On December 17, 2015, the Ontario Superior Court of Justice denied certification in a proposed multiple-model product liability class action (Vester v Boston Scientific Ltd, 2015 ONSC 7950). The plaintiffs alleged that the products in question were negligently designed and that the defendants failed to warn of the dangers associated with the products.

Justice Perell found that the evidence did not establish a basis-in-fact for the proposed common issues, and as such a class proceeding was not the preferable procedure. Certification as a class action was denied, but Justice Perell adjourned the motion pursuant to section 5(4) of the Class Proceedings Act to allow the plaintiffs to provide further evidence and to revise the litigation plan.

The proposed class action involves nine medical products used to treat pelvic organ prolapse and stress urinary incontinence in women. Though all of the products were manufactured using Type I polypropylene mesh, they differ in their dimensions, functions, features, configurations, methods of fixation, and routes of application. The products also have different directions for use and the fibre diameter and pore size differ depending on which condition the product is intended to treat.

This decision is consistent with Justice Perell’s ruling last April in O’Brien v Bard Canada Inc, 2015 ONSC 2470, in which he refused to certify a class action concerning multiple products also used to treat pelvic organ prolapse and stress urinary incontinence in women. We acted for the defendants in that case. In Bard, the court determined that there was a lack of commonality across the products, which ranged in size, density, design purpose, pore size, and several other features.

All nine of Boston Scientific’s products were made of the same type of mesh, whereas in Bard, material makeup varied across the products. Justice Perell noted that while Bard was “all about the mesh”, this motion is “all about the one kind of mesh”. Ultimately, no commonality was established in either case, because the plaintiffs in both cases were unable to point to a specific design defect that was common to all of the products at issue.

The court confirmed the test for determining whether a manufacturer has breached its duty of care in designing a product. This assessment involves a risk-utility analysis that measures whether the utility of the chosen design outweighs the foreseeable risks associated with the chosen design. The 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 court emphasized that the existence of a common feature is not sufficient to establish a common issue unless it is linked to a common defect in manufacture or design. Justice Perell stated that where the plaintiff fails to establish such a relationship, a common feature is simply a “coincidence”.

The plaintiffs did not define the precise design defects being claimed, and as a result did not adequately provide evidence to support specific allegations. In fact, the plaintiffs’ own expert affirmed that the standard of care in the medical community is to use mesh slings for treatment of pelvic organ prolapse and stress urinary incontinence.

Justice Perell reiterated that the some-basis-in-fact test required for certification is a low evidentiary threshold; nevertheless, the plaintiffs failed to meet this standard. The adjournment, however, will permit the plaintiffs a further opportunity to present enough evidence to show a common design defect.