Dussiaume v. Sandoz Canada Inc.

2023 BCSC 797 Dussiaume v. Sandoz Canada Inc.

IN THE SUPREME COURT OF BRITISH COLUMBIA Citation: Dussiaume v. Sandoz Canada Inc., 2023 BCSC 797 Date: 20230511 Docket: S1911469 Registry: Vancouver Between: Gary Dussiaume Plaintiff And: Sandoz Canada Inc., Apotex Inc., Pro Doc Limitee. Sanis Health Inc., Sivem Pharmaceuticals ULC/Sivem Produits Pharmaceutiques ULC, London Drugs Limited, Shoppers Drug Mart Inc., Rexall Pharmacy Group Ltd., Rexall/Pharma Plus Pharmacies Ltd., McKesson Canada Corporation/La Corporation McKesson Canada, McKesson Pharmacy Systems Canada ULC, Pharmasave Drugs Ltd., Loblaws Inc., Westfair Drugs B.C. Ltd., Teva Canada Limited Teva Canada Limitee, Sanofi Consumer Health Inc./Sanofi Sante Grand Public Inc.; 115013 Canada Inc. aka Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc., Vita Health Products Inc., Ranbaxy Pharmaceuticals Canada Inc., GlaxoSmithKline Inc., Save-On-Foods & Drugs Ltd., Wal-Mart Canada Corp., and Costco Wholesale Canada Ltd. Defendants Before: The Honourable Madam Justice Wilkinson Ruling on the Admissibility of the Affidavit of Dr. Keith Reutter Counsel for the Plaintiff: A. Leoni M. Burtini T.P. Charney C. Edwards J. Boyd A. Dimson Counsel for Sandoz Canada Inc.: P. Pliszka A. Borrell Z. Maladwala Counsel for Apotex Inc., Pro Doc Limitee, Sanis Health Inc., Sivem Pharmaceuticals ULC, Shoppers Drug Mart Inc., Rexall Pharmacy Group Ltd., Rexall/Pharma Plus Pharmacies

Ltd., McKesson Canada Corporation, McKesson Pharmacy Systems Canada ULC, Loblaws Inc. and Westfair Drugs B.C. Ltd.: C.E. Hunter, K.C. A. Boctor J.-M. Boudreau S. Penney Counsel for London Drugs Limited: K. Smiley E. Grant Counsel for Teva Canada Limited and Ranbaxy Pharmaceuticals Canada Inc.: L. Fric C. Lockwood Counsel for Sanofi Consumer Health Inc.: C. Zayid B. Shaw A.E. Cocks H. Mallabone Counsel for Vita Health Products Inc.: D. Woodfield S. Barton P. Brooks Counsel for 115013 Canada Inc. aka Dominion Pharmacal, Pharmascience Inc. and Laboratoire Riva Inc.: J. Shore C.M. Woodin A.C. Payne T. Feore Counsel for Save‑On‑Foods & Drugs Ltd.: C.M. Rusnak, K.C. J.A. Morris Counsel for Wal‑Mart Canada Corp.: M. Jilesen J. Chen J. Kras Counsel for Costco Wholesale Canada Ltd.: J. Cytrynbaum D. DiPardo Counsel for GlaxoSmithKline Inc.: R. Sutton E. Friedman No other appearances Place and Date of Hearing: Vancouver, B.C. October 4, 2022 Place and Date of Judgment: Vancouver, B.C. May 11, 2023 [1] This is my ruling on an application by the defendant, Sandoz Canada Inc., for a declaration that the Affidavit No. 1 of Dr. Keith Reutter dated June 9, 2021 is inadmissible. Dr. Reutter's affidavit is filed in support of the plaintiff's, Mr. Dussiaume, application for certification of a proposed class action. [2] For the reasons that follow, I grant the application of the defendant and find

the affidavit inadmissible. Background [3] Mr. Dussiaume proposes to certify a national class action on behalf of individuals who purchased or ingested a heartburn medication containing ranitidine, a histamine H2-receptor antagonist, under the brand name of Zantac, as well as under generic formulations manufactured, sold, or distributed by one or more of the defendants. The plaintiff alleges that ranitidine transforms over time, and under certain conditions, into N-Nitrosodimethylamine ("NDMA") which they submit is a carcinogen, giving rise to a number of causes of action. [4] In support of the certification application, the plaintiff has delivered Dr. Reutter's affidavit which appends his expert report. Mr. Dussiaume relies upon Dr. Reutter in support of his claim that class members have suffered compensable mental injury as result of the discovery of the presence of NDMA in some ranitidine products and the voluntary recall of certain ranitidine products. [5] Dr. Reutter was cross-examined on August 4, 2022. Dr. Reutter's Opinion [6] Dr. Reutter is an economist who was retained to " assess the extent to which individuals in Canada, used various pharmaceutical products containing Ranitidine, have been impact by Health Canada's recalls of Ranitidine products due to the presence of impurities." [7] In order to evaluate such an impact, he " developed and executed a research

methodology using a survey tool to collect additional information from the registrants regarding the experiences of ranitidine users, in light of the Recalls." [8] He does not attribute any academic literature or personal expertise in support of his assertion that the survey was developed " using standard practices in survey design." Dr. Reutter stipulates that the survey " was designed to detect psychological distress experienced by Ranitidine users as a result of Health Canada's Ranitidine investigation and product Recalls". He furthers that the survey was " developed to detect behaviour which is commonly associated with negative psychological events"; however, it is not a "mental health diagnostic tool". [9] Dr. Reutter's report contains his interpretation of the results of the survey. He then extrapolates those results to the population of Canada as a whole. [10] His conclusion is that " the majority of survey participants experienced some level of distress, anxiety, within the first three months after learning about the Recall. For some, anxiety associated with the Recall continued through at least the three month period preceding the survey (February/March 2021)". As well, activities such as doctor visits were common among survey respondents during the first three months after learning about the recall. Dr. Reutter's affidavit further states that some survey respondents

continued these activities during the 30 days preceding the survey. [11] Finally, Dr. Reutter opines that "the survey results can be extrapolated to the Canadian population and serve as evidence of consistent and pervasive mental distress caused by the Ranitidine Recall." Admissibility of Expert Opinion Evidence [12] The law governing admissibility of expert opinion evidence stems from the Supreme Court of Canada's decision in R. v. Mohan, [1994] 2 S.C.R. 9, 1994 CanLII 80, subsequently clarified in White Burgess Langille Inman v. Abbott and Haliburton Co., 2015 SCC 23 [White Burgess]. The party seeking to admit the evidence must satisfy each element in a two-stage inquiry: a) At the threshold stage, the party seeking to admit the evidence must demonstrate that the evidence satisfies the Mohan factors. That is, the evidence must be relevant, necessary, absent of an applicable exclusionary rule, and that the expert providing that evidence is properly qualified: White Burgess at para. 23. b) At the second stage, the trial judge, exercising the gatekeeping role, must decide whether the benefits of admitting the evidence outweigh its potential risks: White Burgess at para. 24. [13] The element of a "properly qualified expert" under Mohan requires that the expert has acquired special or peculiar knowledge through study or experience in respect of the matters the expert undertakes to testify: McEwan v. Canadian Hockey League, 2022 BCSC 1104 at para.

186. The court must be satisfied that the person under consideration has expertise with respect to the opinions to be advanced, which is something distinct from just familiarity or involvement: Hughes v. Haberlin, 49 B.C.L.R. (3d) 366, 1997 CanLII 2186 at paras. 14 and 21 (S.C.). [14] In addition, as noted in R. v. Abbey, 2017 ONCA 640 at para. 48, a properly qualified expert includes the requirement that the expert be willing and able to fulfil the expert's duty to the court to provide evidence that is: a) impartial, b) independent, and c) unbiased. [15] Expert witnesses must be impartial in the sense that their evidence must reflect an objective assessment of the questions presented to them. They must be independent in the sense that their evidence must be the product of their independent judgment, uninfluenced by the party who retained them or the outcome of the litigation. An expert's lack of impartiality and/or independence is relevant not just to the weight to be given to the evidence under the second stage of the test, but also to its admissibility under the first stage of the test, to be addressed under the "qualified expert" element of the Mohan framework: McEwan at paras. 182-183. [16] Survey evidence may be admissible, assuming the survey responses are elicited by a relevant question, where the survey is both reliable, "in the sense that if the survey were repeated it would likely produce the same results", and valid, "in the sense that the right questions have been put to the right pool of survey respondents in the right way, in the right circumstances to provide the information sought": Masterpiece Inc. v. Alavida Lifestyles Inc., 2011 SCC 27 at para.

94. Like all expert evidence, survey evidence must be prepared by a properly qualified expert: Tokai of Canada Ltd. v. Kingsford Product Company, LLC, 2021 FC 782 at para. 25. [17] Evidence tendered on an application for certification must meet the usual criteria for admissibility: Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2008 BCSC 1263 at para. 25; McEwan at paras. 29-32. The court exercises an important gatekeeping function in a proposed class proceeding and must not "shirk" its responsibility to consider the admissibility of evidence: McEwan at para. 31, citing Carter v. Ford Motor Company of Canada, 2021 ONSC 4137 at para.

9. Dr. Reutter's Qualifications [18] Dr. Reutter is an economist. He specialises in providing economic and statistical analysis and expertise in regulatory and complex litigation matters. He has undergraduate and advanced degrees in economics. [19] He has no training, experience or expertise in psychology or psychiatry and has never been qualified to testify about whether an individual has suffered psychological or psychiatric harm. [20] Dr. Reutter has no expertise either in survey design or methodology generally nor in the design of survey methodology. He also does not have expertise concerning what types of questions should be asked to survey respondents for the purpose of assessing the effects of a particular stressor on individuals. Dr. Reutter lacks any experience in ascertaining the relationship between a stressor and symptoms. [21] Dr. Barry Gilbert, a psychiatrist, prepared an expert report for the defendants and the admissibility of this report was not objected to. In Dr. Gilbert's report, they opine that Dr. Reutter was unaware of, and did not control for, the "heuristic and other biases" inherent in "attempt[ing] to accurately determine a causal relationship between symptoms and a stressor", both of which are biases that impair the survey. [22] The survey did not account for the pre-recall behaviours or feelings of survey respondents. For instance, it did not

account for the impact of COVID-19 or COVID‑19 restrictions, which Dr. Reutter admitted would have been a stressor and led to reduced contact with friends and family. [23] In effect, there was no "control" accounted for in the design of the survey. [24] Dr. Paul Janke, a psychiatrist, prepared a commentary on the relevance of the results within the report of Dr. Reutter "from a psychiatric standpoint" for Mr. Dussiaume. Dr. Janke does not rely on Dr. Reutter's opinion and comments that the use of a standardized self-report instrument would have been helpful. Dr. Reutter's Independence [25] On cross-examination, it was disclosed that the substantive 12 questions in the survey administered by Dr. Reutter were initially drafted by counsel for the plaintiff. He stated he "wordsmithed" the questions; however, no wordsmithing appears to have taken place. [26] In addition, all of the literature supporting the survey's design was also supplied by counsel. The survey tools referenced in that literature have been updated and documented in subsequent literature. Conclusion [27] Dr. Reutter does not have the required expertise which is necessary to provide psychiatric expert opinion in his report. The survey used by Dr. Reutter to gather the responses which were analysed and interpreted in his report cannot be shown to have been designed with any proper expertise. [28] In preparing his

report, Dr. Reutter relied on articles and papers supplied to him by plaintiff's counsel, adopted survey questions for the purposes of his survey that were drafted by plaintiff's counsel and prepared a report that not only did not disclose these matters but either stated or implied that the selection of the papers and the drafting of the questions was his own work. The basis for the survey questions and their authorship was not disclosed in Dr. Reutter's expert report and was only revealed on cross-examination. The failure to disclose these matters and the misleading presentation of the work of counsel as his own work calls Dr. Reutter's independence into serious question. [29] Finally, Dr. Reutter's admitted methodological flaws render his report so unreliable as to have no probative value. [30] Therefore, I find that the Affidavit No. 1 of Dr. Keith Reutter dated June 9, 2021 is inadmissible. "Wilkinson J."