



COURT
OF APPEAL FOR BRITISH COLUMBIA




Citation:



Charlton
  v. Abbott Laboratories, Ltd.,









2015 BCCA
  26




Date: 20150122

Dockets: CA041278 & CA041291

Docket: CA041278

Between:

Terry Charlton, Mayra Charlton, Angela
Leone,
Paula Smith-Turner, Carl Turner and Mark Mandell

Respondents

(Plaintiffs)

And

Abbott Laboratories, Ltd.

Appellant

(Defendant)

And

Abbott Laboratories and Apotex Inc.

(Defendants)

- and -

Docket: CA041291

Between:

Terry Charlton, Mayra Charlton, Angela
Leone,
Paula Smith-Turner, Carl Turner and Mark Mandell

Respondents

Appellants on Cross Appeal

(Plaintiffs)

And

Apotex Inc.

Appellant

(Defendant)

And

Abbott Laboratories, Ltd. and Abbott
Laboratories

Respondents on Cross Appeal

(Defendants)




Before:



The
  Honourable Chief Justice Bauman

The Honourable
  Mr. Justice Groberman

The
  Honourable Mr. Justice Willcock




On appeal from:  An order of the Supreme Court of British
Columbia, dated
September 17, 2013 (
Charlton v. Abbott Laboratories, Ltd.
, 2013 BCSC
1712,
Victoria Docket 110721).




Counsel for
  the Appellant Abbott Laboratories, Ltd.:



N. Finkelstein, C.
  Zayid, B. Kain





Counsel for
  the Appellant Apotex Inc.:



K. Kay, S. Hosseini





Counsel for
  the Respondents:



E.F.A. Merchant, Q.C.
C. Churko, A. Sadaghianloo





Place and
  Date of Hearing:



Vancouver, British Columbia

September 29 & 30, 2014





Place and
  Date of Judgment:



Vancouver, British Columbia

January 22, 2015









Written
  Reasons by:





The
  Honourable Mr. Justice Willcock





Concurred
  in by:





The
  Honourable Chief Justice Bauman

The
  Honourable Mr. Justice Groberman








Table of Contents

Introduction
.
4

The Certification Hearing
..
5

The
Pleadings
.
5

Evidence
of Representative Plaintiffs
.
7

The
Plaintiffs Medical Expert

8

The
Defendants Experts
.
13

Apotexs
Evidence
.
15

Judgment Appealed From
..
15

Section
4(1)(a): a cause of action
.
15

Section
4(1)(b): an identifiable class
.
16

Section
4(1)(c): claims raising common issues
.
17

Section
4(1)(d): preferable procedure
.
19

Section
4(1)(e): a representative plaintiff

20

Certification
.
20

Issues
on Appeal and Cross Appeal
.
21

The
Appellants Argument
.
21

Insufficient
Evidence of a Method of Proof of General Causation
.
21

The
Remaining Common Issues
.
23

The
Cross Appeal

25

Applicable
Law
..
26

The
Class Proceedings Act

26

Evidentiary
Basis for Certification
.
27

Identifiable
Class
.
28

Common
Issues
.
29

Preferability
.
37

Standard of Review of a Certification Order

38

Analysis
.
39

Certification
of the General Causation Question
.
39

Other
Common Issues
.
40

Conclusion
.
43



Summary:

Patients who had used sibutramine commenced an action
against Abbott Laboratories, Ltd. and Apotex Inc., founded upon allegations the
drug increased the risk of cardiovascular events, including heart attack and
stroke. They pleaded causes of action in negligence and that sibutramine had
been marketed in breach of obligations described in the Business Practices and
Consumer Protection Act and the Competition Act and sought damages pursuant to
the doctrine of waiver of tort. This is an appeal by the manufacturers from the
certification of the proceedings as a class action against two defendants and a
cross appeal from the refusal of the judge to certify class proceedings against
a third defendant. The appellants argue the plaintiffs failed to meet the criteria
for certification under s. 4 of the Class Proceedings Act by failing to
adduce some evidence of a workable methodology to prove causation of damages on
a class-wide basis.

Held: appeal allowed. The certification judge erred in
certifying the class action. Each common issue required a finding that
sibutramine increases the risk for all class members. The plaintiffs did not
adduce evidence of a methodology to address this question. While the plaintiffs
provided evidence that sibutramine increased the risk of cardiovascular events
for those with pre-existing conditions, there was no evidence before the
certification judge of a method of establishing that sibutramine increased the
risk of harm to patients without pre-existing conditions, for whom it was
intended. The evidence before the certification judge was that the question of
causation for the class was incapable of resolution. The certification order is
set aside.

Reasons for Judgment of the Honourable
Mr. Justice Willcock:

Introduction

[1]

This appeal, from
an order certifying class proceedings against the appellant, for reasons
indexed as
Charlton v.
Abbott Laboratories, Ltd.,
2013
BCSC 1712,
requires us to
consider the nature and extent of the evidentiary burden that must be
discharged by parties seeking to certify class proceedings.

[2]

The
class action is brought on behalf of patients for whom sibutramine was
prescribed. Sibutramine was developed as an antidepressant. In its use for that
purpose it was believed to suppress appetite.
In late 2000, Health Canada approved
the marketing by prescription of Meridia, a drug containing sibutramine, for
use as part of weight loss regimes. Abbott Laboratories, Ltd. (Abbott)
distributed and sold Meridia in Canada. In late 2009, Abbotts exclusive right
to distribute Meridia ended and Health Canada approved an application by Apotex
Inc. (Apotex) to distribute a generic weight loss drug containing sibutramine
under the name Apo-Sibutramine.

[3]

A
clinical trial conducted between January 2003 and March 2009 (the Sibutramine
Cardiovascular Outcome Trial, or SCOUT Study) suggested an increased risk of
serious cardiovascular events was associated with sibutramine use by patients
with pre‑existing heart problems. The results of the SCOUT study were
published in
The New England Journal of Medicine
on September 2,
2010. The drug was voluntarily withdrawn from the Canadian market by Abbott and
Apotex in October 2010.

[4]

The plaintiffs
claim to have suffered
cardiovascular events, ranging from increased heart rates and elevated blood
pressure to myocardial infarction, as a result of their use of Meridia or
Apo-Sibutramine. Their application to certify a class action on behalf of all
Canadian consumers of
sibutramine
resulted in the order from which this appeal is brought.

The
Certification Hearing

The
Pleadings

[5]

The pleadings
describe the proposed class of plaintiffs as persons resident or situated in
British Columbia or another Canadian province or territory who have used or
purchased sibutramine. The plaintiffs allege that ingestion of sibutramine
causes or contributes to an increased risk of adverse cardiovascular events,
such as heart attacks and strokes, increased blood pressure and heart rate, and
irregular heartbeat. They allege that the SCOUT study determined that
sibutramine increases the risk of cardiovascular events. Some named plaintiffs
claim to have suffered cardiovascular events as a result of the use of
sibutramine. The plaintiffs say damages arising from the defendants actions
and omissions in marketing a drug that increased the risk of cardiovascular
events include:

a)

high heart rate and blood pressure,
palpitations, irregular heartbeat, and heart attack;

b)

direct or indirect economic losses
including, but not limited to, out-of-pocket expenses for treatment, cost of
future care and loss of employment income; and

c)

other pain and
loss suffering stemming from illness of a class member as the result of the use
of sibutramine.

[6]

The plaintiffs
claim general and special damages, punitive, aggravated and exemplary damages, and
remedies available under the
Business Practices and Consumer Protection Act,
S.B.C. 2004, c. 2 [
BPCPA
],

and the
Competition Act
,
R.S.C. 1985, c. C‑34.

[7]

Misrepresentation
by the defendants of the risks associated with the use of sibutramine is said
to constitute an unlawful, unfair and deceptive trade practice and a violation
of s. 52 of the
Competition Act
.

[8]

The plaintiffs say
the marketing of sibutramine had the effect of deceiving or misleading
consumers and the defendants engaged in unfair practices under the
BPCPA
.

[9]

The defendants are alleged to have failed to adequately test sibutramine,
to control its quality, or to properly manufacture it.

[10]

It is alleged the
defendants negligently marketed sibutramine when they knew, or should have
known, that its propensity to injure outweighed the value of its use.

[11]

Not having removed
the product from the market, the defendants are alleged to have failed to
adequately and promptly warn consumers of risks. They are said to have promoted
sibutramine as a safe and effective weight loss drug when it was neither safe
nor effective.

[12]

The plaintiffs claim that if the defendants had complied with the
standard of care expected of them, they would not have sold sibutramine to
class members, nor received any of the revenues generated by its sale. As an
alternative to advancing the claims in negligence, the plaintiffs say they will
waive the tort and seek to recover for the class all revenue earned by the
defendants from the sale of sibutramine.

[13]

The pleadings may
be read as advancing claims of two types:

a)

claims on behalf of those members of
the class that have suffered cardiac injuries, founded upon the assertion that
those injuries were caused or contributed to by the use of sibutramine; and

b)

a claim that the
manufacturers should repay all profits earned by marketing sibutramine, because
it was ineffective and its use exposed class members to a risk of harm.

Evidence of Representative Plaintiffs

[14]

Angela Leone
deposes that she was prescribed and began taking Meridia in January 2006, and
had her first heart attack on May 10, 2009.

[15]

Mark Mandell
deposes that he was prescribed and began taking Meridia in February 2009, and
had his first heart attack on May 25, 2009.

[16]

Carl Turner
deposes that his wife Paula Smith-Turner began taking Meridia in November 2006
and had a stroke on December 23, 2006.

[17]

Paula Smith-Turner
deposes that in November 2006 she began taking Meridia as directed by her
doctor, and on December 23, 2006, suffered a stroke. She does not describe
her medical condition before the stroke.

[18]

Terry Charlton
deposes that in May 2010, he began taking Apo-Sibutramine at the direction of
his doctor for a weight loss program and he began to have shortness of breath
around June or July 2010 and chest pains around August 2010. He does not
describe his pre‑June 2010 health.

[19]

Mayra Charlton
deposes that her husband, Terry Charlton, was prescribed and began taking Apo-Sibutramine
in May 2010 and in August 2010, he began to experience chest pains and
shortness of breath. She does not describe Mr. Charltons pre‑August
2010 medical condition.

The Plaintiffs Medical Expert

[20]

In support of
their application for certification, the respondents filed two affidavits sworn
by Dr. David H. Fitchett, a cardiologist at St. Michaels
Hospital, Associate Professor of Medicine at the University of Toronto, and former
director of the coronary care unit of St. Michaels Hospital. Dr. Fitchett
has a particular interest in the management of cardio-metabolic risk and is
familiar with sibutramine.

[21]

He describes sibutramine
as a
monoamine oxidase (MAO)
inhibitor
. H
e
deposes that phase 1 studies, reported in 1988, demonstrated a mean
increase in the resting systolic and diastolic blood pressures of users of the
drug and a mean increase in users heart rates. He summarizes tests of the
efficacy and safety of sibutramine, reported in 2000 and 2004, and notes that
they concluded, Sibutramine has  been shown
to improve cardiovascular risk
factors
such as lipid and glycemic profiles.
The impact of these
improvements on cardiovascular and other clinical outcomes and mortality is
unknown
 (emphasis added).

[22]

Dr. Fitchett
says cardiovascular risks of sibutramine treatment arise from the increase in
sympathetic nervous system activity as a result of its hypertensive effect. He
notes, Agents that increase heart rate, especially in patients with heart
failure, may be associated with greater CV [cardiovascular] events.

[23]

A critical opinion
is set out in paras. 19‑20 of his November 2011 affidavit:

19.       Drugs
that increase blood pressure may be associated with increased CV events
including mortality. In the individual with      pre-existing hypertension, the
hypertensive effect of sibutramine further increases BP and will increase the
CV risk for stroke, myocardial infarction and CV death.

20.       The
mechanism of the increased heart rate and blood pressure is inhibition of
reuptake of the neuro-transmitter norepinepherine in autonomic nerve terminals.
This results in more norepinephrine being     available for sympathetic nerve
terminal stimulation. Increased sympathetic nerve stimulation increases blood
pressure and heart rate. In susceptible individuals increased sympathetic nerve
terminal stimulation can provoke cardiac arrhythmias. Certain medications can
prolong cardiac repolarisation recognized by prolongation of the ECG QT
interval. This results in an increased risk for localized instability and the
generation of ventricular tachycardia that can degenerate to fatal ventricular
fibrillation.

[24]

He describes the
SCOUT study and its conclusion that for subjects receiving sibutramine in the
group of patients studied, those with pre‑existing cardiovascular
disease, the risk of myocardial infarction, stroke, cardiac arrest or
cardiovascular death was increased 16% in comparison with the placebo group. He
summarizes his opinion with respect to the conclusions of the SCOUT study as
follows:

25.       The
conclusions of the authors were that sibutramine should not be used in patients
with existing cardiovascular disease, implying that sibutramine should continue
to be limited to persons without preexisting cardiovascular disease. The editorial
that accompanied the SCOUT publication disagreed with the SCOUT conclusion and
stated The investigators conclusion is based on a narrow interpretation of
the SCOUT data, in which only the patients with preexisting cardiovascular
disease had an increase in the risk of new cardiovascular events. The FDA
advisory committee will now take up the matter, they conclude. We surely need
safe and effective medications to help overweight and obese patients lose
weight and improve their long-term health. But given that sibutramine has
minimal efficacy for weight loss, no apparent benefit for clinical outcomes, a
worrisome cardiovascular risk profile, and a plausible mechanism to explain the
cardiovascular risk, it is difficult to discern a credible rationale for
keeping this medication on the market.

[25]

Addressing the
question whether all patients share an interest in the assessment of the risk
of sibutramine use, Dr. Fitchett deposes:

34.       All
class members have a risk of cardiovascular issues of common cause due to
sibutramine. In this case the effects of one agent, sibutramine, are being considered.
Both Meridia® and Apo-Sibutramine contain the same active agent and will cause
the same adverse outcome profile. Sibutramine causes an increase in heart rate,
blood pressure and risk of arrhythmias, stroke and heart attack. The mechanism
of these adverse events is common in all users and is related to inhibition of
norepinephrine reuptake by sibutramine. Other agents that prevent norepinephrine
re-uptake also result in increased heart rate and blood pressure.
No study
has been performed of any of these agents that has sufficient power to show
adverse cardiovascular events
.

[Emphasis
added.]

[26]

With respect to
the prospect of proving the claim, Dr. Fitchett concludes:

38.       There
has been no controlled study in individuals without cardiovascular disease. Yet
sibutramine has the same pharmacological effect in individuals with and without
CV disease. Individuals with CV disease are more susceptible to CV
complications such as heart attack and stroke as well as arrhythmias. Those
without known CV disease are still at risk but the risk would be smaller. Hence
sibutramine causes harm, with minimal benefit.

[27]

Appended to
Dr. Fitchetts affidavit of November 30, 2011 are studies of the
risks and benefits of sibutramine to which he refers in support of his opinion,
including:

a)

Clinical
pharmacology of sibutramine hydrochloride (BTS 54524), a new antidepressant,
in healthy volunteers,
Br. J. of clin. Pharmac.
(1988), 26, 607 
611, in which the authors note, at p. 608:

Sibutramine
was associated with dose-dependent increases in both supine and standing HR [heart
rate] which were statistically significantly different from placebo for supine
HR at six h after 45 mg and 1, 2, and 6 h after 60 mg
Supine systolic BP [blood pressure] was significantly elevated by the 60 mg
dose at all times and by 30 mg at 2 h, compared with placebo.

b)  The
Data Sheet for REDUCTIL® (sibutramine hydrochloride 10 mg and 15 mg)
which cautioned, at p. 8:

BLOOD
PRESSURE AND PULSE RATE MUST BE MONITORED IN ALL PATIENTS ON REDUCTIL AS
SIBUTRAMINE HAS CAUSED CLINICALLY RELEVANT INCREASES IN BLOOD PRESSURE IN SOME
PATIENTS.

c)  The
Efficacy and Safety of Sibutramine for Weight Loss: A Systemic Review Arch
Intern Med, 2004; 164: 994-1003, at p. 994 and p. 1001:

Conclusions:
Sibutramine is effective in promoting weight loss.
Weight loss with
sibutramine is associated with both positive and negative changes in
cardiovascular and metabolic risk factors. There is insufficient evidence to
actively determine the long-term risk-benefit profile for sibutramine
.



One of our goals was to estimate the
cardiovascular and metabolic effects of sibutramine. The trials we identified
were not designed and powered to detect changes in these outcomes. Among those
trials that did measure cardiovascular and metabolic outcomes, the results were
inconsistently reported, and we could not exclude confounding due to
concomitant changes in the antihypertensive, lipid-lowering, and diabetes
mellitus medications in most of the trials. Given these limitations, the
highest quality trials suggest that weight loss with sibutramine is associated
with modest increases in heart rate and blood pressure, small improvements in
high-density lipoprotein cholesterol and triglycerides levels, and, among
diabetic patients, small improvements in glycemic control. We found no direct
evidence that sibutramine prevents or reduces obesity-associated morbidity or
mortality.
While it is highly probable that weight loss that reduces
blood pressure and cholesterol will reduce the number of deaths from heart
disease and stroke our review suggests that weight loss with sibutramine is
associated with both positive and negative changes in cardiovascular and
metabolic risk factors. Thus, we cannot exclude the possibility that these
changes will have important long-term effects on cardiovascular disease risk
that enhance, diminish or reverse the health benefits that result from modest
weight loss
.

[Emphasis
added.]

d)  Long-term
pharmacotherapy for obesity and overweight (Review)
The Cochrane Library
2009,
Issue 1, at p. 3, p. 12, and p. 13:

Sibutramine,
which inhibits re-uptake of serotonin and norepinephrine, is the most widely
used agent in this category and primarily attacks to suppress appetite. The
most common adverse effects of sibutramine are related to increased adrenergic
activity and include dry mouth, headache, insomnia, and constipation 
Sibutramine may also cause increases in blood pressure and heart rate.
Potential concerns regarding cardiac arrhythmias and cardiac mortality have
been raised and the drug has been reviewed by several regulatory agencies and
deemed safe to remain on the market (Health Canada 2002; Wooltorton 2002).

Sibutramine
increased systolic blood pressure by 1.7 mm Hg  diastolic blood pressure by
2.4 mm Hg  and pulse rate by 4.5 bpm, compared to placebo.

The increase in blood pressure and
heart rate observed with sibutramine therapy are of potential concern,
particularly on a population-wide basis where even mild increases in blood
pressure can be expected to result in an increase in cardiovascular events in a
population already at risk.
A small rise [sic] blood pressure may have a
detrimental effect on patients with pre-existing cardiovascular disease, a patient
population excluded from these trials
. This further underscores the need
for studies examining mortality and cardiovascular morbidity and the ongoing
SCOUT trial should provide further information  If sibutramine is prescribed,
careful blood pressure monitoring is recommended.

[Emphasis
added.]

e)  Effect
of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects
N. Engl. J.
Med
2010; 363: 905‑17 (the SCOUT study), at p. 905:

RESULTS

The
mean duration of treatment was 3.4 years. The mean weight loss during the
lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine
group achieved and maintained further weight reduction (mean, 1.7 kg). The
mean blood pressure decreased in both groups, with greater reductions in the
placebo group than in the sibutramine group (mean difference, 1.2 /1.4 mm Hg).
The risk of a primary outcome event was 11.4% in the sibutramine group as
compared to 10.0% in the placebo group  The rates of nonfatal myocardial
infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and
3.2% and 1.9% in the placebo group, respectively  The rates of cardiovascular
death and death from any cause were not increased.

CONCLUSIONS

Subjects with preexisting
cardiovascular conditions who were receiving long-term sibutramine treatment
had an increased risk of nonfatal myocardial infarction and nonfatal stroke
but not of cardiovascular death or
deaths from any cause.

[Emphasis
added.]

[28]

In his second
affidavit, sworn on May 23, 2013, Dr. Fitchett deposes:

5.         As
described in my first affidavit, scientific evidence establishes that sibutramine
hydrochloride monohydrate, the medicinal ingredient in both Meridia® and Apo-Sibutramine
increases the risk of cardiovascular events such as heart attacks, strokes,
arrhythmias and increased heart rate and blood pressure, and there is a
scientific mechanism for the increase in cardiovascular risk in individuals who
ingest sibutramine.



8.         
[I]n a population with a high incidence of cardiovascular disease (i.e., overweight
or obese individuals in this case), silent disease is  more frequent Hence
the population has an increased risk of cardiovascular events even when there
are no clinically apparent signs or symptoms of cardiovascular disease.

[29]

In short,
Dr. Fitchetts opinion is that sibutramine acts by causing an increase in
sympathetic nervous system activity and an increase in blood pressure and heart
rate. Hypertension is associated with an increased risk of arrhythmias, heart
attacks and strokes in individuals with cardiovascular disease. Dr. Fitchett
does not dispute that, based on the contraindications in the product monograph,
doctors understood that Meridia should not be prescribed to patients with a
history of cardiovascular disease. Those with silent cardiovascular disease are
said by Dr. Fitchett to be at increased risk and the population for whom
sibutramine was prescribed included more patients with silent disease than the
population at large. That is the theoretical basis for the view that the risk
of cardiovascular incidents is increased for this patient population. The extent
of the risk has not been studied. The statistical evidence that is available
suggests there is no measurable increase in the risk for patients without a
diagnosed history of cardiovascular disease and Dr. Fitchett acknowledges
he is unable to quantify the risk.

The Defendants Experts

[30]

Dr. Richard Lewanczuk is an endocrinologist and the Senior Medical
Director for Primary and Community care for Alberta Health Services. He has
prescribed Meridia to patients. He deposes to the physicians role in
understanding the product monograph and appropriately prescribing medication.
He says he understood from published material that Meridia ought not to be
prescribed to patients with a history of coronary artery disease, congestive
heart failure, arrhythmia or cerebrovascular disease, to patients with
inadequately controlled unstable hypertension, or to patients taking certain
other weight reducing drugs or other specified drugs.

[31]

He says he
understood that the risk that Meridia might increase a patients blood pressure
and heart rate and the caution that patients on this medication should have
their blood pressure and heart rate monitored and regulated.

[32]

Dr. Robert
Myers, a cardiologist practicing at Sunnybrook and Womens College Health
Sciences Centre in Toronto as a staff cardiologist and founder of the
Congestive Heart Failure Clinic, deposes that the information in the product
monograph alerts physicians that Meridia should not be prescribed to patients
with a history of cardiovascular disease and makes it clear that the use of
Meridia can cause increased blood pressure. The monograph specifically
recommends regular monitoring of blood pressure and heart rate because
cardiovascular disease is a known complication of hypertension.

[33]

In Dr. Myers
opinion, the SCOUT study demonstrated an increased incidence of primary outcomes,
as defined, among sibutramine treated subjects who had pre‑existing
cardiovascular disease, but that increased incidence was not found in subjects
without a history of cardiovascular disease. He says the results of the SCOUT
study cannot be extrapolated to suggest any increased risk for patients for
whom Meridia had been prescribed by physicians in Canada because the vast majority
of patients in the SCOUT study had a history of cardiovascular disease and would
not have been eligible to receive Meridia. In response to the proposed class action,
Dr. Myers deposes:

68.       For
the reasons discussed above, it will not be possible to determine the cause of
any individual class members medical condition without careful consideration
of the individuals medical history, including all the factors listed in
paragraph 5. [factors listed in paragraph 5 are: patients age, sex,
history of disease, history of hypertension, cholesterol level, diabetes,
smoking history, nutrition, alcohol consumption, stress, physical activity,
weight and body mass index, and family history, as well as dosage of
sibutramine, duration of medication, compliance, and use of other medications.]

[34]

There was evidence before the certification judge to the effect that
sibutramine improves cardiovascular risk factors such as lipid and glycemic
profiles but that it acts by increasing blood pressure and heart rate (its
hypertensive effect), and that hypertension may lead to an increased incidence
of cardiovascular events in patients with a history of coronary artery disease
(and, presumably, undiagnosed coronary artery disease). Dr. Fitchett noted
that the group of patients for whom sibutramine was prescribed, as part of a
weight loss regime, were at increased risk of having silent cardiovascular
disease but he cannot quantify the risk of increased cardiovascular events to
the whole population for whom sibutramine was prescribed. He does not suggest a
method of addressing the question. Dr. Myers says it will not be possible
to determine the cause of any individual class members medical condition
without consideration of the individuals medical history. There is no ongoing
study of the effects of sibutramine because it has been off the market since
October 2010.

Apotexs Evidence

[35]

Bernice Tao, the Director of Apotexs Co-Development Program, deposed to
the nature of the regulatory approval program that preceded the marketing of
Apo‑Sibutramine in Canada, including the provision to Health Canada of
evidence of efficacy and safety. She deposed that an Abbreviated New Drug
Submission (ANDS) for Apo‑Sibutramine was provided to Health Canada on
July 30, 2008 and the Notice of Compliance (NOC) authorizing Apotex to
market sibutramine was issued by Health Canada on December 2, 2009. She
deposed that the NOC would not be issued until Health Canada had reviewed and
approved the manufacturers Product Monograph.

Judgment
Appealed From

[36]

The certification judge, citing
Hollick v. Toronto (City),
2001
SCC 68, [2001] 3 S.C.R. 158, noted that his role was not to test the merits of
the action, but rather, to focus on the
form
of the action: whether the
suit should appropriately be prosecuted as a class action. He recognized that
the class representative was required to show some basis in fact for each of
the certification requirements set out in
s. 4 of the
Class
Proceedings Act
,

R.S.B.C. 1996,
c. 50 [the
Act
]
, other than the requirement that the
pleadings disclose a cause of action.

Section 4(1)(a): a cause of action

[37]

The first
requirement, set out in s.
4
(1)(a), that the pleadings disclose a
cause of action, requires only consideration of whether it is plain and
obvious that no cause of action is disclosed in the pleadings, assuming that
the facts pleaded are true.

[38]

The certification judge
held that the pleadings did not disclose a cause of action against Abbott U.S.
and he declined to certify any part of the action against Abbott U.S.

[39]

He found that the
facts pleaded supported certain claims against the other defendants:

a)

for damages and declaratory relief
arising from alleged breaches of the
BPCPA
;

b)

for damages under the
Competition
Act
;

c)

in negligence for breach of a duty of
care to provide adequate warnings about the side effects of Sibutramine, or
to inform the public and proper governmental authorities of the results (of
ongoing testing for new health risks);

d)

in negligence for breach of a duty of
care to only offer safe drugs for sale and human consumption in the streams of
commerce, or to recall Sibutramine promptly after becoming aware of adverse
health risks.; and

e)

for waiver of
tort, holding at para. 74:

[74]      It
remains unclear whether, as a matter of law, this is a separate cause of
action, or a remedy available on proof of an established cause of action. This
does not require determination at this point. If it is a cause of action,
sufficient facts have been pleaded that I am persuaded that this plea it is
not bound to fail. If it is remedy only, no facts are required beyond those
necessary to support the cause of action giving rise to the claim for the
remedy.

[40]

Claims founded
upon allegations of negligent design and manufacturing were not certified, because
the plaintiff pleaded the defendants inherited sibutramine when Abbott and
Abbott U.S. acquired the Knoll Pharmaceuticals business. There was no
allegation a defendant, or any entity for which a defendant was responsible,
took actions in relation to design, fabrication or manufacturing that fell
below a standard of care.

[41]

A cause of action
founded upon a breach of the
Sale of Goods Act,
R.S.B.C. 1996, c. 410,
was abandoned by the plaintiffs.

Section 4(1)(b): an identifiable class


[42]

The certification
judge observed the criteria for membership in the class should be rationally
related to the claims advanced on behalf of the class and required the
applicants to discharge the burden of demonstrating some basis in fact for that
rational relationship. The proposed class included all persons in Canada who
took sibutramine pursuant to a prescription. The judge held:

[81]      Those who took the drug and who allege harm as a
result have a rational relationship to the negligence, failure to warn, and some
claims pleaded under the
Business Practices and Consumer Protection Act
and
the
Competition Act
.

[82]      Those
who took the drug and suffered no harm but got no benefit have a rational
relationship to the claims based on ineffectiveness of the drug, as well as to
other claims pleaded under the statutes just mentioned.

[43]

In response to the
defendants argument that, in the light of the medical evidence, the plaintiffs
had not and could not show some basis in fact for any of the causes of action,
the judge noted there could be only some limited recourse to the evidence put
forward by the plaintiffs and defendants on the certification hearing. He
observed:

[95]      It
seems to me that the arguments of the defendants invite rather more weighing of
evidence than is appropriate on a certification application, and as well fail
to deal with the individual statutory criteria under s. 4(1) of the
Act
;
instead they drift into broader considerations that tend to detract from the
applicability of the argument to the statutory criteria.

[44]

The plaintiffs were held to have established the existence of an
identifiable class of plaintiffs rationally related to the claims advanced.

Section 4(1)(c): claims raising common issues

[45]

Citing
Campbell
v. Flexwatt Corp.
(1997),
44 B.C.L.R. (3d) 343 (B.C.C.A.), the judge required the plaintiffs to establish
some basis in fact, on the evidence, supporting the conclusion that resolution
of a common issue of fact or law would move the litigation forward and to establish
some basis in fact of a rational relationship between the class proposed and
the proposed common issues. He then turned to specific issues and addressed
them as follows:

1)  Does
sibutramine cause or contribute to heart attacks, strokes, and arrhythmia?

[46]

There was found to be a rational relationship between the proposed class
of people who were prescribed and used Meridia or Apo‑Sibutramine and
this issue.

[47]

The
causation issue was considered to be common to class members. The judge found:

[104]    The affidavits of the four
plaintiffs who took one or other of the drugs, the affidavits of the experts,
which introduce the SCOUT study, the product monograph, and the editorial in
The New England Journal of Medicine that accompanied publication of the SCOUT
study provide a sufficient basis in fact. While the
post hoc
nature of
the plaintiffs affidavits referred to might be open to attack, the evidence as
a whole is sufficient to establish the required rational relationship.

2)  Was
sibutramine unfit for its intended purpose?

[48]

Claims said to arise out of the breach of a warranty or condition
implied into a contract for the sale of goods by s. 18 of the
Sale of
Goods Act
were abandoned by the plaintiffs.

3)  Did
the defendants breach a duty of care owed to the class in the marketing,
selling or distributing of sibutramine?

[49]

These issues were found to be common to all members of the proposed
class as they are the basis for each plaintiffs claim in negligence in
relation to the manufacture and marketing of sibutramine.

4)  Did
the defendants knowingly, recklessly, or negligently breach a duty to warn the
class of the risks of harm from the use of sibutramine?

[50]

The judge found this proposed common issue was necessarily part of the
claims based on the inadequacy of any warning and bore on the question of
negligence generally. This proposed issue was found to be a substantial
ingredient of these claims and common to members of the class.

5)  Did
the defendants engage in conduct that constituted deceptive acts or practices
contrary to the
BPCPA

or equivalent legislation in other provinces?
or

6)  Did
the defendants marketing and sale of sibutramine breach
s. 52
of the
Competition
Act
?

[51]

The members of the proposed class, even those who took sibutramine as prescribed
who did not experience health problems, were held to have this issue in common.
Resolution of this issue was held to be necessary for the claims of all class
members.

7)  If any of
questions 1 to 6 are answered in the affirmative, does the defendants conduct
warrant an award of punitive damages;
and

8)  If any of
questions 1 to 6 are answered in the affirmative, should the defendants be
ordered to disgorge the revenues they received from the sale of sibutramine?

[52]

The judge held that
these claims for remedies beyond damages for injury or breach of statute were truly
common to all members of the class.

Section 4(1)(d): preferable procedure


[53]

Finally, the judge engaged in the exercise described in
Rumley v.
British Columbia,
2001 SCC 69, [2001] 3 S.C.R. 184, by addressing whether
class proceedings would be a fair, efficient and manageable method of advancing
the claims, and whether class proceedings are preferable to other proceedings.

[54]

Resolution of the
common issues by class proceedings was held to be preferable to multiple
individual actions or representative actions because the complexity of the
issues made them unwieldy for resolution by individuals. There was no evidence
of any interest in an individual action. There are no other pending proceedings
arising out of the marketing or use of sibutramine in Canada. There was an
unsuccessful attempt to certify class proceedings in Québec (
MacMillan c.
Abbott Laboratories
, 2012 QCCS 1684), and an action commenced in Ontario has
been abandoned. There was no suggestion of other more efficient means of
addressing the interests of the proposed class plaintiffs. The judge concluded:

[129]    No more
efficient means of resolving the issues raised in the pleadings have been
suggested, nor were there any suggestions of means that would pose fewer
difficulties than if the matter proceeds as class proceedings.

[130]

On balance, therefore, I conclude that
class proceedings are the preferable way to resolve common issues in this case.

Section 4(1)(e): a representative plaintiff

[55]

The proposed
representative plaintiffs were found to have met the statutory criteria.

Certification

[56]

The certification
judge found that all of the requirements of s. 4 of the
Act
were
met and a class proceeding was certified. The class was defined as:

All
persons in Canada who were prescribed and ingested Meridia or Apo-Sibutramine
and all spouses, parents, or children of these primary class members who are
entitled to make claims under the
Family Compensation Act
in B.C. in
respect of the death of such members and all persons outside of B.C., who by
reason of their relationship to a member of the primary class, are entitled to
make claims under the equivalent provincial dependents legislation in respect
of the death or personal injury of such primary class members.

[57]

The following
common issues were identified:

1.       Does sibutramine cause or
contribute to heart attacks, strokes, and arrhythmia?

2.       Did the defendants breach a
duty of care owed to the class in the testing, marketing, selling or
distributing of sibutramine?

3.       Did the defendants knowingly,
recklessly, or negligently breach a duty to warn the class of the risks of harm
from the use of sibutramine?

4.       Did the defendants engage in
conduct that constituted deceptive acts or practices contrary to the
Business
Practices and Consumer Protection Act,
S.B.C. 2004, c. 2,

or
equivalent legislation in other provinces?

5.       Did the defendants marketing
and sale of sibutramine breach
s. 52
of the
Competition Act,
R.S.C.
1985, c. C‑34?

6.       If any of questions 1 to 5
are answered in the affirmative, does the defendants conduct warrant an award
of punitive damages?

7.       If
any of questions 1 to 5 are answered in the affirmative, should the defendants
be ordered to disgorge the revenues they received from the sale of sibutramine?

Issues
on Appeal and Cross Appeal

[58]

The appellants say the certification judge erred in principle by certifying
the class proceedings, because the plaintiffs did not lead evidence of a
methodology for establishing general causation on a class-wide basis. They say
the only evidence of causation before the certifying judge was the SCOUT study,
which pertained to patients with pre‑existing diagnosed cardiovascular
disease for whom
sibutramine ought not to have been prescribed.
It is of no value to the class plaintiffs, they say, to obtain a judgment that
the drug posed a risk to those for whom it ought not to have been prescribed,
precisely because of that acknowledged risk.

[59]

The
appellants further argue that
the
judge erred in certifying the class action because there is no commonality to
the claims of members of the defined class. As a result, it says, a class
action is not the preferable means of addressing the plaintiffs claims.

[60]

The plaintiffs, on
their cross appeal, say the judge erred in law in dismissing the claim against
Abbott U.S. They say the pleadings allege that the defendants collectively
designed, manufactured and distributed sibutramine products in Canada, making
no distinction between them; those allegations are not expressly denied in the
defence filed by Abbott U.S.

The
Appellants Argument

Insufficient
Evidence of a Method of Proof of General Causation

[61]

The appeal is
founded upon the ground that the certifying judge failed to subject the
plaintiffs case to the scrutiny described in the jurisprudence, intended to
ensure that certification serves the purpose of efficiently advancing a claim
in the common interest of class members. No issue is taken with the judges
conclusion that the pleadings disclose a cause of action, that there is an
identifiable class of plaintiffs, or that the proposed representative
plaintiffs meet the criteria set out in the
Act.

[62]

The appellants say
the plaintiffs failed to show any basis in fact to support the conclusion that
a common issue may be effectively adjudicated upon to the benefit of class
members. This is so, in particular, in relation to the common issue of general
causation. Whereas the plaintiffs say the question is whether there is some
basis in fact for the allegation that the product causes harm, the appellants
say the certification judge ought to have considered whether there is some
basis in fact in the evidence of an available methodology to effectively
determine the common questions certified.

[63]

The appellants say
the evidence before the certification judge was insufficient to meet the test
described in the Supreme Court of Canada trilogy of decisions:
AIC Limited
v. Fischer
, 2013 SCC 69, [2013] 3 S.C.R. 949;
Sun‑Rype Products
Ltd. v. Archer Daniels Midland Company
, 2013 SCC 58, [2013] 3 S.C.R. 545;
and
Pro‑Sys Consultants Ltd. v. Microsoft Corporation
, 2013 SCC
57, [2013] 3 S.C.R. 477. They say those cases stand for the proposition a class
action should not be certified unless there is evidence of a
methodology
that
may be used to answer

the common questions. They say it is an error to
simply ask whether there is some basis in fact for the allegation of negligence
in the case. They do not suggest the plaintiffs have to adduce evidence of
the
methodology upon which they intend to rely, but argue they must establish
there is
a workable methodology
so that the Court, in employing its
gatekeeping function, can be confident the case will be efficiently prosecuted.

[64]

The appellants
argue general causation has been certified as a common issue in the absence of
any evidence of a methodology that may be used to address the issue. They say
evidence sibutramine causes or contributes to heart attacks, strokes, and
arrhythmia among class members is non‑existent. In their view, it is
significant that the plaintiffs expert acknowledges no study has been
performed on sibutramine with sufficient power to show adverse cardiovascular
events are associated with its use by patients for whom it should have been
prescribed and to whom it was marketed. There is nothing proffered by the
plaintiffs illustrating how the issue of general causation on a class-wide
basis is going to be litigated.

[65]

The principal attack on the judgment is therefore that the action was
erroneously certified because there was no basis in fact to conclude resolution
of a common issue of fact or law would move the litigation forward. In part,
that is a question of commonality: whether there are questions that can
properly be addressed by the class as a whole; and, in part, it is a question
of preferability: whether a class proceeding would be the preferable procedure
for the efficient resolution of the common issues.

The Remaining Common Issues

[66]

If general
causation is not amenable to a decision on a class-wide basis, the appellants
say the class action is not the preferable procedure for determining the
balance of the questions certified for determination. The remaining common
issues will either collapse or be subsumed by individual ones. All common
issues are said by the appellants to hinge upon general causation.

[67]

With respect to common issue no. 2 (
Did the defendants breach a
duty of care owed to the class in the testing, marketing, selling or
distributing of sibutramine?
), the appellants say: There can be no finding
of negligence applicable to the class if there is no prior finding that Meridia
can cause a health risk on a class wide basis.

[68]

With respect to common issue no. 3 (
Did the defendants
knowingly, recklessly, or negligently breach a duty to warn the class of the
risks of harm from the use of sibutramine?
), the appellants say: The court
cannot ask whether Abbott breached a duty to warn the class if it cannot first
establish what specific danger Meridia creates that is common to the class.

[69]

The appellants say
the same problems arise with respect to common issue no. 4 (
Did the
defendants engage in conduct that constituted deceptive acts or practices
contrary to the BPCPA, or equivalent legislation in other provinces?
) and
common issue no. 5 (
Did the defendants marketing and sale of
sibutramine breach s. 52 of the Competition Act?
), which they say are
largely premised on the existence of deceptive acts relating to Meridias health
risks.

[70]

The appellants say the claim is unmanageable and that the case will be
overwhelmed by the many individual causation issues that would be necessary to
resolve the central allegations in the claim which, they say, will require
particularized evidence and discoveries for every class member.

[71]

In response to the
misrepresentation and trade practice claims, the appellants say the laws that
apply to this issue will vary among the class based upon where each class
member was injured or purchased the drug. Consumer protection statutes in some
provinces contain definitions or provisions that are not common to all
provinces. Some of the statutes were enacted during the class period and others
were amended during the class period.

[72]

The appellants say
the proposed class action would not be a fair, efficient and manageable
procedure for meaningfully advancing the central issue in this case which, in
their words, is whether when used as intended Meridia causes heart attacks,
strokes or arrhythmias.

[73]

In its defence, Apotex adopts the arguments of Abbott. It argues common
issues nos. 2 to 5 all necessitate individual findings of fact which
cannot be made on a class-wide basis. It says that the resolution of those
common issues is entirely dependent upon additional individual findings of fact
pertaining to the role of learned intermediaries. It acknowledges that the
learned intermediary considerations would be irrelevant if the defendants
failed to provide accurate product labels or did not fairly state the risks of
the drugs, but they say there was no evidence before the chambers judge that
there was any such failure on the part of the defendants.

[74]

Apotex adds that
the claim does not disclose causes of action against it for violation of
statutory obligations, negligent testing, negligent marketing and failure to
warn and the chambers judge erred in law in so finding. This distinct defence
is founded upon American cases that limit the liability of generic drug
manufacturers when their acts have been determined by statutory obligations
imposed as a condition of marketing generic drugs.

[75]

Apotex argues,
further, that there is no evidence Mr. Charlton, the only plaintiff who is
said to have consumed Apo‑Sibutramine, suffers from a cardiovascular
disease and the plaintiffs own evidence (that of Dr. Fitchett) is that the
causative association of the drug with his symptoms is less than clear.

[76]

The respondents
say the class action does not hinge upon a finding that sibutramine increases
the risk of heart attacks, strokes and arrhythmia to individuals without pre‑existing
cardiovascular disease. Even if the trial judge finds that only those with cardiovascular
disease are at risk, they will advance the claim described in the respondents factum
as follows: In this case, the plaintiffs allege that sibutramine medication is
defective because it causes minimal weight loss and causes or contributes to
heart attacks, strokes and arrhythmia.

[77]

In response to the
defence of Apotex, the respondents cite
Heward v. Eli Lilly & Company
(2008)
,
91 O.R. (3d) 691 (Ont. S.C.J.), and
Miller v. Merck Frosst Canada
Ltd.
, 2013 BCSC 544, in support of the argument that Canadian courts have
repeatedly held that compliance with Health Canada regulations does not shield an
innovator drug manufacturer. The respondents say the issue is one of first
impression in Canada and for that reason it should not be decided at
certification but at trial on a full record.

The Cross Appeal

[78]

In their cross
appeal, the plaintiffs say the certification judge erred in:

a)

dismissing the claim against Abbott
Laboratories as it was not plain and obvious on reading the pleadings that the
cause of action against Abbott Laboratories would fail;

b)

dismissing the cause of action in
negligent design against Apotex as it was not plain and obvious Apotex could
not be held liable for formulating Apo‑Sibutramine, although it was a
copy; and

c)

dismissing the
cause of action in negligent design against Abbott U.S. when Abbott acquired
the company that designed the drug and is therefore liable.

[79]

In response to the
cross appeal, Abbott U.S. says the certification judge was right to refuse to
certify an action against Abbott U.S. because the pleadings did not contain any
claim that Abbott U.S. had been engaged in a specific act of misconduct. The
defendants say it is expressly pleaded by the plaintiffs that sibutramine was
introduced into the Canadian market in 2000 by Knoll Pharmaceuticals and that
Knoll was acquired by Abbott in 2001. That being the case, on the plaintiffs
own pleadings, Abbott U.S. cannot have been involved in the design, testing or
manufacture of the drug before 2000 and the plaintiffs do not allege that
Abbott U.S. was involved in the marketing of the drug in Canada.

Applicable
Law

The
Class Proceedings Act

[80]

The
Act
reads, in part, as follows:

4

(1) The court must certify a proceeding as a class
proceeding  if all of the following requirements are met:

(a) the pleadings disclose a cause of
action;

(b) there is an identifiable class of
2 or more persons;

(c) the claims of the class members
raise common issues, whether or not those common issues predominate over issues
affecting only individual members;

(d) a class proceeding would be the
preferable procedure for the fair and efficient resolution of the common issues;

(e) there is a representative
plaintiff who

(i) would fairly and adequately
represent the interests of the class,

(ii) has produced a plan for the
proceeding that sets out a workable method of advancing the proceeding on
behalf of the class and of notifying class members of the proceeding, and

(iii) does not have, on the common
issues, an interest that is in conflict with the interests of other class
members.

(2)
In determining whether a class proceeding would be the preferable procedure for
the fair and efficient resolution of the common issues, the court must consider
all relevant matters including the following:

(a) whether questions of fact or law
common to the members of the class predominate over any questions affecting
only individual members;

(b) whether a significant number of
the members of the class have a valid interest in individually controlling the
prosecution of separate actions;

(c) whether the class proceeding would
involve claims that are or have been the subject of any other proceedings;

(d) whether other means of resolving
the claims are less practical or less efficient;

(e)
whether the administration of the class proceeding would create greater
difficulties than those likely to be experienced if relief were sought by other
means.

Evidentiary Basis for Certification

[81]

The
Act
calls for evidence to be introduced at a certification hearing. In
Microsoft,
Rothstein J. for the Court, addressed
the standard of proof. Microsoft, citing American authorities, argued that
because the certification judge was finally determining questions, an applicant
must lead evidence that the case meets the certification requirements on a
balance of probabilities. That argument was rejected:

[99]

The starting point in
determining the standard of proof to be applied to the remaining certification [other
than the existence of a cause of action] requirements is the standard
articulated in this Courts seminal decision in
Hollick
. In that case,
McLachlin C.J. succinctly set out the standard: . . . the class
representative must show
some basis in fact
for each of the
certification requirements set out in . . . the Act, other than the requirement
that the pleadings disclose a cause of action (para. 25 (emphasis
added)). She noted, however, that the certification stage is decidedly not
meant to be a test of the merits of the action (para. 16). Rather, this stage
is concerned with form and with whether the action can properly proceed as a
class action (see
Hollick
,

at para. 16;
Pro-Sys
Consultants Ltd. v. Infineon Technologies AG
, 2009 BCCA 503, 98 B.C.L.R.
(4th) 272 (
Infineon
), at para. 65;
Cloud v. Canada (Attorney
General)
(2004), 73 O.R. (3d) 401 (C.A.), at para. 50).

[Emphasis in original.]

[82]


In
Ernewein v. General Motors of Canada Ltd.
, 2005 BCCA 540, 46 B.C.L.R.
(4th) 234, Newbury J.A., at para. 25, described the evidentiary
requirements for certification as follows:

[25]      Although
it is clear that no assessment of the merits of the claim takes place at the
certification stage, it is equally clear that an evidentiary basis is
required for each of the certification requirements other than that the
pleadings disclose a cause of action. The phrases evidentiary basis and
basis in fact were used by the Supreme Court of Canada in
Hollick
,

(
supra
,
at paras. 24‑26) in such a manner as to be synonymous with
evidence, and as the Chief Justice pointed out, the requirement arose from
the statutory obligation placed on the plaintiff in a class proceeding in
Ontario to file one or more affidavits setting forth the material facts to be
relied upon. The British Columbia legislation is similar in this regard:
s. 5(1) of the
Act
requires an applicant for certification to file
an affidavit containing the items specified at s. 5(5), and the recipient
of the notice of motion may also file affidavit material: s. 5(4). In
Hollick
,
after citing with approval the Ontario cases of
Caputo v. Imperial Tobacco
Ltd.
(2004), 236 D.L.R. (4th) 348 (Ont. Sup. Ct. J.) and
Taub v.
Manufacturers Life Insurance Co.
(1988), 40 O.R. (3d) 379 (Ont. Ct. (Gen.
Div.)), McLachlin C.J.C. noted:

I agree that the representative of the.
asserted class must show some basis in fact to support the certification order.
As the court in
Taub
held, that is not to say that there must be
affidavits from members of the class or that there should be any assessment of
the merits of the claims of other class members. However, the
Report of the
Attorney General's Advisory Committee on Class Action Reform
clearly
contemplates that the class representative
will have to establish an
evidentiary basis for certification
: see Report, at p. 31 (evidence
on the motion for certification should be confined to the [certification]
criteria). The Act, too, obviously contemplates the same thing: see s. 5(4)
([t]he court may adjourn the motion for certification to permit the parties to
amend their materials or pleadings
or to permit further evidence
). In
my view, the
class representative must show some basis in fact for each of
the certification requirements set out in s. 5 of the Act, other than the
requirement that the pleadings disclose a cause of action
. That latter
requirement is of course governed by the rule that a pleading should not be
struck for failure to disclose a cause of action unless it is plain and
obvious that no claim exists: see Branch, supra, at para. 4.60.

[Emphasis
in original.]

Identifiable Class

[83]

Identification
of class members was not a contentious issue in this case. As in other pharmaceutical
cases, the defendants argue that establishing general causation (that
sibutramine causes or contributes to cardiac events) will not greatly assist
individual plaintiffs to establish specific causation (that their injury was
caused or contributed to by the use of sibutramine). But that is a question of
commonality or practicality. This is not a case, like the indirect consumer
cases (such as
Microsoft
and
Sun‑Rype
),
where expert evidence is required to
identify the class of plaintiffs affected by general causation. In those cases,
the plaintiffs themselves could not know if they had been affected by the
impugned market conduct until they were identified by experts. Here,
consumption of sibutramine is the identifying element. The class can be identified
by objective criteria without reference to the merits of the case.

Common Issues

[84]

Where the applicants seek to address questions of causation on a class-wide
basis and where causation is said to give rise to the commonality of interests,
there must be some evidence of a methodology that will enable them to prove
causation on a class-wide basis. While that rule is most clearly evident in
cases brought by indirect purchasers, such as the claims considered in the 2013
Supreme Court trilogy, there is in my view no basis in principle to distinguish
such claims insofar as this requirement is concerned. The evidence at the
certification hearing must support the conclusion that certification of the
common issue will advance the claim as pleaded. Where the proposed common issue
is causation, there must be some evidence that issue may be resolved on a
class-wide basis. Seeking evidence of a methodology of addressing causation for
the class serves the objective of class proceedings and the
Act
must be
applied with a purposive approach.

[85]

Mr. Justice Strathy,
as he then was, described an appropriate analysis of the common issues question
in
Singer v. Schering-Plough Canada Inc.
, 2010 ONSC 42, a product claim
brought against manufacturers. He provided a helpful description of the
jurisprudence prior to the Supreme Court of Canadas recent restatement of the
evidentiary requirements for certification:

[140]    The
following general propositions, which are by no means exhaustive, are supported
by the authorities:

A
: The underlying foundation of a
common issue is whether its resolution will avoid duplication of fact-finding
or legal analysis:
Western Canadian Shopping Centres Inc. v. Dutton
,
above
,
at para. 39.

B
: The common issue criterion is not a
high legal hurdle, and an issue can be a common issue even if it makes up a
very limited aspect of the liability question and even though many individual
issues remain to be decided after its resolution:
Cloud v. Canada (Attorney
General)
, above, at para. 53.

C
:
There must be a basis in the evidence before the court to
establish the existence of common issues
:
Dumoulin v. Ontario
, [2005] O.J. No. 3961
(S.C.J.) at para. 25;
Fresco v. Canadian Imperial Bank of Commerce,
above,
at para. 21. As Cullity J. stated in
Dumoulin v. Ontario
, at
para. 27,
the plaintiff is required to establish a sufficient
evidential basis for the existence of the common issues in the sense that
there is some factual basis for the claims made by the plaintiff and to which
the common issues relate
.

D
:
In considering whether there are common issues, the court
must have in mind the proposed identifiable class. There must be a rational
relationship between the class identified by the Plaintiff and the proposed
common issues:
Cloud v. Canada (Attorney General)
, above at para. 48.

E
:
The proposed common issue must be a substantial
ingredient of each class members claim and its resolution must be necessary to
the resolution of that claim:
Hollick v. Toronto (City),
above, at para. 18.

F
:
A common issue need not dispose of the litigation; it is
sufficient if it is an issue of fact or law common to all claims and its
resolution will advance the litigation for (or against) the class:
Harrington
v. Dow Corning Corp.
, [1996] B.C.J. No. 734, 48 C.P.C. (3d) 28 (S.C.),
affd
2000
BCCA 605,
, [2000]
B.C.J. No. 2237, leave to appeal to S.C.C. refd [2001] S.C.C.A. No. 21.

G
: With regard to the common issues,
success for one member must mean success for all. All members of the class
must benefit from the successful prosecution of the action, although not
necessarily to the same extent. That is, the answer to a question raised by a
common issue for the plaintiff must be capable of extrapolation, in the same
manner, to each member of the class:
Western Canadian Shopping Centres Inc.
v. Dutton
, above, at para. 40,
Ernewein v. General Motors of Canada
Ltd.
, above, at para. 32;
Merck Frosst Canada Ltd. v. Wuttunee
,

2009 SKCA 43, [2009] S.J. No. 179 (C.A.), at paras. 145‑146
and 160.

H
: A common issue cannot be dependent
upon individual findings of fact that have to be made with respect to each
individual claimant:
Williams v. Mutual Life Assurance Co. of Canada
(2000), 51 O.R. (3d) 54, [2000] O.J. No. 3821 (S.C.J.) at para. 39,
affd [2001] O.J. No. 4952, 17 C.P.C. (5
th
) 103 (Div. Ct.),
affd [2003] O.J. No. 1160 and 1161 (C.A.);
Fehringer v. Sun Media Corp
.,
[2002] O.J. No. 4110, 27 C.P.C. (5th) 155, (S.C.J.), affd [2003] O.J.
No. 3918, 39 C.P.C. (5th) 151 (Div. Ct.).

I
:

Where questions relating to causation or damages are proposed as common
issues, the plaintiff must demonstrate (with supporting evidence) that there is
a workable methodology for determining such issues on a class-wide basis
:
Chadha
v. Bayer Inc.
, [2003] O.J. No. 27, 2003 CanLII 35843 (C.A.) at
para. 52, leave to appeal dismissed [2003] S.C.C.A. No. 106, and
Pro-Sys
Consultants Ltd. v. Infineon Technologies AG
, 2008 BCSC 575, [2008] B.C.J.
No. 831 (S.C.) at para. 139.

J
:
Common issues should not be framed in overly broad terms: It would not serve
the ends of either fairness or efficiency to certify an action on the basis of
issues that are common only when stated in the most general terms. Inevitably
such an action would ultimately break down into individual proceedings. That
the suit had initially been certified as a class action could only make the
proceeding less fair and less efficient:
Rumley v. British Columbia,
2001
SCC 69, [2001] 3 S.C.R. 184, [2001] S.C.J. No. 39 at para. 29.

[Emphasis
added.]

[86]

In
Microsoft,
the Court
looked for
some basis in fact upon which
the certifying judge could have concluded questions were capable of resolution
on a common basis. In the case of indirect purchasers, that was
expert evidence
in the form of economic models and methodologies (para. 114) led
to establish that the effects
of the impugned market behaviour were passed on to the indirect purchasers,
making the issue common to the class as a whole. The methodology will,
obviously differ from case to case. In
Microsoft
,

the Court held:

[115]    The
requirement at the certification stage is not that the methodology quantify the
damages in question; rather, the critical element that the methodology must establish
is the ability to prove common impact, as described in the U.S. antitrust
case of
In Re: Linerboard Antitrust Litigation
, 305 F.3d 145 (3rd Cir. 2002).
That is, plaintiffs must demonstrate that sufficient proof [is] available, for
use at trial, to prove antitrust impact common to all the members of the class
(
ibid.
, at p. 155). It is not necessary at the certification stage
that the methodology establish the actual loss to the class, as long as the
plaintiff has demonstrated that there is a methodology capable of doing so.

[87]

In
AIC,
the Court referred with approval to the Ontario Court of Appeals analysis
in
Chadha v.
Bayer Inc.
(2003),
63 O.R. (3d) 22 (C.A.), leave to appeal refused, [2003] 2 S.C.R. vi
:

[43]

The standard of
proof on a motion for certification was at the heart of the appeal in
Chadha
v. Bayer Inc
. The decision makes clear that at the certification stage,
the court cannot engage in any detailed weighing of the evidence but should
confine itself to whether there is some basis in the evidence to support the
certification requirements. In
Chadha
, the court denied certification on
the basis that there was
no
evidence that the loss component of
liability could be proved on a class-wide basis (and thus that there was no
common issue). It was not necessary to establish that there was a compelling
method to prove such loss, but it was necessary to provide some basis in fact
to think that there was
some
method to do so. The plaintiffs had failed
to provide that basis. This Court reached the opposite conclusion in
Pro‑Sys
with regard to the commonality of the issues, because there was an expert
methodology that ha[d] been found to have a realistic prospect of establishing
loss on a class-wide basis (para. 140).

[88]

The 2013 trilogy
was followed in a case relied upon by the appellants, the short, recent
decision of the Alberta Court of Appeal in
Andriuk v. Merrill Lynch Canada

Inc.
, 2014 ABCA 177, dismissing the appeal from the longer and
considered decision of Martin J. reported at 2013 ABQB 422.

[89]

Andriuk
was an appeal from an order
dismissing an application to certify a class action in a financial services
case. The plaintiffs sought damages said to arise from Merrill Lynchs conduct
in relation to the plaintiffs investments in a speculative biotech stock.
They alleged Merrill Lynch had
diminished the stocks value when it orchestrated sales intended to reduce the
concentration of holdings in its hands and its risk position, without regard to
the risk tolerance or priorities of its clients. Those who sold at a nominal
profit, those who sold at a loss, and those who did not sell but were forced to
move their accounts and incurred fees, all claimed to have suffered damages.
The defendants opposed certification, arguing the plaintiffs had adduced no
evidence of how they might establish Merrill Lynchs decision to reduce its
holdings, or the value of holdings, under its management actually affected the
price of the shares sold or still held by proposed class members. Martin J.
held difficulty doing so was not a bar to establishing the existence of a cause
of action. It was, however, problematic for other reasons:

[104]    The
failure to adduce evidence of a methodology to establish
causation and class-wide damage is
not fatal
at the cause of action stage
of the certification hearing. For
reasons to be explained in more detail below, however, the absence of such
evidence
raises insurmountable obstacles to the certification of common
questions of loss and causation
and whether there can be a claim for
aggregate damages.

[Emphasis
added.]

[90]

The certification
judge referred to
Chadha
as authority for the rule that where questions
relating to causation of damages are proposed as common issues, the plaintiff
must demonstrate (with supporting evidence) that there is a workable
methodology for determining such issues on a class‑wide basis:

[132]    In
the case at bar, the Plaintiffs entire theory of liability rests on common
causation and damage, which minimizes the individual assessment and
fact-finding that would normally be required in this type of case. The
Plaintiffs argue that it is neither possible, nor appropriate, to consider each
investor individually. Rather, the cumulative impact of Merrills mandate and
each investors response to that mandate is what has resulted in damage for
all. Yet the Plaintiffs have offered no evidence to substantiate their novel
theory of liability. They indicate that they will proffer an expert after
examinations for discovery who will tease out the impact of the Defendants
mandated actions, solicitation of sales and margin reductions, upon the share
price from the myriad of other factors that can affect a stocks price. They
have not provided any indication in this certification hearing of a methodology
for doing so.

[91]

That decision was
upheld on appeal. The certification judge was held to have properly
set out the statutory framework and
general principles that must be satisfied on a certification application:

[11]      Here, the certification
judge found that the appellants had failed to demonstrate a methodology to determine
causation. The respondents expert testified that he was unaware of any such
methodology. The appellants did not adduce expert evidence on the issue. They
argued on appeal that there was no need for expert evidence at the
certification stage. We do not read the certification judges reasons as
insisting on expert evidence at this stage. It seems to us that the need for
expert evidence would depend upon the nature of the case and the determination
of the common issues. What the certification judge did say was that it was the
appellants burden to demonstrate a methodology and they had failed to do so.

[92]

There was nothing in the reasons, in relation to the certification or
the appeal, to suggest that evidence of a methodology of establishing causation
ought only to be required in class proceedings brought on behalf of indirect
purchasers. I cannot accede to the respondents argument that
Andriuk
was wrongly decided and that the principles described in the 2013 trilogy have
no application in cases other than claims brought by indirect purchasers.

[93]

Where there is
some evidence by which general causation may be proven, that is sufficient; the
evidence ought not to be weighed at certification. As this Court held in
Stanway
v. Wyeth Canada Inc.,
2012 BCCA 260:

[55]

[A]s has been stated many times, on
a certification hearing, the court is not to weigh the competing evidence. Here
there is evidence that, if accepted at the trial of the common issues, may
answer the general causation question as to whether there is a causal
connection between hormone therapy and breast cancer. A positive answer would
obviously move the litigation forward, although individual class members may
face formidable challenges in establishing causation specific to themselves.

[94]

The analysis in
Stanway
is particularly apposite in the case
before us. The pharmaceutical manufacturer in that case, Wyeth, sought to set
aside the certification of a class action brought by patients who had undergone
hormone replacement therapy and were faced with addressing the general
causation question: whether estrogen-progestin therapy can be said to cause or
contribute to breast cancer. At the certification hearing, there was evidence hormone
replacement can effect changes in breast tissue and that the risk of breast
cancer is increased as a result. A causal connection between estrogen-progestin
therapy and the risk of breast cancer was established in a large clinical study.
The central opinion of Wyeths expert was:

The relative risk in the definitive report on breast cancer
from the WHI study was 1.24. Accordingly, allowing for five years of
estrogen-progestin use, the probability of breast cancer would be 1.24-fold
higher than the average womans chance of breast cancer. Instead of ten cases
per 1000 women, there would be 12.5 cases per 1000 women using
estrogen-progestin treatment for five years. Also, with every 12.5 cases of
breast cancer among estrogen-progestin users, ten would have been diagnosed
regardless of the HRT use.
There is no known means to determine which 2.5 of
the 12.5 breast cancer cases might be related to HRT use
.

For this reason as well, none of the members
of the proposed class would be able to demonstrate that her breast cancer was
caused by HRT or by any one or more of numerous other risk factor(s). The
presence of risk factors does not predict who will develop breast cancer or any
other disease
.


[Emphasis
added.]

[95]

The Court
addressed the objection to certification by referring to the judgment of this Court
in
Harrington v. Dow Corning Corp.
, 2000 BCCA 605, and an article by
Patrick Hayes entitled
Exploring the Viability of Class Actions Arising from
Environmental Toxic Torts: Overcoming Barriers to Certification
, 19 J. Env. L.
& Prac. 190 at 195:

Proving
causation in the context of toxic substances, however, puts the added burden on
plaintiffs to establish two types of causation, both general and specific. This
is because, unlike the causal connection between being hit by a car and
suffering a broken bone, for instance, the causal connection between a toxic
substance and a disease is not as easy to decipher. Thus, a plaintiff must
first prove general or generic causation--that a particular substance is
capable of causing a particular illness. The issue must be addressed, whether
explicitly or implicitly, in toxic torts litigation, since it is axiomatic that
an agent cannot be considered to cause the illness of a specific person unless
it is recognized as a cause of that disease in general. Next, a plaintiff must
prove specific or individual causation--that exposure to a particular toxic
substance did, in fact, cause the plaintiffs illness.

[96]

A positive answer
to the general causation question  whether there is a causal connection
between hormone therapy and breast cancer  would obviously move the litigation
forward. The case was held to have been properly certified, despite the fact individual
class members might face formidable challenges in establishing causation
specific to themselves. That conclusion, in my view, is an answer to the argument
founded upon the opinion of Dr. Myers in the case before us: that
it will not be possible to determine
the cause of any individual class members medical condition without careful consideration
of the individuals medical history.

[97]

It is noteworthy, however, that Wyeths unsuccessful challenge to
the certification was not founded upon the argument that there was
no
method of effectively answering the general causation question. It was, rather,
that an answer to the general causation question could not possibly assist in
proving specific causation; that specific causation could not be proven; and if
the action is doomed to fail there is little point in certifying the class
proceeding:
L.(T.) v. Alberta (Director of Child Welfare)
, 2006 ABQB
104 at para. 36, 58 Alta. L.R. (4th) 23. In the case before us, the
question is whether it can be said there was some evidence of a method of
establishing general causation before the certification judge.

[98]

The Qu
é
bec Superior Court refused to certify
as a class action a claim brought on behalf of purchasers of Meridia in
MacMillan c. Abbott Laboratories
, 2012 QCCS 1684. In that case, the Court
having considered much of the evidence that was before the trial judge in this
case, including the SCOUT study, found the evidence insufficient to meet the
statutory requirement in Québec, set out in s. 1003 of the
Code of
Civil Procedure
, CQLR c. C‑25:

1003.  The
court authorizes the bringing of the class action and ascribes the status of
representative to the member it designates if of opinion that:

(a)
the recourses of the members raise
identical, similar or related questions of law or fact;

(b)

the facts alleged seem to justify
the conclusions sought
;

(c)
the composition of the group makes
the application of
article
59
or
67
difficult or
impracticable; and

(d)
the member to whom the court intends to ascribe the status of representative is
in a position to represent the members adequately.

[Emphasis added.]

[99]

The Court
found the proposed class plaintiff had not adduced evidence in the form of a
study, opinion or document that might transform a hypothesis into facts that
might justify the claim. In the Courts opinion, causation of damages and the
quantum of damages would have to be addressed as individual issues. The
question whether the risk of a cardiovascular event had been increased for
patients who had not yet suffered an adverse event could not be certified for
consideration as a class issue because those patients had not suffered
compensable damages. Referring to
Laferrière v. Lawson
,
[1991] 1 S.C.R. 541, the Court noted, at para. 131, that damage which is
only possible and therefore hypothetical is not compensable in Civil Law.

[100]

Given the distinct statutory language and the more recent and explicit
direction with respect to the requisite evidentiary basis for certification in
the 2013 decisions of the Supreme Court of Canada, the decision in
MacMillan
must be read carefully.

Preferability

[101]

The
certification judge must consider the evidence adduced in relation to both
substantive and procedural questions in addressing preferability.

[102]

In
Hollick,
the Supreme Court
of Canada addressed the requirements for certification in the
Ontario
Class Proceedings
Act, 1992
,

S.O. 1992, c. 6
.

Resolving an issue that had divided the lower courts, the Supreme
Court held that the applicants had adequately identified a class of plaintiffs,
but did not certify class proceedings. The Chief Justice held:

[27]      I cannot
concludethat a class proceeding would be the preferable procedure for the
resolution of the common issues, as required by s. 5(1)(d). The parties
agree that, in the absence of legislative guidance, the preferability inquiry
should be conducted through the lens of the three principal advantages of class
actions  judicial economy, access to justice, and behaviour modification: see
also
Abdool v. Anaheim Management Ltd.
(1995), 21 O.R. (2d) 453
(Div. Ct.); compare British Columbia
Class Proceedings Act
,
s. 4(2) (listing factors that court must consider in assessing
preferability).

[103]

Class issues were held, at para. 32, to be negligible in relation
to the individual issues, and, [o]nce the common issue is seen in the context
of the entire claim, it becomes difficult to say that the resolution of the
common issue will significantly advance the action.

[104]

In
Rumley
, the Supreme
Court held that the
preferability inquiry is, in general
terms, the same under British Columbia legislation, with
the caveat that British Columbia
legislation
provides express guidance as to how a court should approach the question.

[105]

The
preferability issue was addressed in
Microsoft
by application of the
principles established in
Hollick
: regard for judicial economy, access
to justice, and behaviour modification. The Court stated:

[140]

In the present case,
there are common issues related to the existence of the causes of action, but
there are also common issues related to loss to the class members. Unlike
Hollick
,
here the loss-related issues can be said to be common because there is an
expert methodology that has been found to have a realistic prospect of
establishing loss on a class-wide basis. If the common issues were to be
resolved, they would be determinative of Microsofts liability and of whether
passing on of the overcharge to the indirect purchasers has occurred.

[106]

In
AIC,
the Court considered statutory
certification requirements
with particular attention to the
preferability requirement.

Cromwell J. for the Court
noted, at para. 4: the
preferability analysis
is not solely focused on procedural considerations but must, within the proper
scope of the certification process, consider both substantive and procedural
aspects.

[107]

Referring to the preferability
requirement in s. 5(1)(d) of the Ontario
Class Proceedings Act
,
the Court held:

[21]      In order to determine whether a class
proceeding would be the preferable procedure for the resolution of the common
issues, those common issues must be considered in the context of the action as
a whole and must take into account the importance of the common issues in
relation to the claims as a whole:
Hollick
, at para. 30. McLachlin C.J.
in
Hollick
accepted the words of a commentator to the effect that in
comparing possible alternatives with the proposed class proceeding, it is
important to adopt a practical cost-benefit approach to this procedural issue,
and to consider the impact of a class proceeding on class members, the
defendants, and the court: para. 29, citing W. K. Branch,
Class
Actions in Canada
(loose-leaf 1998, release 4), at para. 4.690.

Standard of Review of a Certification
Order

[108]

In
Andriuk
,

the Alberta Court
of Appeal set out the standard of review from a decision on a certification hearing
in concise terms, which are equally applicable in this appeal:

[5]        In
certifying a class action, the certification judge is guided by the
Class
Proceedings Act
, SA 2003, c C‑16.5
. Applying the legislated tests to the
evidence involves questions of mixed fact and law. The certification judge is
uniquely familiar with the factual context:
Aryton v PRL Financial (Alta)
Ltd
,
2006
ABCA 88
, 384 AR 1
at para 3. The court must be reluctant to interfere with the exercise of
judicial discretion on part of a case management judge in the context of
complex litigation:
Halvorson v British Columbia (Medical Services
Commission)
,
2008
BCCA 501
, BCJ No 2364
(CA) at para 17. Thus, absent an extricable error of law which attracts a
correctness standard, substantial deference is accorded to a judge certifying a
class proceeding:
Ayrton
at para 3, citing
Campbell v Flexwatt
(1997),
1997
CanLII 4111 (BC CA)
,
44 BCLR (3d) 343 (CA) and
Pearson v Inco Ltd
,
2006
CanLII 913 (ON CA)
,
[2005] OJ No 4918 (CA).

[109]

In
Wakelam v.
Wyeth Consumer Healthcare/Wyeth Soins de Sante Inc
., 2014
BCCA 36,
this Court noted at para. 8: 
Obviously,
while the court must certify an action that meets the requirements in s. 4(1)
of the
CPA
, the overall question of preferability involves considerable
discretion and the decisions of certification judges are to be accorded
deference.

Analysis

Certification
of the General Causation Question

[110]

The trial
judge certified the case on two footings: as a class action brought by those
who have suffered injury to recover damages, and as a class action brought by
patients prescribed a drug that ought not to have been marketed. The claims of
those who have suffered cardiac events are grounded in negligence and require
proof of damages and causation. Such claims will be advanced by a finding of
general causation. The claim advanced on behalf of users who have not suffered
harm appears to be grounded upon the argument alluded to in the
New England Journal
of Medicine
editorial: that relative ineffectiveness coupled with some risk
ought to have kept sibutramine off the market as a weight loss drug. Like the
claim brought by those who claim to have suffered injury, it must be founded
upon some proof of a risk to the population of patients for whom sibutramine
was prescribed. The plaintiffs own evidence at the certification hearing
included evidence that sibutramine has some effect in inducing weight-loss. The
successful prosecution of the class action in relation to the marketing of a
drug with a poor risk-to-benefit ratio also hinges upon the evidence that those
who ought to have been prescribed the drug were put at risk by its use.

[111]

The
question that ought to have been asked at the certification hearing in relation
to both types of claims, is not whether the resolution of the general causation
question will advance the class claims, but rather, whether there is a
reasonable prospect of doing so.

[112]

The evidence
before the certification judge was that the question whether sibutramine causes
or contributes to heart attacks, strokes, and arrhythmia on a class-wide basis
is incapable of resolution. There was no 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 appellants say the trial judge did not properly exercise
his gatekeeping function; he is said to have erred by failing to consider
whether the class had adduced some evidence of a method of proving the claim. I
agree with that submission.

[113]

This cannot be said
to be a case like
Stanway
, where the increased risk of a certain result
to the class as a whole can be quantified. While there is no dispute that those
with pre‑existing cardiopulmonary disease are at a statistically
increased risk of adverse cardiac events, this is not a case where the experts
disagree on the extent of the risk, but rather, a case where the experts are
uncertain whether there is a risk to the class as a whole and cannot describe a
methodology for addressing that question. Further, there is no reason to
believe that the certification of the question whether sibutramine posed a risk
to those with pre‑existing undiagnosed cardiac disease, an undefined
segment of the class, will move the litigation forward.

Other
Common Issues

[114]

The appellants
say that if the general causation question cannot be answered on a class-wide
basis, no other questions are likely to advance the litigation. Further, they
say a class action is not the preferable means of addressing the remaining
questions.

[115]

The question
whether the defendants breached a duty of care owed to the class in the
testing, marketing, selling or distributing of sibutramine can only be answered
in relation to the allegation that it poses a health risk to the population for
whom it was supposed to be prescribed. As mentioned above, the appellants say,
with respect to common issue no. 2, that there can be no finding of
negligence applicable to the class if there is no prior finding that Meridia
can cause a health risk on a class-wide basis. I agree with this submission.

[116]

Likewise, the
question whether the defendants knowingly, recklessly, or negligently breached
a duty to warn the class of the risks of harm from the use of sibutramine, can
only be addressed in relation to an identified risk. If there is no means of
identifying a risk, then the question cannot fruitfully be canvassed in the
class action. The appellants say, with respect to common issue no. 3, the
Court cannot determine whether Abbott breached a duty to warn the class if it
cannot first establish what specific danger Meridia creates that is common to
the class. I agree with this submission.

[117]

The fourth
common issue arises from allegations that the defendants have breached the
provisions of the
BPCPA.
That
Act
affords remedies to consumers
who have been misled by deceptive acts or practices, including representations
by a supplier that goods
have performance
characteristics, uses or benefits that they do not have.
This Court has
upheld the certification of some class proceedings founded upon such
allegations. In
Stanway
,

at para. 82
,
the Court held
that the common issue posed in relation to the
BPCPA
, an alleged
systemic pattern of representation by omission by Wyeth in failing to
disclose the risks of hormone therapy throughout the 27‑year class
period, was supported by the pleadings and was properly certified.

[118]

The
plaintiffs do not seek to advance a claim founded solely upon the alleged
inefficacy of sibutramine as a
weight-loss drug. They seek to establish, rather, that risks associated with
the drug outweighed its purported benefit as a weight-loss drug. A class action
founded upon that allegation might properly have been certified if evidence had
been adduced of a method of establishing the risk to the class.
As I
have noted, no evidence of methodology was before the certification judge.

[119]

We have
previously held class actions founded, in part, upon claims in waiver of tort
to have been properly certified (or certification to have been wrongly refused)
in
Pro‑Sys Consultants Ltd. v. Infineon Technologies AG
,

2009
BCCA 503
,
312 D.L.R.
(4th) 419;
Steele v. Toyota Canada Inc.,
2011 BCCA 98, 329 D.L.R. (4th)
389; and
Stanway.

[120]

In
Serhan Estate v. Johnson &
Johnson
(2006), 85 O.R. (3d) 665, 269 D.L.R. (4th) 279 (Div. Ct.), Epstein J.A.,
writing for the majority, observed that
where a wrong has been committed, it may be
to the plaintiffs advantage to seek recovery of an unjust enrichment accruing
to the defendant rather than normal tort damages, by bringing a claim in waiver
of tort. Discussing that observation in
Koubi v. Mazda Canada Inc.,
2012 BCCA 310
,
Neilson J.A.,
for the majority, wrote
:

[17]

The
advantage to which she refers has been embraced in class actions and the
doctrine has experienced a resurgence in that context, since it may be used to
present damages as a common issue based on benefits obtained by the defendant
through its wrongful conduct, thereby avoiding individual proof of loss by each
class member.

[121]

However,
in
Koubi
,
this Court held that a claim in
waiver
of tort
cannot be founded upon a breach of the
BPCPA
or the
Sale
of Goods Act
because
there
is nothing in the
BPCPA
to support the view that the legislature
intended to augment its statutory remedies by permitting consumers to mount an
action against a supplier for restitutionary relief based on the novel doctrine
of waiver of tort (at para. 64); and a breach of s. 18(a) of
the
SGA
cannot provide the required wrongful act to ground a claim in
waiver of tort (at para. 77).

[122]

The judgment in
Koubi
was more recently considered in
Wakelam
,
where the Court, in the following terms, dismissed claims in relation to
alleged breaches of constructive trust and unjust enrichment as well as waiver
of tort, all said to be founded upon breaches of the
BPCPA
, at para. 66:

In my view, the reasoning in
Koubi
applies not only to the allegation of waiver of tort advanced by Ms. Wakelam
but also to her claims for unjust enrichment and constructive trust insofar as
they are based on breach of the
BPA
. Although I
might not have used the phrase occupying the field (which has constitutional
connotations), I see no legislative intent to create restitutionary causes of
action arising from or based on breaches of the
BPA
; nor has the
plaintiff sought to argue that the
BPA
provides only
ineffective enforcement.

[123]

In light
of the decisions in
Koubi
and
Wakelam
, the class proceeding
cannot have been certified to permit the plaintiffs to advance a claim for
recovery from the defendants of enrichment accruing to them as a result of the
marketing of sibutramine in breach of a statutory duty. The action must be for
damages, or, in waiver of tort, for breach of what are referred to in
Koubi
as
anti-harm torts.

[124]

The
question whether the defendants marketing and sale of sibutramine breached s. 52
of the
Competition Act
also requires consideration of whether the
defendants
, for the purpose of promoting the use of
sibutramine, knowingly or recklessly make a representation to the public that
is false or misleading in a material respect. Such an inquiry necessitates a
determination of whether the drug
causes or contributes to heart
attacks, strokes, and arrhythmia. If there is no methodology of addressing that
question it ought not to have been certified. Posing the question is unlikely
to advance the action.

Conclusion

[125]

In light of the
centrality to all allegations of the establishment that sibutramine caused or
contributed to the occurrence of cardiac events in patients for whom it could
properly have been prescribed, and the absence of a means of establishing that
was the case, I am of the view it was an error to certify the case as a class
proceeding.

[126]

That being the case, it is unnecessary
to address the cross appeal.

[127]

I would allow the
appeal, dismiss the cross appeal and set aside the certification order.

The Honourable Mr. Justice Willcock

I
agree:

The
Honourable Chief Justice Bauman

I agree:

The
Honourable Mr. Justice Groberman


