Terry Charlton, Mayra Charlton, Angela Leone, Paula-Smith Turner, Carl Turner v. Mark Mandell, 2013 BCSC 1712

IN THE SUPREME COURT OF BRITISH COLUMBIA Citation: Charlton v. Abbott Laboratories, Ltd., 2013 BCSC 1712 Date: 20130917 Docket: 11-0721 Registry: Victoria Between: Terry Charlton, Mayra Charlton, Angela Leone, Paula-Smith Turner, Carl Turner and Mark Mandell Plaintiffs And: Abbott Laboratories, Ltd., Abbott Laboratories, and Apotex Inc. Defendants Brought under the Class Proceedings Act, R.S.B.C. 1996, c. 50 Corrected Judgment: The judgment was corrected on the first page to correct the name of A. Sadaghianloo, Counsel for the Plaintiffs. Before: The Honourable Mr.

Justice Johnston Reasons for Judgment Counsel for the Plaintiffs: E.F.A. Merchant, Q.C., C.R. Churko and A. Sadaghianloo Counsel for the Defendants: Abbott Laboratories, Ltd. and Abbott Laboratories N. Finkelstein, W.B. Milman and B. Kain Counsel for the Defendant: Apotex Inc. K.L. Kay Place and Date of Hearing: Victoria, B.C. June 10-14, 2013 Place and Date of Judgment: Victoria, B.C. September 17, 2013 [ 1 ] The plaintiffs apply to certify this action under the Class Proceedings Act, R.S.B.C. 1996, c. 50.

Although I must review the evidence in order to decide the application, I will avoid finding facts where evidence is disputed. [ 2 ] Sibutramine hydrochloride monohydrate (sibutramine) was originally developed as an antidepressant, but in use, it was believed to suppress appetite, leading to weight loss as a side effect. [ 3 ] In late 2000 Health Canada approved an application made by Knoll Pharmaceuticals, or a related company BASF Canada, to market a drug containing sibutramine, which it called Meridia, for use as part of a weight loss regime. Meridia was available by prescription only.

As a condition of being permitted to market the drug, Health Canada required Knoll Pharmaceuticals or BASF Canada to publish a product monograph relating to Meridia, the contents of which had to be approved by Health Canada. This product monograph has not materially changed through several revisions, or change of ownership. [ 4 ] In 2001 Abbott Laboratories (Abbott U.S.), a U.S. corporation, acquired Knoll Pharmaceuticals and BASF Canada.

Abbott Laboratories Ltd. (Abbott) is a Canadian corporation that carries on the business of Abbott U.S. in this country. [ 5 ] Abbott carried on the distribution and sale of Meridia, as well as other drugs containing sibutramine, in Canada. [ 6 ] In late 2009, when Abbott’s exclusive right to distribute ended, Health Canada approved an application by Apotex Inc. to distribute its own version of a weight loss drug containing sibutramine, under the name Apo-Sibutramine. Apotex began selling Apo- Sibutramine in Canada on March 16, 2010.

Apotex Inc. was obliged to publish a product monograph approved by Health Canada, and its version was so similar to the product monograph published by Abbott Canada that any differences are immaterial to this application. Abbott Canada’s product monograph for Meridia was put in evidence on the application. [ 7 ] The product monographs were available to physicians and pharmacists.

[ 8 ] Abbott’s product monograph is 46 pages long. The first 25 pages are in more technical language, and appear to be intended for doctors and pharmacists. The next 10 pages are headed “Information for the Patient”, are in less technical language. The remaining pages revert to technical language, again more appropriate for health care professionals. [ 9 ] In the first more technical section, the results of clinical trials or studies lasting up to one year are described.

That is where this statement appears at page 9: “The safety and effectiveness of MERIDIA beyond one year have not been established.” [ 10 ] The product monograph lists a number of contraindications to the use of Meridia, including “patients with a history of coronary artery disease, congestive heart failure, arrhythmia, or cerebrovascular disease (stroke or TIA) (see “WARNINGS”)”. [ 11 ] Patients with inadequately controlled or unstable hypertension are also stated to be contraindicated. [ 12 ] The product monograph includes a warning that sibutramine substantially increases blood pressure and heart rate in some patients, and suggests that if such an increase is sustained, the drug should be discontinued. [ 13 ] At page 16, the product monograph lists information to be given by doctors to patients about Meridia.

This information includes a recommendation for regular blood pressure and pulse monitoring, the possibility that the drug might impair judgement, thinking or motor skills, and that the drug should not be used by pregnant or nursing women. [ 14 ] At page 20, the product monograph states: “Voluntary reports of adverse events temporally associated with the use of MERIDIA are listed below.

It is important to emphasize that although these events occurred during treatment with MERIDIA, they may have no causal relationship with the drug.” [ 15 ] This is followed by a long list of “events” in alphabetical order, including atrial fibrillation, cerebrovascular accident, chest pressure, chest tightness, myocardial infarction, and sudden unexplained death. [ 16 ] At page 23, still in the portion apparently aimed at health professionals, the product monograph emphasizes the importance of regular monitoring of blood pressure and heart rate because “Meridia substantially increases blood pressure and heart rate in some patients.” [ 17 ] Between January 2003 and March 2009 a clinical trial called the Sibutramine Cardiovascular Outcome Trial, which became known as the SCOUT Study, examined the long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk. [ 18 ] The results were published in The New England Journal of Medicine on September 2, 2010. [ 19 ] In October 2010, Abbott and Apotex Inc. withdrew their sibutramine products from the market in Canada. [ 20 ] In January 2006, the plaintiff Ms.

Leone was prescribed Meridia, and she took it “off and on” until May 2009, when she had a heart attack. [ 21 ] The plaintiff Mr. Mandell was prescribed Meridia in February 2009, and had a heart attack in May 2009. [ 22 ] The plaintiff Ms. Smith-Turner was given a trial sample of Meridia in November 2006 and suffered a stroke December 23, 2006. [ 23 ] The plaintiff Mr. Charlton was prescribed Apo-Sibutramine in May 2010, began to have shortness of breath in June or July 2010, and chest pains in August 2010. He stopped taking Apo-Sibutramine in September 2010.

The law [ 24 ] Certification of an action as a class proceeding is mandatory if the requirements set out in s. 4 of the Act, are met: 4.

(1) The court must certify a proceeding as a class proceeding on an application under

section 2 or 3 if all of the following requirements are met: (

a) the pleadings disclose a cause of action; (

b) there is an identifiable class of 2 or more persons; (

c) the claims of the class members raise common issues, whether or not those common issues predominate over issues affecting only individual members; (

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

e) there is a representative plaintiff 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, an interest that is in conflict with the interests of other class members.

(2) In determining whether a class proceeding would be the preferable procedure for the fair and efficient resolution of thecommon issues, the court must consider all relevant matters including the following: (

a) whether questions of fact or law common to the members of the class predominate over any questions affectingonly individual members; (

b) whether a significant number of the members of the class have a valid interest in individually controlling theprosecution of separate actions; (

c) whether the class proceeding would involve claims that are or have been the subject of any other proceedings; (

d) whether other means of resolving the claims are less practical or less efficient; (

e) whether the administration of the class proceeding would create greater difficulties than those likely to beexperienced if relief were sought by other means. [25] Class proceedings legislation is “a procedural tool” that enables courts to deal efficiently with complicated cases that ofteninvolve “vast numbers of interested parties and complex, intertwined legal issues”: see, Hollick v. Toronto (City), 2001 SCC 68 at paras.14, 15. [26] The certification stage is “decidedly not meant to be a test of the merits of the action: “… Rather the certification stage focuseson the form of the action.

The question at the certification stage is not whether the claim is likely to succeed, but whether the suit isappropriately prosecuted as a class action”: Hollick para. 16. [27] The role of evidence on a certification application was discussed in Hollick at para. 25: I agree that the representative of the asserted class must show some basis in fact to support the certification order. As the court in Taub(Taub v. Manufacturers Life Insurance Co. (1998), (ON SC), 40 O.R. (3d) 379 (Ont. Gen.

Div.)) held, that is not tosay that there must be affidavits from members of the class or that there should be any assessment of the merits of the claims of otherclass members. … In my view, the class representative must show some basis in fact for each of the certification requirements set out ins. 5 of the (Ontario Class Proceedings) Act, other than the requirement that the pleadings disclose a cause of action.

That latterrequirement is of course governed by the rule that a pleading should not be struck for failure to disclose a cause of action unless it is‘plain and obvious’ that no claim exists… Section 4(1)(a): Do the pleadings disclose a cause of action. [28] Under s. 4(1)(a), the onus is on the plaintiff to show that it is not “plain and obvious” that no cause of action is disclosed in thepleadings, assuming that the facts pleaded are true.

The “plain and obvious” test is the same as is applied on a motion to strike pleadingsunder Rule 9-5; the material difference being that on a motion to strike the onus is on the defendant applying to strike to show that it is plain and obvious that the impugned pleadings disclose no cause of action, again assuming the truth of the facts pleaded. See, in thatregard, Elms v. Laurentian Bank of Canada, 2001 BCCA 429 at para. 20. [29] For each cause of action pleaded, the plaintiff must state material facts necessary to formulate a complete cause of action:Homalco Indian Band v.

British Columbia (1998), (BC SC), 25 C.P.C. (4th) 107 (B.C.S.C.), quoted with approval inCanadian Bar Assn. v. British Columbia, 2008 BCCA 92 at para. 59. [30] Abbott argues that the plaintiffs’ pleadings do not meet the test in s. 4(1)(

a) because they are: 1. Bald assertions or legal conclusions without factual foundation; and 2. They “lump together” defendants and causes of action. [31] If I conclude no cause of action is disclosed in the pleadings, a question arises whether I should: 1. Merely decline to certify that cause of action; 2. Give leave to amend; or 3. Strike the pleading. [32] There is some authority for the third option. In Wakelam v. Johnson & Johnson, 2011 BCSC 1765, a claim that “could not besupported by any of the material facts alleged” was ordered struck from the pleading at paras. 106 and 107.

Something similar occurredin Martin v. Astrazeneca Pharmaceuticals plc, 2012 ONSC 2744 at paras. 145 and 148. [33] With deference to the courts that made those decisions, it seems to me that if I conclude that the test for certification unders. 4(1)(

a) of the Act has not been met for a cause of action, it would be preferable to confine my order to a refusal to certify that cause ofaction. I do not view Hollick to be either a direction or an invitation to strike a pleading that because a plaintiff has failed to establish thatit would survive the “plain and obvious” test.

The reference in Hollick is to the test rather than the consequences of failing to meet it on acertification application. [34] I am mindful that the onus is on the plaintiffs on this application to show that the claims pleaded satisfy s. 4(1)(a), whereas itwould be on the defendants if they had applied to strike this aspect of the claim under Rule 9-5. [35] To strike the pleading at this stage, while the onus is on the plaintiffs, would deprive the plaintiffs of any opportunity to seekamendments to shore up their inadequate or defective pleadings. While it may seem that the outcome should not be affected by a

difference in where the burden lies of showing whether something is plain and obvious, a plaintiff’s failure on a certification application to show that it is not plain and obvious that a claim will fail does not necessarily mean that a defendant would succeed on a motion to strike the same pleading. [ 36 ] Turning to the Second Amended Notice of Civil Claim, it does not appear that any claim at all has been pleaded against Abbott U.S. beyond a corporate relationship with Abbott Canada.

There are no facts pleaded from which a finding of direct or vicarious liability for any of the common law or statutory causes of action that could be made against Abbott U.S. The only allegation is that Abbott U.S. is incorporated in Illinois, and is the parent company of the Canadian-incorporated Abbott Canada.

I conclude that it is plain and obvious that the claims against Abbott U.S. are bound to fail, and I decline to certify any part of this action against Abbott U.S. [ 37 ] Apotex argues that the pleadings are primarily directed at Abbott and simply lump Apotex together with Abbott, with little or nothing pleaded separately against Apotex.

Apotex points to the fact that it did not enter the market with its sibutramine product until 2010, that it was tightly controlled by Health Canada in what it had to put into its product monograph, and that the Second Amended Notice of Civil Claim simply tars it with the same brush as that used on Abbott Canada. This argument does not sufficiently recognize that Mr. Charlton alleges that he took the Apotex product, and complains about damaging consequences. [ 38 ] I now turn to the application of s. 4(1)(

a) of the Act to each cause of action pleaded . Breach of Statutory Obligations [ 39 ] The plaintiffs claim damages and seek declaratory relief arising from alleged breaches of the Business Practices and Consumer Protection Act , S.B.C. 2004, c. 2 (BPCPA) . Damages are available under s.171 and declaratory relief under s. 172, both of which are pleaded in the revised Second Amended Notice of Civil Claim. These are statutory causes of action, and the facts supporting the claims are adequately pleaded in paras. 29-31 of the revised Second Amended Notice of Civil Claim. It is not plain and obvious that this claim as pleaded discloses no cause of action. [ 40 ]

Section 36 of the Competition Act, R.S.C. 1985, c. C-34, permits claims for loss or damage resulting from conduct contrary to

Part VI of the Act , and

Part VI includes s. 52, which states: 52.

(1) No person shall, for the purpose of promoting, directly or indirectly, the supply or use of a product or for the purpose of promoting, directly or indirectly, any business interest, by any means whatever, knowingly or recklessly make a representation to the public that is false or misleading in a material respect. [ 41 ] The Second Amended Notice of Civil Claim adequately pleads facts in support of a claim for damages under the Competition Act in paras. 39 and 40, albeit under a heading Failure to Warn, and the statutory cause of action is pleaded in para. 28.

It is not plain and obvious that this claim as pleaded discloses no cause of action. Negligence [ 42 ] The elements of this cause of action are a duty owed, breach of that duty (by failing to meet the applicable standard of care), and damage caused by the breach. [ 43 ] Abbott complains that the plaintiffs do not distinguish among different types of negligence they allege.

Abbott has not sought particulars so far as I know . [ 44 ] The plaintiffs have pleaded in para. 33 of the Second Amended Notice of Civil Claim: The Defendants owed a duty of care to the Plaintiffs and Class Members to: (1) take reasonable care in formulating Sibutramine and testing for the adverse health effects of Sibutramine; (2) ensure Sibutramine was safe for human ingestion and offer only safe drugs for sale and human consumption in the streams of commerce; (3) provide adequate warnings regarding the side effects of Sibutramine; (4) conduct ongoing testing and analyses to learn of any new health risks posed by Sibutramine and to inform the public and proper government authorities of the results; and, (5) recall Sibutramine promptly after becoming aware of adverse health risks. [ 45 ] After pleading that the defendants breached the standards of care expected of them, the plaintiffs plead in para. 35: The Defendants failed to use sufficient quality control, to conduct adequate testing, and to perform proper manufacturing, production, or processing, or failed to take sufficient measures to prevent harmful products from being offered for sale, sold, or used by consumers or alternatively, they failed to promptly remove Sibutramine from the market when the adverse risks became known. [ 46 ] The defendants rely on Astrazeneca to argue that the plaintiffs were required to, and did not, identify a specific defect in the design or testing of sibutramine.

I decline to follow Astrazeneca on this as I think it went too far. At the certification stage, when a plaintiff has not had good opportunity to explore evidence that might be compellable from the defendants on discovery, the requirement to plead specific defects is too onerous. [ 47 ] Subject to what I will have to say about the pleading of negligent design or manufacture, this general pleading of negligence is sufficient for the purposes of s. 4(1)(a), and I am satisfied that the plaintiffs have shown that it is not plain and obvious that it discloses no cause of action.

Negligent Design [48] The plaintiffs plead in para. 2 that Abbott “researches, develops, designs … pharmaceuticals including Meridia.” At para. 13,the plaintiffs plead that Meridia was one of the Abbott products containing sibutramine. [49] They make a similar claim against Apotex in para. 4. [50] In paras. 12 and 13 the plaintiffs claim that “The sibutramine drugs had first been marketed and sold by KnollPharmaceuticals,” that Abbott and/or Abbott U.S. had acquired a pharmaceutical business from BASF Canada Inc. in 2001, and that thisacquisition included the pharmaceutical business of Knoll Pharmaceuticals. [51] The plaintiffs have pleaded, in effect, that the drug was inherited when Abbott and Abbott U.S. acquired the KnollPharmaceuticals business.

This contradicts para. 33 of the NCC that pleaded that the defendants owed a duty of care to the plaintiffs to“take reasonable steps in formulating Sibutramine.” If formulating refers to design, there is no allegation or facts asserted in thepleadings that a defendant, or any entity for which a defendant is at law responsible, took actions that fell below an applicable standard ofcare. [52] I decline to certify a cause of action against the defendants that alleges negligent design of drugs containing sibutramine.

Negligent Manufacture [53] The plaintiffs plead that the defendants “failed … to perform proper manufacturing … or failed to take sufficient measures toprevent harmful products from being offered for sale …” [54] The defendants say that this is defective pleading of negligent manufacturing, relying on Astrazeneca, and cases it cites,including Rowe (Guardian ad litem of) v. Sears Canada, 2005 NLCA 65.

They say that an allegation of negligent manufacturing shouldinclude an averment that: 1. something went awry in the manufacturing process; 2. creating a defect in a manufactured item that would be safe other than for the misadventure in its manufacture; or perhaps 3. that the manner in which the manufacturing process itself was set up introduced a defect in all of the items complained of.They say that the plaintiffs are obliged at this stage to allege, by pleading material facts, what went wrong in the process ofmanufacturing sibutramine: what got into the drug in the manufacturing process that should not have been there, or what was omittedfrom the drug that should have been included. [55] I remind myself that at this stage of inquiry the test is the same as if it were a motion to strike.

It is to be decided on what is pledin the Second Amended Notice of Civil Claim alone, with no recourse to evidence. [56] A pleading can be defective, for example, by lacking in particularity without being bound to fail; in such a case particulars maybe ordered. [57] If particulars were truly required, the defendants would have sought them before responding to the Second Amended Notice ofCivil Claim. [58] I agree with the defendants that the pleading of negligent manufacture is not supported by an assertion of any material factsstating what went wrong in the defendants’ processes of manufacturing sibutramine products, nor do the plaintiffs plead a defectresulting from the manufacturing process that could support an assertion of negligent manufacture. [59] I decline to certify the claim of negligent manufacturing as a class proceeding.

Negligence: Breach of Duty to Warn [60] The plaintiffs plead in para. 33(3) of the Second Amended Notice of Civil Claim that the defendants owed them a duty of careto “provide adequate warnings about the side effects of Sibutramine,” and in sub-paragraph (4): “to inform the public and propergovernmental authorities of the results” (of ongoing testing for new health risks posed by the drug). [61] In paras. 38 through 43 the plaintiffs expand this pleading to allege that sibutramine causes, contributes to, or materiallyincreases the risk of heart attacks, strokes, and arrhythmia and that the defendants knew or ought to have known this fact.

Furthermore,that the defendants had a duty to warn the defendants of this fact, and their failure to warn was a breach of this duty and caused damage. [62] Abbott says the product monograph contains adequate warnings, and that Astrazeneca is authority for the proposition that theproduct monograph is deemed to be incorporated into the pleadings. The court in Astrazeneca relied on the authority of Montreal TrustCo. of Canada v. Toronto-Dominion Bank (1992), 40 C.P.C. (3d) 389 (Ont. Gen. Div.).

Montreal Trust included an application todismiss as showing no cause of action under an Ontario rule similar to Rule 9-5(1)(a). The plaintiff there had pleaded an agreement as itrelied on terms of the agreement as part of its claim. After finding that references to a document in the pleading under attack had theeffect of incorporating the document into the pleading, the court then treated the document as a fact pleaded, not as evidencing itscontents. [63] Somewhat similar reasoning was applied in Monenco Ltd. v.

Commonwealth Insurance Co. (2001), 2001 SCC 49 , 204D.L.R. (4th) 14, [2002] 2 W.W.R. 438 (S.C.C.), an appeal from the British Columbia Court of Appeal where a similar issue had arisenon a

summary trial application for judgment on the question of insurer’s duty to defend. The court considered evidence extrinsic to thepleadings to assist in determining the substance and true nature of the allegations in the pleadings. That was considered necessary inorder to decide whether the insurer had a duty under its policy to defend its insured against the allegations in the pleadings, and

permissible so long as it did not require factual findings that would impact the underlying litigation. [64] Here, on the other hand, the plaintiffs do not rely on the product monograph for any reason other than to allege its deficienciesand inadequacies. If the product monograph is deemed incorporated into the statement of claim here, it will be for the fact of itsexistence is pleaded, and its

interpretation, the weight to be given it, and whether the warnings in it adequately fulfill any duty to warnplaced on Abbott, is a matter for trial. [65] I conclude that whether warnings in the product monograph are adequate is not a relevant inquiry under s. 4(1)(a). Theadequacy of the warning in the product monograph is a matter for trial, where the evidentiary record will be more complete, and properdecisions as to weight can be made. [66] Abbott also relies on the “learned intermediary” rule as applied by the Supreme Court of Canada in Hollis v.

Dow CorningCorp., (SCC), [1995] 4 S.C.R. 634, to argue that claims against it, including those based on the adequacy of warnings,are bound to fail. The “learned intermediary” rule applies where there is an expectation of intermediate inspection of a highly technicalproduct by a trained and knowledgeable intermediary (read physician).

In the case of medical products, making clear, complete andcurrent information available to a learned intermediary may be sufficient to discharge the manufacturer’s duty to warn consumers ofdangers it knows or ought to know are inherent in the product’s use. [67] There are differences, some of them subtle, between the information given to doctors in the product monograph, andinformation the doctors are expected to pass on to the patient.

As an example, both sections contain the statement that the safety andeffectiveness of taking Meridia for more than a year have not been determined, but immediately preceding that statement in the patientinformation section, the product monograph suggests that doctors tell their patients, “You should continue to take MERIDIA while youare losing weight or continuing to maintain your weight loss. Your doctor will determine how long you should take MERIDIA. Followyour doctor’s advice.” [68] I am persuaded that it is not plain and obvious that this plea discloses no cause of action.

Whether or not it succeeds will requirea full exploration of the evidence and an assessment of weight to be placed on it.

Negligence: Marketing [69] In para. 33(2) of the Second Amended Notice of Civil Claim the plaintiffs plead that the defendants owed them a duty of care to“only offer safe drugs for sale and human consumption in the streams of commerce,” and in sub-paragraph (5), a duty to “recallSibutramine promptly after becoming aware of adverse health risks.” [70] In para. 35 the plaintiffs allege that the defendants “failed to take sufficient measure to prevent harmful products from beingoffered for sale, sold or used by consumers or alternatively, they failed to promptly remove Sibutramine from the market when theadverse risks became known.” [71] In paras. 46 through 49, these allegations are expanded: E.

Duty not to market 46. Sibutramine’s propensity to injure outweighed the value of its use. The Defendants were negligent in choosing to distribute,market, and sell Sibutramine. 47. The Plaintiffs and the Class used Sibutramine as prescribed. 48. The Defendants knew that the increased risks of heart attacks, strokes, and arrhythmia to the Plaintiffs and members of the Classwere not justified by the insignificant benefits of using Sibutramine. 49.

If the Defendants had acted appropriately and on a timely basis on the information they had about the safety of Sibutramine andthe lack of effectiveness of Sibutramine, it would not have been marketed or been approved for marketing by Health Canada andalternatively would have been ordered removed from the market long before October 2010. • For up to six months of use, Sibutramine provides insignificant weight loss; • After six months of use, Sibutramine provides no weight loss. [72] It is not plain and obvious that the claim of negligent marketing of the drug, or breach of a duty to not market the drug, disclosesno cause of action in these pleadings.

Breach of Warranty [73] I understand that this cause of action as pleaded was intended to assert claims under the Sale of Goods Act, R.S.B.C. 1996, c.410, but the plaintiffs have abandoned these claims, so I will say no more about them. Waiver of Tort [74] It remains unclear whether, as a matter of law, this is a separate cause of action, or a remedy available on proof of an establishedcause of action. This does not require determination at this point.

If it is a cause of action, sufficient facts have been pleaded in paras. 50through 54 of the Second Amended Notice of Civil Claim that I am persuaded that this plea it is not bound to fail. If it is remedy only, nofacts are required beyond those necessary to support the cause of action giving rise to the claim for the remedy. Section 4(1)(b) - An identifiable class of two or more

[75] The criteria for membership in the class should be rationally related to the claims advanced on behalf of the class. [76] The plaintiff has the burden on a certification application to show some basis in fact for that rational relationship. [77] The plaintiffs amended their proposed class

definitions at the hearing, reducing four proposed classes to one. [78] The single proposed class is now defined by the plaintiffs as: All persons in Canada who were prescribed and ingested Meridia or Apo-Sibutramine and all spouses, parents, or children of theseprimary class members who are entitled to make claims under the Family Compensation Act in B.C. in respect of the death of suchmembers and all persons outside of B.C. who by reason of their relationship to a member of the primary class are entitled to make claimsunder the equivalent provincial dependents legislation in respect of the death or personal injury of such primary class members. [79] This has effectively dealt with Abbott’s argument that the original proposed class

definitions were “deeply flawed,” for beingoverly broad and for lacking rational relationship between the previously proposed family subclasses and common issues. [80] Here, the class definition begins with whether someone was prescribed and took the drug. [81] Those who took the drug and who allege harm as a result have a rational relationship to the negligence, failure to warn, andsome claims pleaded under the Business Practices and Consumer Protection Act and the Competition Act. [82] Those who took the drug and suffered no harm but got no benefit have a rational relationship to the claims based onineffectiveness of the drug, as well as to other claims pleaded under the statutes just mentioned. [83] That leaves Abbott’s argument that the proposed class definition is fatally flawed because it does not exclude residents ofQuebec, where a proposed class action was refused certification in MacMillan v.

Abbott Laboratories, 2012 QCCS 1684, aff’d, 2013QCCA 906. Abbott argues that it would be an abuse of process to bring multiple class actions against the same defendant with respect tothe same subject matter in different jurisdictions. It is not clear to me that the authorities cited in support of this argument, whichincluded Englund v. Pfizer Canada Inc. (2007), 2007 SKCA 62 , 284 D.L.R. (4th) 94 (Sask. C.A.), and MacKinnon v.

NationalMoney Mart Co. (2006), 2006 BCCA 148 , 265 D.L.R. (4th) 214 (B.C.C.A.), are directly on point; the action in Englund wasconditionally stayed because of a contemporaneous action going in Ontario, and the stay could be lifted if the Ontario proceedings werediscontinued or made no provision for Saskatchewan residents; in MacKinnon, the court commented that repeat applications should bediscouraged as matter of judicial economy. [84] The Court of Appeal has described the Quebec class proceedings legislation as having “broad similarities but technicaldifferences” to the British Columbia Act in MacKinnon v.

National Money Mart, 2009 BCCA 109. I do not consider the failure toexclude Quebec residents as members of the class to be an abuse of process because the Quebec court has refused to certify an actionbrought by a different plaintiff, and based on different evidence, some of which the Quebec court found internally contradictory. [85] Apotex, in addition to adopting the Abbott arguments, argued that there is no identifiable class with respect to its product, Apo-Sibutramine, and that Mr.

Charlton, the only one of the named plaintiffs who took Apo-Sibutramine, is not a suitable representativeplaintiff. [86] Apotex complains that the Second Amended Notice of Civil Claim fails to distinguish between the Abbott Canada product,which had been marketed for approximately 10 years, and the Apotex product, which had been marketed for only seven months. [87] Apotex also argues that the proposed class definition includes those who suffered no adverse effects from taking Apo-Sibutramine, that there is no evidence of more than one person in the proposed class (as it would relate to Apotex), and that no memberof the proposed class has a plausible claim against Apotex. [88] Part of the answer to these arguments can be found in the decision in MacKinnon v.

Instaloans Financial Solution Centres(Kelowna) Ltd., 2004 BCCA 472, where the court held that it is not necessary that there be a named plaintiff for each defendant in ananticipated class proceeding. All that is required is that the statement of claim allege for each defendant, a cause of action held bysomeone in the proposed class. The court there said that before certification, an action in which the plaintiffs intend to seek certificationas a class proceeding is not like other actions, it is “an action with ambition” (para. 33). See also, Campbell v.

Flexwatt, (1996), (BC CA), 44 B.C.L.R. (3d) 343. [89] Additionally, the plaintiffs plead at para. 15 that the defendants have sold sibutramine to hundreds of thousands of Canadianconsumers, and at para. 18 that the defendants continued to sell their products while the SCOUT study was underway, and at para. 20that the defendants continued to sell sibutramine for nine or ten months after marketing authorization was suspended in Europe. [90] Apotex further argues that there is no evidence, or basis in fact, that Mr.

Charlton suffered any cardiovascular disease, failed tolose weight while taking Apo-Sibutramine, was denied material information or was misled by the product monograph, or read theproduct monograph, or discussed it with his physician or pharmacist. [91] I have dealt sufficiently with this argument in the course of dealing with the test under s. 4(1)(a). [92] The defendants argue that the affidavits of the medical experts, when read with the product monograph and the SCOUT study,lead inexorably to the conclusion that the plaintiffs have failed to show some basis in fact for any of the causes of action pleaded. [93] The requirement that some basis in fact be identified permits some limited recourse to the evidence put forward by the plaintiffsand defendants on the certification hearing. [94] That evidence includes the opinions of Dr.

Fitchett, and the editorial from The New England Journal of Medicine. It also

includes contrary evidence from Dr. Myers, and the witnesses Del Bosco and Tao. [95] It seems to me that the arguments of the defendants invite rather more weighing of evidence than is appropriate on acertification application, and as well fail to deal with the individual statutory criteria under s. 4(1) of the Act; instead they drift intobroader considerations that tend to detract from the applicability of the argument to the statutory criteria. [96] I conclude that the plaintiffs have satisfied the requirement in s. 4(1)(

b) and have shown that there is an identifiable class of twoor more persons. Section 4(1)(c) – claims of class members raise common issues, whether or not they predominate over individual issues. [97] The plaintiffs are required to show some basis in fact supporting this requirement. [98] An issue has been defined as a point advanced by a party to litigation, controverted by another party: see Harrington v.

DowCorning at paras. 23-25. [99] Common issues need not be factually identical; see the definition of “common issues” in s. 1 of the Act. [100] A common issue is an issue of fact or law that will move the litigation forward: see Campbell v. Flexwatt Corp. (1997), (BC CA), 44 B.C.L.R. (3d) 343 (B.C.C.A.) at para. 53.

Other requirements are that a common issue requires resolution foreach class member to succeed, or at least is important to each class member’s claim: “Thus an issue will be common ‘only where itsresolution is necessary to the resolution of each class member’s claim’”: Western Canadian Shopping Centres Inc. v.

Dutton, 2001 SCC46 at para. 39; “Further, an issue will not be ‘common’ in the requisite sense unless the issue is a ‘substantial … ingredient’ of each ofthe class members’ claims”: Hollick at para. 18. [101] The court can consider evidence in order to assist in identifying common or other issues, but cannot resolve conflicts in theevidence. [102] There must be a rational relationship between the class as proposed and the proposed common issues – Hollick.

I accept thedefendants’ argument that the rational relationship must have some basis in fact, and the basis must come from evidence on theapplication. [103] The plaintiffs propose the following common issues: 1. Does sibutramine cause or contribute to heart attacks, strokes, and arrhythmia? [104] There is a rational relationship between the newly proposed class of people “who were prescribed and ingested Meridia or Apo-Sibutramine …” and this issue.

The affidavits of the four plaintiffs who took one or other of the drugs, the affidavits of the experts,which introduce the SCOUT study, the product monograph, and the editorial in The New England Journal of Medicine that accompaniedpublication of the SCOUT study provide a sufficient basis in fact. While the post hoc nature of the plaintiffs’ affidavits referred to mightbe open to attack, the evidence as a whole is sufficient to establish the required rational relationship. 2.

Was sibutramine unfit for its intended purpose? [105] Fitness for particular purpose is a warranty or condition implied into a contract for the sale of goods by s. 18 of the Sale ofGoods Act, R.S.B.C. 1996, c. 410. In this case, claims pleaded under the Sale of Goods Act were abandoned by the plaintiffs shortlybefore the certification hearing, so I will deal no further with this proposed common issue.

To avoid confusion I will leave thenumbering of the common issues as is. [106] If I have misunderstood this situation, and the plaintiffs continue to seek certification of this common issue, counsel may addressthat in written submissions on a

schedule to be agreed upon or, failing agreement, counsel may speak to a

schedule for writtensubmissions on this question. 3. Did the defendants breach a duty of care owed to the Class in the design, testing, manufacturing, marketing, selling ordistributing sibutramine? [107] I have declined to certify claims based on design or manufacturing on the basis that the plaintiffs have not shown that theseclaims were not bound to fail. What remains are issues common to all members of the proposed class as they must be decided in order toresolve each class member’s claims in negligence, failure to warn or to warn adequately, breach of duty not to market.

This proposedcommon issue is a substantial ingredient of each of those claims, and I am satisfied that the resolution of this issue will advance thelitigation. 4. Did the defendants knowingly, recklessly, or negligently breach a duty to warn the class of the risks of harm from the useof sibutramine? [108] I anticipate that this issue will involve questions such as the adequacy of the information or warnings in the product monographs,or whether either defendant should be insulated from liability by the “learned intermediary” defence and perhaps more.

This proposedcommon issue is necessarily part of the claims based on the adequacy of any warning, and also bears on the question of negligencegenerally. This proposed issue is a substantial ingredient of these claims and common to members of the class. Resolution of this issuewill advance matters. 5. Did the defendants engage in conduct that constituted deceptive acts or practices contrary to the BPCPA or equivalentlegislation in other provinces? [109] Each of the members of the proposed class will have this issue in common, even those who took sibutramine as prescribed and

directed, but who did not experience health problems caused by the drug. Resolution of this issue is necessary for the claims of thoseclass members, as well as for those whose health was affected, and resolving this issue will advance the litigation. 6. Did the defendants’ marketing and sale of sibutramine breach s. 52 of the Competition Act? [110] The comments in relation to proposed common issue 5 apply with equal force to this issue. 7. If any of questions 1 to 6 are answered in the affirmative, does the defendants’ conduct warrant an award of punitivedamages? 8.

If any of questions 1 to 6 are answered in the affirmative, should the defendants be ordered to disgorge the revenues theyreceived from the sale of sibutramine? [111] These last two proposed issues deal with remedies beyond damages for injury or breach of statute. They are truly common to allmembers of the class.

Section 4(1)(d) – class proceeding would be preferable procedure for fair and efficient resolution of common issues. [112] There are two aspects to this question: first, whether class proceedings would be a fair, efficient and manageable method ofadvancing the claims; second, whether class proceedings are preferable to other proceedings: Rumley v.

British Columbia, 2001 SCC 69at para. 35. [113] This requires a comparison of the importance of common issues to the claims as a whole. [114] If comparison indicates that individual issues will predominate, a class action will not achieve judicial economy, and should berefused: Tiemstra v. Insurance Corp. of British Columbia (1997), (BC CA), 38 B.C.L.R. (3d) 377 (B.C.C.A.) atparas. 13-14 and 17-18. [115] The question of preferability is decided on the application of s. 4(2) of the Act, which reads:

(2) In determining whether a class proceeding would be the preferable procedure for the fair and efficient resolution of the commonissues, the court must consider all relevant matters including the following: (

a) whether questions of fact or law common to the members of the class predominate over any questions affecting onlyindividual members; (

b) whether a significant number of the members of the class have a valid interest in individually controlling the prosecutionof separate actions; (

c) whether the class proceeding would involve claims that are or have been the subject of any other proceedings; (

d) whether other means of resolving the claims are less practical or less efficient; (

e) whether the administration of the class proceeding would create greater difficulties than those likely to be experienced ifrelief were sought by other means. [116] Application of these statutory considerations is preferable to an approach based on the nature of the case, as urged by theplaintiffs. While it may be true that product liability claims are “especially well suited for class proceedings” (Logan v.

Dermatech,Intradermal Distribution Inc., 2011 BCSC 1097 at para. 41), or that claims arising out of pharmaceuticals are often certified, as theplaintiffs have argued, this does not relieve the court from the requirement to consider the matters set out in s. 4(2). [117] I shall apply the approach adopted by Gray J. in Bouchanskaia v. Bayer Inc., 2003 BCSC 1306, bearing in mind that the factorsset out in s. 4(2) are not exhaustive of the relevant considerations: see, in that regard, Hoy v. Medtronic Inc., 2003 BCCA 316 at para. 41. (

a) Predominance [118] The question of predominance under s. 4(2)(

a) is not answered by listing issues that will or may arise in the action, categorizingeach as common or individual, and counting the results in each category. [119] Predominance may be a matter of complexity. A single complex common issue, that will require a great deal of evidence andargument to resolve, can predominate over a number of individual issues that can be resolved relatively quickly. See, in that regard,Miller v. Merck Frosst Canada Ltd., 2013 BCSC 544 at para. 233; Tiboni v. Merck Frosst Canada Ltd. (2008), (ONSC), 295 D.L.R. (4th) 32 (Ont.

S.C.J.) at para. 100. [120] In this case, the proposed common issues are complex, and this adds considerable weight to the advantage of class proceedingsover individual actions. [121] For that reason, I conclude that class proceedings to resolve the common issues is preferable to alternative procedures such asmultiple individual actions or representative actions. (

b) Interest of class members in controlling individual actions [122] I consider this, as did Gray J., to ask if there are likely to be class members reluctant to lose status as dominus litus if their rightto pursue an individual claim is subsumed into a class action. This was not argued strenuously by either defendant, and I was not taken toevidence that would persuade me that any such person exists.

[ 123 ] If there is such a person, he or she could opt out of class proceedings in order to pursue their own claim under s. 16 of the Act, with a proper provision having been made in the certification order. This factor does not tell against class proceedings as the preferable procedure. (

c) If this proceeding were certified as a class action, would it involve claims that are or have been subject of other proceedings? [ 124 ] I was not told of any other similar actions in British Columbia. A similar action in Ontario has been discontinued, and an attempt at certification in Quebec has been denied. The discontinued Ontario proceedings are no reason that class proceedings in British Columbia would not be the preferable procedure. [ 125 ] The lack of success in Quebec may militate against certification on other grounds, but it does not detract from the preferability of class proceedings under s. 4(2)(c). (

d) Are other means of resolving the claims less practical or efficient? [ 126 ] It would not be practical for individual litigants to prosecute the claims raised in the remaining common issues. It would simply be beyond the means of most if not all individuals. [ 127 ] As well, individual actions would be a far less efficient use of judicial resources in resolving the remaining common issues. [ 128 ] No other means of dealing with the issues raised in this action was suggested by the defendants. (

e) Would administration of class proceedings create more difficulties than if other means were employed? [ 129 ] No more efficient means of resolving the issues raised in the pleadings have been suggested, nor were there any suggestions of means that would pose fewer difficulties than if the matter proceeds as class proceedings. [ 130 ] On balance, therefore, I conclude that class proceedings are the preferable way to resolve common issues in this case. Section 4(1)(e) – there is a representative plaintiff who: a. Would fairly represent the class; b.

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 [ 131 ] The plaintiffs Terry Charlton, Angela Leone, Paula Smith-Turner and Mark Mandell would fairly represent the class. I agree that it is not necessary that there be a sub-class of family members of those who actually took the drugs in question, and so need not comment on whether Maya Charlton or Carl Turner would fairly represent that sub-class. [ 132 ] The plan for the proceeding is adequate for present purposes.

One aspect of the litigation plan – notice to the public, is addressed in an affidavit of Mr. Battaglia, whose firm has agreed to manage the advertising, media notices across Canada and will administer the contacts initiated by those responding to the notices. [ 133 ] As the matter progresses, and the size and composition of the class becomes better known, the plan can be modified as needed. c.

Does not have, on the common issues, an interest that is in conflict with the interests of other class members. [ 134 ] I have not been shown any evidence that persuades me that there is or might reasonably be a conflict between the remaining four plaintiffs as representatives of the class and other class members. [ 135 ] I conclude that this proceeding must be certified as a class proceeding, as all of the requirements of s. 4 of the Act are met. [ 136 ] The class is defined as: All persons in Canada who were prescribed and ingested Meridia or Apo-Sibutramine and all spouses, parents, or children of these primary class members who are entitled to make claims under the Family Compensation Act in B.C. in respect of the death of such members and all persons outside of B.C., who by reason of their relationship to a member of the primary class, are entitled to make claims under the equivalent provincial dependents legislation in respect of the death or personal injury of such primary class members. [ 137 ] The common issues are: 1.

Does sibutramine cause or contribute to heart attacks, strokes, and arrhythmia? 2. Did the defendants breach a duty of care owed to the class in the testing, marketing, selling or distributing of sibutramine? 3. Did the defendants knowingly, recklessly, or negligently breach a duty to warn the class of the risks of harm from the use of sibutramine? 4. Did the defendants engage in conduct that constituted deceptive acts or practices contrary to the Business Practices and Consumer Protection Act, SBC 2004, c. 2, or equivalent legislation in other provinces? 5.

Did the defendants’ marketing and sale of sibutramine beach s. 52 of the Competition Act, R.S.C. 1985, c. C-34?

6. If any of questions 1 to 5 are answered in the affirmative, does the defendants’ conduct warrant an award of punitive damages? 7. If any of questions 1 to 5 are answered in the affirmative, should the defendants be ordered to disgorge the revenues they received from the sale of sibutramine? “R.T.C. Johnston, J.” The Honourable Mr. Justice Johnston