Court File and Parties

COURT OF APPEAL FOR ONTARIO 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)

Counsel: 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 Amina’s 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 Amina’s cause of death as “undetermined”.

[4] Amina’s parents believed the vaccine had caused their daughter’s 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 daughter’s 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 Amina’s 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 vaccine’s 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. Amina’s mother and older brother received vaccinations at the same time from the same vials. Dr. Ledesma-Cadhit told Amina’s 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 manufacturer’s 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 intermediary’s 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 judge’s 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 Amina’s 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 Amina’s 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 Amina’s 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 Amina’s family doctor. Those circumstances bring the vaccine squarely within the ambit of the learned intermediary rule.

[26] The appellants next submit that Amina’s 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 Minister’s 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 Amina’s family doctor to satisfy its duty to warn. Although the trial judge’s 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 Amina’s 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 Amina’s 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-Cadhit’s evidence also suggested that she had probably read GSK’s 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 what’s in Amina’s record, I’m 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 that’s 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, it’s done by medical groups – advisory groups and is not put in that kind of product information sheet. And that’s true not only for this product, it’s true for drugs, it’s 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 Amina’s 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 GSK’s ongoing disclosure of information about the vaccine; and (iv) Although Amina’s 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 Amina’s mother, including the risk of a high fever.

[34] I have already concluded that there is no reversible error in the trial judge’s finding that GSK was entitled to rely on a learned intermediary, Amina’s 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 Amina’s 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 Amina’s 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, expert 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 judge’s 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: GSK’s 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 vaccine’s 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 GSK’s failure to include Amina’s 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 Amina’s death until this lawsuit was started, the family doctor, Dr. Ledesma-Cadhit, had filed an adverse event report regarding Amina’s 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: “GSK’s failure to investigate Amina’s severe adverse event, and its significant reliance on government actors, amounts to bad faith and ought to have attracted punitive damages awarded to Amina’s 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 coroner’s inquest. Amina’s parents understandably want a definitive explanation about what caused their daughter’s death. The coroner’s investigation and the resulting conclusion that the cause of Amina’s death was “undetermined” did not provide them with such certainty. However, a civil trial is not a form of coroner’s 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 judge’s 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 Amina’s death would require the appellants to demonstrate, on a balance of probabilities, that some act or omission of GSK that took place prior to Amina’s death caused her death. It is difficult to conceive how an act or omission of GSK that took place after Amina’s 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 GSK’s 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 judge’s finding to the contrary, which they have not demonstrated is tainted by palpable and overriding error.

[46] Finally, GSK’s 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 Amina’s 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 Amina’s 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 Amina’s 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 Amina’s death required the trial judge to call on GSK to explain Amina’s 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 Amina’s death, then GSK should “share the family’s 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 Amina’s death. We must, therefore, conclude that it is within the realm of possibility that Arepanrix H1N1 was a cause of Amina’s 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 Amina’s 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 defendant’s 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 Amina’s 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 Amina’s 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 Amina’s 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, Amina’s 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. I’m asking if there is a zero risk. Are you confident in stating there is zero risk? A. Nobody would ever say zero risk. We’d just – we can never rule that out.

[60] On re-examination, Dr. De Serres testified that the likelihood the vaccine contributed to Amina’s 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 Amina’s death was unexplained. She went on to testify that “because we don’t know the cause we can’t exclude anything.” Since there was no evidence of what caused Amina’s 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 Amina’s 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 judge’s 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 case’s 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 GSK’s 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 Amina’s death; (ii) the family had incurred the cost of investigating Amina’s death “which was a severe adverse event to Arepanrix H1N1”; (iii) the information collected pursuant to GSK’s post-marketing commitments increased knowledge about the vaccine; (iv) GSK had a duty to investigate Amina’s 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 judge’s 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 Amina’s death to the vaccine. By the time the plaintiffs had their own expert’s report they should have known that it was highly unlikely that they could establish causation. By the time the plaintiffs had the defence expert’s 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 judge’s 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, aff’d 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.