Torts - Negligence - Product Liability. Fernandez Leon v. Bayer Inc.
In Fernandez Leon v. Bayer Inc. (Ont CA, 2023) the Court of Appeal considered (and granted) an appeal of a motion order that struck product liability pleadings [under R21.01(1)(b)] without leave to amend:
 Bayer’s motion was brought under r. 21.01(1)(b) of the Rules of Civil Procedure, R.R.O. 1990, Reg. 194, asserting that the statement of claim did not disclose a cause of action. The motion judge agreed, concluding that there were substantial foundational deficiencies in the appellants’ claim that could not be cured by simply amending the pleading.. Adam v. Ledesma-Cadhit
 Irrespective of the deficiencies that she identified in the appellants’ pleading, the motion judge erred in refusing to grant leave to amend the statement of claim. She did not advert to or apply the test for amendment of pleadings articulated by this court. Instead, the motion judge concluded that there was “no benefit in permitting the [appellants] to try and find some tenable basis in fact for a claim against Bayer when none [had] been found by them to date”.
 Leave to amend a statement of claim should be denied only in the clearest of cases, when it is plain and obvious there is no tenable cause of action, the proposed pleading is scandalous, frivolous or vexatious, or there is non-compensable prejudice to the defendants: see McHale v. Lewis, 2018 ONCA 1048, at paras. 6 and 22; Klassen v. Beausoleil, 2019 ONCA 407, 34 C.P.C. (8th) 180, at para. 25. This test applies even where it is determined that the statement of claim, as pleaded, should be struck: see Burns v. RBC Life Insurance Company, 2020 ONCA 347, 151 O.R. (3d) 209; Tran v. University of Western Ontario, 2015 ONCA 295. The fact that allegations are bald and lack supporting material facts is not itself a reason for refusing leave to amend: Miguna v. Ontario (Attorney General) (2005), 2005 CanLII 46385 (ON CA), 205 O.A.C. 257, at para. 22.
 The test for striking pleadings for not disclosing a reasonable cause of action is stringent, and the moving party must satisfy a very high threshold in order to succeed. This may occur where the allegations do not fall within a cause of action known to law, or because the statement of claim fails to plead all the essential elements of a recognized cause of action: Dawson v. Rexcraft Storage & Warehouse Inc. (1998), 1998 CanLII 4831 (ON CA), 164 D.L.R. (4th) 257 (Ont. C.A.), at para. 10. Unless it is “plain and obvious” that there is no chance of success, a claim, even a novel one, ought to be allowed to proceed. The pleading must be read generously, erring on the side of permitting an arguable claim to proceed to trial: see Rausch v. Pickering (City), 2013 ONCA 740, 369 D.L.R. (4th) 691, at para. 34.
 In our view the proposed amendments plead the essential elements of the claims for negligent design and manufacture. The proposed amendments plead the material facts that are required to support the pleaded causes of action. That is, they meet the low threshold for pleading a cause of action.
 We do not agree with Bayer that in every case where a plaintiff alleges negligence in the design and manufacture of a product, the statement of claim must be struck unless it identifies the specific defect in the product that caused the injury. The particulars of a specific defect are not in our view elements of the tort that are always required to be pleaded before the claim discloses a cause of action. To identify a specific manufacturing or design defect in every case would place too onerous a burden on a plaintiff at the stage of initiating a proceeding in a product liability action. In this case, involving a medical device that is alleged to have caused injury after it was implanted for its intended use, the appellants meet the requirement to plead a cause of action in negligence, even if they cannot at this time identify a specific defect in the product’s manufacture or design.
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
 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),  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; 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:
(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.
(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?