Dr. Gaston De Serres

The appellants appealed a trial judgment that dismissed their action against GlaxoSmithKline (GSK), alleging that an H1N1 vaccine manufactured by GSK caused their five-year-old daughter's death.

The appeal raised issues concerning GSK's duty to warn (including the learned intermediary rule), its post-marketing commitments, the inference of negligence from circumstantial evidence, and costs.

The Court of Appeal dismissed the appeal, affirming the trial judge's findings that GSK adequately warned the learned intermediary (the physician), met its post-marketing obligations, and that the appellants failed to prove negligence or causation on a balance of probabilities.

The court also upheld the trial judge's discretionary costs award.

The plaintiffs brought an action against GlaxoSmithKline following the sudden and unexplained death of their five-year-old daughter, who died five days after receiving the H1N1 vaccine (Arepanrix).

The plaintiffs alleged that the manufacturer breached its standard of care by failing to adequately test the vaccine and failing to warn of its risks, and that the vaccine caused the child's death.

The court dismissed the action, finding no expert evidence to establish a breach of the standard of care regarding the vaccine's testing, approval, or disclosure of risks.

Furthermore, the court rejected the plaintiffs' expert evidence on causation, relying instead on the forensic pathologist and epidemiological experts who concluded there was no evidence linking the vaccine to the child's death.