The manufacturer of a product owes a duty to take reasonable care to ensure the product does not result in injury within the scope of the foreseeable use of the product. When a patient is injured as a result of an adverse effect of medication or a defect in a product used by a medical practitioner in diagnosing or treating the patient (for example, medical equipment, devices and supplies), the manufacturer may be held liable in an action in negligence for product liability.

In order to obtain judgment in an action in negligence for product liability, the plaintiff must establish that the manufacturer breached the standard of care required by the common law (the law made by judges) and the breach caused or contributed to the injury. A manufacturer can breach the standard of care in many ways. For example, the manufacturer could fail to meet the standard in researching, designing, testing, manufacturing, inspecting, distributing or selling the product. 

The manufacturer could also breach the standard of care in not warning of the dangers of using the product. The Supreme Court of Canada (in Hollis v. Dow Corning Corp. [1995] 4 S.C.R 634) has held that:

“… a manufacturer of a product has a duty to warn consumers of dangers inherent in the use of its product of which it has knowledge or ought to have knowledge.”

“… manufacturers of products that are ingested, consumed or otherwise placed in the body, and thereby have a great capacity to cause injury to consumers, are subject to a correspondingly high standard of care under the law of negligence” 

“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.”

“In light of the enormous informational advantage enjoyed by medical manufacturers over consumers, it is reasonable and just to require manufacturers to make clear, complete and current informational disclosure to consumers concerning the risks inherent in the ordinary use of their products.”

“A high standard for disclosure protects public health by promoting the right to bodily integrity, increasing consumer choice and facilitating a more meaningful doctor-patient relationship.”

“… where a consumer is placing primary reliance on the judgment of a ‘learned intermediary’ and not the manufacturer, a warning to the ultimate consumer may not be necessary and the manufacturer may satisfy its duty to warn the ultimate consumer by warning the learned intermediary of the risks inherent in the use of the product.”

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