Amina Adam, the five year old daughter of two of the appellants, died five days after receiving the Arepanrix vaccine manufactured and distributed by respondent, GlaxoSmithKline (“GSK”). The cause of death was unascertained, and the coroner indicated 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 classified Amina’s death as undetermined.
An action was commenced by Amina’s family against GSK, Dr. Christine J. Ledesma-Cadhit (the family doctor who administered the vaccine), Her Majesty the Queen in Right of Canada, and Her Majesty the Queen in Right of Ontario. The plaintiffs believed that the vaccine had caused their daughter’s death. Prior to the trial, the appellants discontinued the action against the family doctor and the two Crown defendants.
In 2009, the World Health Organization declared H1N1 otherwise known as swine flu, a pandemic. GSK developed two vaccines: Arepanrix and Pandemrix. Arepanrix was manufactured and distributed in Canada. Clinical trials for Arepanrix began in 2009 but were not completed when swine flu was declared a pandemic.
The Canadian Minister of Health authorized the sale of the Arepanrix vaccine pursuant to an Interim Order which indicated that Health Canada would indemnify GSK for any claims brought against it in regards to the administration of the vaccine. Human trials of the Arepanrix vaccine were not completed when Health Canada authorized its use but GSK had developed other pandemic vaccines on which this vaccine was based.
Arepanrix was based on the H5N1 vaccine which was developed for use with an adjuvant. The trial judge explained the role of adjuvant as a substance that enhances the body’s immune response to an antigen. Clinical trials of Arepanrix showed a higher incidence of adverse effects when used with an adjuvant, however, they were not sufficiently severe to cause regulatory concern. Clinical trials involving children had not started when the Interim Order was issued.
Administration to Amina
Amina received the vaccine from Dr. Ledesma-Cadhit. Her mother and older brother also received the vaccine on the same day. Dr. Ledesma-Cadhit advised the mother to give the children Tylenol if they had fever or discomfort. Amina claimed she did not feel well and her discomfort continued for five days. Amina’s mother wanted to take Amina to the hospital, but wanted her to have a bath and eat beforehand. She left Amina unsupervised in the bathroom and after a few minutes her son found Amina collapsed. The plaintiff administered CPR and an ambulance was called. Amina was pronounced dead shortly thereafter.
Trial Judge Decision
The trial judge dismissed the action against GSK because the plaintiffs had not introduced evidence that demonstrated on a balance of probabilities, that GSK breached the applicable standard of care, or that the vaccine had caused Amina’s death.
The plaintiffs appealed on five grounds. The plaintiffs claimed that the trial judge erred in finding that:
- GSK provided an adequate warning to Amina and her mother with respect to the risks of the vaccine;
- GSK discharged its duty to warn by relying on the “learned intermediary rule”;
- GSK had not breached its duty of care in respect to its “post-marketing commitments” and the continuing duty to the consumer to evaluate adverse events;
- The circumstantial evidence in this case did not raise an inference of negligence that called for an explanation from GSK; and
- GSK should not have to pay the plaintiffs’ costs on a full indemnity basis.
Court of Appeal Analysis
The Adequacy of the Warning and the “learned intermediary rule”
The Court of Appeal relied on the Supreme Court of Canada’s (“SCC”) discussion in Hollis for its standard of care analysis, where it was stated that the overarching question to be answered in this type of case is whether a medical product manufacturer owed the patient a duty to warn of a specific risk. The SCC had broken down the question into two sub-questions:
- 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?
- 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?
The plaintiffs submitted that since Amina’s mother learned about the vaccine independently and sought it for her children, the learned intermediary rule did not apply. They further argued that the family doctor did not possess the same level of information as GSK regarding the risk of a high fever in children.
The Court of Appeal found that since the vaccine was a product that was highly technical in nature and could only be obtained with the supervision of an expert, it fell within the realm of the learned intermediary rule.
The Court of Appeal relied on Dr. Ledesma-Cadhit’s testimony at trial, where she stated that prior to administering the vaccine, she disclosed that side effects included fever. The doctor confirmed that before administering the vaccine, she read GSK’s product monograph. As such, the court found there was no error in the trial judge applying the learned intermediary rule.
Regarding the second sub-question, the appellants submitted that GSK failed to adequately warn the family doctor about relevant risks associated with Arepanrix. The Court of Appeal found that the appellants had no evidence that GSK failed to disclose adverse risks that they knew or ought to have known at the time. In addition, there was regulatory information published that informed the public of the cost/benefit assessment which led the Minister to make the Interim order.
An explanatory note accompanying the Interim Order making the vaccine available had stated that GSK was required to submit all the safety and effectiveness data available at the time of the vaccine submission to ensure its safety and effectiveness. At the appeal, the appellants submitted that GSK’s failure to investigate the adverse event amounted to bad faith.
The Court of Appeal indicated that a civil trial is not a form of coroner’s inquest or public inquiry. Liability requires the appellants to demonstrate on a balance of probabilities that GSK’s act or omission that took place prior to Amina’s death caused her death.
The appellants’ allegation in this regard concerned an act or omission occurring after Amina’s death. GSK’s letter to health care professionals was approved by Health Canada, and outlined the proper procedure for reporting adverse effects in patients. The plaintiffs’ family doctor complied with that procedure. This ground of appeal was accordingly rejected.
Circumstantial Evidence on Causation and the Burden of Proof
The appellants argued that since experts could not rule out Arepanrix as the cause of death, it must be concluded that it was within the realm of possibility to have caused the death, and that GSK had the burden of ruling it out.
The Court of Appeal addressed the use of circumstantial evidence in negligence actions. The Court stated that the plaintiffs’ submission in this regard echoed the discarded maxim, res ipsa loquitur (a court can infer negligence from the very nature of an accident or injury).
The Court of Appeal cited the Fontaine decision,where it was outlined that circumstantial evidence should be weighed with the direct evidence by the trier of fact to determine if the plaintiff established a prima facie case of negligence against the defendant. The Court of Appeal found that the trial judge correctly applied the Fontaine approach when he found that there was no direct or circumstantial evidence from which he could infer that GSK had breached its standard of care.
The Court of Appeal agreed with the trial judge 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.
Costs of the Action
The plaintiffs sought an award of costs on the basis that the case had exceptional circumstances. The Court of Appeal rejected this argument, and said that absent an error in principle or unreasonable result, deference is owed to the trial judge’s exercise of discretion in awarding costs.
The appeal was dismissed.
This case will be influential in future litigation concerning medication and vaccines. It reinforces the general principles governing the duty to warn by manufacturers of medical products, and the applicability of the learned intermediary principle.
Where there is no direct link between a medication and a death said to result from it, it will be difficult to hold the manufacturers liable. The fact that experts could not rule out Arepanrix as Amina’s cause of death was not enough to prove a breach of standard of care or causation. Breach of the standard of care, and causation, must be proven on a balance of probabilities in a civil action.
 v. Dow Corning Corp.  4 SCR 634
 Fontaine v. British Columbia (Official Administrator), 1998 CanLII 814 (SCC)