In a landmark ruling released on May 7, Madam Justice Carolyn Horkins of the Ontario Superior Court denied certification of a proposed national class action involving the atypical anti-psychotic medicine, Seroquel®. In Martin v. AstraZeneca Pharmaceuticals Plc, the plaintiffs made a broad range of allegations against three AstraZeneca companies in relation to the design, manufacture, marketing and sale of Seroquel®, a leading medicine used to treat schizophrenia and bipolar disorder. The principal claims were that Seroquel® causes serious health risks that were not adequately warned of in the product monograph approved by Health Canada. The plaintiffs also alleged that the defendants conspired to conceal safety information from Health Canada and to promote the medicine for off-label, unapproved uses. McCarthy Tétrault acts for AstraZeneca in the proceeding.
The Court found that the plaintiffs failed to meet any of the five criteria for class certification. The 78-page decision marks the first time that the Ontario Superior Court has refused to certify a class action relating to a pharmaceutical product. The Court carefully considered the Statement of Claim to determine whether it disclosed a cause of action in any of the multiple forms of alleged negligence (negligent design; negligent manufacture; negligent distribution, marketing and sale), the alleged failure to warn of health risks, as well as claims of conspiracy. Ultimately, the Court found that the Statement of Claim was fundamentally deficient in relation to all of the potential causes of action and therefore the plaintiffs failed to meet their burden under s. 5(1)(a) of the Class Proceedings Act. The record on the motion was extensive. The plaintiffs filed affidavits from the proposed representative plaintiffs as well as two American experts, a psychiatrist and a pharmacologist who also claimed regulatory expertise relating to the FDA. AstraZeneca filed a comprehensive evidentiary record which included an affidavit from the company’s global Head of Patient Safety detailing the evolution of knowledge concerning the health risks associated with Seroquel® and the companies’ pharmacovigilance- the careful monitoring, studying and reporting of adverse effects. The defendants also filed evidence from experts in endocrinology, psychiatry, and a Canadian pharmaceuticals regulatory expert.
Applying well-established legal principles, Justice Horkins noted that the evidentiary burden on the plaintiffs was low and the corresponding burden on the defendants was high. The plaintiffs’ burden was to show that there was some evidence to establish some basis in fact for the existence of a class and the claims. After reserving her decision for five months, Justice Horkins concluded that the plaintiffs failed to satisfy any of the remaining four criteria. She held that the common issues were not shown to be common, that there was no demonstrated methodology to address the proposed common issues on a class wide basis nor that doing so would meaningfully advance the claims of individuals. The Court also found that it had not been demonstrated that a class proceeding would be the preferable procedure for addressing the proposed claims of consumers of Seroquel® in Canada.
Importantly, Justice Horkins held that the mere fact that similar issues have been found worthy of certification in other cases is not a basis to certify the issues in the case before the Court. This decision illustrates that the certification criteria will be assessed on the basis of the claims as formulated, and the evidence filed, in the particular case.
Justice Horkins also rejected a general causation question about whether Seroquel® "can cause" weight gain, diabetes, "and/or related metabolic disturbances" and secondary injuries, on the basis that the question was too vague. Her Honour further found that the expert evidence established that the question could not be answered on a class-wide basis in any way that would materially advance the claims of any single member of the class. The Court also found that after cross-examination, the plaintiffs’ expert evidence constituted no evidence capable of supporting the claims alleging a failure to warn of the health risks. In addition, the Court found that the plaintiffs’ pharmacology expert’s evidence regarding the product warnings was not admissible due to the expert’s lack of proper medical qualifications. Finally, the Court found that there was no evidence to establish any basis in fact for the conspiracy claims.
The decision in Martin v. AstraZeneca Pharmaceuticals Plc establishes that pharmaceutical product liability cases do not constitute a special class of cases that attract a lower threshold for class certification than other types of proposed class actions. Class certification will succeed or fail based on the strengths and weaknesses of the evidence filed by the parties for consideration by the Court, and the adequacy of the formulation of the claims and common issues presented by the plaintiffs in each individual case.