2022 QCCA 553, 2022 QCCA 553

Unofficial English Translation of the Judgment of the Court Gagnon c. Intervet Canada Corp. 2022 QCCA 553 COURT OF APPEAL CANADA PROVINCE OF QUEBEC REGISTRY OF MONTREAL Nos.: 500-09-029268-208 , 500-09-029290-210 (500-06-001003-199) DATE: April 25, 2022 CORAM: THE HONOURABLE MARK SCHRAGER, J.A. MARIE-JOSÉE HOGUE, J.A. STÉPHANE SANSFAÇON, J.A. 500-09-029268-208 JESSICA GAGNON ALLA OLENITCH APPELLANTS/INCIDENTAL RESPONDENTS – Plaintiffs v. INTERVET CANADA CORP. INTERVET GESMBH RESPONDENTS – INCIDENTAL APPELLANTS - Defendants 500-09-029290-210 INTERVET CANADA CORP. INTERVET GESMBH APPELLANTS – Defendants v.

JESSICA GAGNON ALLA OLENITCH RESPONDENTS – Plaintiffs JUDGMENT [ 1 ] The appellants and the incidental appellants appeal from a judgment rendered by the Superior Court, District of Montreal (the Honourable Pierre-C.

Gagnon), on November 26, 2020, granting in part the application for authorization to institute a class action, authorizing the class action, appointing Jessica Gagnon as representative plaintiff of the members of the class, which he redefined, and refusing to appoint Alla Olenitch as representative plaintiff. [ 2 ] For the reasons of Sansfaçon, J.A., with which Schrager and Hogue, JJ.A. agree, THE COURT: [ 3 ] GRANTS the appellants’ application for leave to appeal, with legal costs; [ 4 ] ALLOWS in part the principal appeal, with legal costs, and the incidental appeal, without legal costs; [ 5 ] REMOVES paragraph [204] from the judgment’s conclusions: [ 6 ] REPLACES paragraph [205] of the judgment’s conclusions by the following: [205] APPOINTS Jessica Gagnon and Alla Olenitch as representative plaintiffs for the purpose of instituting the proposed class action on behalf of the following class of persons described below: Any person residing in Quebec who, between July 2, 2014, and November 2, 2018, administered to their dog an oral tablet of the drug

Bravecto (dose between 112.5 mg and 1,400 mg) and whose dog subsequently developed one of the following conditions: • digestive tract disorders; vomiting, diarrhea, hypersalivation, hemorrhagic diarrhea; • systemic disorders: lethargy, anorexia; • skin and appendage disorders: pruritus, alopecia; • neurological disorders, convulsions, ataxia, muscle tremor; • death. [ 7 ] ADDS , following subparagraph (

b) of paragraph [206] of the judgment’s conclusions, the following subparagraph: (

b) breach of the merchant’s or manufacturer’s obligations under the CPA ; [ 8 ] DISMISSES the incidental appellants’ application to strike allegations from the incidental respondents’ brief, with legal costs; [ 9 ] GIVEN the leave to file an incidental appeal granted by Cournoyer, J.A. on February 12, 2021, in file 500-09-029268-208, the notice of appeal and the application de bene esse for leave to appeal by the applicants Intervet Canada Corp. and Intervet GesmbH in file 500-09-029290-210 are moot. MARK SCHRAGER, J.A. MARIE-JOSÉE HOGUE, J.A. STÉPHANE SANSFAÇON, J.A.

Mtre Paule Lafontaine Mtre Robert Eidinger EIDINGER & ASSOCIATES For Jessica Gagnon and Alla Olenitch Mtre Claude Marseille Mtre Cristina Cataldo Mtre Ariane Bisaillon BLAKE, CASSELS & GRAYDON For Intervet Canada Corp. and Intervet Gesmbh Date of hearing: February 7, 2022 REASONS OF SANSFAÇON, J.A. [ 10 ] The appellants appeal from a judgment rendered by the Superior Court, District of Montreal (the Honourable Pierre-C.

Gagnon), on November 26, 2020, granting in part the application for authorization to institute a class action, authorizing the class action, appointing Jessica Gagnon as representative plaintiff of the members of the class, which he redefined, and refusing to appoint Alla Olenitch as representative plaintiff. [1] They also seek leave to appeal the question of whether the Consumer Protection Act [2] (“ CPA ”) applies to the veterinary drug at issue. [3] [ 11 ] The respondents also appeal from that judgment by way of an incidental appeal.

Furthermore, they ask that certain allegations in the appellants’ brief be struck, which request was referred to this Court. [4] Both appeals were authorized by a judge of the Court. [5] [ 12 ] For the reasons below, I would grant the application for leave to appeal and allow both appeals, but only in part, so as to appoint Alla Olenitch as representative plaintiff, amend the start date of the class action period, add death to the list of “conditions” likely to develop after ingesting the product in question, remove suspected lack of efficacy from that list, and add the issue of the application of the CPA to the sale of a product sold on prescription from a veterinarian to the questions of fact and of law that will be dealt with collectively. [ 13 ] The following emerges from the broad strokes of the facts of the case that the judge accepted and that appear in the allegations of the application for authorization and in the exhibits .

a.

The product [ 14 ] Intervet Canada Corp. and Intervet Gesmbh are, respectively, the Canadian distributor and the manufacturer of Bravecto, a drug prescribed by veterinarians to kill ticks and fleas that infest pets, such as dogs. [6] [ 15 ] On July 2, 2014, Bravecto was put on the market in Canada. [7] Under the heading “Adverse reactions”, the product monograph stated that there were “no serious adverse reactions” when ingested, [8] and that the only adverse reactions were vomiting, decreased appetite, diarrhea, lethargy, polydipsia, and flatulence. [ 16 ] On February 16, 2017, the European Medicines Agency (EMA) revealed that it had asked the manufacturer of Bravecto to provide a PSUR (Periodic Safety Update Report ) that should include an analysis of all serious adverse reactions reported during 2016, whether neurological, related to the skin or liver (hepatopathy) or having resulted in the animal’s death or euthanasia. [9] [ 17 ] On October 1, 2018, the Food and Drug Administration (FDA) reported receiving 22,626 reports of adverse reactions in dogs after the ingestion of fluralaner, Bravecto’s active ingredient. [10] On September 20, 2018, this agency had issued an alert to the community informing them that it had asked Bravecto’s manufacturer to change its monograph to include the possibility of adverse neurological reactions after the administration of this product to dogs. [11] [ 18 ] In November 2018, Bravecto’s Canadian monograph was revised to add pruritus and alopecia (two skin disorders) as adverse reactions in addition to hemorrhagic diarrhea. [12] [ 19 ] On January 23, 2019, the EMA reported 10,349 reports of serious adverse reactions to Bravecto. [13] b.

Ms. Olenitch’s dog Willy [ 20 ] On June 1, 2015, Ms. Olenitch administered the dose of Bravecto prescribed by her veterinarian to her dog Willy. On July 14, 2015, she consulted a veterinarian who remarked that Willy had skin disorders (pruritus and alopecia). [14] A few weeks earlier, on June 25, 2015, a veterinarian had prescribed Dermoscent Essential for Willy, although the animal’s medical record does not indicate for which type of skin problem. On July 16, 2015, Ms. Olenitch had an emergency consultation for hemorrhagic diarrhea.

The veterinarian then also observed pruritus on Willy’s ventral abdomen and prescribed an antibiotic cream and cortisone for the skin. [15] [ 21 ] Ms. Olenitch blames the hemorrhagic diarrhea and skin disorders on the Bravecto taken. [16] c. Ms. Gagnon’s dog Snoopy [ 22 ] On September 7, 2018, Ms. Gagnon consulted a veterinarian for a lesion on Snoopy’s eyelid. Although unrelated to this problem, the veterinarian prescribed a Bravecto tablet to prevent demodectic mange. Ms. Gagnon administered this tablet to Snoopy that evening. [17] The next morning, Snoopy displayed worrisome signs. He died that evening and Ms.

Gagnon blames his death on the Bravecto product ingested the day before. [18] [ 23 ] Dr. Jean-Marc Benoît performed a first necropsy on Snoopy on September 12, 2018. [19] His report stated that even though he could not establish the cause of death precisely, he observed numerous multisystemic hemorrhages. [20] On November 9, 2018, an analysis report by Dr.

John Buchweitz of Michigan State University stated that traces of fluralaner, the basic ingredient in Bravecto, were found in Snoopy’s liver. [21] On January 23, 2019, a second analysis of Snoopy’s tissues was performed at the University of Guelph, which analysis determined that he appeared to have died from numerous internal hemorrhages caused by a disorder in the coagulation process, or an “idiopathic thymic hemorrhage/thymic hematoma”, a rare disease in puppies, [22] which this dog no longer was. [ 24 ] On February 19, 2019, Snoopy’s file was sent to Dr.

Jean Dodds who, based on the necropsies and analyses conducted, determined that Snoopy died from a fatal reaction to fluralaner [23] caused by its anticoagulant and antithrombotic effects that led to internal hemorrhaging and death. [ 25 ] The appellants blame fluralaner, [24] Bravecto’s active ingredient, for the death of Snoopy, Jessica Gagnon’s dog, and the skin problems and hemorrhaging of Willy, Alla Olenitch’s dog. They therefore filed an application for the authorization to institute a class action and for the authorization to represent the class members.

In their application, they allege that they were misled about Bravecto’s safety, as were the veterinarians who prescribed this product and were then unable to properly inform them of the associated risks. The trial judgment [ 26 ] The judge described the appellants’ main allegations in support of their action.

Then, after reviewing the history of the government agencies’ interventions referred to above, the judge added: [ translation ] [32] However, despite the interventions of state or suprastate agencies, Intervet continued an aggressive advertising campaign, for example on the us.bravectofacts.com website, where it denounced the “myth” of serious side effects and instead stated that the facts are: Fact- Clinical research data and analysis of adverse events to date do not demonstrate a causal relationship between Bravecto and liver or kidney issues or cancer.

Further, the most common reported events are mild and transient gastrointestinal upset, such as vomiting or diarrhea, and these are noted on the product label . [33] Intervet thus tried to cover up the results of a study by DuPont Pharmaceuticals Company that analyzed the anticoagulant effects of isoxazoline derivatives (which include fluralaner) and was published in the July 1999 Journal of Medicinal Chemistry .

[34] This study discussed the potential of isoxazoline derivatives as blood coagulation inhibitors to prevent certain blood vessel thromboses. [35] In her letter of February 19, 2019, Dr. Dodds noted that, based on this study, isoxazoline derivatives, used to prevent blood clots, could cause excessive bleeding. [36] Health Canada’s pharmacovigilance reports indicate that the department received 3,913 reports of adverse reactions from 2014 to 2019. [37] Ms.

Olenitch stated that she had been in direct contact with 30 Quebecers and 14 other Canadians who maintained that their animal experienced adverse reactions to Bravecto. [38] Lastly, in October 2019, the EMA received a petition with some 102,000 names, including Canadians, demanding that Bravecto be taken off the market. [25] [References omitted] [ 27 ] After reviewing the rules applicable to an application for authorization, the judge addressed those applicable to such an application when it claims that a drug manufacturer and a drug distributor breached their duty to inform and their duty of safety. [ 28 ] The judge first concluded that the CPA does not apply to the sale of products on prescription from a veterinarian, being of the view that this issue had been decided in Abbott . [26] In that judgment, Ruel, J.A., on behalf of the Court, concluded that the sale by a pharmacist of a medically prescribed drug for human consumption is not a consumer contract.

The trial judge therefore held that the class action in the case at bar was governed solely by the ordinary law. [27] [ 29 ] The judge then reviewed the ordinary law principles that apply to the action, and concluded with the following

summary: [ translation ] [115] As for the rest [i.e., after excluding the CPA ], it is clear that drug manufacturers are bound by the duty to inform and the duty of safety regarding their drug. The extent and intensity of these duties depend on the circumstances, however, which requires a factual analysis. [116] In an action in liability for a safety defect in medication, the user benefits from a rebuttable presumption after proving on a balance of probabilities that: (

a) the product presents a danger; (

b) the user sustained an injury; and (

c) there is a causal link between the user’s injury and this danger. [117] The manufacturer has means of exoneration according to the facts it proves. [118] It is not sufficient for the manufacturer to establish, however, that it was always in good standing with Health Canada. Serious dangers may require that manufacturers make disclosures to users and learned intermediaries without waiting for Health Canada’s official reaction. [28] [ 30 ] The judge then analyzed the criterion of colour of right in article 575 (2) CCP and found that Willy’s particular case did not fulfill this requirement, which disqualified Ms.

Olenitch as a representative plaintiff.

He wrote that the record as constituted [ translation ] “ does not establish any logical connection between the issue studied by DuPont (anticoagulant effects of isoxazolines) and the dog Willy’s health problems (skin and fur problems) ”. [29] [ 31 ] The judge then analyzed the animal’s medical record to find evidence of a skin problem and discovered that it was first mentioned only in the notes of July 14, 2015, nearly 45 days after the product was ingested, a delay that was, as it must be understood from the judge’s conclusion, too long to establish a link between taking the veterinary drug and the skin disorder.

The judge also remarked from the medical record that on August 29, 2015, a veterinarian had discussed with Ms. Olenitch whether Willy might instead have been contaminated by an estrogen cream Ms. Olenitch was personally using at the time, or that his skin problem might possibly be caused by food or environmental allergies, which, as must also be understood from the judge’s conclusion in this regard, would exclude the possibility that the dog Willy’s skin problem could have been caused by Bravecto. [ 32 ] As for Ms. Gagnon, the judge concluded that she qualified as representative plaintiff.

He wrote: [ translation ] [166] On September 7, 2018 [the day the product was sold to Ms. Gagnon], the EMA had already sounded the alarm in Europe and the FDA in the United States.

These agencies warned that the pharmacovigilance systems revealed worrisome occurrences of neurological disorders, skin disorders, and blood diseases. [167] It may be inferred that Intervet was aware of the FDA’s concerns at least a few weeks before it issued its alert of September 20, 2018. [168] It is for the judge on the merits to determine the precise date Intervet was bound to fulfill its duty to inform Canadian or Quebec Bravecto consumers. [30]

[References omitted] [ 33 ] The judge pointed out that the file included a letter from veterinarian Dr. Dodds who categorically established a causal link between Snoopy’s death and the ingestion of Bravecto. He wrote that any issue related to this proof, including the credibility of witnesses, was to be decided by the judge on the merits. [ 34 ] The judge then analyzed the criterion of article 575 (1) CCP, which he considered to have been met. [ 35 ] He then moved on to the analysis of the class composition criterion in article 575 (3) CCP and first found that there was indeed a class of Quebec dog owners that would make it difficult or impracticable to apply the rules for mandates to take

part in judicial proceedings on behalf of others or for consolidation of proceedings. The judge then defined this class based on the dog’s type of health issue, related directly to Health Canada’s alert issued on November 2, 2018.

The judge understood from the alert that it listed the potential adverse reactions for dogs for which the respondent Intervet had not yet issued a public warning. [ 36 ] Last, the judge found that the action should be limited in time and would start on February 16, 2017, the date the EMA published its pharmacovigilance bulletin, which, in his view, was the first alleged indication of the adverse reactions eventually accepted by Health Canada, and end on November 2, 2018, the date Health Canada issued an update, after which the alleged failure to inform would no longer have existed.

The application to strike allegations [ 37 ] The incidental appellants ask that certain allegations in the brief of the incidental respondents (Ms. Gagnon and Ms. Olenitch) be struck. [ 38 ] In my view, this application is unfounded. [ 39 ] First, the allegations concerned are merely the incidental respondents’

interpretation of facts already alleged in their application for authorization to institute a class action or of facts that appear in the exhibits filed in its support. Next, their

interpretation of these allegations and facts is not such as to influence the outcome of the appeal. I therefore propose to dismiss this application, with legal costs. Grounds of appeal [ 40 ] The appellants submit that the judge erred in law by deciding, at the authorization stage, that the CPA cannot apply to the sale of veterinary drugs. They also submit that the judge erred in law by imposing an excessive burden of proof on Ms.

Olenitch at the authorization stage and that he made a palpable and overriding error of fact when, in reviewing her dog Willy’s medical record, he found that the dog Willy’s skin problems appeared only on July 14, 2015, but failed to consider his hemorrhagic diarrhea as an alleged consequence of taking the product the previous June 1, errors that led him to refuse to designate her as representative plaintiff.

Last, they add that the judge unduly limited the class action period by having it start on February 16, 2017, the date of the EMA pharmacovigilance bulletin, rather than the day on which it was first sold three years earlier, because that bulletin stated that it relied on reports received during the previous year of which the respondents certainly had to be aware. [ 41 ] The respondents, who are the incidental appellants, submit that the trial judge erred in appointing Ms.

Gagnon as representative plaintiff because she is not a class member of the class action as defined in the conclusions of the authorization judgment since they do not mention internal hemorrhaging or death, the two ailments suffered by the dog Snoopy according to the allegations in the application. They also posit that the judge mistakenly confused hepatopathy and blood disorders and erred in defining the class too broadly. Analysis Principal appeal Ms.

Olenitch’s appeal [ 42 ] The Supreme Court recently pointed out that the plaintiff’s burden at the authorization stage is to establish an “arguable case”. [31] It explained that “[t]he legal threshold requirement under art. 575(2) C.C.P. is a simple burden of ‘demonstration’ that the proposed ‘legal syllogism’ is tenable” [32] and that the plaintiff need only establish a “good colour of right” [33] and does not have to prove an arguable case on a balance of probabilities. [34] [ 43 ] On the extent of this demonstration, Brown, J. wrote in L’Oratoire Saint-Joseph : [59] Furthermore, at the authorization stage, the facts alleged in the application are assumed to be true, so long as the allegations of fact are sufficiently precise : Sibiga , at para. 52; Infineon , at para. 67; Harmegnies , at para. 44; R egroupement des citoyens contre la pollution v.

Alex Couture inc. , 2007 QCCA 565 , [2007] R.J.Q. 859, at para. 32 ; Charles , at para. 43; Toure , at para. 38; Fortier , at para. 69. Where allegations of fact are “vague”, “general” or “imprecise”, they are necessarily more akin to opinion or speculation, and it may therefore be difficult to assume them to be true, in which case they must absolutely “be accompanied by some evidence to form an arguable case”: Infineon , at para. 134.

It is in fact strongly suggested in Infineon , at para. 134 (if not explicitly, then at least implicitly), that “bare allegations”, although “ insufficient to meet the threshold requirement of an arguable case” (emphasis added), can be supplemented by “some evidence” that — “limited though it may be” — must accompany the application in order “to form an arguable case”. [35] [Underlining and italics in the original; bold added.] [ 44 ] In this case, this last statement of the Supreme Court determines the outcome of the appeal. [ 45 ] The allegations in the application for authorization state that the 2014 Bravecto monograph indicated that studies had revealed

only decreased appetite, diarrhea, and flatulence as adverse reactions, whereas the 2018 monograph added pruritus and alopecia, which are skin disorders, and hemorrhagic diarrhea as adverse reactions. Ms.

Olenitch claims that her dog developed several health issues in the weeks after taking the product, including hemorrhagic diarrhea, for which she consulted a veterinarian on July 16, 2015, and a skin disorder, for which she also consulted a veterinarian around the time the product was taken. [ 46 ] With respect, I find that the judge became too involved in analyzing the exhibits alleged in support of the application for authorization, when its allegations were sufficiently clear. His examination of the dog Willy’s medical record caused him to err on aspects that fall to the evidence on the merits.

Contrary to what the judge wrote, the skin disorder appears to have been mentioned to a veterinarian as early as June 25, 2014, not on July 14, 2014. It is safe to assume, without additional evidence, that Ms.

Olenitch had noticed this before going to the veterinary clinic and since, according to the allegations and the monograph at that time, Bravecto’s active ingredient remains in the body up to 112 days after being ingested, the skin problem likely appeared around the time the dog Willy took the product, which is all that can be determined without additional evidence and supports the allegations in the application for authorization. [ 47 ] The judge also appears to have erred in his assessment of the evidence when he rejected any link between taking Bravecto and the dog Willy’s skin problem, by attributing it to a possible skin contamination from Ms.

Olenitch’s estrogen cream. It is true that this hypothesis was raised by veterinarian Dr. Pagé and is noted in the dog Willy’s medical record, but it does not appear in his notes on August 29, 2015, as the judge wrote, but rather two years later, on August 29, 2017. [36] In addition, as appears from the veterinarian’s notes, Ms. Olenitch replied that the hypothesis of estrogen contamination had to be rejected because she started taking this hormone only after her dog’s skin disorders appeared. Ms.

Olenitch’s testimony no doubt could have clarified the date she started taking this hormone, but this step, that is, the presentation of evidence, occurs during the trial on the merits and not during the application for authorization. [ 48 ] That being so, Ms.

Olenitch claims that the respondents breached their duty of safety regarding the product and their duty to inform purchasers and prescribing veterinarians. [ 49 ] In Abbott , [37] Ruel, J.A., on behalf of the Court, wrote in an appeal from a judgment on the merits: [125] Thus, even where evidence does not establish the capacity of a medication to cause side effects, but the side effects of the medication are revealed in pre- or post-market studies, or otherwise within the scope of the continuous monitoring of the side effects of the medication, a court may find that a danger exists and that there is a correlative duty to warn. [126] Factors such as the nature of the medication, and the severity, intensity or frequency of side effects reported in conjunction with taking the medication may establish the existence of a danger and give rise to a duty to warn. [127] All serious risks or dangers a medication entails should be disclosed, regardless of how low the probability is that they will materialize.

A pharmaceutical manufacturer’s failure to do so may give rise to its extra-contractual civil liability towards users. [References omitted; emphasis in the original.] [ 50 ] At the authorization stage, Ms. Olenitch’s burden was not to prove that her dog’s skin problems and hemorrhagic diarrhea were caused by Bravecto, or to prove that the respondents knew that their product was likely the cause, no more than she had to prove that these disorders were a serious danger.

She simply had to allege that the product appeared to present a danger that was not disclosed to her in a timely manner, which, moreover, she established given that her dog’s disorders were added to the product monograph in 2018. The legislature has not set the bar high at the authorization stage. The fact that the appellant has cleared the bar and might have a long way to go at the next stage does not justify dismissing her application.

Her allegations are clear and it will be up to the judge on the merits to determine whether she has discharged her burden in light of the evidence. [ 51 ] Thus, I suggest that Ms. Olenitch’s application for authorization to represent the members be granted and that paragraph [205] of the judgment under appeal be amended to add her as a representative plaintiff. 1.

The class action period [ 52 ] The appellants submit that the judge erred in limiting the class action period, which should start on the product’s market authorization date, July 2, 2014, and not on February 16, 2017, the date the EMA pharmacovigilance bulletin was published. [ 53 ] I agree with the appellants.

While it is true that February 16, 2017, is the date of the first publication identifying the adverse reactions eventually accepted by Health Canada, it cannot be concluded that the respondents themselves were not previously informed of their product’s adverse reactions reported by purchasers, in which case they were possibly required, without waiting, to warn future purchasers and veterinarians. As the judge stated, [38] Dr.

Dodds noted from the DuPont Pharmaceuticals Company study published in July 1999, thus well before Bravecto was marketed, that isoxazoline derivatives can cause excessive bleeding and caused the death of Ms. Gagnon’s dog.

Because the allegations and exhibits date the respondents’ presumed knowledge of their product’s adverse reaction back to a date prior to the publication on February 16, 2017, and because the product was first marketed less than three years earlier, it is this latter date that should mark the starting point for the claim. [ 54 ] I therefore propose to replace the words “February 16, 2017” in paragraph [205] of the judgment under appeal with the words “July 2, 2014”. 2.

CPA [ 55 ] The appellants submit that the judge, who removed their right to raise the Consumer Protection Act because he was of the view that it does not apply to the sale of drugs, which would eliminate the possibility of the members being awarded punitive damages, erred in doing so. Relying on Abbott , the judge wrote: [ translation ]

[110] Moreover, the Court of Appeal has excluded the application of the Consumer Protection Act because the sale of prescription medications by a pharmacist is not a consumer contract. The Civil Code of Québec applies. [39] [References omitted.] and a little further on: [ translation ] [114] An analysis of the specific rules identifies only one pure question of law that may be disposed of at the authorization stage. Thus, the Consumer Protection Act does not govern the sale and distribution of prescription medications.

If this is the case for pharmacists (in Abbott ), it is surely the case for veterinarians. [40] [ 56 ] I am not convinced that the question of whether the Consumer Protection Act applies to the sale of prescription veterinary drugs is a question of pure law to which an answer may be given without evidence having been presented. In Abbott , Ruel, J.A., on behalf of the Court, concluded, as the trial judge noted, that this statute does not apply to the sale and distribution of prescription drugs for human use.

He reached this conclusion, however, after analyzing the evidence presented on the merits, which proved that “the development of medications for purposes of receiving marketing approval is a highly complex process that requires clinical human trials in its last phases”. [ 57 ] It is possible that, as with prescription drugs for human use, the legislature did not want to impose a presumption that veterinary prescription drug manufacturers know a product’s potential dangers that might have materialized post-marketing.

Firstly, however, an animal is not a human, and evidence has yet to be presented on the process required to market drugs for use in animals , such that it is impossible, at this preliminary stage of the case, to extend to them the exclusion from the scope of this statute that the Court in Abbott did with respect to prescription drugs for human use. [ 58 ] I therefore suggest granting leave to appeal this question, allowing the appeal on this question and adding the following question of fact and of law, to be dealt with collectively, to paragraph [206] of the judgment under appeal: 1.1.

Does the Consumer Protection Act apply and, if so, have any obligations of a merchant or a manufacturer under this statute been breached? Incidental appeal [ 59 ] The incidental appellants ask that the entire appeal be dismissed because neither of the principal appellants qualifies as a class member. [ 60 ] Ms. Olenitch’s qualification has already been dealt with and does not need to be revisited. [ 61 ] With respect to Ms.

Gagnon’s qualification as a class member, the incidental appellants argue that the judge erred in recognizing her as such given that her dog Snoopy did not have any of the adverse reactions on which the class action is based. The judge did not accept death or internal hemorrhaging, the only two ailments the dog Snoopy suffered, as potential adverse reactions caused by the product. [ 62 ] Ms. Gagnon replied to this argument by presenting an application to add death to the list of adverse reactions, or alternatively, internal hemorrhaging, as Dr.

Dodds mentioned. [ 63 ] With respect, death should not have been excluded as an adverse reaction to taking the product. [ 64 ] The incidental appellants admit that Bravecto is a drug within the meaning of the Food and Drugs Act [41] and, as such, is subject to various provisions of the Food and Drug Regulations , [42] including

Part C, which covers, with the necessary adjustments, drugs for animal use.

Section C.01.001 of the Regulations states: C.01.001

(1) Serious adverse drug reaction Serious adverse drug reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death ; [43] [Emphasis added.] [ 65 ] Moreover, and as stated above, the EMA also included death as a serious adverse reaction to be subject to a PSUR (Periodic Safety Update Report) in its request to Bravecto’s manufacturer. [44] The judge was clearly correct when he wrote that [ translation ] “death is not a disease but one outcome of a disease”, but at this preliminary stage of the case, to eliminate what Canadian law, on this side of the Atlantic, and the EMA, on the other side, consider [ translation ] “an undesirable reaction” or a “serious adverse reaction” is premature, especially since the class description might eventually be amended to include the necessary precisions, if any. [ 66 ] I therefore suggest dismissing this ground of appeal submitted by the incidental appellants and amending paragraph [205] of the judgment under appeal to add [ translation ] “• death” at the end. [ 67 ] Last, the incidental appellants ask that the words [ translation ] “suspected lack of efficacy” be removed from paragraph [205] of the judgment because Bravecto’s degree of effectiveness was never raised in the application for authorization. [ 68 ] The incidental respondents acknowledge the merits of this ground.

I therefore suggest that it be granted.

STÉPHANE SANSFAÇON, J.A.