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10 September 2009
On August 17 2009 in Goyette v GlaxoSmithKline Inc Justice Mark G Peacock of the Quebec Superior Court ruled in favour of the respondent GlaxoSmithKline Inc (GSK), dismissing a motion for authorization to institute a class action made by the petitioner on behalf of all persons residing in Canada who alleged to have experienced dependency and withdrawal problems caused by the use of the antidepressant medication marketed under the name PAXIL.
The petitioner contended that GSK had:
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.
Notably, 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 of the Code of Civil Procedure, in the form of cross-examinations of the petitioner on her affidavit, along with the affidavit of an expert establishing, among other things, that an individual examination of each member of the proposed group would be required before it could be concluded that the alleged symptoms were related to discontinuation of PAXIL.
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 Compendium of Pharmaceutical Specialties and who had confirmed to her that there would be no risk associated with discontinuing treatment. Listed in the compendium under possible adverse effects were a range of symptoms, described as mild and transient; and under adverse experiences reported, withdrawal syndrome and drug dependence were described as rare. The petitioner alleged that she had experienced severe symptoms after discontinuing treatment. The petitioner maintained that other individuals had experienced similar symptoms, based on certain US and UK news reports and articles and a list of individuals who had signed up on her attorney's website.
Article 1003(a) - identical, similar or related questions
The court began 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. The court acknowledged that the manufacturer meets this obligation by disclosing the risks to a competent intermediary, according to the recognized legal principle known as the 'learned intermediary rule'. The court noted 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 Compendium of Pharmaceutical Specialties, on which the petitioner's motion for authorization was based.
In connection with the analysis of the test set out in Article 1003(a), the court lay down a first important principle. Contrary to previous rulings in pharmaceutical cases, the court established 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. 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 of the Civil Code of Quebec. Article 1621 requires the court to assess punitive damages in light of all appropriate circumstances, including, in particular, the extent of the reparation for which the debtor is already liable to the creditor.
The court also adopted a second important principle, acknowledged by the Quebec Court of Appeal in Voisins du train de banlieue de Blainvile Inc v Agence métropolitaine de transport,(1) which requires that a collective prejudice be established in order for the test in Article 1003(a) of the Civil Code of Procedure to be met. In the case at hand, the court found that establishing collective prejudice was not possible since the alleged symptoms (eg, headaches, dizziness, vertigo and insomnia) were susceptible to infinite variation in their subjective nature, duration and intensity. The court made a distinction with cases involving defective products. It concluded that contrary to the case under consideration, in cases involving defective products, a definite number of difficulties are experienced by the user.
Finally, the court acknowledged that civil liability on the part of GSK could not be established without assessing the specific risks disclosed to each individual patient, which risks vary depending on multiple factors, including:
The court went on to accept the expert opinion that an individual medical examination of each member would be required in order to establish such a causal link between the alleged symptoms and discontinuation of treatment with PAXIL. The court noted that the mere fact that symptoms were alleged to have been suffered immediately after treatment was stopped or reduced could not serve, in itself, to establish such a causal link without considering other factors described in the affidavit which could have caused those symptoms.
In the circumstances, the court decided that there was no real common question to all the members of the proposed group.
Thus, this case 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 manufacturer has prevented a class action from being authorized on the basis that the test of Article 1003(a) of the Civil Code of Procedure has not been met. Unlike certain prior decisions which appear to have skirted around the necessity of establishing a causal link between the fault and the prejudice alleged, in this case the court specifically stated that causality was an essential factor in determining liability. In the court's view, judicial economy would not be served by allowing an action to proceed which would 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). This opinion of the court creates an important precedent as the argument raised to contest authorization based on the necessity of conducting numerous mini-trials has previously been dismissed by the courts in Quebec.
Article 1003(b) - facts do not seem to justify conclusions sought
Although the court recognized that at the authorization stage, the petitioner merely has a burden of serious demonstration, it concluded that the facts alleged were insufficient, even if considered as proven, to justify a cause of action for the petitioner and for those she sought to represent.
In the court's view, the petitioner did not have a case against GSK based on failure to disclose the risks associated with discontinuing treatment with PAXIL, since the symptoms allegedly suffered by the petitioner were disclosed in the Compendium of Pharmaceutical Specialties. The court also based its 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. Finally, the court noted that, unlike other cases that have involved pharmaceutical products, the petitioner failed to file an expert report establishing that the symptoms were caused by the discontinuation of treatment.
The court reiterated the recognized principle that facts considered as proven at the authorization stage did not include impressions, opinion, legal arguments, inferences or hypotheses that are not verified.
As for the appearance of a right of action in regard to the other members of the group, the court noted the petitioner's failure to allege sufficient facts purporting to support that other members of the group had suffered symptoms related to discontinuation of PAXIL. Indeed, the petitioner based her proceedings solely on internet articles and news reports originating from US or UK sources and a list of individuals who signed up on her attorney's website. The court found that her attorney's website did not in itself constitute evidence, without an explanation of the context thereof. Even taking the foreign references as proven, they would not suffice to establish GSK's civil liability towards members in Canada for failure to disclose risks associated with discontinuation of treatment with PAXIL in the Compendium of Pharmaceutical Specialties in Canada.
Article 1003(d) - petitioner not an adequate representative
In light of the evidence presented, the court found that the petitioner was not in a position to represent the members adequately for the following three reasons:
Even though, given its conclusions described above, the court was not obliged to rule on the question of a national class, it nevertheless went on to find that the criteria set out in Article 3148 of the Civil Code of Quebec that are necessary to justify a national class were 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 referred to the recent Quebec Court of Appeal decision in Interinvest (Bermuda) Ltd v Herzog,(2) where it was 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 assume jurisdiction in regard to every Canadian resident. Accordingly, the petitioner could seek to represent only 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 of the Civil Code of Quebec.
This is the first Quebec case in which the court has refused to authorize a class action involving a pharmaceutical product on the basis that an individualized assessment of each member of the proposed group would be required to establish liability. It acknowledges that the class action is a procedural vehicle that should be authorized only where all the elements giving rise to civil liability can be established on a collective basis - namely fault, prejudice and a causal link. In addition, it underscores the fact that while hearsay evidence may be admissible in connection with the test set out in Article 1003(b) of the Civil Code of Procedure, the petitioner will nevertheless have to demonstrate a serious appearance of right. Finally, contrary to certain decisions that appear to suggest that the test in respect of representative status contained in Article 1003(d) of the Civil Code of Procedure can be easily met, this decision advocates a more restrictive and rigorous approach to that test.
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