The evidentiary bar to be met on class certification is low
according to the BC Court of Appeal in a recent decision involving
the certification of a pharmaceutical class action. In Bertram
v GlaxoSmithKline Inc the plaintiff alleged that the
anti-depressant drug Paxil caused cardiovascular defects in some
infants born to women who used the drug during pregnancy.
GlaxoSmithKline ("GSK") has sold Paxil in Canada since
1993. The original product monograph, a document which describes
(among other things) potential adverse effects of a drug, included
a statement that Paxil should not be used by pregnant women unless
the benefit to the patient outweighed possible risks to the fetus,
but did not mention specific adverse effects.
In late 2005, GSK sent a letter to health professionals
referring to a study concluded in 2003 which showed an increased
risk for cardiovascular defects in infants born to mothers who used
Paxil during pregnancy. By February 2006, GSK had updated its
product monograph to include a statement that the risk to fetuses
was twice that of the general population.
The representative plaintiff, Ms. Gibson, took Paxil during her
pregnancy and in September 2005 gave birth to a baby with a
cardiovascular defect of the kind noted by GSK in its subsequent
The statement of claim outlined several claims in negligence,
including an allegation that GSK had a duty to warn that Paxil
could cause serious complications for children born to mothers
taking the drug.
The certification judge certified the class as "any person
in Canada, born with cardiovascular defects, to women who ingested
Paxil while pregnant, and the mothers of those persons" and
the class period as running from 1993 to December 3, 2012 (the date
On the issue of the duty to warn, the certification judge noted
that although some of the evidence advanced by the representative
plaintiff may be inadmissible hearsay at trial, it was not
necessary to consider that evidence for the purposes of
certification. The fact that GSK itself made information public and
that it controlled the evidence of what it may have known and when,
provided sufficient evidence to allow certification on the duty to
GSK appealed on the ruling on the duty to warn. GSK argued the
certification judge erred in finding there was a sufficient
evidentiary basis to certify breach of a duty to warn for the
entire period from 1993 to 2012. GSK argued the common issue of the
duty to warn should be limited to a narrow class period from 2003
to 2005. In GSK's view, prior to 2003 it did not have any more
information than what it disclosed; after 2005, it had already
provided doctors sufficient information to advise pregnant
patients, so there was no further duty to warn or breach.
In dismissing the appeal, the Court found the certification
judge committed no error. The Court confirmed the burden is on the
plaintiff to show "some basis in fact" and it is a low
one: Hollick v Toronto (City)3and the
certification judge need not consider the merits of the claim.
GSK's argument on appeal focused on the potentially
inadmissible hearsay evidence and the merits of the claims, but the
plaintiffs below were not required to prove the actual breaches
occurred. Rather, the Court noted in affirming the certification
judge's decision, GSK's publication of information in late
2005 about birth defects provided "some basis in fact" to
claim that at some point before the publication, GSK was aware
Paxil increased the risk of birth defects.
Furthermore, the Court found that it would not be "legally
logical and efficient" for the purposes of judicial economy
and access to justice to restrict the class period only for the
duty to warn and not the other negligence claims. This decision
(which pre-dates the very recent Supreme Court of Canada trilogy on
class actions and indirect purchasers) is consistent with those
recent rulings regarding the low evidentiary burden on class
plaintiffs at the certification stage.
1 2013 BCCA 462.
2 2012 BCSC 1804.
3 2001 SCC 68.
The foregoing provides only an overview. Readers are
cautioned against making any decisions based on this material
alone. Rather, a qualified lawyer should be consulted.
It's not often that our little blog intersects with such titanic struggles as the U.S. presidential race – and by using the term "titanic" I certainly don't mean to suggest that anything disastrous is in the future.
J.J. v. C.C., is an interesting case in which the court held that an automotive garage owes a duty to minor children to secure the vehicles on the premises by locking the cars and safely storing the car keys...
In Irwin v. Alberta Veterinary Medical Association, 2015 ABCA 396, the Alberta Court of Appeal found that the "ABVMA" failed to afford procedural fairness to a veterinarian undergoing an incapacity assessment.
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