Product Liability Litigation: Bar Raised for Class Action Certification?

In a decision released May 7, 2012, Justice Caroline Horkins of the Superior Court of Ontario has refused to certify a proposed class proceeding in a pharmaceutical product liability claim (Martin et al. v. Astrazeneca Pharmaceuticals PLC et al.).

The decision is significant to both class proceedings and product liability matters in that certification was refused on multiple bases under the Ontario Class Proceedings Act, 1992, including the failure of the plaintiffs to plead a proper cause of action.


The proposed class proceeding was on behalf of all persons who were prescribed and who consumed Seroquel, an anti-psychotic drug, and their families, who advanced Family Law Act claims. The plaintiffs alleged that Seroquel was negligently designed, developed, manufactured and sold by the defendants for both on-label and off-label uses, causing health problems including weight gain and diabetes. In addition, the plaintiffs asserted claims of conspiracy to submit false and misleading information to Health Canada to obtain approval of the drug and pleaded "waiver of tort" as one of a myriad of remedies.

The Decision

Justice Horkins denied certification, ruling that the plaintiffs had failed to establish many of the requirements under s.5 of the Class Proceedings Act, 1992. Central to the ruling was the determination that the statement of claim, which had been amended multiple times, failed to disclose any cause of action. In this respect, while acknowledging that the pleading had to be read liberally, the Court ruled as follows:

  • The claim failed to specify which of the four corporate defendants had committed which impugned acts. Instead it improperly conflated them all as one entity, such that no defendant had sufficient information to know the acts alleged against it.
  • The negligence claim was deficient in that it failed to distinguish between different claims of negligence including negligent design, negligent manufacturing, negligent distribution and sale, and failure to warn. It further failed to plead the essential elements of each such claim and the material facts in support.
  • The conspiracy claim similarly failed to plead with precision the required material elements of the tort, including the parties to the conspiracy, the purposes of the conspiracy, the overt acts and the unlawful means employed.

In addition to the pleading deficiencies, the Court ruled that the plaintiffs had failed to meet the requirements for certification for the following reasons, among others:

  • The plaintiffs failed to provide sufficient evidence that "two or more" persons asserted the common claim. The Court cited an absence of evidence that others who had taken the drug were interested in pursuit of the claim. In any case, the class was defined too broadly in that it was not limited to any time period.
  • The common issues proposed by the plaintiffs lacked the necessary commonality under the Act. The Court noted these deficiencies, among others:
    • A general question of causation as framed by the plaintiffs was "just the beginning of the inquiry"; its "resolution [would be] dependent upon individual findings of fact with respect to each claimant" and thus lacked the necessary commonality required by the Act.
    • Certain common issues were unconnected to the claims in the statement of claim and, in any event, were unsupported by any evidence that they could be determined in common in respect of all proposed class members.
    • The proposed common issue regarding the duty to warn was too broad. If tried, it would therefore result in an answer so general that it would have no impact on the claims as advanced by individual members of the class.

  • The proposed representative plaintiffs were not suitable since they were not adequately informed about the action, nor did they have any real interest in it. The Court cited, among other things, the fact that the proposed plaintiffs had not read the product monograph for the drug and had made no efforts to inform themselves of the roles of each of the named defendants in the matters in issue.

Defendants to product liability class proceedings will be pleased with the Court’s methodical and rigorous application of the criteria for certification, while plaintiffs will be required to carefully consider the sufficiency of their pleadings before moving to certify their claims as class actions.

To discuss these issues, please contact the author(s).

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