2019 QCCA 878, 2019 QCCA 878

Depuy Orthopaedics Inc. c. Melançon 2019 QCCA 878 COURT OF APPEAL CANADA PROVINCE OF QUEBEC REGISTRY OF MONTREAL No.: 500-09-027575-182 (500-06-000643-136) DATE: MAY 16, 2019 CORAM: THE HONOURABLE JACQUES CHAMBERLAND, J.A. SUZANNE GAGNÉ, J.A. STEPHEN W. HAMILTON, J.A. DEPUY ORTHOPAEDICS INC. JOHNSON & JOHNSON CORP. JOHNSON & JOHNSON INC. APPELLANTS – Respondents v. CAROLE MELANÇON RESPONDENT – Petitioner JUDGMENT [ 1 ] The appellants appeal a judgment rendered on May 2, 2018 by the Superior Court, District of Montreal (the Honourable Mr.

Justice Paul Mayer), which authorized the respondent to institute a class action against the appellants and appointed the respondent as representative plaintiff. [1] The issue in appeal pertains only to the condition set out in article 575(2) C.C.P.: “the facts alleged appear to justify the conclusions sought”. [2] * * * [ 2 ] After reviewing the applicable principles, the motion judge noted that the respondent had withdrawn her theory of the case based on the appellants’ failure to satisfy their duty to warn.

He summarized the remaining theory of the case as follows: “[S]he alleges that liability arises from the fact that the Device carried a defect that caused the injury”. He deduced therefrom that the respondent was relying on

article 1457 C.C.Q. and analyzed the three elements of civil liability, namely, fault, damage and a causal link. [ 3 ] He found that the respondent had not succeeded in making a prima facie case for the existence of a fault. In this regard, he stated the following: [84] The remaining evidence submitted by Ms. Melançon likewise provides no clear and evident factual support for the prima facie demonstration of a fault by the Respondents. […] [87] Having reviewed the material adduced by Ms.

Melançon, the Court considers that she struggles to show, on a prima facie basis, the existence of a fault that is causally related to the injury she sustained. [88] Ms. Melançon has throughout her submissions repeatedly stated the existence of the alleged negligence, but failed to provide the Court with prima facie evidence that provides her claim with any clear factual grounding. [89] Ms. Melançon has rather attempted to imply the existence of a fault merely because she suffered adverse health effects after being implanted with the Device.

It is trite law that the existence of an injury is by itself insufficient to establish the existence of a fault. More must be shown to satisfy Article 575(2) C.C.P. [ 4 ] Regarding the causal link, he wrote: [93] However, given that a prima facie fault was not adequately demonstrated, it is difficult for the Court to pronounce on whether the necessary causal link between the injury and the fault was established for the purpose of the evaluation at Article 575(2) C.C.P. [ 5 ] The motion judge, however, hastened to add that the analysis he had just performed was overly severe and strict, perhaps even premature.

In light of the flexible, liberal and generous approach that prevails at the authorization stage, he concluded that the issue of fault should be debated on the merits.

* * * [ 6 ] The appellants argue that the judgment is tainted by a blatant contradiction. After concluding that no prima facie demonstration of a fault and causal link had been made, the judge should have dismissed the motion for authorization. They argue that the motion, once stripped of its allegations pertaining to the failure to warn, is laconic as regards the proposed legal argument.

They argue that the remaining allegations are general allegations that are not supported by the evidence and do not raise any specific claims regarding the design of the prostheses. [ 7 ] At the hearing of the appeal, the Court raised the following questions with respect to the cause of action in relation to the liability of the manufacturer of a defective product under

article 1469 C.C.Q. : 1. Should the motion judge have considered this cause of action, which may or may not arise from the allegations in the motion for authorization? 2. Had the judge considered this cause of action, what impact, if any, would it have had on the judgment? 3. If the authorization is to be confirmed on the basis of this other cause of action, should the questions of fact and law listed at paragraph 122 of the judgment be reworded? If so, how should these questions of fact and law read? [ 8 ] The parties had the opportunity to make additional submissions. In short, the appellants submit that the cause of action under

article 1469 C.C.Q. was waived by the respondent at the hearing in first instance and that in any event, it is doomed to fail in the case at bar. As for the respondent, she argues that the withdrawal of the “failure to warn” element does not amount to a withdrawal of the “defective product” element and that the cause of action under

article 1469 C.C.Q. “would have provided the Court below with an additional avenue on which to maintain authorization of the proceeding as a class action”. * * * [ 9 ] The Court is of the opinion that the motion judge erred by considering only whether or not a fault had been committed under

article 1457 C.C.Q. The applicable legal rules in the case at bar are, in fact, those under articles 1468 and 1469 C.C.Q. , which deal with the extracontractual liability of manufacturers: 1468. The manufacturer of a movable thing is bound to make reparation for injury caused to a third person by reason of a safety defect in the thing, even if it is incorporated with or placed in an immovable for the service or operation of the immovable.

The same rule applies to a person who distributes the thing under his name or as his own and to any supplier of the thing, whether a wholesaler or a retailer and whether or not he imported the thing. 1469. A thing has a safety defect where, having regard to all the circumstances, it does not afford the safety which a person is normally entitled to expect, particularly by reason of a defect in design or manufacture, poor preservation or presentation, or the lack of sufficient indications as to the risks and dangers it involves or as to the means to avoid them. 1468.

Le fabricant d’un bien meuble, même si ce bien est incorporé à un immeuble ou y est placé pour le service ou l’exploitation de celui-ci, est tenu de réparer le préjudice causé à un tiers par le défaut de sécurité du bien. Il en est de même pour la personne qui fait la distribution du bien sous son nom ou comme étant son bien et pour tout fournisseur du bien, qu’il soit grossiste ou détaillant, ou qu’il soit ou non l’importateur du bien. 1469.

Il y a défaut de sécurité du bien lorsque, compte tenu de toutes les circonstances, le bien n’offre pas la sécurité à laquelle on est normalement en droit de s’attendre, notamment en raison d’un vice de conception ou de fabrication du bien, d’une mauvaise conservation ou présentation du bien ou, encore, de l’absence d’indications suffisantes quant aux risques et dangers qu’il comporte ou quant aux moyens de s’en prémunir. [ 10 ]

Article 1473 C.C.Q. sets out the grounds for exoneration a manufacturer can assert: 1473. The manufacturer, distributor or supplier of a movable thing is not bound to make reparation for injury caused by a safety defect in the thing if he proves that the victim knew or could have known of the defect, or could have foreseen the injury.

Nor is he bound to make reparation if he proves that, according to the state of knowledge at the time that he manufactured, distributed or supplied the thing, the existence of the defect could not have been known, and that he was not neglectful of his duty to provide information when he became aware of the defect. 1473. Le fabricant, distributeur ou fournisseur d’un bien meuble n’est pas tenu de réparer le préjudice causé par le défaut de sécurité de ce bien s’il prouve que la victime connaissait ou était en mesure de connaître le défaut du bien, ou qu’elle pouvait prévoir le préjudice.

Il n’est pas tenu, non plus, de réparer le préjudice s’il prouve que le défaut ne pouvait être connu, compte tenu de l’état des connaissances, au moment où il a fabriqué, distribué ou fourni le bien et qu’il n’a pas été négligent dans son devoir d’information lorsqu’il a eu connaissance de l’existence de ce défaut. [ 11 ] This Court recently examined these provisions in Imperial Tobacco Canada ltée c. Conseil québécois sur le tabac et la santé . [3]

It specified that the elements comprising the extracontractual liability of manufacturers are the safety defect affecting the thing, the injury suffered, and the fact that the first element caused the second.

There is no need to prove the manufacturer’s fault. [4] The Court stated it clearly: [ translation ] “The plaintiff’s burden of proof, however, goes only so far as requiring that it show that the thing does not afford the expected safety; the plaintiff does not have to identify the source of the problem”. [5] This also applies where the source of the problem is the lack or insufficiency of the required indications. [6] The liability, therefore, is one without fault, with the only means of exoneration being those set out in

article 1473 C.C.Q. (or superior force under

article 1470 C.C.Q. ). [7] [ 12 ] Consequently, the respondent is not required to prove the appellants’ fault, be it with respect to the design or manufacture of the thing or the duty to warn. She need merely show an arguable case that the DePuy Pinnacle metal on metal Acetubular Cup System prostheses do not afford the safety which a person is normally entitled to expect, as well as the injury suffered and the causal link between the two. [ 13 ] In the Court’s opinion, the respondent has done so.

In essence, she alleges that a defect in the design of the prosthesis causes friction between its metallic components, which releases metallic particles into the patient’s body and blood.

She alleges that the foregoing is the cause of several health problems experienced by patients implanted with the prosthesis. [8] [ 14 ] These allegations are supported by evidence, including an official Health Canada advisory which reads as follows: Health Canada has issued a Health Care Professional letter to Canadian orthopaedic surgeons informing them about potential health risks and recommending patient management strategies following metal-on-metal (MoM) hip implant surgery […]. MoM hip implants are artificial, implantable hip joints containing a metal ball and metal cup components.

These medical devices are used in both total hip replacement (changing the entire hip joint to an artificial hip joint) and hip resurfacing (changing a part of the hip joint) surgeries. In recent years, there has been an increase in awareness of pain, adverse local tissue reactions and implant loosening in patients with MoM hip implants.

If the adverse effects become serious, revision surgery may be required to remove the old system and replace it with another one. […] Surgeons should have the necessary experience to perform MoM hip implantations and be properly trained in the implantation technique and technical aspects of the specific implant to be used. Surgeons should ensure that device components are compatible and should not mix components from different manufacturers’ hip systems. Pay particular attention to the angles of inclination and anteversion of the acetabular cup, as this can predispose the patient to early failure.

Furthermore, the patient should be made fully aware of the risks and benefits of MoM hip replacement, including the risks of high metal ion levels and soft tissue reactions. [9] [Emphasis added] [ 15 ] In addition, a medical study of this type of prosthesis states that “[t]here is general acceptance that large diameter metal on metal (MoM) total hip arthroplasty (THA) has not lived up to clinical expectations”. [10] The

article in question draws the following conclusions: Conclusions: This device was found to have an unacceptably high revision rate. Bilateral prostheses, those implanted into female patients and devices implanted in later years were found to be at greater risk. A significant number of explanted components were found to be manufactured with bearing diameters outside of the manufacturer’s stated tolerances.

Our findings highlight the clinical importance of hitherto unrecognised variations in device production. [11] [ 16 ] In short, the respondent has presented an arguable case based on articles 1468 and 1469 C.C.Q. , notwithstanding the withdrawal of the theory of the case based on the appellants’ failure to satisfy their duty to warn. Moreover, this withdrawal occurred when the legal debate was not yet well-established and, therefore, cannot bind the class members. [12] It will be up to the judge on the merits to rule on the grounds of exoneration set out in

article 1473 C.C.Q. In this regard, it is worthwhile noting that the burden of proof lies entirely on the manufacturer, which must prove that the plaintiff knew or should have known of the danger or injury. [13] [ 17 ] The motion judge therefore did not err in authorizing the class action. However, he did not properly identify the principal questions to be dealt with collectively. These questions should be amended in the manner suggested by the respondent, while omitting questions (c), (

d) and (f), which are redundant. The Court will retain question (a), which addresses fault, because it is always open to the respondent to prove fault, despite the fact that she is not required to do so. [14] [ 18 ] Lastly, the appellants argue that the questions addressing injury and the causal link should be dealt with individually. There is no need to revisit the manner in which the motion judge characterized these questions.

Here, too, if the judge who hears the class action awards damages, it will be up to him or her to decide the method of recovery (collective or individual). [15] FOR THESE REASONS, THE COURT: [ 19 ] ALLOWS the appeal for the sole purpose of amending paragraph 122 of the judgment as follows: [122] IDENTIFIES the principal questions of fact and law to be treated collectively as follows: (

a) Were the Respondents negligent or did they commit faults in the designing, developing, testing, manufacturing, marketing, distributing, labelling or selling of the Pinnacle Hip Implants? (

b) Additionally or in the alternative, do the Pinnacle Hip Implants suffer from a defect in design or manufacture, poor preservation or presentation, such that they fail to accord to the group members the safety which they were otherwise entitled to expect from the devices?

(

c) Are the Respondents liable to pay compensatory damages to the group members, and if so in what amount? (

d) Are the respondents liable to pay exemplary or punitive damages to the group members, and if so in what amount? [ 20 ] WITHOUT legal costs, in light of the circumstances. JACQUES CHAMBERLAND, J.A. SUZANNE GAGNÉ, J.A. STEPHEN W. HAMILTON, J.A. Mtre Robert Torralbo Mtre Ariane Bisaillon BLAKE, CASSELS & GRAYDON For the appellants Mtre Erik Lowe MERCHANT LAW GROUP For the respondent Date of hearing: April 4, 2019 Date judgment reserved: May 2, 2019