Medical Device Class Action Certified on Appeal: Divisional Court Finds “Some Basis in Fact” for Duty to Warn Claim in IVC Filter Case

February 28, 2020

In Kuiper v. Cook (Canada) Inc., Ontario’s Divisional Court ruled in favour of certifying a failure to warn claim in a product liability class action relating to IVC filters, which are medical devices designed to prevent blood clots from reaching the heart and lungs. The Divisional Court’s January 8, 2020 decision partially overturned a previous ruling that had denied certification outright.

Apart from reaffirming the continued applicability of the “two-step analysis” in the common issue inquiry, the Divisional Court’s decision in this appeal has some direct implications for medical device manufacturers and distributors. Specifically, it:

  • Underscores the importance of timely communication of advisories issued by regulators in Canada and around the world, to physicians and other users of the products; and
  • Reinforces that design-defect allegations brought against medical device manufacturers will be struck out where the plaintiff has not identified a safer alternative design or solution.

Overview of the Plaintiffs’ Arguments

The plaintiffs’ case changed over time, but in essence they advanced two principal arguments at certification:

  • The IVC filters were defectively designed (their design caused them to be prone to malfunctions and injuries); and
  • The defendants breached their duty to warn “learned intermediaries” (i.e. the physicians who recommended or prescribed the IVC filters) of the risks of using the IVC filters.

The Initial Denial of Certification

The Certification Judge refused to certify the class proceeding against the defendants, stating that:

  • The pleading of alleged design defects failed to disclose a reasonable cause of action (although the pleading of a duty of warn was sufficient); and
  • The plaintiffs failed to satisfy their onus of demonstrating there were common issues of either defective design or a duty to warn.

Defective design

In assessing whether the pleadings disclosed a cause of action, the Certification Judge accepted the defendants’ argument that the pleadings merely concluded that there was a design defect in the IVC filters, without identifying what the defect actually was.

The Certification Judge also found that the plaintiffs pleadings failed to refer to the specific alternative design that would have been safer and left the defendants to guess at what the plaintiffs said was the better or safer design.

In the analysis of the common issue criterion, the Certification Judge held that the plaintiffs must show “some basis in fact” for the common issue, which requires showing that:

  • The proposed common issue actually exists; and
  • The proposed common issue can be answered in common across the entire class.

The Certification Judge held that the plaintiffs failed to provide evidence to support a design defect and could not satisfy the Court that a specific defect in the IVC filters existed, which meant that they could not succeed on “step one” of the two-step inquiry referred to above. The Court noted that while the “some basis in fact” standard to support the existence of the common issue is low, it is not “subterranean”.

Duty to warn

The Certification Judge found that the pleadings set out a cause of action regarding the plaintiffs’ breach of the duty to warn allegations. However, he held that the plaintiffs had failed to show that the proposed “duty to warn” common issues actually existed. In particular, the plaintiffs failed to demonstrate how the IVC filter warnings provided to physicians were inadequate, whether by commission or omission of information.

The Certification Judge considered it significant that the plaintiffs’ expert admitted that he and his colleagues were well aware of the particular risks related to IVC filters and did not generally read instructions for use (“IFU”) warnings from specific manufacturers. The Certification Judge further noted that the expert had not conducted an analysis of manufacturers’ IFU warnings and could not offer an opinion about what precisely was inadequate about the defendants’ warnings.

The Certification Judge concluded that, contrary to the plaintiffs’ assertions, the IFU did in fact warn about the risks of adverse events, including death, as well as the risk that filters could damage the vena cava and the risk of filter embolization.

Divisional Court Overturns in Part, Certifying on the Duty to Warn Issue Only

On appeal, the Divisional Court:

  • Upheld the ruling that the defective design allegations should not proceed; and
  • Overturned the Certification Judge and certified the case in relation to the failure to warn

On appeal, the plaintiffs argued that the Certification Judge erred in his application of the two-step test to determine whether there were common issues. The plaintiffs argued that the two-step inquiry (originally from Hollick v. Toronto (City)) no longer applies, and that following the Supreme Court of Canada’s decision in Pro-Sys Consultants Ltd. v. Microsoft Corporation, there is only a one-step test and no need to establish an “air of reality”, “colourable claim”, or “arguable case” that the common issue exists.

The Divisional Court disagreed, noting that the weight of judicial and appellate authority – including the Supreme Court of Canada in its recent ruling in Pioneer Corp. v. Godfrey – is that the two-part test is alive and well.

Upon confirming that the two-step still governs the commonality inquiry, the Divisional Court applied it to the two proposed causes of action.

Defective design

The Divisional Court agreed with the Certification Judge that the plaintiffs had not properly pleaded the “defective design” cause of action (i.e. because they failed to set out the particulars of the defect or to show that a safer alternative was available to the defendants). The Divisional Court agreed that the plaintiffs’ expert had no expertise in the design or manufacture of IVC filters and was not qualified to give expert evidence on that subject.

Duty to warn

On the duty to warn allegations, the Divisional Court disagreed with the Certification Judge and found that there was sufficient evidence to establish a common issue with respect to the “duty to warn” cause of action. The Divisional Court held that the plaintiffs successfully met the “some basis in fact” standard because they had presented evidence of several risk advisories concerning the IVC filters issued in the U.K., U.S., and by Health Canada, which had not been incorporated into the defendants’ IFUs.

In their appearance before the Certification Judge, plaintiffs’ counsel had apparently not focused on the advisories. On appeal, however, as the Divisional Court noted, there was a “change in emphasis” and in the Court’s view the existence of the advisories was enough to “[meet] the low bar for finding that the duty to warn is a common issue”. In the result, the Divisional Court certified the case for the alleged breach of the duty to warn.

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