Landmark Precedent: Court Denies Certification of a Product Liability Class Action Related to a Drug Withdrawn From the Market
On April 16, 2012, the Honorable Claudine Roy of the Superior Court of Québec refused to authorize the institution of a class action against Abbott Laboratories (Abbott) and Apotex Inc. concerning a weight-loss drug, Meridia® that had been withdrawn by Abbott from the Canadian marketplace, in collaboration with Health Canada. Abbott was the manufacturer of Meridia®, while Apotex manufactured a generic version of the drug. This is a major jurisprudential development, as it is the first decision rendered in Québec by which the authorization of the institution of a class action for medication that had been withdrawn from the market was refused. McCarthy Tétrault is representing Abbott in this case.
Roy J. stated that the putative class action put forward by the petitioner failed to meet three of the four criteria required by article 1003 of the Québec Code of Civil Procedure for the authorization of a class action, namely that he failed to establish that (i) he had an appearance of right (art. 1003 b)), (ii) it would be difficult or impractical to bring forward individual actions (art. 1003 c)), and (iii) he would have been able to adequately represent the class members (art. 1003 d)).
Drawing upon a detailed analysis of the evidence filed both by the petitioner as well as by the respondents, Roy J. held that the evidence did not establish that any person would have suffered from a heart attack or stroke due to the drug, as had been alleged by the petitioner. Indeed, she noted that the evidence often contradicted the petitioner's allegations and, in other cases, was simply not sufficient to create an appearance of right.
In particular, Roy J. analyzed the medical literature that led to the drug's withdrawal (the SCOUT study), as well as the product's monograph. She noted that the results of the study essentially concerned patients for whom the use of the medication was expressly contraindicated by the product's monograph. More specifically, the SCOUT study did not demonstrate that the use of Meridia® in the patients for whom it was destined increased the risk of a heart attack or a stroke, as alleged by the petitioner. There was thus a lack of evidence supporting the petitioner's allegations on this critical issue.
As for the recommendations by the Food and Drug Administration and Health Canada that the drug be withdrawn from the market, Roy J. noted that this was based on a reassessment of the risk/benefits ratio in light of the SCOUT study. Roy J. stated that the petitioner had not explained how he would use this information to establish the manufacturers' liability. While it is not necessary for a petitioner to provide all answers at the authorization stage, he must minimally explain his theory of the case, which was not the case in this matter.
The petitioner's allegations that he would have suffered from a heart attack were not supported by his medical records. Indeed, such an event is never mentioned in the chart, despite the fact that he had consulted a physician for ailments that were much less significant.
The judge found that the petitioner had done absolutely nothing to verify his hypothesis that he would have suffered from a heart attack in 2005, and that this heart attack would have been caused by Meridia®. Furthermore, there was no evidence that supports his allegation that he would remain at risk of developing heart problems because he had ceased taking the medication. He had not brought forth any element supporting his assertion that the drug would cause such health problems. Therefore, the Court could not authorize the institution of a class action on the basis of inferences or unverified hypotheses.
The petitioner's own personal case was so weak that he could not in any event act as a class representative. He also only made general allegations as to why he would be a proper representative. By failing to adduce appropriate evidence or make any research whatsoever into the case, the petitioner and his counsel were not serious enough to represent the class members in this putative class action.
On another note, Roy J. stated that the determination of causation and moral damages should be analyzed individually for each class member.
Roy J. also held that, given that the petitioner had never taken the generic version of the drug manufactured by Apotex, he had no cause of action against that respondent.
McCarthy Tétrault Notes
This is the first decision in Québec to recognize that the withdrawal of a drug from the market will not necessarily lead to the authorization of a class action. A serious demonstration of a link between the drug and any alleged adverse event is required, regardless of the product's withdrawal.
The Court has also recognized that, in order for a class action to be authorized, the class members must have suffered actual damages. The simple exposure to a situation that could supposedly lead to increased risks of prejudice is not sufficient to create a valid cause of action.
Moreover, it is heartening to see the Court render a decision at the authorization stage based on a rigorous analysis of the evidence submitted by the parties, rather than authorizing a class action on the basis of unsubstantiated vague and general allegations.