In a decision released on August 27, 2013, Justice Belobaba of the Ontario Superior Court of Justice certified a class action against DePuy Orthopaedics Inc. on behalf of persons who were surgically implanted with any one of two DePuy hip systems. The core allegation against the defendants is negligence in the design and manufacturing of the hip replacement systems and in the defendants' failure to warn. Justice Belobaba's decision in Crisante v DePuy Orthopaedics Inc, 2013 ONSC 5186 (DePuy) seems to indicate a retreat from certain recent cases which applied a more cautious approach to the certification of medical device class actions.

The Action

This action was brought on behalf of the 400 to 4,000 persons who were surgically implanted with a DePuy hip replacement system. Of the four representative plaintiffs, two were implanted with the DePuy ASR XL hip system in 2008. Two years later, both of them had to undergo revision surgeries. This coincided with a higher than normal failure and revision rate for both of the new DePuy hip implants being reported by medical registries, which ultimately led to DePuy's voluntary recall of the implants in 2010. The two recipients of the implants (along with their spouses) then commenced the proposed class action.

The Certification Decision

The defendants raised numerous objections to certification of the proposed class action, including arguments that the class definition was overly broad, that the proposed common issues were inappropriate and could not be decided on a class wide basis, and that a class action was not the preferable procedure in the circumstances. Justice Belobaba ultimately dismissed all of the defendants' objections, finding that the plaintiffs satisfied all five of the prerequisites to certification under s. 5(1) of the Class Proceedings Act.

Identifiable Class and Class Definition

On the issue of whether there was an identifiable class, the defendants had argued, among other things, that the class definition should include only those who had revision surgery, as opposed to all persons who have been implanted with either of the DePuy hip systems, regardless of whether revision surgery was required. In rejecting this argument, Justice Belobaba held that the broad class definition was appropriate given the broad pleading and the fact that the recall notices from 2010 had not differentiated between the two products. The proposed class definition reflected the plaintiffs’ claim that the DePuy implants were improperly designed and should not have been sold or implanted at all, and therefore anyone with a DePuy implant is entitled to damages for the implant surgery, related personal injury, emotional distress and associated out-of-pocket expenses.

Justice Belobaba relied on the fact that "an implant definition (rather than revision surgery)" had been accepted in a number of previous medical device cases, and determined that limiting the class to those who had sustained an injury would improperly introduce a merits analysis to the determination of class membership.¹

Common Issues

One of the proposed common issues in the case was whether the defendants breached a duty of care in the design of the implants and/or failed to warn of the materially increased risk of revision surgery associated with the implants. While the defendants argued that a breach of this duty of care could only be determined on an individual basis, Justice Belobaba rejected this position, relying on the plaintiff's expert evidence from an orthopaedic surgeon that there are ten “design defects” in the products and that there was a generalized failure to warn.² Such evidence was held to be sufficient to satisfy the s. 5(1)(c) requirement since none of the defects identified was dependent on individual circumstances.

Despite finding for the plaintiffs on the other principal issues, the judge made short shrift of the plaintiffs' proposed common issue of whether the defendants should be required to implement a medical monitoring regime. He noted that no court would impose a mandatory order requiring the defendants to establish and fund a monitoring system within the framework of a negligence/damages action.³ Specific performance is not available as a remedy in such a case.

Preferable Procedure

With respect to the preferability analysis, Justice Belobaba stated that, while this was the defendants' strongest argument opposing certification, he was satisfied that a class action was the preferable procedure for the resolution of the common issues. The defendants urged the court to reshape the claim such that (i) the focus would only be on the 30 to 40 people who had, thus far, undergone revision surgeries; and then (ii) the preferable procedure would be case management rather than a class proceeding. Justice Belobaba rejected this position on the basis of his earlier finding that the action as pleaded was not just about the individuals who have endured a premature revision surgery but also those who claim damages, including emotional distress damages, simply on the basis that they were implanted with allegedly defective devices. Notably, in reaching this conclusion, Justice Belobaba stated that "it is not the job of the court to redraft the statement of claim or reshape the proposed class action to accommodate the defendants’ or even the judge’s notion of a more sensible or more efficient litigation. Provided the minimal statutory prerequisites are satisfied, the court is obliged to certify a proposed class action."⁴ Since at least 400 people fell under the claim as pleaded, it was therefore too large for case management and, in the absence of any better suggestion by the defendants, was found to be suited to a class proceeding.

Justice Belobaba further held that a class proceeding was preferable given that the proposed common issues trial would answer the breach of duty and defective design questions, and therefore move the litigation forward one way or another and perhaps help the parties achieve an overall settlement.⁵ This was the case even though Justice Belobaba accepted that a finding on the common issues in favour of the class members would lead to a plethora of individual trials being required to determine (a) the specific causation (even if the implants were defective, did they cause the harm alleged?) and (b) the individual damage claims (what losses were actually sustained by the class member?).

Conclusion

Prior to 2012, medical product liability class proceedings had been viewed to be a relatively plaintiff-friendly environment where certification of a proposed class action against manufacturers and distributors of allegedly defective products, particularly medical products, was almost assured. A series of decisions in 2012, such as Martin v AstraZeneca Pharmaceuticals PLC⁶ and Arora v Whirlpool Canada,⁷ prompted some to suggest that the pendulum may have started to swing to a more central position, as the courts appeared to be applying greater scrutiny to, and in some cases refusing, certification. As such, it had been anticipated by some that courts would continue to advance a more cautious approach to the certification of product liability class actions. It is unclear whether DePuy represents a return to the more plaintiff-friendly approach. This case involved a narrow set of issues and only two specific products. Future cases displaying a greater diversity of products and alleged problems may yet prove more difficult to certify.

Notes

1. DePuy, paras. 35- 38.
2. DePuy, para. 44.
3. DePuy, para. 49.
4. DePuy, para. 13.
5. DePuy, para. 53.
6. 2012 ONSC 2744.
7. 2012 ONSC 4642; See also MacMillan c. Abbott Laboratories, 2012 QCCS 1684 and Option Consommateurs c. Merck & Co. Inc., 2013 QCCA 57.