Oft-referred to as "quintessential class actions", the
majority of product liability actions that have sought
certification as class proceedings in the last 10 years have been
granted certification. However, two recent decisions denying
certification may signal a shift towards greater scrutiny of
proposed product liability class actions. Judges have become more
willing to refuse certification where it is not clear there is
sufficient commonality amongst the class members or that a class
proceeding will be the preferable procedure.
In Warner v Smith & Nephew
Inc., a recent Alberta certification decision, the
product at issue was Smith & Nephew's hip resurfacing
system, known as "the Birmingham system". After being
implanted with the Birmingham system, the representative plaintiff
was found to have toxic levels of metal ions in her blood (the
Birmingham system is a metal product) and had to have the device
removed. Certification failed on the issues of identifiable class
and preferable procedure.
Regarding identifiable class, the judge found that a class of
all people who had the Birmingham system implanted and their
dependants would be appropriate since compensable harm could arise
as soon as a defective device is implanted. However, Justice
Poelman held that the plaintiff had not established some basis in
fact for the existence of at least two class members who had
experienced complaints similar to those of the representative
plaintiff. The evidence of the representative plaintiff on this
issue was rejected as double hearsay, "being passed from the
anonymous nine people through an unnamed person at the law firm to
Certification was also denied for failure to meet the preferable
procedure requirement. In finding that a class action was not the
preferable procedure, Justice Poelman pointed out one of the
significant problems in many medical device class actions: that
complaints about the device can be caused by a host of
patient-specific and surgeon-specific factors unrelated to the
device. Here, those factors included the individual nature of the
patient's hip problem, the patient's relevant personal
characteristics and medical background, the recommendation of the
surgeon on the appropriate device, whether the patient accepted
that recommendation, the difficult surgical technique involved with
properly implanting the device, and subsequent monitoring and
general health. Since all of these issues require individual
assessment, they will likely not be common across class members and
are therefore likely more suitable for individual actions.
The decision in Warner follows another denial of
certification in Charlton v Abbott Laboratories,
Ltd. by the British Columbia Court of Appeal. The
proposed class in Charlton was composed of those who took
the drug sibutramine, a prescription weight-loss medication that
allegedly increased the risk of cardiovascular events, such as
heart attack and stroke. The evidence adduced on the certification
motion suggested there might be an important distinction between
class members who had pre-existing cardiovascular conditions, and
those who did not. The defendant manufacturers had warned against
prescribing the drug to patients with pre-existing conditions. The
B.C. Supreme Court originally granted certification, but the Court
of Appeal reversed that decision because the plaintiffs had failed
to establish evidence of a "methodology for establishing that
the class as a whole, as opposed to those who were wrongly
prescribed sibutramine despite a history of disease, was affected
or put at risk by its use of sibutramine".
The requirement of a "methodology" for establishing
harm on a class-wide basis is well-established in indirect
purchaser class actions where price-fixing is alleged, but new to
product liability class actions. Interestingly, the plaintiffs'
expert, a cardiologist, had opined that all class members (both
with and without pre-existing conditions) were put at risk by using
sibutramine. However, the Court of Appeal scrutinized the
evidentiary foundation of the expert's opinion, and found no
support for the proposition that sibutramine users without
pre-existing conditions were at increased risk. There was no
prospect of such evidence being obtained, since the drug had been
pulled off the market in 2010 and was no longer being studied.
Warner and Charlton seem to indicate an
acknowledgement that not all product liability cases are suitable
for class certification. Courts are taking a hard look at the
evidence put forward by plaintiffs and denying certification in
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