



COURT OF APPEAL FOR BRITISH
COLUMBIA




Citation:



Jones v. Zimmer GMBH,









2013 BCCA 21




Date: 20130122

Docket:
CA039378

Between:

Dennis Jones and
Susan Wilkinson

Respondents

(Plaintiffs)

And

Zimmer GMBH,
Zimmer, Inc., and Zimmer of Canada Limited

Appellants

(Defendants)




Before:



The Honourable Mr. Justice K. Smith





The Honourable Mr. Justice Chiasson





The Honourable Madam Justice Bennett




On appeal from: Supreme
Court of British Columbia, September 2, 2011
(
Jones v. Zimmer GMBH
, 2011 BCSC 1198, Vancouver Docket No. S095493)




Counsel for the Appellants:



A.D. Borrell

P. Pliszka





Counsel for the Respondents:



D.A. Klein

J.Z. Murray





Place and Date of Hearing:



Vancouver, British
  Columbia

May 29-30, 2012





Place and Date of Judgment:



Vancouver, British Columbia

January 22, 2013









Written Reasons by:





The Honourable Mr. Justice K. Smith





Concurred in by:





The Honourable Mr. Justice Chiasson

The Honourable Madam Justice Bennett








Reasons
for Judgment of the Honourable Mr. Justice K. Smith:

[1]

This appeal is from an order made by the Honourable Mr. Justice Bowden
of the Supreme Court of British Columbia pursuant to the
Class Proceedings
Act
, R.S.B.C. 1996, c. 50, certifying the underlying product liability
action as a class proceeding and appointing the respondent Susan Wilkinson as
representative plaintiff for [a]ll persons who were implanted with the Durom acetabular
hip implant in Canada.

[2]

The appellants (nothing turns on their separate corporate identities)
manufacture and distribute a hip implant known as the Durom Cup, which is intended
to adhere, without cement, to the surrounding bone as it grows during recovery
from hip implant surgery. The respondents received Durom Cup implants in 2008.
Each subsequently experienced pain and disability and had revision surgery to
have the Durom Cup removed. In each case it appeared during the revision
surgery that the Durom Cups had failed to adhere properly to the surrounding
bone. The respondents claim damages for alleged negligence in the research,
development, testing, manufacture, distribution, and sale of the Durom Cup and,
as well, declaratory and injunctive relief, damages, and statutory compensation
pursuant to the
Business Practices and Consumer Protection Act
, S.B.C.
2004, c. 2 for alleged deceptive acts and practices.

[3]

The appellants contend the certification judge erred in certifying the
following questions for trial as common issues:

(a)      Was the Durom acetabular hip
implant defective and/or unfit for its intended use?

(b)      With respect to British Columbia
residents, did any of the defendants breach a statutory duty under the
Business
Practices and Consumer Protection Act
owed to class members who received
the Durom acetabular hip implant in British Columbia and, if so, when and how?

The judge also certified the questions Did any of the
defendants breach a duty of care owed to class members and, if so, when and
how? and Does the defendants conduct warrant an award of punitive damages,
and, if so, to whom should they be paid and in what amount? as common issues.
It is not disputed that these questions can go forward as common issues if the impugned
questions can properly do so.

[4]

To be a common issue, an issue must be a substantial and necessary
ingredient of the claim of each member of the class:
Hollick

v.
Toronto (City)
, 2001 SCC 68 at para. 18, [2001] 3 S.C.R. 158. It need
not be determinative of liability: rather, it will be sufficient if it is an
issue of fact or law common to all claims and if its resolution will move the litigation
forward:
Campbell v. Flexwatt Corp.
(1997), 44 B.C.L.R. (3d) 343 at
para. 53, 98 B.C.A.C. 22, leave to appeal refd [1998] S.C.C.A. No. 13.

[5]

The proper approach to be taken by the judge hearing a certification
application is summarized in
Pro-Sys Consultants Ltd. v. Infineon
Technologies AG
, 2009 BCCA 503 at paras. 64-65, 312 D.L.R. (4th) 419,
leave to appeal refd [2010] S.C.C.A. 32:

[64]      The provisions of the [
Class Proceedings Act
]
should be construed generously in order to achieve its objects: judicial
economy (by combining similar actions and avoiding unnecessary duplication in
fact-finding and legal analysis); access to justice (by spreading litigation
costs over a large number of plaintiffs, thereby making economical the
prosecution of otherwise unaffordable claims); and behaviour modification (by
deterring wrongdoers and potential wrongdoers through disabusing them of the
assumption that minor but widespread harm will not result in litigation):
Western
Canadian Shopping Centres Inc. v. Dutton
, 2001 SCC 46, [2001] 2 S.C.R. 534
at paras. 26-29 [
Western Canadian Shopping Centres
];
Hollick

v.
Toronto (City)
, 2001 SCC 68, [2001] 3 S.C.R. 158 at para. 15 [
Hollick
].

[65]      The certification hearing does not involve an
assessment of the merits of the claim; rather, it focuses on the form of the
action in order to determine whether the action can appropriately go forward as
a class proceeding:
Hollick
at para. 16.  The burden is on the
plaintiff to show some basis in fact for each of the certification
requirements, other than the requirement that the pleading disclose a cause of
action:
Hollick
, at para. 25.  However, in conformity with
the liberal and purposive approach to certification, the evidentiary burden is
not an onerous one  it requires only a minimum evidentiary basis:
Hollick
,
at paras. 21, 24-25;
Stewart v. General Motors of Canada Ltd.
, [2007]
O.J. No. 2319 (S.C.J.) at para. 19.  As stated in
Cloud v. Canada
(Attorney General)
(2004), 247 D.L.R. (4th) 667 at para. 50, 73 O.R. (3d)
401 (C.A.), leave to appeal refd [2005] S.C.C.A. No. 50 [
Cloud
],

[O]n a certification motion the court is ill equipped to
resolve conflicts in the evidence or to engage in finely calibrated assessments
of evidentiary weight. What it must find is some basis in fact for the
certification requirement in issue.

[6]

The appellants submit the impugned questions are not common issues as
that phrase has been defined, that the certification judge relied on irrelevant
and inadmissible evidence, and that no basis in fact was established to
support these questions as common issues. For the reasons that follow, I would
reject these submissions and dismiss the appeal.

The Respondents Claim

[7]

In their statement of claim, the respondents alleged that the Durom Cup
was defective in that it fails to properly heal or adhere to the surrounding
bone: that it remains loose or separates from the bone causing the patient
pain and necessitating further hip surgery. They pleaded that the appellants
were negligent in the research, development, testing, manufacture, distribution
and sale of the Durom Cup; that they failed to ensure it was effective in
adhering to bone before marketing it; that they failed to monitor its safety
after marketing it; and that they failed to warn the respondents, class
members, their health care providers, and Health Canada (the responsible
federal regulator) of the problems with the Cup. Further, they alleged these acts
and omissions were breaches of the requirements of the
Medical Devices
Regulations
, S.O.R./98-282.

[8]

The respondents also pleaded that they received Durom Cup implants (Mr. Jones
in January 2008 and Ms. Wilkinson in April 2008), that the implants
failed, that Mr. Jones had further surgery in May 2009 in which the Durom
Cup was removed and replaced with a new implant, that Ms. Wilkinson was on
the waiting list for similar surgery, and that both experienced pain and
suffering and other damage as a result of the failures.

[9]

The relevant provisions in respect of the respondents statutory claims are
set out in s. 4 of the
Business Practices and Consumer Protection Act
:

4
(1) In this
Division:

deceptive act or practice
means,
in relation to a consumer transaction,

(a) an
oral, written, visual, descriptive or other representation by a supplier, or

(b) any
conduct by a supplier

that has the capability, tendency or effect of deceiving or
misleading a consumer or guarantor;

representation

includes
any term or form of a contract, notice or other document used or relied on by a
supplier in connection with a consumer transaction.

...

(3) Without limiting subsection
(1), one or more of the following constitutes a deceptive act or practice:

...

(b) a representation by a
supplier

vi)  that uses exaggeration, innuendo or ambiguity about
a material fact or that fails to state a material fact, if the effect is
misleading ....

[10]

The respondents pleaded, and it was not disputed, that the appellants and
respondents were suppliers and consumers respectively and that they were engaged
in consumer transactions. The respondents alleged deceptive and misleading acts
and omissions by the appellants as follows:

27.       The Defendants conduct in their solicitations,
offers, advertisements, promotions, sales and supply of the Product, as
particularized above, had the capability, tendency or effect of deceiving or
misleading consumers regarding the safety and efficacy of the Product. The
Defendants conduct in its solicitations, offers, advertisements, promotions,
sales and supply of the Product were deceptive acts and practices contrary to
s.4 of the BPCPA. The Defendants deceptive acts and practices include the
Defendants failure to properly disclose all material facts regarding the
safety and efficacy of the Product.

28.       Further, in their
marketing brochures, promotional materials, and website directed both to
consumers and their physicians, the Defendants made representations concerning
the efficacy of the Product, including a description of studies that suggested
that the Product had a success rate of up to 99%. In reality, the Products
failure rate is unreasonably high compared to other, available implants. The
Defendants knew or ought to have known that their marketing claims regarding
the Product were inaccurate, incomplete or misleading, and that the Product had
an unreasonably high failure rate. Such marketing claims were deceptive and had
the tendency, capability or effect of misleading consumers and their
physicians.

The Evidence

[11]

The respondents and Gloria McSherry, the proposed representative
plaintiff in a parallel action in Ontario, gave evidence by affidavit that they
received Durom Cup hip implants in January 2008, April 2008, and August 2007
respectively. All said they subsequently suffered debilitating pain in the
region of their replaced hip, and that they had surgery to remove and replace
the Durom Cup in May 2009, October 2009, and June 2010 respectively. Mr. Jones
surgeon said, in his operative note, that the Durom Cup was tapped and easily
removed showing no bony ingrowth in any area. Ms. Wilkinson deposed that
she was awake and aware during her replacement surgery and remembers the Durom
Cup popping out merely with the force of her surgeons hand. Ms. McSherrys
surgeon said, in his operative note, Durom cup appeared to be solid but
following removal there was no bone ingrowth on cup.

[12]

In April 2008, an American orthopaedic surgeon published a letter he
wrote to his colleagues in the American Association of Hip and Knee Surgeons
advising of several Durom Cup failures among his patients.  As a result, the
appellants undertook an investigation and, on July 22, 2008, they issued
an Urgent Device Correction letter to U.S. surgeons to whom they had supplied
Durom Cups. In the letter, they attributed the failures to the surgical
techniques used by the doctors and disclaimed any defect in the Durom Cup. The
letter said their investigation led them to conclude that additional surgical
technique instructions and training are necessary for surgeons in the U.S. and
strongly recommended that U.S. surgeons stop implanting the
Durom
Cup until
receiving such training. The letter announced that the appellants would
suspend marketing and distribution of the Durom Cup in the U.S. while we
update product labeling to provide more detailed surgical technique
instructions and implement a surgical training program for U.S. surgeons. It
added that they had found [n]o evidence of a defect in the materials,
manufacture, or design of the Durom Cup. The letter also stated the appellants
would be developing a comprehensive surgical skills training curriculum,
working with experts in the U.S. and in Europe and that the Cup would be made
available to surgeons as they complete training.

[13]

Also on July 22, 2008, the appellants published a press release
announcing the suspension of marketing and distribution of the Durom Cup in the
U.S. and adding that it would continue to be marketed outside the U.S.,
including in Canada where it had been made available in 2003. The press release
contained this passage:

Data from clinical trials
sponsored by Zimmer and conducted outside the U.S. have demonstrated no
revisions with the
Durom
Cup in 386 cases, after two to seven years of
follow-up. In addition, the Swedish Registry, an independent total joint
registry, reports a 99.5 percent survivorship with the
Durom
Cup (222
patients with three-year follow-up).

[14]

In a letter of October 3, 2008 to Canadian Durom Cup users, the
appellants described their U.S. investigation and stated that because
substantial surgeon training for the
Durom
Cup has been offered in
Canada since the system ... was launched, and because the reported clinical
results for the
Durom
Cup in Canada have been excellent, Zimmer
determined that no suspension of marketing in Canada is required. The letter noted
that, over the next several weeks, they would provide updated Instructions For
Use ... commonly called package inserts or product labeling, as well as updated
surgical techniques that will include more detailed surgical technique
instructions in Canada, as has already been done in the US.

[15]

One year later, in response to reports of Durom Cup implant failures in
Europe, the appellants issued an Urgent Field Safety Notice to surgeons using
the Durom Cup in Europe. The notice, dated October 13, 2009, stated that
the most probable root cause of the failures was the use of incorrect surgical
technique and advised that additional training was required and that the
surgeons would receive updated written surgical techniques, a training DVD,
and knowledge checks to be completed before they could obtain further supply
of the Cup.

[16]

On November 9, 2009, the appellants sent a letter to Canadian user surgeons
in which they advised of the reports of revision surgeries in Europe involving
loose Durom Cups. The letter stated that the most probable root cause for the
reported revisions for loose acetabular cups is using a surgical technique
which differs from that prescribed in the surgical technique for the
Durom
Acetabular
cup. They enclosed updated surgical techniques, the training DVD, and the
knowledge-check questionnaire, and said Canadian surgeons would not be
supplied with further Durom Cups until they certified to the appellants that
they had reviewed and understood the updated instructions and the DVD and had
completed the knowledge-check questions.

[17]

Also enclosed with the letter of November 9 was an Urgent Field Safety
Notice to Canadian surgeons, which the appellants delivered concurrently to
Health Canada and which was subsequently published by Health Canada on December 7,
2009. The notice advised that the appellants had concluded that the most
probable root cause of the reported failures in Europe was deficient surgical
technique. This document fell within the definition of a recall in s. 1
of the
Medical Devices Regulations
(enacted pursuant to the
Food and
Drugs Act
, R.S.C. 1985, c. F-27) and as such it was posted on Health Canadas
Medical Device Recall List from October 2009 to December 2009.

[18]

The appellants were required to deliver Medical Devices Problem
Reports to Health Canada in respect of all Canadian revision surgeries. As of September 1,
2010, there had been 33 such reports delivered since March 2008 and others were
in process. Nineteen of these reports described patient pain in the hip and
groin area and eleven referred to Cup loosening and/or absence of bone
ingrowth.

[19]

Also in evidence was an excerpt from a Correction and Removal Report
dated July 31, 2008 submitted by the appellants to the U.S. Food and Drug
Administration. The accompanying letter advised the FDA that the appellants had
received some reports of persistent post-operative pain, dislocation, and
loosening of the acetabular implant leading to revision surgery and said the
purpose of the submission was to report their corrective actions. Included in
the report was a table listing 51 revision surgeries reported in Medical Device
Reports filed between March 16, 2006 and July 15, 2008, of which 45
reported pain, loosening, and/or lack of bone ingrowth as the reason for the
revision.

[20]

The respondents placed in evidence the expert opinion of Dr. Nizar
Mahomed, an orthopaedic surgeon with extensive experience in adult hip and knee
replacement surgeries. His qualifications were not challenged by the
appellants. Dr. Mahomed stated he had reviewed the Urgent Device
Correction sent by the appellants in July 2008 to American orthopaedic
surgeons (described in paragraph 12 above); a published medical article by Long
et al, Failure of the Durom Metasul Acetabular Component, Clin Orthop Relat
Res (2010) 468:400-405; the Urgent Field Safety Notice dated October 13,
2009 sent by the appellants to European orthopaedic surgeons (described in
paragraph 15 above); and the recall listing on Health Canadas website
indicating a recall for the Durom Cup posted December 7, 2009 (described
in paragraph 17 above), copies of all of which he attached to his opinion.

[21]

Dr. Mahomed opined,

Based on the information in these four documents including
the excellent peer reviewed published article by Long et al about the
performance of the Zimmer Durom Cup, there is clear concern about the clinical
performance of this device in the clinical situation. The failure rates
reported by Long et al are quite concerning and clearly not in keeping with
what would be expected for the clinical performance of an average total hip
replacement device.

The revision rates quoted in the
paper, as well as in Zimmers own documents to surgeons in the United States
would quote revisio[n] rates ranging from 1 to 15% at one to two years post
surgery; this failure rate is far in excess of what would be expected in the
performance of an average hip replacement done at this point in time.

[22]

In reference to the respondents emphasis on surgical technique as the
cause of the failures, Dr. Mahomed opined as follows:

The documents provided point toward surgical technique as the
cause of failure for the implants. In the materials provided, including the
materials Zimmer United States to the Zimmer Orthopaedic Surgeons, the
technique described in that document is not significantly different than what
would be described for insertion of a standard uncemented acetabular component.
The articles from Long et al highlights the issues of difficulty in adequate
insertion and fixation of this device, given its unique geometric construct,
particularly the fact that this is not a hemispherical cup but it has multiple
radii of curvature making fixations and insertion technically much more
demanding and challenging. Given this scenario, it would in my opinion, be the
manufacture[rs] responsibility to provide adequate information and training to
surgeons who choose to use this device, in order to obtain optimal clinical
performance. Given the unique geometric design of this implant, it would be the
manufacturers responsibility to highlight changes in surgical technique over
the standard technique most surgeons would employ to insert an uncemented
acetabular component.

Furthermore, as Zimmer in the US
moved towards requiring surgeons to complete adequate training prior to further
distribution of their implant. This strategy should have been implemented by
the manufacturer before allowing clinical use of the device from the outset
given the change in decision philosophy of this device.

[23]

In response, the appellants filed the opinion of Dr. Etienne
Belzile, also a well-qualified orthopaedic surgeon with extensive experience in
hip replacements, including replacements done with the Durom Cup. Dr. Belzile
disagreed with Dr. Mahomeds opinion. In his view, revisions of the Durom
Cup implants would have been dependent on a number of individualized factors
unique to each patient. Further, he said, acetabular cups like the Durom Cup
can become loose for a variety of reasons having nothing to do with the device
itself, including the patients post-operative care and activities. Relying on
information provided by the appellants, he derived a reported revision rate for
Canadian Durom Cup recipients of 0.67% which, in his opinion, was very low
and does not present a cause for concern about the safety and effectiveness of
this device as used in Canada. He opined that no one could state, to a reasonable
degree of medical certainty, that these 33 patients shared a common clinical experience.
On reviewing the affidavit evidence given by the respondents, he concluded it
could not be said to a reasonable degree of medical certainty that they shared
a common clinical experience. He observed that it appeared to him that Dr. Mahomed
has no actual clinical experience with the Durom Cup and that his conclusions
were based on a review of events in the U.S. without reference to the Canadian
clinical experience. Dr. Belzile said it appeared to him the revision
rates in Europe and the U.S. were quite different and not analogous to the
Canadian revision rate. He stated that Dr. Mahomeds opinion ignores the
plethora of reasons that any implantable medical device, including the Durom
Cup, might fail.

[24]

Dr. Mahomed replied. He said personal experience with the Durom Cup
does not have a meaningful bearing on the matter since there are established
clinical standards for implants in the published literature. He acknowledged
there are multiple reasons for requiring hip replacement surgery, but said the
majority of Durom Cup failures

are occurring due to significant
or persistent pain as a result of implantation of this device and this failure
is not the common mode for revision hip surgery in the short post-operative
follow-up period as is the case that has been reported for Durom cup.

He added it was not reasonable to imply that patient outcome
is dependent on post-operative care and activity since established clinical
expectations of performance for such a hip implant would not require specific
special precautions. He said that since the clinical design and recommendations
for use of the Durom Cup are materially the same in all jurisdictions, the
lower Canadian reporting rate of failure may represent under-reporting rather
than a unique clinical performance of the Durom Cup in Canada versus the United
States. He repeated his opinion that the early failure rate is a matter of
clinical concern and added, [e]ven if there were only a relatively small
number of failures in Canada, as is suggested in Dr. Belziles report,
this would still be cause for concern and the failures of the Durom cup
reported in the literature are fundamental to how the device is supposed to
function.

The Certification Decision

[25]

The certification judge correctly noted that the burden on the
respondents to show some basis in fact to support the proposed common issues
was not an onerous one. He concluded the burden had been met. He said the
evidence given by Mr. Jones, Ms. Wilkinson, and Ms. McSherry
raises the question of the cause of the failure of the Durom Cup to attach
itself to the bone or what is described as the lack of ingrowth. He referred
to the evidence of at least 33 failures of Durom Cup implants in Canada and
observed that the appellants evidence of the number of suspected failures in
Canada did not correspond with the experience in the U.S. and Europe even
though the clinical design and recommendations for use of the Durom Cup are
materially the same in all jurisdictions. He mentioned the appellants July
2008 suspension of marketing and distribution of the Cup in the U.S. because of
elevated revision rates and the appellants announced conclusion that
additional instructions and training in surgical technique were necessary. He
referred to the similar events in Europe and the Safety notices issued by the
appellants in Europe and in Canada in the fall of 2009. As well, he noted that
the Urgent Safety Notice sent to Health Canada that identified inappropriate
surgical technique as the most probable root cause of the failures was not
conclusive of the cause and that the appellants notices made it clear that
the surgical techniques in use had to be reviewed as they appear to have been
defective. Further, he found that the appellants warning letter to Canadian
surgeons was a recall of the Durom Cup within the regulatory definition of
that word. He concluded, echoing the opinion of Dr. Mahomed, that there
is a clear concern about the performance of the Durom Cup in clinical
situtations.

[26]

The certification judge rejected the appellants submission that,
because each implant failure was unique with a multitude of possible causes and
because causation must be determined on a patient-by-patient basis, the defect
question was not a common issue for all class members. He quoted
Harrington
v. Dow Corning Corp.
, 2000 BCCA 605 at paras. 42-46, 82 B.C.L.R. (3d)
1, leave to appeal refd [2001] S.C.C.A. No. 21, to point out that the
determination of individual causation and damages is the
last
step in a
product liability action.

[27]

As for the sufficiency of the evidence of some basis in fact, he mentioned
the difficulty faced by the respondents in showing a defect at the
certification stage when they had not yet had any discovery from the appellants
of the relevant aspects of the design and intended function of the Durom Cup, which
he described as a highly technical medical device, and observed that it is
difficult to see how the plaintiffs could present any more evidence than they
have done at this Chambers hearing in support of their allegation that the
Durom Cup was defective.

[28]

The certification judge referred to the conflicting expert opinions and
said he did not have to resolve the conflict because the certification decision
was not a decision on the merits. In this regard, he referred to
Chalmers v.
AMO Canada Company
, 2009 BCSC 689 at para. 17, 178 A.C.W.S. (3d) 313,
affd 2010 BCCA 560, 297 B.C.A.C. 186.

[29]

Accordingly, he concluded that whether the Durom Cup was defective or
unfit for its intended use was a question common to the claims of all class
members and that the determination of this question would move the litigation
along.

[30]

Next, the certification judge concluded that whether the appellants breached
a duty of care owed was a question common to all class members and did not
depend on their individual evidence. He observed, as I understand his reasons,
that whether the appellants owed a duty to warn regarding deficiencies in the
surgical technique originally recommended by them as soon as that was
discovered by them would be subsumed in this question.

[31]

As for the statutory claim, the certification judge began by summarizing
the appellants position that there was no evidence of any representation ever
made to the respondents or to any class member and no evidence that any class
member suffered loss or damage as a result of any representation. As well, he
noted the respondents position that the
Business Practices and Consumer
Protection Act
addresses conduct and representations by a supplier to the
world at large in the marketing of its products, rather than to individual
consumers.

[32]

He accepted the respondents submission, adopting a passage from
Wakelam
v. Johnson & Johnson
, 2009 BCSC 839 at para. 39, 179 A.C.W.S. (3d)
809, in which the Court said whether a representation was deceptive or
misleading does not depend on an individual inquiry but can be litigated
without reference to the circumstances of the representative plaintiff or
individual class members.

[33]

He added that the respondents claim was also based on the appellants
failure to state a material fact. In this regard, he noted that the appellants
did not publish the Field Safety Notification in Canada until December 7,
2009, while they had suspended marketing and distribution in the U.S. in July
2008 and had issued an Urgent Safety Notice in Europe in October 2009, and
that it remained to be determined how many failed Durom Cups had been implanted
in Canadian residents during that intervening period of time.

Discussion

[34]

The appellants submit the certification judge failed to appreciate that
whether the Durom Cup was defective and/or unfit for its intended use could not
be certified as a common issue unless there was some evidence that the cause of
the failures in Canada was a defect in the Cup and some evidence that these defects
were common across the class. They note that the respondents pleaded the Cup
was defective because it failed to adhere to the surrounding bone but did not plead
any causal connection between this outcome and any particular defect. In their
submission, it should have been fatal to the certification application that
there was no evidence before the certification judge of any specific defect or
of any causal relationship between such a defect and the Canadian hip implant
revisions identified in the evidence.

[35]

Similarly, the appellants contend there was no evidence of any
particular deficiency in their initially-recommended surgical technique and no
evidence of any causal relationship between any such deficiency and the failed Canadian
implants.

[36]

In order to establish liability in negligence, each class member must
ultimately prove that a specific defect in the Durom Cup or deficiency in the
surgical instructions was a cause of the failure of his or her hip implant.
However, proof of a causal connection between a defect or deficiency and an
individual plaintiffs failed implant is, along with damages, the final step in
a product liability action:
Harrington
at para. 46. Causation and
damages are individual issues, but proof of a defect in the Cup or a deficiency
in the surgical instructions is a substantial and necessary factual link in the
chain of proof leading to liability for every member of the class. One or more
of the respondents allegations of defects and deficiencies must be proven
before the question of individual causation can be reached. It follows that
proof of a defect in the cup or a deficiency in the surgical instructions is an
issue common to all plaintiffs, the resolution of which will move the
litigation along significantly. Accordingly, I would reject the submission that
the chambers judge erred in certifying question (a) as a common issue without
evidence of a specific defect or deficiency and without evidence that specific
defects or deficiencies were common to the failed implants of all class
members.

[37]

Next, the appellants contend the respondents failed to establish some
basis in fact for certification of the common issues.

[38]

First, in the appellants submission, the evidence of events in the U.S.
and Europe and of their responses to these events was irrelevant and the
certification judge erred in relying on it. They say their investigations
established that the problem in both instances was surgical technique rather
than anything to do with the Durom Cup itself. They note that there was no
evidence that any Canadian surgeons were not employing proper surgical
techniques and emphasize their evidence that the updated instructions to
Canadian surgeons were merely precautionary. Thus, they argue, the evidence
of events in the other jurisdictions lacked any nexus to Canada that would make
such evidence relevant on the certification application.

[39]

I am unable to accept this submission.

[40]

To be admissible, evidence must be relevant. In
Anderson v. Maple
Ridge (District)
(1992), 71 B.C.L.R. (2d) 68 at para. 17, [1993] 1
W.W.R. 172 (C.A.), Mr. Justice Wood (as he then was), writing for the
Court, described relevance as follows:

Evidence is relevant if it is
logically probative of either a fact in issue or a fact which itself is
probative of a fact in issue. Evidence which tends to make the existence of a
fact in issue either more or less probable is logically probative of that fact:
see Stephen,
A Digest of the Law of Evidence
, 12th ed. (London:
MacMillan & Co., 1948), art. 1;
Cross on Evidence
, 7th ed. (London:
Butterworths, 1990), p. 51; Thayer,
A Preliminary Treatise on Evidence at
the Common Law
(Boston: Little, Brown & Co.,1898), pp. 264-65.

See also, to the same effect,
R. v. Watson
(1996), 108 C.C.C. (3d) 310 at 323-24, 30 O.R. (3d) 161 (C.A.):

Relevance as explained in these
authorities requires a determination of whether as a matter of human experience
and logic the existence of 
Fact
A makes the existence or non-existence of Fact B more
probable than it would be without the existence of 
Fact
A. If it does then 
Fact
A is relevant to Fact B. As long as Fact B is itself a
material fact in issue or is relevant to a material fact in issue in the
litigation then 
Fact
A is
relevant and
prima facie
admissible.

[41]

Here, the fact in issue is that the failure of the Durom Cup implants
received by class members resulted from a defect in the Cup or a deficiency in
the surgical instructions for which the appellants are responsible. It is not
disputed that the Durom Cup was intended to adhere to the surrounding bone
following implant surgery. Therefore, evidence that it failed to do so in a
particular case is, as a matter of human experience and logic, circumstantial
evidence that is probative of the fact in issue.
Where
the implants
failed because the Cup did not adhere to the bone is immaterial.
That
the implants failed because the Cup did not adhere to the bone is relevant
because that fact makes it more probable than it would otherwise be that the
failures were a result of the appellants alleged delicts.

[42]

Similarly, evidence that the clinical design of the Cup and the
recommended surgical technique were materially the same in the U.S., Europe,
and Canada, coupled with the evidence that the appellants suspended marketing
of the Cup in the U.S. because of elevated revision rates and determined that additional
training in surgical technique was necessary in the U.S. and Europe as a result
of the elevated revision rates, also provided relevant circumstantial evidence
in support of the respondents allegations.

[43]

Relevance is not to be confused with weight. The weight to be afforded
relevant evidence is for the trial judge to consider in adjudging the merits of
the case. The certification judge is not to assess the merits. Rather, the
certification judge needs only to be satisfied that there is a minimum
evidentiary basis for the common issue.

[44]

Accordingly, evidence of the events in the U.S. and Europe was relevant
and the certification judge did not err in admitting and considering it.

[45]

The appellants second evidentiary objection is that the certification
judge erred in admitting and relying on the opinion of Dr. Mahomed because
it was based on hearsay statements taken from the article by Long et al and was
therefore inadmissible.

[46]

The appellants rely for this contention on
Ernewein v. General Motors
of Canada Ltd.
, 2005 BCCA 540, 46 B.C.L.R. (4th) 234. Mr. Ernewein
claimed that certain vehicles manufactured by the defendant had been
negligently designed such that they created a risk of harm to consumers in the
event of side-impact collisions. In support of his application to certify the
action as a class proceeding, Mr. Ernewein filed an affidavit of a lawyer to
which was exhibited a report prepared by an agency of the U.S. government
following an investigation of the safety of the vehicles in side-impact
collisions. The report supported Mr. Erneweins case and the certification
judge relied on it in certifying the action. However, the report was offered in
evidence as proof of its contents without any authentication or any attempt to
prove by admissible evidence that the statements in the report were true or the
conclusions were reliable. This Court observed on appeal that information that
does not meet the usual criteria for admissibility of evidence is not admissible
for purposes of a certification hearing (at para. 31). Thus, the report
was adjudged hearsay and inadmissible as evidence of the truth of its contents.

[47]

In this case, however, the evidence on which the respondents relied was
the expert opinion of Dr. Mahomed. The Long article merely provided one of
the bases of Dr. Mahomeds opinion. It was not offered as proof in itself
of the truth of its contents. Accordingly,
Ernewein
is materially
different on its facts and is of no assistance to the appellants.

[48]

The criteria for admissibility of expert opinion evidence are that the
expert must be properly qualified, the opinion must be relevant to a fact in
issue, the opinion must be necessary to assist the trier of fact to draw a
correct inference when the subject matter is likely outside the knowledge and
experience of the trier of fact, and the opinion must not otherwise be excluded
by an exclusionary rule of evidence:
R. v. Mohan
, [1994] 2
S.C.R. 9 at 20-25. Dr. Mahomeds opinion satisfied these criteria and was
therefore admissible.

[49]

Dr. Mahomed did not express an opinion on the respondents
contentions that the Durom Cup was defective and that the surgical instructions
were deficient. These contentions go to the merits of the respondents claims
and, at the appropriate time, would call for an expert opinion to the standard
of a reasonable degree of medical certainty or its equivalent, the standard
to which Dr. Belzile adverted. Rather, Dr. Mahomeds opinion was that,
given the information he reviewed, including the Long article, there was reason
to be concerned about the efficacy of the Durom Cup and the surgical
instructions provided with it. Dr. Mahomed did not comment on the truth of
any of the statements made or on the quality of any opinion expressed or
conclusion reached in the Long article. He characterized the article as an
excellent peer reviewed published article and, as such, its publication was a
fact supporting his conclusion that there was reason for concern.

[50]

Moreover, even if Dr. Mahomeds opinion was based in part on
hearsay, that is no objection to its admissibility. Experts must as a matter of
practical necessity rely on second-hand source material for their opinions. Proponents
of expert opinions cannot be expected to prove independently the truth of what
the experts were taught by others during their education, training, and
experience or the truth of second-hand information of a type customarily and reasonably
relied upon by experts in the field. Accordingly, the degree to which an expert
opinion is based on hearsay evidence is a matter to be considered in assessing
the weight to be given the opinion:
R. v. Wilband
, [1967]
S.C.R. 14 at 21, [1967] 2 C.C.C. 6;
R. v. Lavallee
, [1990] 1
S.C.R. 852 at 896, 899-900, 55 C.C.C. (3d) 97.

[51]

Assessing the weight of the evidence was within the province of the
certification judge. This Court will not substitute its view of the weight of
the evidence and will not interfere with the certification judges assessment in
the absence of an error in principle or unless he was clearly wrong. In my
view, neither ground for interference was shown here.

[52]

Accordingly, I would not accede to the appellants submission that the
certification judge erred in admitting and relying upon Dr. Mahomeds
opinion.

[53]

Finally, the appellants submit the certification judge erred in
certifying the statutory common issue since there was no evidence that the
appellants committed any deceptive acts or engaged in any deceptive practices
in British Columbia. Clearly, the
Business Practices and Consumer Protection
Act
, a provincial statute, can have no application to deceptive acts and
practices occurring outside the territorial boundaries of this province.

[54]

The respondents allege the July 22, 2008 press release issued by
the appellants, which claims a 99.5 percent survivorship with the
Durom
Cup (222 patients with three-year follow-up) in Sweden, was deceptive and
misleading because, in Dr. Mahomeds opinion, the published revision rates
quoted in the Long paper and those set out in the appellants documents sent to
U.S. surgeons demonstrated a failure rate [that] is far in excess of what
would be expected in the performance of an average hip replacement done at this
point in time. However, there is nothing in the evidence to suggest that this
representation was published anywhere other than in the United States. The
respondents identify no similar statement made in British Columbia and I
therefore agree with the appellants that the respondents have shown no
deceptive or misleading statement that would be actionable under the statute.

[55]

However, the respondents point out that a representation under s. 4(3)(b)(vi)
includes a failure to state a material fact if the effect is misleading. The
certification judge found there was a basis in fact for the statutory common
issue on this ground. As I have already noted, he said the appellants did not
publish the Field Safety Notification in Canada until December 7, 2009,
while they had suspended marketing and distribution in the U.S. in July 2008
and had issued an Urgent Safety Notice in Europe in October 2009, and that it
remained to be determined how many failed Durom Cups had been implanted in
Canadian residents during that intervening period of time.

[56]

That a failure to state a material fact can ground a claim of deceptive
acts or practices under s. 4 has been confirmed since the hearing of this
appeal: see
Stanway v. Wyeth Canada Inc.
, 2012 BCCA 260 at para. 80,
34 B.C.L.R. (5th) 85.

[57]

The appellants also argue that the statutory common issue could not be
certified in the absence of some basis in fact that the respondents relied on
the alleged deceptive acts and practices. They cite a passage from
Loychuk
v. Cougar Mountain Adventures Ltd.
, 2012 BCCA 122 at paras. 59-60, 31
B.C.L.R. (5th) 23, in support of this argument. However,
Loychuk
was not
an action brought under the statute. Rather, the appellants, who were injured
in an accident on the respondents zip-line, claimed damages for the
respondents negligence and they invoked the statutory provisions in an attempt
to avoid the effect of liability waivers they had signed. In the passage in
question, the Court noted that the appellants could not resist the operation of
the waivers on the basis of allegedly deceptive statements unless they showed
they had relied on the statements. These remarks must be considered in their
particular context and they are of no assistance to the appellants for present
purposes. It may be that class members who claim compensatory damages pursuant
to the
Business Practices and Consumer Protection Act
will have to prove
reliance to recover them. However, that question does not arise at the
certification stage. All that is required at this stage is a common issue the
resolution of which will move the action along. I am satisfied that the
certification judge did not err in certifying the statutory common issue for
trial on that basis.

[58]

For the reasons I have set out, I would dismiss the appeal.

The Honourable Mr. Justice K. Smith

I agree:

The
Honourable Mr. Justice Chiasson

I agree:

The
Honourable Madam Justice Bennett


