Canada: Suggesting An Alternative Approach To An Uncommon Medical Device Class Action

In O'Brien v Bard Canada Inc, the Ontario Superior Court of Justice recently declined to certify a medical device class action because the plaintiff failed to provide sufficient evidence that there was commonality in respect of the 19 different mesh products implicated in the proposed class action.

The court suggested an alternative approach might be undertaken to litigate the claims, potentially by way of separate claims for each product. The court also rejected waiver of tort as a cause of action on the basis that it would be inconceivable that the representative plaintiff might waive the tort in the case before it, and rejected waiver of tort as a viable cause of action because it would not be reasonable to pursue such a claim in the context of the proposed class action.


O'Brien involved a proposed products liability class action. The defendants manufactured pelvic mesh products, 19 of which were involved in the proposed class action. The defendants submitted that there was no commonality between the 19 products, thereby precluding a judge from making "legally meaningful findings" about their conduct.1 It was argued that certification as a class proceeding would therefore impede the defendants' ability to defend the claims relating to the different products.

Ms. O'Brien claimed negligence and waiver of tort, alleging the products were associated with serious health complications, the defendants were negligent in designing the products and failed to warn physicians and consumers. She claimed pecuniary and special damages for each person who had the products implanted.

Categories for products liability claims

In order to review the parties' submissions on the certification motion, the court situated the action within two established categories of product liability claims: negligence in design and failure to warn. The court relied on Goodridge v Pfizer Canada Inc2  and Andersen v St. Jude Medical Inc3  for the principle that in respect of design, determining whether a manufacturer breached its duty required a risk-utility analysis "that measures whether the utility of the chosen design outweighs the foreseeable risks associated with the chosen design." Such an analysis would be "based on the information available to the manufacturer at the time of distribution or implantation and without the benefit of hindsight."4

The court then rejected certification because there was no basis in fact for commonality given the different products at issue. While the merits of a plaintiff's proposed class action are not to be considered at a certification motion, the court noted there must be some basis in the evidence for certification. Ms. O'Brien argued that the evidentiary standard necessary to meet this test was a low one and it would suffice to satisfy the certification criteria on the basis of the pleadings alone. The court rejected this argument and found there must be some admissible evidence to find commonality.

The court identified several insufficiencies in Ms. O'Brien's evidence, which consisted of her affidavit, an affidavit of her counsel, and that of a medical expert.

The affidavit of Ms. O'Brien's counsel was held inadmissible as irrelevant and hearsay that was likely prejudicial. Further, the court found the medical expert's evidence did not contradict the defendants' evidence that each of its products was designed differently, with different purposes. Finally, the court held that Ms. O'Brien's own affidavit evidence, while indicative of her own suffering, simply "had no basis-in-fact"5 to go beyond her own experiences.

The court noted Ms. O'Brien had failed to show any commonality in how each of the 19 different products caused the alleged injuries to the putative class members. As such, the court held that, "The causation issue in the case at bar lacks commonality"6  – and declined to certify the motion as a class proceeding.

No cause of action for waiver of tort

Interestingly, in addition to the products liability claim, Ms. O'Brien also pleaded waiver of tort. However, the court made short work of this claim, noting it would be "irresponsible to the point of absurdity to waive individual tort claims which in the aggregate are pleaded to be worth billions of dollars."7 

The court held that while waiver of tort made sense in other circumstances – namely, where "there were zero monetary damage and waiver of tort was the route to access to justice and behaviour modification" – it was "inconceivable" that it would apply in the case before it.8 The court stated there would be no such behaviour modification or access to justice, and further, such a claim would only waste the court's and parties' resources as they attempted to calculate how the profits should be distributed. In making these findings, the court clearly rejected the waiver of tort claim as a basis for the class action before it, and one can expect that similar criticisms could be made of waiver of tort in similar actions.

The alternatives motion

The court's decision to dismiss the certification was, however, subject to what it described an "alternatives motion." Because it was the lack of commonality across the 19 different products that was determinative of the decision to dismiss the motion, the court held that, "There are several different ways that the putative Class Members in the case at bar might obtain access to justice."9 This, the court held, included "individual claims or the possibility that there might be up to 19 separate class actions or joined claims against Bard, one for each of its products."10 Ms. O'Brien was therefore given time to bring an alternatives motion and potentially continue her action in another form.


Despite arguments to the contrary by Ms. O'Brien, the court held that no type of class action is quintessentially certifiable, even a products liability class action. Each class action must be individually assessed. In this case, the various products that were brought together, and the lack of an evidentiary basis for commonality, meant all the proposed questions were not common, which was fatal on the certification motion.

This case underscores the importance of sufficient evidence on a certification motion. A lack of such evidence will be fatal to certifying a proposed class action. The court also clearly questioned the necessity and appropriateness of waiver of tort in these types of actions, a welcome comment on a cause of action that is frequently advanced in product liability claims.

The author wishes to thank Dina Peat, articling student, for her help in preparing this legal update.


1. See paragraph 6.

2. 2010 ONSC 1095.

3. 2012 ONSC 3660.

4. See paragraph 15.

5.See paragraph 135.

6. See paragraph 203.

7. See paragraph 161.

8. See paragraphs 160, 162.

9. See paragraph 245.

10. Ibid.

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