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Canadian Court Strikes Plaintiffs’ Expert Evidence, Denies Certification of Pharmaceutical Class Action

June 12, 2023

The Canadian Legal Information Institute recently published an overlooked but important class action decision of the Saskatchewan Court of King’s Bench (Court) in Graham et al. v. Hoffmann-La Roche Limited et al. (Graham). The Court struck the plaintiffs’ expert opinion on the alleged link between a well-known medicine for severe acne (Medicine) and inflammatory bowel disease (IBD). The Court also refused to certify the proposed national class action.

The authors, Gord McKee, Catherine Beagan Flood and Daniel Szirmak, represented the brand manufacturer defendant at the hearing together with local counsel (now a judge of the Court).

Reasons for Striking Expert Evidence

The plaintiffs served and relied on an expert report of a gastroenterologist in support of their application for certification of the proposed class action. Specifically, they relied on that report as some basis in fact for a causation common issue that underpinned all other common issues. The expert opined that it was probable the Medicine could cause IBD in some patients.

The defendants brought an application to strike the plaintiffs’ expert evidence on a number of grounds, namely that:

  1. He did not have the expertise to give the opinions expressed in his report.

  2. His evidence was partisan and not objective.

  3. His evidence was not reliable because his methodology was incomplete, not scientifically valid and not consistent with generally accepted scientific methods for assessing causation.

The judge hearing the motion agreed that the expert evidence was inadmissible.

The Court discussed the two-stage analysis for admissibility of expert evidence set out in White Burgess Langille Inman v. Abbott and Haliburton Co. (White Burgess). The courts are not to weigh competing expert evidence at certification. Therefore, the Court concluded that it should not, on a certification application, consider the second stage discretionary gatekeeper analysis. However, the Court considered admissibility of the opinion under all aspects of the first stage of the White Burgess test. Ultimately, the Court granted the defendants’ application to strike on the grounds that the expert was not properly qualified to give the causation opinion in his report. While the Court recognized his experience as a treating physician and his general gastroenterology knowledge, it did not accept that he was an expert in the particular issues on which he opined, namely the cause and pathology of IBD. His expertise was in diagnosis and treatment of IBD, not causation. The Court rejected the plaintiffs’ argument that the threshold for qualification of a proposed expert is lower in the certification context than in other cases.

The Court also noted that the proposed expert did not, in coming to his opinion, take the necessary steps to use his medical training to develop expertise on the cause of IBD. In particular, his review of a subset of articles on the issue provided by plaintiffs’ counsel did not make him an expert.

Reasons for Denying Certification

The Court declined to certify Graham on the primary grounds that the plaintiffs had failed to establish an evidentiary basis for a causal link between the Medicine and IBD. This was a necessary element of each of the plaintiffs’ asserted causes of action and proposed common issues.

The Court also found that the plaintiffs had failed to demonstrate a workable methodology for determining causation on a class-wide basis. The Court’s decision in its result echoed an earlier decision of the Quebec Superior Court in Lebrasseur v. Hoffmann-La Roche Limitée. The decision denied an application to authorize a Quebec class proceeding on behalf of a similar class of persons who had consumed the Medicine and suffered from IBD. In that case, the Court cited a lack of evidence to establish a causal relationship between the Medicine and the Quebec plaintiff’s alleged Crohn’s disease.

The Court’s decision to strike the proposed expert’s evidence (as summarized above) was critical to its decision. According to the Court, his evidence would have provided a basis to certify the proposed issue regarding the alleged link between the Medicine and IBD had it been accepted.

The Court rejected the plaintiffs’ arguments that a basis in fact for the common causation issue was provided by:

  1. The scientific literature on its own.

  2. Health Canada’s adverse reaction reports.

  3. A statement in one of the defendants’ product monographs that the Medicine “has been temporally associated with inflammatory bowel disease.” 

The Court then accepted that the defendants’ own expert evidence had shown that there was no basis in fact for the plaintiffs’ proposed common causation issue.

Separately, the Court found that if the proposed class action had succeeded, it would have narrowed the class to Saskatchewan residents only. This was partly because class counsel had failed to give proper statutory notice of the certification application to counsel in parallel class actions in other provinces. Notably, since the Graham decision was rendered, all of those other cases have also been dismissed or discontinued (see, for example, Patkus v. Hoffmann-La Roche et al.).

Conclusion and Implications 

The Court’s decision in Graham highlights that expert evidence on a certification motion must meet the threshold requirements for admissibility under the first stage of the White Burgess analysis. It also highlights that other evidence alleged to provide a basis in fact for common causation issues must be carefully scrutinized to determine if it truly supports such an assertion or something more limited.

The defendants’ expert evidence can be considered by the court and determinative at certification in some cases even if it may not be weighed. The case also highlights the important screening role of the judge at the certification stage. Finally, it reaffirms the importance of establishing evidence of class-wide causation in cases where causation is a necessary element of a cause of action or proposed common issue.

For further information, please contact:

Gordon McKee                        +1-416-863-3884
Catherine Beagan Flood       +1-416-863-2269
Daniel Szirmak                        +1-416-863-2548
Sam Cotton                              +1-416-863-2438
or any member of our Class Actions, Litigation & Dispute Resolution and Life Sciences groups.