Goyette v. GlaxoSmithKline Inc.  

On August 17, 2009, Justice Mark G. Peacock of the Quebec Superior Court ruled in favour of the respondent GlaxoSmithKline Inc. (GSK), represented by Ogilvy Renault, dismissing a Motion for Authorization to Institute a Class Action (the “Motion for Authorization”) made by the petitioner on behalf of all persons residing in Canada who have experienced dependency and withdrawal problems owing to the use of the antidepressant medication marketed under the name PAXIL. The petitioner contended that GSK had introduced PAXIL to the market without ensuring its safety, failed to inform health professionals, physicians and consumers of the risks associated with discontinuing this medication or reducing the dose, and misrepresented the facts in regard thereto. Accordingly, she claimed compensation on behalf of the members for physical, economic and moral damages suffered, along with punitive damages. The Court refused to allow a class action to be brought, on the basis that the three tests set out in paragraphs (a), (b) and (d) of article 1003 of the Code of Civil Procedure had not been met.  

FACTS AND CIRCUMSTANCES  

It should be noted that the Motion for Authorization had been made before the Code of Civil Procedure was amended in 2003, when appropriate evidence could still be filed without leave of the Court. In support of its contestation, GSK was able to present evidence to the Court with respect to the application of the tests in article 1003 C.C.P., in the form of cross-examinations of the petitioner on her affidavit, along with the affidavit of an expert to the effect that an individual examination of each member would be required before it could be concluded that the alleged symptoms were related to discontinuing PAXIL or reducing the dose.  

Among other things, the examinations revealed that the petitioner had agreed to take PAXIL after consulting her doctor, with whom she had read the entry in the CPS (Compendium of Pharmaceutical Specialties/Compendium des produits et spécialités pharmaceutiques) and who had confirmed to her that there would be no risk associated with stopping treatment. Listed in the CPS under possible adverse effects were a range of symptoms, described as mild and transient, and under adverse experiences reported, withdrawal syndrome and drug dependence, described as rare. The petitioner stated that she had experienced severe symptoms after stopping treatment and, basing herself on certain U.S. and British news reports and articles, a U.S. website and a list of individuals who had signed up on her attorneys’ website, maintained that other individuals had experienced similar symptoms,  

  1. Article 1003 (a) C.C.P. – Identical, similar or related questions

The Court begins by recalling the obligation that Quebec law imposes on a pharmaceutical manufacturer to inform consumers of the risks associated with a medication that it sells. It acknowledges that the manufacturer meets that obligation by disclosing the risks to a competent intermediary, according to the recognized legal principle known as the “learned intermediary rule.” The Court notes that one means by which a pharmaceutical manufacturer can provide adequate information about the risks associated with a medication to the physicians who will be prescribing it is to disclose them in the CPS, on which the petitioner’s Motion for Authorization is based.

In connection with the analysis of the test set out in article 1003 (a), the Court lays down a first important principle.  

Contrary to previous rulings in pharmaceutical cases, the Court establishes that in Quebec, the question of whether punitive damages should be awarded under the Consumer Protection Act for failure to inform cannot constitute a common question since it requires an individual analysis. Indeed, only when the members of the prospective group have proven physical, psychological, economic and moral damages on the basis of individual hearings and the amounts of those damages have been decided individually can the Court consider what, if any, amount should be awarded as punitive damages, based on the criteria set out in article 1621 C.C.Q., which requires the Court to assess punitive damages in light of all the appropriate circumstances, including in particular the extent of the reparation for which the debtor is already liable to the creditor.  

The Court adopts a second important principle, acknowledged by the Quebec Court of Appeal in Voisins du train de banlieue de Blainvile Inc c. Agence métropolitaine de transport,1 which requires there to be a possibility of establishing collective prejudice in order for the test in article 1003 (a) C.C.P. to be met. In the case at issue here, the Court finds that establishing collective prejudice is not possible since the alleged symptoms, such as headaches, dizziness, vertigo or insomnia, are susceptible of infinite variation as to their subjective nature, duration and intensity.  

Lastly, the Court acknowledges the importance of causality, finding that civil liability on the part of GSK could not be established without multiple factors being examined, including the nature of the symptoms suffered by the members and whether or not they were described in the CPS; the information received from the treating physician or the pharmacist, and the causal connection between the symptoms and the use of PAXIL. The Court goes on to accept the expert opinion to the effect that an individual medical examination of each member would be required in order to establish such a causal connection between the existence of the alleged symptoms and discontinuation of treatment with PAXIL, noting that the mere fact that symptoms are alleged to have been suffered immediately after treatment was stopped or reduced cannot serve, in itself, to establish such a causal connection without considering other factors which could have caused those symptoms.  

This case thus marks the first time in Quebec where, in a matter involving a pharmaceutical product, the fact that an individual examination of each member would be needed in order to establish liability on the part of the respondent manufacturer has prevented a class action from being authorized on the basis that the test of article 1003 (a) C.C.P. has not been met. Unlike certain prior decisions which appear to have skirted around the necessity of establishing a causal connection between the fault and the prejudice alleged, the Court has declined to allow a class action to proceed against a pharmaceutical company where the only common question to be decided would involve determining whether fault had occurred. In the Court’s view, judicial economy would not be served by allowing an action to go ahead which would in reality require an individual trial on the merits for each member in order to establish civil liability on the part of the manufacturer (based on fault, prejudice and a causal connection).

  1. Article 1003 (b) C.C.P. – Facts do not seem to justify conclusions sought

In the Court’s view, the petitioner does not have a case against the manufacturer based on failure to provide sufficient information on the risks associated with stopping treatment with PAXIL since the alleged symptoms were disclosed in the CPS. The judge also bases his conclusion on the petitioner’s admission that her treating physician confirmed to her that the symptoms she reportedly suffered were not linked to discontinuation of PAXIL. Lastly, the Court notes that, unlike other cases that have involved pharmaceutical products, the petitioner did not file an expert report establishing that the symptoms were connected with discontinuation of treatment.  

As for the appearance of right in regard to the other members of the group, the Court notes the failure to allege sufficient facts purporting to support that other members of the group suffered symptoms related to discontinuation of PAXIL. Indeed, the petitioner based her proceedings solely on a list of individuals who she says signed up on her attorneys’ website, and on Internet articles and documents originating from U.S. or British sources. The Court finds that her attorneys’ website does not in itself constitute evidence, without an explanation of the context, and that even taking the foreign references as proven, they would not suffice to establish GSK’s civil liability toward members in Canada for failure to disclose, in the CPS in Canada, risks associated with discontinuation of treatment with PAXIL.  

  1. Article 1003 (d) C.C.P. – Petitioner not an adequate representative

In light of the evidence presented, the Court finds that the petitioner is not in a position to represent the members adequately for the following three reasons: 1) she does not have an individual case to make against GSK; 2) she showed a singular lack of interest in the class action that she was seeking to have authorized in that she never spoke to any member of the group, does not know any member of the group and never tried to contact any of the individuals who she says signed up on her attorneys’ website; and 3) she was unable to explain why the proceedings remained dormant for five years.  

  1. National class

Even though, given its conclusions described above, the Court was not obliged to rule on the question of a national class, it nevertheless goes on to find that the criteria set out in article 3148 of the Civil Code of Québec necessary to justify a national class are not met. Indeed, the petitioner admitted not knowing whether GSK had any business activities in Quebec and she had not alleged that the PAXIL sold in Canada was in fact manufactured or distributed in Quebec or that the monograph for it was printed in Quebec. The Court refers to the recent Quebec Court of Appeal decision in Interinvest (Bermuda) Ltd c. Herzog,2 where it is established that the business activities implicated in the dispute must be connected to a place of business of the respondent in Quebec in order for the Quebec courts to be able to take jurisdiction in regard to every Canadian resident. Accordingly, the petitioner could only apply to represent members residing in Quebec since they alone could demonstrate that they had suffered damage in Quebec, according to one of the criteria set out in article 3148 C.C.Q.  

CONCLUSION  

This is the first Quebec case in which the Court has refused to authorize a class action involving a pharmaceutical product. It acknowledges that the class action is a procedural vehicle that should only be authorized where all the elements giving rise to civil liability can be established on a collective basis, namely, fault, prejudice and a causal connection between the two. In addition, it underscores the fact that while hearsay evidence may be admissible in connection with the test set out in article 1003 (b) C.C.P., the petitioner will nevertheless have to demonstrate a serious appearance of right. Lastly, contrary to certain decisions that appeared to suggest that the test in article 1003 (d) C.C.P. could be easily met, this decision advocates a more restrictive and rigorous approach to that test.