evidentiary burden is low in class certification: Bertram v GlaxoSmithKline Inc1  


November 2013

class action bulletin
Joan M. Young, David Andrews, student at law

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 publications.

certification decision2

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 of certification).

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 warn.

appeal decision

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)3 and 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.

a cautionary note

The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained.

© McMillan LLP 2013