COURT FILE NO.: CV-19-00620048-00CP

DATE: 20231201

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

DARRYL GEBIEN

Plaintiff

• and –

APOTEX INC., APOTEX PHARMACEUTICAL HOLDINGS, INC., BRISTOL- MYERS SQUIBB CANADA, BRISTOL-MYERS SQUIBB COMPANY, PALADIN LABS, ENDO PHARMACEUTICALS INC., ENDO INTERNATIONAL PLC, JANSSEN INC., JOHNSON & JOHNSON, PHARMASCIENCE INC., JODDES LIMITED, PRO DOC LIMITEE, THE JEAN COUTU GROUP (PJC) INC., MYLAN PHARMACEUTICALS ULC, MYLAN N.V., PURDUE PHARMA INC., PURDUE PHARMA L.P., THE PURDUE FREDERICK COMPANY INC., PURDUE FREDERICK INC., RANBAXY PHARMACEUTICALS CANADA INC., SUN PHARMACEUTICAL INDUSTRIES LTD., HIKMA LABS INC., HIKMA PHARMACEUTICALS PLC, WEST-WARD COLUMBUS INC., SANIS HEALTH INC., SANDOZ CANADA INC., SANDOZ INTERNATIONAL GMBH, TEVA CANADA LIMITED, TEVA PHARMACEUTICALS USA, INC., TEVA PHARMACEUTICAL INDUSTRIES LTD., ACTAVIS PHARMA COMPANY, VALEANT CANADA LP/ VALEANT CANADA S.E.C, BAUSCH HEALTH COMPANIES INC., AMERISOURCEBERGEN CANADA CORPORATION, KOHL + FRISCH DISTRIBUTION INC., NU-QUEST DISTRIBUTION INC., ABBOTT LABORATORIES, LIMITED, and PROCURITY INC.

Defendants

Adam Tanel, Vlad Calina, Caitlin Leach, and Alec Angle for the Plaintiff

Fadi Amine, Yves Robillard, and Baktash Waseil for Pro Doc

Peter J. Pliszka, Caroline Youdan, and Pavel Sergeyev for Sandoz Canada Inc.

Scott Maidment and Jennifer Dent for Mylan Pharmaceuticals ULC and Mylan N.V.

Jill Lawrie, Gordon McKee, and Sanjit Rajayer for Janssen Inc. and Johnson & Johnson

Laura Fric and Robert Carson for Pharmascience Inc., Joddes Limited, Ranbaxy, Pharmaceuticals Canada Inc., Sun Pharmaceutical Industries Ltd, Teva Canada Limited, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., and Actavis Pharma Company

Caroline Zayid and Byron Shaw for Abbott Laboratories Inc.

Barry Glaspell, Cindy Clarke, and Adrian Pel for Purdue Pharma Inc. and Purdue Frederick Inc.

Geoffrey B. Shaw, and Derek Ronde for The Jean Coutu Group (PJC) Inc.

Lesley Mercer, for The Purdue Frederick Company Inc. and Purdue Pharma LP (watching brief)

Harry Radomski and Nando De Luca for Apotex Inc. and Apotex Pharmaceutical Holdings Inc.

David Neave and Rebecca von Rüti for Bristol-Myers Squibb Canada and Bristol-Myers Squibb Company

Robert J. McDonell for Hikma Pharmaceuticals PLC, Hikma Labs Inc., West-Ward Columbus Inc.

Ankita Gupta for Sanis Health Inc.

Andrew Skodyn, Melanie Baird, and Rebecca Torrance for Valeant Canada LP / Valeant Canada S.E.C. and Bausch Health Companies Inc.

Tim Farrell and Anna Iourina for Amerisourcebergen Canada Corporation, Kohl & Frisch Distribution Inc., and Procurity Inc. [and Kohl & Frisch Limited]

Keith S. Morgan for Nu-Quest Distribution Inc.

HEARD: October 17-19, 2023

Contents

Prologue. 4

A. Introduction. 4

B. Housekeeping. 4

(a) Kohl & Frisch Distribution Inc. and Kohl & Frisch Limited. 4

(b) Mylan Pharmaceuticals Inc. 5

(c) The Purdue Defendants. 5

(d) The Endo Defendants. 6

C. Synopsis. 6

D. Procedural and Evidentiary Background. 9

E. Facts: The Regulation of Pharmaceuticals. 12

F. Facts. 14

1. The Plaintiff. 14

2. The “Manufacturer Defendants”. 14

3. The “Distributor Defendants”. 16

4. Opioids and the “New Narrative”. 16

5. The End of the New Narrative. 19

6. Damages and Other Remedies. 20

7. Jurisdictional Connection to Ontario. 20

G. Miscellaneous Facts: Parallel Opioid Actions. 20

1. 2017 OxyContin®/OxyNEO® Settlement 20

2. Bourassa c. Abbott Laboratories Limited et al. 21

3. British Columbia v. Apotex Inc. et al. 21

H. Pro Doc’s Jurisdiction Motion: Facts. 22

I. Pro Doc’s Jurisdiction Motion: Legal Background. 25

1. Jurisdiction Simpliciter. 25

2. Forum Conveniens and Forum Non Conveniens. 30

3. British Columbia v. Apotex Inc., et al. 31

J. Pro Doc’s Jurisdiction Motion: Discussion and Analysis. 33

1. Analysis: Jurisdiction Simpliciter. 33

2. Analysis: Forum Conveniens. 35

K. The Claim Against The Jean Coutu Group (PJC) Inc. 35

L. Cause of Action Criterion and the Defendants’ Motion to Strike the Pleadings. 36

1. Methodology and the Ragoonanan Principle. 36

2. Pleadings Motion: General Principles. 38

3. Is there Collective or is there Separate Liability in the Immediate Case?. 44

4. The Problems of Pleading Joint Misconduct 50

(a) Corporate Enterprise Liability. 51

(b) Sweeping Allegations or Synchroneity. 53

5. Breach of the Competition Act 56

6. Negligent and Fraudulent Misrepresentation or Deceit 59

7. Negligence of the Manufacturer Defendants. 62

(a) Outline. 62

(b) Analysis and Discussion. 63

8. Negligence of the Distributor Defendants. 67

M. Conclusion. 69

PERELL, J.

REASONS FOR DECISION

Prologue

For ere this the tribes of men lived on earth remote and free from ills and hard toil and heavy sickness which bring the Fates upon men; for in misery men grow old quickly. But the woman [Pandora] took off the great lid of the jar with her hands and scattered all these and her thought caused sorrow and mischief to men. […] But the rest, countless plagues, wander amongst men; for earth is full of evils and the sea is full. Of themselves diseases come upon men continually by day and by night, bringing mischief to mortals silently; …. [Hesiod: Works and Days (circa 750 BCE) (translated by Hugh G. Evelyn-White, 1914)

[1] In the misogynistic Greek creation myth of Pandora’s Box, the cause of evil, including plagues innumerable, is attributed to the deceitfulness of Pandora who opened a box and released around the world countless illnesses and miseries. In this proposed Pandora’s Box of a class action, the opioid epidemic, an epidemic that has caused widespread pain, misery, and death around the world, is attributed to the deceitfulness and avarice of the Defendants who manufactured and distributed Opioids.

A. Introduction

[2] In this action, pursuant to the Class Proceedings Act, 1992,[^1] the Plaintiff, Dr. Darryl Gebien, moves for certification of his action as a class proceeding.

[3] The Defendants, which are described in the Fresh as Amended Statement of Claim as comprising two groups, i.e., the “Manufacturer Defendants” and the “Distributor Defendants”, bring motions to have the Plaintiff’s Statement of Claim struck for failure to disclose a reasonable cause of action or for violating the rules of pleading.

[4] The Defendant Pro Doc Limitée, which is a subsidiary of the Defendant The Jean Coutu Group (PJC) Inc., brings a motion pursuant to rule 21.01 (3)(a) of the Rules of Civil Procedure[^2] for an Order dismissing the action on the grounds that the Ontario court lacks jurisdiction simpliciter, or in the alternative pursuant to rule 17.06(1)(b),(2)(c) for an Order staying the action on the grounds that Ontario is forum non conveniens.

[5] This is a hearing of Pro Doc’s Jurisdiction Motion. It is also a hearing of the Defendants’ Motions to Strike. This hearing is also Phase One of Dr. Gebien’s motion to certify his action as a class action. Phase One of the Certification Motion is to determine whether or not the cause of action criterion (s. 5(1)(a) of the Class Proceedings Act, 1992) has been satisfied as against the Manufacturer Defendants and the Distributor Defendants, respectively.

B. Housekeeping

(a) Kohl & Frisch Distribution Inc. and Kohl & Frisch Limited

[6] The Defendant Kohl & Frisch Distribution Inc. is misspelled in the Fresh as Amended Statement of Claim with a “+” instead of an “&”.

[7] A separate corporation which is related to Kohl & Frisch Distribution Inc. is Kohl & Frisch Limited. That separate company is included as a defendant in the body of the Fresh as Amended Statement of Claim; however, it is not named in the style of cause.

[8] In the body of the Fresh as Amended Statement of Claim, Kohl & Frisch Limited is sued as a distributor of Opioids. In a parallel cloned class action, Dr. Gebien sues Kohl & Frisch Limited as a distributor but also as a manufacturer of Opioids.

[9] Dr. Gebien and Kohl & Frisch Limited have agreed to apply the findings in the motions now before the court in both actions.

[10] Therefore, as a housekeeping matter, I order that the style of cause be amended: (a) to correct the misspelling of Kohl & Frisch Distribution Inc.; and (b) to include Kohl & Frisch Limited as a party defendant.

[11] Further, I order that the Fresh as Amended Statement of Claim be amended to sue Kohl & Frisch Limited as both an opioid distributor and as an opioid manufacturer.

(b) Mylan Pharmaceuticals Inc.

[12] Mylan Pharmaceuticals ULC, Mylan Pharmaceuticals Inc., and Mylan N.V. (collectively, "Mylan") are among the “Manufacturer Defendants” described in the Fresh as Amended Statement of Claim; however, only Mylan Pharmaceuticals ULC and Mylan N.V. are to be found in the style of cause.

[13] As a housekeeping matter, I order that the style of cause be amended to include Mylan Pharmaceuticals Inc.

(c) The Purdue Defendants

[14] Dr. Gebien sues as a group, (1) Purdue Pharma Inc., (2) Purdue Frederick Inc., (3) The Purdue Frederick Company Inc., and (4) Purdue Pharma L.P. They are sued as “Manufacturer Defendants”.

[15] Purdue Pharma Inc. and Purdue Frederick Inc. are Canadian corporations. The Purdue Frederick Company Inc. and Purdue Pharma L.P. are American corporations.

[16] The American Purdue Companies are in bankruptcy; the Canadian Purdue Companies are not bankrupt.

[17] Pursuant to U.S. and Canadian bankruptcy and insolvency proceedings, there is a stay of proceedings against the American and the Canadian companies.[^3] By Order of Justice Conway dated June 1, 2022 the stay of proceedings was lifted in respect of the Canadian companies (Purdue Pharma Inc. and Purdue Frederick Inc.) to allow the motion for certification to proceed as against them.

[18] The stay of proceedings against the American companies continues, but their counsel appeared on a watching brief.

(d) The Endo Defendants

[19] Dr. Gebien sues as a group, Paladin Inc., Endo Pharmaceuticals Inc. and Endo International plc (collectively the “Endo Defendants”). They are sued as “Manufacturer Defendants”.

[20] Pursuant to the Companies’ Creditors Arrangement Act, on August 17, 2022 and August 19, 2022, Chief Justice Morawetz stayed all Canadian proceedings against the Endo Defendants.

[21] The Endo Defendants did not appear and did not participate in the hearing and no relief can be sought or obtained in respect of the Endo Defendants while the stay remains in place.

C. Synopsis

[22] For the reasons that follow:

[23] The Ontario Court does not have jurisdiction simpliciter and it is forum non conveniens with respect to Dr. Gebien’s claims against Pro Doc. Therefore, Pro Doc’s Jurisdiction Motion should be granted.

[24] There are no reasonable causes of action as against the “Distributor Defendants”. Therefore, the claims in Dr. Gebien’s Fresh as Amended Statement of Claim as against: (1) Abbott Laboratories Inc.; (2) AmerisourceBergen Canada Corporation; (3) Kohl & Frisch Distribution Inc.; (4) Kohl & Frisch Limited - in its capacity as a Distributor; (5) Nu-Quest Distribution Inc.; (6) Pro Doc Limitée; (7) Procurity Inc.; and (8) The Jean Coutu Group (PJC) Inc. - in its capacity as a Distributor Defendant, are struck out without leave to amend.

[25] The claim in the Fresh as Amended Statement of Claim as against The Jean Coutu Group (PJC) Inc. in its capacity as a Manufacturer Defendant should also be struck out without leave to amend. It is not a manufacturer of Opioids and hence is not a Manufacturer Defendant.

[26] Subject to the joinder of Representative Plaintiffs and compliance with the Ragoonanan Principle, which is authority that in a proposed class action, there must be a representative plaintiff with a claim against each defendant,[^4] there are four discrete certifiable causes of action against the remaining Manufacturer Defendants. The discrete certifiable causes of action against the Manufacturer Defendants are: (1) breach of the Competition Act;[^5] (2) negligent misrepresentation; (3) fraudulent misrepresentation or deceit; and (4) products liability negligence for breach of a duty to warn.

[27] If properly pleaded, each of these four causes of action would satisfy the cause of action criterion of the Class Proceedings Act, 1992. To be clear, if properly pleaded with material facts and particulars of the frauds and misrepresentations, these four causes of action would satisfy the cause of action criterion of the Class Proceedings Act, 1992.

[28] Although there are legally viable causes of action, Dr. Gebien’s Fresh as Amended Statement of Claim, however, is not a proper pleading of the four discrete certifiable causes of action. The pleading is the opposite of concise, and it includes a plethora of evidence and irrelevant material and although the pleading demonstrates some reasonable causes of action, it fails to be concise to the point that the Defendants are hindered in developing a responsive pleading.[^6] Therefore, the Manufacturer Defendants’ motion to strike the Fresh as Amended Statement of Claim should be granted on terms that Dr. Gebien is granted leave to deliver a Second Fresh as Amended Statement of Claim subject to the directions set out next.

[29] The Second Fresh as Amended Statement of Claim should comply with the technical rules of a proper pleading.

[30] Excluding The Jean Coutu Group (PJC) Inc. and Pro Doc Limitée, which were joined in the previous pleadings, for the Second Fresh as Amended Statement of Claim, the Manufacturer Defendants are the following 14 groups of defendants:

1. Apotex Inc. and Apotex Pharmaceutical Holdings, Inc. (collectively, "Apotex");

2. Bristol-Myers Squibb Canada and Bristol-Myers Squibb Company (collectively “Bristol-Myers”);

3. Endo Pharmaceuticals Inc., Endo International PLC and Paladin Labs (collectively “Endo”);

4. Janssen Inc. (formerly Janssen-Ortho Inc.), Johnson & Johnson, and Oklahoma & Johnson (collectively “Janssen”);

5. Kohl & Frisch Limited;

6. Mylan Pharmaceuticals ULC, Mylan Pharmaceuticals Inc., and Mylan N.V. (collectively, "Mylan");

7. Pharmascience Inc. and Joddes Limited (collectively, "Pharmascience");

8. Purdue Pharma Inc., Purdue Frederick Inc., Purdue Pharma L.P., and Purdue Frederick Company Inc. (collectively “Purdue”);

9. Ranbaxy Pharmaceuticals Canada Inc. and Sun Pharmaceutical Industries Ltd. (collectively, "Ranbaxy");

10. Hikma Labs Inc., West-Ward Columbus Inc., and Hikma Pharmaceuticals PLC (collectively, "Roxane");

11. Sandoz Canada Inc.;

12. Sanis Health Inc.;

13. Teva Canada Limited, Actavis Pharma Company, Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively “Teva”); and

14. Valeant Canada LP/ Valeant Canada S.E.C. and Bausch Health Companies Inc. (collectively, "Valeant").

[31] In the Second Fresh as Amended Statement of Claim the 14 groups of Manufacturer Defendants may be sued as 14 groups.

[32] The Second Fresh as Amended Statement of Claim should join a Representative Plaintiff for each of these groups of defendants.

[33] In the Second Fresh as Amended Statement of Claim, Dr. Gebien and the other plaintiffs may, as they may be advised, make allegations of material facts severally or they may make allegations collectively as against some or all of the groups of Manufacturing Defendants. As the discussion later will reveal, allegations of the same misconduct may sometimes be made by “lumping” the defendants together. The appropriateness of synchronized allegations of material fact will depend on the circumstances of the particular case. A synchronized pleading is appropriate in the immediate case.

[34] To be clear, for the Second Fresh as Amended Statement of Claim the only products liability claims that Dr. Gebien and the other Representative Plaintiffs may assert are claims for: (a) breach of the Competition Act; (b) negligent misrepresentation; (c) fraudulent misrepresentation; and (d) for a breach of a duty of warn.

[35] Dr. Gebien and his co-Plaintiffs are not granted leave to plead: manufacturing negligence, distribution negligence, or negligent design or a novel products’ liability claim.

[36] To be clear, for the Second Fresh as Amended Statement of Claim, it is plain and obvious that Dr. Gebien does not have a cause of action based on common-design liability nor does he have common-design as a form of concurrent or joint liability. Dr. Gebien and the other co-Plaintiffs are not granted leave to amend to assert such a common-design claim. Apart from the joint and several liability that might arise from the 14 intercorporate grouping of Defendants, there is no joint and several liability in the immediate case.

[37] To be clear, for the Second Fresh as Amended Statement of Claim, it is plain and obvious that Dr. Gebien does not have a cause of action against the Manufacturer Defendants with respect to enabling the black market, and Dr. Gebien and the other Representative Plaintiffs are not granted leave to amend to assert such a claim.

[38] To be clear, there are no causes of action against the Distributor Defendants and they should be removed from the Second Fresh as Amended Statement of Claim.

[39] Subject to Dr. Gebien appealing this Order, he shall have 120 days to deliver a Second Fresh as Amended Statement of Claim that: (a) joins Representative Plaintiffs (the Ragoonanan Principle); (b) pleads in accordance with the Rules of Civil Procedure; and (c) pleads in accordance with these Reasons for Decision, failing which Dr. Gebien’s action shall be dismissed.

[40] If Dr. Gebien delivers a Second Fresh as Amended Statement of Claim, then the Manufacturer Defendants shall have 20 days to bring Motions to Strike the Second Fresh as Amended Statement of Claim, failing which the Certification Motion shall proceed to Phase Two.

[41] If the Manufacturer Defendants or any of them brings a Motion to Strike the Second Fresh as Amended Statement of Claim, the motion(s) shall be scheduled before the hearing of Phase Two of the Certification Motion.

[42] If within 20 days of the delivery of the Second Fresh as Amended Statement of Claim the Manufacturer Defendants do not bring any Motions to Strike, Dr. Gebien’s Certification Motion shall proceed to Phase Two.

[43] Subject to the following exceptions, the costs of Dr. Gebien’s Phase One Certification Motion and the costs of the Defendants’ Motion to Strike shall be costs in the cause of the Certification Motion.

[44] The exceptions are that Pro Doc, Jean Coutu Group, and the Distributor Defendants may make costs submissions within twenty days of the release of these Reasons for Decision followed by Dr. Gebien’s submissions within the following twenty days. Any reply costs submissions shall be made within a further ten days.

D. Procedural and Evidentiary Background

[45] On May 15, 2019, pursuant to the Class Proceedings Act, 1992,[^7] Dr. Gebien commenced a proposed class action.

[46] On November 4, 2019, Dr. Gebien commenced a parallel action (CV-19-630389-00CP) against Kohl & Frisch Limited, which was sued as a manufacturer and as a distributor of Opioids. The material allegations are identical.

[47] On November 14, 2019, Dr. Gebien delivered an Amended Statement of Claim.

[48] On June 22, 2022, Dr. Gebien delivered a Fresh as Amended Statement of Claim.

[49] The “Manufacturer Defendants” are: (1) Apotex Inc. and Apotex Pharmaceutical Holdings, Inc. (collectively, "Apotex"); (2) Bristol-Myers Squibb Canada and Bristol-Myers Squibb Company (collectively “Bristol-Myers”); (3) Endo Pharmaceuticals Inc., Endo International PLC and Paladin Labs Inc. (collectively “Endo”); (4) Janssen Inc. (formerly Janssen-Ortho Inc.) Johnson & Johnson, and Oklahoma & Johnson (collectively, “Janssen”); (5) Mylan Pharmaceuticals ULC, Mylan Pharmaceuticals Inc., and Mylan N.V. (collectively, "Mylan"); (6) Pharmascience Inc. and Joddes Limited (collectively, "Pharmascience"); (7) Pro Doc Limitée and The Jean Coutu Group (PJC) Inc.; (8) Purdue Pharma Inc., Purdue Frederick Inc., Purdue Pharma L.P., and Purdue Frederick Company Inc. (collectively, “Purdue”); (9) Ranbaxy Pharmaceuticals Canada Inc. and Sun Pharmaceutical Industries Ltd. (collectively, "Ranbaxy"); (10) Hikma Labs Inc. (formerly known as Roxane Laboratories Inc.) and West-Ward Columbus Inc. (formerly known as Boehringer Ingelheim Roxane Inc.) and Hikma Pharmaceuticals PLC (collectively, "Roxane"); (11) Sandoz Canada Inc.; (12) Sanis Health Inc.; (13) Teva Canada Limited, Actavis Pharma Company (formerly, Cobalt Pharmaceutical Company), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively, “Teva”); and (14) Valeant Canada LP/ Valeant Canada S.E.C. and Bausch Health Companies Inc. (collectively, "Valeant") [and (15) Kohl & Frisch Limited].

[50] The “Distributor Defendants” are: (1) Abbott Laboratories Inc. (formerly, Abbott Laboratories, Limited); (2) AmerisourceBergen Canada Corporation; (3) Kohl & Frisch Distribution Inc.; (4) Kohl & Frisch Limited; (5) Nu-Quest Distribution Inc.; (6) Pro Doc Limitée; (7) Procurity Inc.; and (8) The Jean Coutu Group (PJC) Inc. in its capacity as a distributor.

[51] The Defendants are manufacturers and/or distributors of Opioids, which are a class of drugs that are defined by a chemical compound that is naturally found in the opium poppy plant or which is synthetically made using the same chemical structure.

[52] Dr. Gebien sues on behalf of the following class:

(a) "Class" and "Class Members" means all persons in Canada, save for excluded persons, who were prescribed Opioids manufactured, marketed or distributed by the Defendants from January 1, 1996 to the present day ("Class Period") and who suffer or have suffered from Opioid Use Disorder, according to the diagnostic criteria hereafter described;

(b) The Class includes the direct heirs of any deceased persons who met the abovementioned criteria;

(c) "Excluded Persons" means:

(i) any person who was prescribed OxyContin® or OxyNEO® in Canada at any time between January 1, 1996 and April 15, 2016 inclusive, and was not prescribed any other Opioids, as defined below, at any time during the Class Period: and,

(ii) any officer or director of any of the Defendants;

(d) "Family Law Class" and "Family Law Class Members" means all persons within Canada, except for excluded persons, who by reason of his or her relationship to a Class Member have standing pursuant to s. 61 (1) of the Family Law Act, R.S.O. 1990, c. F.3, or equivalent legislation in other provinces and territories, or the common law; …

[53] Thus, Dr. Gebien seeks to represent a class of all persons in Canada who were prescribed Opioids manufactured, marketed, or distributed by the Defendants from January 1, 1996 to the present day and who suffer or have suffered from Opioid Use Disorder.

[54] “Opioid Use Disorder” means use of Opioids resulting in: (a) giving up important social occupation or recreational activities; (b) persistent desire or unsuccessful efforts to reduce Opioid use; (c) failure to fulfill occupational, scholastics or home life obligations; (d) persistent or recurrent social or interpersonal problems; (e) impairment in physically hazardous situations; (f) drug tolerance requiring use of larger amounts of Opioids than intended; (g) a persistent or recurrent physical or psychological problems; or (h) Opioid withdrawal syndrome.

[55] On behalf of the class, Dr. Gebien pleads: (a) breaches of the Competition Act; (b) negligent misrepresentation; (c) fraudulent misrepresentation or deceit; and (d) common law negligence.

[56] On December 12, 2022, I directed that the Certification Motion proceed in two phases. Phase One is to consider whether the cause of action criterion has been satisfied. If that criterion is satisfied, then Phase Two will consider whether the remaining certification criteria are met.

[57] As noted above, the Manufacturer Defendants and the Distributor Defendants brought motions to strike Dr. Gebien’s Fresh as Amended Statement of Claim for failing to disclose a reasonable cause of action. This motion is a non-evidentiary motion based on the legal adequacy of the statement of claim. I directed that the motion to strike be heard along with Phase One of the Certification Motion.

[58] As noted above, Pro Doc brought a Jurisdiction Motion. This motion also was to be heard with Phase One of the Certification Motion. Unlike a pure pleadings motion, a jurisdiction motion may have evidence.

[59] Pro Doc supported its Jurisdiction Motion with the following evidence:

a. Affidavit dated February 28, 2023 and expert report of Patrice Deslauriers, LL.B, D.E.A., LL.M of Montreal Québec. Mr. Deslauriers is a practising lawyer and since 1995, a Professor of Law at the University of Montreal, where he teaches Québec civil liability law. He is an Associate Director of the Canadian Bar Review and the co-author with Jean-Louis Baudouin and Menoit Moore of La responsabilité civil (9^th^ ed.) (Éditions Yvon Blais, 2020).

b. Affidavit dated June 7, 2023 of Chantal Goudreau of the City of Laval, Québec. Ms. Goudreau is Director of Planning and Inventory Management with Pro Doc, where she has been employed for over 25 years. Between January 1998 to 2000, she was the Assistant to the President. Then she became Purchasing Manager, responsible for purchases from drug suppliers. In 2008, she became the Director-Planning and Inventory Management, where she participates in operations and management committee meetings and product launch working groups, including the sales and market analysis groups. She has direct knowledge of Pro Doc's business and of the pharmaceuticals and drugs it distributes, including Opioids.

c. Affidavit dated February 24, 2023 of Robert Labrosse of the City of Laval, Québec. Mr. Labrosse is an engineer registered with the Order of Engineers of Québec since 1992. Mr. Labrosse has been involved in the pharmaceutical industry for almost two decades. He joined Pro Doc in 2015 as a Vice President. He worked closely with the former president (2007-2020) Marcel Raymond. In 2020, Mr. Labrosse became the President of Pro Doc.

[60] As I shall explain in more detail below, The Jean Coutu Group (PJC) Inc. relied on the evidence in the Jurisdiction Motion as a part of its own motion to strike. It relied on rule 25.11, which is a normal motion that can be supported by affidavit evidence.

[61] Dr. Gebien did not file any responding material in the Jurisdiction Motion, although he had filed a ten-volume Motion Record for the Certification Motion. That material was filed before I allowed the Jurisdiction Motion to be heard as part of the Certification Motion and before I ordered the Certification Motion proceed in two phases.

[62] On June 7, 2023, Mr. Labrosse was cross-examined.

[63] On July 6, 2023, Ms. Goudreau was cross-examined.

[64] During their cross-examinations, Mr. Labrosse and Ms. Goudreau refused to answer some questions, but Dr. Gebien did not bring a Refusals Motion.

[65] For the Jurisdiction Motion, Pro Doc delivered a factum (88 pages), Dr. Gebien delivered a Responding Factum (65 pages), and Pro Doc delivered a Reply Factum (43 pages).

[66] For the Phase One Certification Motion and for the Defendants’ Motions to Strike the Fresh as Amended Statement of Claim: (a) Dr. Gebien deliver a Factum (95 pages); (b) the Defendants collaborated to deliver six factums: Sandoz Canada Inc.’s Factum (46 pages); Mylan Pharmaceuticals ULC’s Factum (40 pages); Janssen Inc. and Johnson & Johnson’s Factum (44 pages); TRP Defendants’[^8] Factum (19 pages -); Distributors’ Factum[^9] (18 pages); and Purdue Pharma Inc. and Purdue Frederick Inc.’s Factum (20 pages); and (c) Dr. Gebien delivered a Reply Factum (63 pages). All the Manufacturing Defendants and all the Distributor Defendants relied on each other’s factums.

E. Facts: The Regulation of Pharmaceuticals

[67] The following facts underly the allegations contained in the Fresh as Amended Statement of Claim.

[68] Health Canada is responsible for approving drugs for sale in Canada. The Manufacturer Defendants and the Distributor Defendants were authorized by Health Canada to manufacture, distribute, and sell prescription opioid products for the treatment of pain in adults.

[69] A drug is licensed for sale by Health Canada issuing a Notice of Compliance (“NOC”) after an elaborate and intensive submission and review process. Pursuant to the Food and Drugs Act,[^10] and the Food and Drug Regulations,[^11] the manufacturer, described as the sponsor, must file a New Drug Submission ("NDS"). The NDS contains detailed information about: the chemistry of the drug; the manufacturing process; the results of pre-clinical and clinical testing; information about the proposed indications, dosage, and conditions of use; the drug’s claimed therapeutic value; and warnings about potential side effects and risks. The NDS submissions by the manufacturer include a draft Product Monograph.

[70] The NDS/NOC process includes an extensive review of the manufacturer’s submission and a review of the proposed Product Monograph for the drug. The Health Canada reviewers are physicians, pharmacologists, or other scientists. In determining whether to approve or reject a submission, the reviewers will scrutinize: whether the drug can be made consistently; whether the product quality can be assured; whether the efficacy of the drug is acceptable based on a randomized controlled trial(s), and whether the safety profile of the drug is acceptable based on the risk/benefit analysis.

[71] The Product Monograph is subject to a review by Health Canada’s Therapeutic Products Directorate. The Directorate is staffed by scientific experts with extensive clinical and/or medical expertise. The Product Monograph provides pertinent information about the nature and uses of the drug including cautions and warnings. The Product Monograph summarizes the results of the studies submitted to Health Canada.

[72] A Product Monograph consists of three distinct parts; that is: (1) Part I: Health Professional Information, which provides information to healthcare professionals for the prescribing, dispensing, and administering of the medication; (2) Part II: Scientific Information, which provides highly detailed scientific research information such as the drug’s chemical composition, toxicology and data from clinical trials; and (3): Part III: Consumer Information, which provides information for the consumer about the medication, how to use it and what are the side effects.

[73] Within a Product Monograph, any particular risk can be profiled with greater or lesser prominence. The most prominent warnings take the form of “boxed warnings,” found in Part I and repeated in Part III that highlight serious risks that are clinically significant or life-threatening. Other serious risks will be presented within the WARNINGS AND PRECAUTIONS section in Parts I and III.

[74] If satisfied that the drug and its Product Monograph satisfy the requirements of the Food and Drugs Act, Health Canada will issue a NOC as well as a Drug Identification Number (“DIN”) that permits the sponsor to sell the drug in Canada. When a NOC is issued, Health Canada also prepares a "Summary Basis of Decision" ("SBD"). The SBD explains why Health Canada authorized the drug for sale in Canada. The document includes regulatory, safety, effectiveness, and quality (chemistry and manufacturing) considerations.

[75] Health Canada is also responsible for the post-marketing surveillance of drugs once they have been marketed, including monitoring drug safety and ensuring that drug manufacturers comply with the regulations, which include reporting and recordkeeping obligations about the effects of the drug on patients. For example, manufacturers are required to deliver expedited adverse drug reaction (ADR) reports of all serious adverse drug reactions that occur in Canada and all serious and unexpected ADRs that occur outside of Canada. ADRs may also be submitted by patients, health professionals or others.

[76] As new information about a drug becomes available, or as changes are made by the manufacturer, a follow-up submission to Health Canada may be required. If the manufacturer expands the indications for a drug, a supplemental NDS (“SNDS”) must be filed. For a change to identify adverse events or to take risk management measures, the manufacturer must file a NOC submission and the changes can be implemented only after Health Canada issues a No Objection Letter (NOL).

[77] After a drug has been approved, Health Canada's Marketed Health Products Directorate (MHPD) monitors ADRs including the required reports from manufacturers and also spontaneous reports of ADRs from healthcare professionals across Canada.

[78] The Defendants are regulated as "manufacturers" under the Food and Drugs Act,[^12] and the Food and Drug Regulations,[^13] and as "licensed dealers" under the Controlled Drugs and Substances Act, and the Narcotic Control Regulations.[^14] Under these regulations: (a) the Defendants cannot create an erroneous impression regarding the character, merit, or safety of a drug through labelling, packaging, or advertising;[^15] (b) the Defendants must disclose information about serious drug reactions within 15 days of receiving or becoming aware of the information;[^16] (c) the Defendants must provide annual reports disclosing whether there has been a change in what is known about the risks and benefit of a drug;[^17] (d) the Defendants must record, investigate, and if necessary, correct any issue relating to the quality, deficiencies, or hazards of a drug;[^18] (e) the Defendants must keep records of adverse reactions, product testing, investigation of drug tests, and drug sales;[^19] and (f) the Defendants must report the loss or theft of a narcotic.[^20]

F. Facts

[79] For the Defendants’ Motion to Strike and for Dr. Gebien’s Phase One Certification Motion, the material facts are taken from the Fresh as Amended Statement of Claim. For the purposes of the Certification Motion, I assume the following description of the facts to be true and to be provable. (At this juncture, the Defendants admit nothing and will contest everything.)

[80] The Fresh as Amended Statement of Claim, in numerous respects, violates the rules of pleading, particularly by containing evidence to prove the material facts and by other pleading irregularities. It is a prolix-polemical editorial. The pleading is rhetorical and argumentative. The pleading offends rule 25.06 (1) that requires that a pleading to contain a “concise statement of the material facts on which the party relies for the claim or defence, but not the evidence by which those facts are to be proved.” The pleading includes a plethora of evidence and irrelevant material and although the pleading demonstrates some reasonable causes of action, it is the opposite of concise. The following description of the material facts describes the material facts without Dr. Gebien’s lawyers’ conclusory language and rhetorical embellishments.

[81] (As noted above in the Synopsis, should Dr. Gebien deliver a Second Fresh as Amended Statement of Claim, I have directed that this pleading comply with the Rules of Civil Procedure so that the Defendants are not hampered in delivering their defence. I have reserved the Defendants’ right to bring a pleadings motion to challenge the regularity of the Second Fresh as Amended Statement of Claim.)

1. The Plaintiff

[82] Darry Gebien is a resident of the City of Toronto. He is a formerly suspended emergency room physician now practising medicine under supervised conditions.

[83] Dr. Gebien’s sad story began when he suffered a ligament injury in his thumb while playing recreational hockey. He was prescribed the opioid Percocet for pain. Percocet is manufactured by Bristol-Myers Squibb Canada, a Canadian company, and Bristol-Myers Squibb Company an American company. There is no pleading that Dr. Gebien was prescribed an Opioid manufactured by any other manufacturer.

[84] Dr. Gebien became addicted. As an addict, he committed crimes. He stole opioid drugs, and he falsified prescriptions. His license to practise medicine was suspended. He went to prison. He lost his job. He lost his marriage. He lost custody of his children. He experienced an excruciatingly difficult substance abuse rehabilitation.

2. The “Manufacturer Defendants”

[85] Apotex Inc. and Apotex Pharmaceutical Holdings, Inc. (collectively, "Apotex") are Canadian companies. They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Apo-Tramadol, Apo-Fentanyl Matrix, Apo-Hydromorphone, and Apo-Oxycodone CR.

[86] Bristol-Myers Squibb Canada is a Canadian company and Bristol-Myers Squibb Company is an American company (collectively “Bristol-Myers”). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Endocet, Percocet, Percocet-DEMI, Percodan, and Percodan-Demi.

[87] Endo Pharmaceuticals Inc. ("Endo USA"), which is an American company, and Endo International PLC ("Endo International"), which is an Irish company, control Paladin Labs, which is a Canadian company (collectively “Endo”). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Opana ER, Abstral, Metadol, Statex, Tridural, pms-Methadone, and Nucynta.

[88] Janssen Inc. (formerly Janssen-Ortho Inc.) is a Canadian company and Johnson & Johnson is an American company, which is a subsidiary of Oklahoma & Johnson (collectively “Janssen”). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada and the U.S.A., including Duragesic, Tramacet, Ultram, Nucynta CR, PAT-Tramadol/Acet, Tylenol with Codeine No. 2, Tylenol with Codeine No. 3, Tylenol with Codeine No. 4, and Tylenol with Codeine Elixir.

[89] Mylan Pharmaceuticals ULC is a Canadian company. It and Mylan Pharmaceuticals Inc. are subsidiaries of Mylan N.V., a Dutch company (collectively, "Mylan"). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Mylan-Fentanyl Matrix Patch, and Mylan-Tramadol/Acet.

[90] Pharmascience Inc. is a Canadian company, which is a subsidiary of Joddes Limited, also a Canadian company (collectively, "Pharmascience"). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including PMS-Butorphanol, PMS-Oxycodone CR, PMS-Fentanyl MTX, PMSHydromorphone, PMS-Morphine Sulfate SR, and PDP-Hydrocodone.

[91] Pro Doc Limitée is a Canadian company that is a subsidiary of The Jean Coutu Group (PJC) Inc., also a Canadian company. They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Fentanyl Patch, Oxycodone, Oxycodone-Acet, and Tramadol-Acet. The Jean Coutu Group (PJC) Inc. also distributed Opioids to pharmacies, hospitals, and other dispensaries across Canada.

[92] Purdue Pharma L.P. and the Purdue Frederick Company Inc. are American companies, and Purdue Pharma Inc. and Purdue Frederick Inc. are Canadian companies (collectively “Purdue”). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Belbuca, BuTrans, Targin, MS Contin, Hydromorph Contin, Oxycontin and OxyNEO.

[93] Ranbaxy Pharmaceuticals Canada Inc. is a Canadian company that is a subsidiary of Sun Pharmaceutical Industries Ltd. which is an Indian company (collectively, "Ranbaxy"). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including RAN-Fentanyl Matrix Patch and RAN-Oxycodone CR.

[94] Hikma Labs Inc. (formerly known as Roxane Laboratories Inc.) and West-Ward Columbus Inc. (formerly known as Boehringer Ingelheim Roxane Inc.) are American companies, and Hikma Pharmaceuticals PLC is a Jordanian company (collectively, "Roxane"). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada, including Hydromorphone HCL, Oramorph SR, and Roxicet.

[95] Sanis Health Inc. is a Canadian company. It manufactured, marketed, and sold Opioids in Canada, including Oxycodone/Acet, Tramadol/Acet, and Morphine SR.

[96] Sandoz Canada Inc. is a Canadian company. It manufactured, marketed, and sold Opioids in Canada including Sandoz Fentanyl Patch, Sandoz Oxycodone, Fentanyl Citrate Injection SDZ, Morphine HP 25, Morphine HP 50, Sandoz Opium & Belladonna, Sandoz Methadone, Sandoz Morphine SR, Morphine Sulfate Injection USP, and Meperidine Hydrochloride Injection USP.

[97] Teva Canada Limited and Actavis Pharma Company (formerly Cobalt Pharmaceutical Company) are Canadian companies, and Teva Pharmaceuticals USA, Inc. is an American company, Teva Pharmaceutical Industries Ltd. is an Israeli company. Teva Canada Limited, Actavis Pharma Company, and Teva USA are subsidiaries of Teva Pharmaceutical Industries Ltd. (collectively “Teva”). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada and the U.S.A. including Teva-Oxycocet, Teva-Tramadol/Acetaminophen, Teva-Fentanyl, Teva-Hydromorphone, Teva-Morphine SR, and ACT Oxycodone CR and CO Fentanyl.

[98] Valeant Canada LP/ Valeant Canada S.E.C., which is a Canadian company, is a branch of Bausch Health Companies Inc., another Canadian company (collectively, "Valeant"). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of manufacturing, marketing, and selling Opioids in Canada including M.O.S.-SR (Morphine Hydrochloride), Cophylac, and Cophylac Drops.

[99] The Manufacturer Defendants marketed and sold in Canada prescription pain medications that contained Opioids under brand names and generic counterparts.

3. The “Distributor Defendants”

[100] Abbott Laboratories Inc. (formerly Abbott Laboratories Limited) is an American company with Canadian offices in Ontario and Quebec. During the Class Period, it distributed Opioids to pharmacies, hospitals, and other dispensaries across Canada.

[101] Kohl & Frisch Distribution Inc. and Kohl & Frisch Limited are Canadian companies. AmerisourceBergen Canada Corporation is a Canadian Company that on March 28, 2013 was acquired by Kohl & Frisch Limited (collectively "Kohl & Frisch"). They are inextricably interwoven businesses. Each is the agent of the other for the purposes of distributing Opioids in Canada.

[102] Nu-Quest Distribution Inc. is a Canadian company. It distributed Opioids to pharmacies, hospitals, and other dispensaries across Canada.

[103] Procurity Inc. is a Canadian Company. It distributed Opioids to pharmacies, hospitals, and other dispensaries across Canada.

4. Opioids and the “New Narrative”

[104] Opioids are controlled substances, some listed under Schedule I of the Controlled Drugs and Substances Act.[^21] The Defendants are regulated as "manufacturers" under the Food and Drugs Act,[^22] and the Food and Drug Regulations,[^23] and as "licensed dealers" under the Controlled Drugs and Substances Act, and the Narcotic Control Regulations.[^24]

[105] The Opioid supply chain begins with the Manufacturer Defendants, who develop the Opioids, obtain regulatory approval, and market the drugs. The manufacturers transfer the Opioids to wholesale distributors, the Distributor Defendants, who then dispense the Opioids to hospitals and pharmacies. Physicians prescribe the drugs, which cannot be purchased off the shelf. Hospitals and pharmacies then dispense the Opioids to patients. The availability of Opioids is highly regulated.

[106] Prescription Opioids are powerful pain reducing medicines that encourage the release of dopamine. Opioids present potentially serious risks of drug addiction and substance abuse. With continued use, patients become tolerant to the drug and patients require progressively higher doses to abate their pain. With increased doses, the risk of addiction, overdose, and death also increases. Withdrawal symptoms are severe including nausea, muscle pain, depression, anxiety, diarrhea, vomiting, restlessness, and chills.

[107] Until the mid-1990s, the medical profession’s orthodoxy was that Opioids should be prescribed sparingly and only for palliative care or for short-term conditions such as surgery for an acute injury. Opioids were thought to be too addictive to treat pain conditions that would require long-term Opioid use.

[108] In the mid-1990s, the Manufacturer Defendants introduced time-release formulations of Opioids. The manufacturers claimed these Opioid drugs were safe for long-term use.

[109] The Manufacturer Defendants were able very lucratively to market these products for a wider range of pain conditions. The Manufacturer Defendants developed and promoted a false and misleading “New Narrative” about Opioids to broaden the market and to increase sales of Opioids.

[110] Each of the Manufacturer Defendants by the various acts and omissions contributed to promoting the New Narrative.

[111] Each of the Manufacturer Defendants acted in furtherance of a common design, the object of which was to broaden the market for and increase the sale of Opioids without regard for the risk of addiction and at the expense of the class.

[112] To create a demand for Opioid drugs, the Manufacturer Defendants deliberately downplayed risks in order to displace the medical orthodoxy that Opioids are too addictive and too dangerous for widespread or long-term use. The Manufacturer Defendants promulgated the inaccurate and fraudulent message that concerns about addiction were overblown and that screening and monitoring would be able to prevent addiction. They marketed Opioids as less addictive than they knew the drugs to be. They promoted Opioids as safe, effective, and appropriate for long-term use in routine pain conditions when they knew or reasonably ought to have known that this use was inappropriate and dangerous and that marketing them as safe for long-term use would lead to greater Opioid addiction and death. The Manufacturer Defendants concealed the dangers of the New Narrative from regulators, health care professionals, and patients.

[113] Each of the Manufacturer Defendants, through their acts and omissions, contributed to creating and promoting the New Narrative. The hallmarks of the New Narrative were seven core false messages that induced the overprescribing of Opioids to patients who ought not to have been prescribed the drug.

[114] First, the New Narrative stated that Opioids were safe for long-term use. The Manufacturer Defendants misrepresented that there was little risk of addiction from Opioid drug use.

[115] Second, the New Narrative overstated the safety and effectiveness of long-acting, time-release Opioids. The Manufacturer Defendants knowingly falsely stated that long-acting Opioids would provide long-term pain relief when the Opioids were not effective for 12 hours in many, if not most, patients. The Manufacturer Defendants did not warn of the adverse effects or disclose the risks of Opioid use, including the risks of overdose, addiction, hyperalgesia (hypersensitivity to pain, hormonal and immunity dysfunction, disorientation), respiratory depression, and death, including fatal interactions with alcohol or benzodiazepines. The Manufacturer Defendants’ warnings in the drug packaging were insufficient. The Manufacturer Defendants failed to properly warn healthcare professionals and consumers of the risks and dangers associated with Opioid use in the Information for Patients and Product Monographs found in the Compendium of Pharmaceuticals and Specialties.

[116] Third, the New Narrative exaggerated the benefits of Opioids for patient health, function, flourishing, and quality of life. Without genuine clinical evidence, the Manufacturer Defendants represented that Opioids were therapeutic and would improve patient functioning and quality of life.

[117] Fourth, the New Narrative understated the risk that patients would become tolerant to time-release Opioids and require higher doses, which in turn increased the risk of addiction. The Manufacturer Defendants misrepresented that even patients with a high risk of addiction could be prescribed Opioids. Healthcare professionals and patients were not warned that increased doses of Opioids increase the risks. The Manufacturer Defendants failed to warn that higher doses increase tolerance to the drug that, in turn, requires still higher doses for pain, which, in turn, increases the risk of addiction, the difficulties of withdrawal, and the chances of respiratory depression, overdose, and death.

[118] Fifth, the New Narrative minimized the risk of Opioid addiction being caused by their drugs. The Manufacturer Defendants created the term "pseudoaddiction" to promote the idea that patients were not addicted to Opioids. Conversely, they attributed addiction to patients who abused the drug or were criminals.

[119] Sixth, the New Narrative misrepresented that Opioid withdrawal could be easily managed. The Manufacturer Defendants misrepresented that withdrawal from Opioids could be easily managed knowing that healthcare professionals would be induced to prescribe Opioids.

[120] Seventh, the New Narrative falsely compared the side effects from Opioids to the side effects from common over-the-counter drugs like nonsteroidal anti-inflammatory drugs (“NSAIDs”) when the side effects from Opioids were far more serious and dangerous. The Manufacturer Defendants' marketing materials did not refer to the known risks of chronic Opioid therapy and exaggerated risks of competing products such as the NSAIDs.

[121] The Manufacturer Defendants developed marketing campaigns to influence the prescription behaviour of healthcare providers and to influence patient (consumer) behaviour to increase the use of Opioids.

[122] In furtherance of their marketing campaigns to increase Opioid use and sales of their drugs, the Manufacturer Defendants: (a) placed false advertisements about the safety and efficacy of their drugs and the New Narrative; (b) recruited Key Opinion Leaders, peer physicians to campaign on behalf of Opioid drugs; (c) systematically financially awarded and influenced healthcare providers to prescribe Opioid drugs through speakers’ bureaus, medical societies, think tanks, and/or patient advocacy groups (“Front Groups”) to promote the New Narrative with false and misleading educational materials; (d) sponsored and funded educational programs at medical schools at continuing education programs that were disguised marketing presentations for increasing opioid prescriptions.

[123] The Manufacturer Defendants promulgated false scientific literature, concealing its biased sources.

[124] The Defendants fraudulently concealed their conduct from detection by the public, the Plaintiff, and patients.

[125] The Manufacturer Defendants and the Distributor Defendants supplied Opioids in quantities that they knew or should have known exceeded any legitimate market. The Defendants knew or ought to have known that there was a suspicious rise in distribution of Opioids to retailers in Canada and did nothing to prevent or reduce the diversion of drugs. The Distributor Defendants failed to put in place systems to identify suspicious orders of Opioids and they failed to report suspicious orders of which they were aware. The Defendants enabled the expansion of the black market, paving the way for a public health crisis.

[126] As a result of the Manufacturer Defendants' marketing activities, the prescribing of Opioids as a long-term means to treat chronic pain became routine and widespread. After the 1980s, Opioids sold to hospitals and pharmacies in Canada increased by more than 3,000%. Many Canadians became addicted to Opioids. More than 30,000 Canadians are estimated to have died of Opioid overdoses in the past two decades.

[127] On average, every day, approximately eleven Canadians die of Opioid overdoses.

5. The End of the New Narrative

[128] In June 2018, the Minister of Health sent a letter to manufacturers and distributors of opioids in Canada calling on them voluntarily to stop all marketing and advertising of Opioids to healthcare professionals.

[129] On October 23, 2018, Health Canada under the Food and Drug Regulations,[^25] ordered the Manufacturer Defendants to provide clear information about the safe use of opioids and the risks associated with their use. The new regulations require the Manufacturer Defendants to include a warning sticker and information handout. The warning indicates that opioids can cause dependence, addiction, and overdose. The warning states that the use of opioids can result in overdose, addiction, physical dependence, life-threatening breathing problems, worsening rather than improving pain and withdrawal.

[130] Opioids continue to be used for patient treatment and care.

6. Damages and Other Remedies

[131] The Plaintiff and the Class Members claim compensatory damages including damages for personal injuries, mental anguish, pain and suffering, loss of employment income and benefits, loss of enjoyment of life, possible death, and special damages and expenses.

[132] The Family Law Class has suffered damages, including: (a) actual expenses reasonably incurred for Class Members; (b) travelling expenses incurred while visiting Class Members during treatment or recovery; (c) loss of income or the value of services provided for Class Members where services, including nursing and housekeeping have been provided; and (d) compensation for loss of support, guidance, care, and companionship that they might reasonably have expected to receive from Class Members.

[133] The Plaintiff claims punitive damages in the sum of $100 million as a result of the egregious, outrageous, and unlawful conduct of the Defendants, and in particular, their callous disregard for the health and lives of vulnerable patients in Canada.

[134] The plaintiff claims an accounting of all profits earned by the defendants during the class period from the sale of Opioids pursuant to the New Narrative and disgorgement.

[135] Dr. Gebien pleads that the Manufacturer Defendants and Distributor Defendants are jointly and severally liable for the damage suffered by the Class.

7. Jurisdictional Connection to Ontario

[136] Dr. Gebien pleads that his action has a real and substantial connection to Ontario because: (a) the Defendants distribute and sell their products in Ontario and derive substantial revenue; (b) the Defendants' head offices are located in Ontario; (c) the Defendants advertised their products, including Opioids, in Ontario; (d) the torts were committed in Ontario; (e) the Plaintiff and Class Members were administered Opioids in Ontario and sustained consequent damages in Ontario; and (f) the Defendants are necessary and proper parties to the action.

G. Miscellaneous Facts: Parallel Opioid Actions

1. 2017 OxyContin®/OxyNEO® Settlement

[137] Between 2007 and 2012, class actions were brought with respect to claims arising from patients prescribed OxyContin® and/or OxyNEO®tablets in Canada. These actions were settled nationally in 2017 for claims up to March 1, 2017.[^26] The 2017 Settlement was approved by the courts of Saskatchewan, Ontario, Québec, and Nova Scotia. The claims protocol is currently being administered by RicePoint.

[138] The defined class under the 2017 Settlement is:

“All persons including their estates, who at any time between January 1, 1996 and February 28, 2017 inclusive were prescribed … and ingested OxyContin® tablets and/or OxyNEO® tablets, manufactured, marketed and/or sold or otherwise placed into the stream of commerce in Canada by one or more of the Defendants”, as well as the family members of such patients. The 2017 Settlement released their claims.

2. Bourassa c. Abbott Laboratories Limited et al.

[139] In Québec Jean-François Bourassa has brought an action on behalf of Québec consumers of opioids manufactured by a group of defendants. The action is Bourassa v. Abbott Laboratories Limited et al.[^27] The class definition is:

All persons in Québec who have been prescribed and consumed any one or more of the opioids manufactured, marketed, distributed, and/or sold by the Defendants between 1996 and the present day and who suffer or have suffered from Opioid Use Disorder.

[140] A motion for authorization is currently under reserve.

3. British Columbia v. Apotex Inc. et al.

[141] In British Columbia, pursuant to British Columbia's Opioid Damages and Health Care Costs Recovery Act,[^28] the Government of British Columbia has brought an action against approximately 50 opioid manufacturers, wholesalers, and distributors. The action also includes pharmacy franchisor and franchisee retailers. The action, which is in part a statutory action, is British Columbia v. Apotex Inc. et al.[^29]

[142] The Government of British Columbia’s claim is advanced on behalf of a class of all federal, provincial, and territorial governments that, during the period from 1996 to the present (the "Class Period"), paid healthcare, pharmaceutical, treatment and other costs related to Opioids. It is alleged that the defendants created or assisted in the creation of an epidemic of addiction that caused deaths and serious and long-lasting injuries and harmed the governments’ ability to deliver health care to their citizens. The Government alleges that manufacturer defendants marketed and promoted opioids in Canada as less addictive than they knew them to be, and for conditions they knew the drugs were not effective in treating. The claim against the distributor defendants is that they delivered opioids in quantities they knew or should have known exceeded any legitimate market, thereby intensifying the crisis of opioid use, addiction, and death in Canada.

[143] The Government of British Columbia’s action was filed on August 29, 2018. The pleading was amended on June 20, 2019 after the passage of the Opioid Damages and Health Care Costs Recovery Act. The pleading was further amended after a pleadings motion similar to the motions now before the court. As in the immediate case, the Defendants, many of them the same as in the immediate case, brought motions to strike the pleading for failure to plead viable causes of action. In a decision affirmed by the British Columbia Court of Appeal Justice Brundrett dismissed the motions to strike.[^30]

[144] The Government of British Columbia’s proposed class action advances both statutory and common law causes of action. The Opioid Damages and Health Care Costs Recovery Act provides the government has a direct and distinct action against a manufacturer or wholesaler to recover the cost of health care benefits caused or contributed to by an opioid-related wrong. The Government’s common law actions include: negligent misrepresentation, fraudulent misrepresentation, deceit, design negligence, and failure to warn. There is also a statutory cause of action for misrepresentations and liability under the Competition Act. Without advancing a conspiracy cause of action, the Government of British Columbia also submitted that the defendants were jointly and severally liable based on their having a common design that caused harm.

[145] In 2022, in a decision subsequently affirmed by the British Columbia Court of Appeal, Justice Brundrett dismissed a motion to declare the Opioid Damages and Health Care Costs Recovery Act, ultra vires.[^31]

[146] Also in 2022, in British Columbia v. Apotex Inc., et al., Pro Doc and Jean Coutu Group brought applications challenging the jurisdiction simpliciter of the Supreme Court of British Columbia. They reserved the right to challenge forum conveniens. In a decision now under appeal, Justice Brundrett dismissed Pro Doc’s and Jean Coutu Group’s jurisdiction simpliciter motion.[^32]

[147] There are obviously many similarities between the immediate case and British Columbia v. Apotex Inc., et al. I shall have more to say about British Columbia v. Apotex Inc., et al later in the discussion of Pro Doc’s Jurisdiction motion, to which I now turn.

H. Pro Doc’s Jurisdiction Motion: Facts

[148] Unlike a pure pleadings motion, where no evidence is admissible without leave of the court, on a Jurisdiction Motion, the defendant may deliver evidence to contest jurisdiction. If the defendant delivers evidence to challenge the factual allegations contained in the Statement of Claim, the plaintiff must meet the evidentiary challenge by cross-examination or by filing evidence of its own.

[149] In the immediate case, as noted above, Pro Doc supported its Jurisdiction Motion with the evidence of Professor Deslauriers, Ms. Goudreau, and Mr. Labrosse. In the immediate case, Dr. Gebien cross-examined Pro Doc’s witnesses, but on the Jurisdiction Motion, he did not deliver evidence to contradict the evidence provided by Pro Doc.

[150] Before describing the evidence on the Jurisdiction Motion, as mentioned above and as discussed later in these Reasons for Decision, it shall become important to note and to keep in mind that in its motion to strike Dr. Gebien’s Fresh as Amended Statement of Claim as an abuse of process, The Jean Coutu Group (PJC) Inc. relies on the evidence proffered on the Jurisdiction Motion.

[151] Turning to the evidence, notwithstanding Dr. Gebien’s arguments about the quality and the admissibility of the evidence, the evidence on the Jurisdiction Motion from Ms. Goudreau and Mr. Labrosse establishes the following jurisdictional facts.

[152] Pro Doc is a wholly owned subsidiary of The Jean Coutu Group (PJC) Inc., a company incorporated under the laws of Québec with its head office in Montréal, Québec. Jean Coutu Group is a franchisor for a network of retail stores that sell pharmaceutical products, and consumer goods. Jean Coutu Group’s franchisees comprise a major chain of pharmacies with stores in Québec, New Brunswick, and nine stores in Ontario. Jean Coutu Group is not a manufacturer of Opioids. It does not develop, test, manufacture, produce, assemble, or package Opioid products. Jean Coutu Group’s principal business is operating a franchise pharmacy business much like the large pharmacies in Ontario like Rexall or Shoppers Drug Stores.

[153] Pro Doc is a company incorporated under the laws of Québec with its head office in Laval, Québec. Pro Doc specializes in the distribution of pharmaceutical private label generic drugs that it purchases from manufacturers.

[154] Pro Doc does not manufacture drugs. At all material times, Pro Doc was a reseller of Opioid Products, even though within the meaning of the Food and Drug Regulations, it is identified as a "manufacturer".

[155] The uncontroverted evidence is that Pro Doc is a small Québec-only based business. It sells private label generic drugs, which are manufactured by other third party manufacturers. Pro Doc is the distributor of products sold at the stores of the pharmacist franchisees of Jean Coutu Group.

[156] As part of its role as a supplier to a franchisor for its franchisees, Pro Doc purchases Opioids from Laboratoire Riva Inc. Pro Doc also purchases Opioids from Apotex Canada Inc., Pharmascience Inc., and Sandoz Canada Inc., three of the Manufacturer Defendants in this proposed class action. Pro Doc does not itself develop, test, manufacture, produce, assemble, or package Opioid products.

[157] The evidence establishes that Pro Doc does not carry on business in Ontario. It does not sell its products in Ontario. Pro Doc’s private label generic drugs are not authorized for sale in Ontario. It has no offices, no factory, nor any other business premises in Ontario. It does not have, nor is it required to have, a registered office or address in Ontario. It does not store in or ship goods to Ontario. It does not have any inventory or any other assets located in Ontario. It does not generate any revenue from activities in Ontario. It does not employ any employees, agents, or other representatives in Ontario nor is any management function exercised in Ontario.

[158] Pro Doc purchases drugs from generic manufacturers, and then it resells 98.7% to Jean Coutu Group for it to supply its franchisee pharmacies, which are owned by independent pharmacists. Although there are a few Jean Coutu Group pharmacies in Ontario, Pro Doc did not supply the Ontario pharmacies of the Jean Coutu Group. The balance of 1.3% of Pro Doc’s sales are to wholesalers in Québec.

[159] Pro Doc distributed only six generic opioid analgesics between 2009 and 2019, namely: Fentanyl Patch, Oxycodone, Oxycodone-Acet, Procet-30, Pronal C, and Tramadol-Acet. The distribution of these drugs was only in Québec. Pro Doc received Health Canada approval before distributing the drugs in Québec.

[160] Pro Doc has a relationship with the Province of Québec with respect to prescription drugs, which are known as "formulary" drugs. The prices of formulary drugs are regulated and set by the Province of Québec. Of the Pro Doc Opioid Products, Fentanyl Patch, Oxycodone and Procet 30 were formulary drugs.

[161] Pro Doc did not sell Opioid products outside of Québec. Pro Doc did not sell any Opioids to the Province of Ontario, nor did it have any contractual arrangements with the Province of Ontario. Pro Doc products are not listed on the Ontario Formulary. Pro Doc always limited itself to distributing its opioids in the province of Québec. Pro Doc ’s relationship with Jean Coutu Group stopped at the border, and the franchisees in Ontario sold non-Pro Doc Opioids.

[162] To be clear, although there are some Jean Coutu Group locations in Ontario, Jean Coutu Group did not distribute Pro Doc products to the Ontario pharmacies. This is because, before 2020, private label generic drugs could not be dispensed under Ontario regulations.

[163] As a result of the Ontario Regulations, Pro Doc always limited itself to distributing its Opioids to wholesalers in the province of Québec so as to not be in breach of Ontario laws.

[164] In 2019, Pro Doc discontinued supplying any Opioid products.

[165] Pro Doc is only affiliated with Jean Coutu Group. It is not affiliated with any of the other Defendants in this action. Pro Doc does not have any agency agreements or agency arrangements with any of the other Defendants. As noted above, it is supplied Opioids by three of the Manufacturer Defendants in this action.

[166] As required by regulatory law, Pro Doc tracked all of its shipments and ensured that the delivery arrived at its destination and that the quantities shipped were received. Pro Doc used couriers to transport packages of designated substances. These packages were shipped with a chain of signatures allowing careful and diligent recording of any handling of the parcel as well as the signature of any person having carried out this handling during transport, until its delivery to the recipient and confirmation of receipt by the pharmacies. All Opioid Products were shipped to wholesalers in Québec.

[167] There is a single instance where one product worth $12 was accidentally sent to New Brunswick. No Opioid Products were shipped to Ontario.

[168] Pro Doc has never engaged in any marketing activities directly or indirectly in relation to the Opioid Products in Ontario, or – elsewhere. Advertising of Pro Doc’s products to the general public is prohibited by Canadian Regulations and at all times Pro Doc complied with the law. And, its evidence was that it has never taken steps to promote or advance the “New Narrative” as alleged in Dr. Gebien’s Fresh as Amended Statement of Claim.

[169] There are Pro Doc Health Canada-approved monographs for its private label Opioid products. Pro Doc issued newsletters at the launch of each of the Opioid Products. The newsletters stated the name of the new product available. The newsletters were distributed only in Québec and only to those Jean Coutu Group pharmacies that were selling Pro Doc’s products. The newsletters merely listed what products were available. The newsletters are in French.

[170] Information about Pro Doc’s products was also available on Pro Doc’s website; the information was limited to: DIN, Format, UPC, pictures, product description, active ingredient name, non-medicinal ingredients list, and Québec formulary status. Most of the information was available on the section of the website that was accessible only to health care professionals. There are no marketing representations.

[171] The business records of Pro Doc are located in Québec and most of the business records are in French only.

[172] Pro Doc’s representatives and witnesses are domiciled in Québec. They are predominantly francophone.

[173] Pro Doc anticipates that its witnesses will include pharmacists who have counseled users and physicians who have prescribed Opioids to users. These witnesses are domiciled in Québec and are predominantly francophone.

[174] Pro Doc is named as a Defendant in an application for authorization to institute a class action filed in the Superior Court of Québec, District of Montreal No. 500-06-001004-197, Bourassa v. Abbott Laboratories, Limited et al. The judgment on that class action authorization is currently under reserve.

[175] Pro Doc, along with Jean Coutu Group are named defendants in British Columbia v. Apotex Inc., et al., where they unsuccessfully brought a Jurisdiction Motion about jurisdiction simpliciter, i.e., about where there is assumption-based jurisdiction in British Columbia. The jurisdiction decision is under appeal and the matter of forum conveniens remains to be argued in British Columbia.

I. Pro Doc’s Jurisdiction Motion: Legal Background

[176] In this next section of these Reasons for Decision, I discuss the legal background to Pro Doc’s Jurisdiction Motion.

1. Jurisdiction Simpliciter

[177] Pro Doc’s Jurisdiction motion is brought pursuant to rule 23.01 (3) of the Rules of Civil Procedure, which states:

To Defendant

21.01 (3) A defendant may move before a judge to have an action stayed or dismissed on the ground that,

Jurisdiction

(a) The court has no jurisdiction over the subject matter of the action,

and the judge may make an order or grant judgment accordingly.

[178] Jurisdiction simpliciter addresses the procedural question whether an Ontario court can properly assume jurisdiction over a matter, given the interrelationships among the matter, the parties, and Ontario.

[179] Jurisdiction simpliciter, or subject-matter jurisdiction, exists if the court has authority over the party and the subject matter and the power to make the order sought.[^33] There are three ways in which the Ontario court may assert jurisdiction against an out-of-province defendant: (1) consent-based jurisdiction; (2) presence-based jurisdiction; and (3) assumed jurisdiction.[^34] Pro Doc’s motion is about assumed jurisdiction.

[180] Assumed jurisdiction arises when the court takes jurisdiction because the litigation with a foreign element has a “real and substantial connection” to Ontario. Before a court can assume jurisdiction over a claim, a “real and substantial connection” must be shown between the circumstances giving rise to the claim and the jurisdiction where the claim is brought.[^35]

[181] The test for whether an Ontario court has jurisdiction simpliciter based on assumed jurisdiction is whether there is a real and substantial connection between the matter, the parties, and Ontario.[^36] The real and substantial connection test for assumed jurisdiction was designed to ensure that claims are not prosecuted in a jurisdiction that has little or no connection with either the transactions or the parties, and the test requires that a judgment rendered by a court which has properly assumed jurisdiction in a given case be recognized and enforced.[^37]

[182] In Club Resorts Ltd. v. Van Breda,[^38] the Supreme Court of Canada developed an analytical framework to determine when a court has jurisdiction simpliciter by assumed jurisdiction. The analytical framework begins by identifying circumstances where a court may presumptively assume jurisdiction on the basis of a real and substantial connection with the litigation. The underlying idea to all presumptive factors is that there are some circumstances where there would be a relationship between the subject matter of the litigation and the forum where it would be reasonable to expect that the defendant attend to answer the claim made against him or her in that forum.

[183] The list of presumptive connecting factors is not closed; however, the court should not adopt an ad hoc approach to assuming jurisdiction based upon the circumstances of a particular case. The court may, however, identify new factors that will establish a new presumptive connection, which can be used in other cases presumptively to assume jurisdiction.

[184] In identifying new presumptive factors, a court should look to connections that give rise to a relationship with the forum that is similar in nature to the ones which result from the established factors. Relevant considerations include: (a) similarity of the connecting factor with the recognized presumptive connecting factors; (b) treatment of the connecting factor in the case law; (c) treatment of the connecting factor in statute law; and (d) treatment of the connecting factor in the private international law of other legal systems with a shared commitment to order, fairness and comity.[^39] A new presumptive factor must have a genuine factual connection to the domestic court; the fact that a foreign party qualifies as a third party in an existing action in the domestic forum is not by itself a reliable indicator that there is a real and substantial connection to establish a presumptive factor or to support the assertion of jurisdiction over the foreign party.[^40]

[185] If a presumptive connection (established or newly established) applies, the connection can be rebutted by the defendant through evidence that the connection is weak.[^41] The ability to rebut the presumption of jurisdiction serves as an important check on a court overreaching and assuming jurisdiction. The burden of rebutting the presumption of jurisdiction rests on the defendant. In order to rebut the presumption, the defendant must demonstrate that the relationship between the forum and the subject matter of the litigation is such that it would not be reasonable to expect that the defendant would be called to answer proceedings in that forum.[^42]

[186] In Club Resorts Ltd. v. Van B