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
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
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
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
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The recent decision of the Ontario Court of Appeal in BMW Financial Services Canada, a Division of BMW Canada Inc. v. McLean provides some useful insight into the relationship between automobile dealers and the financing arms of the manufacturers for whom those dealers are franchisees.
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