Second ranitidine class action decision reaffirms that claims are without merit

On May 11, 2023, the British Columbia Supreme Court handed down a decision entirely dismissing a proposed class action lawsuit on behalf of Canadians who had purchased or taken ranitidine. The decision to dismiss this claim reinforces a previous decision made by the Ontario Superior Court on the same topic.

Pharmascience, as a drug manufacturer, is pleased to see this decision as we believe the two recent cases were without merit.

This latest case in British Columbia concerned a proposed class action lawsuit alleged harms due to the presence of nitrosamines in ranitidine, a common over-the-counter medication used to reduce stomach acid.

Nitrosamines are suspected to be potentially toxic impurities that may also be carcinogenic that may be present in pharmaceuticals at very low levels and, may also be present in a number of different sources, such as in drinking water, meats, cheeses and vegetables.

In the previous case before the Ontario Superior Court, the Court found that there was no basis in fact that either the stated nitrosamines cause cancer in humans and that exposure to nitrosamines in the specific drug product increases the risk of being diagnosed with cancer.

In this latest decision, the British Columbia Court agreed with Pharmascience’s submissions that the claims by the proposed class members for damages for an increased risk of contracting cancer, associated claims of mental upset and anxiety, and medical monitoring costs, would not be successful.

Specifically, the Court found that there was “uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk”, and, “the plaintiff has failed to raise a bona fide triable issue regarding injury due to the ingestion and/or purchase of ranitidine.”

Pharmascience believes the decisions of the British Columbia and Ontario Courts are positive and important developments, as pharmaceutical manufacturers continue to face a wave of litigation following publicity in 2018 and 2019 about regulatory investigations into the presence of nitrosamines in certain drug products.

Pharmascience does, and will continue to ensure that all drug products are manufactured to the highest quality standards for patients in Canada and around the world and continues in its extensive efforts to monitor the safety profiles of all its drugs through the continuous collection and detailed analysis of spontaneously reported adverse drug reactions.