clear and specific to the dangers that arise from ordinary use; and

iv. The duty varies with the level of danger associated with ordinary use of the product.
See also Rivtow Marine Ltd. v. Washington Iron Works, 1973 CanLII 6 (SCC), [1974] S.C.R. 1189, at p. 1200.


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Last modified: 17-02-24
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