Canada: Ontario Superior Court Filters Out Proposed Medical Implant Device Class Action

It is often said that product liability cases are ideal for class treatment. The Ontario Superior Court of Justice's recent denial of certification in Kuiper v Cook (Canada) Inc. demonstrates that this is not always the case. In Kuiper, the failure of the plaintiffs to identify a common design defect and proffer sufficient evidence proved fatal to achieving certification and being granted leave to amend their pleadings. Barring a successful appeal, there appears to be no hope of a happy ending for these plaintiffs in the class action world. Overall, the decision serves as a reminder that, while the certification process is not a merit-based exploration of a claim, the exercise is not merely symbolic or superficial. Poorly pleaded allegations and insufficient expert evidence can prove fatal to a proposed class action, particularly when such deficiencies appear together.

Background

Inferior vena cava ("IVC") filters were the product at issue. These implantable devices are used to trap blood clots before they reach the heart and lungs to avoid life threatening emboli. In this case, the plaintiffs targeted three of the defendants' IVC filters, all of which were designed to be permanently placed in the body, but which were optionally retrievable. Initially, the plaintiffs pleaded the widest-possible products liability claims against the manufacturer defendants, ranging from allegations of negligence in research, design, development, testing, licensing, manufacture, labelling, warning, marketing, distribution, sale, and monitoring to misrepresentation. While these allegations persisted until the certification motion, at the hearing, the plaintiffs sought certification on the basis of alleged design negligence and the breach of a duty to warn. The plaintiffs adduced a single expert report in support of the low-evidentiary standard of "some- basis-in-fact", in hopes of achieving certification on these two issues. The defendants adduced five expert reports (three independent experts and two experts internal to the defendants).

The Achilles Heel: Failure to Identify a Design Defect

Early on in the decision, the Court identified what it believed to be the 'Achilles heel' of the plaintiffs' action, namely their failure to identify a design defect. In assessing whether the pleadings disclosed a cause of action, the Court endorsed the defendants' assertion that the pleadings had merely concluded that there was a design defect in the IVC filters, without any identification of the actual design failure. The Court noted that medical devices, like the IVC filters at issue, are inherently dangerous. The fact that those dangers materialize does not automatically lead to the manufacturer incurring legal liability.

In reasoning similar to the failed cause of action criterion, the plaintiffs failed to demonstrate that the design defects actually existed. The Court was particularly critical of the expert evidence adduced on behalf of the plaintiff, which the Court found failed to address any specific design failure of the IVC filters at issue. Indeed, as the common issues criterion is often regarded as the most important criterion for certification, the Court noted that the "the some-basis-in-fact standard is low, but it is not subterranean" (para. 134). The significance of this failure to assert common design defect issues provided the Court's rationale for refusing to allow the plaintiffs an opportunity to amend their pleadings to reapply for certification.

Searching for Some-Basis-in-Fact: The Duty to Warn

The Court found that the pleadings sufficiently set out a cause of action in regard to the alleged failure to warn, but that the corresponding common issues did not meet the required low evidentiary threshold. Once again, the plaintiffs failed to show that the common issues existed as they did not demonstrate how the IVC filter warnings provided to physicians were inadequate by commission or by omission of information.

The expert evidence provided by the plaintiffs was found to only peripherally address the duty to warn issue. The court found that the expert opinion on this issue did not relate specifically to the material provided by the defendants but rather spoke to warnings given on IVC filters at large. This left the Court curious as to how the expert could assert inadequacy of the defendants' warnings, having not meaningfully evaluated the substance of the written material at issue. Furthermore, the warnings that were provided by the defendants appeared to address risks of adverse events, including death, as well as the risk that filters could damage the vena cava and the risk of filter embolization. Additionally, the Court noted that whether individual class members were adequately informed by their health care providers of the risks associated with the filters would be for the individual issues trials. The Court noted that "informed consent is not a class-wide common issue" (para. 187).

Key Takeaway

Device manufacturers and distributors defending a class action should be aware of the basic shortcomings in plaintiffs' materials that can assist defendants in resisting certification. These include deficient pleadings and imprecise expert evidence that provides little or no support for the core issues on which certification rests. As this case demonstrates, certification is never certain, even for those cases that appear to be the perfect fit for the class action mold.

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