2017 QCCA 1050, 2017 QCCA 1050

Pfizer inc. c. Sifneos 2017 QCCA 1050 COURT OF APPEAL CANADA PROVINCE OF QUEBEC REGISTRY OF MONTREAL No: 500-09-026763-177 (500-06-000576-112) MINUTES OF THE HEARING DATE: July 5, 2017 THE HONOURABLE NICHOLAS KASIRER, J.A. APPLICANTS COUNSELS PFIZER INC. PFIZER CANADA INC. WYETH WYETH CANADA WYETH CANADA INC. WYETH HOLDINGS CANADA INC. WYETH PHARMACEUTICALS INC. WYETH-AYERST INTERNATIONAL INC.

Mtre Paul Prosterman Mtre Dominique Noel (Norton Rose Fulbright Canada S.E.N.C.R.L., s.r.l.) RESPONDENT COUNSEL ROSLYN SIFNEOS Mtre ROCH dupont (Merchant Law Group) DESCRIPTION: Amended application for leave to appeal from a judgment rendered on March 16, 2017 by the Honourable Mr. Justice Martin Castonguay of the Superior Court, District of Montreal (Articles 357 and 578 C.C.P. )

Clerk: Marie Gamelin Courtroom: RC-18 HEARING 9:43 Commencement of the hearing. Identification of counsel. 9:44 The Judge addresses Mtre Paul Prosterman. 9:46 Submissions by Mtre Prosterman. 9:50 Exchanges between the Judge and Mtre Prosterman. 9:55 Submissions by Mtre Prosterman. 10:02 Submissions by Mtre Roch Dupont. 10:05 Exchanges between the Judge and Mtre Dupont. 10:07 Reply by Mtre Prosterman. The Judge addresses Mtre Prosterman. 10:10 Reply by Mtre Prosterman. 10:16 The Judge indicated that he expected to render its decision today, July 5, 2017, and if not, that the matter would be taken under advisement.

Recess. 13:53 Resumption of the hearing. BY THE JUDGE: Judgment – see page 3. Conclusion of the hearing. (

s) Marie Gamelin Clerk BY THE JUDGE JUDGMENT [ 1 ] The petitioners seek leave to appeal from a judgment of the Superior Court, District of Montreal, (the Honourable Mr Justice Martin Castonguay), rendered on March 16, 2017, which authorized Rosyln Sifneos to institute a class action in damages for product liability on behalf of persons having used the drugs Premarin and Premplus and who developed breast cancer. [ 2 ] The application for leave to appeal is brought pursuant to

article 578 C.C.P. [ 3 ] In Centrale des syndicats du Québec v. Allen , [1] my colleague Chamberland, J.A., writing for the Court, explained that the test for granting leave under

article 578 C.C.P. is necessarily a strict one because the test for obtaining authorization of a class action in Superior Court is not onerous: [55] La vérification des critères énoncés à l’article 575 n. C.p.c . est souple et peu exigeante. Le seuil de preuve requis à ce stade est peu élevé; le fardeau du requérant en est un de démonstration

sommaire et non de persuasion quant au bien-fondé du recours. Le juge saisi de la requête en autorisation d’exercice de l’action collective jouit d’une vaste latitude; en corollaire, la norme d’intervention en appel d’une décision autorisant, ou refusant, l’exercice de l’action collective est exigeante. Le jugement autorisant l’exercice de l’action collective ne met pas fin au litige et ne décide pas du fond de l’affaire. Le processus d’autorisation ne doit pas constituer un frein au bon

déroulement de l’instance. [56] Ce sont là autant d’éléments à prendre en compte dans la formulation du test que le juge d’appel doit appliquer au moment de trancher une requête en autorisation de faire appel d’un jugement autorisant l’exercice d’une action collective. [ 4 ] Chamberland, J.A., described this strict test to be applied for determining whether leave should be granted under

article 578 C.C.P. as follows: [59] Le juge accordera la permission de faire appel lorsque le jugement lui paraîtra comporter à sa face même une erreur déterminante concernant l’interprétation des conditions d’exercice de l’action collective ou l’appréciation des faits relatifs à ces conditions , ou encore, lorsqu’il s’agira d’un cas flagrant d’incompétence de la Cour supérieure. [ 5 ] The application for leave must be decided with these considerations in mind. *** [ 6 ] The petitioners submit that the motion judge made the following “fatal errors of law”, relevant to the requirements in article 575(2) and 575(4) C.C.P., for assessing whether the respondent had an arguable personal claim and whether she could be an adequate representative: (

a) The motion judge failed to determine whether there is an arguable causal relationship between the alleged faults and the respondent’s injury. Had the Superior Court made such a determination, it would have concluded that the respondent began using the products in 2006, at a time when the risk of breast cancer had been identified and adequately disclosed in the product monographs; (

b) The motion judge failed to consider and apply the “learned intermediary doctrine”, pursuant to which Pfizer Inc. cannot be held liable for the respondent’s injury because the risk of breast cancer had been adequately disclosed to “learned intermediaries” in the product monographs years before the time when the respondent was first prescribed and began using the products. [ 7 ] Both arguments turn in large measure on the motion judge’s alleged failure to consider the “learned intermediary doctrine” as part of his causation analysis in authorizing the class action, and specifically its impact on the respondent’s own cause of action. [ 8 ] The learned intermediary doctrine is typically deployed as a defence in actions for civil liability by manufacturers, including in suits against defendants in the pharmaceutical industry, who seek to avoid liability by showing that they disclosed all the relevant risks to a “learned intermediary” between the manufacturer and the ultimate consumer. [2] The defence can take different forms including, as is argued here, that the disclosure served to break the chain of causation between the conduct of Pfizer and the injury suffered by the representative. (In the application for leave, the petitioners explicitly describe the doctrine as a “defence” (para. 38)). [ 9 ] The petitioners argue that Pfizer had adequately disclosed the risk of breast cancer to “learned intermediaries” by 2006, the time at which, according to the judge’s own finding, the respondent herself began using the products.

Even if the faults of failing to conduct adequate clinical testing and disclose the associated risk were established, say the petitioners, these civil wrongs could not have caused the respondent’s loss because, in 2003, warnings were added by the manufacturer to the product monographs. On their face, argue the petitioners, the monographs “provided adequate warning of the risk of breast cancer associated with the use of the products”.

Moreover, given the fact that the respondent and her physician decided to use the products in her treatment in 2006, the risk of breast cancer disclosed to learned intermediaries as of 2003 serves to break the chain of causation between the alleged faults and the respondent’s loss. The petitioners add that nothing in the motion for authorization alleges that the warnings given in 2003 were inadequate. [ 10 ] They say the judge completely failed to take this matter into account such that he erred in deciding that the facts alleged support a prima facie case for the cause of action pursuant to article 575(2) C.C.P.

Moreover, he failed to note that the respondent’s own circumstances mean that she cannot invoke the alleged faults for which her doctors were apprised, via the learned intermediary doctrine, as representative for the class pursuant to article 575(4) C.C.P. *** [ 11 ] Leave should be refused. [ 12 ] The petitioners have not convinced me that the judgment reflects on its face, an apparent overriding error in respect of the criteria for authorization of the class action according to the strict test set forth in Allen , supra . [ 13 ] It is true that the judge devotes little discussion to causation in his reasons, and that he does not explicitly consider the application of the learned intermediary doctrine to the respondent’s own circumstances.

But thus alone is no reason to grant leave here. [ 14 ] First, reading the judgment as a whole, and specifically paragraphs [47], [48] and [61] to [71], it is clear that the judge’s understanding of the so-called “syllogism” on which Ms Sifneos’ cause of action rests required proof of fault, damage, and the fact that her cancer was caused by the drugs in question. [ 15 ] It is also clear that the judge understood that causation is a question of fact that would be decided upon, ultimately, on the merits.

He wrote that his role was confined to determining whether, according to the standard set by the Supreme Court in Infineon Technologies v. Options Consommateurs , [3] the representative had made out a prima facie case for authorization pursuant to the criteria in

article 575 C.C.P. As paragraph [45] of his reasons make plain, the judge rightly sought to avoid trenching on the evidentiary role of the judge at trial, notwithstanding the “efforts considérables [by the petitioners] pour amener le Tribunal à considerer une prevue qui relève plus du fond que de l’autorisation d’une action collective” (para. [45]). [ 16 ] While he did not discuss the learned intermediary doctrine in named terms, the judge was mindful of the warnings published in

the monographs in 2003 and that these warnings predated the time that the representative began taking the medication in 2006 (see, for example, paras [39], [49], [67], and [77]). [ 17 ] The learned intermediary doctrine is, by the petitioners’ own characterization, raised as a defence to the allegation that the faults imputed to them caused the respondent’s loss. The question as to whether the chain of causation between the alleged faults and her loss was broken is one that has a clear evidentiary component.

In my view, the judge was not mistaken in refraining at this early stage from deciding whether, in whole or in part, the learned intermediary doctrine provides an effective defence on the facts of the case. [ 18 ] The application of a defence that turns on the facts is, as a general rule, properly left to the trial judge on the merits, as the jurisprudence decided under

article 575 C.C.P. and its predecessor make plain. Considering the defence of immunity that the government sought to raise at authorization in Carrier , [4] my colleague Guy Gagnon, J.A., wrote the following for the Court: [37] Au moment de l'autorisation, alors que la suffisance de la preuve n'est appréciée que de manière prima facie , règle générale, il sera prématuré de conclure qu'une défense d'immunité s'applique en faveur de l'État.

Ce qui n'est qu'un moyen de défense parmi d'autres, celui de l'immunité ici invoquée par l'intimé ne peut, lors de l'examen portant sur l'autorisation, être érigée au rang de moyen de non- recevabilité. À moins de convenir que la demande à sa face même est frivole, manifestement vouée à l'échec ou encore que les allégations de faits sont insuffisantes ou qu'il soit « incontestable » que le droit invoqué est mal fondé, il me paraît, outre ces circonstances, qu'il n'est pas souhaitable en début d'analyse de décider de la valeur absolue d'un tel moyen de défense. [ 19 ] The petitioners cite Masson v.

Centre de santé et de services sociaux de St-Jérôme [5] as proof that the 2003 warnings were adequate for the purposes of the immediate application of the learned intermediary doctrine in the present case. They are mistaken. In Masson , the Superior Court did made observations that indicate that Pfizer had adequately informed learned intermediaries of certain risks by way of the 2003 monograph warnings.

But importantly, Masson was decided on another basis. [6] The conclusions the judge arrived at in that case – which was not a class action, which dealt with different facts and where all the evidence was in – cannot be dispositive for the purposes of authorization here. Furthermore, the case of F.L. v. Astrazenca Pharmaceuticals, p.l.c . [7] , in which the learned intermediary doctrine was accepted as a bar to authorization of a class action, is of little direct help here.

Decided prior to Infineon , this case deals with a different drug and different facts. [ 20 ] The application of the doctrine to any given drug and in any given setting is determined with a view to a range of circumstances, as the Supreme Court indicated in Hollis . [8] In particular, the adequacy of a warning is in large measure dictated by the facts. The judge did not decide the factual adequacy of the warning when he wrote that the 2003 warning was “un avertissement en bonne et due forme” at paragraph [67].

In so arguing, the petitioners misinterpret the judgment given the great care the judge took, throughout his reasons, not to trench on the role of the judge on the merits. [ 21 ] I am inclined to think that if the judge had excluded the application of the learned intermediary defence at the authorization stage, the petitioners would have been the first to object, arguing that the authorization judge had usurped the role of the judge on the merits. [ 22 ] In sum, by leaving the determination as to whether or not the chain of causation had been broken to the trial, the judge made no “error on the face of the judgment” that would justify granting leave by the Allen standard. [ 23 ] I note finally that in Allen , the Court dismissed an application for leave from a judgment authorizing a class action for the very reason that the proposed appeal turned on a supposed error by the motion judge in respect of defence to the action. [9] [ 24 ] FOR THE FOREGOING REASONS , the undersigned: [ 25 ] DISMISSES the application for leave, with legal costs.

NICHOLAS KASIRER, J.A.