) ) JENNIFER PRICE v. MATTHEW JANZIC, 2024 ONSC 845

CITATION : Price v. Lundbeck, 2024 ONSC 845 DIVISIONAL COURT FILE NO.: 032/23 DATE: 20240213 ONTARIO SUPERIOR COURT OF JUSTICE DIVISIONAL COURT J.A. Ramsay, Matheson and Schabas JJ. BETWEEN: ) ) JENNIFER PRICE and MATTHEW JANZIC by his Litigation Guardian JENNIFER PRICE Appellants – and – H LUNDBECK A/S and LUNDBECK CANADA INC. Respondents ) ) ) ) ) ) ) ) )))) Paul Bates and Anthony Tibbs , for the Appellants F. McLaughlin, B. Kain and D.

Charach , for the Respondents ) HEARD at Toronto: October 12, 2023 Matheson J.: [ 1 ] This is an appeal from the dismissal of a motion to certify this action as a class proceeding under the Class Proceedings Act, 1992 , S.O. 1992, c. 6 . The appeal challenges the decision of Glustein J. (the “Class Proceedings Judge”) dated December 20, 2023 (the “Decision”). [1] The underlying claim alleges a failure to warn about the risks of a prescription drug with the brand name Celexa® . [ 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. Brief Background [ 3 ] In the underlying claim, the appellants/plaintiffs allege that Celexa®, which is used to treat depression, is a “teratogen”. A teratogen is any agent that can, under reasonable circumstances of exposure, disturb the development of an embryo or fetus and cause congenital malformations. [ 4 ] This is a duty to warn claim.

The plaintiffs allege that the defendants manufactured, distributed, and marketed Celexa®, and that the defendants knew or ought to have known that Celexa® “is or may be” a teratogen”, and “breached a duty to warn Canadian physicians and patients that Celexa® is or may be teratogenic”. [ 5 ] The proposed class includes women who were prescribed and took Celexa® while pregnant in Canada and subsequently aborted, delivered, or miscarried children with congenital malformations.

The proposed class also includes the children born to those women and family members who may have claims under family compensation legislation. [ 6 ] The motion to certify this claim as a class proceeding first came before Perell J., who denied certification. [2] Over the course of that motion, the plaintiffs changed the proposed common issues.

On the first appeal to this court, those changes were the focal point, including whether counsel to the plaintiffs had made a concession that excluded causation from any consideration. [3] The Divisional Court noted that the plaintiffs’ counsel may have created the confusion from which they then appealed. [4] [ 7 ] On that appeal, the Divisional Court concluded that despite plaintiffs’ counsel’s submissions to the motion judge about general causation, the common issue they continued to propose included a general causation issue.

The Divisional Court allowed the appeal from the denial of certification, concluding that the motion judge had erred as follows: (

a) in concluding that the appellants had made a “strategic decision” that excluded all general causation issues from the common issue; and,

(

b) in reframing and analyzing the common issue as the duty to warn in isolation, based on that strategic decision. [5] [ 8 ] On that appeal, the Divisional Court found that there was a common issue that included at least one aspect of general causation and may be common across the proposed class and bear upon other causation issues in the case. [6] However, there had yet to be a consideration of whether the proposed common issue satisfied each aspect of the certification test. [ 9 ] The Divisional Court therefore ordered that the certification motion be heard “afresh” by a different judge. [7] [ 10 ] The certification motion was then heard by the Class Proceedings Judge, giving rise to the Decision now under appeal.

Decision [ 11 ] As directed by the Divisional Court, the Class Proceedings Judge considered the motion afresh subject only to applying the court’s ruling about the causation issue. [ 12 ] The Class Proceedings Judge recognized that the Divisional Court had determined that the proposed common issue advanced by the plaintiffs “included an aspect of general causation” and that the Divisional Court had then expressly declined to decide whether or not the certification criteria were satisfied. [ 13 ] The Class Proceedings Judge noted that the plaintiffs did not seek to certify a general causation or duty to warn issue linking Celexa® to any particular congenital malformation.

This was important because hundreds of different congenital malformations can either arise upon birth or cause a spontaneous abortion. Instead, the proposed common issue was: “From 1999, did the Defendants breach their duty to warn Canadian physicians and patients that Celexa® is or may be teratogenic?” [ 14 ] As put by the plaintiffs, the proposed common issue was a two-step inquiry, asking the questions: (1) is or may Celexa® (citalopram) be teratogenic?; and if so, (2) did the defendants breach their duty to warn of that teratogenicity? [ 15 ] The Class Proceedings Judge dismissed the motion for certification.

He found that the plaintiffs had not established some basis in fact that the common issue could be certified as a common issue and, even if it could, the plaintiffs had not established some basis in fact that a class action would be the preferable procedure. [ 16 ] As set out in the Decision, the core problem was still causation because all pregnancies have a baseline risk of congenital malformations, most of which arise from gene absences or abnormalities or are idiopathic (of unknown cause).

Further, hundreds of different congenital malformations exist and there is no common etiology (cause, set of causes, or manner of causation of a disease or condition) for these defects. [ 17 ] In addition to the risk that applies to everyone, hundreds of different malformations, and no common etiology, the Class Proceedings Judge noted as follows: (

i) each congenital malformation has its own unique epidemiological data, its own set of risk factors and its own criteria for screening and diagnosis; (ii) there are no known teratogens capable of causing all congenital malformations; and, (iii) there are several chemical substances that are known to cause congenital malformations (e.g., cigarette smoke and alcohol) but very few confirmed pharmaceutical teratogens. [ 18 ] The Decision also reviewed the disclosure in the product monograph required by Health Canada. The Canadian product monograph included cautions about the use of the drug during pregnancy.

Because it would be unethical to do so, there were no randomized clinical trials on pregnant women. The product monograph warned that safety during pregnancy had not been established and said the drug should not be used during pregnancy subject to a physician’s opinion to the contrary. The plaintiffs relied on a stronger caution that was apparently used in Denmark. [ 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 meaningfulway was not met.

He found that even if the proposed common issue that Celexa® “is or may be” teratogenic was decided in theplaintiffs’ favour, no class member’s case would be advanced because each claim, to be successful, would have to show that it causedthe 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 courtsnarrowed the common issue to a specific defect before certifying: Bartram (Litigation guardian of) v. GlaxoSmithKline Inc., 2012 BCSC1804, 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 ofpotential 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, inview of the leading case of Hollis v. Dow Corning Corp., (SCC), [1995] 4 S.C.R. 634 and other authorities includingAdam v.

Ledesma-Cadhit, 2021 ONCA 828, leave to appeal refused, [2022] S.C.C.A. No. 13. He followed Hollis, under which a duty towarn must arise from specific risks, which must also be material.

In turn, the risk is relevant to the other issues surrounding the duty towarn, including whether a defendant ought to have reasonably foreseen that the plaintiff might suffer a loss, the question of what warningwould 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 ageneral warning of teratogenicity from a doctor would have no basis to assess the specific risk and make an informed decision as towhether to take Celexa® to help protect both the mother and the baby from potential risks arising from depression, or to choose not to doso.

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 proposedcommon issue]. … “Teratogenicity” is not the harm suffered, but instead a term that relates to the possibility of hundreds of congenital malformations, onlysome of which (if any) might have been reasonably foreseeable.

If it were found that the defendants ought to have known that citalopramis a teratogen because it can cause clubfoot, it may not have been the case that the defendants ought to have known (or known at thesame time) that citalopram is a teratogen because it can cause craniosynostosis. The etiologies and evolving epidemiological data differfor each congenital malformation. The reasonable foreseeability of any particular congenital malformation would require analysis of the etiology for each suchmalformation, which will vary.

Not every congenital malformation would be, or could have been, reasonably foreseeable based on theetiology and epidemiological studies available at a particular time. Consequently, there could be no commonality under the proposedterms 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. Incontrast, the duty to warn step of the proposed common issue was based on general causation – whether Celexa® “is or may beteratogenic”.

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 factthat either step was a common issue that should be certified under s. 5(1)(

c) of the Act. Although this was sufficient to dismiss thecertification 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 legalprinciples, including as set out by Strathy C.J.O. in Amyotrophic Lateral Sclerosis Society of Essex County v. Windsor (City), 2015ONCA 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 noother procedure which is preferable to a class proceeding. The court must also be satisfied that a class proceeding would be fair, efficientand 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 thepreferrable procedure for the resolution of the common issues, the question of preferability “must take into account the importance of thecommon 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 toadvance the litigation (which he did not find), any such advance would be peripheral and minor.

The individual issues would overwhelmany 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 liabilityand damages issue to be proven, including general causation of the particular congenital malformation, since the class does not purport tocertify such an issue. [33] The Class Proceedings Judge then addressed some ancillary issues, one of which is raised on this appeal.

He concluded thatthe claims in strict liability and direct negligence to the unborn fetuses in utero and children must be struck out based on settled law. [34] The certification motion was therefore dismissed. This appeal was brought as of right. Standard of Review and Issues

[ 35 ] This is a statutory appeal and the appellate standard of review therefore applies, as set out in Housen v. Nikolaisen , 2002 SCC 33 , [2002] 2 S.C.R. 235. Errors of law are reviewed on a correctness standard. For errors of fact, there must be a palpable and overriding error.

Errors of mixed fact and law also require a palpable and overriding error unless there is an extricable error of law or principle, which is reviewed on a correctness standard. [ 36 ] Further, a decision by a certification judge is entitled to substantial deference, including the determination of the common issues and the determination of preferrable procedure: Price v. Lundbeck , 2020 ONSC 913 (Div. Ct.), at para. 17 . [ 37 ] There is no issue that if the requirements of s. 5 of the Act are met, an action shall be certified. [ 38 ] The appellants submit that the Class Proceedings Judge erred as follows: (

i) in failing to give due regard for the findings in the first Divisional Court decision; (ii) in finding that there was no common issue as required under s. 5(1)(

c) of the Act; (iii) in finding that the proposed class proceeding was not the preferrable procedure for the resolution of the common issues under s. 5(1)(

d) of the Act (iv) in the finding that the proposed litigation plan was inadequate; and, (

v) if the class action were to be certified, in excluding the proposed direct claims by children.

(1) Due regard for prior Divisional Court decision [ 39 ] The appellants submit that the Class Proceedings Judge erred by conducting a rehearing of all matters in the certification motion. [ 40 ] The Class Proceedings Judge did not err. The Divisional Court held, at para. 49, that the certification motion “must be heard afresh”. This was subject only to the binding determination on the general causation issue.

On that issue, the Class Proceedings Judge recognized, at paras. 72-73, that the Divisional Court had determined the substantive issue that the proposed common issue advanced by the appellants “included an aspect of general causation”. The Divisional Court expressly declined to decide whether or not the certification criteria were satisfied.

As required, the Class Proceedings Judge heard the certification motion afresh, subject to the Divisional Court decision on causation. [ 41 ] The appellants also submit that the Class Proceedings Judge ought to have considered himself bound by a finding of Perell J. in the first certification decision. In particular, Perell J. found that there was some basis in fact for the duty to warn issue (but he also found that the duty to warn was not a common issue). The Class Proceedings Judge was not bound by isolated findings in the original certification decision.

He was obliged to, and did, consider the matter afresh. [ 42 ] The appellants also submit that the Class Proceedings Judge ought to have given effect to the Divisional Court decision in the same way as was done in Singh v Glaxosmithkline , 2022 ABKB 762 , [2023] A.W.L.D. 1677. That Alberta case was released during the argument before the Class Proceedings Judge. It was not provided to him and is not addressed in the Decision. In Singh , the motion judge relied on the decision of the Divisional Court in these Ontario proceedings, concluding that the claim should be certified.

Although it involved a different drug, the claim was also based on teratogenicity. [ 43 ] The Singh case is not binding. Further, in Singh , at para. 40 , the motion judge acknowledged that his

interpretation of the Divisional Court decision was broader than the decision itself. He said it would be correct to describe the issue before the Divisional Court more narrowly. However, in his view, the decision supported certification. The decision in Singh shows a different approach but it does not show that the Class Proceedings Judge erred in his application of the decision of the Divisional Court.

(2) Common issues [ 44 ] The appellants submit that the Class Proceedings Judge erred in concluding that even if they succeeded in showing that Celexa® is a teratogen that would not advance the individual class members’ claims. The appellants suggest that the first Divisional Court decision addressed this issue. As discussed above, it did not do so.

The appellants also rely on the Singh decision, in which the certification judge interpreted the Divisional Court’s decision broadly, discussed above. [ 45 ] The appellants further submit that the Class Proceedings Judge wrongly decided an issue on the merits – specifically, that there was “no chance of success” because finding any duty of care would require that the duty be limited to a particular malformation. That legal conclusion does not appear in the Decision. [ 46 ] The essence of the appellants’ submission is that the Class Proceedings Judge misinterpreted Hollis .

As the appellants submitted to the Class Proceedings Judge in the certification motion, they submit on the appeal that Hollis mentions general risks, not only specific risks, and the duty to warn is not limited to specific risks. Hollis does mention general risk when considering the learned intermediary rule. That rule allows a manufacturer to rely on warnings given to doctors rather than directly to the patient.

The Supreme Court found, at para. 31, that a manufacturer could discharge its duty to the ultimate consumer by giving the physician the required information about any “general and specific risks that arise from the ordinary use of the product.” The Class Proceedings Judge considered this very argument as well as other arguments made at the certification motion about the legal framework that applied to the claim. It was not improper to do so.

Nor have the appellants shown a legal error about the duty to warn in the Decision. [ 47 ] The appellants’ submissions fail to address the basis for the decision about the common issue requirement. The Class Proceedings Judge concluded that the appellants had not met the low threshold to show some basis in fact that either step in the proposed

common issue should be certified under s. 5(1)(

c) of the Act. There were hundreds of potential congenital malformations The risk applied to all pregnancies. There were hundreds of different malformations and no common etiology. The option of narrowing the issues was not available. The proposed common issue seized on superficial commonality, as cautioned against in Rumley . The appellants have not shown that there was a reviewable error in the conclusion on s. 5(1)(c).

(3) Preferable procedure [ 48 ] The appellants acknowledge that preferability under s. 5(1)(

d) is considered discretionary and would ordinarily be owed some deference on appeal. However, they submit that the preferability analysis is coloured by the common issues analysis. However, the appellants failed to show error in the common issue analysis. [ 49 ] The appellants further submit that the Class Proceedings Judge saw the preferable procedure analysis as “entirely superfluous”. I disagree.

As it shown in the reasons for the Decision, the Class Proceedings Judge considered the relevant factors in the exercise of his discretion and expressly considered whether the proposed class action was preferable even if there was a common issue. [ 50 ] The appellants submit that the Class Proceedings Judge ought to have done a comparative analysis between the proposed class action and alternatives to the proposed class proceeding as set out in AIC Limited v. Fischer , 2013 SCC 69 , [2013] 3 S.C.R. 949.

The Class Proceedings Judge addressed that issue, following both AIC , at para. 48, and Amyotrophic Lateral Sclerosis , at para. 62. The court must be, and was not, satisfied that a class proceeding would be fair, efficient and manageable. [ 51 ] The Class Proceedings Judge articulated the many individual issues, where were vast in number, complex and idiosyncratic individual issues.

He found as follows, at para. 200: Given that each of the hundreds of malformations has its own unique etiology, epidemiological data, set of risk factors, and criteria for screening and diagnosis, the nature of the individual inquiries is particularly complex and unique. There are no known teratogens capable of causing all congenital malformations.

The plaintiffs did not pursue a general causation issue linked to a particular congenital malformation or type of congenital malformation. [ 52 ] The Class Proceedings Judge found that even if the proposed common issue were found to advance the litigation, any such advance would be peripheral and minor. He followed Hollick , in which the Supreme Court held that the question of preferability must take into account the importance of the common issues in relation to the claims as a whole.

The Class Proceedings Judge found that the individual issues would overwhelm any benefit from a common determination of teratogenicity and a concomitant duty to warn of general teratogenicity. He made no legal error in the exercise of his discretion. [ 53 ] The appellants have not shown that the Class Proceedings Judge made a legal error with respect to his conclusions on either s. 5(1)(

c) or s. 5(1)(

d) of the Act. If the Divisional Court were to uphold the Class Proceeding Judge's findings with respect to even one of those two subsections, the appeal would be dismissed. Here, the appellants have not shown that the appeal should be granted on either one. Other issues [ 54 ] As a result of the above conclusions, I need not address the remaining issues regarding the litigation plan and the class definition. Order [ 55 ] This appeal is denied. As agreed between the parties, there shall be no order as to costs. ___________________________ Matheson J. I agree ___________________________ J.A. Ramsay J. I agree ___________________________ Schabas J.

Date: February 13, 2024 CITATION : Price v. Lundbeck, 2024 ONSC 845 DIVISIONAL COURT FILE NO.: 032/23 DATE: 20240213 ONTARIO SUPERIOR COURT OF JUSTICE DIVISIONAL COURT J.A. Ramsay, Matheson and Schabas JJ. BETWEEN: JENNIFER PRICE and MATTHEW JANZIC by his Litigation Guardian JENNIFER PRICE Appellants – and – H LUNDBECK A/S and LUNCBECK CANADA INC. Respondents REASONS FOR DECISION Matheson J. Date of Release: February 13, 2024