IN THE SUPREME COURT OF BRITISH COLUMBIA

Date: 20110830

Docket: S081441

Registry:
Vancouver

Brought
under the Class Proceedings Act, R.S.B.C. 1996, c. 50

Between:

Meah Bartram an
Infant, by her Mother and Litigation Guardian,
Faith Gibson, and the said Faith Gibson

Plaintiffs

And

Glaxosmithkline
Inc. and Glaxosmithkline UK Limited

Defendants

Before: The Honourable Mr. Justice
Nathan Smith

Reasons for Judgment

[1]            
The plaintiffs allege that a child suffered birth defects as a result of
her mother’s use of the antidepressant Paxil during her pregnancy. They have
applied to certify this action as a class proceeding. The present issue is
whether the defendants, who manufactured and marketed the drug, should have
access to the plaintiffs’ medical records before they respond to the
certification application.

[2]            
According to the statement of claim, the infant plaintiff Meah Bartram
was born on September 14, 2005. It is alleged that:

The Plaintiff, Meah Bartram,
suffered serious complications during her birth. In particular, Meah Bartram
suffered cardiovascular defects, and was born with a moderate sized
perimembranous Ventricular Septal Defect.

[3]            
That condition is alleged to have been caused by her mother, the adult
plaintiff Faith Gibson, using Paxil before and during her pregnancy. The
statement of claim alleges:

The Defendants knew or ought to
have known at least as early as June, 2003, that there was a significant risk
of serious adverse cardiovascular complication for newborns from pregnant
mothers ingesting Paxil. The Defendants failed to apprise the Plaintiff, Faith
Gibson or her physicians of that risk.

[4]            
The certification application, which has not yet been heard, seeks the appointment
of Faith Gibson as representative plaintiff in a class proceeding and seeks to
define the class as “any person in Canada, born with cardiovascular defects, to
women who ingested Paxil while pregnant, and the mothers of those persons”.

[5]            
The application also seeks to certify nine issues as issues common to
all members of the class. For present purposes, the most significant of those
proposed common issues are:

(a)    did Paxil cause or
increase the likelihood of birth defects?

(b)    is Paxil unfit for its
intended purpose?

(c)    did the Defendant
Glaxosmithkline Inc. fail to warn class members and/or Health Canada of the
true risk of birth defects caused by using Paxil?

(d)    did
the Defendant Glaxosmithkline Inc. breach a duty of care to class members and
if so, when and how?

The balance of the proposed common issues deal with
questions of punitive damages and the possible application of the Business
Practices and Consumer Protection Act, S.B.C. 2004, c. 2.

[6]            
On this application, the defendants seek production of all medical and
pharmaceutical records for both the adult and infant plaintiffs for a period
beginning two years before Ms. Gibson first took Paxil and continuing to
the present. They say that they and their experts require these records in
order to fully respond to the issues on the certification application.

[7]            
The plaintiffs concede that, if the action is certified, some or all of
these records may become producible at some point, but say they are not
relevant on the certification application. The plaintiffs also point out that
the defendants have not filed a statement of defence under the former rules of
court or a response to civil claim under the current rules. They say there can
be no obligation to provide discovery of documents because, until pleadings are
closed, it is not possible to say what documents are relevant to issues in the
litigation.

[8]            
The requirements for certification and the matters that must be
considered on a certification application are set out in s. 4 of the Class
Proceedings Act, which reads:

4 (1)     The court must certify a proceeding as a class
proceeding on an application under section 2 or 3 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.

[9]            
The act defines “common issues” as:  “(a) common but not
necessarily identical issues of fact, or (b) common but not necessarily
identical issues of law that arise from common but not necessarily identical
facts”.

[10]        
In Jones v. Zimmer GMBH, 2010 BCSC 1504, at paras. 10-11, Loo J.
described a class action as a multistage process that begins with the
certification hearing, proceeds through the determination of issues common to
the class and concludes with the determination of issues specific to individual
class members:

… The common issues at the initial certification stage must
not be confused with the individual issues at the last stage:  s. 4 of the
Class Proceedings Act, […]; Harrington v. Dow Corning, 2000
BCCA 605 at paras. 42-46; T.L. v. Alberta (Child, Youth and Family
Enhancement Act, Director), 2010 ABQB 203 at para. 16.

The certification stage is
procedural. It focuses on the form of the action and whether the action is
properly a class action. The issue on the certification stage is not whether
the plaintiffs’ claim is likely to succeed: Hollick v. Toronto City,
[2001] 3 S.C.R. 158, 2001 SCC 68 at para. 16.

[11]        
There is no automatic right to document discovery at the certification
stage and a party seeking such discovery must demonstrate the need for it. In Pro-Sys
Consultants Ltd. v. Microsoft Corp., 2007 BCSC 1663, at paras. 23-25,
Myers J. stated:

In Mathews v. Servier Canada Inc. (1999), 65 B.C.L.R.
(3d) 348, [1999] B.C.J. No. 435 (S.C.) [Matthews cited to B.C.L.R.],
Edwards J. stated at pp. 349-350:

The question of whether document
discovery should be permitted before certification was addressed earlier in
this case and in Endean v. Canadian Red Cross Society, [1997] B.C.J.
No. 295 (February 6, 1997) Doc. Vancouver C965349 (B.C.S.C.). Document
discovery, if ordered before certification in a case such as this where it will
be an enormous task for the defendants to produce all potentially relevant
documents will not be ordered automatically. The plaintiff will be required to
show discovery of documents is necessary in order to inform the certification
process.

This could lead to a “chicken and
egg” debate over which comes first, but unless a plausible basis for requiring
extensive pre-certification document discovery is demonstrated, there is a risk
that a requirement to make full disclosure before certification will be so
onerous it will amount to an unfair imposition on defendants and potential
settlement tool in the hands of a plaintiff who may not have a certifiable
class action.

That analysis was adopted by Bauman J. in Samos
Investments Inc. v. Pattison, 2001 BCSC 440, [2001] B.C.J. No. 578. It is
also consistent with the approach taken in other jurisdictions. See Murray
v. Alberta (Minister of Health), 2007 ABQB 231, 76 Alta. L.R. (4th) 118 and
Pardy v. Bayer Inc., 2003 NLSCTD 130, 230 Nfld. and P.E.I.R. 325.

I, too, would adopt that approach.
It appears to me that at the certification stage of a class proceeding, a party
must justify the need for document disclosure. It must show that the
sought-after documents would inform the certification process. I do not say the
onus is a high one: that is not an issue I need address because I do not
think the plaintiffs have even met a low threshold here.

[12]        
Two recent decisions of this Court have considered applications for
pre-certification production of the proposed representative plaintiffs’ medical
records. Both thoroughly reviewed the applicable case law from across Canada,
but came to opposite conclusions on the facts of each case. The governing
principles were summarized by Gropper J. in Stanway v. Wyeth Canada,
2010 BCSC 1497, at para. 21:

The principles thus derived are:

1.   Precertification
disclosure is ordered in the exceptional case where the defendant demonstrates
that the record before the court for the certification hearing will be
inadequate for consideration of the issues at that stage of the proceedings.

2.   In
considering whether an order for disclosure ought to be made the court must
address the goals of judicial economy, access to justice, and behaviour
modification.

3.   It can be
assumed that each individual’s medical record will be unique. However, the
medical evidence suggesting the significance of the individual factors of those
who may have been prescribed and ingested the prescription drug may be
necessary to furnish the evidentiary record;

and specifically in British Columbia,

5.   There is no
right to examine the representative plaintiff or other affiants in British
Columbia; an order of the court is required.

6.   In British Columbia, in accordance
with the Act, the court must consider whether the claims of the class members
raise common issues, whether or not those common issues predominate over issues
affecting only individual members, and whether questions of fact or law common
to the members of the class predominate over any questions affecting only
individual members.

[13]        
The proposed common issues in Stanway dealt with an alleged
causal link between certain medications and breast cancer. The medical evidence
identified a wide range of individual risk factors for breast cancer and
suggested that treatment decisions may be highly individualized in each case. Gropper J.
held that it was “the exceptional case” where pre-certification disclosure of
medical records was required in order to determine the predominance of common
issues.

[14]        
The proposed common issues and proposed class here appear to be more
narrowly defined than in Stanway. This action focuses on the use of the
drug during a defined, relatively brief period of time (pregnancy) and alleges
a close temporal connection between that use and the time the alleged injury
occurred or became manifest (at or near the time of birth.)

[15]        
I also note that, subsequent to this application being argued,
Gropper J. has given reasons for judgment on certification in Stanway
v. Wyeth Canada Inc., 2011 BCSC 1057. Although production of medical
records had been ordered, evidence from those records does not appear to have
played a significant role in the certification hearing. Only one of 82
paragraphs in the judgment refers to a submission based on the records and
Gropper J. did not accept that submission.

[16]        
In Jones, which was decided the day before Stanway was argued,
Loo J. denied the defendant’s application for production of medical
records prior to certification. Jones concerned an allegedly defective hip
implant. Loo J. referred (as did Gropper J. in Stanway) to Pardy
v. Bayer Inc., 2003 NLSCTD 130. In that case, which dealt with the alleged
adverse effects of a drug, the court said at paras. 47 and 48:

The Defendant contended that the medical records are relevant
to whether the Plaintiffs are in the classes proposed, whether the Plaintiffs
are representative and whether certification is warranted. The Defendant
challenged the class definition proposed by the Plaintiffs and argued that
factors such as the timing of prescriptions, the amount of prescribed dosages,
co-prescription of other drugs and the advice of the Plaintiffs’ physicians may
indicate that the only classes worthy of consideration would be too narrow to
warrant certification. The Defendant submitted that the Plaintiffs’ medical
records may provide information on these factors.

The medical records of the
Plaintiffs are clearly relevant to the merits of their individual claims but,
as noted above, the certification stage is not meant to determine the merits of
the action. Indeed the Court must be vigilant to ensure that the
certification application does not become mired down in the merits of an
individual claim. [Emphasis added]

[17]        
The defendants rely on an affidavit from Dr. Edward Lammer, a
paediatrician and medical geneticist, who says there are a large number of cardiovascular
malformations and abnormalities with a variety of causes:

Ms. Gibson’s daughter, [Meah], is stated to have been
both with a ventricular septal defect (“VSD”), a structural
cardiovascular condition that characterized by a hole in the wall that divides
the lower pumping chambers of the heart into right and left ventricles. There
are different types of VSDs characterized both by anatomic location of the
defect and its pathogenesis – i.e., its developmental origin. [Emphasis
in original.]

In addition to VSDs, there are
numerous other types of structural cardiovascular malformations as well as
functional cardiovascular abnormalities. While most structural malformations
have their genesis during the first trimester of pregnancy, functional
abnormalities may occur at any time during gestation, and even postnatally. In
addition, within the first trimester, there are different windows of
vulnerability during which the heart is susceptible to different types of
structural malformations.

[18]        
Dr. Lammer’s affidavit exhibits a copy of an opinion he provided
for use in a proposed Paxil class action in Saskatchewan, which did not proceed.
In that opinion, he states:

A causation determination is not
a “one size fits all” proposition. Rather, it is a determination that must be
made with defect and pathogenetic specificity. Consequently, before undertaking
an appropriate causation inquiry, it is imperative to have a precise clinical
diagnosis and phonotypic description for each child included in the purported
class. Without such phonotypic specificity, a valid causation hypothesis cannot
be formulated and a meaningful causation determination cannot be undertaken.

[19]        
Dr. Lammer reviewed records in the Saskatchewan case and says:

… Based on my review, I was
able to comment more specifically on: (i) the nature of each child’s birth
defect; (ii) individual genetic and other factors involved in their
etiology; and (iii) how, ultimately, these particular birth defects
related to and differed from the broad range of alleged conditions encompassed
by the class definition. The medical records also provided an effective context
for explaining the necessary scientific inquiries that would need to be
undertaken in assessing any possible connection between Paxil® use and the
alleged conditions.

[20]        
In my view, Dr. Lammer’s evidence serves to negate, rather than
support, the relevance of individual medical records at this stage of this
proceeding. I have no doubt that there are many different cardiovascular defects,
each of which may have a number of possible causes. The number and nature of
those variables and how they may affect the causation analysis in an individual
case may be an important factor to consider on the certification application
and the defendants may wish to present evidence, from Dr. Lammer or other
experts, on those matters. Such evidence would likely be based largely on
general medical principles, medical literature and perhaps the experts’ own
experience and research. In that context, I fail to see how the specific
condition and medical history of only one infant and one adult member of the
proposed class will either advance the defendants’ position or assist the
court.

[21]        
In conclusion, I am not persuaded that this is one of the exceptional cases
where pre-certification disclosure of medical records is necessary. Indeed, the
introduction of individual medical records at this stage would be more likely
to improperly confuse the issues on the certification action with a premature
consideration of the merits of an individual claim.

[22]        
The defendants’ application is dismissed.

“N.
Smith J.”