The plaintiff brought a class action against the Crown alleging negligent regulation of Vitek Proplast temporomandibular joint (TMJ) implants by Health Canada.
The plaintiff claimed that the Crown owed a private law duty of care to the class members and breached that duty by failing to properly regulate the devices, issuing Notices of Compliance negligently, and failing to adequately warn the public or recall the devices.
Following a lengthy common issues trial, the Superior Court of Justice dismissed the action.
The court applied the Anns test and concluded that the Crown did not owe a private law duty of care to the class members, as there was insufficient proximity between the regulator and the unidentifiable group of potential implant recipients.
Furthermore, the court found that even if a duty of care existed, the Crown did not breach the applicable standard of care, as its regulatory actions and responses to the evolving scientific understanding of the implants' risks were reasonable and appropriate.