On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions.

Case: Apotex Inc v Canada (Minister of Health) (SCC Docket: 37593)

Drug: Apo-Trazodone

Nature of case: Application for leave to appeal related to action for damages in tort and breach of contract

Appellant: Apotex Inc.

Respondent: Her Majesty the Queen

Date of decision: December 14, 2017

Federal Court of Appeal decision

As we reported, the Federal Court of Appeal (FCA) allowed Apotex’s appeal, in part, from the Federal Court decision that found Apotex was entitled to damages for misfeasance of public office based on Health Canada’s review of Apotex’s drug submission for Apo-Trazodone.

The FCA, however, dismissed Apotex’s claim that the Federal Court erred in failing to conduct an analysis of negligence outside of Health Canada’s liability arising from the settlement agreement between the parties. The FCA found that Health Canada does not owe a prima facie duty of care to Apotex, or any other drug manufacturer, since this duty would conflict with the intent of the Food and Drugs Act and Regulations, which is directed to public health and safety through regulation of drug manufacturers.