Kirsh v. Bristol-Myers Squibb, 2020 ONSC 1499

COURT FILE NO.: CV-16-553833-00CP

DATE: 20200313

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

Matthew Kirsh and Gayle Kirsh

Plaintiffs

– and –

Bristol-Myers Squibb, Bristol-Myers Squibb Canada Co./La Société Bristol-Myers Squibb, Otsuka Pharmaceutical Co, Ltd., Otsuka Canada Pharmaceutical Inc., Otsuka America Pharmaceutical, Inc., Otsuka America, Inc., Otsuka Maryland Medicinal Laboratories, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., H. Lundbeck A/S, and Lundbeck Canada Inc.

Defendants

Joel Rochon and Golnaz Nayerahmadi, for the Plaintiffs

Gordon McKee, Robin Linley, Justin Manoryk, and Natasha Lombardi, for the Defendant, Bristol-Myers Squibb Canada Co./La Société Bristol-Myers Squibb

Frank McLaughlin, Dorothy Charach, and Brandon Kain, for the Defendants, H. Lundbeck A/S and Lundbeck Canada Inc.

Randy Sutton and Erika Anschuetz, for the Defendant, Otsuka Canada Pharmaceutical

HEARD: March 4-6, 2020

E.M. Morgan, J.

AMENDED REASONS FOR JUDGMENT

RE CERTIFICATION AND STAY MOTIONS

I. The two motions

[1] This proposed class action concerns a claim of negligence, failure to warn, and conspiracy with respect to side effects allegedly caused by the medications Abilify and Abilify Maintena.

[2] Abilify and Abilify Maintena are atypical antipsychotics. The active ingredient of both products is aripiprazole. Abilify is available in tablet form in various dosages, while Abilify Maintena is a prolonged release injectable form of aripiprazole available in higher doses than Abilify tablets. Abilify is approved for use in the treatment of schizophrenia in adults as well as in the treatment of manic episodes associated with bipolar disorder. It is also used as a supplement to other treatments for major depressive disorder. Abilify Maintena is approved for use in the treatment of schizophrenia and for maintenance monotherapy following remission of bipolar disorder.

[3] The Plaintiffs allege that the aripiprazole contained in Abilify and Abilify Maintena causes psychiatric disorders in the nature of compulsive conduct that reflect an inability to control impulsive behaviours – specifically pathological gambling, compulsive shopping and spending, binge-eating, and hypersexuality (“Impulse Control Disorders”). Affidavits from the Plaintiffs describe sometimes life-ruining descents into these destructive behaviours which they attribute to the drugs in issue here.

[4] The Amended Statement of Claim alleges the pharmaceutical manufacturers’ and marketers’ failure to conduct adequate pre- and post-marketing testing and research and to warn consumers of the known and foreseeable risks of harmful side effects. It also alleges a conspiracy among them to knowingly or recklessly, in their mutual economic interests, make false or misleading representations to consumers about the health and safety risks associated with Abilify and Abilify Maintena.

[5] The Plaintiffs seek to certify the claim under the Class Proceedings Act, 1992, SO 1992 c. 6 (“CPA”). Their counsel submit that this is a quintessential products liability case where all of the putative class members took the same medication and have many issues in common. Defendants’ counsel submit that this case ought not be certified. They say that there is no evidence of any harms suffered in common by the class members and that the Plaintiffs have not proposed a methodology for demonstrating that the Defendants’ products have caused the alleged harmful effects.

[6] The Defendants also submit that this action is duplicative and serves no legitimate purpose as it replicates a claim already authorized (i.e. certified) as a national class action by the Superior Court of Québec on December 12, 2019: Scheer v Bristol-Myers Squibb Canada Co., No. 500-06-000831-160 (District of Montréal). As will be discussed in Part III below, the Scheer claim, as authorized, is strikingly similar to the Plaintiffs’ claim.

[7] One group of Defendants, H. Lundbeck A/S and Lundbeck Canada Inc. (“Lundbeck”), has been released from the Scheer case in a discontinuance approved by the Québec court: Scheer v Bristol-Myers Squibb Canada Co., 2018 QCCS 4608. The claim against Lundbeck was with respect to Abilify Maintena only. The other Defendants, Bristol-Myers Squibb Canada Co./La Société Bristol-Myers Squibb (“Bristol-Myers”) and Otsuka Canada Pharmaceutical (“Otsuka”), move to have the entire matter stayed on the grounds of its being an abuse of process insofar as it merely duplicates the Scheer case. They submit that no legitimate purpose would be served by allowing the present case to proceed.

[8] Strictly speaking, it would be logical to start the analysis with the stay motion. It is a threshold motion that, if successful, would obviate the need to consider most of the certification motion. However, the analysis involved in the stay motion is facilitated by a review of the certification motion.

[9] A stay of proceedings is available under Rule 21.01(3)(d) of the Rules of Civil Procedure and as a matter of the court’s inherent jurisdiction to prevent an abuse of power. But this remedy is discretionary: Toronto (City) v CUPE, Local 79, 2003 SCC 63, [2003] 3 SCR 77, at para 35. In order to properly weigh that exercise of discretion, it is important to fully understand the certification motion in all of its aspects. I will therefore proceed with the certification motion in its entirety before returning to evaluate the Defendants’ request for a stay.

II. Certification under the CPA

[10] Although the test for certification under section 5(1) of the CPA is well known, it is worth setting out the statutory requirements for ease of reference as this motion proceeds. Section 5(1) provides:

5(1) The court shall certify a class proceeding on a motion under section 2, 3 or 4 if,

(a) the pleadings or the notice of application discloses a cause of action;

(b) there is an identifiable class of two or more persons that would be represented by the representative plaintiff or defendant;

(c) the claims or defences of the class members raise common issues;

(d) a class proceeding would be the preferable procedure for the resolution of the common issues; and

(e) there is a representative plaintiff or defendant who,

(i) would fairly and adequately represent the interests of the class,

(ii) has produced a plan for the proceeding that sets out a workable method of advancing the proceeding on behalf of the class and of notifying class members of the proceeding, and

(iii) does not have, on the common issues for the class, an interest in conflict with the interests of other class members.

[11] Before delving into the detailed analysis of the section 5(1) criteria, I will take note that certification is a procedural, not a substantive matter. Furthermore, the bar has not been set at a particularly high level for Plaintiffs moving for certification. As the Supreme Court of Canada has stated, “[t]he certification stage does not involve an assessment of the merits of the claim and is not intended to be a pronouncement on the viability or strength of the action”: Pro-Sys Consultants Ltd. v Microsoft Corporation, 2013 SCC 57, [2013] 3 SCR 477, at para 102.

[12] Having said that, “a certification motion is an important screening mechanism for claims that ‘…are not appropriate for class actions’”: Arabi v Toronto-Dominion Bank, 2007 CanLII 56527 (ON SCDC), [2007] OJ No 5035, at para 18 (Div Ct). Accordingly, the Plaintiffs “must show some basis in fact for each of the certification requirements…other than the requirement that the pleadings disclose a cause of action”: Hollick v Toronto (City), 2001 SCC 68, [2001] 3 SCR 158, at para 25. Thus, although the merits are not in issue here, the ‘some basis in fact’ test does require a consideration of the evidence in the record.

a) Is there a cause of action?

[13] In McCracken v Canadian National Railway, 2012 ONCA 445, at at para 75, Winkler CJO indicated that identifying a cause (or causes) of action is the one certification criterion for which there is no requirement that the Plaintiff demonstrate an evidentiary foundation. The test is essentially the same as that on a motion under Rule 21.01 for striking out a claim: the pleading can stand unless it is “plain and obvious” that it discloses no reasonable cause of action: Pro-Sys, at para 63; Cloud v Canada (Attorney General)(2004), 2004 CanLII 45444 (ON CA), 73 OR (3d) 401, at para 41 (Ont CA), leave to appeal refused [2005] 1 SCR vi.

[14] The Plaintiffs’ claim in negligence is based on two allegations: a) that the Defendants failed to provide adequate and timely warning of the causal association between Abilify/Abilify Maintena and the several identified Impulse Control Disorders, and b) that the Defendants failed to conduct any (or any reasonable) pre- and/or post-marketing testing and research to confirm the safety of these two aripiprazole-based medications. Their pleading states that the Defendants owed them a duty of care which was breached, and that the Plaintiffs suffered damages that were foreseeable and causally linked to the Defendants’ breach of the requisite standard of care.

[15] The Amended Statement of Claim specifically alleges that even after knowing of the side effects experienced from the use of Abilify and Abilify Maintena – indeed, even after warnings about these side effects were issued for these medications in Europe – the Defendants failed to issue warnings to consumers about the known risks, or to withdraw the products from the market, or to appropriately modify the product monographs and promptly disclose the information to Health Canada. Specifically, the Plaintiffs plead:

(a) the product monograph for Abilify and Abilify Maintena failed to warn of the increased risk of Impulse Control Disorders;

(b) even the revised November and September 2015 product monographs for Abilify and Abilify Maintena failed to reference all of the risks associated with aripiprazole aripiprazole-based drugs; and

(c) the product monographs for Abilify and Abilify Maintena failed to disclose the severity of such adverse effects prior to February 2017 and December 2016, respectively.

[16] Counsel for the Plaintiffs submit that this action is a paradigm case for a failure to warn class action. They point out that the type of allegations made here, involving pharmaceutical manufactures’ failure to conduct adequate testing and research and to warn consumers of the known risks of harmful side effects, has been the subject of other certified class actions: see, e.g., Heward v Eli Lilly & Co., 2007 CanLII 2651 (ON SC), [2007] OJ No 404 (S.C.J.), aff’d (2008), 2008 CanLII 32303 (ON SCDC), 91 OR (3d) 691 (Div Ct); Schick v Boehringer Ingelheim (Canada) Ltd., 2011 ONSC 1942.

[17] Strathy J. (as he then was) observed in Schick, at para 14, citing Hollis v Dow Corning Corp., 1995 CanLII 55 (SCC), [1995] 4 SCR 634, at para 20, that “[i]t is settled law that a manufacturer has a duty to warn consumers of dangers inherent in the use of the product of which the manufacturer has knowledge or ought to have knowledge”. Warnings must be sufficiently detailed to convey a comprehensive indication of the specific dangers that can arise from the use of the product: Lambert v Lastoplex Chemicals, 1971 CanLII 27 (SCC), [1972] SCR 569, at para. 12.

[18] As pleaded by the Plaintiffs, this duty sounds in negligence. In that respect, it is closely tied to the duty of a manufacturer and marketer of a product to do appropriate research and testing of the product both before and after placing it into the stream of commerce. The duty to test for adverse side effects and the duty to warn of the risk of adverse side effects are related duties that sometimes overlap, but that can have slight factual distinctions that prompt claimants to plead them separately.

[19] The Supreme Court of Canada confirmed the viability of the negligence/failure to warn cause of action in Hollis, at para 23:

The courts in this country have long recognized that 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.

[20] The Plaintiffs allege that the Defendants’ breach of this duty and failure to live up to the required standard of care has resulted in substantial economic loss, emotional and psychiatric harm, loss of employment, and loss of family. In so pleading, the Plaintiffs have satisfied all of the criteria for causes of action in negligence and failure to warn: see Schick, at para 18, citing Mustapha v Culligan of Canada Ltd., 2008 SCC 27, [2008] 2 SCR 114.

[21] As for the pleading of conspiracy, the Defendants submit that there are insufficient particulars to support the Plaintiffs’ claim. Defendants’ counsel argue that the conspiracy allegations in the Amended Statement of Claim amount to bald assertions rather than a properly pleaded cause of action.

[22] Both sides agree that the governing test for unlawful means conspiracy is found in Canada Cement LaFarge v BC Lightweight Aggregate, 1983 CanLII 23 (SCC), [1983] 1 SCR 452, 471-2. Under that test, the Plaintiffs must establish that the Defendants acted in combination, that their conduct was unlawful and directed towards the Plaintiffs, that they knew or ought to have known in the circumstances that injury to the Plaintiffs was likely to occur; and the plaintiffs suffered actual damages. Counsel for the Defendants state that the Plaintiffs’ pleading does not adequately address all of these necessary elements.

[23] It is evident that some of the points that would need to be made to meet the Cement LaFarge test are similar to those involved in the failure to warn/negligence claim. In that regard, I note that a claim in conspiracy will generally not be struck just because its elements overlap with a claim in negligence: Peter v Medtronic Inc., [2007] OJ No 4828, at paras 40-41 (SCJ).

[24] The Plaintiffs have pleaded that the Defendants entered into co-development and co-commercialization agreements for the purpose of maximizing profit, revenue, sales and market share. They state that Otsuka struck a commercialization and collaboration agreement with Bristol-Myers to co-develop and co-promote Abilify in Canada, and that it struck a similar agreement with Lundbeck to co-develop and co-commercialize Abilify Maintena in Canada.

[25] As pleaded, the allegation in respect of these agreements is that the three sets of Defendants, acting in concert, and despite being aware of the risks of Impulse Control Disorders associated with the use of dopamine agonists, decided not to conduct any, or any adequate, testing to confirm this causal association. In doing so, the claim asserts that the Defendants collectively misrepresented to the Plaintiffs and to all class members that Abilify and Abilify Maintena were safe for use. The Plaintiffs further plead that together the Defendants aggressively promoted the two medications through television and internet, in disregard of the known fact that they increase the risk of developing Impulse Control Disorders.

[26] The Amended Statement of Claim goes on to allege that the Defendants agreed to disregard or downplay the existing body of scientific evidence on the risk of Impulse Control Disorders associated with the use of Abilify and Abilify Maintena. It states that the Defendants together knowingly or recklessly represented to the class members that these aripiprazole-based medications were safe at a time when they knew or ought to have known that their use had been associated with an increased risk of Impulse Control Disorders; and they did so without warning of such risks. The Plaintiffs’ pleading states that in doing so, the Defendants breached the Competition Act, RSC, 1985, c. C-34, s. 36, along with the Food and Drug Act, RSC 1985, c. F-27.

[27] In Normart Management Ltd. v West Hill redevelopment Co. Ltd. (1998), 1998 CanLII 2447 (ON CA), 37 OR (3d) 97, the Court of Appeal confirmed the elements required for a pleading of civil conspiracy as follows:

The statement of claim should describe who the several parties are and their relationship with each other. It should allege the agreement between the defendants to conspire, and state precisely what the purpose or what were the objects of the alleged conspiracy, and it must then proceed to set forth, with clarity and precision, the overt acts which are alleged to have been done by each of the alleged conspirators in pursuance and in furtherance of the conspiracy; and lastly, it must allege the injury and damage occasioned to the plaintiff thereby.

[28] Each of these ingredients is present in the Amended Statement of Claim. In addition, the Court of Appeal has acknowledged that an allegation of breach of statute can constitute the ‘unlawful’ element required for a proper pleading of conspiracy: Fanshawe College of Applied Arts and Technology v AU Optronics Corporation, 2016 ONCA 621, at para 73.

[29] It therefore appears to me that the Plaintiffs have covered all necessary bases in their pleading. Much as with the negligence and failure to warn claims, it is not plain and obvious that the conspiracy claim cannot succeed.

[30] On a final note, counsel for Lundbeck submits that the Amended Statement of Claim is deficient insofar as it puts forward a claim against H. Lundbeck A/S, the parent company of Lundbeck Canada Inc. The applicable paragraph in the Plaintiffs’ pleading says little more than that the parent gave the Canadian subsidiary the right to market Abilify Maintena in Canada. Lundbeck’s counsel argues that to hold the parent liable in these circumstances is contrary to the separate entity/corporate veil concept.

[31] In my view, the pleading must be read as a whole, with the failure to warn and negligence claim taken in conjunction with the conspiracy claim. The Amended Statement of Claim speaks of a willful collaboration among the Defendants to get Abilify and Abilify Maintena to market in a way that avoided issuing the warnings and conducting the testing that ought rightly to have been done. In this respect, it can be read as making the point that Lundbeck Canada Inc. was misused by its parent.

[32] While the pleading with respect to H. Lundbeck A/S is admittedly sparse on particulars, it is not so sparse that it cannot be defended. The claim against the Lundbeck parent will either be filled in with further evidence at discovery and trial or will fail at the trial stage. As it is, there is enough to get it past the “plain and obvious” standard that prevails under s. 5(1)(a) of the CPA.

b) Is there an identifiable class?

[33] Counsel for the Plaintiffs propose four separate classes: (a) those who ingested Abilify; (b) those who were injected with Abilify Maintena; (c) and (d) family classes respecting each of (a) and (b).

[34] The proposed classes are circumscribed in time, beginning with the dates on which Abilify and Abilify Maintena were approved in Canada and ending on the dates on which the product monographs for the two drugs were revised to provide adequate and detailed warnings regarding the risk of Impulse Control Disorders. The four classes, therefore, are defined as all persons who took Abilify or Abilify Maintena during the period when the product monographs for the two drugs lacked adequate warning, along with the dependents of those persons, as follows:

All persons in Canada, including their estates, who were prescribed and ingested Abilify between July 9, 2009 and February 23, 2017;

All persons in Canada, including their estates, who were prescribed and used Abilify Maintena between February 6, 2014 and December 16, 2016;

All persons resident in Canada who, by virtue of a personal relationship with an Abilify Class Member, are entitled to assert a derivative claim for damages pursuant to Family Law Act, RSO 1990, c. F.3, as amended or equivalent provincial and territorial legislation; and

All persons resident in Canada who, by virtue of a personal relationship with an Abilify Maintena Class Member, are entitled to assert a derivative claim for damages pursuant to Family Law Act, RSO 1990, c. F.3, as amended or equivalent provincial and territorial legislation.

[35] Generally, a class will satisfy the requirement of s. 5(1)(b) if members of the class can be identified using objective criteria to determine whether any particular individual is a class member: Robertson v Thomson Corp. (1999), 1999 CanLII 14768 (ON SC), 43 OR (3d) 161, 169 (Gen Div). The proposed class members need not have identical claims or interests, but rather must show that their claims will be advanced by the resolution of the common issues: Sankar v Bell Mobility, 2013 ONSC 5916, at para 57. On the other hand, the class definition is not to be excessively broad; the onus is on the Plaintiffs to show that “the class could not be defined more narrowly without arbitrarily excluding some people who share the same interest in the resolution of the common issue”: Hollick, at para 21.

[36] Counsel for the Defendants submit that the classes are overly broad. In particular, they state that the relevant classes should be limited to those persons who took Abilify and/or Abilify Maintena and who can demonstrate that they suffered one of the Impulse Control Disorders as a result.

[37] Counsel for the Plaintiffs argue that the Defendants’ proposed limitation on the class definition is inherently merits-based, which is not appropriate as a means of defining at the outset who is in the class. Winkler, RSJ (as he then was) noted in Frohlinger v Nortel Networks Corporation, 2007 CanLII 696, at para 27 (SCJ), that “a proper class definition does not include only those persons whose claims will be successful.” As in Cloud, supra, at para 47, “[a]ll class members share the same interest in the resolution of whether they were owed these duties and whether these duties were breached. Any narrower class definition would necessarily leave out some who share that interest.”

[38] The class of Abilify users, and of Abilify Maintena to a lesser degree, are large, but they are not unwieldly. Defining the classes by reference to users of the two medications provides a readily discernable and objective definition. It is easily evidenced since these drugs are only available on a prescription basis.

[39] While there may be many class members who never recover any damages as they did not suffer an Impulse Control Disorder as a consequence of taking either of the two medications, the class definitions as proposed by the Plaintiffs do not require any onerous fact-finding. The classes therefore meet the criteria for an identifiable class under section 5(1)(b) of the CPA.

c) Are there common issues?

[40] It is the common issues requirement under section 5(1)(c) of the CPA that is at the heart of the dispute between the parties. Counsel for each of the Defendants submit that the common issues are ill-defined and, more to the point, are overshadowed and rendered meaningless by the many individual issues that would remain to be determined even after a common issues trial.

[41] In Western Canadian Shopping Centres Inc. v Dutton, 2001 SCC 46, [2001] 2 SCR 534, at para 39, the Supreme Court of Canada instructed that, when it comes to identifying common issues in a certification motion, “[t]he underlying question is whether allowing the suit to proceed as a [class proceeding] will avoid duplication of fact-finding or legal analysis”. The Court went on to state, at paras 39-40, that a “common issue” is one which is necessary to resolve each class member’s claim, and that all class members must to one extent or another benefit from the disposition of the issue. At the very least, “success for one member must not result in failure for another”: Vivendi Canada Inc. v Dell’Aniello, 2014 SCC 1, [2014] 1 SCR 3, at para 45.

[42] The common issues proposed by Plaintiffs’ counsel were initially contained in their factum on this motion. They were then slightly edited and revised and handed to all counsel (and to me) at the hearing of this motion. As revised, the proposed common issues are:

(1) Does aripiprazole, used as indicated, cause, contribute to, or exacerbate the following compulsive behaviours and impulse control disorders, namely: i) compulsive gambling; ii) compulsive shopping; iii) hypersexuality; iv) binge eating?

(2) If the answer to question (1) is ‘yes’, when did the Defendants know, or when ought the Defendants to have known, of this causal relationship or association?

(3) If the answer to question (1) is ‘yes’, did the Defendants have a duty to warn the Abilify Class members and the Abilify Maintena Class members of the increased risk of the compulsive behaviours and impulse control disorders described in (1) above associated with Abilify and Abilify Maintena?

(4) If the answer to question (1) is ‘yes’, did the Defendants breach their duty to warn the Abilify Class members and the Abilify Maintena Class members of the increased risk of the compulsive behaviours and impulse control disorders described in (1) above associated with Abilify and Abilify Maintena?

(5) If the answer to question (4) is ‘yes’, how long did that breach continue for i) the Abilify Class; and ii) the Abilify Maintena Class.

(6) If the answer to question (1) is ‘yes’, were the Defendants negligent in failing to conduct reasonable pre- and post-marketing research, investigation and testing of aripiprazole in relation to the risk of the compulsive behaviours and impulse control disorders described in (1) above?

(7) Are the Defendants, or some of them, liable for conspiracy to promote, market, and distribute Abilify and/or Abilify Maintena in Canada without adequate and timely warnings about the increased risk of the compulsive behaviours and impulse control disorders described in question (1)?

(8) If the answer to question (7) is ‘yes’, over what period of time did the conspiracy take place and over what period of time did the conspiracy affect the adequacy of the warnings about the increased risk of the compulsive behaviours and impulse control disorders described in (1) above associated with Abilify and Abilify Maintena in Canada?

(9) Does the conduct of the Defendants justify an award of punitive damages?

[43] A reading of the proposed common issues reveals that it is the first question – that of general causation – that is the lynchpin for the entire exercise. Once that question is answered, the rest fall into place. Accordingly, if proposed common issue 1 is answered in the affirmative, the claim is likely to be certified. If not, it is unlikely to be certified.

[44] In approaching the general causation question as the foundational step in the analysis, counsel for the Plaintiffs rely on Batten v Boehringer Ingelheim (Canada) Ltd., 2017 ONSC 53, aff’d 2017 ONSC 6098 (Div Ct). At first instance, Perell J. indicated, at para 38, that the logic of a products liability claim dictates the following analytic process:

The first step, known as the general causation step, determines whether the product is capable of causing harm. The second step is part of determining whether the manufacturer had a duty of care not to sell the product or to sell it only with an appropriate warning. The third step focuses on the adequacy of the warning. The fourth step will determine individual causation and the quantification of the compensation for the consequent harm.

[45] The Plaintiffs’ record contains the affidavits of three expert witnesses who address the general causation question:

i) Dr. Eric Hollander – a psychiatrist, professor of Psychiatry and Behavioral Sciences, and director of the Compulsive, Impulsive, Autism Spectrum Disorder Program at the Albert Einstein College of Medicine in New York. Dr. Hollander has been qualified as an expert in the side effects of Abilify in parallel U.S. litigation. His evidence here provides information on the clinical features of the side effects of dopaminergic drugs such as aripiprazole and opines on the link between Abilify/Abilify Maintena and Impulse Control Disorders. Among other things, he sets out in his affidavit that as a dopaminergic drug and partial dopamine agonist, Abilify can stimulate D2 and D3 receptors in the brain, leading to activation of dopamine activity. In this respect, it is similar to full dopamine agonists, like Mirapex (the subject of the class action certification order issued by Strathy J. in Schick). Dr. Hollander also provides evidence about the historic knowledge of the link between dopaminergic drugs and Impulse Control Disorders, and opines that Defendants should have been alerted to propensity of Abilify/Abilify Maintena to cause these side effects prior to the July 9, 2009 approval of these medications in Canada.

ii) Dr. Celeste Napier – a professor in the Department of Psychiatry and the director of the Center for Compulsive Behavior and Addiction at the Rush University Medical Center in Chicago. Dr. Napier is widely published in professional journals and has provided expert testimony to, among others, the U.S. Congress and Illinois House of Representatives, on issues of neuropharmacology, neuroscience, and addictions. She also provided expert evidence on dopamine agonists to the Ontario Superior Court in Schick, and is the only neuropharmacologist to provide evidence in this motion. She opined that the fact that Abilify/Abilify Maintena are partial dopamine agonists does not change the foreseeability of their having side effects similar to those of full dopamine agonists like Mirapex. She explains in her affidavit that it has been known for nearly 5 decades that long-term treatment with antipsychotics for schizophrenia or bipolar disorder increases the number of certain dopamine receptors in the brain, and that this increase can increase the risk of Impulse Control Disorders when using dopaminergic medication. In other words, it has long been known that using Abilify and Abilify Maintena for their specific indications may tend to exacerbate the side effects even more than full dopamine agonists like Mirapex (which are primarily used to treat Parkinson’s disease).

iii) Dr. David Gardner – a pharmacist and professor at Dalhousie University’s Department of Psychiatry and College of Pharmacy in Halifax. He has expertise in pharmacoepidemiology and psychopharmacology and has published extensively on antipsychotics. Dr. Gardner has also served on the government of Canada’s Ministerial Advisory Committee on Mental Health as well as on national, provincial, and hospital committees to assess the efficacy and safety of drugs in approving them for patient use. He opines that publications from Otsuka employees suggest that they failed to adequately focus on the risks of Abilify’s partial agonist properties during the drug’s development process, and that given the data available at the time of production the Abilify and Abilify Maintena monographs “poorly or inaccurately described” the risk factors for Impulse Control Disorders (and that, in fact, the FDA drug safety warnings in the U.S. were more inclusive). He further opines that the Impulse Control Disorders described in the Plaintiffs’ affidavits are explainable with reference to their use of Abilify/Abilify Maintena, even after considering their underlying conditions.

[46] The Defendants contest much of this evidence. They observe, for example, that the particular side effects identified by the Plaintiffs and their expert witnesses – the Impulse Control Disorders – are not even identified as diagnostic phenomena in the American Psychiatric Association’s most recent iteration of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

[47] Counsel for Bristol-Myers submits that, “[W]hile the DSM-5 does contain a category called ‘Disruptive, Impulse-Control, and Conduct Disorders’, none of the specific so-called ‘impulse-control disorders’ identified by the plaintiffs in the proposed general causation question – compulsive gambling, hypersexuality, and compulsive shopping – fall within that category in the DSM-5.” They go on to state that, “‘So-called ‘Impulse-control Disorders’ cannot be considered as one entity”, and that “[t]he so-called ‘impulse-control disorders’ identified by the plaintiffs are varied and diverse and lack consistent (or in some case any) diagnostic criteria in the DSM-5.”

[48] In making this point, they rely on the evidence of their expert witness, Dr. Marc Potenza. Dr. Potenza was also an expert witness that filed a report with respect to these drugs on behalf of the defendants in the U.S. litigation. He is a professor of Psychiatry at the Yale University School of Medicine and director of Yale’s Center of Excellence in Gambling Research as well as the director of the Yale Program for Research on Impulsivity and Impulse Control Disorders. Dr. Potenza explains in his affidavit that Pathological Gambling is identified in DSM-5 as “Gaming Disorder”, and that it is now better understood in the scientific community as a behavioural condition that is dependent on the presence of a number of individual and sociological factors. He likewise opines that “the absence of agreed-upon criteria for compulsive shopping or buying has not only led to the perpetuation of significant gaps in understanding, but also does not permit accurate application.”

[49] Dr. Potenza goes on to note that binge-eating disorder is not classified as a “Disruptive, Impulse-Control and Conduct Disorders” category in DSM-5, but rather is grouped together with other, non-compulsive eating disorders. Similarly, he observes that compulsive shopping and hypersexuality are not recognized in the DSM-5 at all. Counsel for Bristol-Myers follows this up by pointing out that the DSM-5 states: “groups of repetitive behaviors, which some term behavioral addictions, with such subcategories as ‘sex addiction,’ ‘exercise addiction,’ or ‘shopping addiction,’ are not included because at this time there is insufficient peer-reviewed evidence to establish the diagnostic criteria and course descriptions needed to identify these behaviors as mental disorders”.

[50] It is fair to say that counsel for the Defendants generally take Dr. Potenza’s observations and his readings of the DSM-5 categories and make what Perell J. has termed the “inevitably argument”. I say this without in any way diminishing Dr. Potenza’s credentials, which are indeed impressive, or his recognized expertise on impulse control issues and related behavioural conditions. But it is essentially Defendants’ counsel’s position that, “inevitably, this action will break down into individual proceedings, creating a monster of complexity that would made a common issues trial unproductive”: Parker v Pfizer Canada Inc., 2012 ONSC 3681, at para 122. As counsel for Bristol-Myers put it, “each of the so-called compulsive behaviours and impulse control disorders which the plaintiffs allege can be caused by the use of Abilify and Abilify Maintena has its own unique set of diagnostic criteria, symptomatology, biological underpinnings, and treatments.”

[51] Dr. Potenza’s affidavit does in fact make this point. He expressly states that, “[d]efining general causation with respect to neuropsychiatric conditions involves multiple considerations. There is insufficient evidence of general causation for aripiprazole and pathological gambling or aripiprazole and so-called impulse control disorders”. That said, he also qualifies the analysis, and in doing so may provide insight into the difference between his view and that of the Plaintiffs’ experts. Dr. Potenza advises that, “For the purpose of my report, I have not been asked to provide my complete analysis of general causation…”

[52] Counsel for the Plaintiffs points out that the DSM-5 category of Gambling Disorder, which, as Dr. Potenza observes, contains a number of individualized markers to be used in the diagnostic process, also contains a category of “Differential diagnosis” pertaining to the specific category of drug-induced gambling disorder. This differential diagnosis is not mentioned in Dr. Potenza’s affidavit. Rather, his affidavit submitted in this litigation is limited to consideration of idiopathic, or spontaneously erupting versions of the Impulse Control Disorders identified by the Plaintiffs.

[53] Plaintiffs’ counsel submit that this omission is all the more interesting as it was not omitted from Dr. Potenza’s report filed in the litigation over these drugs in the United States. In cross-examination they put this discrepancy to Dr. Potenza, but counsel for Bristol-Myers objected to the question.

[54] Defendants’ counsel explain this by reminding us of the fact that the American and Canadian legal systems do not operate in exactly the same way. They point out that the U.S. litigation involved different legal considerations and the expert evidence presented there was aimed at the relevant criteria that needed to be addressed under that country’s laws.

[55] That observation is, of course, correct as a general legal matter. Nevertheless, this one difference between the two reports filed by Dr. Potenza is arresting. It involves the very issue at stake in the present motion, making the explanation that it was relevant in the United States but not in Ontario a proposition about which one can only be skeptical.

[56] In fact, the American Psychiatric Association’s manual, on which so much of the Defendants’ objection to the Plaintiffs’ expert evidence rests, does recognize a category of drug-induced gambling disorder as a “differential diagnosis” for Gambling Disorder. In his Reply Affidavit, Dr. Hollander explains, quoting the DSM-5:

‘Some patients taking dopaminergic medications (e.g. for Parkinson’s disease) may experience urges to gamble. If such symptoms dissipate when dopaminergic medications are reduced in dosage or ceased, then a diagnosis of gambling disorder would not be indicated.’ The statement included in the DSM-5 pertaining to drug-induced gambling would also pertain to other compulsive-impulsive behaviors which may be caused by dopaminergic drugs like Abilify. These include compulsive shopping, hypersexuality, binge or compulsive eating and other compulsive urges, which share many of the features of Gambling Disorder, Pathological Gambling and drug-induced gambling.

[57] Dr. Hollander confirms that the DSM-5 does indeed recognize drug-induced gambling as a distinct condition that is to be diagnosed in a different way than idiopathic or other forms of pathological gambling. He explains that for this differential diagnosis, one essentially looks at the timing of the drug and the symptoms – when was the drug in question started and stopped by the patient, and when did the Impulse Control Disorder appear and subside? Dr. Hollander elaborated in cross-examination: “[I]f you can attribute a syndrome to a known medical cause, or a known variable, like a drug, then you shouldn’t be calling it the idiopathic condition, because it doesn’t fit. You have to call it something different.”

[58] Defendants’ counsel also submit that scientists do not agree on how, exactly, aripiprazole works at the cellular level to impact on the brain’s dopamine receptors. While everyone concedes that aripiprazole is a partial agonist that binds to the D2 and D3 receptors, there is scientific controversy over the precise way in which it affects those receptors.

[59] Counsel for Bristol-Myers argues that the Plaintiffs’ experts cannot even agree among themselves on this question. Thus, for example, they point out that unlike Parkinson’s, a disease characterized by a lack of dopamine that requires a full agonist to stimulate production, bipolar condition and schizophrenia – the two predominant indications for Abilify/Abilify Maintena – are more complex to address. Dr. Hollander’s view is that Abilify blocks D2 receptors, while Dr. Napier testifies that “the action of aripiprazole likely reflects activation of both D3 and D2 subtypes.

[60] Defendants’ counsel submit that these appear to be contradictory theories. To be sure, Dr. Napier conceded in cross-examination that it is controversial whether Abilify causes upregulation or prevents upregulation of dopamine. She testified that she is of the view that it causes upregulation, but at the same time she acknowledges a paper by Shigenori Tadokoro published in the Schizophrenia Bulletin in 2011 entitled “Chronic Treatment with Aripiprazole prevents development of Dopamine Supersensitivity and potential Supersensitivity Psychosis”, which holds that aripiprazole acts on receptors to reduce excessive sensitivity to dopamine and stabilize the brain’s sensitivity to dopamine. This seems to be in line with Dr. Gardner’s statement in his affidavit that aripiprazole can have both a stimulating and a blocking effect.

[61] As Dr. Gardner explains it, aripiprazole “can act as a partial agonist, meaning that intrinsically it’s stimulating the dopaminergic receptor, but if it wasn’t there, dopamine would stimulate it slightly more, or it can act as an antagonist because it’s interfering with dopamine being able to bind to that receptor.” In this description, the active ingredient in Abilify/Abilify Maintena is what has been called a dopamine “thermostat”. If there is an excess of dopamine it will bring the level down, and if there is a lack of dopamine it will bring the level up. It works on the D2 and D3 receptors as a modulator. In her cross-examination, Dr. Napier expounds that for a “partial agonist like Abilify…their function reflects this environment, this context, this status of the dopamine system”.

[62] There is no doubt that the science is not only complex, but somewhat up for debate among the experts. Counsel for Bristol-Myers says that all of this amounts to “lots of theory, not really any evidence.”

[63] It is obvious that, “[T]he question whether the defendants knowingly, recklessly, or negligently breached a duty to warn the class of the risks of harm…can only be addressed in relation to an identified risk.”: Charlton v Abbott Laboratories Ltd., 2015 BCCA 26, para 116. In order to assess this, the Plaintiffs need not prove every scientific aspect of their case at the certification stage. What they must establish is that they have a “plausible methodology” for analyzing the issues, and expert evidence that will support that methodology: Pro-Sys, supra, at paras 125-6.

[64] In presenting a methodology based on expert evidence, the Plaintiffs do not have to demonstrate that all expert opinion aligns in their favour. Rather, for certification they must demonstrate that they have some evidence on which their methodology is based and with which to work. As the Supreme Court has noted, “It is indeed possible that at trial the expert evidence presented by [the Defendants] will prove to be stronger and more credible than the evidence of [Plaintiffs’ experts]. However, resolving conflicts between the experts is an issue for the trial judge and not one that should be engaged in at certification”: Ibid., at para 126.

[65] Chief Justice Strathy, on behalf of a unanimous Court of Appeal, clarified in Fehr v Sun Life Assurance Company of Canada, 2018 ONCA 718, at para 85, that “[t]he question for the motions judge was whether there was some basis in fact for the existence of common issues of fact and law…” The point at this stage is to show a basis for the commonality of the issues; that is what makes the certification process a “meaningful screening device”: Pro-Sys, at para 103. The point is not to show a basis for resolving the issues in the Plaintiffs’ favour on the merits. To this end, the Plaintiffs’ methodology needs to be workable, not bullet-proof and ready for victory at trial.

[66] The British Columbia Court of Appeal has made this point specifically with respect to drug product liability claims:

It is not necessary at this stage that there be specified a ‘gold standard’ randomized, double blind, clinical trial involving thousands of men over a lengthy period… to determine whether the plaintiff has passed the ‘some basis in fact’ threshold and to establish whether there is some viable, plausible way in which general causation could be proven at trial…

Legal degrees of proof are not mathematical probabilities but legal or epistemic likelihoods. There are no hard and fast rules for inferring causation in any given case.

Miller v Merck Frosst Canada Ltd., 2015 BCCA 353, at paras 49, 58, 59.

[67] In my view, the evidence of Drs. Hollander, Napier, and Gardner establishes some basis in fact for common issue 1 as set out at para 42 above – i.e. that aripiprazole, used as indicated, causes or exacerbates the identified Impulse Control Disorders. There is some basis that the historical knowledge and literature on the subject ought to have led the Defendants to realize prior to approval in Canada in July 2009 that Abilify and Abilify Maintena could cause or exacerbate these side effects. And there is some basis in fact that the product monographs for Abilify/Abilify Maintena inadequately described the risks of these drugs and continued to fall short of an adequate warning even after they were subsequently updated in November and September 2015.

[68] Thus, while there will still be individual causation issues to be determined, the Plaintiffs have established that there is “some evidence of a methodology that will enable them to prove causation on a class-wide basis”: Charlton v Abbott Laboratories Ltd., 2015 BCCA 26, at para 84. The general causation question is therefore a proper common issue that will significantly advance the case. Likewise, common issues 2 through 9 all flow directly from common issue 1 and are also proper common issues.

[69] Turning more specifically to the follow-up issues, common issues 2 through 5 deal with the alleged failure to warn. Claims dealing with the existence of this duty are commonly certified: see Crisante v DePuy Orthopaedics Inc., 2013 ONSC 5186; Kuiper v Cook (Canada) Inc., 2020 ONSC 128 (Div Ct). In fact, this was one of the central common issues certified by Strathy J. with respect to Mirapex in Schick.

[70] There is a basis in fact from all three of the Plaintiffs’ expert witnesses to explore what knowledge the Defendants had, and when, regarding the risks of Impulse Control Disorder side-effects. In addition, there is evidence in the record that European regulators had required a warning to be added to the updated product monograph for aripiprazole in 2012. As already indicated, an advisory issued by a regulatory body can provide a basis in fact for a duty to warn: Kuiper, at para 44.

[71] Common issue 6 relates to the allegation of negligent pre- and post-marketing research and testing by the Defendants. The question of whether a duty exists for the Defendants to conduct such research and testing is by definition common to all class members.

[72] In Anderson v St. Jude Medical Inc., 2003 CanLII 5686 (ON SC), [2003] OJ No 3556, a similar common issue was certified relating to the alleged failure of the defendant to conduct research and testing of heart valves. The court held that this issue was a crucial one regardless of the variability of the medical conditions experienced by individual class members: Ibid., at para 40.

[73] Having said that, it is possible that this question is subsumed within the duty to warn addressed in common issues 3 to 5. Defendants’ counsel makes the point that there is no viable distinction between an allegation of failure to warn of risks and an allegation of failure to conduct research and testing with respect to the risks about which there was a failure to warn. Plaintiffs’ counsel acknowledged this point in argument at the hearing, although they did not agree to omit the question.

[74] In my view, it is worthwhile to pose it as a separate question, even if the answer is similar to those of the questions that precede it. Answering the question of failure to warn and the question of failure to adequately test and research separately may add some helpful clarity to the common issues. Under the circumstances, a potential for some redundancy does not detract from the analytic exercise.

[75] Common issues 7 and 8 relate to the pleading of civil conspiracy. There is evidence in the record that the Defendants developed and marketed a drug that acts as a partial dopamine agonist, and that they knew or ought to have known that it could potentially cause Impulse Control Disorders. Furthermore, there is some basis in fact for exploring through the common issues the allegation that the Defendants did not disclose this risk to users of the drug. The evidence reviewed above that the Defendants acted in concert in bringing Abilify/Abilify Maintena to consumers, and that they collectively misled users of these drugs about their safety, provides a basis in fact to explore the conspiracy question on a common basis: see LeFrancois v Guidant Corporation, 2008 CanLII 15770, at para 43.

[76] Common issue 9 poses the question of punitive damages. The issue with respect to punitive damages will ultimately be whether the acts of the Defendants in developing and marketing Abilify/Abilify Maintena without warning of the risk of Impulse Control Disorders was “sufficiently reprehensible or high-handed to warrant punishment”: Parker, supra, at para 115. Like the conspiracy claim, the punitive damages issue relies on the overall evidence about how Abilify was developed and how it was marketed in a global alliance to commercialize it.

[77] To be clear, at this stage it is not necessary to decide whether punitive damages are warranted, but only to decide whether the issue is “capable of being determined as a common issue at the trial in this proceeding where the other common issues will be determined”: Chalmers v AMO Canada Company, 2010 BCCA 560, at para 31. Given the commonality of the general causation issue on which it is based, the punitive damages issue likewise passes the common issues hurdle.

d) Is a class action the preferable procedure?

[78] In Myotrophic Lateral Sclerosis Society v Windson, 2015 ONCA 572, the Court of Appeal stated that to meet the test for certification, the class proceeding must be “fair, efficient and manageable”. There must be no other procedure that is preferable.

[79] With this test in mind, the Defendants make a number of disparate attacks on the Plaintiffs’ claim. In the first place, they contend that the claim with respect to Abilify Maintena engages too small a group of drug users for a class proceeding to be preferred over individual proceedings. While the Defendants recognize that section 5(1)(b) of the CPA requires only that two or more class members exist, they contend that this minimalist requirement does not end the matter. They contend that small class size, even if the class meets the section 5(1)b) requirement, impacts on the preferability analysis under section 5(1)(d).

[80] In making this point, counsel for Lundbeck relies on the statement by Nordheimer J. (as he then was) in Ward-Price v Mariners Haven Inc., 2002 CanLII 38058, at para 39: “[s]imply put, the smaller the membership of the proposed class, the more difficult it is to see a class proceeding as accomplishing the goal of judicial economy.” They also go on to suggest that the one Plaintiff whose affidavit indicates that he was an Abilify Maintena user, Mahon Das Seenauth, is not a particularly good representative Plaintiff. They point out that he has a hard time identifying any other Abilify Maintena user, and that he may in any case encounter individual causation problems with his case down the road.

[81] Abilify Maintena is only indicated for treatment of schizophrenia in adults, and is not indicated for the other illnesses for which the orally ingested Abilify is often prescribed. For that reason, there are considerably fewer Abilify Maintena users overall.

[82] In support of that point, counsel for Lundbeck points out that, as noted in Part I above, in the Scheer litigation in Québec the plaintiffs have discontinued their claim against Lundbeck with respect to Abilify Maintena. Lundbeck’s counsel explains that the reason for this is that Abilify Maintena was on the market for a far shorter time than Abilify before the product monograph warnings were revised. In addition, apparently only 3 people had put their names on the Québec website for the case identifying themselves as Abilify Maintena users, as opposed to over 1,000 people for Abilify.

[83] Although Mr. Seenauth may be personally unaware of the number of people who have suffered Impulse Control Disorders as side effects of Abilify Maintena, counsel for the Plaintiffs went part way toward answering this question in addressing an undertaking given on Mr. Seenauth’s cross-examination. Plaintiffs’ counsel provided Defendants’ counsel with a spreadsheet identifying 34 people who have contacted their firm as Abilify Maintena class members.

[84] Defendants’ counsel take the position that this information does not constitute evidence on the motion as it comes directly from Plaintiffs’ counsel rather than in affidavit form. The fact is, however, that it arises from a specific question asked by Defendants’ counsel in an examination of Mr. Seenauth under oath. In providing the answer by way of undertaking, Plaintiffs’ counsel delivered to the Defendants the equivalent of an answer given under oath.

[85] Plaintiffs’ counsel’s spreadsheet therefore counts as evidence and is admissible in this motion. Counsel for the Defendants asked for this information themselves. Their objection to its admissibility as an answer to an undertaking suggests that they asked the question strategically, and that what disappoints them is the content rather than the form of the answer that they have received.

[86] Moreover, there are apparently 80,000 prescriptions for Abilify Maintena in Canada. And while that number may pale in comparison with the some 7.7 million Abilify prescriptions, it is nevertheless not what one would call a de minimis number of people. I see no reason not to include the Abilify Maintena class in this action. To make them bring individual actions, with their own expert witnesses, etc., when the general causation issue in all of its aspects will be canvassed in the Abilify common issues trial, would run directly counter to the goal of access to justice for which the CPA stands.

[87] Of larger concern is the Defendants’ argument that the individual issues left after the common issues trial will so vastly overwhelm the common issues that the common issues trial will become all but irrelevant. In response, Plaintiffs’ counsel do not dispute that there will be individual causation issues to be worked out for each class member following the determination of the common issues at trial. But they present these individual issues as a requiring a far lesser degree of inquiry.

[88] Dr. Gardner testifies that there must of course be individual inquiries made of each class member making a claim in order to determine whether they have suffered an Impulse Control Disorder as a result of taking Abilify/Abilify Maintena. This may be a simple exercise or it may be a difficult one. It is not hard to discern whether a person is engaged in a compulsive form of gambling; one might have to do little more than to track his or her number of visits to a casino or gambling website. On the other hand, Dr. Hollander concedes that patients with schizophrenia, bipolar disorder, and depression may be predisposed to the disorders that make up the impugned side effects of aripiprazole, which may complicate the individual causation inquiry. For example, Mr. Seenauth has given evidence that he had a gambling problem before every taking Abilify Maintena.

[89] It is certainly a concern if the individual issues appear excessively voluminous. The Supreme Court has instructed that under section 5(1)(d) of the CPA, the Plaintiffs must “demonstrate that, given all of the circumstances of the particular claim, [a class action] would be preferable to other methods of resolving these claims and, in particular, that it would be preferable to the use of individual proceedings”: Hollick at para 30, quoting M.G. Cochrane, Class Actions: A Guide to the Class Proceedings Act, 1992 (1993), at p. 27.

[90] That said, it is not a mathematical tally of the overall number of individual issues that guides the certification analysis. I must keep in mind that “the Act contemplates that class actions will be allowable even where there are substantial individual issues”: Ibid., at para 30. The question is whether “a class action [is] the preferable procedure for ‘the resolution of the common issues’…and not that a class action be the preferable procedure for the resolution of the class members’ claims”: Ibid., at para 29 [emphasis in the original].

[91] There is no single, objective measure like a simple blood test that can be applied to determine whether any individual suffers drug-induced gambling or another Impulse Control Disorder as a result of taking Abilify or Abilify Maintena. A more in-depth inquiry will doubtless need to be made in some individual cases. However, that is not to say that “the supposed efficiencies of the common issues trial will turn out to be imagined and not real”: Cavanaugh v Grenville Christian College, 2012 ONSC 2995, at para 153. The complex scientific controversy in this case is the general causation issue – does aripiprazole, as a partial dopamine agonist, cause the Impulse Control Disorders identified by the Plaintiffs as side effects of Abilify/Abilify Maintena?

[92] Once the question of general causation is resolved, the individual causation issues will be the tail end of the litigation, even if it is a relatively long tail. “The preferability determination must be made by looking at the common issues in context, meaning, the importance of the common issues must be taken into account in relation to the claims as a whole”: Markson v MBNA Canada Bank (2007), 2007 ONCA 334, 85 OR (3d) 321, at para 69 (Ont CA). Taken in context, and analyzed “through the lens of the three principal advantages of a class proceeding: judicial economy, access to justice and behaviour modification”, ibid., litigating this case as a class action is the preferable procedure. The unwieldly alternative would be to require every class member making a claim to individually “replicate the fact-finding and legal analysis of the common issues trial”: Cavanaugh, at para 152.

[93] Finally, the Defendants argue that the overlap between the issues here and those in the Scheer claim in Québec make a class action in this case not the preferable procedure. In effect, these are the same arguments that they make in their motion to stay the present proceedings. I will therefore discuss the relationship between the present claim and the Scheer claim in Part III below, in the context of the stay motion. Suffice it to say that if this action needs to be stayed then it is also not the preferable procedure, and if it does not need to be stayed then it can be evaluated on its own without reference to the parallel Québec claim.

e) Is there a representative Plaintiff with a workable litigation plan?

[94] There are two named Plaintiffs in the style of cause and another 5 Plaintiffs identified in the claim. All of them state that they took Abilify or, in Mr. Seenauth’s case, Abilify Maintena, and that they suffered an Impulse Control Disorder as a result. They appear to be fully engaged in the case. Their counsel has produced a workable litigation plan that will take this matter through to the end of the common issues trial.

[95] Counsel for the Defendants make a number of what I can only call half-hearted objections to the representative Plaintiffs under the CPA’s section 5(1)(e) criteria. In the first place, counsel for Bristol-Myers state in their factum that, “At this time, pending full document discovery, there is an insufficient factual basis on which the Court could conclude that interests of the proposed representative plaintiffs might conflict with the interests of other class members. However, given the highly individualized nature of the representative plaintiffs claims, the potential for conflicts to arise cannot be ruled out.” They provide no examples or further explanation of what type of conflict they have in mind.

[96] It is no objection to say that there is a theoretical possibility of a conflict but that there is “an insufficient factual basis” to determine whether or not it is real. It is also difficult to understand how one person’s claim to have suffered a damaging side-effect from the drugs produced and marketed by the Defendants could create an actual conflict with another person’s claim to have suffered as well. Each claim, whether by a representative Plaintiff or any other class member, can be assessed in the same way following conclusion of the common issues trial. This line of attack by the Defendants has no cogency and is an unnecessary addition to a case that is already sufficiently lengthy and complex.

[97] Secondly, counsel for the Defendants complain that the litigation plan put forward by the Plaintiffs does not cover the post-common issues trial proceedings. In my view, however, the Plaintiffs’ approach is entirely logical. Neither the Plaintiffs nor their counsel know what position the case will be in at the post-trial stage.

[98] Everyone acknowledges that there will be a need for some form of individualized inquiry at the end of the class proceeding process. But the extent of those procedures may have to wait to see what transpires with the general causation issues that will be determined in common. Whether a simple questionnaire designed by a claims administrator will suffice, or more elaborate mini-trials will have to be conducted, might well turn on the common issues judge’s findings and reasons for decision.

[99] Accordingly, it is reasonable to wait in designing a litigation plan for the post-trial inquiry. Up until that point, the litigation plan submitted by the Plaintiffs is acceptable.

III. The Québec litigation

[100] As indicated in Part I above, Bristol-Myers and Otsuka move to stay these proceedings based on there being an authorized class action in Québec, the Scheer case, making the same claims against the same Defendants (except for Lundbeck, against whom the Scheer case has been discontinued). As counsel for Otsuka explain it in their factum:

As this action and the Certified Québec Proceeding are substantively the same as they relate to Abilify, no legitimate purpose exists to justify continuing this action as it relates to Abilify. Staying the Abilify portion of this action promotes judicial economy and avoids multiplicity of legal proceedings, the risk of confusion and inconsistent judgments.

[101] The sequence in which these cases have been litigated in the two provinces should be of minimal importance here, since Ontario courts have not adopted a first-to-certify rule: DALI 675 Pension Fund v SNC Lavalin, 2019 ONSC 6512. Having said that, counsel for Otsuko submits that I must at least consider “whether issuing a stay will prevent unnecessary and costly duplication of judicial and legal resources.”

[102] I do not take issue with that suggested approach. One has to acknowledge that the costs of litigation are often so steep that they threaten to impede access to justice; and, if so, the costs of litigating the same issues twice are ipso facto problematic. I only reference Otsuko’s position in order to demonstrate that sequence is inevitably important in this analysis. In order for one proceeding to be called a “costly duplication” of another, the duplicating proceeding must be later in sequence than the duplicated one.

[103] The sequence of events here, however, is not apparent on the surface. Rather, the two cases present a chicken-and-egg question about who is authentically ‘first’, or which case is it that spawned the other. I will spare the parties further commentary about whether one case is a mere shell, or which party has borne the yoke of the litigation.

a) Chronology of events

[104] The original Statement of Claim in this action was issued on June 16, 2016. It pleaded causes of action in negligence and conspiracy, and sought a combination of compensatory damages for pecuniary loss and pain and suffering and, in addition, punitive damages. The Plaintiffs sought to establish a national class action of Abilify/Abilify Maintena users across Canada.

[105] The Plaintiffs’ affidavits attest to the fact that a substantial amount of research went into the claim both before and after the issuance of the originating pleading. I have little reason to doubt this description of the effort put into the case as I have seen the ultimate product of this work. The research by Plaintiffs’ counsel culminated in the serving of a voluminous certification record on October 5, 2018. As outlined in Part II of this decision, the record contained multiple affidavits and numerous exhibits from a number of different experts as well as from the Plaintiffs.

[106] Roughly six months after issuance of the Statement of Claim herein, a law firm in Québec issued the Scheer claim as a parallel proposed national class action claiming negligence as its sole cause of action. There was no claim in civil conspiracy in the Scheer pleading.

[107] On February 2, 2017, another Ontario law firm commenced a parallel proposed class action making similar allegations against the same Defendants as the present action. Then, on March 15, 2017, a Calgary-based law firm commenced yet another proposed national class action on a similar basis in Alberta.

[108] As the Plaintiffs relate it, on September 6, 2018, counsel in the Alberta action agreed to stay that action in favour of the present action – or to stand it down without the need of a court order – on condition that Plaintiffs’ counsel herein remain counsel of record for the class. After passage of another several months, the carriage battle in Ontario was resolved in favour of present counsel for the Plaintiffs. On that basis, the Alberta action has been informally stayed, with the Alberta plaintiffs reserving the right to proceed with their claim if the Ontario action is “discontinued or if certification is denied”.

[109] At a case conference on January 24, 2019, I set a timetable for certification of the present action, with the certification motion scheduled for one year hence – i.e. in January 2020. There was no mention of a stay motion at the January 2019 case conference. In any case, the certification hearing date was subsequently postponed for a number of weeks due to scheduling conflicts, with the present hearing ultimately taking place in the first week of March 2020.

[110] In the meantime, in September 2018 the motion for authorization (certification) in Scheer was set down to be heard in November-December 2019. Counsel for the Québec plaintiff served his Plan of Argument (factum) on October 24, 2019, some two weeks before the authorization hearing was set to begin on November 7, 2019.

[111] In keeping with its pleading, the written submissions served by Québec plaintiff’s counsel made no reference to a cause of action in conspiracy and proposed no common issues relating to any conspiracy claim. The end date for the class period proposed in Québec counsel’s materials was November 30, 2017, making the class period considerably longer than that proposed here (which ends in February 2017).

[112] Unbeknownst to the Ontario Plaintiffs and their counsel, on November 5, 2019, two days before the authorization hearing, the plaintiff in Scheer amended his pleading. Among other things, his counsel added a claim in civil conspiracy and shortened the class period to February 2017 to match that of the Ontario Plaintiffs. The Scheer claim and Notice to the class were substantially amended in order to mirror the Ontario claim in virtually every respect.

[113] The authorization hearing in Scheer took place in Québec Superior Court on November 7 and December 5, 2019. It was unopposed by the Defendants, who filed no materials whatsoever in response.

[114] In a relatively brief judgment and on a relatively thin record (in comparison with the record in the motion before me), the court authorized the Scheer action as a national class action. I do not say this in criticism of the Québec court; it evaluated the unopposed motion before it in an entirely proper way. I have little doubt that the Scheer claim was duly authorized in accordance with Québec law and procedure.

b) The duplicated claims

[115] As indicated, the Defendants (other than Lundbeck) now move to stay the present action on the grounds that it is an abuse of process.

[116] The Notice of Motion for a stay of proceedings states, inter alia, that: “The allegations raised in the Québec proceeding relating to Abilify are substantially similar to the allegations raised by the Plaintiffs relating to Abilify in the Ontario Proceeding”. It concludes, therefore, that: “The Québec Proceeding will determine substantially the same issues proposed in the Ontario Proceeding as they related to Abilify.”

[117] Counsel for the Plaintiffs concede that the allegations and common issues in the Scheer action and the present action are now “substantially similar”. They add, however, that in this unique circumstance, where the Scheer action was amended on the eve of authorization to duplicate the present action, the similarity does not make the present action an abuse of process.

[118] Plaintiffs’ counsel has produced a helpful chart of the last-minute amendments in Scheer, which I have reproduced below. When these are juxtaposed side-by-side with the relevant portions of the Ontario pleading, one can see just how similar the amended Scheer pleading has become to the within pleading.

[119] In fact, to say that it is “substantially similar”, as Defendants’ counsel do in their Notice of Motion, is to understate the situation. In crucial parts, the Québec pleading, with minor grammatical changes, is now virtually a copy of the Ontario pleading:

Ontario Amended Statement of Claim	Québec Fourth Amended Application for Authorization, November 5, 2019
148. The Defendants’ negligence involved both lawful and unlawful means with the predominant purpose of causing Class members to acquire and use Abilify and Abilify Maintena when they knew or should have known that such use would cause harm to the Class members and the Family Class members.	92.1 The Defendants’ negligence involved both lawful and unlawful means with the predominant purpose of causing Class members to acquire and use Abilify when they knew or should have known that such use would cause harm to the Class members and their family members;
149. …Yet, motivated by financial gain, including, inter alia, increased sales and profits, the Defendants acted in concert to conceal the risk of Compulsive Behaviours associated with the use of Abilify and Abilify Maintena.	92.2 The Defendants further acted in concert to conceal the risk of Impulse Control Disorders associated with the use of Abilify;
150. At all relevant times, Otsuka and BMS, by their directors, officers, servants and agents, wrongfully, unlawfully, maliciously and lacking bona fides, conspired and agreed together, the one with the other, to, among other things, conceal the risk of Compulsive Behaviours associated with the use of Abilify, and to mislead the Plaintiffs and other Class members about the health and safety risks associated with the use of the drug.	92.3 At all relevant times, Otsuka and Bristol-Myers, by their directors, officers, servants and agents wrongfully, unlawfully, maliciously and lacking bona fides, conspired and agreed together, to, among other things, conceal the risk of Impulse Control Disorders associated with the use of Abilify, and to mislead Class members about the health and safety risks associated with the use of the drug;
152. The Defendants’ conduct as described herein was unlawful and constituted material and misleading information in breach of sections 36 and 52 of the Competition Act.	92.4 The Defendants’ conduct as described herein was unlawful and constituted material and misleading information in breach of sections 36 and 52 of the Competition Act
154. In conspiring to conceal the risk of Compulsive Behaviours from the Class members, each of the Defendants was motivated predominantly by the following concerns and motivations: a) to increase or maintain sales volumes of Abilify and Abilify Maintena; b) to increase or maintain revenue; c) to increase or maintain profit; d) to increase or maintain market share; e) to avoid negative publicity and preserve public goodwill; f) to avoid the costs associated with conducting adequate, effective and targeted testing to study the link between the use of Abilify and Abilify Maintena and the risk of developing Compulsive Behaviours; and g) to place corporate revenue and profit above the safety of the Class members.	92.5 In conspiring to conceal the risk of Impulse Control Disorders from the Class members, each of the Defendants was motivated, among other things: a) to increase or maintain sales volumes of Abilify; b) to increase or maintain revenue; c) to increase or maintain profit; d) to increase of maintain market share; and e) to avoid negative publicity and preserve public goodwill;
156. The conspiracy was unlawful because the Defendants knowingly or recklessly, directly and indirectly, and in pursuit of their mutual business interests, made representations to the Plaintiffs, other Class members and the public which were false or misleading in a material respect and which deceived them as to the health and safety risks associated with the use of Abilify and Abilify Maintena. In making the misrepresentations as described herein, the Defendants breached sections 36 and 52 of the Competition Act.	92.6 The conspiracy was unlawful because the Defendants knowingly or recklessly, directly and indirectly, and in pursuit of their mutual business interests, made representations to Class members and the public which were false or misleading in a material respect and which deceived them as to the health and safety risks associated with the use of Abilify. In making the misrepresentations as described herein, the Defendants breached sections 36 and 52 of the Competition Act;
158. In the circumstances, the Defendants knew that the conspiracy would, and did, cause the Plaintiffs and other Class members to suffer losses as described herein.	92.7 In the circumstances, the Defendants knew that the conspiracy would, and did, cause the Class members to suffer damages as described herein;

[120] As for the common issues on conspiracy:

Proposed Common Issues in Ontario

Québec Fourth Amended Application for Authorization

8) Are the Defendants, or some of them, liable for conspiracy to promote, market, and distribute aripiprazole in Canada without adequate and timely warnings about the increased risk of Compulsive Behaviours? 9) If the answer to question (8) is "yes", over what period of time did the conspiracy take place and over what period of time did the conspiracy affect the adequacy of the warnings about the increased risk of aripiprazole in Canada?

d.1) Are the Defendants, or some of them, liable for conspiracy to promote, market, and distribute Abilify in Canada without adequate and timely warnings about the risk of Impulse Control Disorders and, if so, over what period of time?

c) Is a stay of proceedings justified?

[121] Belobaba J. observed in SNC Lavalin, at para 12, that, “[I]n the class action context, proposed class actions which arise from the same occurrence and proceed in two or more provinces in parallel are not unusual.” With the frequency of these occurrences, it has over time come to be acknowledged that “[e]ven where a class proceeding has been certified elsewhere, parallel proceedings may be permitted to continue”: Silver v Imax Corporation, 2009 CanLII 72334, at para 133.

[122] Having said that, the courts in England have for over a century considered that, “[i]t is prima facie vexatious to bring two actions where one will do”: McHenry v Lewis, [1883] 22 Ch D 397. In this vein, the Supreme Court of Canada indicated in Toronto v CUPE, supra, at para 51, that “the doctrine of abuse of process concentrates on the integrity of the adjudicative process.”

[123] With the development of class actions, the courts have reflected this view and have expressed considerable distaste for “class actions which duplicate, for no legitimate reason, actions which have been filed in other provinces”: Asquith v George Weston Limited, 2018 BCSC 1557, at para 71. Actions falling into this mould and found to be an abuse of process have frequently taken the form of claims which represent “no more than an attempt to expropriate a piece of the class-action-action”: Kowalyshyn v Valeant Pharmaceuticals International, Inc., 2016 ONSC 3819, at para 264.

[124] Courts have been equally critical of so-called “carbon copy” class actions being launched in separate provinces. Ironically, however, the duplication that has been of concern to the courts is of quite a different character than the duplication at issue here. That is, the concern is generally with respect to the same plaintiff seeking to litigate in more than one province.

[125] Thus, for example, the Manitoba Court of Appeal commented in Hafichuk-Walkin v BCE Inc., 2016 MBCA 32, at para 57, that, “we see little in the way of a legitimate reason for what are, in substance, ‘carbon copy’ class actions involving the same plaintiffs, defendants, lawyers and allegations being allowed to proceed in two different jurisdictions.” Similar logic applies where different lawyers or different named plaintiffs have commenced coordinated class actions in two or more provinces: see Boehringer Ingelheim (Canada) Ltd. v Englund, 2007 SKCA 62, at paras 37-38.

[126] Most frequently, the test of ‘duplicative and no legitimate purpose’ has been applied to actions perceived as ones that, as described by Branch J. in the British Columbia Supreme Court, “sow ‘chaos and confusion’”: Wilson v Depuy International Ltd., 2018 BCSC 1192, at para. 92. On the other hand, ‘[t]he case law does not suggest that a class action is abusive simply because there is another class action ongoing in another jurisdiction dealing with similar subject matter. The focus is always on whether there is a legitimate purpose…”: Asquith, at para 77.

[127] In fact, the courts have expressed concern that competing class actions commenced in different jurisdictions may prompt forum shopping by defendants, resulting in a form of race-to-the-bottom in terms of how rigorous the claims are prosecuted. Perell J. warned of this in a prescient comment in Kutlu v Laboratorios Leon Farma, S.A., 2015 ONSC 7117, at para 10:

…where there are rival national class actions, there is the unseemly prospect that the defendant may be able to engineer a sort of reverse auction and settle the certification motion or the class action with the least formidable foe or the lowest bidder. The defendant then can rely on the releases in one class action to fend off a rival national class action.

[128] Counsel for the Plaintiffs submit that this is precisely what has transpired here. That is, they perceive the Defendants as embracing the Scheer case with a certain enthusiasm.

[129] I cannot help but observe that the present claim has prompted an impressive effort by Defendants’ counsel. They compiled a very substantial record with several expert witnesses and complex scientific data, conducted thorough cross-examinations of the Plaintiffs and all of their experts, and filed detailed and lengthy written submissions. And yet with all of that, the identical action in Québec was met with no opposition at all by the very same Defendants (minus Lundbeck).

[130] Along the same lines, one would think that the Defendants and their counsel would have been unpleasantly surprised to find the plaintiff in Scheer amending his claim at the last moment, especially since the amendments were designed to mirror the better crafted Ontario pleading. But as it turns out, the Defendants and their counsel appear to have been pleasantly surprised – or, perhaps, not surprised at all. The Scheer plaintiff’s substantive changes and self-evident attempt to mimic the present action – an action which the Defendants were in the process of so vigorously defending – prompted no objection or, apparently, any submissions for the Québec judge to consider in his judgment.

[131] I understand that the test for authorization in Québec is somewhat different than the test for certification in Ontario. Counsel for the Defendants say that it is this legal difference that prompted them not to respond to the Scheer authorization motion. They specifically point to two paragraphs in the Scheer reasons for judgment which they say describes a significant difference between the two jurisdictions:

The parties agree that the authorization hearing is not the proper forum to entertain expert debates nor to rule on contradicting medical or scientific theories.

The parties also agree that the proposed class action raises complex scientific and technical issues which can only be addressed in the course of an eventual trial on the merits rather than at this preliminary stage.

[132] While I profess no expertise in the nuances of Québec civil law, this statement is not substantially different than what an Ontario judge might say in elaborating on the “some basis in fact” test. In this province, most certification judgments find a place to explain that certification under the CPA is procedural only, and that it poses a low threshold. In fact, I have done so myself in para 11 above, quoting the Supreme Court of Canada in Pro-Sys making the same point for Ontario certification motions that the Scheer judgment makes for Québec authorization motions. The legal situation described by the Québec court in Scheer does not adequately explain the radically different approaches taken by the Defendants to the two actions.

[133] There is no evidence that the Defendants have done anything improper. However, they are undoubtedly trying to benefit from the Scheer plaintiff’s mysterious, last-minute decision to make his pleading look like the pleading herein. This circumstance has allowed them to pass the authorization hurdle in Québec without a response, allowing them to contend with a plaintiff who in seeking authorization has not had to put in the deep work that the Plaintiffs before me have done. To use the words of Justice Perell in Kutlu, the Defendants’ request for a stay of proceedings looks like a way of ensuring that they will go to trial on the merits with what they hope is “the least formidable foe”.

[134] A stay of proceedings is a discretionary remedy, to be done only after “consider[ing] the entire context in which the actions have been brought”: Hafichuk-Walkin, at para 43. As the Saskatchewan Court of Appeal has said about the prospect of sustaining two claims in two provinces with the same subject matter against the same defendant, “There will sometimes be entirely valid reasons for such an approach”: Boehringer, at para 40.

[135] For class actions, this discretion is augmented by the statutory authority of the certification judge to control the proceedings. The Divisional Court has specifically held that the staying of a proceeding in favour of an extra-provincial proceeding falls within the certification judge’s “extensive powers and discretion under s. 25 of the CPA to permit them to fashion ways to address novel issues as they arise”: Mignacca v Merck Frosst Canada Ltd. (2009), 2009 CanLII 10059 (ON SCDC), 95 OR (3d) 269, at para 52.

[136] My colleague Justice Belobaba observed in SNC Lavelin, supra, at para 32, that “if [the first] action was not duplicative and was not an abuse of process when it was filed, it cannot become so, four months later, when [a party in another jurisdiction] filed a significantly amended pleading.” A similar observation is applicable here. Under the circumstances, I do not consider the present action to be an abuse of power.

[137] The present action was commenced for legitimate reasons and continues to have a legitimate reason to carry on.

IV. Disposition

[138] The action is hereby certified as a class proceeding under the CPA.

[139] The classes are as described in para 34 above.

[140] The common issues are as set out in para 42 above.

[141] Matthew Kirsh, Gabriel Critchfield, Suerekha Ramdeo and Diana Senis are appointed as representative plaintiffs for the Abilify class; Mohan Das Seenauth is appointed as the representative plaintiff for the Abilify Maintena class; Gayle Kirsh is appointed as the representative plaintiff for the Abilify family class; Dhanesri Persaud is appointed as the representative plaintiff for the Abilify Maintena family class. Counsel for the Plaintiffs herein are appointed as class counsel.

[142] The motion for a stay of proceedings is dismissed.

[143] Counsel may make written submissions on costs. I would ask that counsel for the Plaintiffs email my assistant with brief submissions (3 pages maximum) by two weeks from today’s date, and that all three sets of counsel for the Defendants email my assistant with equally brief submissions by two weeks thereafter. Digital links to authorities will suffice; there is no need for counsel to email or deliver briefs of authorities with full copies of any case law referenced in their submissions.

Date: March 13, 2020 Morgan J.

COURT FILE NO.: CV-16-553833-00CP

DATE: 20200312

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

Matthew Kirsh and Gayle Kirsh

Plaintiffs

– and –

Bristol-Myers Squibb, Bristol-Myers Squibb Canada Co./La Société Bristol-Myers Squibb, Otsuka Pharmaceutical Co, Ltd., Otsuka Canada Pharmaceutical Inc., Otsuka America Pharmaceutical, Inc., Otsuka America, Inc., Otsuka Maryland Medicinal Laboratories, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., H. Lundbeck A/S, and Lundbeck Canada Inc.

Defendants

AMENDED REASONS FOR JUDGMENT RE CERTIFICATION AND STAY MOTIONS

Morgan J.

Released: March 13, 2020