20 | LEXPERT • December 2016 | www.lexpert.ca
PRODUCT LIABILITY
STRICTLY SPEAKING, the doctrine of preemption does not exist in Canada, as it does
in the United States. That, however, should not be taken to mean that regulatory compliance is
irrelevant in Canadian product-liability law.
"Canadian courts have ruled that compliance with a regulatory regime does provide persuasive
evidence that a defendant met a standard of care and may indeed provide a substantive defense
to product-liability claims," says Craig Lockwood of Osler, Hoskin & Harcourt LLP in Toronto.
"Indeed, the Supreme Court of Canada has ruled that legislative standards are relevant to, but not
co-extensive with, the common-law duty of care."
The extent of the gulf between regulatory and common-law duties, then, is an issue of consider-
able significance. "Recent jurisprudence suggests that that gulf may not be as broad as earlier juris-
prudence has suggested," Lockwood says. "In particular, recent decisions in the Food and Drugs Act
context demonstrate that, while compliance with federal regulations does not preclude a manufac-
turer's or distributor's liability to consumers as a matter of law, it may do so as a matter of fact or —
at the very least — will be materially relevant to the defense of consumer claims."
In Andersen v. St. Jude Medical, the Ontario Superior Court of Justice dismissed claims involv-
ing the Silzone prosthetic heart valve. In doing so, the court gave significant weight to the evidence
of regulatory compliance. "The very fact of regulatory approval led the trial judge to conclude that
St. Jude conducted appropriate and sufficient testing that met industry and regulatory standards."
The plaintiffs in this case also claimed that St. Jude's post-market surveillance and warnings were
inadequate, notwithstanding the fact that Health Canada had not made any recommendations
regarding changes to the label or product design. As Lockwood explains, "The fact that Health
Canada was aware of the risks but took no action led the trial judge to find that the plaintiffs had
not established that St. Jude fell below the requisite standard of care."
A door to preemption
may be opening in Canada.
And while multi-jurisdictional
product-liability class
actions remain uncertain,
the mass tort movement
has found increasing favor
by Julius Melnitzer
PHOTO:
SHUTTERSTOCK
AND LIMITED PREEMPTION
CLASS ACTIONS
