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Torts - Negligence - Product Liability

. Adam v. Ledesma-Cadhit

In Adam v. Ledesma-Cadhit (Ont CA, 2021) the Court of Appeal reviewed 'duty to warn' negligence principles for manufacturers in medical product liability cases:
The governing legal principles

[19] The general principles governing the duty to warn by manufacturers of medical products are well known, not in dispute, and were summarized by the Supreme Court in Hollis v. Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634, at paras. 20 to 29:
(i) A manufacturer of a product has a duty in tort to warn consumers of dangers inherent in the use of its product of which it has knowledge or ought to have knowledge;

(ii) The duty to warn is a continuing duty, requiring manufacturers to warn not only of dangers known at the time of sale, but also of dangers discovered after the product has been sold and delivered;

(iii) All warnings must be reasonably communicated and must clearly describe any specific dangers that arise from the ordinary use of the product;

(iv) The nature and scope of the manufacturer’s duty to warn varies with the level of danger associated with the ordinary use of the product. Where there are significant dangers, it will rarely be sufficient for manufacturers to give general warnings concerning those dangers. Instead, the warnings must be sufficiently detailed to give the consumer a full indication of each of the specific dangers arising from the use of the product;

(v) Manufacturers of products such as drugs 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;

(vi) There is a heavy onus on manufacturers of drugs to provide clear, complete, and current information concerning the risks inherent in the ordinary use of their product;

(vii) As a general rule, the duty to warn is owed directly by the manufacturer to the ultimate consumer. However, an exception known as the “learned intermediary rule” applies where a product is highly technical in nature and is intended to be used only under the supervision of experts, such as physicians, or where the nature of the product is such that the consumer will not realistically receive a direct warning from the manufacturer before using the product. Where an intermediate inspection of the product is anticipated or where a consumer is placing primary reliance on the judgment of a “learned intermediary”, such as a physician, and not on 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;

(viii) The “learned intermediary” rule presumes that the intermediary physician is “learned”, in the sense that the physician is fully apprised of the risks associated with the use of the product. A manufacturer can only be said to have discharged its duty to the consumer when the intermediary’s knowledge approximates that of the manufacturer. To allow manufacturers to claim the benefit of the rule where they have not fully warned the physician would undermine the policy rationale for the duty to warn, which is to ensure that the consumer is fully informed of all risks.
[20] In Hollis, the Supreme Court identified the overarching question to be answered as whether the manufacturer owed the patient a duty to warn of a specific risk. The Supreme Court broke that overarching question down into two sub-questions:
(i) Did the manufacturer have a duty to warn recipients of the medical product directly or could it satisfy its duty by warning a learned intermediary, such as a physician?

(ii) If the manufacturer could properly discharge its duty by warning the physician, did it adequately warn the physician of the specific risk in light of its state of knowledge at that time?



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