Tort case dealt with allegedly carcinogenic medication Health Canada recalled in 2018
The Ontario Court of Appeal recently denied certification in a class action claiming damages from the allegedly heightened cancer risk caused by a contamination in an over-the-counter blood pressure medication.
Palmer v. Teva Canada Limited, 2024 ONCA 220 dealt with the fallout from a Health Canada recall of Valsartan, which was found to contain the contaminants N-nitrosodiethylamine (NDEA) and N-Nitrosodiisopropylamine (NDIPA). The class action plaintiffs alleged NDEA and NDIPA are toxic carcinogens, and they sought compensation for an increased future cancer risk, medical services and monitoring costs, refunds for the Valsartan that they consumed or threw away after the recall, and psychological and punitive damages.
According to the decision, written by Justice Bradley Miller, the defendants’ supplier changed the valsartan manufacturing process and contaminated the medication in 2012. The recall occurred in 2018.
The Superior Court dismissed their certification motion, finding the causes of action were based on speculation rather than a concrete injury and were unviable. The Court of Appeal dismissed the appeal, finding that the drug manufacturers’ wrongful conduct was non-compensable. The physical harm had yet to materialize, and the psychological harm that had materialized “was not sufficiently serious to be compensable in tort law,” said Miller.
The problem with the claim was that the plaintiffs were not alleging that anyone had developed cancer as a result of the contaminated medication but that they had an enhanced risk of doing so in the future, says Peter Pliszka, a senior partner in Fasken’s litigation group who acted for Sandoz Canada Inc., Pro Doc Limitee, Sanis Health Inc., and Sivem Pharmaceuticals, four of the defendants.
“The law of tort is intended to protect people from actual harms, not the mere creation of a risk,” he says.
“The Court of Appeal emphatically affirmed that important principle of tort law, which has actually been repeatedly reiterated by a series of court decisions over the last five years,” says Pliszka. “The law of torts serves to compensate those who have suffered damage from the wrongdoing of others. Not every instance of an alleged wrongful act supports a legally viable cause of action.”
“Where there is no legally compensable harm, there is no legally viable claim. And where there's no legally compensable harm, there's nothing to certify.”
The recall impacted 316,000 Canadians and caused “significant economic losses for medical consultation and discarding useless, expensive prescription medicines,” says Paul Bates, who acted for the plaintiffs in the appeal. “Some of them suffered a nervous shock from the situation because of the uncertainty about the degree of risk from the contaminants.
The Superior Court looked at the epidemiological data and found that there was a “measurable increase” in cancer risk as a result of being prescribed the product and taking it for years, says Bates.
“But he said the evidence did not yet show that it was a legal cause of cancer,” he says. “And the Court of Appeal upheld those views and held therefore that there was not sufficient risk of harm for purposes of tort compensation, that the epidemiological connection to a cancer risk in statistics was not enough.”
Palmer does not represent a significant change in the law as the appeal court relied on and applied established legal principles, says Robert Carson, a litigation partner at Osler Hoskin & Harcourt LLP. The Supreme Court of Canada has already confirmed that an increased risk of future injury is not compensable, he says.
“It's meaningful because it's a Court of Appeal decision in the class action context. It applies a line of caselaw that focuses on the need for plaintiffs to show actual harm before a product liability class action can be certified. But it is not a sea change in the law.”
