FCA Upholds Ruling That Health Canada Liable For Negligence And Misfeasance In A Public Office

In Apotex Inc. v. Canada, 2017 FCA 73, the Federal Court of Appeal dealt with various appeals from the finding that Health Canada was liable to Apotex for negligence and misfeasance in a public office in their review of Apotex' drug submission for Apo-trazadone.

Apotex filed a submission with Health Canada in 1988 for approval to sell a generic version of the drug trazadone. The submission referenced an allegedly identical US product to rely on bioavailability studies previously used in an American application. Health Canada did not approve the submission and advised that there was a "normal requirement" for a Canadian reference product and that Apotex would need to "conclusively prove" the US product to be identical to the "standard trazadone product marketed in Canada."