MacInnis v Bayer Inc., 2023 SKCA 37

Court of Appeal for Saskatchewan Docket: CACV3740 Citation: MacInnis v Bayer Inc. , 2023 SKCA 37 Date: 2023-03-20 Between: Amanda MacInnis Applicant/Appellant (Plaintiff) And Bayer Inc. and Bayer Healthcare LLC Respondents/Respondents (Defendants) Before: Caldwell, Barrington-Foote, and Tholl JJ.A. Disposition: Appeal allowed Written reasons by: The Court On appeal from: 2020 SKQB 307 , Regina Appeal heard: May 13, 2022 Counsel: E.F. Anthony Merchant, K.C., and Anthony Tibbs for the Appellant William McNamara, Nicole Mantini, and Alicja Puchta for the Respondents The Court I.

INTRODUCTION [ 1 ] Amanda MacInnis is the proposed representative plaintiff in an action that seeks to become a class action. Her certification application was dismissed with costs: MacInnis v Bayer Inc ., 2020 SKQB 307 [ Chambers Decision ]. As a result, she has appealed to this Court and raises a variety of concerns about the determinations made by the Court of Queen’s Bench Chambers judge. Ms.

MacInnis’s arguments focus on the Chambers judge’s assessment of the common issues, his failure to amend the common issues, his determination regarding the preferable procedure, and the award of costs. [ 2 ] In support of her appeal, Ms. MacInnis filed a fresh evidence application, which the Court dismissed orally. [ 3 ] For the reasons that follow, the appeal is allowed, and the matter is remitted to the Court of King’s Bench. II. BACKGROUND [ 4 ] The Essure Permanent Birth Control System [Essure] is a contraceptive device for women, which was designed, developed, and marketed by one or both of the respondents.

It consists of two metal coils that are inserted into a patient’s fallopian tubes by a physician, typically in a medical office on an out-patient basis. The insertion of the product results in a blockage of the fallopian tubes that is irreversible. Essure was approved for use in Canada in 2002. [ 5 ] In April of 2012, Ms. MacInnis was implanted with the Essure device. She alleges that, shortly after implantation, she suffered sharp pain and discomfort in her pelvic region. Ms.

MacInnis further asserts that she experienced, among other things, irregular menstrual cycles, dyspareunia, and significant cramping, pain, and bloating. The device was removed in September of 2014, when she had a total hysterectomy. Her symptoms were considerably reduced after surgery. [ 6 ] On March 12, 2015, Ms. MacInnis and another plaintiff caused a statement of claim to be issued, seeking damages and other relief in relation to Essure. The claim was amended over time, resulting in a third amended statement of claim.

At some point, the other plaintiff determined that she no longer wished to serve as a representative plaintiff. As a consequence, she was removed from being considered as a plaintiff for purposes of the certification application: Stout v Bayer Inc. , 2017 SKQB 329 at para 3 , 19 CPC (8th) 416, and the Chambers Decision at para 6. [ 7 ] On April 26, 2016, Ms. MacInnis applied to have her action certified as a class action pursuant to s. 6 of The Class Actions Act , SS 2001, c C-12.01 [ CAA ].

In support of her application, she filed her own affidavit plus two affidavits from Anick Bérard, Ph.D., an affidavit from Brendon Ralfe, and an affidavit from Lenitta Covill (not included in the appeal book). Dr. Bérard is an epidemiologist and a full professor of perinatal pharmacoepidemiology at the Faculty of Pharmacy of the Université de Montréal. She is also an adjunct professor at universities in France and China. Mr. Ralfe was an information technology manager at the law firm engaged by Ms. MacInnis. Ms. Covill is a legal assistant at the same law firm. Ms.

MacInnis also filed an affidavit from Sara Brown in which Ms. Brown averred that she had been implanted with Essure in June of 2015 and stated her agreement to be a representative plaintiff. However, there was no formal request to add Ms. Brown as a plaintiff to the action. [ 8 ] The respondents filed three affidavits from Jay Goldberg, M.D., an affidavit from Robert Sabbah, M.D., an affidavit from Anne Tomalin, and an affidavit from Sancia Thompson (not included in the appeal book). Dr.

Goldberg is the vice chair of Obstetrics and Gynecology and the director of the Fibroid Center at the Einstein Healthcare Network. He is also the director of research for that organization. Dr. Sabbah is the chief of gynecology at Hôpital du Sacré-Coeur in Montréal and a clinical assistant professor at the Université de Montr éal. Ms. Tomalin is the president of Therapeutic Products Inc., a consulting firm that provides services to the health

care industry. Ms. Thompson is a legal assistant at the law firm that represents the respondents. [ 9 ] Some of the affiants were cross-examined, and transcripts of the cross-examinations were provided as part of the evidence. Responses to undertakings from Mr. Ralfe were also filed. III. DECISION IN THE COURT OF Queen’S BENCH [ 10 ] The certification hearing commenced on October 16, 2019.

On November 20, 2020, the Chambers judge rendered the Chambers Decision in which he dismissed the application in its entirety. [ 11 ] After a brief introduction, the Chambers judge reviewed the pleadings and summarized the claim and the causes of action. As part of that description, he characterized the core of the causes of action in the following terms: “Bayer designed and developed a medical device that, either through design deficiencies or inadequate training of attending physicians, was dangerous to the women who were treated with it.

The allegations of false labelling, marketing and advertising, asserted through other common law and/or statutory causes of action, also rest on this premise” (at para 12). [ 12 ] The Chambers judge set out the six proposed common issues, which, after taking into account proposed or required amendments, consisted of the following (at paras 16–18): 1. Did Essure pose an unreasonable risk of bleeding, bloating and other side effects? 2. Did Essure have any benefits that were unique to Essure or that exceeded the benefits of other artificial birth control procedures? 3.

Having regard to the answers to common issues 1 and 2, did the defendants breach the standard of care by distributing Essure for sale in Canada? 4. If the answer to common question 3 is no, and having regard to the answer to common question 1: (

a) Did the Essure directions for use provide reasonable instructions for using Essure and for managing the risks of bleeding, bloating and other side effects? (

b) Did the Essure directions for use provide a clear, current and complete warning of the risks of bleeding, bloating and other side effects? 5. Should the defendants account for and disgorge all or any of their revenues from selling Essure in Canada? If so, to whom, for what period, in what amount and, if distributed in the aggregate, on what basis? 6.

Does the manner in which the defendants marketed Essure in Canada warrant an award of punitive damages, and, if so, how much should be awarded and to whom and on what basis should they be distributed? [ 13 ] The evidence of each party was comprehensively canvassed by the Chambers judge. He then began his analysis by setting out the general requirements for certification as found in s. 2 (definitions) and s. 6(1) of the CAA :

Interpretation 2 In this Act … “common issues” means: (

a) common but not necessarily identical issues of fact; or (

b) common but not necessarily identical issues of law that arise from common but not necessarily identical facts … . … Class certification 6

(1) Subject to subsections (2) and (3), the court shall certify an action as a class action on an application pursuant to

section 4 or 5 if the court is satisfied that: (

a) the pleadings disclose a cause of action; (

b) there is an identifiable class; (

c) the claims of the class members raise common issues, whether or not the common issues predominate over other issues affecting individual members; (

d) a class action would be the preferable procedure for the resolution of the common issues; and (

e) there is a person willing to be appointed as a representative plaintiff who: (

i) would fairly and adequately represent the interests of the class; (ii) has produced a plan for the class action that sets out a workable method of advancing the action on behalf of the class and of notifying class members of the action; and

(iii) does not have, on the common issues, an interest that is in conflict with the interests of other class members. [14] The Chambers judge emphasized the need to assess the requirements from s. 6(1) in a purposive way that serves the threeaccepted goals of class proceedings: judicial economy, access to justice, and behaviour modification.

He discussed the purpose and focusof a certification hearing and, in paragraphs 103–106, the some basis in fact test, as set out in Hollick v Toronto (City), 2001 SCC 68,[2001] 3 SCR 158 [Hollick], and examined in Ramdath v George Brown College, 2010 ONSC 2019, 93 CPC (6th) 106 [Ramdath], Pro-Sys Consultants Ltd. v Microsoft Corporation, 2013 SCC 57, [2013] 3 SCR 477 [Pro-Sys], Pederson v Saskatchewan (Minister of SocialServices), 2016 SKCA 142, 408 DLR (4th) 661 [Pederson], leave to appeal to SCC refused, , and G.C. v MerckCanada Inc., 2019 SKQB 42 [G.C.]. He then rejected Ms.

MacInnis’s submission that medical device cases or medical product cases (orboth) are categorically certifiable. In doing so, the Chambers judge noted that there is no shortcut to certification. [15] The analysis then turned to a general discussion of the probative value of expert evidence. The Chambers judge, relying onWiegers v Apple, Inc., 2020 SKQB 24, noted that such evidence must be viewed in a certification hearing through a lens that is palpablydifferent than that which would be used at trial. [16] Pivoting to an examination of s. 6(1)(

a) of the CAA – whether the pleadings disclose a cause of action – the Chambers judgeemployed the plain and obvious test. After doing so, and noting some flaws in the statement of claim, he determined that, with oneexception, it was not plain and obvious that the claim did not disclose the causes of actions pleaded. The Chambers judge found that oneof the causes of action, the waiver of tort claim, had to be discarded, as per Atlantic Lottery Corp. v Babstock, 2020 SCC 19, 447 DLR(4th) 543 [Atlantic Lottery], and could not survive the certification process.

Otherwise, the causes of action pleaded met the requirement ofs. 6(1)(a). With regard to s. 6(1)(b) – an identifiable class – the Chambers judge was satisfied that there was an identifiable class. [17] The most contentious portion of the Chambers Decision is the Chambers judge’s analysis of s. 6(1)(

c) of the CAA. That sectionrequires the claim to raise common issues. The Chambers judge noted the definition of common issues in s. 2 of the CAA, canvassedjurisprudence establishing that the common issues requirement is at the heart of a class action certification proceeding, and, referencingFulawka v Bank of Nova Scotia, 2012 ONCA 443, 352 DLR (4th) 1, leave to appeal to SCC refused, [Fulawka], andPederson, set out eight principles that are typically engaged in this part of a certification analysis.

He found that the some basis in fact testwas the proper test to apply and addressed several nuances of the required analysis. The Chambers judge then turned to a specificassessment of each proposed common issue, noting that the first three were pivotal, with the remaining ones fundamentally depending onthe certification of them. After an examination of the proposed common issues, he rejected each one. The details of why he did so aremore fully discussed under the related grounds of appeal. [18] With regard to the preferable procedure – s. 6(1)(

d) of the CAA – the Chambers judge noted that, in the absence of commonissues, “the preferable procedure criterion has not been met” (at para 196). However, he determined that it was appropriate to continue hisanalysis and address this aspect of the application.

After reviewing the general principles, the Chambers judge stated that, even if he “hadcertified any of the proposed common issues”, he would not have found a class action to be the preferable procedure (at para 203). [19] For the last substantive part of his s. 6(1) analysis – the requirement for an appropriate representative plaintiff as set out ins. 6(1)(e) – the Chambers judge determined only the suitability of the proposed litigation plan was in question.

After stating the applicableprinciples, the Chambers judge concluded that the proposed litigation plan was rather general in nature but found he would be “hard-pressed to derail certification” on this basis alone “if the other required criteria had been met” (at para 210). Instead, he made no specificruling on this aspect, noting that Ms. MacInnis would be well-advised to file a revised litigation plan if the matter were to be remitted tohis court after the anticipated appeal. [20] The certification application was dismissed.

Costs for the application, under Column 3 of the Tariff of Costs, were awarded tothe respondents. IV. ISSUES [21] Leave to appeal was granted on March 30, 2021: MacInnis v Bayer Inc. (30 March 2021) Regina, CACV3740 (Sask CA). [22] The grounds of appeal, as restated by Ottenbreit J.A., are as follows (at para 26): 1. The Chambers judge erred by impermissibly weighing evidence and making factual findings as to the merits of the claims rather thanapplying the “some basis in fact” approach to the evidence; 2. The Chambers judge erred by concluding that the common issues were stated too broadly; 3.

The Chambers judge erred by finding that the common issues lacked commonality in that they called for an individual inquiry; 4. The Chambers judge erred by finding the preferable procedure requirement had not been met as the issues necessitated inherentlyindividualistic inquiries; 5. The Chambers judge erred by misdirecting himself as to the nature of the “plausible methodology” required for certification of thecommon issues and by concluding that the evidence disclosed no plausible methodology respecting those issues; 6.

The Chambers judge erred by conflating the medical “standard of care” with the legal “duty of care” analysis, with respect to commonissue #3; 7. The Chambers judge erred by failing to certify common issue #4 as a duty to warn on its own independently from the other commonissues; 8. The Chambers judge erred by failing to amend the claim and common issues as could be amended; and

9. The Chambers judge erred by awarding costs. V. ANALYSIS A. Fresh evidence application [23] Ms. MacInnis sought to introduce fresh evidence on appeal, pursuant to Rule 59 of The Court of Appeal Rules. That evidenceconsisted of the following: (

a) A February 25, 2022, affidavit of Louis-Paul Marin, an engineer and lawyer, who prepared and submitted a report to theSuperior Court of Québec in an action regarding Essure in Québec. That action was authorized as a class action for class members in thatprovince on March 20, 2019: Letarte c Bayer inc., 2019 QCCS 934 [Letarte]. In his report, Mr.

Marin provided his opinion regarding thisquestion: “In light of the available evidence regarding the occurrence and associated risks of complications in connection with the EssureSystem did the ESSURE IFUs (with IFUs meaning “Instructions for Use”), at all material times, present clear, complete, and currentinformation as to the potential risks?” That report, dated September 15, 2021, was appended to his affidavit. (

b) A February 21, 2022, affidavit of Ernest P. Chiodo, a medical doctor, who also prepared and submitted a report to theSuperior Court of Québec in the Letarte class action. He was asked to “conduct a search of peer reviewed medical literature concerningthe toxicity of ‘Essure’ and provide an opinion”. His report, dated September 8, 2021, was appended to his affidavit. (

c) A February 16, 2022, affidavit of James M. Wheeler, a medical doctor, who also prepared and submitted a report to theSuperior Court of Québec in the Letarte class action. In his report, he responded to the request to provide his opinion in three areas: 1. Describe Essure, including its purpose, indications, use, design, and associated procedures; 2. Outline post-implantation symptoms “caused, exacerbated, or contributed” by Essure; and 3. Propose reasonably expected recoverable damages sustained by women suffering these post-placement consequences of Essureimplantation.

His report, dated September 13, 2021, is appended to his affidavit. [24] All three of the affiants confirmed their opinions as contained in their reports. Each one averred that they had agreed to act as anexpert in the trial of the common issues in the related class action in the Superior Court of Québec and were prepared to act as an expertwitness in the Saskatchewan action. [25] The Court dismissed Ms. MacInnis’s fresh evidence application orally during the course of the appeal hearing.

We did so forthe following reasons. [26] In general, the test for the admission of additional evidence on appeal is as set out in R v Palmer, (SCC), [1980]1 SCR 759 at 775. This approach applies whether a party is asking for fresh evidence or new evidence to be admitted: Barendregt vGrebliunas, 2022 SCC 22 at paras 2–3 and 34, 469 DLR (4th) 1. The four factors that are examined consist of the following: (

a) Could the evidence, by the exercise of due diligence, have been obtained for the original hearing? (

b) Is the evidence relevant in that it bears upon a decisive or potentially decisive issue? (

c) Is the evidence credible in the sense that it is reasonably capable of belief? (

d) Is the evidence such that, if believed, it could have affected the result at the hearing? [27] Despite the use of this test in a wide range of matters, Ms. MacInnis submitted that none of the Palmer criteria apply in anappeal from a certification decision. She contended that the policy reasons encapsulated by that test are not relevant in a class actionproceeding. Ms. MacInnis asserted that the Palmer test is directed towards appeals after trial, not at matters such as the one at hand.

In acertification hearing, she argued, the judge may certify new common issues or decertify a class action based on additional evidence afteran initial hearing and, as a consequence, is obligated to request such new evidence when necessary. She noted that, in such an applicationin the Court of King’s Bench, the new evidence need not be fresh evidence. Ms. MacInnis submitted that this Court should likewisereceive additional evidence in appeals of this nature, without applying the usual test. Other than extensive reference to jurisprudence andsections of the CAA that illustrate the nature of class actions, Ms.

MacInnis provided no authority for her proposition that the Palmer testis not operative in an appeal from a certification decision. Instead, she relied heavily on her submission that “class actions are differentthan ordinary actions” and should be dealt with in a “liberal and flexible manner”. As noted, this action has not been certified as a classaction. [28] We rejected these arguments because, in our view, the Palmer test applies and has not been met. In Pederson, at paragraphs 21–25, this Court dismissed an assertion that is very similar to the one that Ms. MacInnis made.

In doing so, Ottenbreit J.A. stated thefollowing: [24] However, the appellants argue that this Court has the power in a class action appeal to receive further evidence in the same way as adesignated s. 16 judge under the CAA because of ss. 5(1), 10 and 12 of The Court of Appeal Act, 2000, SS 2000, c C-42.1. I disagree. Noneof these sections of The Court of Appeal Act, 2000 allow this Court to treat an application for fresh evidence and the attendant appeal as ahearing de novo, which would be the case if Ms. Fayant’s affidavit was to be considered on this appeal.

An appeal is not a continuation ofthe certification hearing by a s. 16 judge. Nor is an appeal a proceeding where it is necessary for this Court to exercise original jurisdictionwith respect to the certification process in order to decide the appeal.

[29] The Palmer test has also been applied by the British Columbia Court of Appeal and the Alberta Court of Appeal whenconsidering the admission of additional evidence in appeals from orders made in the context of proposed class actions: Harrison v AfexaLife Sciences Inc., 2018 BCCA 165 at para 18, 9 BCLR (6th) 271, leave to appeal to SCC refused, , and T.L. v Alberta(Child Youth and Family Enhancement Act, Director), 2013 ABCA 368 at paras 22–23, 561 AR 297. [30] This Court is exercising appellate jurisdiction, not original jurisdiction, when it considers an appeal from a certificationdecision.

The fact that this action aspires to be a class action does not convert this Court into a court of first instance that may receiveadditional evidence as a matter of course and then, of necessity, consider the application afresh. That would be the effect of acceptingMs. MacInnis’s submissions in relation to the inapplicability of the Palmer test. Such a finding would not respect the need for finality andcertainty that exists even within a proposed class action proceeding nor would it correspond with the proper role of this Court.

Likevirtually all types of litigation, a party is expected to put their “best case forward on the first go around” at a certification hearing andshould not expect to be able to conduct “litigation by instalment” (Bear v Merck Frosst Canada & Co., 2011 SKCA 152 at para 60, 345DLR (4th) 152).

As noted by Ottenbreit J.A. in Pederson, an appeal is not an extension or “continuation of the certification hearing by as. 16 judge” (at para 24). [31] For these reasons, the Palmer test is properly applied in an appeal from a certification decision when a party seeks to tenderadditional evidence. [32] Although all of the Palmer criteria must be considered, the first factor is determinative in this case. The evidence cannot beadmitted because it fails the due diligence criterion. [33] The proffered reports consist of additional expert opinion evidence.

While they are dated after the certification application washeard, that reality does not place them in the same category as averments regarding events that occurred or were discovered after thematter was argued. The reports themselves do not analyze facts that became subsequently known. With the exception of a very smallnumber of marginally relevant publications referred to by Dr. Wheeler and Dr. Chiodo in their reports, the contents of each of the reportsare an examination of the facts and publications that were in existence at the time of the hearing.

Further, there is no explanation in theaffidavits as to why this evidence was not tendered in the Court of Queen’s Bench. [34] Ms. MacInnis contended that if the Court found that the Palmer test applies, the additional evidence is required because theChambers judge changed the law and created a more stringent benchmark for certification in relation to the some basis in fact test and therequired plausible methodology aspect of the certification application.

She says that the proposed evidence was not adduced at thecertification hearing because, based on the state of the law at the time of the hearing, she could not have known that it would be required.Given our conclusions regarding these grounds of appeal at a later point in this judgment, this argument carries no weight. [35] In our view, the tendering of these affidavits on appeal merely represents an attempt to supplement the record in anunacceptable manner.

Evidence of this nature could have been produced for the certification hearing through the exercise of due diligence.It should not be admitted on this appeal. [36] This ruling is without prejudice to Ms. MacInnis’s ability to seek to file this or other evidence in the Court of King’s Benchupon the resumption of the certification hearing in accordance with this judgment. B.

Standards of review [37] The grounds of appeal accepted by Ottenbreit J.A., when granting leave to appeal, allege that the Chambers judge committedvarious errors of law and of mixed fact and law in deciding that the common issue and preferable procedure criteria specified in s. 6(1)(c)and s. 6(1)(

d) of the CAA were not satisfied and in refusing certification for that reason. To reiterate, those provisions are as follows: Class certification 6(1) Subject to subsections (2) and (3), the court shall certify an action as a class action on an application pursuant to

section 4 or 5 if thecourt is satisfied that: … (

c) the claims of the class members raise common issues, whether or not the common issues predominate over other issues affectingindividual members; (

d) a class action would be the preferable procedure for the resolution of the common issues … . [38] A decision by a certification judge as to whether these two criteria are satisfied involves the exercise of discretion. Although itis often said that discretionary decisions are entitled to deference, the fact is that an alleged error by a court in arriving at a discretionarydecision is subject to appellate review in accordance with the appellate standards of review specified in Housen v Nikolaisen, 2002 SCC33, [2002] 2 SCR 235.

As is always the case, the standard of review depends on the nature of the error alleged, not the type of decisionthat was made. The standard of review in relation to alleged errors of law is correctness, where no deference is called for.

An appellatecourt may intervene in a discretionary decision if there has been an error of law, including an error in the identification or application ofthe legal criteria that govern the exercise of the discretion: “Such errors may include a failure to give any or sufficient weight to a relevantconsideration” (Kot v Kot, 2021 SKCA 4 at para 20, 63 ETR (4th) 161). [39] An appellate court may also intervene if there has been a palpable and overriding error of fact or of mixed fact and law: seealso, for example, 676083 B.C.

Ltd. v Revolution Resource Recovery Inc., 2021 BCCA 85 at para 30, 49 BCLR (6th) 101; Ernst & Youngv Koroluk, 2022 SKCA 81 at paras 25–26; Finkel v Coast Capital Credit Union, 2017 BCCA 361 at para 55, 2 BCLR (6th) 300; AICLimited v Fischer, 2013 SCC 69 at para 65, [2013] 3 SCR 949 [Fischer]; and Lewis v WestJet Airlines Ltd., 2022 BCCA 145 at paras 30–31, 468 DLR (4th) 713. However, an appellate court is not entitled to substitute its own decision for that of the judge merely because itwould have exercised the discretion differently: Friends of the Oldman River Society v Canada (Minister of Transport),

(SCC) , [1992] 1 SCR 3 at 76–77. C. Identification and application of the some basis in fact test [ 40 ] Ms. MacInnis submits that the Chambers judge erred by creating a new and more onerous test with regard to the common issues criteria specified in s. 6(1) (

c) of the CAA . She also asserts that he erred by impermissibly weighing the expert evidence and resolving conflicts in the evidence. Ms. MacInnis contends that, in doing so, the Chambers judge misapplied the some basis in fact test and created a higher hurdle for certification than is set out in the leading cases.

The respondents disagree, arguing that the Chambers judge identified and applied the correct evidentiary test. [ 41 ] The issue of whether the Chambers judge adopted and applied the correct test when examining the evidence at the certification hearing is a question of law that is reviewable on the correctness standard. [ 42 ] We begin by observing that Ms. MacInnis does not identify any errors in the test that the Chambers judge identified and articulated regarding the assessment of the evidence related to the common issues.

He noted that the burden on an applicant is not onerous and that the some basis in fact test is the applicable standard to meet. A reference to the reasoning by Strathy J. (as he then was) at paragraph 40 of Ramdath highlighted the Chambers judge’s understanding that “certification is not a test of the merits” of the action ( Chambers Decision at para 103). The Chambers judge traced the history of the some basis in fact test and rejected the notion that it is equivalent to proof on a balance of probabilities.

He referenced and quoted extensively from the leading cases of Hollick , Pro-Sys , and Pederson and clearly set out the correct test: see paragraphs 101–106. When he returned to his assessment of the common issues, the Chambers judge reiterated these same principles and referred to them extensively in his analysis: see paragraphs 140–146. In doing so, he acknowledged the limited purposes to which evidence can be put in determining a certification application. [ 43 ] However, Ms.

MacInnis asserts that, while the some basis in fact test may have been properly set out in the Chambers judge’s general review of the law, he erred because he applied a different and more onerous test when he conducted his analysis. She argues that he inappropriately delved into the merits and resolved conflicts in the evidence in favour of the respondents. [ 44 ] Many of Ms. MacInnis’s concerns arise out of the

summary of the evidence by the Chambers judge in paragraphs 19–99 of the Chambers Decision . Ms. MacInnis says that parts of that

summary represent a weighing of the evidence, a resolution of conflicts in the evidence, and an acceptance of Dr. Sabbah’s evidence in preference to her own expert evidence. She refers generally to paragraphs 30–98 and specifically to paragraphs 98 and 99 as indicative of these alleged defects. Those latter paragraphs are as follows: [98] As for the evidence presented by the plaintiff, Dr. Sabbah was extremely critical of the conclusion, drawn from Dr.

Bérard’s evidence, that the presence of certain symptoms necessarily identifies a direct relationship between those symptoms and the placement of the Essure device. In Dr. Sabbah’s opinion, such a conclusion ignores the possible association of comorbidities which may be more causative of the symptoms in question. One particular factor that Dr. Sabbah isolated was the use of oral contraceptives prior to the placement of Essure, and the impact that may have. On this point, Dr. Sabbah deposed to the following at para. 25 of his affidavit: 25.

Simply because a patient reports symptoms does not mean that those symptoms have a direct relationship with Essure. For example, many women who experience abnormal uterine bleeding or premenstrual symptoms elect to use oral contraceptives to alleviate the symptoms. As they age, they may decide to cease using oral contraceptives and proceed to a more permanent method of birth control, such as Essure.

Many of the symptoms the women previously experienced reappear because they have stopped oral contraceptive use; however, because the symptoms also coincide with the implantation of an Essure device, some of these women may erroneously blame Essure for their symptoms even though the symptoms are not caused by Essure. [99] Finally, Dr. Sabbah was also asked to address the May 2016 Notice from Health Canada. In his experience, the risks and potential adverse events referenced in the notice were well known to Canadian gynecologists at the time the notice was published.

From the perspective of a Canadian gynecologist experienced with Essure, Dr. Sabbah deposed to his understanding that the purpose of the notice was to ensure that Canadian patients were fully informed by their physicians of the potential risks and complications associated with the device before undergoing placement. [ 45 ] In our view, Ms. MacInnis’ assertions about an improper assessment of the evidence have no merit.

While the Chambers judge did note that there was varying expert evidence, he did not go so far as to analyze which evidence should be given more weight nor did he make any findings of the nature asserted by Ms. MacInnis. Rather, as we read this portion of his reasons, the Chambers judge was summarizing, taking inventory of and noting important aspects of the evidence as a whole to aid in his later analysis of whether there was some basis in fact to support certification. He was careful to use phrases such as “In Dr. Sabbah’s opinion” and “Dr.

Sabbah deposed” to distinguish his narration of the evidence itself from any findings of fact made on the basis of that evidence. The Chambers judge did not say that he found one expert witness to be more credible or reliable than the other. He made no comments that can be characterized as weighing evidence, expressing preference for one witness over another, or assessing merit in the impugned paragraphs. As we interpret his reasons, he had not reached any conclusions at this point in his judgment.

It cannot be an error to accurately, even exhaustively, set out each party’s evidence to assist in analyzing the issues to which it relates. [ 46 ] For these reasons, it is our view that, based on the Chambers Decision as a whole, the Chambers judge did not create a new and more onerous test with regard to the common issue criteria, nor did he impermissibly weigh the expert evidence or resolve conflicts in the evidence. In the result, we cannot give effect to this ground of appeal. D. Common issues #1 and #4: Overbreadth and the potential for reformulation to cure the defect [ 47 ] Ms.

MacInnis submits that the Chambers judge erred by concluding that proposed common issues #1 and #4 were stated too broadly. More specifically, it is her view that the Chambers judge adopted a requirement that the adverse side effects referred to in these common issues had to be “specifically described” (at para 186), and, by doing so, he erred in law by adopting the wrong legal test. She

contends that a common issue can be certified in a product liability case even though it is not clear from the outset what adverse sideeffects, in the end, will have been caused by the product.

She cites Pardy v Bayer Inc., 2004 NLSCTD 72, 237 Nfld & PEIR 179, Walls vBayer Inc., 2005 MBQB 3, [2006] 4 WWR 720, Boulanger v Johnson & Johnson Corporation, (Ont Sup Ct), leave toappeal to Ont Sup Ct (DC) refused, 2007 CarswellOnt 3360 (WL), Heward v Eli Lilly & Company, (Ont Sup Ct), aff’d(2008), (ON SCDC), 239 OAC 273 (Sup Ct (DC)), and Williamson v Johnson & Johnson, 2020 BCSC 1746, as casesin which courts certified common issues similar to proposed common issues #1 and #4. [48] In reply, the respondents submit that the Chambers judge identified and applied the correct legal test.

They argue that thecommon issues as pleaded were fundamentally flawed because it would not have been possible to determine (

a) what was an unreasonablerisk, and (

b) what is meant by other side effects. [49] In the alternative, Ms. MacInnis asserts that, if the Chambers judge did not err in concluding that the description of adverse sideeffects in proposed common issues #1 and #4 was too vague, he should have ordered that the issues be modified or sought submissions ashow they could be modified to cure the defects. [50] We will begin by restating proposed common issues #1 and #4 for ease of reference: 1. Did Essure pose an unreasonable risk of bleeding, bloating and other side effects? … 4. If the answer to common question 3 is no, and having regard to the answer to common question 1: (

a) Did the Essure directions for use provide reasonable instructions for using Essure and for managing the risks of bleeding, bloating andother side effects? (

b) Did the Essure directions for use provide a clear, current and complete warning of the risks of bleeding, bloating and other sideeffects? [51] Dealing first with the allegation that the Chambers judge adopted a new legal test, there is no doubt that he concluded that thereference to risk of “bleeding, bloating and other side effects” was too broad to be certified. Indeed, he used the precise language identifiedby Ms.

MacInnis – specifically described – when recounting this defect in relation to common issue #4: [186] I should also comment that, aside from the faulty presumption described above, proposed common issue 4 suffers from the sameproblem as proposed common issue 1 in that it is overly broad. To state the obvious, it simply repeats the overly broad description ofadverse events and side effects. In the context of measuring the reasonableness of the manufacturer’s warnings, I am satisfied that theinjury or damage forming the subject of the warning must be specifically described.

For example, in Tluchak [2018 SKQB 311],Barrington-Foote J.A. certified a common issue that questioned whether the manufacturer of Xarelto had provided a reasonable warningthat the drug could cause serious and irreversible bleeding. (Emphasis added) Further, although he did not use the phrase specifically described when dealing with the overbreadth issue in relation to proposed commonissue #1, he expressed the same substantive concern as to the lack of specificity. [52] That is demonstrated by the Chambers judge’s conclusions on this point: [160] With respect to the exceptional breadth of proposed common issue 1, its description of the adverse events “bleeding, bloating andother side effects” begs more questions than it answers.

No definition or meaning is given to the phrase “other side effects”. One isobliged to ask whether the phrase is intended to include adverse events that bear no resemblance to, or are not associated with, thespecifically identified risks of “bleeding” and “bloating”. [161] In my view, this proposed common issue does not contain the kind of specificity called for in the referenced authorities, particularlythe decisions in AstraZeneca [2012 ONSC 2744] and Schroeder [2011 SKCA 106], decisions which contain accurate statements of theapplicable principle.

Moreover, and with the possible exception of the decision in Wheadon [2004 NLSCTD 72], I find that the authoritiescited by the plaintiff do not assist her case on this point, either. In both Heward and Boulanger, the respective case management judgeswere careful to ensure that the disease or injury alleged to have been caused by the relevant drug was narrowly described. (Emphasis added) [53] The first question that must be answered, then, is whether the Chambers judge erred in law by adopting a new legal test. In ourview, he did not.

The requirement for clarity in a common issue as to the existence of risks arising from the ordinary use of a productresults from the purpose of common issues. The following was noted by Rothstein J. in Pro-Sys: [106] The commonality requirement has been described as “[t]he central notion of a class proceeding” (M.A. Eizenga et al., Class ActionsLaw and Practice (loose-leaf), at p. 3-34.6).

It is based on the notion that “individuals who have litigation concerns ‘in common’ ought tobe able to resolve those common concerns in one central proceeding rather than through an inefficient multitude of repetitive proceedings”(ibid). [54] In order to achieve this goal, the law requires that a common issue be common to all claims and that its resolution will advancethe litigation for (or against) the class or, as applicable, subclass: Harrington v Dow Corning Corporation, (BC SC),[1996] 8 WWR 485 (BCSC) at para 47 [Harrington], aff’d 2000 BCCA 605, 193 DLR (4th) 67 [CA-Harrington], leave to appeal to SCCrefused, [2001] SCCA No 21 (QL), and Vivendi Canada Inc. v Dell’Aniello, 2014 SCC 1 at paras 41–46, [2014] 1 SCR 3 [Vivendi].

InWestern Canadian Shopping Centres Inc. v Dutton, 2001 SCC 46, [2001] 2 SCR 534 [Dutton], McLachlin C.J.C. summarized theseprinciples as follows:

39 … there must be issues of fact or law common to all class members. Commonality tests have been a source of confusion in the courts. The commonality question should be approached purposively. The underlying question is whether allowing the suit to proceed as a representative one will avoid duplication of fact-finding or legal analysis. Thus an issue will be “common” only where its resolution is necessary to the resolution of each class member’s claim. It is not essential that the class members be identically situated vis-à-vis the opposing party.

Nor is it necessary that common issues predominate over non-common issues or that the resolution of the common issues would be determinative of each class member’s claim. However, the class members’ claims must share a substantial common ingredient to justify a class action. 40 … with regard to the common issues, success for one class member must mean success for all.

All members of the class must benefit from the successful prosecution of the action, although not necessarily to the same extent. [ 55 ] These goals will only be served by a common issue if it is stated with sufficient particularity that it will produce a meaningful answer to a material question that must be addressed to decide the claim. Chief Justice McLachlin noted why this is so in Rumley v British Columbia , 2001 SCC 69 , [2001] 3 SCR 184 [ Rumley ]: 29 … a court should avoid framing commonality between class members in overly broad terms.

As I discussed in Western Canadian Shopping Centres , [2001 SCC 46], at para. 39, the guiding question should be the practical one of “whether allowing the suit to proceed as a representative one will avoid duplication of fact-finding or legal analysis”. 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.

That the suit had initially been certified as a class action could only make the proceeding less fair and less efficient. [ 56 ] It is common for manufacturers and distributors of drugs and medical devices, faced with claims of this kind, to plant their flag on this hill, asserting that there are too many differing adverse effects or too many different factors that affect the risk to and effect on individual users to identify common issues that will avoid duplication in this way. [ 57 ] How, then, do these principles play out in this case? Ms.

MacInnis’s proposed class action is based on the allegation that there are risks of adverse side effects inherent in the ordinary use of Essure. In order to answer this general causation question, the nature and extent of those adverse effects must be identified with sufficient precision to enable the parties to prove and the court to determine whether those effects do or do not exist and be of use in advancing the claims made by Ms. MacInnis and the other class members.

She asserts that the warning to consumers was not sufficiently clear and detailed to comply with the duty to warn of the alleged risk of adverse side effects, such as excessive bleeding or bloating. In the alternative, she claims that Essure should not have been marketed at all or should have been withdrawn from the market, as it was unreasonably dangerous.

Clearly, the answer to so general a question as “Is there a risk of side effects?” or “Is there a risk of adverse effects?” would not advance these claims. [ 58 ] For these reasons, the Chambers judge did not err in law by requiring that the adverse effects of Essure be described with sufficient particularity or specificity. Nor did he commit a palpable and overriding error of mixed fact and law by finding that proposed common issues #1 and #4 were too broad to meet this standard because they asked if there was a risk of “other side effects”. [ 59 ] As Ms.

MacInnis notes, courts have certified common issues that, on the face of it, have similar characteristics to proposed common issues #1 and #4 in terms of their lack of specificity.

Although that is so, appellate courts have also denied leave to appeal or upheld the refusal by certification judges to certify common issues that have similar characteristics: see, for example, Brooks v Canada (Attorney General) , 2009 SKQB 509 , [2010] 6 WWR 81, leave to appeal to Sask CA refused, 2010 SKCA 55 ; Schroeder v DJO Canada, Inc. , 2010 SKQB 125 , [2010] 10 WWR 324, aff’d 2011 SKCA 106 , [2012] 1 WWR 485 [ Schroeder ]; Martin v Astrazeneca Pharmaceuticals Plc ., 2012 ONSC 2744 , 27 CPC (7th) 32, aff’d 2013 ONSC 1169 (Sup Ct (Div Ct) [ Astrazeneca ]; and Sweetland v GlaxoSmithKline Inc., 2016 NSSC 18 , 80 CPC (7th) 251 [ Sweetland ].

This reflects the requirement that every certification application must be determined based on its own unique circumstances, including the pleadings, the evidence relied upon to demonstrate some basis in fact, and the manner in which the application is cast. For that reason, the fact that a common issue has been certified in one case does not mean a similarly worded common issue must be certified in another: Astrazeneca at para 226. [ 60 ] This leaves the alternative ground of appeal advanced by Ms. MacInnis.

She suggests if, as we have determined, the Chambers judge did not err in finding common issues #1 and #4 were overly broad, then we should conclude he nonetheless erred by failing to order that the pleadings be modified in a manner that would have cured the defect or by failing to adjourn the application to permit her to propose amendments and to file additional evidence. She notes that s. 7(1) of the CAA authorizes a certification judge to make the latter form of order: Certification application 7

(1) The court may adjourn the application for certification to permit the parties to amend their materials or pleadings or to permit further evidence to be introduced. [ 61 ] This ground of appeal constitutes an allegation that the Chambers judge committed an error of mixed fact and law. Accordingly, it, too, is reviewable on the palpable and overriding error standard. [ 62 ] The core of the argument advanced by Ms. MacInnis in this context is that certification is not an all-or-nothing proposition: this means if a narrower certification order is possible, a judge is obliged to make it.

This would include an order by a certification judge reformulating the proposed common issues of their own accord or an order seeking input and further submissions and material from the plaintiff as to how that could be achieved. She relies on Canada v Imperial Tobacco , 2011 SCC 42 at paras 19–21 , [2011] 3 SCR 45, Schroeder at paras 93–96, and Sweetland at paras 60–64 and 80 as authority for these propositions. [ 63 ] The respondents disagree. They submit that the role of a certification judge is to assess the claim as it is pleaded and argued.

While they acknowledge that a judge can flexibly exercise judicial discretion when it comes to the formulation of common issues, they submit that modifications to the original proposed issues cannot be stretched to the point of requiring a re-imagining or a re-drafting of the claim. In their view, the power to alter the wording of a proposed common issue must be exercised only exceptionally and with great

caution. [64] Ms. MacInnis did not advance this alternative argument in the Court of Queen’s Bench. She did not ask the Chambers judge toamend the proposed common issues or to adjourn the certification hearing to enable her to propose amendments. However, while the lackof a request for this remedy at the certification hearing would, depending on the circumstances, justify a failure to make such an order insome circumstances, it is of no significance here. The Chambers judge was well aware he had the authority to make an order that wouldcure the defects in common issues #1 and #4.

That is demonstrated by his review of the reasoning on this point in Schroeder and by thefact that he considered this option in relation to proposed common issue #1 and chose to reject it. He explained his conclusion in this way: [162] As a final comment on the exceptional breadth of proposed common issue 1, I am not satisfied that the deficiency in it can beaddressed with the same kind of modification as was applied in Schroeder. It must be remembered that the applicable common issue thereinvolved only one adverse event … .

As such, the easily worded modification allowed the case management judge to achieve the requiredcommonality. [163] That is not the situation in the present case. In this respect, it must be remembered that the FDA [United States Food and DrugAdministration] Review, which was part of the plaintiff’s evidence, specifically addressed adverse events not identified with the samespecificity in the proposed common issue. For example, the FDA Review discussed incidence of post-procedure chronic pain, headache,nickel allergy or hypersensitivity, perforation and implant migration (but not bloating).

Certain of these noted adverse events, such asnickel hypersensitivity and perforation, are so materially different from each other that it would be difficult to modify the common issue insuch a way that would clothe them with the kind of commonality required to advance the claim on a class basis. In my view, it wouldrequire the Court to rewrite the proposed common issue in its entirety. The Court is not inclined to do so. [65] It is clear that a certification judge has the authority to modify proposed common issues in some circumstances. However, thatauthority is not unfettered.

There is, among other things, support for the proposition that this discretion must be “exercised with cautionand restraint and should be the exception rather than the norm” when it fundamentally alters the proposed common issues (McCracken vCanadian National Railway, 2012 ONCA 445 at para 144, 293 OAC 274 [McCracken]).

The following discussion by Richards J.A. (as hethen was) in Alves v First Choice Canada Inc., 2011 SKCA 118, 342 DLR (4th) 427, leave to appeal to SCC refused,[Alves], illuminates the role of a certification judge when the certification material, including the formulation of the proposed commonissues, is deficient: [31] Speaking generally, it is obviously not acceptable to simply assume a court will, on its own initiative, repair the problems found toexist in the certification application.

A court must operate with an eye to satisfying the objectives of the [CAA] and with sufficientflexibility to ensure that justice is done. It must also be sensitive to the reality that new facts and insights into claims can emerge duringthe certification process as affidavits are filed and arguments are sharpened. Reasonably liberal efforts should be made to accommodatesuch developments by way of amendments to the pleadings, adjustments to common issues and otherwise. Sometimes the judge or courtmight have suggestions or thoughts about how best to proceed.

However, all of that said, counsel have an obligation to do more than placethe raw ingredients of a class action before the court and then expect the court itself to construct a viable proceeding. This is especially soat the appellate level. [32] There are no bright lines in any of this. Each case will have its own dynamics.

But, while avoiding an unreasonably rigid approach tothe certification process and appreciating its somewhat evolving nature, a judge or a court must nonetheless avoid being inappropriatelyconscripted into the role of ongoing assistant to one side or the other of the litigation. [66] This passage reflects the tension between the liberal approach taken by courts to certification applications on the one hand andthe need to impose obligations on representative plaintiffs on the other, which results from the fact that certification applications, whileprocedural, are also an important aspect of, and a common battle ground in, an adversarial process.

The same tension, and the resultingneed to strike a balance between these different interests, is reflected in the following description of the discretionary authority of acertification judge to amend the common issues proposed by an applicant (The Honourable Mr. Justice Ward K. Branch and Mathew P.Good, Class Actions in Canada, loose-leaf (Rel No 2, May 2022) 2d ed (Toronto: Thomson Reuters, 2019) at §4:8): When certifying the action, the court has some discretion to redefine the common issues proposed by the representative plaintiff.

Thatsaid, litigants are entitled to a fair process on certification motions—particularly as a certification judge’s conclusions are not easily setaside on appeal.

Unless the modification made by the judge is a “distinction without a difference”, the parties ought to have theopportunity to address any proposed alterations before judgment is rendered. (Footnotes omitted) [67] Wholesale changes to the wording of proposed common issues by a certification judge raise issues of fairness to both parties.While such concerns might be addressed by seeking additional submissions before a final determination is made as to whether or how theyshould be modified, a certification judge must, as noted in Alves, “avoid being inappropriately conscripted into the role of ongoingassistant to one side or the other of the litigation” (at para 32). [68] In this case, the Chambers judge concluded that amending to cure the defect would place him on the wrong side of this line.

Inhis view, he would have to rewrite proposed common issue #1 in its entirety. For that reason, he refused to certify these common issues. [69] As we have noted above, the question is whether, given the nature and limits of the authority to order or permit modification ofthese common issues, the Chambers judge’s decision in this regard was the result of a palpable and overriding error. It is our respectfulopinion that it was. As we understand it, this reasoning by the Chambers judge resulted from the presence of the phrase “other sideeffects” in the proposed common issues.

He concluded that it was necessary to unpack that opaque and overly broad language so as tocapture all of the many potential adverse side effects for which some basis in fact might be disclosed by the material before him. [70] We do not agree with this reasoning. There is no requirement that the common issues that are certified in a class action of thiskind catch each and every or even most side effects. The Chambers judge could have ordered that these words be deleted and certifiedcommon issues based on the alleged risks of bleeding and bloating. There would appear to be some basis in fact that using Essure

increased the potential risk of these adverse events. An amendment of this kind certainly could not be said to constitute a rewrite of these common issues in their entirety or to fundamentally alter them in the sense referred to in McCracken . The result in Schroeder is instructive in this context. [ 71 ] Ms. MacInnis also notes that in Letarte the following common issues were certified by the Superior Court of Québec in relation to Québec residents that had utilized Essure (at para 80): 1.

Does Essure cause, exacerbate or contribute to a risk of having urinary tract infections, perforated organs, implant migration, pelvic pain, menorrhagia and autoimmune symptoms? If the answer to question 1 is yes: 2. Did the Defendants commit a fault in failing to adequately warn the class members and/or their physicians about a risk associated with the use of Essure? 3. Did the Defendants commit a fault by marketing, packaging, promoting, advertising, distributing, labelling and selling Essure the way they did? 5. Are members of the class entitled to damages? 4.

Are members of the class entitled to punitive damages? [ 72 ] The language used in the first two of these common issues could also have provided assistance to the Chambers judge or, if the Chambers judge had adjourned to enable the parties to make further submissions, to the parties in recasting common issues #1 and #4. The first Letarte common issue is also useful in that it casts the question as relating to the exacerbation of the risks it identifies, rather than to the presence of unreasonable risks.

The word unreasonable is ambiguous in this context and may be apposite only in relation to the proposed marketing claim, but not the warning claim. [ 73 ] In the result, it is our opinion that, to the extent common issues #1 and #4 were defective, because they were overly broad or lacked specificity, the failure by the Chambers judge to either order that they be modified to cure this defect or to invite further submissions from the parties as to alternative formulations constituted a palpable and overriding error. There was some basis in fact for certification of common issues relating to general causation.

That the Chambers judge understood this is readily apparent in his comment as to the results of the United States Food and Drug Administration and Health Canada reviews, which were appended to Ms. Covill’s affidavit ( Chambers Decision ): [190] … I am not particularly confident about Bayer’s argument that the other evidence does not raise some basis in fact about the adequacy of the Essure warning. In this respect, I refer to the review process conducted by both the FDA and Health Canada in 2015–16.

The evidence of that review, particularly from the Advisory Panel, raised concerns that treating physicians may have lacked the information required either to address or to prevent some of the adverse events and side effects raised in the FDA Review. In saying this, I candidly acknowledge that the evidence received by the Court, and by the Advisory Panel for that matter, is far from definitive. This was particularly so with respect to causation and the impact of underlying conditions and co-morbidities.

Even so, at this stage, that evidence need not be definitive. [ 74 ] In our view, the proper course, in the interests of fairness and efficiency, would have been to seek further submissions from the parties as to the content of these common issues. As a result, the matter must be remitted to the Court of King’s Bench. E. Common issues lack commonality [ 75 ] The Chambers judge also concluded that proposed common issues #1 and #2 could not be certified because they lacked commonality.

It is useful to reproduce the key aspects of his analysis in relation to this issue in its entirety as they contain certain unique elements: (

a) Proposed common issue #1: [164] With respect to the Court’s second reason [lack of commonality] to refuse certification, I am satisfied that, as worded, the resolution of proposed common issue 1 will demand inquiry of individual members of the class. In large measure, this is attributable to the use of the words “unreasonable risk” in relation to adverse events and/or side effects of an entirely elective medical procedure. [165] It is undeniable that the term “reasonable” will frequently imply something that is objectively measurable.

The yardstick for the measurement may be derived from a number of sources, such as community standards, industry standards, professional standards, statute law or common law. There are other aspects of life, however, where measures of reasonableness, or lack thereof, are not entirely objective. I think it fair to say that a patient’s assessment of the reasonableness of the risks associated with an available medical procedure is one such aspect, particularly where the procedure is entirely elective.

Such a patient can reasonably be expected to weigh the likelihood and magnitude of harm against the likelihood and magnitude of the expected benefit, and to do so in the context of all the available alternatives to the subject procedure. Measuring the potential for harm against the potential for benefit will not be the same for all patients. Aside from particular susceptibilities to harm, there may be certain personal, religious, family or occupational factors at play.

In short, a patient’s measure of reasonable risk will have both objective and subjective elements, neither of which can be ignored. [166] In the case of Essure, the presence of the subjective element is particularly obvious. It must be remembered that a woman’s decision to undergo a permanent form of birth control is an exceptionally personal decision. Her choice of contraception, whether temporary or permanent, is entirely elective.

As such, the decision the patient makes is a matter of consultation between her, her physician and, if she so chooses, members of her family. [167] The consultation with the physician is particularly critical. If conducted properly and with informed consent, the consultation will

necessarily include a discussion of the material risk that a known adverse event or side effect of Essure may occur. In this respect, I amsatisfied that the Court can take judicial notice that all treatments, including intrusive medical procedures, involve some measure of riskthat something unpleasant may occur. In some cases, the adversity may be well-known and commonly expected, such as pain in the post-procedure recovery period.

Some adversity, however, may be known but less common. [168] In the case of Essure, this would necessarily engage an inquiry into such matters as the importance of the procedure to the patient,the patient’s experience with alternative forms of birth control and any possible hypersensitivity to the material used in the procedure (suchas nickel). These are subjective considerations particular to the patient’s circumstances.

In this respect, they are, as Bayer suggests,“inherently individualistic”. [169] I think it important to note that the subjective aspect of this consideration is not unknown to Canadian tort law. In medical liabilitycases based on an absence of informed consent, Canadian courts have long recognized the so-called “modified objective” test as a meansof assessing the likelihood of a patient agreeing to receive the treatment if the risk of what actually occurred was properly disclosed. It isan objective test with the undeniably subjective element of considering the specific circumstances of the patient in question.

As articulatedby the Supreme Court of Canada in Arndt v Smith, (SCC), [1997] 2 SCR 539 at para 17, the modified objective test isconcerned with “whether a reasonable person in the circumstances of the plaintiff would have consented to the proposed treatment if allthe risks had been disclosed”.

See also Reibl v Hughes, (SCC), [1980] 2 SCR 880; Hollis v Dow Corning Corp., (SCC), [1995] 4 SCR 634; Baert v Graham, 2011 SKCA 21 at para 27, 371 Sask R 1; and Prevost v Ali, 2011 SKCA 50, 371Sask R 166. [170] In my view, the subjective element of the “unreasonable risk” inquiry takes away the required commonality necessary to certifyproposed common issue 1. [171] As a supplemental observation to my finding of the need for individual inquiry, it bears repeating that certain of the adverse eventsdiscussed in the FDA Review, such as sensitivity to nickel, are particular to those with the required susceptibilities.

In my view, they areso personal in nature that proposed common issue 1, as framed, would almost certainly lead to the individual inquiries. This was the verydanger identified in Rumley. (

b) Proposed common issue #2: [176] Aside from the absence of any evidence on the existence of proposed common issue 2, I find that it calls for the same kind ofindividual inquiry as that in the case of proposed common issue 1. The principal reason, if not the only reason, for comparing benefitsbetween procedures is to allow an individual to choose between all the available options, arguably including the option not to adopt anyform of artificial contraception.

In my view, the yardstick by which one elective birth control option is perceived to have more or lessbenefits than another will almost certainly vary from patient to patient. At the very least, it will almost certainly require the same kind ofacceptance-of-risk inquiry as that for proposed common issue 1. Moreover, it will also engage an inquiry about the importance to theindividual patient about permanent or temporary birth control solutions.

The plaintiff’s submission in this regard presumes that theconcept of relative benefits between procedures is a purely objective one, capable of application to all members of the class. Respectfully,and for the same reasons expressed about proposed common issue 1, I disagree. [76] Ms. MacInnis submits that the Chambers judge erred both in the identification of the relevant principles of law and in theirapplication.

She contends that he impermissibly imported issues from the individual stage of the proceedings and erred in finding thatthere were no common issues because it would be necessary, at the individual stage, to conduct separate inquiries into the discussion eachclass member had with their doctor, their myriad medical histories, the circumstances as to individual levels of risk tolerance andacceptability, and as to each class member’s very personal decisions regarding mechanisms of elective birth control. [77] We would first note that the Chambers judge did not err in his identification of the law regarding commonality and therelationship between individual issues and common issues. [78] The question of whether the proposed common issues are sufficiently common must be approached purposively: Dutton atpara 39 and Vivendi at para 41.

Establishing commonality at the certification stage requires only that the issues “are common to allmembers of the class” (Pro-Sys at para 110).

In addressing the question of whether an issue is sufficiently common, a certification judgeshould consider whether the resolution of the issue will avoid duplicative fact-finding or legal analysis – Dutton at para 39, Rumley atpara 29, and Vivendi at para 44 – whether the issue is a substantial ingredient to each class member’s claim in that its resolution isrequired to resolve the claim – Dutton at para 39, Hollick at para 18, Rumley at para 27, and Vivendi at para 41 – and whether the successof one class member on the issue will result in the failure of another class member – Dutton at para 40 and Vivendi at para 45. [79] The Chambers judge correctly identified these principles set out by the Supreme Court in Dutton, Hollick, Rumley, Vivendi, andAtlantic Lottery.

He referenced the requirements under s. 6(1)(

c) of the CAA and noted its stipulation that common issues need notpredominate over issues affecting individual class members. He cited, at paragraph 140, the common issues criterion identified inPederson, reproducing the following statement by Ottenbreit J.A. in that case: [80] … In Fulawka v Bank of Nova Scotia, 2012 ONCA 443, 352 DLR (4th) 1, leave to appeal refused [2013] 2 SCR vi, the Ontario Courtof Appeal explained the principles regarding how to determine whether a common issue exists: [81] There are a number of legal principles concerning the common issues requirement in s. 5(1)(

c) that can be discerned from the caselaw. Strathy J. provided a helpful

summary of these principles in Singer v. Schering-Plough Canada Inc., 2010 ONSC 42, 87 CPC (6th)276. Aside from the requirement just described that there must be a basis in the evidence to establish the existence of the common issues,the legal principles concerning the common issues requirement as described by Strathy J. in Singer, at para. 140, are as follows: A: The underlying foundation of a common issue is whether its resolution will avoid duplication of fact-finding or legal analysis: WesternCanadian Shopping Centres Inc. v. Dutton, 2001 SCC 46, [2001] S.C.R. 534 at para. 39.

B: The common issue criterion is not a high legal hurdle, and an issue can be a common issue even if it makes up a very limited aspect ofthe liability question and even though many individual issues remain to be decided after its resolution: Cloud v. Canada (Attorney

General), at para. 53. … E: The proposed common issue must be a substantial ingredient of each class member’s claim and its resolution must be necessary to theresolution of that claim: Hollick, at para. 18. F: A common issue need not dispose of the litigation; it is sufficient if it is an issue of fact or law common to all claims and its resolutionwill advance the litigation for (or against) the class: Harrington v Dow Corning Corp., (BC SC), [1996] BCJ No. 734,48 CPC (3d) 28 (S.C.), aff’d 2000 BCCA 605, [2000] BCJ No 2237, leave to appeal to SCC ref’d [2001] SCCA No. 21.

G: With regard to the common issues, “success for one member must mean success for all. All members of the class must benefit from thesuccessful prosecution of the action, although not necessarily to the same extent”. That is, the answer to a question raised by a commonissue for the plaintiff must be capable of extrapolation, in the same manner, to each member of the class: Dutton, at para. 40, Ernewein vGeneral Motors of Canada Ltd., 2005 BCCA 540, 46 BCLR (4th) 234, at para. 32; Merck Frosst Canada Ltd. v Wuttunee, 2009 SKCA43, [2009] SJ No 179 (CA), at paras. 145–146 and 160.

H: A common issue cannot be dependent upon individual findings of fact that have to be made with respect to each individual claimant:Williams v. Mutual Life Assurance Co. of Canada (2000), (ON SC), 51 OR (3d) 54 at para. 39, aff’d [2001] OJ No.4952, 17 CPC (5th) 103 (Div. Ct.), aff’d (ON CA), [2003] OJ No. 1160 and 1161 (CA); Fehringer v Sun MediaCorp., [2002] OJ No 4110, 27 CPC. (5th) 155 (SCJ), aff’d [2003] OJ No. 3918, 39 CPC. (5th) 151 (Div. Ct.).

I: Where questions relating to causation or damages are proposed as common issues, the plaintiff must demonstrate (with supportingevidence) that there is a workable methodology for determining such issues on a class-wide basis: Chadha v. Bayer Inc., [2003] OJ No.27, (CA), at para. 52, leave to appeal dismissed [2003] SCCA No. 106, and Pro-Sys Consultants Ltd. v InfineonTechnologies AG, 2008 BCSC 575, [2008] BCJ No. 831 at para. 139.

J: Common issues should not be framed in overly broad terms: “It would not serve the ends of either fairness or efficiency to certify anaction on the basis of issues that are common only when stated in the most general terms. Inevitably such an action would ultimately breakdown into individual proceedings. That the suit had initially been certified as a class action could only make the proceeding less fair andless efficient”: Rumley v.

British Columbia, 2001 SCC 69 , [2001] 3 S.C.R. 184 at para. 29. (Emphasis in original) [80] As Strathy J. (as he then was) commented in Singer v Schering-Plough Canada Inc., 2010 ONSC 42, 87 CPC (6th) 276[Singer], these general propositions are by no means exhaustive.

Further, as Winkler C.J.O. said in Fulawka, “it is up to the motion judgeto decide what legal principles are the contentious ones in any particular case and to focus the analysis accordingly” and to then “considerthe pertinent legal principles with reference to the evidence adduced on the motion to decide if there is some basis in the evidence toestablish the existence of the common issues” (at para 82).

Despite those caveats, these remarks from Singer and Fulawka nonethelessrepresent an accurate statement of the law. [81] In the result, we find the Chambers judge did not, with the exceptions noted below, err in law by concluding that the commonissues could only be certified if they fully disposed of the case. Nor did his reasons indicate that, as a matter of law, common issues mustpredominate over individual issues. [82] Further, the conclusion by the Chambers judge that the use of the phrase unreasonable risk in proposed common issue #1 wasunacceptable did not reflect palpable and overriding error.

As he noted, the word unreasonable can certainly be read as introducing asubjective element that is difficult to square with the requirement for commonality.

On a similar note, the use of the word unreasonablesuggests that this question may be directed at the relative risks and benefits of Essure – that is, whether the risks are a reasonable price topay for permanent birth control – which was not the intended purpose of this general causation common issue and would not pose ageneral causation question suitable for certification. [83] We do, however, conclude that the reasoning of the Chambers judge in relation to proposed common issue #1 reflects error.That is so in two respects.

First, to the extent that this defect in proposed common issue #1 results from the use of the word unreasonablein the pleadings, the Chambers judge – as is the case with the phrase other side effects – should have ordered an amendment to cure thedefect, either of his own accord or following further submissions by the parties. [84] Second, the Chambers judge suggested that a question as to the risk of certain adverse effects, such as those resulting from anallergy or sensitivity to nickel, could not be certified, as susceptibility to those adverse effects would vary from person to person, with theresult that individual enquiries would be required at the individual stage.

This reasoning cannot be squared with the legal principlesrelating to common issues adopted by the Chambers judge.

This issue was discussed in Tluchak Estate v Bayer Inc., 2018 SKQB 311,leave to appeal to Sask CA refused, 2019 SKCA 64, leave to appeal to SCC refused, [Tluchak], in relation to thedifferent risks for different users of an anti-coagulant in that action: [136] … The issue at this stage is whether there is some basis in fact to conclude there is a risk of injury – that is, an increased possibility– from ordinary use for all class members, and that the warning has not reasonably communicated and clearly described the dangers thatarise from that ordinary use.

In a pharmaceutical case relating to the duty to warn, the likelihood that risk will cause injury to an individualwill generally vary based on a variety of factors. There will often be alternative therapies. [137] That does not mean there is no duty to warn, or that the answer to a common issue as to a breach of that duty cannot advance theclaim of every class member. It means that in this and many other cases, many individual issues relating to injury and causation willremain to be resolved.

It bears repeating that the CAA expressly provides (in s. 6(1)(c)) that a claim shall be certified “whether or not thecommon issues predominate over other issues affecting individual members”. (Emphasis in original)

[ 85 ] It is also our opinion that the reasoning of the Chambers judge as to proposed common issue #2 reflects an error of law. To repeat, that proposed common issue is as follows: “2. Did Essure have any benefits that were unique to Essure or that exceeded the benefits of other artificial birth control procedures?” [ 86 ] Ms. MacInnis seeks certification of both a warning claim and a marketing claim. Marketing claims turn on the issue of whether the benefits from the use of the product outweigh its propensity to injure.

That risk–benefit analysis will require a comparison of the risks and benefits of the use of Essure to the use of alternative methods of contraception. This reflects the analytical framework that applies to product liability cases in general, which was outlined by Huddart J.A. in CA-Harrington : [42] At the risk of oversimplifying a complex decision–path, I venture to suggest the first step in every products liability case alleging negligent design, manufacture, or marketing is the determination of whether the product is defective under ordinary use or, although non- defective, has a propensity to injure.

Some American authorities refer to this step as “general causation”, whether a product is capable of causing the harm alleged in its ordinary use. [43] The second step is the assessment of the state of the manufacturer’s knowledge of the dangerousness of its product to determine whether the manufacturer’s duty was not to manufacture and distribute, or to distribute only with an appropriate warning. … … [45] If the value of the product’s use outweighed its propensity to injure such that distribution with a warning was appropriate, the third step will be an assessment of the reasonableness of the warning (whether direct or by a learned intermediary) given the state of the art and the extent of the risks inherent in the product’s use. [46] The final step will be the determination of individual causation and damages.

The difficult question will be whether the individual’s knowledge of the risks would have prevented the injury.

If the product should not have been manufactured or distributed, the determination of whether the product caused the injuries to the individual seeking damages and the assessment of those damages will be the last step. [ 87 ] Seen from this perspective, the question as to whether there are unique benefits of Essure, in light of its purpose and that of other contraceptive devices or methods – such as the permanence and relative effectiveness of Essure in preventing pregnancies – is not only relevant to but is a central issue in the marketing claim.

The fact that the value of that benefit would be assessed differently by different class members does not preclude certification of such a claim. Indeed, it has little, if any, relevance to the question of benefit, when properly understood. [ 88 ] The determination that a class member’s assessment of the benefits of Essure would involve subjective considerations is also of no moment.

The choice to use a birth control device may well engage different considerations than the choice to use an alternate method of contraception, just as different issues may be engaged by the choice to use one antidepressant as opposed to another or, for that matter, to use no contraception or antidepressant at all. These decisions necessarily involve both objective and subjective considerations. Choices about medical treatment often involve highly personal considerations.

Class actions involving drugs and medical devices have nonetheless been properly and frequently certified: in this province, for example, see Tluchak , G.C. , Dembrowski v Bayer Inc ., 2015 SKQB 286 , 482 Sask R 211, and Dembrowski v Bayer Inc. , 2016 SKQB 324 , 5 CPC (8th) 422, which related to birth control pills. [ 89 ] In the result, it is our view that the decision of the Chambers judge to refuse to certify proposed common issue #2, on the basis he expressed, reflected a legal error.

For this reason, it must be set aside and the question of whether the proposed common issue should be certified, rejected, or modified must be remitted to the Court of King’s Bench. F. Conflating the medical standard of care with the legal duty of care [ 90 ] The Chambers judge determined that his rejection of proposed common issues #1 and #2 implicitly required him to reject proposed common issue #3. This finding has not been challenged on appeal. For ease of reference, we will repeat proposed common issue #3: “3.

Having regard to the answers to common issues 1 and 2, did the defendants breach the standard of care by distributing Essure for sale in Canada?” [ 91 ] Ms. MacInnis conceded that common issue #3 could not be certified in the absence of answers to the questions posed by proposed common issues #1 and #2.

Given we have directed a remittal to reformulate common issues #1 and #2, common issue #3 will also have to be reconsidered. [ 92 ] The Chambers judge also identified a second reason for refusing to certify common issue #3, which is set out in the following excerpt from the Chambers Decision : [180] The second reason is purely evidentiary. As I read the presented evidence, none of it establishes any basis in fact that a standard of care issue exists about the distribution and sale of Essure in Canada. Dr. Bérard did not identify anything in her literature review to suggest that such an issue exists.

Moreover, without clinical training and/or experience in

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