Certification was denied in a recent proposed multiple-model product liability class action before the Ontario Superior Court of Justice in O'Brien v Bard Canada Inc. We acted for the defendants.

The case concerned over 15 different medical products intended for permanent implantation in the female pelvis to treat various types of pelvic organ prolapse and stress urinary incontinence. The products differed in multiple ways, including their material makeup, shape, size, weight, density, weave, porosity, flexibility, configuration, fixation methodology, design purpose and product warning. The plaintiffs alleged all of Bard's products were negligently designed and that Bard failed to warn of their associated dangers.

Justice Perell set out the test applicable in negligent design cases as follows:

Whether a manufacturer breaches its duty of care in designing a product depends upon a risk-utility analysis that measures whether the utility of the chosen design outweighs the foreseeable risks associated with the chosen design. The risk-utility analysis requires weighing any foreseeable risk against the foreseeable utility of the product based on the information available to the manufacturer at the time of distribution or implantation and without the benefit of hindsight.

The case turned on Justice Perell's analysis of the inadmissibility of the majority of the plaintiffs' evidence, the lack of an identifiable common design feature across the proposed class as well as the preferable procedure analysis.

Justice Perell held much of the plaintiffs' evidence to be inadmissible, even in light of his acknowledgment that the some basis in fact test sets a low evidentiary standard for plaintiffs.

Interestingly, the plaintiffs' own expert, an experienced surgeon in the field of pelvic medicine and reconstructive surgery, acknowledged that there is a role for product-assisted pelvic repair surgery. Justice Perell found that there were limits to the use that could properly be made of his evidence. In certain paragraphs of his affidavit, the plaintiffs' expert had relied on allegations about Bard's products that he found on the webpage of a plaintiff law firm in the US that is suing Bard, as well as information in a Bloomberg news article. Justice Perell gave this information no weight. He further found that since the plaintiffs' expert did not review the documents where Bard provided its warnings and did not attend Bard training sessions, he did not have the factual basis to provide evidence as to whether the warnings provided by Bard were adequate.

Regarding the proposed common issues, Justice Perell found that Bard's products did not have a common design feature that could be extrapolated across the class. He further found that each of Bard's products have a different risk-benefit profile. Further still, that the plaintiffs' expert witness and non-expert witnesses did not provide admissible evidence to show a singular or common design defect across Bard's products.

Justice Perell found that there was no basis in fact to support the general causation issue proposed by the plaintiffs ("can the defendants' pelvic mesh products cause or contribute to injuries, conditions and complications) because the question "wants for commonality." Justice Perell endorsed the recent decision in Charlton v Abbott Laboratories Ltd., 2015 BCCA 26, noting that where a plaintiff seeks to address questions of causation on a class-wide basis as the foundation for his or her class action, there must be some evidence of a methodology that will enable the plaintiff to prove causation on a class-wide basis.

Regarding preferable procedure, Justice Perell found that where there is no basis in fact for common issues, there is no basis in fact for a class action satisfying the preferable procedure criterion. As a result, he found that a class action in this case was not the preferable procedure.

Justice Perell refused to certify the class action, but left open the option for the plaintiffs to bring an "alternatives motion" on the basis of sections 5(4), 7, 12, 13, 17(3), (4) and (5), 19, 29 and 35 of the Class Proceedings Act.

This decision is illustrative of the fact that not all product liability cases are suitable for certification. The plaintiffs in this case relied on the oft-cited reference in the caselaw that product liability cases are "quintessential class actions." Justice Perell disagreed. He said "no type of class action is quintessentially certifiable, even a product liability class action." Further, that in multiple-model product liability class actions, the plaintiffs must put forward enough evidence to show that there is a common design feature across all product models or, at the very least, some methodology that would enable the plaintiffs to prove causation on a class-wide basis.