On May 8, 2019, the Quebec Court of Appeal rendered an important judgment regarding pharmaceutical manufacturers' duty to inform.
The appellants brought a class action against Abbott Laboratories Limited ("Abbott") in relation to its prescription antibiotic Biaxin®, seeking to sanction Abbott for breach of its obligation, as a pharmaceutical manufacturer, to provide information regarding the neuropsychiatric side effects of Biaxin®.
Legal Basis for the Action
The appellants based the class action on two legal grounds, namely contractual liability for latent defects pursuant to section 53 of the Consumer Protection Act (the "C.P.A.") and a manufacturer's extra-contractual liability relating to a good's safety defect, pursuant to sections 1468, 1469 and 1473 of the Civil Code of Québec ("C.C.Q.").
First, the Court analysed and dismissed the action brought under section 53 C.P.A. The Court considered that, depending on the context, a pharmacist may act as a merchant within the meaning of the C.P.A, but that, in the specific context of the sale of prescription drugs, the C.P.A. does not apply. This is because the sale of prescription drugs involves, on the one hand, the professional judgment of a physician who prescribes a drug that he or she considers necessary for the health of a patient and, on the other hand, the professional judgment of a pharmacist, who assesses and ensures the appropriate use of the drug. Thus, the Court considered that a pharmacist who sells prescription drugs to a patient does not fall within the definition of a merchant as per the C.P.A.
Second, the Court rejected the argument raised by the appellants under the extra-contractual regime of sections 1468, 1469 and 1473 C.C.Q. concerning the fact that Abbott had not adequately informed Biaxin® users of the risks of neuropsychiatric side effects.
To succeed under the extra-contractual regime applicable to safety defects, the appellants had to demonstrate on a balance of probabilities:
- that the good poses a risk,
- that they had suffered harm, and
- that there is a causal link between (1) and (2), i e. that the harm constitutes the concrete materialization of the risk.
If the plaintiffs succeed in demonstrating this, there is a presumption that the manufacturer is liable. The manufacturer can, however, exonerate itself by demonstrating that it has fulfilled its duty to inform by providing adequate information about the risks associated to a particular drug.
In this case, the judge first ruled that the causality analysis must be done on an individual basis and not collectively. In a case involving the use of a drug, causality is defined as the overriding evidence of the risk of a particular side effect of the drug materializing. Here, since there was no evidence of the drug's ability to cause neuropsychiatric effects, only an individual review of the members' medical records would make it possible to exclude other possible causes of the neuropsychiatric effects experienced.
After ruling that, in light of the evidence, Abbott had a duty to inform Biaxin® users of the serious neuropsychiatric side effects, the Court acknowledged that Abbott had discharged its duty to inform said users. Indeed, with respect to the duty to inform, the Court recognized, that the "learned intermediary" doctrine applies in Quebec in the specific context of the acquisition of prescription drugs, given that the intervention of learned intermediaries, either the physician or the pharmacist, is essential. This rule requires the manufacturer of a prescription drug to discharge its duty to inform users through adequately warning learned intermediaries, who must then transmit the information they deem relevant to the user. In this case, neuropsychiatric side effects were listed in the "Side Effects" section in Part I of the drug's monograph.
In a product monograph, Part I is intended for health professionals and Part III, for consumers. The "Warnings and Precautions" section in Part I must indicate "information on all serious effects that may endanger the patient's health". Information will be included in this section to the extent that there is scientific consensus that the drug is likely to cause the side effect. The decision to include information is made by the manufacturer in conjunction with, and with the approval of, Health Canada. Only information from the "Warnings and Precautions" section will appear in Part III.
In the case at hand, the drug's ability to cause neuropsychiatric side effects could not be established despite rigorous evaluation spanning almost thirty years. In addition, the prevalence of such side effects is very low. Abbott was therefore justified in including these side effects in the "Side Effects" section in Part I of the successive Biaxin® monographs, rather than in the "Warnings and Precautions" section. Indeed, inclusion in the "Side Effects" section presents a lower threshold, since it includes effects that occur only in conjunction with the use of the drug. The purpose of this section is primarily to inform physicians that there may be a possible relationship between these effects and the drug.
The Court thus concluded that, by including neuropsychiatric side effects in the "Side Effects" section in Part I of the successive Biaxin® monographs, Abbott had properly discharged its duty to inform.
This decision provides a concrete example of Quebec legislation being applied within the context of the duty to inform of pharmaceutical manufacturers. In particular, this decision states that the C.P.A. does not apply in the context of the sale of prescription drugs by a pharmacist, it explains the apportionment of information in the various sections of Part I of a drug's monograph, and it formally incorporates the doctrine of the learned intermediary in Quebec law.