IN THE SUPREME COURT OF BRITISH COLUMBIA

Date: 20140620

Docket: 10-3561

Registry:
Victoria

Between:

Estate of Wade Robert Player,
Desiree Marine Player, Estate of Daniel Charles
Pollock and Elaine Mills

Plaintiffs

And:

Janssen-Ortho Inc.,
Ranbaxy Pharmaceuticals Canada Inc.,
Ratiopharm Inc.,
Sandoz Canada Incorporated, and
Teva Canada Limited

Defendants

Before:
The Honourable Mr. Justice Bracken

Reasons for Judgment

INTRODUCTION

[1]            
In this proposed class action against five corporate defendants, two of
the defendants, Teva Canada Limited (“Teva”) and Sandoz Canada Incorporated
(“Sandoz”), seek an order dismissing the action against them on a summary trial
prior to a certification hearing.

[2]            
The claim in question involves transdermal fentanyl patches, a form of
prescription painkiller where the active opioid, fentanyl, is delivered by a
patch applied directly to the patient’s skin.  The defendants, including Teva
and Sandoz, manufacture, market and distribute transdermal fentanyl patches in
Canada.  The plaintiffs say that fentanyl patches are defectively designed,
such that they cause serious harm in ordinary use, and seek to certify a class
action against all of the defendants.

[3]            
For the reasons set out below, I find that this matter is suitable for
determination on summary trial.  Based on my conclusions of fact and law, the
action of the plaintiffs against Teva and Sandoz is dismissed.

BACKGROUND

The Plaintiffs

[4]            
Wade Robert Player died on August 10, 2007, at the age of 34.  Not long
before his death Mr. Player had suffered severe injuries in a motor vehicle
accident and as a result had a prescription for pain management via a
transdermal fentanyl patch.  He was wearing a fentanyl patch at the time of his
death, although there is some uncertainty as to the brand of patch Mr. Player
was using that day.  A coroner’s report concluded that Mr. Player died as a
result of fatal respiratory depression due to prescription drug interaction.  Desiree
Player is Mr. Player’s widow.

[5]            
Daniel Charles Pollock had a prescription for transdermal fentanyl
patches, which he used to treat chronic back pain.  He died on June 26, 2008,
at the age of 63.  The post-mortem examination determined that he died of acute
mixed/combined drug intoxication.  He had morphine, oxycodone, and fentanyl in
his system at the time of death.  Elaine Mills is his widow.

Litigation History

[6]            
On September 1, 2010, Ms. Player commenced an action against the
defendants on behalf of herself, her husband’s estate, and the proposed class.  Ms. Player
is the proposed representative plaintiff for the resident subclass, described
as all persons resident in British Columbia, including their estates, who used
fentanyl patches between December 20, 1991 to the date of certification and all
persons who assert a derivative claim on account of a family relationship to
the deceased.

[7]            
Ms. Mills joined the action on August 22, 2011, as the proposed
representative plaintiff for the non-resident subclass, which includes
residents of other Canadian provinces or territories.

[8]            
The plaintiffs then applied for certification of the matter as a class
action.  At the same time, Teva and Sandoz advised they wished to apply for an
order directing a summary trial of the claims against them pursuant to Rule 9-7
of the Supreme Court Civil Rules.  I held a sequencing hearing in order
to determine the order in which the applications should proceed.  In oral
reasons for judgment given on October 14, 2011, I ordered that the summary
trial could proceed prior to the certification hearing.

Basis for Summary Trial Application

[9]            
As noted above, all of the defendants in the proposed class action
manufacture, market and distribute transdermal fentanyl patches.  However,
according to the defendants, they actually manufacture two very distinct
products.  Teva and Sandoz both manufacture “matrix” drug-in-adhesive patches,
where the active drug is suspended in a semi-solid state in the adhesive of the
patch.  The other defendants manufacture “reservoir” style patches, which have
a reservoir of liquid/gel fentanyl that is released into the patient’s
bloodstream through a rate-controlling membrane.

[10]        
Teva and Sandoz in this application ask that the court dismiss the plaintiffs’
claims in respect of their particular transdermal fentanyl patch products.  They
say the plaintiffs’ claims are over-inclusive and that their matrix style
patches do not cause harm as alleged.

[11]        
The remaining defendants took no position on this application.  Although
counsel for Janssen-Ortho Inc. and Ranbaxy Pharmaceuticals Canada Inc. attended
as observers, only the plaintiffs and Teva and Sandoz participated in the
summary trial application.

Summary Trial or Summary Dismissal?

[12]        
At the hearing of this matter, the plaintiffs made an initial submission
that this process was not a summary trial but rather an application for
“summary dismissal”, which Mr. Merchant described as a type of summary judgment
where Teva and Sandoz were required to establish that “their product could not
have caused any harm.”

[13]        
Teva and Sandoz submit that the matter was clearly understood to be a
summary trial pursuant to Rule 9-7.  In fact, the plaintiffs themselves referred
to the process as a summary trial in an application for document discovery they
filed April 26, 2012.  It appears that as of that date, at least, they
understood that this matter would proceed pursuant to Rule 9-7, with the onus
and procedures as set by that Rule.  I agree with Teva and Sandoz that this
hearing was always intended and understood to be a summary trial of the
plaintiffs’ action against Teva and Sandoz, and I will proceed on that basis.

ISSUES

[14]        
The plaintiffs allege that transdermal fentanyl patches can cause
serious injuries in ordinary use, including respiratory depression and death.  They
say that there is a safer alternative design of patch available, and that as
such the defendants’ design is negligent.  Further, they say that the
defendants failed to warn consumers of the risks associated with use of their
products.  In this action brought under the Class Proceedings Act,
R.S.B.C. 1996, c. 50, they claim in negligence, negligent misrepresentation,
breach of warranty, and breach of fiduciary duty.  They also claim that, in
marketing and selling a defective product to consumers, the defendants are in
breach of the Food and Drugs Act, R.S.C 1985, c. F-27, the Competition
Act, R.S.C. 1985, c. C-34, the Sale of Goods Act, R.S.B.C. 1996, c.
410, and the Business Practices and Consumer Protection Act, S.B.C.
2004, c. 2.

[15]        
There are two preliminary issues that must be addressed prior to any
determination of the merits of these claims.  First, the court must determine
the correct scope of inquiry in a summary trial for a pre-certification class
proceeding.  As the parties have not yet gone to certification, there is no
“class” of litigants before the court.  Only the named plaintiffs are parties
to this matter at this point.  Generally speaking, in an individual action,
only facts relating to the named plaintiffs could be considered.  However, the
plaintiffs say that the status of this matter as a proposed class action
changes matters, and that the Court should consider the claims of the entire
proposed class.  Before proceeding, then, I must determine whether this court
should consider facts relating to potential class members, or only those
relating to the named plaintiffs.

[16]        
Second, the court must determine whether this matter is suitable for
determination by way of a summary trial.  The plaintiffs say it is not, on the
basis that a full trial is required for a full appreciation of the facts.  Teva
and Sandoz say that I can find the necessary facts in the evidence as tendered
and that it can be fairly and justly dealt with by way of a summary trial.

[17]        
If the matter is found suitable for summary trial, Teva and Sandoz
(collectively, the “applicant defendants”) request judgment on the following
issues:

1.       Are the
applicant defendants strictly liable to the plaintiffs?

2.       Did the
applicant defendants breach a duty of care to the plaintiffs by distributing a
product that was defectively designed?

3.       Did the
applicant defendants breach a duty of care to the plaintiffs by failing to
provide a reasonable warning of the risks associated with transdermal fentanyl
patches?

4.       Did the
applicant defendants make any negligent misrepresentation to the plaintiffs
with respect to the use of their transdermal fentanyl patch products?

5.       Did the
applicant defendants breach any express or implied warranty owed to the
plaintiffs in respect of their transdermal fentanyl patches, either at common
law or by operation of the Sale of Goods Act?

6.       Did the
applicant defendants owe a fiduciary duty to the plaintiffs, and, if so, did
they breach that duty?

7.       Did the
applicant defendants engage in any unlawful, unfair or deceptive trade
practices within the meaning of the Competition Act?

8.       Did the
applicant defendants make any false or misleading representations regarding
their transdermal fentanyl patch products, contrary to s. 9 of the Food and
Drugs Act?

9.       Did the
applicant defendants breach any of the provisions of the Business Practices
and Consumer Protection Act?

[18]        
I will begin by discussing the scope of inquiry in a pre-certification
class proceeding, as it is necessary to conclude that point before reviewing
the evidence.  For the reasons set out below, I have concluded that in British
Columbia, the Court should consider the facts applicable to the members of the
proposed class in addition to those concerning the individual plaintiffs.  With
that in mind, I will then review and assess the evidence presented by the
parties.  I then turn to the question of whether this matter is suitable for
summary determination.  Finally, I will apply the law to the facts I as I find
them following my review of the evidence.

SCOPE OF INQUIRY IN A PRE-CERTIFICATION CLASS
PROCEEDING

[19]        
In most Canadian provinces, a pre-certification class proceeding is
treated as an individual action:  see Ragoonan Estate v. Imperial Tobacco
Canada Ltd. (2000), 51 O.R. (3d) 603 (Sup. Ct. J.), and Hughes v.
Sunbeam Corp. (Canada) Ltd. (2002), 61 O.R. (3d) 433 (C.A.).  Those
decisions establish that there must be a representative plaintiff with a cause
of action against each defendant.  Where the named plaintiffs have no personal
or direct cause of action against a defendant, or the defendant can
successfully establish a defence to the individual plaintiff’s claim, the
action must be dismissed.

[20]        
That is not the case in British Columbia.  In MacKinnon v. Instaloans
Financial Solutions Centres (Kelowna) Ltd., 2004 BCCA 472 at para. 33, our
Court of Appeal said as follows:

I think it is also clear that an
action commenced under the Class Proceedings Act is, even before the
certification application, more than just “any old action”:  it is an action
with ambition.

[21]        
In MacKinnon the proposed class action involved allegations that
payday loan companies in the province were charging a criminal rate of
interest.  A number of the defendant companies applied to have the claims
against them struck out on the basis that they disclosed no cause of action, as
Mr. MacKinnon, the representative plaintiff, had only borrowed money from (and
thus only had a cause of action against) the other defendants.  The court
refused to dismiss the claim against the applicant defendants, concluding that
it was not necessary that the representative plaintiff have a cause of action
against each defendant:  “while the Act requires a cause of action against each
named defendant, that cause of action must be held by [potential] class
members, not necessarily the representative plaintiff” (para. 51).  An
application to strike a claim must be “considered in the context of its stated
ambition to be a class proceeding” (para. 38).

[22]        
Subsequent cases have applied the principles from MacKinnon in
the context of other rules of court.  In Birrell v. Providence Health Care
Society et al., 2006 BCSC 1814 at para. 9, aff’d 2009 BCCA 109, on an
application to add plaintiffs, both the chambers judge and the Court of Appeal took
into account the potential prejudice to the proposed class members if the court
refused the application.  The chambers judge commented that, following MacKinnon,
“a proposed class proceeding is subject to the ordinary Rules of Court,
but those rules are to be applied in the context of considering its potential
future as a class action” (para. 9).  The Court of Appeal held that
although the ultimate limitation period had expired for the proposed
representative plaintiffs in their claim against the hospital defendants, they
should still be added “as parties to the class action … in order to preserve
any cause of action members of the putative class may have that is not
time-barred against the hospitals” (para. 29).

[23]        
The plaintiffs in this case submit that MacKinnon applies to
alter the ordinary approach to summary trials under Rule 9-7.  They say that
the court cannot narrow its evidentiary focus to the circumstances surrounding
the deaths of the named plaintiffs, but must instead consider the claims of the
proposed class as a whole.

[24]        
In Alberta, when this same issue arose, the court held that the chambers
judge did “not have to engage in an investigation into possible worlds which
might contain class members whose claims might not be proscribed.  We need only
consider the facts of these two [named] Plaintiffs” (Kowch v. Gibraltar
Mortgage Ltd., 2013 ABQB 317 at para. 45).  Alberta does not follow the MacKinnon
line of authority, however.  I think the situation here must be different.

[25]        
It is clear that in British Columbia, a pre-certification class
proceeding cannot be dismissed solely on the basis that the representative
plaintiff does not have a claim against any particular defendant.  In my view, on
that basis, the plaintiff is correct to say that the court on this summary
trial hearing must go beyond the evidence relating to the claims of the
individual plaintiffs, and consider any properly admissible evidence relating
to the claims of potential class members.  This could take the form of evidence
from proposed class members themselves, or expert opinion evidence establishing
that Teva or Sandoz’s products are defective in their design and thus in breach
of a duty of care to Canadian consumers.

[26]        
A summary trial pursuant to Rule 9-7 is a true trial of the action, in
the sense that “judgment may be granted in favour of any party, regardless of
which party has brought the application,” so long as the court concludes that
it can find the necessary facts to decide the issues and is of the view that it
would be just to decide the issues in that manner: Gichuru v. Pallai,
2013 BCCA 60 at para. 23.  That statement is complicated somewhat by the
extended evidentiary focus just discussed, however.

[27]        
Obviously, I cannot issue judgment against Teva and Sandoz on the basis
of evidence concerning persons who are not parties to the action; doing so
would violate the rules of natural justice and the foundational principles of
our adversarial system of justice.  Pre-certification class action proceedings
cannot be used as a vehicle for persons who are not parties to the proceeding
to prosecute a claim against the defendants:  see Birrell (S.C.) at
para. 11.  Thus, I can only issue judgment in favour of the plaintiffs if they
are able to prove their claims as individuals.  The question is, then, what
role can evidence related to potential class members play in a summary trial?

[28]        
Considering the principle articulated in MacKinnon, and the law
applicable to Rule 9-7, I conclude that evidence relating to the proposed class
can be considered in determining whether it would be unjust to decide the
issues on the application.  If the plaintiffs fail to prove the claims of the
individual plaintiffs, but there is evidence that Teva and Sandoz have breached
a duty of care to the Canadian users of their transdermal fentanyl patches, I
should refuse to issue judgment on the summary trial and allow the claim
against Teva and Sandoz to continue to the certification hearing.

REVIEW
OF THE EVIDENCE

[29]        
The evidence tendered in this matter consisted of affidavits from
Desiree Player and Elaine Mills, the plaintiffs; a number of affidavits from
legal assistants and associates employed by the parties’ counsel; and extensive
expert opinion evidence, that I will discuss in more detail below.  The
majority of these deponents were cross‑examined and transcripts of those
examinations were provided to the court.  For the reasons given above, I will
review all of the evidence, not just that related to the claims of the
individual plaintiffs.

[30]        
Before setting out the evidence presented in the affidavits, I will
briefly lay out the law of products liability in Canada.  Although I intend to discuss
the law in more detail later in the judgment, some comment on the law of
negligent design and failure to warn is necessary to put the evidence in
context.

[31]        
There is no question that all the defendants in this matter owe a duty
of care to the end users of their product.  They have a duty to take reasonable
care in the design, manufacture and distribution of transdermal fentanyl
patches, so as to eliminate any unreasonable risk or foreseeable harm inherent
in the use of that product.  To escape liability, they must produce a
“reasonably safe” product.

[32]        
Determining whether something is “reasonably safe” requires the court to
undertake a risk-utility analysis.  Factors to consider in this balancing
include the utility of the product, the risk of injury inherent in the product,
the availability of a safer design, the potential for designing or
manufacturing the product so it is safer but remains functional and reasonably
priced, and, among others, the plaintiff’s ability to avoid injury with careful
use of the product.  Much of the conflicting evidence in this case focuses on
two of these factors: first, the risks inherent in the use of transdermal
fentanyl patches; and, second, the availability of a safer design.

[33]        
Even where the design itself is not negligent, so long as there is some
danger associated with the use of the product, the manufacturer and distributor
of that product has a duty to warn those who use the product about those
dangers.  The warnings must be reasonably communicated and must clearly
describe any specific dangers arising from the ordinary use of the product.

Evidence
of Named Plaintiffs and Proposed Class Members

  Death of Robert
Player

[34]        
In September 2006, Mr. Player was in a motor vehicle accident where he
suffered a severe head injury.  Beginning in December 2006, he was prescribed
fentanyl for pain relief.  Mr. Player’s treating physician also prescribed a
number of other drugs following the injury, including a sedative, an
anticonvulsant, an anti-inflammatory, an antidepressant, and a drug for
neuropathic pain.

[35]        
At the time, Ms. Player was in training as a registered nurse.  She was
responsible for applying Mr. Player’s fentanyl patches.  She says she did so
according to the instructions, and that she was always careful to remove the
old patch before applying a new one.  She was also responsible for organizing
and administering his other medications.

[36]        
On August 9, 2007, Ms. Player was going to be away from home overnight and
so arranged for Mr. Player to spend the night at her mother’s house.  She did
not return to her mother’s home until late in the afternoon on August 10.  Mr. Player
was last seen alive by a family member around 6:30 a.m. that morning, asleep on
a sofa.  When Ms. Player arrived around 3:00 p.m., she discovered Mr. Player
lying dead on the same sofa.

[37]        
Ms. Player provided a copy of the coroner’s report issued following Mr. Player’s
death.  The report lists the cause of death as fatal respiratory depression due
to a prescription drug interaction.  A toxicology examination revealed the
presence of Fentanyl, Trazodone, Carbamezepine, Gabapentin, Celecoxib,
Citalopram, and Olanzapine in Mr. Player’s bloodstream.  The report notes that
all seven of these drugs are respiratory depressants, and concludes that “[t]he
combined effect of these medications caused hypoventilation, or respiratory
depression.”  The investigative findings in the report indicate that several
prescription medications were found by Mr. Player’s body and that several doses
were missing, suggesting that he may have taken extra doses of some of his
medications prior to his death.

[38]        
During cross-examination, Ms. Player admitted that Mr. Player had
accidentally over-medicated on a number of occasions prior to his death, but
said that as the majority of the medications were in blister packs, it was not
possible to determine whether he had over-medicated on the day of his death.  She
also acknowledged that while Mr. Player had prescriptions for six of the seven
drugs found in his system, he did not have a prescription for Trazodone, a
sleeping pill.  He instead had a prescription for Zoplicone, likewise a sleep
aid.  Ms. Player herself did, however, have a prescription for Trazodone.  She
said that she thought Mr. Player had probably found the Trazodone at her
mother’s house and taken it in error, thinking it was one of his own
medications.  I note that the toxicology examination shows that Mr. Player did
not have any Zoplicone in his bloodstream at the time of his death.

[39]        
According to Ms. Player, Mr. Player had used both ratio-FENTANYL and
Duragesic brand patches during the course of his treatment.  As noted above,
ratio-FENTANYL is a matrix drug-in-adhesive style patch manufactured by Teva,
while Duragesic is a reservoir patch manufactured by one of the other
defendants.  Ms. Player was not certain which patch Mr. Player was using
when he died, but deposed that she believed it was “most likely”
ratio-FENTANYL.  She did not provide any basis for this belief.  Nor did she
provide prescription records or any other supporting documentary evidence that
might have established the brand of fentanyl patch used by Mr. Player in August
2007.

[40]        
Ms. Player stated that she had read the information leaflet and warnings
included with the fentanyl patches used by Mr. Player and understood that there
were risks associated with the use of fentanyl.  In particular, she noted that
she and Mr. Player felt a “great deal of apprehension” over a warning that
those sleeping in the same bed with a person using a fentanyl patch could be
injured or even die, if the patch detached and adhered to the other person’s
skin.

[41]        
However, Ms. Player also said that at the time of Mr. Player’s death she
was not aware that fentanyl could cause respiratory depression, or that the
patches could release more of the active drug than intended.  She was also not
aware that mixing fentanyl with a sedative, such as a sleeping pill, could be
fatal.  In her view, she was not accurately informed of the risks associated
with the use of fentanyl.  She said that if she had been aware of the dangers,
she would not have allowed Mr. Player to use fentanyl patches.

[42]        
During cross-examination, Ms. Player reviewed the patient information
provided with transdermal fentanyl patch products and agreed that it did
mention the risk of respiratory depression.  She stated that she could not
recall if she had read that section of the information leaflet at the time of
Mr. Player’s death.  She also acknowledged that the leaflet advises that
fentanyl may have potentially harmful interactions — including drowsiness,
depressed breathing, low blood pressure or coma — when mixed with other
medications, particularly sleeping pills or other sedatives.  Ms. Player
testified that she did not understand from the leaflet that depressed breathing could cause death.

 The Extended Coroner’s Report

[43]        
As noted above, Ms. Player attached a copy of the coroner’s report to
her affidavit.  She did not include a copy of the autopsy report or toxicology
report completed following his death.  Both documents were instead tendered by
the applicant defendants, who, it appears, received these additional documents
when they requested a certified copy of the full coroner’s report from the
coroner’s office.  It is not clear from the evidence whether Ms. Player
received either document from the coroner’s office.

[44]        
These documents provide a number of further details from Mr. Player’s
post-mortem examination.  The autopsy report indicates that at the time of
death, Mr. Player was wearing two fentanyl patches, one on each arm.  Ms.
Player stated in cross-examination that she would not have put a second patch
on Mr. Player without removing the first one.  She believes he must have put
the second patch on himself.

[45]        
The report does not suggest that the first patch was still active when
Mr. Player put the second patch on.  Nor does it suggest that the use of
two patches resulted in a fentanyl overdose.  The toxicology report includes a
somewhat cryptic comment that suggests otherwise, as it says “[b]lood level of
fentanyl as found after regular application of patches.”  Neither party
presented any evidence from the forensic toxicologist, post-mortem examiner or
the coroner and there was no expert opinion tendered interpreting the coroner’s
report or the additional documents.

[46]        
The plaintiffs objected to the admission of the autopsy and toxicology
reports on a number of bases.  They say that they were deliberately withheld by
the applicant defendants until the last possible moment, and then sprung upon
Ms. Player at cross-examination in a form of prohibited “trial by ambush”;
that they were filed too late, after the agreed deadline for filing evidence;
and that they were inadmissible hearsay.  At the summary trial the reports were
filed as exhibits to an affidavit from Andrew Aguilar, a lawyer with counsel
for Teva.  In the affidavit Mr. Aguilar indicates that he received the
report from the coroner’s office.

[47]        
According to the plaintiffs, the reports could not be received for the
proof of their contents unless the coroner swore an affidavit.  Even if the
coroner did so, the plaintiffs submit that the resulting affidavit would also
be inadmissible as the coroner is not a doctor and cannot give an opinion as to
cause of death.

[48]        
As the plaintiffs point out, in a summary trial deponents must swear to
evidence from personal knowledge, not evidence based on information and
belief.  The plaintiffs rely on Huron-Perth Children’s Aid Society v. C.H.,
2007 ONCJ 744, where the court stated that a party seeking to rely on hearsay
evidence in an affidavit should explain why the person who tendered the
information could not swear an affidavit of their own and be made available for
cross-examination.  Further, in British Columbia (Public Guardian and
Trustee of) v. Egli, 2003 BCSC 1716, this court held that medical records
expressing an opinion as to the mental capacity of a patient were inadmissible
for the truth of their contents where the person giving the opinion did not
provide an affidavit.

[49]        
In submissions on this matter, the plaintiffs also addressed the
evidentiary value of the original coroner’s report, which, as I have indicated,
was filed as an attachment to Ms. Player’s affidavit.  They say that they did
not submit it as proof of the contents of that report, but only in support of
the evidence of Ms. Player.  According to the plaintiffs, the report is
only relevant to show that Mr. Player was taking fentanyl at the time of
his death, and that therefore his claim to be a member of the potential class
is not baseless.  They say that it is not, and cannot be, evidence that Mr. Player
died or was otherwise injured because he was taking fentanyl.

[50]        
Given the context, that submission is somewhat surprising.  In her
affidavit Ms. Player deposes that Mr. Player’s cause of death was fatal
respiratory depression.  She also says that he died while using fentanyl
patches for pain relief.  This is not sufficient to establish — nor does it
even suggest — that Mr. Player’s death was caused by his use of fentanyl
transdermal patches.  If the coroner’s report is not tendered for the truth of
its contents, there is no admissible evidence to link Mr. Player’s death
with his use of fentanyl.

 Conclusion on Evidence Relating to Mr.
Player

[51]        
In the circumstances, I cannot place any reliance on the details of Mr. Player’s
death as evidence of the plaintiffs’ claims.  The plaintiffs have not put
forward any admissible evidence establishing fentanyl as a cause of Mr.
Player’s death and the resulting injuries to his estate and Ms. Player.  They
relied on Ms. Player’s affidavit, which establishes the fact of his death and
the fact that he was using fentanyl at the time.  The affidavit does not permit
me to conclude that Mr. Player was using a matrix-style patch at the time
of his death, as at best, Ms. Player can only say, without corroborating
evidence, that it was “most likely” the ratio-Fentanyl patch.

[52]        
The affidavit included a coroner’s report that lists the cause of death
as fatal respiratory depression due to a prescription drug interaction.  It
appears that fentanyl was one of the drugs in Mr. Player’s system at the time
of death, but as the plaintiffs themselves submitted, there is no expert
evidence that would allow me to determine what role, if any, fentanyl played in
his death.  In addition, I accept that a coroner’s report, without some expert
interpretation, cannot prove cause of death.  Evidence from the toxicologist,
post-mortem examiner, or an expert interpreting the autopsy and toxicology
findings would be necessary to prove causation.

[53]        
The best that can be said on the facts of Mr. Player’s death is that at
the time of his death he was wearing two fentanyl patches and using other drugs
and that death likely resulted from an interaction of the drugs found in
his system upon post-mortem examination.  This sort of evidence cannot be
dispositive at a summary trial.  As I have said, a summary trial is a true
trial of the action.  The onus remains with the plaintiff and the rules of
evidence apply as they do at a full trial.

[54]        
I conclude that the evidence concerning Mr. Player’s death is not
sufficient to prove it was more likely than not that Mr. Player died as a
result of his use of a matrix fentanyl patch manufactured by either Teva or
Sandoz.  Therefore, the evidence does not support the claim by the Estate of
Robert Player or Ms. Desiree Marine Player against Teva or Sandoz.  Given
this conclusion, there is no need for me to comment further on the
admissibility of the additional two reports.

 Death of Daniel Pollock

[55]        
Daniel Charles Pollock, whose estate and widow, Elaine Mills, are also
named as plaintiffs, died while using fentanyl transdermal patches.  However,
as Dr. Mills acknowledges in her affidavit, Dr. Pollock was prescribed and
used the Duragesic fentanyl patches, which utilized the reservoir design.  While
Dr. Pollock’s injuries are relevant to the claim against the other defendants,
they do not have any bearing on the question of whether the matrix-style
patches manufactured by Teva and Sandoz cause injuries as alleged.  As a
result, I will not say any more about Dr. Mills’
evidence.

 Reported
Injuries to Members of the Proposed Class

[56]        
Ruel Mugot, a legal assistant employed at Merchant Law Group LLP,
deposed that he spoke via telephone with eight potential class members in the
proposed fentanyl class action.  It appears that these individuals were
identified after they entered their contact information into an online database
that plaintiffs’ counsel has access to respecting fentanyl litigation.

[57]        
Mr. Mugot says that each of the individuals he spoke with identified
themselves as a current or former fentanyl patch user, or as a family member of
a person who had died while using fentanyl patches.  During his conversations
with these individuals Mr. Mugot asked them to identify the brand and dosage of
fentanyl patch used, the dates of use, and any adverse events experienced while
using the patches.  He also asked them whether they, or their relative, had
ever misused or misapplied fentanyl patches.  He deposed that “[e]very individual
with whom I spoke indicated that in their case the fentanyl patches had always
been used as directed.”

[58]        
Melissa Coghill, a legal researcher at Merchant Law Group, also deposed
that she spoke by telephone with 24 potential class members.  She repeated the
same questions used by Mr. Mugot and stated that all the respondents had all
indicated that their fentanyl patches had always been used as directed.

[59]        
The persons interviewed by Mr. Mugot and Ms. Coghill reported the
following adverse events:

• twelve people
reported that their relatives died while using fentanyl patches;

• five people reported
dermal irritation, defined as skin rashes, hives, or open sores;

• thirteen people
reported that they or their relatives suffered cognitive impairment, defined as
including dizziness, drowsiness, nervousness, hallucinations, anxiety or
depression;

• eighteen people
reported experiencing respiratory difficulties, such as respiratory arrest,
difficulty breathing, weak or shallow breathing, or shortness of breath; and

• two people did not
report any adverse events.

[60]        
A number of the people interviewed could not recall what brand or dosage
of fentanyl transdermal patch they or their relative had used.  The others
reported use of a variety of brands, including patches manufactured by both
Teva and Sandoz.

[61]        
The applicant defendants object to the admissibility of this evidence,
on the grounds that it is hearsay.  While the affidavits list the names of the
persons interviewed, none of those people provided affidavits of their own and
were as a result not available for cross-examination.  They say that the
plaintiffs could, and should, have provided evidence directly from the
potential class members.

[62]        
At a summary trial, evidence must be based on personal knowledge, not on
information and belief:  see L.E.W. v. United Church of Canada, 2005
BCSC 564 at para. 7.  The plaintiffs acknowledged that in their own submissions
with regards to the coroners’ report.

[63]        
I find that the evidence of potential class members is not admissible as
proof to support the plaintiffs’ claims upon this summary trial.  However,
bearing in mind the principle established in MacKinnon, v. Instaloans, supra
the evidence can be considered and may be a factor in determining whether
it is just to determine this matter on a summary trial.  However, I agree with
Teva and Sandoz that it would have been possible for the plaintiffs to provide
affidavits from these proposed class members themselves.  As such, given the
hearsay nature of the information provided, it is only entitled to minimal
weight, even for this limited purpose.

 Adverse Event Reports

[64]        
Ms. Coghill also swore an affidavit in which she says that she examined
publicly available data about adverse events experienced by the users of
fentanyl transdermal patches in Canada.  In particular, she examined the Canada
Vigilance Adverse Reaction Online Database, a site maintained by Health Canada.
The reports in the database are submitted to Health Canada by health
professionals, consumers, or drug manufacturers and distributors.  Health
Canada issues a number of caveats about the use of the reports, stating that
the reported clinical data is often incomplete and that the reports cannot be
used to establish that the health products in question caused the reported
reaction.

[65]        
Ms. Coghill acknowledged that the reports cannot establish a causal link
between a drug and a specific adverse event, but stated that they do indicate a
temporal relationship between the use of a drug and a reported adverse advent.  In
the case of fentanyl users, reported adverse events included respiratory
difficulties, cognitive impairment, dermal irritation, and death.  Other
reports indicated that the patient complained that the drug was ineffective for
its prescribed purpose.

[66]        
Again, Teva and Sandoz oppose the admission of this evidence.  They
point out that the reports are double hearsay:  Health Canada simply reports
the information provided by other parties.  The plaintiffs in their own
submissions regarding the admissibility of the autopsy report relied on Rosetim
Investments Inc v. BCE Inc, 2011 SKQB 253, where the court ruled that
reports downloaded from the Internet were inadmissible because the affiant had
no personal knowledge of the contents and there was no way to establish the reliability
of the reports.  That principle seems equally applicable here.

[67]        
Further, the applicant defendants argued that even absent the concern
about hearsay, no weight for any purpose can be given to the adverse event
reports as they contain incomplete or misleading information.  Both Teva and
Sandoz sought to demonstrate that the reports do not contain all of the
relevant information regarding the alleged adverse event.  Teva provided a
record of their own submissions to Health Canada corresponding to two vigilance
reports that listed “death” as an adverse event and indicated that the patient
had been using a Teva fentanyl patch.  In both cases Teva’s records indicate
that the deaths were associated with drug abuse.  In one, Teva received
information from a police officer that a woman was found dead with a fentanyl
patch in her mouth.  She did not have a prescription for the product.  Similarly,
in the other incident, police reported a death involving suspected drug abuse;
the decedent did not have a prescription for fentanyl.

[68]        
Sandoz also provided its own adverse event case files for two vigilance
reports listing “death” as an adverse event in association with use of a Sandoz
fentanyl product.  In one case the reporting doctor indicated that the patient
died of prostate cancer and that the reported opioid toxicity cleared up prior
to death.  In addition, the reporting pharmacist indicated that while the
patient was taking fentanyl, it did not appear that fentanyl played any role in
the opioid toxicity, which was registered as a reaction to Sandoz Opium and
Belladonna.  It was not clear what brand of fentanyl the patient was using.

[69]        
In the second case, the patient presented at a hospital with confusion
and delirium and was found to be wearing two Sandoz Fentanyl patches, which she
had unintentionally left on for 7 days.  The patient’s delirium resolved after
treatment in the hospital; she died approximately five days later from
metastatic cervical cancer.  There was no evidence that the death was in any
way related to the patient’s use of fentanyl.

[70]        
These examples highlight the danger of relying on the Health Canada
reports, either as evidence of injuries caused by fentanyl transdermal patches
or as of risks associated with those products.  I agree with Teva and Sandoz
that no weight can be given to this evidence as proof of the plaintiffs’ claims
or in considering whether the case is appropriate for determination on summary
trial.

EXPERT AND SCIENTIFIC EVIDENCE

[71]        
The parties to this summary trial application filed extensive evidence.  The
plaintiffs relied on an expert opinion from Dr. Bozena Michniak-Kohn, an
American scientist specializing in the area of transdermal and topical drug
delivery.  She is currently a tenured professor of pharmaceutics at Rutgers
University and she is the Director of the Center for Dermal Research and the
Laboratory for Drug Delivery of the New Jersey Center for Biomaterials.

[72]        
Teva provided affidavits from Paul Stojanovski, the Executive Director
of Quality and Compliance at Teva, and W. Bruce Valliant, Director of
Pharmacovigilance with Teva.  Pharmacovigilance is an umbrella term that
describes a company’s drug safety practices, including the detection,
assessment, monitoring and prevention of adverse drug affects.  Sandoz
similarly provided affidavits from Nathalie Fortier, their Drug Information and
Pharmacovigilance Manager, and Jo-anne Soltesz, Manager of the Regulatory
Competency Centre for Sandoz.  Generally speaking, the evidence they provided
dealt with the regulatory regime governing pharmaceutical products in Canada,
the quality control and assurance practices at each company, and their respective
pharmacovigilance records.

[73]        
Teva also provided two expert opinions.  Dr. Brenda Lau, a licensed
British Columbia physician with a specialty in pain medication, provided an
opinion on the utility of fentanyl transdermal patches and the risks associated
with their use.  Dr. Lau works at Surrey Memorial Hospital and St. Paul’s
Hospital and is the Chair of the Regional Pain Services Division, where she
oversees the development of pain management services for hospitals in the
Fraser Health Authority.

[74]        
Dr. Marianna Foldvari provided an affidavit as an expert in the area of
transdermal drug delivery systems.  She is a professor of pharmaceutical sciences
at the University of Waterloo and the Canada Research Chair in
Bionanotechnology and Nanomedicine.  She provided her opinion with regards to
the design of Teva’s matrix transdermal fentanyl patches relative to the risks
associated with their use.

[75]        
Sandoz provided an expert opinion from Dr. Philippa Hawley, a licensed
physician specializing in the area of pain management and palliative care.  She
currently does clinical work at the British Columbia Cancer Agency, based in
Vancouver.  Beginning in 1997, she initiated and developed the Cancer Agency’s
Pain and Symptom Management/Palliative Care Program, a clinical program
providing medical services to patients with a cancer history who present with
pain as their primary problem.  She is currently the Provincial Medical leader
of that program.  She estimates that between 2011 and 2013 the clinic has
treated 900-950 patients, of whom she has personally treated between one-third
and one-half.  She is also the head of the Division of Palliative Care at the University
of British Columbia.  Dr. Hawley provided an opinion with regards to the role
of transdermal fentanyl patches in cancer pain management and the risks
associated with transdermal fentanyl use.

[76]        
As will become apparent in the review of the scientific evidence, there
were a number of conflicts between the expert opinions.  Each expert provided
response affidavits addressing their concerns with the other opinions.  The
parties also challenged the admissibility and weight to be given to some of the
opinions.  I have attempted to clearly set out the information provided and
highlight the points of conflict and concern, although this task was made more
difficult by the “she said – she said” nature of the battling affidavit
evidence.  I have left the questions of admissibility and weight for discussion
following the review of the scientific evidence.

Fentanyl and the Pharmaceutical Context

 Fentanyl Transdermal Patch Technology in Canada

[77]        
Fentanyl is a member of the opioid family.  It is a potent drug and,
along with morphine, hydromorphone, oxycontin, methadone and tapentadol, is
categorized as a “strong opioid.”  In Canada it is authorized for use for the
treatment of moderate to severe pain.  It is only available by prescription.

[78]        
Unlike the other strong opioids, fentanyl is fat soluble, and as a
result can permeate a patient’s skin.  It can therefore be administered
transdermally, in the form of a patch.  Generally speaking, these transdermal
patches are designed to release a constant flow of fentanyl into the patient’s
bloodstream over a 72-hour period.

[79]        
Transdermal fentanyl patches have been available in Canada since 1991,
when Health Canada granted Janssen-Ortho Inc. authorization for the sale of
Duragesic brand patches.  Duragesic manufactures “reservoir” type transdermal
fentanyl patches.  As an innovator drug, Duragesic was initially protected by
patent, so that no other companies were permitted to sell transdermal fentanyl
patches prior to 2006.  Once the drug entered the “off-patent” period, a number
of other companies applied for authorization to release generic versions of the
product.

[80]        
Among the pharmaceutical companies that successfully received
Health Canada authorization for sale of generic transdermal fentanyl patches
were Ratiopharm Inc., Novopharm Ltd., and Sandoz.  Ratiopharm manufactured the
ratio-FENTANYL patch, Novopharm the Novo-Fentanyl patch, and Sandoz the Sandoz
Fentanyl patch.  Health Canada authorized the sale of ratio-FENTANYL in July
2006, Novo-Fentanyl in August 2008 and Sandoz Fentanyl in June 2009.

[81]        
As a result of corporate mergers, Teva is now the successor
company to both Ratiopharm and Novopharm.  The ratio-FENTANYL patch is still
available in the market but the Novo-Fentanyl patch has subsequently been
rebranded as the TEVA-Fentanyl patch.

[82]        
All the patches manufactured by Teva and Sandoz are matrix
drug-in-adhesive style patches.  As I will discuss in more detail below,
generic drugs are not required to match the innovator products exactly.  They
only need to be “bioequivalent,” so that the same level of active ingredient is
released from the generic product at the same rate as it is released from the
innovator product.  The generic versions may therefore differ from the
innovator product in their delivery mechanisms or other design elements.

 The Regulation of Pharmaceuticals in Canada

[83]        
Health Canada is the independent federal agency responsible for
regulating the sale, safety and efficacy of drugs in Canada.  In particular,
the Health Products Food Branch (“HPFB”) is responsible for the regulation of
pharmaceuticals.  A drug cannot be sold in Canada until it receives market
authorization from the HPFB, which requires that an applicant organization
demonstrate a drug’s safety and efficacy in accordance with Health Canada
regulations.

[84]        
The process for demonstrating drug safety and efficacy is a complicated
one, particularly where the drug is an “innovator”, or the first of its kind.  I
summarize it here as follows:

• The applicant must
conduct pre-clinical studies, which involve in vitro (test tube) and in vivo
(animal) testing for the performance of the drug and any potential toxic
effects.

• The applicant may
then apply to HPFB for authorization to conduct a clinical trial on human
subjects.  The purpose of the clinical trial is to verify the pharmacological
effects of the drug, identify any adverse events, study the absorption,
distribution, and metabolism of the drug, and ascertain its safety and
efficacy.  The HPFB regulates the design of clinical trials and ascertains that
they do not expose participants to any undue risk.  The clinical trials for
innovator drugs are performed both with healthy volunteers and with the patients
who are the target subjects for the drug.

• If the clinical trial
indicates that the drug has a therapeutic value that outweighs any risks
associated with its use, the applicant can file a New Drug Submission (“NDS”)
with HPFB.  This form contains information about the product’s safety, efficacy
and quality, relying on the results of the pre-clinical and clinical trials.  It
also details the production method for the drug and its packaging and
labelling, including the product monograph.  The HPFB reviews this information
and, if satisfied that the benefits of the drug outweigh the risks, issues a
Notice of Compliance and Drug Identification Number, both of which are required
prior to any sale in Canada.

• The approval process
for generic drugs is streamlined, as it relies on much of the data put forward
in the original NDS.  The applicant for a generic drug files an Abbreviated NDS
(“ANDS”) with the HPFB.  The ANDS is focused on demonstrating that the generic
drug is bioequivalent to the innovator drug.  Bioequivalence, as discussed
above, assures that the same level of active ingredient is released from the
generic product at the same rate as from the innovator product.  HPFB proceeds
on the assumption that so long as the drugs are bioequivalent, the generic drug
has the same safety profile as the innovator drug.  As a result, no further
safety and efficacy testing is required.

• The manufacturers of
generic drugs conduct clinical studies in testing for bioequivalence.  The
company administers the proposed generic drug to a group of healthy volunteers
and also administers the innovator drug to the same group of volunteers.  From
there, the company can sample how quickly each drug enters the bloodstream and
how much total drug enters the bloodstream over the dosage period.  Unlike the
innovator drug, generic drugs are not tested in clinical trials with diseased
or injured patients.

[85]        
As discussed, both Teva and Sandoz manufacture generic versions of
Duragesic, the innovator product.  They were granted authorization for sale
after establishing bioequivalence with that product.

[86]        
Dr. Foldvari reviewed the ANDS for both ratio-FENTANYL and
Teva-Fentanyl, which included records of the bioequivalence studies conducted
for both drugs.  In Dr. Foldvari’s opinion, both Teva patches were tested for
safety and efficacy in accordance with all applicable industry standards.  She
deposed that the studies in question were done in accordance with Good Clinical
Practice (“GCP”), an international ethical and scientific quality standard used
in designing, conducting, recording and reporting clinical trials on human
subjects.  Health Canada, like other national drug regulators, has adopted GCP
as the required standard for use in clinical trials.

Quality Control for Teva
and Sandoz Patches

[87]        
Both Teva and Sandoz provided information about their manufacturing and
quality control processes.  Ratio-FENTANYL matrix patches are manufactured in
Germany, while Novo-Fentanyl and the subsequent TEVA-fentanyl matrix patches
are manufactured in Florida.  Sandoz Fentanyl patches are manufactured in
Germany.

[88]        
Mr. Stojanovski and Ms. Soltesz, who monitor quality control and
regulatory compliance at Teva and Sandoz respectively, said that the drug manufacturers
are required to test the products for compliance with Health Canada
specifications as well as with each company’s own quality control
specifications.  In this process the manufacturers take representative samples
from each lot and test them for potency, purity, and content uniformity.  The
manufacturers then issue Certificates of Analysis, which certify that the
patches in each lot meet the chemical composition specifications approved by
Health Canada.  They also issue a Certificate of Manufacture, which certify
that the patches in the lot were manufactured in accordance with Health
Canada’s approved manufacturing processes.  These materials are reviewed by
quality assurance staff upon arrival at Teva’s and Sandoz’s Canadian
facilities.

[89]        
Mr. Stojanovski deposed that as far as he is aware, neither Ratiopharm,
Novopharm nor Teva has ever released a fentanyl patch in Canada that was
non-compliant with Health Canada quality control specifications.  Similarly,
Ms. Soltesz states that she is not aware that any non-compliant Sandoz Fentanyl
patch has ever been released into the Canadian
marketplace.

Evidence on Negligent
Design Claim

 Medical Utility
of Transdermal Fentanyl Patches

[90]        
According to Dr. Lau, who specializes in pain medication, opioids are “the
cornerstone therapy for moderate to severe tissue injury pain.”  Fentanyl, and
in particular the patch dosage form, provide a number of unique benefits in use
for pain management.  First, fentanyl is up to 100 times more potent than
morphine, another common opioid, so that effective pain relief requires lower
concentrations of the active drug, thus reducing side effects and improving
patient tolerance.  Dr. Lau notes that fentanyl is the preferred strong opioid
for use in patients with renal failure as many of the other drugs can have
adverse effects on the kidneys.  In addition, she states that fentanyl does not
cause histamine release and is the preferred opioid for use in those who are
susceptible to hypotension from histamine effects.  As it can be delivered via
patch, it is the only opioid treatment for severe pain in patients who cannot
tolerate drugs taken by oral, intravenous or rectal administration.  “Accordingly,”
Dr. Lau states, “there are certain categories of patients for which fentanyl is
the only opioid available to physicians for the management of severe pain.”

[91]        
Dr. Hawley provided a similar opinion, stating that transdermal fentanyl
patches have “a unique and very valuable place in the management of cancer
pain,” particularly with patients who have digestive or swallowing
difficulties.  She noted that the patch dosage form also allows for treating
physicians or caretakers to control the risk of abuse and monitor drug
compliance more easily than with injection or oral-dose medications.  She indicates
that fentanyl is currently the only publicly-funded transdermal opioid
available in Canada.

[92]        
Both doctors agreed that transdermal fentanyl patches have a number of
practical benefits.  Transdermal patches provide a constant dose over a period
of time, thereby maximizing pain relief and avoiding patient overdose by
diminishing the effect of erratic or inconsistent dosing.  A patch also
provides a benefit to pain sufferers because it can be used at home, rather
than in a hospital setting, as it is easy to administer.  Dr. Hawley states
that the benefits of fentanyl patches for patients and caregivers include a
reduction in opioid-induced constipation; reduction in caregiver burden due to
reduced frequency of administration; sleep improvements from stable dose flow
at night; improved patient independence with less need for medication
assistance; and improved patient confidence, self-esteem and dignity, as a
result of the other listed benefits.  In a palliative context, she notes that a
reduced caregiver burden allows patients to rely on hospice care, which is
inexpensive in comparison with a hospital bed in a
palliative care unit.

 Risks with Use with Fentanyl Transdermal
Patches

[93]        
Dr. Lau and Dr. Hawley agreed that fentanyl use, as with all opioids,
carries a risk of respiratory depression.  However, both doctors opined that
serious injury or death from opioid-induced respiratory depression would be
“extremely unlikely” as long as the transdermal fentanyl patches were properly
prescribed and applied.  In Dr. Lau’s experience, overdose and respiratory
depression “almost invariably” result from a patient using a patch incorrectly
or from errors in prescription.  Like Dr. Lau, Dr. Hawley opined that “[i]f
transdermal fentanyl is prescribed and used appropriately, I would not expect
to see any serious respiratory issues associated with its use.”  She bases this
conclusion on her own clinical practice.  She estimates that of 3,000 patients
seen between 2001 and 2011, she prescribed fentanyl for 15%.  She included data
from the Vancouver Centre Palliative Care Database showing the incidence of
fentanyl patch use among patients at the clinics since 2005 varied between
12-18%.  She is not aware of any episodes of respiratory depression due to
transdermal fentanyl occurring in any cancer patients at the BC Cancer Agency.

[94]        
Dr. Lau and Dr. Hawley defined “appropriate” use or prescription of
transdermal fentanyl patches as follows:

• The patch should not
be applied to broken or altered skin, used while damaged, exposed to a heat
source, or applied by a patient who has a fever.  All of these factors may
result in an accelerated rate of drug release.

• The patch must be
used by a patient with a prescription and in accordance with the instructions
as to application.  Intentional misuse or abuse, as where the patient applies
additional patches, consumes the patches orally, or uses the patches without a
prescription, can result in overdose.

• The patient should
not use the patch in conjunction with certain other drugs, particularly other
opioids or sedatives, as the interaction may lead to a dangerous increase in
the risk of respiratory depression.  A risk of drug interaction can arise where
the patient fails to inform the prescribing physician of other medications they
are taking or the physician fails to adequately monitor or assess the potential
for drug interactions.

• The patient should be
exposed to fentanyl through the use of gradual dose titration, a process where
the dose of the chosen opioid is started low and slowly increased, allowing the
patient to develop tolerance to the respiratory depressant effect.  The
prescribing doctor is meant to monitor the patient while the appropriate dosage
is determined.  A patient who is exposed too quickly to too much fentanyl may
be susceptible to respiratory depression.

• The patch can only be
prescribed for use by a patient who is opioid-tolerant.  In Dr. Hawley’s view,
fentanyl cannot be safely used as a first-line opioid (i.e. with patients who
are opioid-naïve).  She notes that physicians are aware of this limitation on
the safe use of fentanyl products.

[95]        
Dr. Hawley noted that the potential for respiratory depression with
opioid use is well-known in the medical community.  She deposed that a
qualified and reasonably competent physician would, in prescribing transdermal
fentanyl patches, advise the patients of the risks of respiratory depression or
overdose.  A physician would also rely on strategies for managing or mitigating
the risk of respiratory depression, such as the gradual does titration
described above.

[96]        
Dr. Michniak-Kohn disagreed with this view.  In her opinion, fentanyl transdermal
patches are dangerous in ordinary use, as individuals who use them
appropriately may still die with lethal levels of fentanyl in their blood.

[97]        
In giving this opinion, Dr. Michniak-Kohn relied on FDA adverse event
reports, reports regarding deaths and injuries in Canada associated with use of
transdermal fentanyl patches, and her experience as an expert in transdermal
fentanyl litigation in the United States.

[98]        
However, as the applicant defendants pointed out, many of these source
documents do not appear to support Dr. Michniak-Kohn’s conclusion.  While the
sources do suggest that fentanyl is dangerous, after reviewing their content I
am not persuaded that they establish that fentanyl is dangerous in ordinary
use.  One source, the Canadian Adverse Reaction Newsletter, relies on the
Health Canada adverse reaction reports discussed above.  As such the article is
already based on incomplete information.  In addition, the adverse reactions listed
appear to be the result of intentional drug abuse or overdose, misuse or
misapplication of the patch, prescriptions to opioid-naïve patients,
inappropriate dose titration, or reactions between fentanyl and other drugs,
such as sedatives.  The article concludes by saying that the safe use of
fentanyl is contingent on “its use according to the conditions recommended in the
Canadian product monograph.”

[99]        
Similarly, Dr. Michniak-Kohn cites an American article for the claim
that “[m]any deaths have been reported after a single patch application in
ordinary use.”  However, the article in fact says that “rare deaths have been
reported after just a single patch application” and all those cases
specifically discussed involved patients who were opioid-naïve.  The other
deaths discussed in the article involve individuals who did not have a fentanyl
prescription or who were administered fentanyl without gradual dose titration.

[100]     I will
discuss Dr. Michniak-Kohn’s reliance on evidence tendered in American fentanyl
litigation in more detail below.  At this point I will simply note that Dr. Michniak-Kohn
did not provide any documentation relating to her involvement
in that litigation.

 The
Availability of a Safer Design

  Matrix Patches
versus Reservoir Patches

[101]     Dr.
Foldvari gave the opinion that matrix patches (and in particular, Teva’s
patches) are “state of the art, leading technology” in the transdermal
administration of fentanyl.  She is of the opinion that there is no extant
safer alternative delivery mechanism for the administration of fentanyl.

[102]     In her
view, the safety profile for a matrix-style patch is superior to a
reservoir-style patch.  She deposed that the design of the matrix patch
protects against the sudden or inadvertent release of large amounts of active
drug, known as “dose-dumping,” and the consequent risk of overdose.  In her
view, a reservoir patch allows for dose-dumping because any issue with the
structural integrity of the patch itself can allow the patch to “dump” the
entire dose out of the patch unexpectedly.

[103]     Dr.
Foldvari provided a comparison of the key features of reservoir patches and
drug-in-adhesive matrix patches.  Although noting that the two products are
considered bioequivalent by Health Canada, and therefore deliver a
statistically similar amount of active drug over the same period of time, she
states that there are “significant, functional differences” between the two
types of patch, including:

• Control of drug
release:  In a reservoir patch the release of the drug is controlled by a
rate-controlling membrane.  If the membrane is pierced or damaged, the drug may
flow freely from the patch, potentially resulting in overdose.  The drug in a
matrix patch is controlled by the components of the matrix itself and a
concentration gradient between the patch and the skin.  The drug moves from an
area of high concentration (the gradient) to an area of low concentration (the
skin).  Because there is no membrane, there is no risk of drug release due to
membrane damage.  There is no concentration gradient controlling release in the
reservoir-style patch.

• State of the drug:
the active drug in a reservoir patch is in a gel form in the reservoir
compartment.  If the reservoir or the membrane between the reservoir and the
skin is cut, torn or punctured, the drug may leak out of the patch resulting in
an overdose.  In a matrix patch, the drug is dissolved in the matrix and kept
in a semi-solid state.  It cannot leak, even if the patch is cut, torn or
punctured.

• Stability of active
drug:  The stability of the fentanyl in a matrix patch remains constant.  In a
reservoir patch, the stability is dependent on the protective backing; where it
is removed or damaged, components of the drug formulation, such as ethanol, may
evaporate and change the chemical composition of the drug formula in the
reservoir.

[104]     According
to Dr. Foldvari, the risks inherent in the use of a matrix fentanyl patches are
shared by all transdermal fentanyl patches.  In her opinion, it is not possible
to design a patch that prevents drug abuse or deliberate misuse, or one that
can deliver active drug at a constant rate to both normal and compromised skin. 
She also says it is not possible to design a patch that is unaffected by
exposure to heat.

[105]     It appears
that the risks inherent in reservoir-style patches have, on at least one
occasion, led to a recall for those products.  In February 2008, Health Canada
issued a recall notice for fentanyl patches marketed and distributed by Janssen
and Ranbaxy.  According to an advisory released by Health Canada, 25 mcg/hr
Duragesic patches were recalled “because they may have a cut along one side of
the patch which could result in leaking of the fentanyl gel from the patch.”  Teva
was not subject to the recall notice in February 2008 (the Sandoz product had
not yet come to market).  Indeed, Mr. Valliant, Teva’s Director of Pharmacovigilance,
says that no matrix-style fentanyl patches have ever been recalled in Canada.

[106]     In her
affidavit Dr. Hawley agreed with Dr. Foldvari on this point, stating that the
safety profile for transdermal fentanyl patches is increased with use of a
matrix-style design, as compared with a reservoir-style design, because there is no risk of gel leakage.

  Matrix Patches with Rate Control Membrane

[107]     Dr.
Michniak-Kohn acknowledges that there is no danger of drug leaking from a
matrix patch if it is torn or cut.  However, in her opinion, there is a safer
alternative design available.  According to Dr. Michniak-Kohn, there are more
than two categories of transdermal fentanyl patch designs available on the
market.  In addition to the reservoir and matrix products, there are patches
that she describes as “matrix with rate control membrane.”  She notes that
specific brands may vary in a number of other ways, including through the use
of permeation enhancers, the amount of fentanyl in the patch, the size of the
patch, the type of adhesive, and the composition of the gel.

[108]     In Dr.
Michniak-Kohn’s opinion, “a fentanyl patch that has both a matrix and
rate-control membrane is superior to a patch without such a membrane,” and
that, as a result, there is an alternative design of a patch safer than those
manufactured and marketed by Teva and Sandoz.

[109]     According
to Dr. Michniak-Kohn, examples of a matrix transdermal fentanyl patch with a
rate controlling membrane are commercially available in Europe, under the brand
names Matrifen and Fentadur, and in the United States, from Mallinckrodt Inc.

[110]     In her
opinion, adding a rate control membrane to a matrix patch “significantly
reduces [the] risk” of unintended or accelerated drug release where the patch
is applied to broken or altered skin.  Without the rate control membrane, if a
patch is applied to compromised skin, she says that “delivery of fentanyl at a
rate much higher than the labeled dose is likely to occur.”

[111]     In support
of this opinion, Dr. Michniak-Kohn cited Suneela Prodduturi et al,
“Transdermal Delivery of Fentanyl from Matrix and Reservoir Systems:  Effect of
Heat and Compromised Skin” (2010) 99:5 Journal of Pharmaceutical Sciences 2357.

[112]    
The article itself begins by indicating that there are, generally
speaking, two types of transdermal drug delivery via adhesive patch:  matrix,
or drug-in-adhesive, systems; and reservoir, or membrane-controlled systems.  I
note that the article says nothing about the possibility of a matrix system
with a rate-controlled membrane.  The article notes that:

matrix and reservoir systems have
different characteristics, especially with regard to dosage form design and
drug release … which makes direct comparison difficult.

[113]     The purpose
of the study was to assess the robustness of the two design forms when exposed
to variations in skin condition (elevated temperature or compromised skin). 
The experiments were conducted using human cadaver skin samples, some of which
were “tape stripped” to compromise the epidermal surface, and then again using
synthetic membranes.  The authors concluded that in conditions of compromised
or highly variable skin, “a matrix FTS (Fentanyl Transdermal System) may be
more affected than a reservoir FTS.”  The authors also note that “[i]n
conditions of misuse or abuse such as elevated temperature or application of
heat, either of these systems may cause an overdose.”

[114]     In Dr.
Michniak-Kohn’s opinion, matrix patches without a rate control membrane also
result in greater variability in drug absorption rates, and “are more likely to
lead to fatal overdoses than are matrix patches with a rate control membrane.”  She
says that with matrix patches, only a user’s skin controls the absorption,
leading to great variability in absorption rates.  She indicates that the data
on Duragesic shows that the rate-control membrane accounted for over 50% of the
rate control, so that fentanyl delivery across the skin without the membrane
would encounter only half the resistance and double the delivery on average.  The
applicant defendants challenged this statement, pointing out that Dr.
Michniak-Kohn did not cite any study, or provide any data, to support that
conclusion.

[115]     Dr.
Foldvari also disagreed with this view.  She states that it is inaccurate to
say that it is only the user’s skin controlling absorption with the matrix
patch.  In her view, the bioequivalence studies required by Health Canada for
the matrix patches demonstrated that the matrix patches delivered a
statistically similar amount of drug to patients over the same period of time
as a reservoir patch.  Teva’s bioequivalence studies particularly tested the
effect of skin variability, by using a direct cross-comparison of both products
on the same volunteers, and found that the products released the active drug in
an equivalent manner regardless of the patient’s individual skin permeability.

[116]     Dr.
Michniak-Kohn did depose that she has provided expert opinions in numerous
American court cases involving transdermal fentanyl patches.  She says that in
each case she gave the same opinion that she presents here: that a matrix patch
without a rate control membrane is more dangerous than a matrix patch with a
membrane.  She says that in those cases she assessed autopsy records for 48 individuals
who died while using the Mylan patch, a matrix patch available in the United States
(but not available for sale in Canada).  According to Dr. Michniak-Kohn, there
was no reported misuse or abuse of the patches in the cases and in each, post-mortem
levels of fentanyl in the bloodstream were significantly higher than the concentration
the patches were intended to deliver.  She says that in each case the deaths
were “all ruled to have been caused by fentanyl and they had higher levels than
the patch should have produced.”

[117]     She states
the records provided in those cases supported her opinion that the monolithic
matrix patches, without a rate-controlling membrane, were responsible for the
decedent’s deaths.  Again, Dr. Michniak-Kohn did not provide records from these
cases.  Nor did she provide the court with any decisions released by U.S.
courts.

[118]     During
cross-examination Dr. Michniak-Kohn acknowledged that she herself has not
conducted any studies comparing the performance of monolithic matrix patches
with matrix patches with a rate-control membrane.

[119]     Dr.
Foldvari responded to Dr. Michniak-Kohn’s opinion.  To begin, she challenges Dr.
Michniak-Kohn’s classification of transdermal fentanyl patch design into three
categories, with one described as a “matrix with a rate control membrane.”  Dr.
Foldvari deposes that the classification of fentanyl patches is subjective and
that any category grouping does not mean that the patches in the category have
identical characteristics, mechanisms, or designs.  Further, she says it would
be more appropriate to describe the Fentadur, Matrifen and Mallinckrodt
products as using a “modified reservoir design.”  She says the fentanyl in each
is contained in a reservoir, with the release controlled by a physical membrane
as opposed to the form of physico-chemical control used in a drug-in-adhesive
patch like those manufactured by Teva and Sandoz.

[120]     She
provided a copy of the patent for the Fentadur product manufactured in the
United States by Lavipharm.  Based on her review of the technology in the
patent, she states that the rate-control membrane is essential to the proper
functioning of the patch.  Without the membrane, the transfer of fentanyl from
patch to skin would be too variable for safe use.  She deposes that the rate
control membrane is not, as Dr. Michniak-Kohn states, a secondary or
supplementary safety device, but rather an essential element of the safe
operation for that form of patch.  Dr. Foldvari’s review of the in vitro and in
vivo testing of the Teva patches indicated that the matrix patches achieved
effective rate control without a membrane.

[121]     Nor does
Dr. Foldvari agree that these patches offer a superior safety profile to a
drug-in-adhesive matrix patch.  In her view, there is no evidence that a rate
control membrane reduces the risk of accelerated absorption, particularly when
used on compromised skin.  She notes that there is no scientific study
supporting this position and states that a higher delivery rate may occur
regardless of the presence of a rate control membrane.  Dr. Foldvari concludes
her response by stating that there is simply no scientific evidence that the
patch brands identified by Dr. Michniak-Kohn are safer than matrix
patches, or that they are less likely to produce an overdose when applied to
compromised skin.

 Buprenorphine
and Butrans Patch

[122]     Dr.
Michniak-Kohn also gave the opinion that Butrans, another opioid pain patch, is
as effective as fentanyl in treating pain but does not present the same risk of
death due to respiratory depression.  The active drug in Butrans,
buprenorphine, has a “ceiling effect”, where elevated levels of the drug in the
bloodstream have the effect of preventing respiratory depression, rather than
causing it. Butrans patches have been approved for sale in Canada since 2010.  In
her opinion, buprenorphine provides a safer alternative transdermal opioid
formulation when compared with fentanyl.

[123]     Both Dr.
Lau and Dr. Hawley disagreed with this conclusion.  Dr. Lau indicated that she
was familiar with the Butrans patch and had prescribed it in her pain
management practice.  However, she emphasized that Butrans does not provide a
replacement or alternative for fentanyl products, as Butrans is only approved
by Health Canada for the management of moderate pain, while fentanyl patches
are approved for the management of severe pain.  In her clinical experience,
Dr. Lau has not found buprenorphine to be generally preferable to fentanyl; in
her opinion, the Butrans patches are not as effective as the available fentanyl
patches.  She also notes that some of her patients have had adverse reactions
to Butrans (rashes, sedation, constipation, nausea) but were able to better
tolerate fentanyl.  On that basis, she gave the opinion that the buprenorphine
patch did not provide a viable alternative for the use of transdermal fentanyl
products.

[124]     Dr. Hawley
agreed with Dr. Lau, giving the opinion that Butrans is not a viable substitute
for fentanyl transdermal patches as it is not approved in Canada in dosages
sufficient to address severe pain.  She also noted that it is not publicly
funded and is therefore unaffordable for many patients.

Evidence on Duty to Warn

[125]     In Canada,
pharmaceutical companies are prohibited from communicating drug information to
patients without Health Canada approval of the form and content of that
communication.  This information is contained in the “product monograph,” a
document that describes the properties, claims, indications and conditions for
use of the drug, along with any other information that may be required for the
optimal, safe and effective use of the drug.  The monograph contains separate
sections with information for health professionals and consumers.  The
information provided to consumers is reproduced in a patient information
leaflet, which Teva includes with every package of fentanyl matrix patches sold
in Canada.  Sandoz also includes a patient information leaflet with every box
of Sandoz Fentanyl.

[126]     For
generic drugs, Health Canada requires that the consumer information portion of
the monograph match the form and content of the monograph for the innovator
drug.  Only warnings which are included with the innovator’s product may be
included with the generic drug’s consumer information.  A generic manufacturer
may not unilaterally add warnings to its consumer information, or change the
wording of the existing warning.  The warnings for the innovator drug and the
generic drugs are, as a result, identical.

[127]     Health
Canada, as a part of its oversight of the pharmaceutical industry, will direct
changes to a drug’s product monograph from time to time.  As indicated by Ms.
Soltesz, this is only done where the manufacturer of the innovator drug comes
forward with a recommendation for a change.  The generic companies cannot
change warnings without Health Canada’s approval.

[128]     The Teva
and Sandoz provided copies of all the product monographs issued for
ratio-FENTANYL, TEVA-fentanyl, and Sandoz Fentanyl from launch until the date
of summary trial.  Both defendants also provided copies of their patient
information leaflets.

[129]    
With regard to the risk of respiratory depression, a review of the Teva
product information leaflets shows that, with some variation, the leaflets
provide the following warning:

When [fentanyl] should not
be used:

Because life-threatening decreases in breathing rate could
occur, ratio-FENTANYL should not be used:

·       
for the relief of pain following surgery.

·       
for the relief of pain which is only mild, or expected to last
less than several weeks.

·       
if you have acute or severe bronchial asthma.

·       
If you are having difficulty in breathing.

For the same reason, do not start
on ratio-FENTANYL unless you have already been taking a strong opioid
medication.

[130]    
Two of the later leaflets, produced for NOVO-FENTANYL between 2008-2010,
instead say that:

“Fentanyl is a very strong opioid
narcotic pain medicine that can cause serious and life-threatening breathing
problems. Serious and life-threatening breathing problems can happen
because of an overdose or if the dose you are using is too high for you” [emphasis
in original].

The leaflet advises patients to seek emergency medical help
immediately if they have trouble breathing, experience slow or shallow
breathing or a slow heartbeat, have severe sleepiness, feel faint, dizzy, or
confused, or have a seizure or hallucinations.

[131]     The leaflets
also address the potential for abuse, and advise patients to dispose of
leftover and discarded patches by flushing the patch down the toilet, not to
damage or chew the patch, and not to let anyone else use the patch.  Patients
are also advised that they should not exceed the dose recommended by their
doctor.

[132]     A number
of the experts reviewed the product information provided by Teva and Sandoz and
provided opinions as to the accuracy and comprehensiveness of the included warnings. 
Dr. Lau gave the opinion that all of the risks associated with the use of
fentanyl transdermal patches are reflected in Teva’s product monographs.  In
her opinion, the patient information leaflets “comprehensively addresses all
of the known patient safety risks relating to fentanyl patches of which the
patient should be made aware” (emphasis in original).  In particular, she
opines that the leaflet “reasonably warns of the risk of life-threatening
decreases in breathing rate.”

[133]     Dr. Lau
also states that the patient information adequately addresses the risk of
accelerated drug release through the provision of instructions designed to
mitigate the potential for inadvertent acceleration of the drug release rate. 
The leaflets advise the patient to apply the patch to a dry, non-hairy portion of
the body, and in particular, to apply to the chest, back, flank or upper arm;
to clip (not shave) the hair close to the skin, in order to avoid the risk of
cuts; not to put the patch on skin that is excessively oily, burned, broken
out, cut, irritated or damaged in any other way; not to clean the skin in the
application area with soaps, oils, or lotions which may irritate the skin; and
warns not to use soap, alcohol or other solvents to remove the patch because
they may increase the drug’s ability to go through the skin.  The leaflets
state that patients should remove one patch before applying the next one and
should apply the new patch in a different location on the skin, as Dr. Lau
notes that applying a new patch to the same area may increase the risk of
acceleration.  The leaflets also state that patients should not expose the
patch to sources of heat and should not be used if the patient develops a
fever.

[134]     Finally,
Dr. Lau gave the opinion that the leaflets reasonably address the risk of
interactions between fentanyl and other drugs, as the patient is warned not to
use the patch while using certain other medications or consuming particular
substances.  The patient is advised to inform the physician if taking any other
medications, while a list headed “interactions with this medication” indicates
that medications such as tranquilizers and sleeping pills may, in combination
with the fentanyl patch, “cause drowsiness, depressed breathing, low blood
pressure and possibly coma.”

[135]     Dr. Hawley
reviewed the product monographs issued by Sandoz in 2009-2010 and gave the
opinion that they adequately identify the risks of fentanyl use for physicians,
pharmacists and patients.  She also reviewed the patient information leaflet
and again deposed that the leaflet clearly and accurately explains the risks of
use with the Sandoz Fentanyl patch, including the statement that “Fentanyl is a
very strong opioid narcotic pain medicine that can cause SERIOUS AND LIFE-THREATENING
BREATHING PROBLEMS.”

ASSESSMENT OF THE EVIDENCE

[136]     As already
noted, Dr. Foldvari, Dr. Hawley and Dr. Lau all disagreed with various aspects
of Dr. Michniak-Kohn’s opinion.  The applicant defendants also challenged the
admissibility of much of Dr. Michniak-Kohn’s evidence.  In their submission,
she provided opinions on matters outside her area of expertise, misrepresented
or overstated the factual basis for her opinion, and acted as an advocate,
rather than a neutral or objective party.  Essentially, they say that Dr. Michniak-Kohn’s
opinion is not reliable, as she has not performed any studies or tests to
measure and compare the safety and performance of the two types of patch, or
provided any data or studies that provide direct support for her conclusion.

Matters Outside the Witness’ Area of Expertise or Lacking
a Reliable Factual Basis

[137]     The
applicant defendants particularly challenged Dr. Michniak-Kohn’s ability to
give evidence that relies on the interpretation of post-mortem fentanyl blood
levels.  In her affidavit she indicated that “[e]xperts in forensic toxicology
and forensic pathology have expressed the opinion that post-mortem fentanyl
levels can be relied upon as an estimate of the fentanyl level in the decedent’s
blood at the time of death.”  She says she relied on post-mortem blood levels
in reaching conclusions as to the safety of the matrix patches in the Mylan
fentanyl litigation.  However, as she admitted on cross-examination, she
herself is not qualified as an expert in forensic toxicology or pathology.

[138]     On
cross-examination the applicant defendants confronted Dr. Michniak-Kohn
with evidence given by toxicologists in the U.S. Mylan proceedings she
referenced.  In the transcripts, the toxicologists indicate that post-mortem
fentanyl levels are not a reliable indicator of the level of fentanyl in the
blood at time of death or the drug release rate of the fentanyl patch in
question.  Dr. Michniak-Kohn then acknowledged that reliance on
post-mortem fentanyl levels in determining cause of death is somewhat
controversial, as there are studies that suggest it is reliable and studies
that suggest it is not.  She did continue to state her opinion that the
evidence in the Mylan litigation, including the post-mortem fentanyl levels,
established that the patches had caused injuries in ordinary use by releasing the
drug at an accelerated rate.

[139]     In her
affidavit, Dr. Lau deposed that the difficulties in correlating ante-mortem and
post-mortem drug levels are well-recognized in the scientific community — she
provided a number of studies discussing these difficulties — and stated that
accurate interpretation requires an individualized approach with communication
with the decedent’s physician and other medical professionals.  In Dr. Lau’s
opinion, there was nothing in Dr. Michniak-Kohn’s report, curriculum vitae, or
the exhibits to her affidavit that suggest she has any proper basis for
offering an opinion regarding the significance of post-mortem drug levels in
determining cause of death.

[140]     Dr. Lau
also challenged Dr. Michniak-Kohn’s ability to give an opinion as to the
suitability of a particular medication (i.e. Butrans) for use in a clinical
setting.  She points out that Dr. Michniak-Kohn is not a licensed physician (a
fact that Dr.  Michniak-Kohn acknowledges) and is not qualified to
prescribe opioids or treat patients for pain.

[141]    
On cross-examination Dr. Michniak-Kohn admitted that she is aware that
buprenorphine cannot be used as an alternative for fentanyl with every patient.
She clarified that her view on Butrans is that it is “possibly safer than
fentanyl and could be an alternative.”  She says:

…in certain cases I am sure
Buprenorphine can be used.  Because I read in my literature search that that
could be an alternative.  … So I am not the only one looking at Buprenorphine
as a possible alternative.

[142]     The
applicant defendants say that Dr. Michniak-Kohn mischaracterized some of the
studies she relied on.  I have already noted some of these concerns above, with
regards to sources Dr. Michniak-Kohn relies on to establish that fentanyl may
cause death with ordinary use.  In addition, the applicant defendants say that
the Prodduturi article referred to above does not actually support the
conclusion that a matrix patch is more affected by variations in skin
permeability than a patch with a rate-controlling membrane.  It says that the
matrix patch may be more affected, but also acknowledges that the
experiments in the study were not sufficient to indicate whether the rate
control membrane could prevent an overdose in the case of heat damage to the
patch.

[143]     Dr.
Foldvari in her affidavit also says that the findings in the article are not
statistically significant as the variability in the results obtained was high
enough that conclusions could not safely be drawn without a larger sample size.

[144]     Finally,
the applicant defendants point out that Dr. Michniak-Kohn has herself has not
conducted any tests to determine how the matrix patches performed in relation
to patches with an additional membrane, or how the patches might perform with
the addition of another membrane.  Indeed, she acknowledged that she was not
aware that anyone has done direct head-to-head safety testing comparing
monolithic matrix patches and matrix patches with a rate-controlling membrane.

Dr. Michniak-Kohn as an Advocate

[145]     In
Canadian courts expert witnesses are required to be neutral and objective,
rather than advocating for a party or position. Indeed, pursuant to Rule 11-2
of the British Columbia Supreme Court Civil Rules, affidavits from
experts must contain a statement noting that they understand that their duty is
to assist the court, rather than to act as an advocate for any party.

[146]     The
applicant defendants say that Dr. Michniak-Kohn misunderstood her role as
expert and acted as an advocate for the plaintiffs, in particular by selecting
materials she felt supported her position while purposely omitting sources that
did not support her conclusion.  In cross-examination, Dr. Michniak-Kohn agreed
that she did not put in all the materials available to her but stated that
“everything is available in the public domain and I had to support the argument
I was presenting.”

[147]     The
applicant defendants particularly point to Dr. Michniak-Kohn’s reliance on a
letter from Alza, a US pharmaceutical company, to the FDA, where Alza alleges
that patches lacking a rate-controlling membrane may release significantly more
fentanyl than those that have one.  Alza’s letter also argued that patches
without a rate-controlling membrane may perform differently than products with
a membrane when applied to compromised skin, and as such should be treated as
different dosage forms.  Dr. Michniak-Kohn provided this letter as an exhibit
in support of her opinion that a matrix patch without a rate-control membrane
is not as safe as one that has a membrane.

[148]     As Dr.
Foldvari points out in her response affidavit, Alza, as the manufacturer of a
Duragesic-brand reservoir patch, has a direct interest in promoting its own
product over matrix style patches.  In her view, it is not proper scientific
technique to rely on material with such an obvious bias.  Further, she provided
a copy of the FDA response where the agency rejects Alza’s argument.  In it,
the FDA finds that Alza has not provided any reliable data to show that a
matrix system was less safe than a patch with a rate-controlling membrane.  The
FDA noted that while there may be some variability in skin permeability among
individuals that can affect the rate of absorption, there was no data showing
that a physical control (the membrane) provides a superior protection against
variations in absorption rate than a chemical (matrix) control.

[149]     Dr.
Michniak-Kohn acknowledged on cross-examination that she was aware that there
was an FDA reply, but did not think it necessary to include in her affidavit
as, in her view, the FDA simply took the position that Alza had not provided
sufficient data to accept their conclusion, rather than directly dismissing
Alza’s point of view.  When asked why she included the Alza letter in her
affidavit, she responded that it demonstrated that “the main company that was
and is involved in transdermal patches … also had concerns about the rate
controlling membrane.”  Once again, Dr. Michniak-Kohn appears to have been
selective in placing material before the court that support her opinion while
omitting contradictory material.

Conclusion on Dr. Michniak-Kohn’s Evidence

[150]     In
cross-examination Dr. Michniak-Kohn clarified a number of aspects of her
initial opinion.  Although in her affidavit she states that the matrix with a
membrane is a safer product, in her cross-examination she appeared to add a
caveat, repeating that the matrix patch with a rate controlling membrane may
be a safer product.  Noting that she had not done any comparisons in the
laboratory, she said that the literature suggests “that if we did those
studies, we may get some very favourable results.”  She also stated
that, in essence, her message is that the existing designs can be improved, and
that the addition of a “rate controlling membrane would potentially improve the
design of those patches …  Obviously, it is always a ‘may’ because … we haven’t
done the clinical trials on it.”

[151]    
Asked whether there is any peer-reviewed literature that addresses the
risk of overdose when a patch does not have a rate controlling membrane, she
responds:

…we know that rate controlling
membranes control permeability of drugs. That is well-known in the scientific
literature.  So if you are trying to make a matrix patch more safer … if you
add this rate controlling membrane, it should help.  … if you added that extra
layer, I think it is not high science to say that it would prevent some
problems with those patches.

She says that there is no need to do comparison testing
because it is obvious that adding another barrier to release — an additional
fail-safe — increases the safety profile.

[152]     The
opinion of Dr. Michniak-Kohn is not that the matrix patch manufactured and
distributed by Teva and Sandoz is unsafe.  Rather, she is of the opinion that
if a membrane was added to the patch it might be safer.  No tests have
been conducted to support her opinion and thus her opinion is speculative.  The
evidence of Dr. Foldvari is that patches sold in Europe and the United
States which Dr. Michniak-Kohn claims offer a matrix patch with an additional
membrane are not a third category of patch that is safer, but rather a patch in
which the membrane is a necessary feature of the patch to control the rate of
release of fentanyl.

[153]     I find
that Dr. Michniak-Kohn is qualified to give expert opinion evidence on some
aspects of this case, however she is not qualified to give opinion evidence on
the appropriateness of drugs that could be used in substitution for fentanyl. 
I also find that in the areas where she is qualified, her opinion that the
matrix patches manufactured by Teva and Sandoz are unsafe lacks a proper
factual foundation.  Finally, she has chosen to ignore evidence that contradicts
her opinion and has taken on the role of advocate for the opinion she is
advancing contrary to Rule 11-2(1) of the Supreme Court Civil Rules.

[154]     I find
that while her evidence is admissible, it is of little weight on the critical
issue of whether the matrix patches manufactured by Teva and Sandoz are unsafe
when used in accordance with the manufacturers’ directions.

Other Challenges to Expert Evidence

[155]     The
plaintiffs challenged the evidence given by Drs. Foldvari and Hawley.  They say
that Dr. Hawley’s assessment of the patches was overly focused on their value
for money, in particular the cost savings associated with the use of
transdermal fentanyl patches.

[156]     The
plaintiffs say the form of Dr. Foldvari’s affidavit — in which she appears to
express an opinion as to whether the applicant defendants met the legal
standard of care — undermines her neutrality and also deprives the court of
the ability to assess credibility or make the necessary factual findings.  They
say she relies too much on Health Canada approvals and bioequivalence studies
in establishing safety, rather than focusing on the question of whether the
products in question are reasonably safe or could cause harm in the manner
alleged.  They also say that her answers in cross-examination regarding the
role of bioequivalence in establishing safety were revealing, as she refused to
say that the bioequivalency studies established that the products were equally
safe.

[157]     The
plaintiffs also say that Dr. Foldvari, as an expert in transdermal delivery
systems, should have responded to questions on cross-examination about the
potential for increasing the safety profile of a matrix patch with the addition
of a rate-controlling membrane.  Asked whether two safety features would be better
than one safety feature, she responded that adding another rate-controlling
mechanism to a patch would not be “rational,” as it would suggest that the
first rate-control mechanism was not adequately tested or sufficiently
well-designed.

[158]     The
defendants’ experts provided clear and well supported opinions.  They have deep
knowledge and are experienced in their respective areas of expertise. Drs.
Hawley and Lau are practising physicians in the field of pain control and have
first-hand experience in the administration and monitoring of pain control
using fentanyl.  They acknowledge placing reliance on Health Canada regulation
and approvals of fentanyl products manufactured by Teva and Sandoz.  They did
not present as advocates for any product and they gave opinions on products
that have been approved for use in Canada by Health Canada.  The products
apparently favoured by Dr. Michniak-Kohn, Matrifen and Fentadur, have not been
approved for use in Canada.

[159]     I find the
expert evidence presented by Teva and Sandoz to be admissible and credible.

SUITABILITY FOR SUMMARY TRIAL

[160]     Rule 9-7
of the Supreme Court Civil Rules permits any party to an action to apply
to the court for judgment, either on an issue or generally, by way of a summary
trial.  The Rule, like its predecessor, Rule 18A, is meant to expedite the
early resolution of cases by allowing parties to put forward their evidence via
affidavits and other written materials, rather than by viva voce testimony.

[161]     Not all
matters are suitable for determination by this process.  As set out in Rule
9-7(15)(a), the court may not grant judgment in a summary trial where the judge
is unable to find the facts necessary to determine the issues, or is of the
opinion that it would be unjust to decide the issues summarily.

[162]    
The leading case on summary trial, Inspiration Management Ltd. v.
McDermid St. Lawrence Ltd., [1989] B.C.J. No. 1003 sets out a number of
factors for the court to consider in determining whether it would be unjust to
grant judgment at summary trial:

The chambers judge is entitled to
consider, inter alia, the amount involved, the complexity of the matter, its
urgency, any prejudice likely to arise by reason of delay, the cost of taking
the case forward to a conventional trial in relation to the amount involved,
the course of the proceedings and any other matters which arise for consideration
on this important question.

[163]     Subsequent
cases have identified a number of additional factors, including the cost of the
litigation, the time needed for summary trial, whether credibility is a
critical factor in the determination of the dispute, and whether the
application would result in “litigating in slices”:  see Dahl v. Royal Bank
of Canada, 2005 BCSC 1263 at para. 12, aff’d on appeal 2006 BCCA 369; and Gichuru
at para. 31.

[164]     In
addition, as noted in Dahl at para. 13, the court should not issue
judgment if doing so would require findings of fact that could embarrass the
court at the hearing of any subsequent issues, as may happen where there are
overlapping issues or multiple defendants.  See also Bacchus Agents (1981)
Ltd. v. Philippe Dandurand Wines Ltd., 2002 BCCA 138.

[165]     In Gichuru
at para. 35, the Court of Appeal affirmed that the onus on summary trial
remains with the plaintiff, even where the defendant has brought the application.
All parties must come to the summary trial hearing “prepared to prove their
claim, or defence” (para. 32).  In other words, there is no “respondent’s veto”
at summary trial:  the respondents — in this case, the plaintiffs — cannot
argue that the matter is unsuitable for summary disposition on the basis that
they have put forward insufficient evidence to prove their case (see Everest
Canada Properties Ltd. v. Mallmann, 2008 BCCA 275
at para. 34).

Positions of the Parties

[166]     The
plaintiffs argue that the proceedings involve complex factual issues that
require full examination for discovery and a conventional trial in order to
provide the court with a full appreciation of the facts.  They submit that
these matters are not suitable for summary trial, due to the complexity of the
case and the fact that conflicts in the evidence on the central issue will
require the court to assess credibility.  They also say that it is
inappropriate to use a summary trial process in the context of a
pre-certification class proceeding, as resolving the issues prior to
certification is inconsistent with the goals and principles of the Class
Proceedings Act.

[167]     Teva and
Sandoz point to a number of British Columbia cases where the court has issued
judgment under Rule 9-7 in a pre-certification class proceeding.  They also
submit that conflicts in the evidence and credibility issues are not an
absolute bar to proceeding summarily: MacMillan v. Kaiser Equipment Ltd.,
2004 BCCA 270 at para. 22.  Even if there are conflicts in the evidence,
provided there is sufficient admissible evidence to allow the judge to find the
necessary facts, summary trial may still be appropriate.  Finally, they say
that there are no conflicts in the evidence, and that the plaintiffs have
failed to meet their onus, as, in their submission, the affidavits tendered by
the plaintiffs are not admissible as proof of their claims.

Summary Trials and
Pre-Certification Class Proceedings

[168]     At the
summary trial hearing a major portion of the plaintiffs’ submissions were
concerned with the idea that a summary trial is prima facie inappropriate
for determining issues in a proposed class action.  As Teva and Sandoz point
out, relying on The Consumers’ Association et al. v. Coca-Cola Bottling
Company et al, 2006 BCSC 863, aff’d 2007 BCCA 356, and Dahl, there
are examples of British Columbia courts hearing pre-certification summary
trials on the issue of ultimate liability.  However, the plaintiffs’
submissions raise a question as to whether the status of this matter as a
proposed class proceeding is a factor to consider in determining whether it is
suitable for summary determination.

[169]     Section 40
of Class Proceedings Act expressly provides that the Supreme Court
Civil Rules apply to class actions, both pre- and post-certification.  There
is therefore no statutory bar on this court issuing judgment under Rule 9-7 for
a matter brought under the Class Proceedings Act.  However, as discussed
above, the rules may alter in application in order to recognize the class
proceedings context.

[170]     For the
reasons set out below, I conclude that the status of this matter as an “action
with ambition” is not in itself a factor that would render it unjust to issue
judgment.  The factors set out in Inspiration Management and the
subsequent case law provides sufficient safeguards against injustice, just as
they do in an ordinary action.

[171]     To begin, I
do not accept the plaintiffs’ argument that summary trial is not suitable
because determining the case prior to certification would be inefficient.  The
plaintiffs argued that, because the decision would not be binding on the
proposed class, judgment against the plaintiffs would simply result in another
member of the class stepping forward to pursue the claim on behalf of the
class.

[172]    
It is true that if this Court issues judgment against the plaintiffs and
dismisses the claim against Teva and Sandoz, that decision only binds the named
plaintiffs.  As noted in Michael Eizenga et al, Class Actions Law and
Practice 2d ed. (Markham: LexisNexis Canada, 2008):

Motions brought before the
certification motion, even where successful, may not mean an end to the
litigation for the defendant. The determination will not bind the potential
class members, and another class proceeding may be commenced.

[173]     In some
cases this might be a reason to deny the application for a summary trial; see
for example Sharrock v. Moneyflow Capital Corp., 2010 BCSC 1219.  In Pausche
v. B.C. Hydro et al., 2000 BCSC 1556, the court refused to issue judgment
on a limitations issue argued at a pre-certification summary trial, noting that
to do so could lead to a “pyrrhic victory for the defendants” as a new action
might immediately be begun by another representative plaintiff “who was not
susceptible to the limitations defence” (para. 22).  However, as Bauman J. (as
he then was) pointed out in Pausche, the application did not concern an
issue common to all members of the proposed class.  The same is true of Sharrock,
where the applicant defendants advanced a defence unique to the representative
plaintiff.

[174]     In cases
where the application concerns the defendant’s liability to the class a whole,
the concern about a replacement plaintiff is practically, if not legally,
alleviated: Martin v. Astrazeneca Pharmaceuticals PLC, [2009] O.J. No.
3847 (S.C.J.), noting that summary determination would likely have “the
practical effect of leading to an abandonment of the claims of other class
members, an early settlement or a narrowing of the issues to be tried” (para. 17).

[175]     Although
Teva and Sandoz have made submissions regarding the named plaintiffs, their
application for dismissal is based on the position that they are not in breach
of any duty in law to the users of their matrix transdermal fentanyl patches
they produce.  If they succeed on summary trial, it is difficult to imagine
that any new representative plaintiff would step forward to re-argue these
issues.

[176]     As Teva
and Sandoz point out, there are a number of decisions where this court issued
judgments under Rule 9-7 in pre-certification class proceedings.  In Dahl,
the plaintiffs brought a proposed class action against a number of defendant
banks, alleging a failure by the banks to disclose the amount they charged to
consumers using their credit cards.  The banks applied under Rule 18A for
dismissal on a number of the statutory claims, arguing that they had properly
disclosed the amounts in question as interest charges.  The court found that
the matter was suitable for summary trial.  The court also rejected the
plaintiffs’ argument that there were significant overlapping issues arising out
of the issue proposed for summary determination and the issues that remained to
be determined in the case.

[177]     Consumers’
Assn. of Canada involved a claim by the named consumers’ association on
behalf of all consumers who had purchased beverages in the province after 1997.
The plaintiffs claimed that the deposits for recyclable beverage containers
collected from consumers were to be held in trust until refunded to the consumer,
and alleged that the various corporate defendants (beverage manufacturers and
Encorp, the not-for-profit agency in charge of beverage returns and recycling)
had in fact converted $70 million in deposit funds to their own benefit.  The
court held that the matter was suitable for summary disposition, as the claims
were not factually complex, there were no significant credibility issues, and
the ample affidavit evidence addressed what few questions of fact arose in the
matter.

[178]     In
addition to Dahl and Consumers’ Assn. of Canada, the following
decisions also involved a summary proceeding, either under Rule 9-7 or Rule
18A, in a pre-certification class proceeding:

•  Pfeiffer v.
Pacific Coast Savings Credit Union, 2000 BCSC 1472, var’d on other grounds,
2003 BCCA 122.  Both parties applied for judgment under Rule 18A, the defendant
seeking dismissal and the plaintiff seeking judgment on three substantive
issues.  The case involved the interpretation of a mortgage contract.  The
plaintiff was successful at summary trial and received an individual award,
with the court directing that the hearing of the certification application be
heard at a later date.  The Court of Appeal disagreed with the chambers’
judge’s interpretation of the contract and reduced the award substantially, but
did not disagree with the decision to issue judgment on summary trial.

•  Royster v. 3584747
Canada Inc. dba Kmart Canada Ltd. et al, 2001 BCSC 153.  This proposed
class action involved the wrongful termination of Kmart employees following the
closure of a particular branch of the store.  The court found that the employer
had given reasonable notice, in the form of working notice and pay in lieu of
notice, and dismissed the claim following the summary trial.

•  Azevedo v. Legal
Services Society (British Columbia) (1998), 49 B.C.L.R. (3d) 45 (C.A.).  On
a summary trial the court found in favour of the defendant and dismissed the
claim; the Court of Appeal upheld the decision.  The plaintiff lawyer had
brought a proposed class action on behalf of all lawyers who had acted on
behalf of legal aid clients, alleging that the Society had breached the terms
of a contract by refusing to pay certain hold backs from legal fees.  The court
found that there was no promise to repay the hold backs in the contract.

•  Blackman v. Fedex
Trade Networks Transport & Brokerage (Canada), Inc., 2009 BCSC 201.  The
plaintiff alleged that the defendants were in breach of the Business
Practices and Consumer Protection Act in the manner in which they charged
customs brokerage fees to their customers.  The parties agreed that the matter
was suitable for disposition at summary trial; the court found in favour of the
defendants and dismissed the action.

[179]     I note
that in each of these cases the application concerned issues common to all
members of the proposed class.  I conclude that the “binding” concern raised by
the plaintiff is not sufficient, in itself, to find that it would be
inappropriate to issue judgment under Rule 9-7.

[180]    
In addition, regardless of any potential inefficiency, there are
legitimate policy reasons to allow for summary determination in proposed class
actions.  In Consumers’ Assn. of Canada, addressing a similar argument
from the plaintiffs, the court said as follows:

[35]  The fact that
this is a potential class action does not militate against the use of pre-trial
applications generally, or this R. 18A application specifically, as the
plaintiff argues.  The Class Proceedings Act at ss. 4 and 11 sets out a
sequence which trifurcates the proceeding into certification, trial of common
issues, and trial of individual issues.  One probably unintended consequence of
class proceedings statutes has been the transformation of certification
proceedings from preliminary step to battleground; in some senses, the certification
proceeding is the trial …  That being the case, I view pre-trial
interlocutory applications in an appropriate case as potentially streamlining
an increasingly cumbersome process, particularly in cases where the pleadings
are lacking in merit, yet may meet the low threshold for certification.

As stated in Kowch at para. 14, “[i]t is not a
principle of class action law that weeds should be allowed to ripen and grow,
instead of being nipped in the bud.”

[181]     Further,
if the matter has no merit, allowing it to continue to certification will
undoubtedly cause prejudice to Teva and Sandoz.  Where the court can find the
necessary facts through the summary process, it promotes efficiency to issue
judgment at the pre-certification stage.

[182]    
I am bolstered in this conclusion by the recent decision of the Supreme
Court of Canada in Hryniak v. Mauldin, 2014 SCC 7.  In that decision,
Karakatsanis J. began her judgment delivered for the Court in this way:

[1]        Ensuring access to justice is the greatest
challenge to the rule of law in Canada today.  Trials have become increasingly
expensive and protracted. Most Canadians cannot afford to sue when they are
wronged or defend themselves when they are sued, and cannot afford to go to
trial.  Without an effective and accessible means of enforcing rights, the rule
of law is threatened.  Without public adjudication of civil cases, the
development of the common law is stunted.

[2]        Increasingly, there is recognition that a culture
shift is required in order to create an environment promoting timely and
affordable access to the civil justice system.  This shift entails simplifying
pre-trial procedures and moving the emphasis away from the conventional trial
in favour of proportional procedures tailored to the needs of the particular
case.  The balance between procedure and access struck by our justice system
must come to reflect modern reality and recognize that new models of
adjudication can be fair and just.

[4]        In interpreting these provisions, the Ontario
Court of Appeal placed too high a premium on the "full appreciation"
of evidence that can be gained at a conventional trial, given that such a trial
is not a realistic alternative for most litigants.  In my view, a trial is not
required if a summary judgment motion can achieve a fair and just adjudication,
if it provides a process that allows the judge to make the necessary findings
of fact, apply the law to those facts, and is a proportionate, more expeditious
and less expensive means to achieve a just result than going to trial.

[5]        To that end, I
conclude that summary judgment rules must be interpreted broadly, favouring
proportionality and fair access to the affordable, timely and just adjudication
of claims.

[183]     While the
court acknowledged that the inappropriate use of summary procedures will likely
result in delays and increased costs, the view expressed resonates in an action
like this one where the process is likely to be long and expensive.

[184]     No doubt
Teva and Sandoz have the ability to fund this litigation, but money is not the
only cost associated with a class action that calls into question the safety of
a product such as fentanyl.  Upon certification public notices stating that the
drug is the subject of a class action and alleging the drug is unsafe and can
cause death in ordinary use is likely to alarm anyone who is using or perhaps
even prescribing fentanyl.  On the evidence presented, the consumers of
fentanyl are most likely to be people who are seriously ill and who use the
drug to control serious chronic pain.  That is, of course, of no consequence if
there is evidence to justify the action.  However, if the evidence is
insufficient to support the action then the consequences associated with
involvement in an extensive and expensive class action are very serious.

[185]     Although I
find that a pre-certification class action is not inherently unsuitable for
summary determination, it is not a simple matter to determine whether this
particular matter is suitable for summary determination.  There are a number of
factors — the complexity of the factual issues and the voluminous nature of
the filed materials, for example — that suggest that it would not be
appropriate to issue judgment.  On the other hand, as the defendants point out,
there are difficulties with the admissibility and weight of the plaintiffs’
evidence, and the onus remains with the plaintiffs.  If the plaintiffs have
failed to put forward sufficient evidence to make their case, it may be that
refusing judgment would be tantamount to allowing a respondent’s veto.

Complexity, Conflicting
Evidence and the Need for Full Appreciation

[186]     The matter
is not directly analogous to any of the previous summary trials held in
pre-certification class proceedings.  Those cases all concerned questions of
contract or statutory interpretation.  They involved few, if any, disputed
facts, and could be determined on the basis of a minimal evidentiary record.

[187]     That is
not the case here.  This matter requires the court to make findings of fact
concerning pharmaceutical design and drug safety.  The complexity of that
endeavour is perhaps best demonstrated by the fact that the parties filed more
than 5,000 pages in materials for this application, including affidavits,
exhibits, submissions and case authorities.

[188]     The
summary trial procedure is not well suited to factually complex cases.  In Chu
v. Chen, 2002 BCSC 906, this court indicated that a case involving copious
or voluminous affidavit materials may not be suitable for summary disposition.  I
note that in that case, the court refused to grant judgment when faced with
less than 900 pages in materials.  See also Simon Fraser Student Society v.
Canadian Federation of Students, 2009 BCSC 1081 at paras. 17, 21; again,
the court found that, due to the sheer volume of material before the court,
issuing judgment would prove “difficult, elusive and not necessarily fair or
just” (para. 22).

[189]     The
complexity in this case is exacerbated by the fact that the central issue —
the question of negligent design and the availability of a safer alternative
product — turns on conflicting expert opinion evidence.  The experts disagreed
about the relative safety and utility of the fentanyl transdermal patch products,
the relevance and correct interpretation of scientific studies, and even, at
some points, about the correct terminology to be applied to fentanyl drug
dosage forms.

[190]     Where
there are conflicting affidavits it may not be possible for the judge to find
the necessary facts.  In Inspiration Management the court said that
generally speaking, the chambers judge should not decide issues of fact or law
“solely on the basis of conflicting affidavits even if he prefers one version
to the other” (para. 55).  Certainly, in some cases the court may resolve the
conflict or find the necessary facts by looking to other admissible evidence.  However,
where there is a “head on” conflict in the evidence regarding an important
issue, and the court cannot resolve the issue without assessing the deponents’
credibility, it will not be suitable for summary determination: Jutt v.
Doehring (1993), 82 B.C.L.R. (2d) 223 (C.A.) at para. 13.

[191]     Teva and
Sandoz say that there is, in fact, no conflict in the evidence here because the
plaintiffs’ expert evidence is inadmissible or, if admissible, should receive
little to no weight.  I note that in British Columbia (Director of Civil
Forfeiture) v. Nguyen, 2011 BCSC 1792, the court commented that before a
judge will find that a conventional trial is required to resolve conflicts in
the evidence, the conflicts must be rooted in admissible evidence.

[192]     While the
materials filed in this trial are extensive, two key issues are reasonably
straightforward:

1.       Is
there evidence to connect the matrix patches manufactured by Teva and Sandoz to
the deaths of Mr. Player or Mr. Pollock? and

2.       Is
there sufficient evidence presented to establish that the Teva or Sandoz
patches are defectively designed?

[193]     As already
discussed, there is no evidence to connect either the Teva or Sandoz matrix
patch to the death of Mr. Pollock.  As to Mr. Player, the only evidence
presented is that Mr. Player died as a result of respiratory depression and
that fentanyl was one of several drugs that can cause fatal respiratory
depression.

[194]     On the
evidence, it is not known whether Mr. Player was using a fentanyl patch
manufactured by Teva or Sandoz.  There is no evidence available on that issue
and the evidence that is available is not sufficient to conclude that Mr. Player
died as a result of his use of fentanyl patch manufactured by Teva or Sandoz or
that his death was caused by fentanyl.  The best that can be said is that
fentanyl was among several other drugs in Mr. Player’s system that can cause
fatal respiratory depression.  The evidence is not sufficient to prove it was
more likely than not that Mr. Player died as a result of fentanyl use.

[195]     As to the
evidence respecting defective design, again, the evidence falls short.  As
already stated, I am not able to give the evidence of Dr. Michniak-Kohn
sufficient weight to support a finding of defective design.  At best, her
evidence is that there is another design or designs that might be safer.  The
alternate patches identified by Dr. Michniak-Kohn are Fentadur, Matrifen and
Mallinckrodt’s Fentanyl Transdermal system.  None have been approved for use in
Canada by Health Canada and all three are described as a “modified reservoir”
design.  Dr. Foldvari said in her evidence that the additional membrane in
those patches is an essential feature necessary to control the delivery of the
drug and that it is not an additional safety feature.

[196]     Dr.
Foldvari’s opinion is well documented and there is no evidence to show that the
patches have any problem with the delivery rate of the drug that could cause injury
or death in ordinary use.  I accept the opinion of Dr. Foldvari that there
is no known safer alternative to the matrix patches produced by Teva and
Sandoz.

[197]    
Despite the volume of material, I do not find this action to be so
complex that it would not be appropriate to deal with it on summary trial with
respect to the defendants Teva and Sandoz.

[198]     There are
comments in the law, as in Ho v. Ho, 2013 BCSC 559, that the court
should be hesitant to grant judgment on a summary trial where a party has not
yet had an opportunity to conduct examinations for discovery and where there
appears to be an issue that requires exploration by way of examinations or
production of documents.  Similarly, the court should be reluctant to resolve
factual issues on a summary trial application in the absence of admissible
evidence where the evidence “may well be tendered in admissible form at the
subsequent trial” (Farallon Mining Ltd. v. St. Eloi, 2012 BCSC 264 at
para. 31).  However, in this case, the parties have conducted full examinations
for discovery and cross-examinations of the respective experts.  The evidence
has been fully developed.  The plaintiffs had a full opportunity to present
evidence supporting their claims.

Overlapping Issues and the
Potential for Embarrassment

[199]     Where only
a few of the defendants apply for dismissal in a complex, multi-party
negligence case, the summary trial judge may be asked to “cross a legal
minefield, not knowing where to step to avoid making decisions with unforeseen
consequences or unintended results”: Privest Properties ltd. v. Foundation
Co. of Canada, [1990] B.C.J. No. 1349 (S.C.).

[200]     In my view
that is not a concern in this matter, as the issues to be determined need not
actually overlap with those involved with the claim against the other
defendants.  The products at issue in this summary trial are sufficiently
distinct in their design, so as to explain why any finding of fact in this
matter may not match the finding of fact in subsequent proceedings involving
the other defendants.

[201]     I have
tried to limit my comments on the facts to avoid making any findings about
fentanyl transdermal patches that might be construed as applying directly to
the reservoir-style products manufactured by the other defendants.  To be
clear, nothing I have said or will say in this judgment is intended as a
comment on whether those products are reasonably safe or not, or whether those
defendants have breached a duty of care to their consumers.  Although some of
the evidence dealt with the safety profile of the reservoir-style product, none
of the parties had argued that those products represented a safer alternative
design.  As such there is no need to reach any conclusion on their comparative
safety or design.  Similarly, although the evidence on failure to warn dealt
with a product monograph shared by all the fentanyl transdermal patches, my conclusions
on that point are limited to the duty to warn as it applies to Teva and
Sandoz’s matrix fentanyl transdermal patch products.  as the other products
rely on an alternative design, the same warning materials may lead to a
different conclusion on the standard of care.

[202]     In my
view, the crux of this case was the claim that a matrix patch with a
rate-controlling membrane represented a safer alternative design than that used
by Teva and Sandoz.  I can reach a conclusion on that point without foreclosing
any future submissions that may arise in subsequent proceedings between the
plaintiffs and the other defendants.

Conclusion on
Suitability for Summary Trial

[203]     In a
summary trial, as in any trial, the plaintiffs carry the obligation to prove
their claims through admissible evidence.  The rules of court and applicable
case authority establish that provided the facts can be found and it would not
be unjust to decide the matter on summary trial, the court can issue judgment: 
see Inspiration Management Ltd., and Rule 9-7(15) of the Supreme
Court Civil Rules.

[204]    
As Levine J.A. stated in Harrison v. British Columbia (Children and
Family Development), 2010 BCCA 220 at para. 40:

[40]      The trial judge was required to grant judgment if
the evidence adduced on the R. 18A application provided the facts necessary to
decide the issue of liability, and it would not have been unjust to do so.  It
is not a question of whether a full trial could conceivably “turn something up”
or produce a different result.  Rather, as stated by McEachern C.J.B.C in Inspiration
Management Ltd. v. McDermid St. Lawrence Ltd. (1989), 36 B.C.L.R. (2d) 202
at 215 (C.A.).

Anything might happen at a trial
and one can never say that the result will always or inevitably be the same.  If
the chambers judge can find the facts, then he must give judgment as he would
upon a trial unless for any proper judicial reason he has the opinion that it
would be unjust to do so.

The test for Rule 18A, in my view, is the same as on a
trial.  Upon the facts being found the chambers judge must apply the law and
all appropriate legal principles.  If then satisfied that the claim or defence
has been established according to the appropriate onus of proof he must give
judgment according to law unless he has the opinion that it will be unjust to
give such judgment.

[205]     On the
evidence before the court, I am satisfied that it is possible to find the
necessary facts to decide this case on summary trial.  The essential facts and
issues are not as complex as the considerable material placed before the court
may suggest.  There are conflicts in the expert evidence, but on my findings
that the opinion evidence of Dr. Michniak-Kohn is not of sufficient weight to
support the allegations made by the plaintiffs, there is no credible evidence
to support the plaintiffs’ claim.

[206]     There was
a significant body of evidence placed before the court on the summary trial and
the expert evidence has been thoroughly canvassed.  There is no suggestion that
the plaintiffs were not able to present all of the scientific evidence
available.  The same is true of Teva and Sandoz.  The evidence that has been
presented allows a full appreciation of the facts that are essential to the
determination of the plaintiffs’ action.

[207]     Class
actions are a powerful tool.  They allow an action to proceed where an
individual plaintiff would find the cost of an action prohibitive as well as in
actions where the research and investigation is not within the ability of a
single plaintiff.  However, it is not a tool where simply making an allegation
against a defendant or group of defendants is sufficient.  There must be
evidence to warrant the expense of a full trial.

[208]     In this
case the evidence against Teva and Sandoz is not sufficient to warrant such an
expense.  The plaintiffs’ expert has damaged her credibility by acting as an
advocate.  But perhaps more importantly, even if I accepted it, taken at its
best her evidence is that Teva and Sandoz marketed a product that was defective
because it did not utilize a membrane as was used in Fentadur, Matrifen and
Mallinckrodt’s fentanyl products.  Leaving aside the fact that none of those
products were approved for use in Canada at the relevant times, the expert
evidence that I do accept is that those products are a different reservoir type
design and not a safer matrix design.

[209]     I conclude
that this matter is suitable for summary determination.  I turn now to discuss
the application of the law to the facts.

NEGLIGENCE

[210]    
The law in Canada provides guidance as to the factors for consideration
in deciding if a product is unsafe for consumers in ordinary use.  See: More
v. Bauer Nike Hockey Inc., 2010 BCSC 1395, at paras. 195 and 202, aff’d by
2011 BCCA 419, Harrington v. Dow Corning Corp., 2000 BCCA 605.  The law
was nicely summarized by Nation J. in Daishowa-Marubeni International Ltd.
v. Toshiba International Corp., 2010 ABQB 627 at paras. 37-40 where she
said:

[37]      The manufacturer, who has the knowledge that the
absence of reasonable care in the design and manufacture of its product may
result in injury to the consumer’s life and property, owes a duty to the
consumer to take that reasonable care: Donoghue v. Stevenson, [1932]
A.C. 562 (H.L.) at p. 599.

[38]      The duty of reasonable care in design rests on the
principle that the manufacturer should use reasonable care to eliminate any
unreasonable risk or foreseeable harm …

[39]      Claims in negligent design require the court to
balance the risk inherent in the product as designed, considering its utility
and cost, against the risks inherent in a safer, alternate product or design.  One
has to look at the utility of the product, the nature of the product in terms
of the likelihood it will cause injury, the availability of a safer design, the
potential for designing and manufacturing the product so it is safer but
remains functional and reasonably priced, the ability of the plaintiff to have
avoided injury with careful use of the product, the degree of awareness of the
potential danger that can be attributed to the plaintiff and the manufacturer’s
ability to spread any costs related to improving the safely of the design.

[40]      The law does not impose
strict liability on manufacturers, the onus does not require that they produce
items that are accident proof or incapable of doing harm.  The manufacturer is
not the insurer of anyone who suffers injury while using or misusing a product.

[211]     The onus
is on the plaintiff to show that the item as designed was not reasonably safe
as there was a substantial likelihood of harm and it was feasible to design the
product in a safer manner: Tabrizi v. Whallon Machine Inc. (1996), 29
C.C.L.T. (2d) 176 (B.C.S.C.).

[212]     It is
clear from the evidence that Teva and Sandoz each complied with the appropriate
regulatory standards in manufacturing their respective fentanyl matrix
patches.  The evidence of Drs. Hawley and Lau attest to the utility or
usefulness of fentanyl in pain management and that there is no suitable
alternative available.  Dr. Lau said that the fentanyl transdermal patch is the
only effective transdermal patch available approved for the treatment of
moderate to severe pain.  Even Dr. Michniak-Kohn acknowledged in
cross-examination that fentanyl was required for some patients.

[213]     Dr.
Michniak-Kohn’s evidence is that Teva and Sandoz manufactured defective
products when different design choices would have made their products safer. 
But the evidence of Dr. Foldvari is that the products referred to, Fentadur,
Matrifen and the fentanyl patch manufactured by Mallinckrodt Inc., are really
modified reservoir patches where the so-called additional membrane is necessary
to control the release of the drug rather than an additional membrane to provide
extra safety benefits.

[214]     I find
that the matrix patches manufactured by Teva and Sandoz satisfy the
requirements as required by the law in Canada.  There is no satisfactory
evidence to show that there is a safer alternative design or that an alternate
design of the fentanyl patches was available and could have been used but for
the negligence of Teva and Sandoz.

FAILURE TO WARN

[215]    
The plaintiffs submit that Teva and Sandoz failed to provide an adequate
warning to consumers of the dangers associated with the use of fentanyl.  They
rely on Hollis v. Dow Corning Corp., [1995] 4 S.C.R. 634 at paras.
20 – 23.  In that case the court said:

[20]      It is well established in Canadian law that a
manufacturer of a product has a duty in tort to warn consumers of dangers
inherent in the use of its product of which it has knowledge or ought to have
knowledge.  This principle was enunciated by Laskin J. (as he then was), for
the Court, in Lambert v. Lastoplex Chemicals Co., [1972] S.C.R. 569, at
p. 574, where he stated:

Manufacturers owe a duty to
consumers of their products to see that there are no defects in manufacture
which are likely to give rise to injury in the ordinary course of use.  Their
duty does not, however, end if the product, although suitable for the purpose
for which it is manufactured and marketed, is at the same time dangerous to
use; and if they are aware of its dangerous character they cannot, without
more, pass the risk of injury to the consumer.

The duty to warn is a continuing
duty, requiring manufacturers to warn not only of dangers known at the time of
sale, but also of dangers discovered after the product has been sold and
delivered; see Rivtow Marine Ltd. v. Washington Iron Works, [1974]
S.C.R. 1189, at p. 1200, per Ritchie J.  All warnings must be reasonably
communicated, and must clearly describe any specific dangers that arise from
the ordinary use of the product

[216]     The court
went on to note that the rationale for the duty placed upon manufacturers can
be traced to the well-known case of Donoghue v. Stevenson. As
manufacturers who produce and distribute the drugs have a significantly greater
knowledge of the potential dangers of their products than consumers of the
drugs, the manufacturers bear a duty to warn to correct the imbalance of
knowledge between manufacturers and consumers so as to allow an informed
choice.

[217]     The higher
the danger associated with the ordinary use of the product the greater is the
burden upon manufacturers.  A general warning will not be sufficient.  A
warning must be sufficiently detailed to allow the consumers of the drug and
their professional advisors a full indication of the specific dangers that can
arise from the use of the product: Lambert v. Lastoplex Chemicals Co., [1972]
S.C.R. 569. The standard is necessarily a high one for pharmaceutical
products that people ingest, often when affected by serious illness.  What is
required is that accurate and understandable information be communicated.

[218]     Fentanyl
is not a product that can be purchased at a store. It is a product that
is only to be used when authorized by prescription and then only when the
consumer has been conditioned to opioid drugs through a period of titration
under the supervision of a qualified physician.

[219]     The
product at issue in Hollis was breast implants.  The defendant failed to
include a warning in its product monograph respecting the possibility of
unexplained ruptures of its product, a hazard it knew existed.  In Lambert  the
product was a highly inflammable lacquer/sealer the defendant knew could be
ignited by an open flame such as a pilot light in a furnace.

[220]     The
plaintiffs say that fentanyl is a highly dangerous drug that can cause
decreased heart rate and fatal respiratory depression and there is a duty to
provide “clear, complete and current” information to users of the drug.  The
plaintiffs submit the warning provided in this case were inadequate.

[221]    
Fentanyl is a drug that is only used under the supervision of a physician. 
Thus, there is a “learned intermediary” standing between the consumer of the
drug and the manufacturer.  The principle respecting a learned intermediary was
stated in Hollis this way:

[28]      … Generally, the [learned
intermediary] rule is applicable either where a product is highly technical in
nature and is intended to be used only under the supervision of experts, or
where the nature of the product is such that the consumer will not
realistically receive a direct warning from the manufacturer before using the
product.  In such cases, where an intermediate inspection of the product is
anticipated or where a consumer is placing primary reliance on the judgment of
a "learned intermediary" and not the manufacturer, a warning to the
ultimate consumer may not be necessary and the manufacturer may satisfy its
duty to warn the ultimate consumer by warning the learned intermediary of the
risks inherent in the use of the product.

[222]     Teva and
Sandoz submit that the product monographs relevant to this action were “clear,
complete and current.”  They are in identical form to the warnings of the
innovator drug that have been approved by Health Canada.  The Teva monograph
that is reproduced in the evidence clearly advised physicians that fentanyl
should only be prescribed by physicians knowledgeable about “…the continuous
administration of opioids and the management of patients receiving potent
opioids for treatment of pain and in the detection and management of
respiratory depression…”  Teva submits that the prescribing physician is able
to assess the dangers of the drug with respect to the particular patient.  It
argues the physician has a duty to know the potential dangers of the medication
prescribed to a patient and to exercise independent judgment about the product
with respect to the patient: Buchan v. Ortho Pharmaceutical (Canada) Ltd., [1986]
O.J. No. 2331 at para. 24; (1986), 54 O.R. (2d) 92 (C.A.).

[223]     Part I of
the Teva product monograph is directed to physicians.  It warns of all of the
risks associated with fentanyl that are relevant to the allegations in this
case.  In particular, it warns of potential deaths from hypoventilation and
states “…caution must be exercised and patients carefully observed for untoward
reactions.”

[224]     As noted
above, Dr. Hawley reviewed the product monographs and said that in her opinion
the product monographs are clear and that upon reviewing them the risks of
fentanyl use can be readily understood by physicians, pharmacists and
patients.  She said the monographs addressed all of the risks associated with
the use of fentanyl.  Her evidence was unchallenged and there is no evidence to
contradict her opinion.

[225]     The
plaintiffs note that the adequacy of the warnings in the product monographs is
a legal question for the court.  That is so, but the evidence of Dr. Hawley
and Dr. Lau can inform that decision and be of assistance in reaching a
conclusion.  Whether a product monograph respecting a pharmaceutical product is
clear, complete and current, is not likely a decision a court could make in the
absence of medical evidence.  In this case, I accept the evidence of Drs. Lau
and Hawley and rely on it in assessing the adequacy of the warnings in the
product monograph.

[226]     As to the
warnings in the patient monograph Ms. Player said that she was aware that only
one patch should be worn at a time and acknowledged that she and her husband
had reviewed the patient information received with the fentanyl patches he was
using.

[227]     The
product monographs that contain warnings to physicians and patients included
with the Sandoz and Teva matrix patches are required to be and have been
approved by Health Canada.  Dr. Hawley’s evidence is that the monographs
outline the risk of respiratory depression.  She also testified that the risks
fentanyl use outlined for patients in the monograph are clear and accurate and
reasonably understandable by patients.

[228]     Dr. Hawley
also said that in her opinion the information in the patient monograph provides
clear instructions on how to safely apply the patch and provides a reasonable
warning about the dangers of not following the instructions.  Her opinion is
not contradicted by any other evidence.

[229]     I find
that the product monographs distributed to physicians and pharmacists as well
as the product monograph in the form of a package insert for patients contain
clear, accurate and understandable warnings that are sufficient to satisfy the
test set out in Hollis at para. 20.  I therefore find that Teva and
Sandoz are not liable on the ground of failure to warn of the risks of using
fentanyl.

ADDITIONAL GROUNDS OF
LIABILITY

[230]     The
plaintiffs also advance several other grounds of liability.  As is common, their
action is cast in the broadest possible terms.  Given my findings and
conclusions on the product liability and failure to warn portions of the action,
I do not find it necessary to deal extensively with the remaining categories of
the claim.

Misrepresentation

[231]     The
plaintiffs claim that Teva and Sandoz misrepresented their products to
consumers and say that had the true facts been known, the plaintiffs and other
consumers would not have used fentanyl or would have ceased using it upon
becoming aware of the true facts.  The plaintiffs have issued a general
pleading on this point and have not particularized the precise
misrepresentations alleged.  However, it is my finding that there was no
misrepresentation of the facts made by either Teva or Sandoz in their product
monographs.  I find that the nature of the product and the risks of use were
clearly stated in a readily understandable way and that there was appropriate
advice given through the monographs and the advice of intermediary
professionals.  There is no evidence to support a claim of misrepresentation
and the action on that head of damage is dismissed.

Competition Act

[232]     The
plaintiffs’ next claim is that Teva and Sandoz engaged in unlawful, unfair and
deceptive trade practices that are proscribed by the Competition Act. 
Teva and Sandoz submit that there is no evidence to support any claim under the
Competition Act. Given my findings respecting the matrix patches
manufactured and distributed by Teva and Sandoz, it follows that there is no
evidence that either Teva or Sandoz are liable for a violation of the Competition
Act or that there is any causal connection between the matrix patches and
any loss or damage by the plaintiffs.

Other Statutes

[233]     I have
reached the same conclusion respecting the Food and Drugs Act, the Business
Practices and Consumer Protection Act, and the Sale of Goods Act. 
These claims rest on a necessary finding that Teva or Sandoz breached the
provisions of the statutes by manufacturing and distributing a dangerous
product even under ordinary use.  Upon my findings the claims must fail and
they are dismissed.  Likewise, there is no evidence that Teva or Sandoz
breached any warranty under the sale of goods or any express or implied
warranty that might arise as part of a collateral contract.

Breach of Fiduciary Duty

[234]    
The plaintiffs also claim that Teva and Sandoz breached a fiduciary duty
owed by drug manufacturers to consumers of fentanyl.  Teva and Sandoz submit
that the evidence in this case does not support a claim for breach of fiduciary
duty.  A similar submission was made by plaintiffs’ counsel and rejected in Wuttunee
v. Merck Frosst Canada Ltd., 2007 SKQB 29.  At paras. 60-63 of Wuttunee the
court said:

[60]      The plaintiffs acknowledge their claim based on a
breach of fiduciary duty is novel to the extent they seek to extend the
fiduciary relationship extant between doctor and patient to drug manufacturer
and their targeted consumers.  They submit that courts should acknowledge the
high degree of inequality between manufacturers of drugs and doctors is
comparable to the one between a doctor and a patient to the extent that drug
manufacturers are subject to a fiduciary duty to make full disclosure of any
deficiency in their product to doctors in their capacity as agents for patients
and to consumers directly.  They further argue that, without the extension of
fiduciary duty, current remedies are limited to "recoverable damages"
which are inadequate in the instant case.

[61]      The position of Merck in response may be summarized
as follows:

(a)  Fiduciary
duty exists where the defendant is in a position of power vis-à-vis the
plaintiff.  No such power exists in the instant case.  See: Lac Minerals
Ltd. v. International Corona Resources Ltd., [1989] 2 S.C.R. 574 at pp.
598-600; Norberg v. Wynrib, supra;

(b   A fiduciary is subject to
strict obligations otherwise unknown at law and is expected to act in a manner
consistent with the best interests of the beneficiary and Merck is not subject
to such an obligation;

(c)  There are no reported
decisions opining that a manufacturer or distributor of a controlled drug owes
a fiduciary duty to the consumer of its products; therefore, no cause of action
based on a fiduciary duty is available against it;

(d)  The plaintiffs’ proposed
subrogation by way of a fiduciary duty is inconsistent with the concept of
fiduciary duty to the extent that it contemplates the duty owed to one person
being imputed for the benefit of another.

[62] Waters’ Law of Trusts in Canada, 3d ed.
(Toronto: Thomson Carswell, 2005) summarizes the law regarding fiduciary
relationships generally at pp. 41-42 as follows:

Several relationships, in addition
to the relationship between trustee and beneficiary, have been generally
recognized as giving rise to fiduciary obligations.  These include the
relationship between partners, directors and corporations, solicitors and
clients, and agents and principals.  While these relationships are generally
recognized as giving rise to fiduciary obligations, they do not invariably do
so.  Although there are categories that are generally recognized as giving rise
to fiduciary obligations, the situations in which fiduciary relationships can
arise are not closed.  Identifying these situations can be difficult as there
is no widely accepted definition of what gives rise to a fiduciary
relationship.  However, in Frame v. Smith, [ [1987] 2 S.C.R. 99, 42
D.L.R. (4th) 81], Wilson J. suggested the following indicia of a fiduciary
relationship that have been accepted as a "rough and ready guide:"

(i)         The
fiduciary has scope for the exercise of some discretion or power.

(ii)        The
fiduciary can unilaterally exercise that power or discretion so as to affect
the beneficiary’s legal or practical interests.

(iii)       The
fiduciary is peculiarly vulnerable to or at the mercy of the fiduciary holding
the discretion or power.

[Citations omitted.]

[63]      Based on the facts
pled, the absence of any case authority or jurisprudential writing positing
that a fiduciary relationship arises in circumstances akin to those in the
instant case, and the additional reasons advanced by Merck, I conclude the
plaintiffs have no arguable cause of action based on breach of fiduciary duty
owed them by Merck.  While it is important not to foreclose the extension of
the fiduciary duties in appropriate circumstances, more than what is before the
Court is required to warrant an extension of fiduciary relationships in the
manner advocated by the plaintiffs, including detailed pleadings and a
comprehensive brief of law in support thereof.

[235]     Teva and
Sandoz take the same position as the defendants in Wuttunee, and rely on
Frame v. Smith to say the claim should be dismissed.  The plaintiffs’
invite the court to reconsider Wuttunee in light of recent developments
in the law.  However, the law in Canada is found in Frame v. Smith and
not Wuttunee; it is not open to me to “reconsider” the law as set out by
the Supreme Court of Canada.  While I accept the categories of fiduciary
relationship are not closed there is no evidence before me upon which I can
find that Teva or Sandoz had any scope for the exercise of discretion or power
that either defendant could exercise to affect the plaintiffs’ legal or
practical interests.  Further, there is no evidence that either of the
plaintiffs or a potential member of the proposed class was vulnerable to or at
the mercy of the exercise of the discretion or power.  I agree with the court’s
finding at para. 63 of Wuttunee, and dismiss the claim for breach of
fiduciary duty.

Strict Liability

[236]     The
plaintiffs say the defendants in this case are strictly liable to the
plaintiffs.  Teva and Sandoz argue that courts in Canada have rejected the
doctrine of strict liability in products liability cases.  I agree with that
submission.  The law in Canada is as stated in Daishowa-Marubeni
International Ltd.

CONCLUSION AND SUMMARY

[237]     The action
of the plaintiffs is dismissed as against Teva and Sandoz.  I find that Teva
and Sandoz did not breach any duty of care to the plaintiffs by selling a
product that was defectively designed.

[238]     I find
that the product monographs to physicians, pharmacists and consumers contained
information about the risk of using fentanyl patches manufactured and
distributed by Teva and Sandoz contained information that was clear, complete and
current and that Teva and Sandoz did not breach any duty of care by failing to
provide a reasonable warning to the plaintiffs.

[239]     Given my
finding that the patches manufactured by Teva and Sandoz were not defectively
designed, I find that there was no negligent misrepresentation to the
plaintiffs respecting the Teva and Sandoz matrix patches.

[240]     I also
find that there was no breach of statute by Teva or Sandoz respecting the sale
and distribution of their respective transdermal matrix fentanyl patches.

[241]     The action
by the plaintiffs against Teva and Sandoz is dismissed.  Costs may be spoken to
if necessary.

               “J.
K. Bracken, J.”                

The
Honourable Mr. Justice Bracken