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The Class Actions team at Siskinds LLP recently commenced a new case against the pharmaceutical manufacturers of Zofran. The class action claim alleges that the drug manufacturers failed to warn that Zofran is unsafe for pregnant women.

In Canada, drug manufacturers have a duty to warn of the risks associated with the use of their drug products that are within their knowledge or should be within their knowledge.[1] The duty is continuing, meaning that manufacturers must warn of dangers known at the time of sale and of dangers discovered after the product has been sold and delivered. The warning must clearly describe specific dangers that can arise from using the product. When manufacturers place drug products on the market, there is an informational imbalance between the manufacturer and patient or prescribing physician. The duty to warn serves to mitigate this imbalance by alerting physicians and patients to the risks associated with certain medications and to facilitate informed decision making.

In Hollis v Dow Corning Corp., the Supreme Court of Canada considered the scope of a manufacturer’s duty to warn in the context of medical products.  The Supreme Court held that in this context, the standard of care to be met by manufacturers in ensuring that customers are properly warned is necessarily high:

Given the intimate relationship between medical products and the consumer’s body, and the resulting risk created to the consumer, there will almost always be a heavy onus on manufacturers of medical products to provide clear, complete and current information concerning the dangers inherent in the ordinary use of their product.

The Zofran claim alleges that the drug manufacturers failed to discharge their duty to warn. The claim alleges that the Defendant drug manufacturers misrepresented to physicians and pregnant women that Zofran is a safe and effective treatment for nausea and vomiting during pregnancy and specifically marketed and promoted Zofran as a morning sickness drug. When in fact, the drug was never approved for this off-label use, and Zofran has never been studied in pregnant women, much less shown to be safe and effective to ingest during pregnancy.

If you were prescribed Zofran during the first trimester of pregnancy to treat morning sickness, and your child suffered birth defects, we encourage you to join Siskinds LLP’s Zofran class action. Visit www.classaction.ca/zofran, email [email protected] or call 1-800-461-6166.


[1] Hollis v Dow Corning Corp., [1995] 4 SCR 634, [1995] SCJ No 104.

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