



COURT OF APPEAL FOR ONTARIO

CITATION:
Adam v. Ledesma-Cadhit, 2021 ONCA 828

DATE: 20211122

DOCKET: C67828

Brown, Roberts and Zarnett JJ.A.

BETWEEN

Abudu Ibn Adam, May Hyacenth
    Abudu, Ibrahim A.C. Abudu (a minor by his litigation guardian, Abudu Ibn Adam),
    and The Estate of Aminatawalla Napoga Chidinma Abudu (by the litigation
    administrator, Abudu Ibn Adam)

Plaintiffs (Appellants)

and

Christine J. Ledesma-Cadhit,
GlaxoSmithKline Inc.
, Her Majesty the Queen in Right of Canada,
    Her Majesty the Queen in Right of Ontario

Defendants (
Respondent
)

Jasmine M. Ghosn, for the appellants

Randy C. Sutton, Kate Findlay and Justine
    Smith, for the respondent GlaxoSmithKline Inc.

Heard: June 28, 2021 by video conference

On appeal from the judgment of Justice Markus
    Koehnen of the Superior Court of Justice, dated December 10, 2019, with reasons
    reported at 2019 ONSC 7066.

Brown J.A.:

OVERVIEW


[1]

Amina Adam was the daughter of the appellants, May Hyacenth Abudu and Abudu
    Ibn Adam. Amina died on November 28, 2009. She was five years old.

[2]

Five days prior to her death, Amina had received a vaccine called
    Arepanrix, which was manufactured and distributed by the respondent
    GlaxoSmithKline (GSK). Arepanrix was designed to protect against the H1N1
    influenza, known as the swine flu.

[3]

An autopsy concluded that the cause of Aminas death was unascertained,
    with sudden arrhythmic death syndrome not excluded. The investigating coroner
    found that the most likely cause of death was sudden arrhythmic death syndrome.
    However, the Paediatric Death Review Committee of the Office of the Chief Coroner
    ultimately classified Aminas cause of death as undetermined.

[4]

Aminas parents believed the vaccine had caused their daughters death.
    They commenced this action against GSK, Dr.
Christine J.
    Ledesma-Cadhit, their family physician who had administered the vaccine to
    Amina, Her Majesty The Queen in Right of Canada, and Her Majesty The Queen in
    Right of Ontario, alleging that Arepanrix had caused their daughters death.

[5]

Prior to trial, the
appellants discontinued the
    action against Dr.
Ledesma-Cadhit, and in 2014 the action was
    dismissed against the two government defendants: 2014 ONSC 5726.

[6]

Following a three-week trial, the trial judge dismissed
    the action against GSK. He began his reasons for judgment by observing that
    [a] parent can suffer no greater loss than that of a young child. As a father
    and grandfather, I share that sentiment; this is a very sad case. However, the
    trial judge concluded that the appellants had not introduced evidence that
    would demonstrate, on a balance of probabilities, that GSK breached the
    applicable standard of care or that Arepanrix caused Aminas death.

[7]

The appellants appeal. I will examine each of their grounds of appeal
    later in these reasons. However, having examined the evidence from the trial, I
    have concluded that the trial judge did not commit any reversible error that
    would justify interference by this court. Accordingly, I would dismiss the
    appeal.

BACKGROUND

The distribution of Arepanrix in the fall of 2009

[8]

In early 2009, the World Health Organization (WHO) learned about the
    development of a new strain of influenza virus: H1N1, commonly known as the
    swine flu. The WHO declared H1N1 to be a pandemic and, in the summer of 2009,
    called on drug manufacturers to begin clinical trials for a vaccine to combat
    H1N1.

[9]

GSK developed two vaccines: Arepanrix and Pandemrix. Pandemrix was
    manufactured and distributed in Europe; Arepanrix was manufactured and distributed
    in Canada. Clinical trials for Arepanrix began in 2008 but had not been
    completed when the pandemic was declared.

[10]

The
    Canadian Minister of Health authorized the sale of the Arepanrix vaccine
    pursuant to an interim order dated October 13, 2009 (Interim Order). As part
    of the Interim Order process, Health Canada agreed to indemnify GSK for any
    claims brought against it in relation to the administration of the Arepanrix
    vaccine.

[11]

Although
    human trials of Arepanrix were not finished by the time Health Canada
    authorized the vaccines use, the product was not without clinical history. GSK
    had developed other pandemic vaccines on which the H1N1 vaccine was based. The
    principal precursor was the H5N1 vaccine, developed in the early 2000s against
    bird flu that had developed in Hong Kong. The H5N1 vaccine was developed for
    use with an adjuvant, the role of which was explained by the trial judge:

An adjuvant is a substance that enhances the body's immune
    response to an antigen. When used with vaccines, an adjuvant is administered as
    a second injection separate from the vaccine. Use of an adjuvant is beneficial
    when dealing with an unexpected strain of influenza because manufacturing a
    sufficient number of vaccine doses for an unexpected virus can be problematic.
    An adjuvant, in effect, boosts the power of a vaccine, thereby allowing a lower
    dosage of the vaccine to be used.  This in turn allows a given number of
    vaccines to be distributed over a larger population than would be possible
    without an adjuvant.

[12]

Arepanrix
    was based on the H5N1 vaccine. The adjuvant that was used together with the
    vaccine had already been approved by Health Canada in another context. While
    clinical trials of both Arepanrix and Pandemrix showed a higher incidence of
    adverse events, particularly when used with an adjuvant, the intensity and
    frequency of the events were not sufficiently severe to cause regulatory concern.

[13]

Clinical
    trials of Arepanrix involving children had not started when Health Canada
    issued the Interim Order, nor was there any data about the use of Arepanrix in
    children at the time GSK received authorization for its sale. However, there
    was data on the use of the adjuvant with the H5N1 vaccine on children.

The administration of Arepanrix to Amina

[14]

Amina
    received the Arepanrix vaccine on Monday, November 23, 2009 from her family
    physician, Dr. Ledesma-Cadhit. Aminas mother and older brother received
    vaccinations at the same time from the same vials. Dr. Ledesma-Cadhit told
    Aminas mother to give the children Tylenol in the event of discomfort or
    fever.

[15]

Although
    Amina complained that she was not feeling well, she continued to attend school
    for the balance of the week.

[16]

On
    Saturday, November 28, Amina again complained that she was not well  she had
    pain in her feet and an upset stomach, but she continued to eat, although not
    as much as usual. Ms. Hyacenth took the children to a pharmacy across the
    street from their apartment to buy more Tylenol. As described by the trial
    judge:

After returning home, Ms. Hyacenth had decided to bring Amina
    to the emergency ward of a nearby hospital but would give Amina a bath and
    something to eat before doing so.

Ms. Hyacenth ran a bath for Amina. Amina needed to use the
    toilet. Ms. Hyacenth left her alone to do so but told her to call out when she
    was done.  Ms. Hyacenth returned to the kitchen to check on the soup she was
    cooking. When Ms. Hyacenth had not heard anything for a few minutes, she sent
    her son Ibrahim to check on Amina.  Upon entering the washroom he screamed for
    help. Amina appeared to have collapsed off of the toilet halfway into the tub.
    Ms. Hyacenth rushed to get Amina, laid her out on the living room floor and
    began administering cardiopulmonary resuscitation. An ambulance was called. 
    Amina was taken to Scarborough General Hospital where she was pronounced dead
    shortly after arrival.

ISSUES ON APPEAL

[17]

The
    appellants advance five grounds of appeal:

Breach of the standard of care:

(i)

The trial judge erred in finding that GSK
    provided an adequate warning to Amina and her mother, as caregiver to Amina,
    with respect to Arepanrix;

(ii)

The trial judge erred in finding that GSK
    discharged its duty to warn by relying on the learned intermediary rule;

(iii)

The trial judge erred in failing to find that
    GSK did not meet the standard of care required of it with respect to its
    post-marketing commitments in terms of its continuing duty to the consumer to
    evaluate adverse events;

Causation:

(iv)

The trial judge erred in failing to find that
    the circumstantial evidence in this case raised an inference of negligence that
    called for an explanation from GSK;

Costs:

(v)

The trial judge erred in failing to award the
    unsuccessful appellants their full indemnity costs. The appellants submit that
    this case required adjudication by the courts as it was in the public interest
    and met the test of novelty, thereby justifying an award of costs to them.

FIRST ISSUE:
The adequacy of the warning by
    GSK

SECOND ISSUE: The application of the
learned
    intermediary rule

[18]

I
    propose to deal with the first and second issues together as the application of
    the learned intermediary rule is subsumed within the larger issue of whether
    GSK discharged its duty to warn of risks of the vaccine.

The governing legal principles

[19]

The
    general principles governing the duty to warn by manufacturers of medical
    products are well known, not in dispute, and were summarized by the Supreme
    Court in
Hollis v. Dow Corning Corp.
, [1995] 4
    S.C.R. 634, at paras. 20 to 29:

(i)

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;

(ii)

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;

(iii)

All
    warnings must be reasonably communicated and must clearly describe any specific
    dangers that arise from the ordinary use of the product;

(iv)

The nature
    and scope of the manufacturers duty to warn varies with the level of danger associated
    with the ordinary use of the product. Where there are significant dangers, it
    will rarely be sufficient for manufacturers to give general warnings concerning
    those dangers. Instead, the warnings must be sufficiently detailed to give the
    consumer a full indication of each of the specific dangers arising from the use
    of the product;

(v)

Manufacturers
    of products such as drugs that are ingested, consumed or otherwise placed in
    the body, and thereby have a great capacity to cause injury to consumers, are subject
    to a correspondingly high standard of care under the law of negligence;

(vi)

There is a heavy onus on manufacturers of drugs to provide clear,
    complete, and current information concerning the risks inherent in the ordinary
    use of their product
;

(vii)

As a general
    rule, the duty to warn is owed directly by the manufacturer to the ultimate
    consumer. However, an exception known as the learned intermediary rule applies
    where a product is highly technical in nature and is intended to be used only
    under the supervision of experts, such as physicians, 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. Where an intermediate
    inspection of the product is anticipated or where a consumer is placing primary
    reliance on the judgment of a learned intermediary, such as a physician, and
    not on 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;

(viii)

The learned intermediary
    rule presumes that the intermediary physician is learned, in the sense that
    the physician is fully apprised of the risks associated with the use of the
    product. A manufacturer can only be said to have discharged its duty to the
    consumer when the intermediarys knowledge approximates that of the
    manufacturer. To allow manufacturers to claim the benefit of the rule where
    they have not fully warned the physician would undermine the policy rationale
    for the duty to warn, which is to ensure that the consumer is fully informed of
    all risks.

[20]

In
Hollis
, the Supreme Court identified the overarching
    question to be answered as whether the manufacturer owed the patient a duty to
    warn of a specific risk. The Supreme Court broke that overarching question down
    into two sub-questions:

(i)

Did the manufacturer have a duty to warn recipients of the medical
    product directly or could it satisfy its duty by warning a learned
    intermediary, such as a physician?

(ii)

If
    the manufacturer could properly discharge its duty by warning the physician,
    did it adequately warn the physician of the specific risk in light of its state
    of knowledge at that time?

[21]

I
    will follow the framework used by the Supreme Court in
Hollis
and review the trial judges reasons in light of the following two questions:

(i)

Did the trial judge err by concluding that GSK could satisfy its duty to
    warn recipients of Arepanrix by warning a learned intermediary physician, in
    this case Aminas family doctor, Dr. Ledesma-Cadhit?

(ii)

If
    GSK could properly discharge its duty by warning the physician, did the trial
    judge err in concluding that GSK adequately warned Dr. Ledesma-Cadhit of the
    relevant risks of Arepanrix in light of its state of knowledge at that time?

[22]

Whether
    GSK discharged its duty of care is a question of mixed fact and law, as it
    involves applying legal principles to facts, which requires interpreting and
    weighing evidence. That exercise attracts a standard of review of palpable and
    overriding error:
Housen v. Nikolaisen
, 2002
    SCC 33, [2002] 2 S.C.R. 235, at paras. 29 and 36.

Did the trial
    judge err by concluding that GSK could satisfy its duty to warn by warning an
    intermediary physician?

[23]

The
    trial judge held, in effect, that GSK could satisfy its duty to warn by
    informing Aminas family doctor of the risks associated with Arepanrix through
    the product monograph that accompanied each vial of vaccine and a Product
    Information Leaflet that was posted on the websites of GSK and Health Canada.
    He wrote, at paras. 37 and 38:

GSK did disclose in its Product Information
    Leaflet for the Arepanrix vaccine and in its product monograph that Health
    Canada had authorized the sale of the vaccine based on only limited clinical
    testing and no clinical experience at all with children. Dr. Ledesma-Cadhit
    believes she knew this from the Health Canada website.  She was also aware
    that Arepanrix was authorized through a special process because of the
    pandemic.

The product monograph for Arepanrix disclosed that there was
    limited clinical experience with an investigational formulation of another
    adjuvanted vaccine but no clinical experience with children.  In addition,
    the product information leaflet and product monograph disclosed a number of
    risks.

[24]

The
    appellants contend that the trial judge erred in so holding.

[25]

The
    appellants first submit that since Aminas mother independently learned about
    the vaccine and sought it out for her children, the learned intermediary rule
    does not apply. I disagree. The vaccine was a product that was highly technical
    in nature and which could only be obtained and used under the supervision of an
    expert, in this case Aminas family doctor. Those circumstances bring the
    vaccine squarely within the ambit of the learned intermediary rule.

[26]

The
    appellants next submit that Aminas family doctor did not possess the same
    level of information as GSK regarding the risk of a high fever in a child after
    receiving the vaccine and how to treat such a high fever. Specifically, they
    argue that:

(i)

on November 16, 2009, about a week before Amina received her dose of the
    vaccine, Health Canada had emailed GSK asking for more information about three
    cases of significant or high-level fever observed in children who had received
    the full dose antigen plus adjuvant. Yet, following that request for
    information, GSK did not publish to the general public any advisory regarding
    fever; and

(ii)

GSK
    prepared a Product Information Leaflet, which was approved by Health Canada. In
    its November 12, 2009 communication about the Ministers authorization of the
    vaccine sent out to about 50,000 physicians, GSK advised physicians to consult
    the Leaflet for detailed information about the vaccine and provided links to
    the document on the websites of Health Canada and GSK. The Leaflet contained a
    Consumer Information section that stated a common side effect of the
    vaccine was fever. The Leaflet advised that common side effects were usually
    mild and should only last a day or two. It went on to state: If any of these
    side effects occur, please tell your doctor or nurse immediately. If any of the
    side effects gets serious, or if you notice any side effects not listed in this
    leaflet, please tell your doctor. However, the product monograph placed in
    boxes of Arepanrix distributed to physicians did not contain the Consumer
    Information section.

[27]

It
    is clear the trial judge did not accept that either consideration prevented GSK
    from relying on Aminas family doctor to satisfy its duty to warn. Although the
    trial judges reasons do not offer a specific reason for that conclusion, the
    answer is clear from and supported by two pieces of evidence that came out of
    the testimony of Dr. Ledesma-Cadhit: see
R. v. G.F.
,
    2021 SCC 20, 71 C.R. (7th) 1, at para. 70. The record disclosed that:

(i)

Dr. Ledesma-Cadhit testified that, prior to administering the
    vaccine to Amina, she told Aminas mother that the side effects included fever
    and, if a fever appeared, she should administer Tylenol. As far as she could
    remember, Dr. Ledesma-Cadhit told Aminas mother
to return to
    her office if she had any concerns, if the children experienced any side effect
    the mother considered to be serious, or if the common symptoms described lasted
    a day or two;

(ii)

Dr. Ledesma-Cadhit also confirmed that before administering the
    vaccine to Amina, she had read the GSK product monograph for Arepanrix. The
    adverse reactions section of that document was identical to that in the Product
    Information Leaflet, describing the incidence of significant and high-level
    fevers in children who were part of the H5N1 study. Dr. Ledesma-Cadhit
    testified that she believed she went to the Health Canada website mentioned in
    the product monograph to obtain information about the vaccine. Dr.
    Ledesma-Cadhits evidence also suggested that she had probably read GSKs
    November 12, 2009 letter sent to physicians.

[28]

As
    well, during his cross-examination, Dr. Gaston De Serres, a medical doctor and
    epidemiologist called by GSK who was qualified as an expert witness at trial,
    responded to questions about the information included in the Arepanrix product
    monograph:

Q. Well, regardless of whats in Aminas
    record, Im just asking a clean question here on whether there is anything in
    the product monograph that gives guidance to doctors around use of the vaccine
    with children who have some history of respiratory illness?

A. I have not read this whole document but I
    would probably guess that there was none.

Q. Okay. And would  are you aware of any
    guidance given to doctors around the issue of fever as an adverse event thats
    coming out with the adjuvanted vaccine and how to manage the fever in the
    document?

A. Well, as I wrote in my report, this is not
    part of what we expect from product leaflet or inserts. This is done by, you
    know, how you care or how you manage patients with fever or adverse events
    following immunization is completely outside the realm of what is put in
    product leaflets. This is not done by manufacturers, its done by medical
    groups  advisory groups and is not put in that kind of product information
    sheet. And thats true not only for this product, its true for drugs, its
    true for everything, you know.

[29]

In
    light of that evidence, I see no reversible error in the trial judge applying
    the learned intermediary rule in the circumstances of this case.

Did the trial judge err in concluding that GSK adequately warned Dr.
    Ledesma-Cadhit of the relevant risks of Arepanrix in light of its state of
    knowledge at that time?

[30]

At
    trial, the appellants advanced several reasons why GSK had failed to adequately
    warn Dr. Ledesma-Cadhit about relevant risks associated with Arepanrix: some
    countries had refused to make the vaccine available because of safety concerns;
    Arepanrix was not appropriate for people with asthma; GSK had failed to convey
    at an early stage findings concerning unexplained phenomena and harm caused
    by its product; and the adverse event of Aminas death was not included in
    tracking data about the vaccine.

[31]

The
    trial judge addressed each submission. He held that the evidence did not
    establish the deficiencies asserted by the appellants:

(i)

There was no reliable evidence about the reasons why some other
    countries did not make Arepanrix available and the simple fact that certain
    jurisdictions did not approve Arepanrix is not enough to prove that GSK fell
    short of its standard of care by distributing Arepanrix in Canada;

(ii)

The
    medical evidence at trial was consistent that patients with asthma were
    preferred candidates to receive the vaccine because asthmatics can suffer more
    serious complications from flu than non-asthmatics and, in any event, Amina was
    never diagnosed with asthma;

(iii)

There was
    no evidence that GSK failed to convey at an early stage findings concerning
    unexplained phenomena and harm caused by Arepanrix. At paras. 43 to 51 of his
    reasons, the trial judge reviewed in some detail GSKs ongoing disclosure of
    information about the vaccine; and

(iv)

Although
    Aminas death was not reported directly to GSK, Dr. Ledesma-Cadhit had filed a
    timely adverse event report with Toronto Public Health Authorities, one of the
    approved channels for reporting adverse events.

[32]

The
    trial judge concluded, at para. 60:

The issues surrounding the standard of care here involve an
    understanding of the appropriate standards applicable to manufacturing, testing
    and approving drugs, as well as standards of disclosure to governments,
    physicians and the public when drugs are distributed.  In the absence of
    expert evidence that GSK failed to meet a particular standard and in the face
    of evidence that demonstrates GSK acted responsibly to disclose information,
    test products and manufacture products all in circumstances of urgency, I
    cannot find any breach of a standard of care.

[33]

On
    appeal, the crux of the appellants challenge to this holding by the trial
    judge is found in para. 56 of their factum where they list eight matters that
    GSK should have disclosed to Aminas mother, including the risk of a high
    fever.

[34]

I
    have already concluded that there is no reversible error in the trial judges
    finding that GSK was entitled to rely on a learned intermediary, Aminas family
    doctor, to satisfy its obligation to convey information about risks to the
    recipients of the vaccine. Further, the product monograph that accompanied the
    vaccine vial identified in some detail known adverse reactions to the vaccine,
    as disclosed both in the H1N1 studies conducted up until that time, as well as
    in the prior studies of the H5N1 vaccine which used the AS03 adjuvant. The
    appellants have not pointed to any evidence that GSK failed to disclose adverse
    risks that were known or ought to have been known at the time.

[35]

Moreover,
    the regulatory information published at the time informed the public of the cost/benefit
    assessment that led the Minister to make the Interim Order authorizing the
    administration of Arepanrix. GSK summarized the key parts of that regulatory
    information in the opening of the Arepanrix product monograph, which Aminas
    family physician testified that she read:

Health Canada has authorized the sale of
    Arepanrix H1N1 based on limited clinical testing in humans under the provision
    of an Interim Order (I0) issued on October 13, 2009.
The
    authorization is based on the Health Canada review of the available data on
    quality, safety and immunogenicity, and given the current pandemic threat and
    its risk to human health, Health Canada considers that the benefit/risk profile
    of the Arepanrix

H1N1 vaccine is favourable for
    active immunization against the H1N1 2009 influenza strain in an officially
    declared pandemic situation
.

[Emphasis added]

[36]

Given
    the making of the Interim Order, the onus of proof that lies on a plaintiff in
    any negligence action required the appellants to establish, on the balance of
    probabilities, that GSK did not meet its duty to provide Aminas family
    physician with clear, complete, and current information concerning the risks
    and dangers inherent in the ordinary use of Arepanrix:
F.H.
    v. McDougall
, 2008 SCC 53, [2008] 3 S.C.R. 41, at para. 40. The
    record discloses that the appellants failed to do so. As observed by the trial
    judge, one of the forensic difficulties of the appellants case at trial was
    that they did not adduce expert evidence that GSK had failed to adequately warn
    about specific risks of the vaccine. As a practical matter, e
xpert
    evidence concerning the complex area of vaccine manufacture and distribution was
    necessary
in the circumstances of this case
for the
    court to reach a conclusion of a breach in the standard.
Given the lack
    of any such evidence adduced by the plaintiffs, I see no reversible error in
    the trial judges conclusion that the appellants had failed to establish, on
    the requisite balance of probabilities, that GSK breached the applicable duty
    to warn.

[37]

I am
    not persuaded by this ground of appeal.

THIRD ISSUE:
GSKs post-marketing commitments

[38]

As
    stated in the Explanatory Note accompanying the Interim Order that authorized
    the sale of Arepanrix, GSK was
required to submit all the
    safety and

effectiveness data
    available at the time of the vaccine submission as well as a plan to

allow for the collection, assessment and
    reporting of information about the vaccines

safety and effectiveness.

[39]

Although
    the appellants Fresh as Amended Statement of Claim did not allege that GSK was
    negligent because it had failed to meet its post-marketing commitments, at
    trial the appellants alleged that GSKs failure to include Aminas death in its
    post-marketing tracking data constituted a breach of the standard of care.

[40]

The
    trial judge did not accept that submission. He held that although GSK did not
    learn of Aminas death until this lawsuit was started, the family doctor, Dr. Ledesma-Cadhit,
    had filed an adverse event report regarding Aminas death with the Toronto
    Public Health authorities.

[41]

The
    trial judge also found that there was no evidence to suggest that the tracking
    system that GSK or any of the public health authorities established somehow
    fell short of the standard of care applicable to tracking systems of this
    sort. Dr. Carole Legare, who in 2009 had been assigned to the Biologics and
    Genetics Therapies Directorate of Health Canada, testified about the
    post-marketing review of data concerning Arepanrix conducted by that agency. Dominique
    Barbeau, an employee of GSK, testified that the company had met all the
    post-marketing commitments that it had agreed to perform. The appellants did
    not lead any evidence to the contrary.

[42]

On
    appeal, the appellants repeat the submission they made at trial, in even stronger
    terms. As put in para. 68 of their factum: GSKs failure to investigate
    Aminas severe adverse event, and its significant reliance on government
    actors, amounts to bad faith and ought to have attracted punitive damages
    awarded to Aminas estate.

[43]

I do
    not accept this submission for several reasons.

[44]

First,
    this submission confuses the purpose of a civil trial with the purpose of a
    public inquiry or coroners inquest. Aminas parents understandably want a
    definitive explanation about what caused their daughters death. The coroners
    investigation and the resulting conclusion that the cause of Aminas death was
    undetermined did not provide them with such certainty. However, a civil trial
    is not a form of coroners inquest or public inquiry. While the civil pre-trial
    discovery process may disclose information not previously known by a party, the
    plaintiffs in a civil action labour under an obligation to establish, on a
    balance of probabilities, that some identifiable legal wrongdoing by the
    defendant caused an injury or death. The record fully supports the trial
    judges conclusion that the appellants failed to do so.

[45]

Second,
    the appellants action alleges that the administration of Arepanrix to Amina
    caused her death. Establishing liability for Aminas death would require the
    appellants to demonstrate, on a balance of probabilities, that some act or
    omission of GSK that took place
prior
to Aminas death caused her death. It is difficult to conceive how an act or
    omission of GSK that took place after Aminas death could have contributed to
    her death, which is essentially the thrust of the appellants breach of
    post-marketing commitment allegation. If, however, the appellants contention
    is that GSKs post-marketing activities failed to disclose a risk of the vaccine
    that should have been known to GSK
before
the vaccine was administered to Amina, their argument fails in light of the
    trial judges finding to the contrary, which they have not demonstrated is
    tainted by palpable and overriding error.

[46]

Finally,
    GSKs November 12, 2009 Letter to Health Care Professionals, which had been
    approved by Health Canada, asked physicians to report any case of serious or
    unexpected adverse events in patients receiving Arepanrix to their local public
    health authorities, the Public Health Agency of Canada, or GSK. On December 8,
    2009, Dr. Ledesma-Cadhit sent an adverse event report to Toronto Public Health
    that reported Aminas death five days following her vaccination. While there
    certainly is common sense merit to the appellants contention that local public
    health authorities should pass on adverse event information to a drug
    manufacturer, the failure to do so in this case did not cause or contribute to
    Aminas death and, therefore, cannot be a basis for civil liability in negligence
    against GSK.

[47]

Accordingly,
    I am not persuaded by this ground of appeal.

FOURTH ISSUE:
    The inference of negligence from the circumstantial evidence

[48]

The
    appellants also take issue with two findings made by the trial judge: (i) there
    was no direct or circumstantial evidence from which he could infer that GSK
    breached the standard of care ; and (ii) there was no evidence that Arepanrix
    could cause or in fact caused Aminas death.  In challenging those findings as
    errors, the appellants advance submissions that blend the issue of negligence
    (breach of standard of care) with the issue of causation. They argue that:

(i)

The circumstances surrounding Aminas death required the trial judge to
    call on GSK to explain Aminas death;

(ii)

If
    a risk falls within the realm of possibility, no matter how small or miniscule,
    causation is proved; and

(iii)

Consequently,
    if GSK could not rule out the vaccine as a cause of Aminas death, then GSK
    should share the familys burden and be found liable.

[49]

The
    appellants summarized their submission in para. 117 of their factum, stating:

The experts could not rule out Arepanrix H1N1 as a cause of
    Aminas death. We must, therefore, conclude that it is within the realm of
    possibility that Arepanrix H1N1 was a cause of Aminas death. Once that
    conclusion was reached, given that only GSK as the distributor of Arepanrix
    H1N1, could possibly have the relevant expertise to answer to the concerns
    arising from such conclusion, GSK must carry the burden (not the Plaintiffs) of
    going to the next step of ruling it out.

[50]

In
    considering this ground of appeal, I will first deal with the aspect of
    inferring a breach of the standard of care from circumstantial evidence and
    then with the aspect of causation.

(1)

Inferring a breach of the standard of care from circumstantial evidence

[51]

The
    appellants submission that the circumstances surrounding Aminas death
    required the trial judge to call on GSK to explain her death contains echoes of
    the discarded maxim of
res ipsa loquitur
,
    which dealt with the use of circumstantial evidence in negligence cases. The
    old maxim provided that a plaintiff could establish negligence by a defendant
    if (i) the thing that inflicted the damage on the plaintiff was under the sole
    management and control of the defendant, (ii) the occurrence in issue was such
    that it would not have happened without negligence, and (iii) there was no
    evidence as to why or how the occurrence took place:
Fontaine
    v. British Columbia (Official Administrator)
, [1998] 1 S.C.R. 424,
    at para. 18.

[52]

In
Fontaine
,
the Supreme Court of
    Canada concluded that whatever value
res ipsa loquitur
may once have provided to the adjudicative process had long since passed and
    went on to clarify, at para. 27, the proper use of circumstantial evidence in
    negligence cases:

It would appear that the law would be better served if the
    maxim was treated as expired and no longer used as a separate component in
    negligence actions.  After all, it was nothing more than an attempt to
    deal with circumstantial evidence.  That evidence is more sensibly dealt
    with by the trier of fact, who should weigh the circumstantial evidence with
    the direct evidence, if any, to determine whether the plaintiff has established
    on a balance of probabilities a
prima facie
case
    of negligence against the defendant.  Once the plaintiff has done so, the
    defendant must present evidence negating that of the plaintiff or necessarily
    the plaintiff will succeed.

See also:
Dickie v. Minett
,
    2014 ONCA 265, at para. 3.

[53]

The
    trial judge followed the approach directed by
Fontaine
but it led him to conclude that
there was no direct or
    circumstantial evidence from which he could infer that GSK breached its
    standard of care. Paragraphs 57 to 59 of his reasons explain the basis for that
    conclusion:

Arepanrix was developed based on the fully
    tested H5N1 vaccine. Even though Arepanrix was distributed and administered
    before the full course of clinical testing had run its course, that was done
    for valid public health concerns and with government approval, not by virtue of
    carelessness.

There was no evidence at trial to suggest that
    GSK had failed to disclose relevant information to Health Canada or to
    physicians. Similarly, there is no evidence to suggest that GSK disclosed false
    or misleading information to Health Canada or to physicians. Manufacture of
    Arepanrix was subject to government testing. Proactive measures were taken to
    become aware of safety signals once administration of Arepanrix began.

In the absence of contrary expert evidence
    about industry or regulatory standards, these circumstances indicate that GSK
    was acting responsibly and meeting its standard of care.
While
    I agree it is possible that GSK breached its standard of care in one or more of
    these steps or may have otherwise breached its standard of care, I am not able
    to make such a finding based on the evidence before me.
I note that GSK
    had a standard of care expert whom they did not call at trial after I
    questioned whether it was necessary to take trial time for that expert given
    the absence of any evidence on the issue from the plaintiffs. [Emphasis added]

[54]

The
    appellants have not established that those conclusions of the trial judge rest
    on any misunderstanding of the applicable law, misapprehension of the evidence,
    or palpable and overriding error of fact.

(2)

Causation

[55]

To
    succeed in an action for negligence, a plaintiff must establish that the
    defendants breach of the standard of care caused the injury or death:
Clements v. Clements
, 2012 SCC 32, [2012] 2 S.C.R. 181, at
    para. 6. In
Rothwell v. Raes
(1990), 2 O.R.
    (3d) 332 (C.A.), leave to appeal refused, [1991] S.C.C.A. No. 58, it was
    alleged that the administration of a vaccine to an infant had caused him brain
    damage. This court stated, at p. 333, that unless it was established that the
    vaccine could cause such damage, the plaintiff could not succeed. If such a
    general causal relationship was found to exist, the question became whether the
    vaccine did cause the damage suffered by the infant plaintiff.
[1]


[56]

In
    the present case, the trial judge carefully and accurately reviewed the
    evidence of the expert and lay witnesses relating to causation. He held that
    there was no evidence that the vaccine was capable of causing death and there
    was an absence of medical evidence that the vaccine caused or contributed to
    Aminas death: at paras. 119-120. Those findings were firmly anchored in the
    evidence adduced at trial.

[57]

The
    appellants submission that if a risk falls within the realm of possibility, no
    matter how small or miniscule, causation has been demonstrated mis-apprehends the
    established legal principles concerning causation. The trial judge properly
    rejected that submission when, at para. 64, he accurately stated and applied
    the governing legal principles:

The plaintiffs point to a number of witnesses, including
    defence experts, who agreed that the vaccine could not be excluded as a cause
    of death. That, however, is not the test that the plaintiffs must meet. The
    plaintiffs must prove on a balance of probabilities that the vaccine
caused
Aminas death. The fact that it could not be
    excluded as a possible cause does not meet the burden the plaintiffs must meet.

[58]

Further,
    the appellants submission that they had established the vaccine caused Aminas
    death because some defence experts, Drs. De Serres and Langley, testified they
    could not rule out the vaccine as the cause of her death ignores the entirety
    of those experts evidence.

[59]

In
    examination-in-chief, Dr. De Serres testified that in his opinion, Aminas
    death was not caused by the Arepanrix vaccine. On cross-examination, he
    testified as follows:

Q. So then doctor, would you say then
    confidently, there is no risk of a death in a child five days post vaccination
    with Arepanrix?

A. I would say that the likelihood of such an
    event...

Q. Im asking if there is a zero risk. Are you
    confident in stating there is zero risk?

A. Nobody would ever say zero risk. Wed just
     we can never rule that out.


[60]

On
    re-examination, Dr. De Serres testified that the likelihood the vaccine
    contributed to Aminas death was extremely low.

[61]

In
    her expert report, which was treated as her evidence-in-chief, Dr. Langley
    opined:

There is no evidence to support sudden death
    or cardiac arrest in humans at any point following receipt of H1N1 vaccine, and
    no evidence in that it led to this most unfortunate death in this child. The autopsy,
    biochemical tests and cultures do not identify a cause of death.

[62]

On
    cross-examination, Dr. Langley expressed the opinion that Aminas death was
    unexplained. She went on to testify that 
because we dont
    know the cause we cant exclude anything. Since there was no evidence of what
    caused Aminas death, anything could be the cause really, but we have no
    evidence.

[63]

When
    fairly read in their entirety, the testimony of Drs. De Serres and Langley
    provide no assistance to the appellants task of establishing, on a balance of
    probabilities, that the vaccine caused Aminas death.

[64]

I am
    not persuaded by this ground of appeal.

FIFTH ISSUE: The failure to award costs to the unsuccessful
    appellants

[65]

The
    appellants final ground of appeal concerns the trial judges award of costs to
    GSK.

[66]

While
    the appellants were unsuccessful at trial, they sought a cost award of
    $564,559.30 on the basis of the cases exceptional circumstances.

[67]

The
    trial judge concluded that this was not one of those exceptional cases in which
    the unsuccessful party should be awarded costs. He rejected the appellants
    submission that there were prelitigation circumstances that had provoked the
    litigation, making this case an exceptional circumstance. As well, he noted
    that prior to trial, GSK had made three settlement offers to the appellants,
    which increased in amount from the payment of $150,000 to the appellants to
    $300,000.

[68]

Although
    GSKs partial indemnity costs of the action were about $450,000, the company
    only sought costs of $50,000, which the trial judge awarded on the basis that
    GSK was the successful party at trial.

[69]

The
    appellants submit that cost award was an error. They advance several reasons
    why the trial judge should have made an exceptional award of costs to them
    notwithstanding they had failed to prove their case: (i) the vaccine could not
    be excluded as a cause of Aminas death; (ii) the family had incurred the cost
    of investigating Aminas death which was a severe adverse event to Arepanrix
    H1N1; (iii) the information collected pursuant to GSKs post-marketing
    commitments increased knowledge about the vaccine; (iv) GSK had a duty to
    investigate Aminas death; (v) when Amina took the jab, this benefited the
    community as a whole as part of the concept of herd immunity; and (vi) the
    case involved a matter of public interest, namely the consumer protection of
    vulnerable children.

[70]

I am
    not persuaded by the appellants submissions. Absent an error in principle or a
    clearly unreasonable result, deference is owed to a trial judges exercise of
    discretion in awarding costs. The trial judge recognized that he could award
    costs in favour of the unsuccessful appellants, but he concluded that this is
    not a case that even approaches the circumstances in which such an order should
    be made. Specifically, he wrote:

While it may have been appropriate for the
    plaintiffs to commence the action when they did, none of the information as it
    evolved pointed to the GlaxoSmithKline vaccine as a cause of death. As noted in
    my reasons, this was not a case that came close to establishing liability nor
    was it anywhere near a tough call. There was simply no evidence to relate
    Aminas death to the vaccine. By the time the plaintiffs had their own experts
    report they should have known that it was highly unlikely that they could
    establish causation. By the time the plaintiffs had the defence experts
    reports, that became even clearer.

In those circumstances, an offer of $300,000
    shortly before trial was one that was objectively highly attractive.

[71]

I
    see no basis upon which to interfere with the trial judges discretionary award
    of costs to GSK. He took into account factors relevant to a request for costs
    by an unsuccessful party and explained why those factors did not justify
    departing from the generally applicable principle that costs follow the cause.

DISPOSITION

[72]

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

[73]

If the parties are unable to agree on the costs of the appeal
    within 15 days of the release of these reasons, they may submit written cost
    submissions, which are not to exceed 5 pages in length, excluding any cost
    outline or bill of costs.

Released: November 22, 2021 DB

David
    Brown J.A.

I
    agree. L.B. Roberts J.A.

I
    agree. B. Zarnett J.A.





[1]
In the
    defective drug jurisprudence, whether a drug is capable of causing harm is
    referred to as general causation; whether it in fact caused harm to the
    plaintiff is known as individual or particular causation. For a discussion, see
Harrington v. Dow Corning Corp
.
,
    2000 BCCA 605, 82 B.C.L.R. (3d) 1, at paras. 42 to 46, leave to appeal refused,
    [2001] S.C.C.A. No. 21;
Batten v.
    Boehringer Ingelheim (Canada) Ltd.
, 2017 ONSC 53, at para. 38, affd 2017
    ONSC 6098 (Div. Ct.), 20 C.P.C. (8th) 414, leave to appeal to Ont. C.A.
    refused, M48535 (February 28, 2018);
Wise
    v. Abbott Laboratories, Limited
, 2016 ONSC 7275, 34 C.C.L.T. (4th) 25,
    at para. 340; Patricia Peppin, Vaccines and Emerging Challenges for Public Health
    Law in Tracey M. Bailey, C. Tess Sheldon, Jacob J. Shelley, eds.,
Public Health Law and Policy in Canada
,
4th ed. (Toronto: LexisNexis Canada, 2019), §III.


