22 | LEXPERT • December 2016 | www.lexpert.ca
PRODUCT LIABILITY
Interestingly, the trial judge also took the fact of regulatory ap-
proval into account on the issue of causation. As the court saw
it, Health Canada's subsequent approval of similar devices cor-
roborated the safety of the Silzone device. "The decision suggests
that the regulatory standards developed and applied by Health
Canada may be the most persuasive evidence of the correspond-
ing common-law standard of care," Lockwood says. "By exten-
sion, any plaintiff who seeks to prove that a different or higher
standard should apply will be tasked with compiling significant
evidence sufficient to displace the evidentiary impact of the regu-
lator's approval."
Still, the British Columbia Court of Appeal's decision in
Wakelam v. Wyeth Consumer Healthcare represents the closest
a Canadian court has come to adopting some form of the pre-
emption doctrine. The case involved labeling rules introduced in
2008. They required the re-labeling of children's cough medicine
to provide that the products not be administered to children un-
der six. Wyeth complied with the rules. The plaintiffs, however,
claimed that in failing to provide the warning before 2008, Wy-
eth had engaged in a "deceptive practice" contrary to BC's Busi-
ness Practices and Consumer Protection Act.
Wyeth raised a constitutional paramountcy argument in de-
fense, alleging that it would have been impossible to comply with
federal regulations as they existed before 2008 without breaching
the BC statute. Although the court ruled that there was no "real
conflict" between the two, it suggested that a conflict could arise
"at a future time and on different facts."
According to Lockwood, this statement means that the doc-
trine of paramountcy could be a defense to a statutory product-
liability claim. "Arguably, the Wakelam decision leaves open
the possibility of a modified form of preemption defense in the
context of claims brought pursuant to consumer protection — or
other — provincial legislation, where there is actual conflict with
the FDA or related federal regulatory schemes."
Legislative and regulatory developments may also be opening
the door to preemption in Canada. Of particular significance
are the marketing authorization (MA) regulations introduced
by the federal Health Minister in 2012. They allow the Minister
to exempt products from certain FDA requirements. "Unlike the
provisions of the FDA that give rise to regulation, provisions that
exempt products from regulation are arguably regulatory ceil-
ings," Lockwood explains. "The federal government, by granting
an exemption, is expressly telling a market participant what they
do not have to do."
According to Health Canada, the MA regulations are intend-
ed to "allow more efficient approvals of safe foods that can ad-
dress emerging safety issues, and better respond to innovation."
Courts could conclude that provincial laws that effectively un-
dermine these exemptions would frustrate their regulatory pur-
poses and be rendered ineffective by the paramountcy doctrine.
Still, the issue has not been considered by any court. "The most
that can be said at this stage is that MAs and other exemptions
have the potential to breathe life into a more expansive para-
mountcy defense — on the appropriate facts — which may be
in line with certain aspects of the pre-
emption doctrine that has developed
in the US," Lockwood says.
CLASS ACTION SCRUTINY
Plaintiffs are facing new challenges in
product-liability class actions, an arena
that their lawyers have traditionally
prodded to fertility with a fair degree
of success. "These cases are getting a
lot more scrutiny, even though judges
have in the past referred to them as
quintessential class proceedings," says
Michael Eizenga of Bennett Jones LLP
in Toronto.
One key issue is whether courts
should allow certification of class
proceedings by genre. "The question
is whether plaintiffs should be able to lump a bunch of multiple
model products into a case without showing they have a common
specific design defect," Eizenga says.
But the law remains unclear. "Judges are moving down differ-
ent tracks," says Derek Ricci of Davies Ward Phillips & Vineberg
LLP in Toronto. Ricci cites conflicting decisions in Ontario aris-
ing from Superior Court Justice Edward Belobaba's certifying a
class in Dine v. Biomet (leave to appeal denied), in which Ricci
was co-counsel with colleague Kent Thomson, and Justice Paul
Perell's refusal to grant certification in O'Brien v. Bard Canada
and in Vester v. Boston Scientific. "In some cases, judges are taking
a hard look at the evidence to see whether the products are similar
enough," Ricci says. "In others, judges are criticizing counsel for
even leading evidence on the issue."
The plaintiffs' Bar is reacting to the uncertainty by investigat-
ing new approaches to product-liability litigation involving medi-
cal devices. "Mass torts are now clearly at our doors," Eizenga
says. These lawsuits cover a much broader range of claim types
than class actions. They are particularly useful when defective
products injure a large number of consumers. Because defects can
cause a wide range of problems for claimants, the cases may be
difficult to group into a single class.
Wendy Berman
Cassels Brock & Blackwell LLP
"There is definitely a rise in carriage
fights. The problem is that counsel
appear to be moving away from their
prior approach of working out carriage
disputes to letting the courts
sort them out."
