[1]               The Plaintiffs, Albert C. Batten, the Estate of Margaret Jane Hamilton, and Wendy Nelson, in her personal capacity and as estate representative of the late Mrs. Hamilton, bring a proposed class action under the Class Proceedings Act, 1992, S.O. 1992, c. 6 against: (a) Boehringer Ingelheim (Canada) Ltd. (“Boehringer-Canada”); (b) Boehringer Ingelheim Pharmaceuticals, Inc.; (c) Boehringer Ingelheim Pharma GmbH & Co. KG; and (d) Boehringer Ingelheim International GmbH. I shall refer to the Defendants collectively as “Boehringer”.

[2]               Boehringer-Canada is a pharmaceutical company that manufactures and distributes in Canada, dabigatran, a drug marketed as Pradaxa® (formerly Pradax®). Pradaxa® is an anticoagulant. Its Product Monograph specifies that Pradaxa® is indicated for: hip and knee surgery; venous thromboembolism events (deep vein thrombosis or “DVT”); pulmonary embolism (“PE”); and atrial fibrillation (“AF”), which is a serious heart condition that causes strokes and heart attacks. The use of anticoagulants for the treatment of AF to prevent strokes and heart attacks is long established, and Pradaxa® has become the predominant choice of an anticoagulant for AF treatment.

[3]               Up until April 2016, when Praxbind® (the drug idarucizumab) was approved for sale in Canada, Pradaxa® was sold without an antidote. Mr. Batten, the Hamilton Estate, and Ms. Nelson allege that using Pradaxa® carried the risk of excessive bleeding and that Boehringer breached a duty to warn that there was no antidote for the drug.

[4]               Mr. Batten, the Hamilton Estate, and Ms. Nelson bring a motion for certification of their duty to warn claim. In their Statement of Claim, under the headings of failure to warn and negligence, they plead most every kind of products liability claim and they join claims of breach of express warranty, breach of implied warranty, breach of statutes, waiver of tort, and unjust enrichment. This plethora of causes of action, however, is not being pursued for the purposes of the certification of the action. The Plaintiffs pursue only their duty to warn claim, a type of claim that has often satisfied the criteria for certification as a class action. See among others: Wilson v. Servier Canada Inc. (2000), 2000 CanLII 22407 (ON SC), 50 O.R. (3d) 219 (S.C.J.), leave to appeal ref'd (2000), 2000 CanLII 29052 (ON SC), 52 O.R. (3d) 20 (Div. Ct.), leave to appeal to S.C.C. ref'd [2001] S.C.C.A. No. 88; Heward v. Eli Lilly & Co., [2007] O.J.  No. 404 (S.C.J.), leave to appeal to Div. Ct. granted 2007 CanLII 26607 (ON SC), [2007] O.J. No. 2709 (S.C.J.), appeal dismissed 2008 CanLII 32303 (ON SCDC), [2008] O.J. No. 2610 (Div. Ct.); Goodridge v. Pfizer Canada Inc., 2010 ONSC 1095; Parker v. Pfizer, 2012 ONSC 361, leave to appeal refused 2012 ONSC 6604 (Div. Ct.).

[5]               Notwithstanding that pharmaceutical class actions have come to be often certified, Boehringer, nevertheless, resists the certification motion, and it brings a cross-motion to have the action dismissed for the failure of the Statement of Claim to plead a cause of action. However, because of the very narrow or circumscribed way that the Plaintiffs now wish to advance their proposed class action, it is not necessary to address the cross-motion, and I shall, therefore, adjourn the cross-motion and address just the certification motion.

[6]               As will become most apparent during the discussion and analysis portion of these Reasons for Decision, it was wise for Mr. Batten, the Hamilton Estate, and Ms. Nelson to focus on just the duty to warn cause of action since the very broad scope of the original action would have confronted enormous difficulties. The difficulties were: (a) very serious pleading deficiencies, some of which were likely insolvable; (b) the speculative joinder of: Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. KG, and Boehringer Ingelheim International GmbH, discussed below, seemingly for the purposes of fishing for claims against them and to secure discovery rights; (c) showing that there was some basis in fact for the proposed common issues; and (d) showing that there was some-basis-in-fact for a class action being the preferable procedure for Class Members to pursue their claims rather than proceed by individual actions.     

[7]               Unfortunately, for Mr. Batten, the Hamilton Estate, and Ms. Nelson, there are similar fundamental problems to their duty to warn class action that persist into their much more focused proposed class action.  As the discussion below with reveal, making their duty to warn claim fit within the criteria for certification has proved difficult for the Plaintiffs. The fundamental problem is that as their duty to warn claim narrowed to the failure to adequately warn about the absence of an antidote, Mr. Batten, the Hamilton Estate, and Ms. Nelson were unable to connect the dots between the duty to warn and the consequent harm suffered in a way that would satisfy the criteria for certification as a class action. Having focused on the absence of an antidote as the subject-matter of the warning, unlike the Plaintiffs in other duty to warn cases involving pharmaceuticals that have been certified, Mr. Batten, the Hamilton Estate, and Ms. Nelson have been unable to posit a common failure to warn issue that would justify a class proceeding.  

[8]               I, therefore, dismiss the certification motion. The parties have agreed that there shall be no costs of the motion.    

[9]               Mr. Batten, the Hamilton Estate, and Ms. Nelson supported their motion for certification with affidavits from: (a)  Mr. Batten, sworn September 6, 2014. Mr. Batten was cross-examined; (b) Mr. Stanley North, sworn January 24, 2014 and June 23, 2016. Mr. North was cross-examined; (c) Dr. Leeor Zeev Sommer, sworn November 13, 2013. Dr. Sommer was cross-examined; (d) Ms. Lisa Staffieri, sworn July 5, 2016. Ms. Staffieri was not cross-examined; and (e) Mr. Peter E. Tuovi, sworn October 17, 2014. Mr. Tuovi was not cross-examined.

[10]           Mr. North is a graduate of the University of Waterloo (B.Sc., 1990) and McGill University (M.Sc., Molecular Biology, 1993). He was a regulatory affairs assistant and associate at Agriculture Canada, then worked at Nordic Merrel Dow Research and Berlex Canada from 1988 to 2007. He is the principal and owner of Stan North Consultation, which he founded in 2007. Mr. North provides advice and services to clients in the pharmaceutical, biotech, medical device, and natural health product industries with respect to regulatory matters. He is a member and a former director (2007-2009) of the Canadian Association of Professional Regulatory Affairs.

[11]           Dr. Sommer is a graduate of the University of Toronto (B.Sc., 1996, MD, 2000). Since 2005, he has an appointment as a lecturer at the University of Toronto, Department of Family and Community Medicine. Dr. Sommer has a specialty in emergency medicine, and since 2003, he has been on staff in the emergency departments at Peel Memorial Hospital (2003-2006), St Joseph’s Health Centre, Toronto (2003-to date) and North York General Hospital (2003-to present). He is a member of the Canadian College of Family Physicians, Canadian Association of Emergency Physicians, Ontario Medical Association, Canadian Medical Association, College of Physicians and Surgeons of Ontario, Canadian Medical Protective Association, and Canadian Emergency Ultrasound Society. 

[12]           Ms. Staffieri is a legal assistant with McPhadden Samac Tuovi, lawyers for the Plaintiffs.

[13]           Mr. Tuovi is a lawyer with McPhadden Samac Tuovi, lawyers for the Plaintiffs.

[14]           Boehringer opposed the motion for certification with affidavits from: (a) Ms. Nancy Chaves, sworn April 28, 2016. Ms. Chaves was not cross-examined; (b) Dr. Anil Chopra, sworn March 30, 2016. Dr. Chopra was cross-examined; (c) Ms. Anne Tomalin, sworn April 25, 2016. Ms. Tomalin was cross-examined; and (d) Dr. Zaev Wulffhart, sworn April 5, 2016 and April 8, 2016. Dr. Wulffhart was cross-examined.

[15]           Ms. Chaves is a law clerk at McMillan LLP, lawyers for Boehringer.

[16]           Dr. Chopra is a graduate of the University of Toronto (B.Sc. 1985, MD, 1989). He completed a Fellowship in Emergency Medicine at the University of Toronto in 1994 and since that time has served as a physician in the Emergency Department of the University Health Network (“UHN”) (Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Care Centre, and the Toronto Rehab Centre). Since 2006, he has served as the Head and Medical Director of the UHN’s Emergency Department. He is a member of Thrombosis Canada, which is an international organization aiming to educate physicians in the prevention and treatment of thrombotic vascular disease. Dr. Chopra has prescribed Pradaxa®, and he has treated patients in the Emergency Department who were bleeding while on anticoagulants, including Pradaxa®. He chaired a committee charged with developing a protocol to govern the use of Praxbind® (Pradaxa®’s antidote) for the Emergency Department. In 2011, Dr. Chopra published a peer reviewed research paper on the subject of, “New Anticoagulants for Atrial Fibrillation: The Beginning of a New Era in Stroke Prevention”.

[17]           Ms. Tomalin is a graduate of York University (B.A., English, 1970; B.Sc., Chemistry, 1980). She received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for U.S. Regulatory Affairs (1997), European Regulatory Affairs (2001), and Canadian Regulatory Affairs (2005). She is the President and Founder of TPIreg, a consulting company that provides training services to pharmaceutical companies in regulatory affairs. She has worked in-house at pharmaceutical companies including Wyeth Ltd. and Hoffman-LaRoche Limited, as well as Searle Canada (a unit of Monsanto, Inc.). She teaches Regulatory Affairs at Humber College in Toronto. She served on the executive of the Pharmaceutical Sciences Group and the Canadian Association of Professional Regulatory Affairs, which are industry associations focusing on regulatory issues.

[18]           Dr. Wulffhart is a graduate of the University of Witwatersrand Medical School, Johannesburg, South Africa (Bachelor of Medicine and Bachelor of Surgery, 1984). He is a licentiate of the Medical Council of Canada (1987). He is a Fellow of the American College of Cardiology, a Fellow of the Royal College of Physicians – Cardiology, a Fellow of the Royal College of Physicians – Internal Medicine and a member of the Canadian Cardiovascular Society. Between 1993 and 1996, Dr. Wulffhart was a lecturer at the University of Toronto Faculty of Medicine, and he became an Assistant Professor in 1996 in the area of general cardiology, which appointment has continued since that time. He has participated in numerous medical research trials and published numerous abstracts and articles. Since 2001, Dr. Wulffhart has been a staff cardiologist at the Southlake Regional Health Centre, where he was Director of the Heart Rhythm Program from 2001-2013 and Head of the Cardiology Division from 2008 to 2013. Since 2013, he has served as the Physician Leader of Southlake’s Regional Cardiac Program, which is Ontario’s largest centre for the treatment of AF.   

[19]            Albert C. Batten is 81 years of age and was diagnosed with AF. In May 2012, his doctor prescribed Pradaxa® for treatment. For several years previously, Mr. Batten had been prescribed warfarin, another anticoagulant, without problems, but with the inconvenience of the constant monitoring that a warfarin prescription entails.

[20]           On July 7, 2012, while taking Pradaxa®, Mr. Batten experienced blood in the stool. At the time, he was also taking aspirin and indomethacin, a nonsteroidal anti-inflammatory drug, both of which are known to cause gastrointestinal bleeding. He attended at an emergency department and was released to go home. His medical problems continued, however, and he was hospitalized from July 16 to July 19, 2012. He stopped taking Pradaxa® and resumed taking warfarin. 

[21]           Wendy Nelson is the estate executor and daughter of the late Margaret Jane Hamilton. Mrs. Hamilton died at 87 years of age. She had been prescribed Pradaxa® for the treatment of AF. Mrs. Hamilton began using Pradaxa® on or about April 2012, and on May 16, 2013, while home alone, she suffered an intracranial cerebral hemorrhage (ICH) from which she died in the hospital a few hours later. 

[22]           There are four other proposed Representative Plaintiffs to represent Class Members in various provinces; namely: (1) Marilyn Tanguay, a British Columbia resident, as personal representative of the Estate of Gladys Chouinard; (2) Dimitre Stoianov Karpuzov, an Alberta resident; (3) Edward McAlpine, a Manitoba resident; and (4) Dawn Rae Downton, a Nova Scotia resident, as executor of the Estate of Marion Wiseman. For the purposes of the certification motion, it is not necessary to discuss their personal circumstances and without meaning any disrespect to them, I shall not refer to them again.

[23]           Mr. Batten, the Hamilton Estate, and Ms. Nelson sue: (a) Boehringer-Canada; (b) Boehringer Ingelheim Pharmaceuticals, Inc.; (c) Boehringer Ingelheim Pharma GmbH & Co. KG; and (d) Boehringer Ingelheim International GmbH.

[24]           Boehringer-Canada is a Canadian corporation with its registered office at Burlington, Ontario. It was the sponsor for Pradaxa® in Canada, which is to say that it is registered with Health Canada to seek a drug approval, and if approval is granted, to market the drug in Canada. It was granted an approval and it manufactured and distributed Pradaxa® in Canada.

[25]           Boehringer Ingelheim International GmbH is a German corporation with its registered office located at Ingelheim am Rhein, Germany. It owns the Canadian patent for the manufacture of Pradaxa®.

[26]           Boehringer Ingelheim Pharma GmbH & Co., KG is a German corporation with its registered office located in Ingelheim am Rhein, Germany. It owns the trademark Pradaxa® which it licensed to Boehringer-Canada and to Boehringer Ingelheim Pharmaceuticals, Inc.

[27]            Boehringer Ingelheim Pharmaceuticals, Inc. is a Connecticut corporation with its head office located at Ridgefield, Connecticut. In the United States, it was the sponsor of Pradaxa®  and obtained the approval of the United States Food and Drug Administration (“FDA”) to sell the drug in the United States. It operates a website www.pradaxa.com that provides health information, safety information, and a medication guide about Pradaxa®.

[28]           Boehringer-Canada does not operate a website providing information about Pradaxa®. As the internet and the website www.pradaxa.com are universally accessible, I conclude that Canadian Class Members would have received health and safety information from Boehringer Ingelheim Pharmaceuticals, Inc.’s website.

[29]           On March 7, 2013, Mr. Batten commenced his proposed class action against Boehringer-Canada, Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. KG and Boehringer Ingelheim International GmbH (collectively “Boehringer”), the Defendants in the case at bar. Mr. Batten also included claims against: Boehringer Ingelheim Vetmedica, Inc.; Boehringer Ingelheim Corporation; Boehringer Ingelheim USA Corporation; and; Bidachem S.P.A., but the claims against these Defendants were discontinued in 2015.

[30]           Pradaxa® class actions were also commenced in British Columbia, Alberta, Manitoba, Ontario, Québec, and Nova Scotia. In October 2015, an agreement was reached between the various Class Counsel in the parallel class actions. Boehringer was also a party to the agreement. It was agreed that Mr. Batten would seek certification of a national class action in Ontario. If certification was granted, then all the Pradaxa® alass actions, other than the one in Ontario, would be discontinued. If certification was refused in Ontario, the other class actions could be resumed within 100 days.

[31]           McPhadden Samac Tuovi LLP and Siskinds LLP are the proposed Class Counsel for the Ontario action. McMillan LLP is the lawyer of record for Boehringer.

[32]           There were parallel proceedings in the United States District Court, Southern District of Illinois, in a multi-district litigation known as MDL 2385. McPhadden Samac Tuovi LLP and Siskinds LLP have worked closely with the Plaintiff Steering Committee that prosecuted the actions in the United States.

[33]           In their Amended Statement of Claim, Mr. Batten, the Hamilton Estate, and Ms. Nelson plead that Boehringer breached its duty to warn consumers of dangers inherent in the use of Pradaxa® of which it had knowledge or ought to have had knowledge. They also plead a breach of the duty to manufacture Pradaxa® free of defects that are likely to give rise to injury in the ordinary course of its use and a breach of the duty to design Pradaxa® to avoid safety risks and to make the product reasonably safe for its intended purposes.

[34]           However, as noted above, for purposes of certification, Mr. Batten, the Hamilton Estate, and Ms. Nelson seek to certify only the common issues of whether Boehringer failed to adequately warn about the lack of an antidote for Pradaxa®. The Plaintiffs are no longer pursuing the claim of waiver of tort and are no longer proposing common issues regarding negligent design and negligent manufacture, and they are not advancing the plethora of other causes of action and breaches of statute that were pleaded.

[35]           To make the point that the focus of the Plaintiffs’ claim as a class action changed fundamentally in the run up to the certification motion, I note that the first formulation of their common issues was in their notice of motion dated October 2014. About a year later, in September 2015, they substantially reformulated the questions in an amended notice of motion. The common issues were again substantially reformulated in their factum, and further revisions were discussed during the argument of the certification motion.

[36]           For the purposes of this certification motion, the pertinent portions of the Amended Statement of Claim are set out in Schedule “A” to these Reasons for Decision.

[37]           As mentioned several times, for the purposes of certification, Mr. Batten, the Hamilton Estate, and Ms. Nelson focus on Boehringer’s duty to warn. To understand both the factual background that follows and also the legal analysis later in this decision, it is necessary to describe the law associated with a duty to warn.

[38]           As explained by Justice Huddart of the British Columbia Court of Appeal in Harrington v. Dow Corning Corp., 2000 BCCA 605, affg. 1996 CanLII 3118 (BC SC), [1996] B.C.J. No. 734 (S.C.), leave to appeal to S.C.C. ref'd. [2001] S.C.C.A. No. 21, at paras. 42 to 46, typically the four steps in a products liability class action are: (1) determining whether the product is defective or whether, although non-defective, the product has a propensity to injure; (2) determining what the manufacturer knew about the dangerousness of its product; (3) given the state of the art and the extent of the risks inherent in the product’s use, determining the reasonableness of the warning whether made directly to the consumer or to a learned intermediary; and (4) determining individual causation and damages. The first step, known as the general causation step, determines whether the product is capable of causing harm. The second step is part of determining whether the manufacturer had a duty of care not to sell the product or to sell it only with an appropriate warning. The third step focuses on the adequacy of the warning. The fourth step will determine individual causation and the quantification of the compensation for the consequent harm.

[39]           In Hollis v. Dow Corning Corp.,  1995 CanLII 55 (SCC), [1995] 4 S.C.R. 634 at para. 21, Justice La Forest explained the rationale for a manufacturer's duty to warn. He stated:

[40]           A manufacturer of a product has a duty to warn consumers of dangers inherent in the use of the product of which the manufacturer has knowledge or ought to have knowledge: Hollis v. Dow Corning Corp., supra, at para. 20; Lambert v. Lastoplex Chemicals Co., 1971 CanLII 27 (SCC), [1972] S.C.R. 569 at p. 574; Bow Valley Husky (Bermuda) Ltd. v. Saint John Shipbuilding Ltd., 1997 CanLII 307 (SCC), [1997] 3 S.C.R. 1210. The warnings must be reasonably communicated and detailed to give the consumer a full indication of each of the specific dangers that arise from the ordinary use of the product: Hollis v. Dow Corning Corp., supra, at paras. 20-21; Lambert v. Lastoplex Chemicals Co., supra, at pp. 574-75.

[41]           If a product, although suitable for the purpose for which it is manufactured, is at the same time dangerous to use, the manufacturer of the product has a duty of to warn of the attendant dangers in using the product. In Lambert v. Lastoplex Chemicals Co., supra, Justice Laskin stated:

[42]           The manufacturer's duty to alert consumers about dangers associated with the use of a product is a continuing duty, requiring manufacturers to warn not only of dangers known at the time of sale, but also of dangers discovered after the product has been sold and delivered: Hollis v. Dow Corning Corp., supra, at para. 20; Rivtow Marine Ltd. v. Washington Iron Works, 1973 CanLII 6 (SCC), [1974] S.C.R. 1189 at p. 1200. In the case of medical products, given their substantial risk of harm from improper use, the standard of care is correspondingly high and there will almost always be a heavy onus on the manufacturer to provide clear, complete and current information concerning the dangers inherent in the ordinary use of its product: Hollis v. Dow Corning Corp., supra, at para. 23.

[43]           There is a high standard of care. In Buchan v. Ortho Pharmaceutical (Can.) Ltd. (1986), 1986 CanLII 114 (ON CA), 54 O.R. (2d) 92 (C.A.), Justice Robins stated at para. 18:

[44]           In cases involving highly technical products intended to be used under the supervision of experts or where the nature of the product is such that the consumer will not realistically receive information directly from the manufacturer without the intervention of a learned intermediary, the duty of the manufacturer is discharged if the manufacturer provides the learned intermediary (for example, physicians or surgeons), rather than the consumers, with an adequate warning of the potential dangers associated with the use of its product: Hollis v. Dow Corning Corp., supra, at paras. 28-29; Buchan v. Ortho Pharmaceutical (Canada) Ltd., supra, at paras. 23, 59.

[45]           In the context of manufacturers of pharmaceuticals and medical devices the learned intermediary is the physician that prescribes the drug or medical device. The legal theory here is that where a consumer places primary reliance on the judgment of a learned intermediary, then the manufacturer will satisfy its duty to warn the consumer by adequately warning the learned intermediary of the risks inherent in the use of the product. In Hollis v. Dow Corning Corp., supra, Justice La Forest stated at para. 27:

[46]           The rationalization for the learned intermediary rule for pharmaceutical products is summarized by Patricia Peppin in "Drug/Vaccine Risks: Patient Decision-Making and Harm Reduction in the Pharmaceutical Company Duty to Warn Action", (1991) 70 Can. Bar Rev. at p. 484:

[47]           The ability of the blood to coagulate; i.e., to clot and seal off a wound and to stop the bleeding is critically important for health, but clotting can also be dangerous as blood clots can block blood vessels and deprive body organs from the oxygen contained in the blood, which, in turn, leads to heart attacks and strokes.

[48]           Coagulation is a complex process, and two of the substances that play an important role are vitamin K and thrombin. Anticoagulants are substances that interfere with the coagulation process, and the anticoagulant drug warfarin inhibits the ability of the body to use vitamin K. In comparison, the anticoagulant drug dabigatran inhibits the ability of the body to use the protein thrombin, which is the main active principle in plasma.

[49]           In June 2008, Health Canada approved Pradaxa® (dabigatran) for use in Canada. 

[50]           Pradaxa® is a prescription drug found on the Prescription Drug List. It was the first of a class of drugs known as Novel Oral Anticoagulants (“NOACs”). It was introduced for anticoagulation therapy as an alternative to warfarin, which had been prescribed since 1954. Warfarin is a vitamin K antagonist and produces an anticoagulant effect for up to 48 hours by reducing vitamin K. After the approval of Pradaxa®, Health Canada approved two competing NOACs, Xarelto and Eliquis.

[51]           Pradaxa® is indicated for, among other things, the prevention of stroke and systemic embolism in patients with AF. AF is the most common arrhythmia (heart rhythm disturbance). It affects approximately 350,000 Canadians.  Approximately 6% to 10% of the population over the age of 65 have AF, and 25% of people over the age of 75 will develop AF. AF is at epidemic levels, it is increasing, and it is estimated that by 2050, the number of patients with AF will likely double. The most serious consequence of AF is its propensity for causing strokes.

[52]           People with AF are at risk of having the flow of blood slow or stagnate in areas of the heart. Blood clots can then form, and the clots account for the increased risk of stroke associated with AF. The risk of stroke increases significantly with advancing age, from 1.5% per year for people in their 50s to 24% per year for people in their 80s.

[53]           Strokes that arise from AF are often fatal (20%), and when not fatal they can cause temporary or permanent disabilities (60%). The strokes attributable to AF have a higher mortality and morbidity rate as compared to strokes from other causes.

[54]           The treatment of patients with AF has two goals. One goal is to treat the rhythm disorder and the second goal is to prevent strokes, and it is for this second goal that anticoagulants play a prominent role. Anticoagulants reduce the risk of clot formation, and thereby reduce the risk of stroke.

[55]           Historically, and before the development of the NOACs, the treatment for AF has involved the administration of warfarin (also known by the brand name Coumadin among others) or aspirin (also known as acetylsalicylic acid), both of which have limitations and risks.

[56]           Warfarin patients require frequent access to medical services for close medical monitoring, routine coagulation tests, and frequent dose adjustments. Since warfarin acts as a vitamin K antagonist, patients must abide by dietary restrictions, including the need to avoid green leafy vegetables that contain vitamin K, which reduces warfarin’s effectiveness in stroke prevention. These requirements made warfarin extremely inconvenient for patients to use and physicians to prescribe.

[57]           A patient taking warfarin must maintain an International Normalized Ratio (“INR”) between 2 and 3, which is difficult for the patient to do. The INR is a measurement of how long it takes blood to form a clot. An INR below 2 is associated with an increased risk of stroke – obviously a dangerous risk - and an INR above 3 is associated with an increased risk of bleeding - also obviously a dangerous risk. A patient’s INR fluctuates due to dietary changes, interactions with other medications, alcohol consumption, or as a result of genetic variability in the patient’s ability to metabolize warfarin.

[58]           The pharmacokinetic effect of warfarin is idiosyncratic and poorly predictable, which is to say determining the optimum dosage for a particular patient is difficult. Because of the significance of genetic makeup, determining the appropriate dosage of warfarin is patient specific. For example, some patients will require a daily dose of 12-15 mg of warfarin to achieve an INR between 2 and 3, while others will require a daily dose of only 1 mg of warfarin to achieve the same INR. And some patients metabolize warfarin so quickly that it is not effective at all.

[59]           It is estimated that patients who are treated with warfarin are within the therapeutic range for stroke prevention only 50% of the time; the other 50% of the time, they are either at an increased risk of stroke or an increased risk of bleeding.

[60]           Historically, some AF patients with a lower risk of stroke were not prescribed warfarin because of an increased risk of intracranial hemorrhage (“ICH”), bleeding in the brain, a devastating form of bleeding that was associated with warfarin use. Because these patients were not receiving warfarin due to the risks of ICH, they did not have access to effective protection from stroke.

[61]           Aspirin’s efficacy in stroke prevention is substantially less than that of warfarin and the risk of bleeding when on aspirin is significant. Aspirin is in the top three categories of drugs that result in emergency department visits due to its adverse consequences.

[62]           In contrast to warfarin and aspirin, Pradaxa®: has a wider therapeutic range; has a fixed dosing regimen; has minimal drug interactions; has no food interactions, and has a predictable anticoagulant response with a rapid onset and a faster decline of effectiveness. Patients taking Pradaxa® can consume green leafy vegetables and other vitamin K rich foods, without increasing their risk of stroke. There is no need or utility to measuring the INR of patients taking Pradaxa®.

[63]           It is alleged that Boehringer promoted Pradaxa® as being more effective than warfarin in preventing stroke and systemic embolism and providing a convenient alternative to warfarin therapy because Pradaxa® did not require blood monitoring or dose adjustments and it did not require dietary restrictions.

[64]           A major benefit of using Pradaxa® over warfarin is the reduced rate of ICH. There is at least 50% lower frequency of ICH with Pradaxa® use than with warfarin use. The introduction of Pradaxa® and the other NOACs resulted in a larger percentage of AF patients receiving anticoagulant therapy for stroke prevention because Pradaxa® and other NOACs have a significantly lower risk of ICH as compared to warfarin. With the development of Pradaxa® and the other NOACs, a higher proportion of AF patients are being prescribed anticoagulation therapy, resulting in fewer strokes and reducing the mortality and morbidity associated with AF.

[65]           Testing a lower and a higher dose of Pradaxa®, an extensive clinical trial known as the RE-LY TRIAL, studied Pradaxa® in 18,133 patients. The study found there were significant clinical advantages to Pradaxa® over warfarin: namely: (a) the risk of first stroke or systemic embolism (blood clot to another part of the body other than the brain) for patients taking Pradaxa®  was reduced by 35% when compared to warfarin; (b) the lower dose of Pradaxa® had a similar efficacy to warfarin, but with a lower risk of bleeding; (c) both tested doses of Pradaxa® had a significant reduction in ICH and life-threatening bleeding as compared to warfarin; (d) the lower dose of Pradaxa® had a lower risk of bleeding (including GI bleeding) than warfarin; and (e) both doses of Pradaxa® had a similar all-cause mortality to warfarin.

[66]           Based on the findings of the RE-LY Trial, Pradaxa® was accepted, approved and introduced rapidly into clinical practice for the treatment of stroke prevention in AF.  Pradaxa® was introduced into the Canadian Cardiovascular Society (“CCS”) Guidelines in 2010 as a first choice over warfarin for stroke prevention. The 2014 CCS Guidelines recommend that when oral anticoagulant therapy is indicated for patients with non-valvular AF, most patients should receive a NOAC in preference to warfarin.  In 2014, the CCS Guidelines introduced a decision tree algorithm for physicians to assess the individual patient’s risk of stroke and, therefore, the therapeutic benefit of anticoagulation.

[67]           In determining whether a particular patient will benefit from anticoagulant therapy, a clinician must first assess the patient’s risk of stroke and the risks of bleeding; the greater the risk of stroke, the more benefit the patient will receive from anticoagulation. A physician will also consider the presence of a variety of conditions, such as very poor renal function (measured by creatinine clearance), patients with prosthetic mechanical heart valves, and those patients with rheumatic valvular heart disease. Patients with these particular characteristics would have to use warfarin because NOACs are contraindicated.

[68]           Physicians must engage in a complex decision making process in deciding whether to recommend a NOAC or warfarin. When considering anticoagulant therapy for AF patients, physicians use a scoring system to assess an individual patient’s risk of stroke and, therefore, the therapeutic benefit of anticoagulation. Clinically relevant scoring systems include the Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitis and Prior Stroke or Transient Ischemic Attack index (“CHADS2”) and the Congestive Heart Failure, Hypertension, Diabetes Mellitis, Stroke, Vascular Disease, Age 65 to 74 years, Sex Category index (“CHADSVASC”).

[69]           If a determination is made that a particular patient will benefit from anticoagulant therapy, the physician must then balance this benefit against the risk of hemorrhage, which is associated with all anticoagulants. The risk of major hemorrhage depends upon individual patient characteristics. Physicians use a scoring system to predict a patient’s individual bleeding risk.  The CCS Guidelines recommend that physicians use the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly (age >65), Drugs/Alcohol Concomitantly score schema (“HAS-BLED”). A high HAS-BLED score indicates to the physician that a particular patient may be at an increased risk for bleeding. A physician will use this information to either use the lower dose of Pradaxa® or consider using warfarin, aspirin, or nothing.

[70]           Bleeding may result in death, and all anticoagulants, including warfarin, Pradaxa® and the other NOACs, are associated with an increased risk of bleeding. It should, however, be kept in mind – indeed it needs to be emphasized - that anticoagulants do not cause bleeding, which rather is caused by a variety of disease states, can take many forms, and can occur in any location in the human body.

[71]           The point is subtle - but the point is important for this certification motion – although warfarin, Pradaxa® and the other NOACs do not “cause” bleeding, they all “propagate” bleeding, which is to say that the all are associated with the bringing about of the risks of prolonged or persistent bleeding. As their description or nomenclature suggests, all anticoagulants work to prevent blood coagulation, which explains how they propagate bleeding without causing bleeding. In a sense, although warfarin, Pradaxa® and the other NOACs do not cause bleeding in the first instance, they do cause bleeding in the sense of causing bleeding to continue or to be prolonged. To foreshadow the discussion later in the analysis, the subtle point about propagating but not causing bleeding is important because it makes it extremely difficult for the Plaintiffs to articulate common issues to satisfy the tests for certifying a class action.

[72]           The evidence about coagulants and their benefits and risks, which were highly dependent on the idiosyncrasies of the patients, compound the Plaintiffs’ difficulties in articulating a satisfactory common issue. The evidence about antidotes and the need for them further compounded the Plaintiffs’ difficulties in articulating a satisfactory common issue. To understand the role of antidotes, it is important to note that Pradaxa® has a biological half-life of approximately 12-14 hours; i.e., after 12-14 hours it loses its efficacy. Thus, a patient who last consumed Pradaxa® 12 to 24 hours before presenting at an emergency department would experience little remaining anticoagulation effect. In contrast, warfarin, unlike Pradaxa®, which wears off relatively quickly, has a much longer anticoagulant effect, lasting up to 48 hours. For warfarin, it could take 16 hours to produce a reduction in INR with a therapeutic level being reached by the second day.

[73]           The outcome of any bleeding for any patient on warfarin, Pradaxa®, or any other anticoagulant will be dependent on individualized factors such as the patient’s underlying diagnosis, the state of the patient’s health, size of the bleed, location of the bleed, timing of last anticoagulant dose, time to presentation, patient co-morbidity, and co-medications. The measures applied for the management of bleeding will differ depending upon each patient’s particular circumstances. In the majority of cases, no reversal agent for an anticoagulant will be necessary.

[74]           In the great majority of cases, there is no material difference in the management of bleeding as between Pradaxa® patients and warfarin patients. Most patients who present with bleeding while taking any anticoagulant have mild to moderate transient bleeding, such as a nosebleed and skin bruising. These types of bleeding can typically be managed with conservative measures such as local compression. A minority of patients taking an oral anticoagulant will have a major bleeding episode. Major bleeding may require resuscitation with intravenous fluids and blood products, and may require interventional procedures such as surgery, cauterization, or an endoscopic procedure. The blood products that may be transfused to treat bleeding include Prothrombin Complex Concentrate (“PCC”), a concoction of blood clotting factors and proteins made from human blood plasma or Fresh-Frozen Plasma (“FFP”).

[75]           However, because anticoagulants propagate bleeding, there may be circumstances in which reversing their anticoagulant effect is called for. In the case of warfarin, as already noted, its anticoagulant effect can be long-lasting. It is, therefore, appropriate in some circumstances to reverse the anticoagulant effect of warfarin by administering both vitamin K and a PCC or FFP. The administration of vitamin K reverses that anticoagulant effect of warfarin, which is a vitamin K antagonist.

[76]           However, the evidence suggested that it takes longer to reverse the longer-lasting anticoagulant effect of warfarin by the administration of vitamin K than it takes Pradaxa® to lose its anticoagulant effect because of its shorter biological half-life. If the patient has taken Pradaxa® in the previous one to two hours, activated charcoal might be given to the patient to absorb any free remaining drug in the stomach or intestines, but the vast majority of patients could safely wait till the anticoagulant effect of Pradaxa® has worn off.

[77]           Studies show that in patients who have major bleeding while taking either warfarin or Pradaxa®, all-cause mortality is lower with Pradaxa® than with warfarin. The mortality rate from major bleeding is higher for warfarin patients than for Pradaxa® patients. Even without an antidote or reversal agent for Pradaxa®, fewer patients are expected to die from a Pradaxa®-associated major bleed than a warfarin-associated major bleed.   

[78]           In any event, regardless of the anticoagulant, reversal is not the immediate or automatic response to a patient presenting with bleeding. That is because reversal of the anticoagulant carries very serious risks, including an increased risk of stroke. The Pradaxa® Product Monograph states that all temporary discontinuations should be avoided, unless medically indicated. Thus, the decision to apply a reversal agent of an anticoagulant will depend on the site of the bleeding, the nature of the bleeding, the underlying disease state, and the adequacy of the conventional means to arrest bleeding and the dangers of discontinuing the administration of an anticoagulant.

[79]           Pradaxa® did not have an approved specific reversal agent until May of 2016, when Praxbind® was approved. The other NOACs do not have an approved reversal agent.

[80]           Following the approval of Praxbind®, administration of a reversal agent for Pradaxa® became an option for physicians treating a bleeding Pradaxa® patient. It, however, was never envisioned that Praxbind® would be used in every case of bleeding, and the use of Praxbind® will not be appropriate for the great majority of patients who experience bleeding while on Pradaxa®. Praxbind® may be appropriate for patients in rare cases where very rapid reversal of the anticoagulation effect of Pradaxa® is necessary. Whether the use of Praxbind® is appropriate in any particular case is a matter of the treating physician’s professional judgment and the circumstances of the particular patient.   

[81]           Health Canada is responsible for approving drugs for sale in Canada. A drug is licensed for sale by Health Canada issuing a Notice of Compliance (“NOC”) after an elaborate submission and review process.

[82]           Pursuant to the Food and Drugs Act, R.S.C. 1985, F.27, and its regulations, 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.

[83]           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.

[84]           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. Health Canada's publication, "Guidance for Industry: Product Monograph" describes the role of the Product Monograph as follows:

[85]           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.

[86]           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.

[87]           If satisfied that the drug and its Product Monograph satisfies 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.

[88]           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.

[89]           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).  

[90]           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.

[91]           Health Canada first approved Pradaxa® for sale in June of 2008. The same year, Pradaxa® was approved by European regulators for sale in Europe. It was approved for sale in the United States in 2010. There is no evidence that Pradaxa® is ineffective for any of its approved uses, and Health Canada’s marketing approval of Pradaxa® has never been suspended or withdrawn.

[92]           Boehringer-Canada submitted an NDS for Pradaxa® with Health Canada on June 19, 2007, and Pradaxa® was approved as of June 10, 2008 for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery. 

[93]           Boehringer-Canada submitted a SNDS for Pradaxa® to Health Canada on December 23, 2009 for the prevention of stroke, systemic embolism and reduction in vascular mortality in patients with AF. Health Canada gave it a priority review, which Health Canada reserves for circumstances where the drug could be prescribed for a serious, life-threatening, or severely debilitating disease or condition for which there is substantial evidence of clinical effectiveness that the drug provides: (1) effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or (2) a significant increase in efficacy and or significant decrease in risk such that the overall benefit risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada. The drug was approved as of October 26, 2010.

[94]           Around the world, once approved for use by the regulator, Pradaxa® became a very popular prescription drug. For example, in the United States, the 2013 sales for Pradaxa® totaled $825 million.

[95]           Shortly after Pradaxa® was approved for sale in Canada and in the United States, adverse events began to be reported to the FDA in the United States and to Health Canada in Canada, respectively. By the end of December 2011, there were thousands of reports, most of them involving life-threatening bleeding or blood clots in the elderly. There were hundreds of reports of rectal hemorrhages, cerebrovascular events, and deaths linked to Pradaxa®. In Canada, in 2014, the Canadian Vigilance Adverse Reaction Online Database had 818 reports of “bleeding” or “hemorrhage.”

[96]           On June 26, 2014, Pradaxa® was granted further approval for the treatment of VTE and DVT and pulmonary embolism (“PE”) and the prevention of recurrent DVT and PE.

[97]           Pradaxa® did not have an approved specific reversal agent until May of 2016, when Praxbind® was approved.   

[98]           Using the Pradaxa® Product Monograph dated May 14, 2013 as the illustration, I have set out the pertinent portions of the Product Monograph in Schedule “B” to these Reasons for Decision.

[99]           As may be seen, the excerpt is extensive. It is necessary to include this large excerpt because the nature of the Plaintiffs’ allegations about the failure to warn requires the alleged deficiencies to be put into the context of the totality of information provided by Boehringer in its Product Monograph and because, as noted above, the nature of the allegations at the certification motion changed from the much broader allegations made at the outset of the proposed class action and narrowed to a failure to warn claim associated with an alleged inadequate notice of the absence of an antidote.

[100]      Although the whole excerpt from the Product Monograph must be read to understand the parties’ arguments, it is helpful to summarize some of the more important aspects of it.

[101]      In this regard, the Product Monograph has always been copiously replete with warnings about bleeding, including a warning that “major or severe bleeding may occur” and “may lead to disabling, life-threatening or even fatal outcomes.” The WARNINGS AND PRECAUTIONS section of Part I begins with a warning about the risks of all anticoagulants as follows:

[102]      Part I of the Pradaxa® Product Monograph discusses bleeding in: the CONTRAINDICATIONS section, the WARNINGS AND PRECAUTIONS section, the ADVERSE REACTIONS section, the DOSAGE AND ADMINISTRATION section, and the OVERDOSAGE section. Part I refers to common ADRs that include “anemia, epistaxis (nosebleeds), gastrointestinal hemorrhage, urogenital hemorrhage hematoma (abnormal collection of blood outside of a blood vessel), hematuria (the presence of blood in urine), wound hemorrhage, wound secretion, post-procedural hematoma, post-procedural hemorrhage, traumatic hematoma, post-procedural discharge. Part I provides information regarding bleeding risks and advises that should severe bleeding occur, treatment with Pradaxa® must be discontinued and the source of bleeding investigated promptly.

[103]      There are pages and pages of text and charts discussing bleeding and its association with anticoagulants and with bleeding. The text notes that although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.

[104]      Part II of the Pradaxa® Product Monograph discusses bleeding in the CLINICAL TRIALS section and provides a great deal of information.

[105]      Part III of the Product Monograph discusses bleeding under numerous headings and identifies numerous serious side effects, many of which are bleeding related. Part III, states in bold that major or severe bleeding can occur in any part of the body while taking Pradaxa® and also that although rare, major or severe bleeding may occur and regardless of its location, may become disabling, life-threatening or even lead to death.

[106]      The Product Monograph advises that bleeding was the most relevant side effect and that bleeding occurred in approximately 14% of patients treated short-term for elective hip or knee replacement surgery and in long-term treatment in 16.5% of patients with AF treated for the prevention of stroke and systemic embolism.

[107]      Until the approval of Praxbind®, every version of the Canadian Product Monograph for Pradaxa® since the launch of the product indicated under the OVERDOSAGE Section of Part I that there is no antidote for this drug.

[108]      After Praxbind® was approved, the Product Monograph of Pradaxa® was revised.   

[109]      For the time before the introduction of Praxbind®, the Plaintiffs asked Mr. North to provide an opinion regarding the adequacy of the statements in the Product Monograph for Pradaxa® about the lack of a reversal agent (antidote), and the prominence given to those statements.

[110]      Mr. North reviewed all the iterations of the Product Monograph for Pradaxa® to determine whether the lack of an antidote was ever profiled and if so, when and how it was profiled. He considered whether any references to the lack of an antidote were adequate and timely, given the state of Boehringer’s knowledge.

[111]      Mr. North observed that in Canada, for its Product Monographs, Boehringer warned about the lack of an antidote for the anticoagulant effects of Pradaxa® in only the OVERDOSAGE section of the Product Monograph and not under the WARNINGS AND PRECAUTIONS section.

[112]      Mr. North noted that in January 2012, in the United States, Boehringer revised the Product Monograph to include information about the lack of an antidote in both the OVERDOSAGE and WARNINGS AND PRECAUTIONS sections of the Product Monograph. The warning in the Product Monograph in the United States stated:

[113]      Subsequent versions of the U.S. label continued to include the statement about the lack of a reversal agent in the OVERDOSAGE section and a warning in the WARNINGS AND PRECAUTIONS section. In his report, Mr. North noted that the Australian label for Pradaxa® underwent a similar process of revision comparable to what had occurred in the United States.

[114]      Although Mr. North had not read the evidence of the Plaintiffs’ emergency medicine expert (Dr. Sommer) and had no independent knowledge of how bleeding events are managed by physicians, it was Mr. North’s opinion that the statements in the Canadian Product Monograph were inadequate to alert healthcare professionals and the public about the lack of an antidote for Pradaxa®.

[115]      More particularly, Mr. North concluded that it is not sufficient for the information concerning the lack of a reversal agent to be found only in the OVERDOSAGE section of Part I. Mr. North submitted that since Pradaxa® users can experience excessive bleeding in numerous circumstances unrelated to overdosing, reference to the absence of an antidote only with respect to overdosing was inadequate. Rather, in his opinion, the absence of an antidote should have been profiled in the WARNINGS AND PRECAUTIONS section of Part I and arguably, in a Boxed Warning. It was his opinion that the warning should also have included in Part III of the Product Monograph so that patients could become aware of this risk independent of any information, if any, provided by their physician.

[116]      It was Mr. North’s opinion that the fact there was no antidote to Pradaxa® qualified as a clinically significant or life-threatening safety hazard and would thus properly belong in a Boxed Warning.

[117]      During cross-examination, Mr. North admitted that a physician would be better placed to know whether simple cessation of Pradaxa® would be adequate to address bleeding. He admitted that: it would not be appropriate for all information in Part I of the Product Monograph to be included in Part III and that where information is placed is ultimately determined by Health Canada. He also admitted that for some drugs that carry a risk of bleeding it would be appropriate to put the absence of a reversal agent only in the OVERDOSAGE section and that the decision would depend on the particular drug.   

[118]      Boehringer argues that I should reject Mr. North’s evidence about the adequacy of the warnings in the Pradaxa® Product Monograph in its entirety. I, think, however, that would go too far. What I will say is that Mr. North’s evidence is very weak in making a connection between any harm being suffered by the alleged deficiencies in the warnings contained in the Product Monograph. Mr. North did not take into account the reviewing role of Health Canada or the circumstance that most drugs do not have a reversal agent and he had done no research into the practice of physicians in prescribing anticoagulants and the significance, if any, of the absence of an antidote for Pradaxa® to an emergency department doctor responding to a bleeding event. Mr. North spoke to no physician before he prepared his reports, and he was unaware of the evidence that a reversal agent for Pradaxa® would only be useful in very rare cases.

[119]      Dr. Sommer delivered a very short report of 41 paragraphs of which the opinion portion comprised 18 paragraphs. As an emergency department physician, his opinion was that when confronted with a patient suffering from major bleeding, he felt that it was far more difficult to manage patients taking Pradaxa® who presented with excessive bleeding because there was no way to measure the state of the anticoagulants of the drug as was the case for warfarin, for which the INR could be measured. It was his opinion that there were no treatment options for the patient on Pradaxa® because there was no antidote and no simple way to reverse its anticoagulant effect, as was the case for warfarin, which had the reversal agent of vitamin K.

[120]      I found Dr. Sommer’s evidence unhelpful and unconvincing, and I very much prefer the evidence of Dr. Wulffhart and Dr. Chopra set out below. Dr. Wulffhart’s, and particularly, Dr. Chopra’s, detailed and cogent opinions demonstrated that Dr. Sommer was wrong in his analysis of the comparative treatment options for a patient presenting with excessive bleeding on warfarin and a patient presenting with excessive bleeding on Pradaxa®. While Dr. Sommer was correct in his description of anticoagulation, he was wrong in his general assessment about the need for reversal agents when a patient on a anticoagulant presents with excessive bleeding, and he was wrong in suggesting that there were no treatment options to respond to excessive bleeding presented by a patient on Pradaxa®. While Dr. Sommer was correct in stating that there was no comparable measure like INR for Pradaxa®, he missed the point that given the short biological half-life of the drug, very little purpose would be accomplished by having a test and that in most cases what the emergency doctor needed to know is when did the patient last take the drug.

[121]      And Dr. Sommer was certainly wrong in suggesting that the choice of administering vitamin K or any reversal agent was an easy matter. As Dr. Chopra’s evidence revealed, the decision to reverse warfarin with vitamin K (or to reverse Pradaxa® with Praxbind®) is bursting with serious and dangerous problems including precipitating the lethal stroke or heart attack that warfarin and Pradaxa® were prescribed to prevent.   

[122]      In his testimony, Dr. Chopra described in detail the nature of coagulation, anticoagulation, natural and pharmaceutical anticoagulants, and how physicians make treatment decisions about how to treat patients on anticoagulant drugs that present with bleeding. Some of the evidence is already described earlier in this judgment.   

[123]      Dr. Chopra said that when faced with a bleeding patient taking Pradaxa®, even a patient who just recently consumed the drug, emergency room physicians have non-antidote measures available to effectively manage bleeding, as they do in the case of warfarin patients. Dr. Chopra said that most patients who present with bleeding while taking an anticoagulant have simple bleeding, such as nosebleeds or bruising, and this bleeding can typically be managed with conservative measures such as compression. Regardless of whether the patient is on an anticoagulant, other measures for patients presenting with bleeding are cauterization and the transfusion of PCC or FPP. In these cases, no reversal agent would be necessary.

[124]      Dr. Chopra said that in other cases of patients admitted with serious bleeding, the availability of an antidote would be meaningless. He testified that for patients who are admitted with ICH, approximately 30 to 50 percent die in hospital, and some come in so sick after their bleeding that giving them a drug to reverse their coagulation status is essentially futile and would not alter their outcome.

[125]      Dr. Chopra said that a physician had to exercise great care on an individual case-by-case basis to determine whether it was medically advisable to move beyond conservative measures to apply a reversal agent to an anticoagulant because this might not be necessary and could expose the patient to a risk of stroke or thromboembolism. He said that in the vast majority of patients, the benefits of stroke prevention were far greater than the risks of major bleeding. He said that there must be good reason to reverse the anticoagulant effect of warfarin and the physician must be sure that reversal, in all of the specific circumstances relevant to that patient, will not cause more harm than good.  

[126]      Dr. Chopra said that in the great majority of cases, there is no material difference in the management of bleeding as between a Pradaxa® patient and a warfarin patient. He said that for the vast majority of patients on Pradaxa®, they could safely wait for the anticoagulant effect of the drug to wear off even if surgery was required.

[127]      Dr. Chopra’s evidence revealed that in the circumstances when it would be medically desirable to manage the bleeding by reversing an anticoagulant, treating the patient on warfarin was problematic because unlike Pradaxa® there was no alternative of just administering PCC and FPP and waiting until the drug wore off (likely just a few hours) because given the longer-lasting effect of warfarin (up to 48 hours), there might be a need to reverse the warfarin by administering vitamin K. The administration of vitamin K, however, presented serious challenges and risks. In his report, Dr. Chopra stated:

[128]      Dr. Chopra stated that the absence of an approved specific reversal agent for Pradaxa® did not render Pradaxa® inferior to warfarin from a patient safety point of view. He said that the studies indicated the opposite, and that patients who had major bleeding while taking either warfarin or Pradaxa®, had lower all-cause mortality with Pradaxa® than with warfarin notwithstanding the absence of an antidote for Pradaxa®.

[129]      Dr. Chopra said the ability to administer a reversal agent in late presenters on warfarin who have critical bleeding was of unproven benefit and likely unprovable because the outcome is a moving target in terms of the time of presentation and intervention because it depends on numerous individual patient factors.

[130]      Dr. Chopra stated that in cases where a reversal agent might have been indicated had the patient been on warfarin, to determine whether the administration of vitamin K would have had any material effect one would need to know, among other things: (a) the disease state that caused the bleeding, (b) the location of the bleed in the patient's body, (c) the amount of time that passed between the onset of bleeding and the presentation of the patient, (d) the seriousness or extent of the bleeding, (e) the patient's age, (f) any co-medications, and (g) any comorbidities. It would also be necessary to know whether the bleeding stopped spontaneously or whether surgical intervention occurred, and whether the intervention was successful.

[131]      Dr. Chopra said that Praxbind® had been used only twice at the UHN Emergency Department and in both cases the hospital’s staff haematologist felt that the use of Praxbind® was actually inappropriate. 

[132]      Dr. Chopra said that an important clinical judgment issue facing doctors considering administering a reversal agent to an anticoagulated patient (whether the agent is Praxbind® for Pradaxa® or vitamin K for warfarin) was the risks associated with stopping the patient’s anticoagulation which was indicated to prevent life-threatening blood clots. He said: “So when you use Praxbind® in antidote, the anticoagulation effect of the drug Pradaxa® goes away very quickly and the patient very soon becomes at risk of having a stroke, of having a pulmonary embolism, of having a deep vein thrombosis, all of which can be potentially life threatening.” He said that these risks meant that the use of Praxbind® would not be appropriate for the great majority of patients who experienced bleeding while on Pradaxa®.

[133]      Dr. Wulffhart, whose clinical practice and research work involved the use of anticoagulants, was asked to provide an opinion about their use, including Pradaxa®, for the prevention of strokes in patients with AF and to opine on the risks and benefits of the various anticoagulants.

[134]      In his evidence Dr. Wulffhart described much of the medical evidence about AF and about anticoagulants that I have set out above, and he described how the introduction of NOACs had a major impact upon the treatment of AF.

[135]      Dr. Wulffhart said that a physician’s recommendation about the administration of an anticoagulant and dosing decisions for AF treatment were based on patient-specific factors including an assessment of the individual patient’s risk of stroke and the individual patient’s risk of bleeding, both of which are patient specific.

[136]      Dr. Wulffhart said that the introduction of the NOACs had revolutionized the treatment of stroke prevention. It was Dr. Wulffhart’s opinion that the introduction of Pradaxa® presented AF patients with a treatment option that was more effective in the prevention of strokes and is superior in terms of its overall risk profile. He said that the risk of stroke with AF was about 5 to 6% per year on no anticoagulants, about 2% on warfarin, and about 1.0 to 1.5% on Pradaxa®. He said that Pradaxa® has become preferred over warfarin and aspirin for the prevention of strokes in AF patients.

[137]      Dr. Wulffhart testified that the lack of an antidote for Pradaxa® was well known because it had routinely been discussed in medical journals and at medical educational conferences and the absence of an antidote was common knowledge amongst doctors prescribing the drug. He said that this aspect of the drug was so well known that he could not imagine any competent Canadian physician to have prescribed Pradaxa® in ignorance of it.

[138]      It was Dr. Wulffhart’s opinion that the absence of a specific reversal agent for Pradaxa® was appropriately and adequately disclosed in the OVERDOSAGE section found in Part I of the Pradaxa® Product Monograph. He said prescribing physicians typically considered whether there was an antidote or reversal agent for a particular drug by looking in the OVERDOSAGE section of a product monograph.

[139]      Dr. Wulffhart testified that the choice of an anticoagulant involves a complex risk-benefit analysis, and that it is only in rare cases that a reversal agent for Pradaxa® is likely to be of benefit. He said that his practice was to inform patients about the lack of an antidote for Pradaxa® or for the other NOACs, none of which have an antidote, but that his practice was to encourage the patient to take the drug notwithstanding the absence of an antidote. He said that he told patients that the risk of having a life-threatening bleed or intracranial hemorrhage on Pradaxa® is much less than it is on warfarin, which has an antidote.

[140]      Dr. Wulffhart also said that the availability of the antidote was unlikely to make any difference to a patient being treated for AF. He would encourage them to take a drug that had a lower risk of bleeding in the first place rather than succumbing to the fear of not having an antidote which might not make any difference. He said that more than 95% of his patients were comfortable with the lack of a reversal agent for the NOACs because of the convenience of NOACs over warfarin and because a NOAC materially reduces the risk of stroke and ICH relative to warfarin. He said about 3-5% of his patients preferred warfarin because they felt more comfortable with the knowledge that bleeding can be actively reversed. He said, however, that this was not the best decision in terms of overall risk-benefit.

[141]      For the circumstance where a patient presented in an emergency department suffering from bleeding, Dr. Wulffhart strongly disagreed with Dr. Sommer’s view about the significance to warfarin having an antidote and Pradaxa® (until recently) not having an antidote.

[142]      Ms. Tomalin described the regulatory regime in Canada and described the information about bleeding contained in the various Pradaxa® Product Monographs in great detail.

[143]      Ms. Tomalin reviewed the evidence of Dr. Chopra and Dr. Wulffhart and opined that physicians and patients were adequately informed of the recognized risk of bleeding in the Product Monograph.

[144]      Ms. Tomalin noted that Health Canada’s Product Monograph Guideline recommends that information on any available antidote be placed under the OVERDOSAGE section of the Product Monograph. She testified that noting the absence of an antidote in Part III of the Product Monograph was not required by any regulation or principle of regulatory practice.

[145]      In her opinion, the approach taken by Boehringer-Canada in disclosing the lack of an antidote for Pradaxa® was appropriate and in accord with the regulatory requirements in Canada. She noted that although the United States and Australian labels were revised to include information about the lack of antidote in the WARNINGS AND PRECAUTIONS section, no change was made to the European label and that Health Canada had reviewed the Pradaxa® Product Monograph at least five times after the United States’ label revision was made without directing any change to the Product Monograph.  

[146]       Mr. Batten, the Hamilton Estate, and Ms. Nelson seek to certify as a class action a breach of duty to warn product’s liability negligence claim against: (a) Boehringer-Canada; (b)  Boehringer Ingelheim Pharmaceuticals, Inc.; (c) Boehringer Ingelheim Pharma GmbH & Co. KG; and (d) Boehringer Ingelheim International GmbH. Before addressing the criteria for certification and whether they are satisfied, I shall first address the matter of the joinder of all of the Defendants other than Boehringer. After the matter of the joinder of the Defendants is discussed, I shall proceed to analyze the certification criteria. In that discussion, I shall assume that all of the Defendants were properly joined and I shall continue to refer to the collective of Boehringer as referring to all of them.

[147]      In addition to suing Boehringer-Canada, Mr. Batten, the Hamilton Estate, and Ms. Nelson sue (a) Boehringer Ingelheim Pharmaceuticals, Inc., (b) Boehringer Ingelheim Pharma GmbH & Co. KG, and (c) Boehringer Ingelheim International GmbH as several; i.e., independent co-defendants.

[148]      To be clear, for the purposes of the certification motion, although their Statement of Claim is replete with vague, undifferentiated, and not particularized allegations of a joint endeavor, the Plaintiffs disavow that they are relying on any allegation of enterprise liability, vicarious liability, or the piercing the corporate veil. For the purpose of the certification motion, the Plaintiffs submit that Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. KG, and Boehringer Ingelheim International GmbH are sued for their own discrete failures to warn about the dangers of there being no antidote in the Pradaxa® Product Monograph.

[149]      For example, although at present, Mr. Batten, the Hamilton Estate, and Ms. Nelson do not have any evidence that Boehringer Ingelheim Pharmaceuticals, Inc. had responsibility for disseminating information about Pradaxa® on a worldwide scale, including to Canadian residents, their position is that if Boehringer Ingelheim Pharmaceuticals, Inc. did have this responsibility, then it had a duty to adequately warn of any dangers associated with Pradaxa®, such as the lack of an antidote. Although at present, the Plaintiffs do not have any evidence that Boehringer Ingelheim Pharmaceuticals, Inc., which distributed Pradaxa® in the United States, also distributed it in Canada, their position is that if it did distribute the drug in Canada, then it would be a necessary party.

[150]      Mr. Batten, the Hamilton Estate, and Ms. Nelson explain why, in their view, Boehringer Ingelheim Pharmaceuticals, Inc. is a necessary party in paragraphs 53-55 of their factum, as follows:

[151]      Mr. Batten, the Hamilton Estate, and Ms. Nelson make similar arguments about Boehringer Ingelheim Pharma GmbH & Co. KG, and about Boehringer Ingelheim International GmbH.

[152]      There is no doubt that there is a proximate relationship between the Canadian Plaintiffs and Boehringer-Canada, which applied for the regulatory approval and which is distributing Pradaxa® in Canada and this proximate relationship gives rise to a duty of care between the Plaintiffs and Boehringer-Canada, but it is not readily apparent why associated and parent companies outside of Canada and associated companies involved in obtaining approvals in other countries who are at a more remote level of proximity should have a duty of care to Canadian consumers.

[153]      In other words, the claims against Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. KG, and Boehringer Ingelheim International GmbH cannot be justified on the basis of enterprise liability and the claims might not survive a duty of care analysis based on the Defendants’ more remote proximity and public policy factors negating a duty of care. For instance, it is not readily apparent why the foreign licensor of a patent or the licensor of trademark has a foreseeable duty of care about what is said in the Product Monograph of the Canadian licensee who would be obliged to obtain the Canadian regulator’s approval for the content of its Product Monograph.   

[154]      Moreover, there is strong evidence in the case at bar that the real purpose of the joinder of the various Boehringer co-Defendants is to fish for a cause of action and to obtain documentary discovery to bolster the claims against Boehringer-Canada. A plaintiff may not plead for the purpose of using the examinations for discovery for what is colloquially referred to as a “fishing expedition”. The plaintiff must plead material facts that lay the foundation for a cause of action before the examinations for discovery and not frame his or her pleadings for the purpose of providing a basis for searching or probing for the foundation of a cause of action at the examinations for discovery: McMahon v. Healey, [1946] O.J. No. 391 (H.C.J.); Rose Park Wellesley Investment Ltd. v. Sewell, 1972 CanLII 354 (ON SC), [1973] 1 O.R. 102 (Ont. S.C.); Basdeo (Litigation guardian of) v. University Health Network, [2002] O.J. No. 263 (S.C.J.); Lysko v. Braley (2006), 2006 CanLII 11846 (ON CA), 79 O.R. (3d) 721 (C.A.).

[155]       Because I am adjourning Boehringer’s pleadings motion and because I shall be dismissing the certification motion, I shall not rule on whether Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. KG, and Boehringer Ingelheim International GmbH are necessary, proper, or improperly joined defendants. For the purposes of the certification motion, I will simply assume that all of the Defendants have been properly joined.

[156]      The court is required to certify the action as a class proceeding where the following five-part test in s. 5 of the Class Proceedings Act, 1992 is met: (1) the pleadings disclose a cause of action; (2) there is an identifiable class of two or more persons that would be represented by the representative plaintiff; (3) the claims of the Class Members raise common issues; (4) a class proceeding would be the preferable procedure for the resolution of the common issues; and (5) there is a representative plaintiff who: (a) would fairly and adequately represent the interests of 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 (c) does not have, on the common issues for the class, an interest in conflict with the interests of other class members.

[157]      For an action to be certified as a class proceeding, there must be a cause of action shared by an identifiable class from which common issues arise that can be resolved in a fair, efficient, and manageable way that will advance the proceeding and achieve access to justice, judicial economy, and the modification of behaviour of wrongdoers: Sauer v. Canada (Attorney General), 2008 CanLII 43774 (ON SC), [2008] O.J. No. 3419 (S.C.J.) at para. 14, leave to appeal to Div. Ct. refused, 2009 CanLII 2924 (ON SCDC), [2009] O.J. No. 402 (Div. Ct.).

[158]      On a certification motion, the question is not whether the plaintiff's claims are likely to succeed on the merits, but whether the claims can appropriately be prosecuted as a class proceeding: Hollick v. Toronto (City), 2001 SCC 68 (CanLII), [2001] 3 S.C.R. 158 at para. 16.

[159]      The test for certification is to be applied in a purposive and generous manner, to give effect to the important goals of class actions -- providing access to justice for litigants; promoting the efficient use of judicial resources; and sanctioning wrongdoers to encourage behaviour modification: Western Canadian Shopping Centres Inc. v. Dutton, 2001 SCC 46 (CanLII), [2001] 2 S.C.R. 534 at paras. 26 to 29; Hollick v. Toronto (City), supra at paras. 15 and 16.

[160]      The representative plaintiff must come forward with sufficient evidence to support certification, and the opposing party may respond with evidence of its own to challenge certification: Hollick v. Toronto (City), supra at para. 22.

[161]      The purpose of a certification motion is to determine how the litigation is to proceed and not to address the merits of the plaintiff's claim; there is to be no preliminary review of the merits of the claim: Hollick v. Toronto (City), supra at paras. 28 and 29. However, the plaintiff must show “some-basis-in-fact” for each of the certification criteria other than the requirement that the pleadings disclose a cause of action: Hollick v. Toronto (City), supra at paras. 16-26. Certification will be denied if there is an insufficient evidentiary basis for the facts on which the claims of the class members depend: Williams v. Canon Canada Inc., 2011 ONSC 6571, aff’d 2012 ONSC 3992 (Div. Ct.); Chadha v. Bayer Inc. (2003), 2003 CanLII 35843 (ON CA), 63 O.R. (3d) 22 (C.A.), leave to appeal to S.C.C. ref’d [2003] S.C.C.A. No. 106; Ernewein v. General Motors of Canada Ltd., 2005 BCCA 540 (C.A.), leave to appeal to S.C.C. ref’d, [2005] S.C.C.A. No. 545; Taub v. Manufacturers Life Insurance Co. (1998), 1998 CanLII 14853 (ON SC), 40 O.R. (3d) 379 (Gen. Div.), aff’d (1999), 1999 CanLII 19922 (ON SC), 42 O.R. (3d) 576 (Div. Ct.).

[162]      In particular, there must be a basis in the evidence before the court to establish the existence of common issues: Dumoulin v. Ontario, [2005] O.J. No. 3961 (S.C.J.) at para. 25; Fresco v. Canadian Imperial Bank of Commerce, 2009 CanLII 31177 (ON SC), [2009] O.J. No. 2531 (S.C.J.) at para. 21; Singer v. Schering-Plough Canada Inc., 2010 ONSC 42 at para. 140. In order to establish commonality, evidence that the alleged misconduct actually occurred is not required; rather, the necessary evidence goes only to establishing whether the questions are common to all the class members: Pro-Sys Consultants v. Microsoft, 2013 SCC 57 at para. 110.   

[163]      On a certification motion, evidence directed at the merits may be admissible if it also bears on the requirements for certification but, in such cases, the issues are not decided on the basis of a balance of probabilities but rather on that of the much less stringent test of "some-basis-in-fact": Hollick v. Toronto (City), supra at paras. 16-26; Cloud v. Canada, 2004), 2004 CanLII 45444 (ON CA), 73 O.R. (3d) 401 (C.A.) at para. 50, leave to appeal to the S.C.C. ref'd, [2005] S.C.C.A. No. 50 , rev'g (2003), 2003 CanLII 72353 (ON SCDC), 65 O.R. (3d) 492 (Div. Ct.). The evidence on a motion for certification must meet the usual standards for admissibility: Martin v. Astrazeneca Pharmaceuticals PLC, supra; Williams v. Canon Canada Inc., supra; Ernewein v. General Motors of Canada Ltd., supra; Schick v. Boehringer Ingelheim (Canada) Ltd., 2011 ONSC 63 at para.13. While evidence on a certification motion must meet the usual standards for admissibility, the weighing and testing of the evidence is not meant to be extensive and if the expert evidence is admissible the scrutiny of it is modest: Griffin v. Dell Canada Inc., 2009 CanLII 3557 (ON SC), [2009] O.J. No. 418 (S.C.J.) at para. 76. In a class proceeding, the close scrutiny of the evidence of experts should be reserved for the trial judge: Stanway v. Wyeth Canada Inc., 2011 BCSC 1057, aff’d 2012 BCCA 260.

[164]      The some-basis-in-fact test sets a low evidentiary standard for plaintiffs, and a court should not resolve conflicting facts and evidence at the certification stage or opine on the strengths of the plaintiff’s case; the focus at certification is whether the action can appropriately go forward as a class proceeding: Pro-Sys Consultants v. Microsoft, supra; McCracken v. CNR Co., 2012 ONCA 445.  

[165]      The first criterion for certification is that the plaintiff's pleading discloses a cause of action. The "plain and obvious" test for disclosing a cause of action from Hunt v. Carey Canada, 1990 CanLII 90 (SCC), [1990] 2 S.C.R. 959 is used to determine whether a proposed class proceeding discloses a cause of action for the purposes of s. 5(1)(a) of the Class Proceedings Act, 1992.

[166]      Thus, to satisfy the first criterion for certification, a claim will be satisfactory, unless it has a radical defect or it is plain and obvious that it could not succeed: Anderson v. Wilson (1999), 1999 CanLII 3753 (ON CA), 44 O.R. (3d) 673 (C.A.) at p. 679, leave to appeal to S.C.C. ref'd, [1999] S.C.C.A. No. 476; 176560 Ontario Ltd. v. Great Atlantic & Pacific Co. of Canada Ltd. (2002), 2002 CanLII 6199 (ON SC), 62 O.R. (3d) 535 (S.C.J.) at para. 19, leave to appeal granted, 2003 CanLII 36393 (ON SCDC), 64 O.R. (3d) 42 (S.C.J.), aff'd (2004), 2004 CanLII 16620 (ON SCDC), 70 O.R. (3d) 182 (Div. Ct.).

[167]      In a proposed class proceeding, in determining whether the pleading discloses a cause of action, no evidence is admissible, and the material facts pleaded are accepted as true, unless patently ridiculous or incapable of proof. The pleading is read generously and it will be unsatisfactory only if it is plain, obvious, and beyond a reasonable doubt that the plaintiff cannot succeed: Hollick v. Toronto (City), supra at para. 25; Cloud v. Canada (Attorney General) supra at para. 41; Abdool v. Anaheim Management Ltd. (1995), 1995 CanLII 5597 (ON SCDC), 21 O.R. (3d) 453 (Div. Ct.) at p. 469.

[168]      In the case at bar, as noted above, I have serious reservations about the joinder of causes of action against Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. KG, and Boehringer Ingelheim International GmbH but there is no doubt that there is cause of action against Boehringer-Canada. I, therefore, conclude that the first criterion for certification is satisfied in the case at bar.

[169]      The definition of an identifiable class serves three purposes: (1) it identifies the persons who have a potential claim against the defendant; (2) it defines the parameters of the lawsuit so as to identify those persons bound by the result of the action; and (3) it describes who is entitled to notice: Bywater v. Toronto Transit Commission, [1998] O.J. No. 4913 (Gen. Div.).

[170]      In defining class membership, there must be a rational relationship between the class, the causes of action, and the common issues, and the class must not be unnecessarily broad or over-inclusive: Pearson v. Inco Ltd. (2006), 2006 CanLII 913 (ON CA), 78 O.R. (3d) 641 (C.A.) at para. 57, rev'g 2004 CanLII 34446 (ON SCDC), [2004] O.J. No. 317 (Div. Ct.), which had aff'd [2002] O.J. No. 2764 (S.C.J.).

[171]      Mr. Batten, the Hamilton Estate, and Ms. Nelson propose the following definition for the classes:

[172]      More than 800 people have reported Pradaxa® bleeding events to Health Canada.

[173]      In proposed pharmaceutical or medical device products liability class actions, defining the class by reference to those who were prescribed the drug or medical device is a conventional technique, and in my opinion, the class definition in the immediate case is technically satisfactory. I conclude that the identifiable class criterion is satisfied. 

[174]      The third criterion for certification is the common issues criterion. For an issue to be a common issue, it must be a substantial ingredient of each class member's claim and its resolution must be necessary to the resolution of each class member's claim: Hollick v. Toronto (City), supra at para. 18.

[175]      With regard to the common issues, success for one member must mean success for all. All members of the class must benefit from the successful prosecution of the action, although not necessarily to the same extent. The answer to a question raised by a common issue for the plaintiff must be capable of extrapolation, in the same manner, to each member of the class. See: Western Canadian Shopping Centres Inc. v. Dutton, supra at para. 40; Ernewein v. General Motors of Canada Ltd., supra at para. 32; Merck Frosst Canada Ltd. v. Wuttunee, 2009 SKCA 43 at paras. 145-46 and 160, leave to appeal to S.C.C. refused, [2008] S.C.C.A. No. 512; McCracken v. Canadian National Railway Co., supra, at para. 183.

[176]      In Pro-Sys Consultants v. Microsoft, supra at para. 106, the Supreme Court of Canada describes the commonality requirement as the central notion of a class proceeding which is that individuals who have litigation concerns in common ought to be able to resolve those common concerns in one central proceeding rather than through an inefficient multitude of repetitive proceedings.

[177]      An issue is not a common issue if its resolution is dependent upon individual findings of fact that would have to be made for each class member: Fehringer v. Sun Media Corp., [2003] O.J. No. 3918 (Div. Ct.) at paras. 3, 6. Common issues cannot be dependent upon findings which will have to be made at individual trials, nor can they be based on assumptions that circumvent the necessity for individual inquiries: Nadolny v. Peel (Region), [2009] O.J. No. 4006 (S.C.J.) at paras. 50-52; Collette v. Great Pacific Management Co., 2003 BCSC 332 (CanLII), [2003] B.C.J. No. 529 (B.C.S.C.) at para. 51, varied on other grounds (2004) 2004 BCCA 110 (CanLII), 42 B.L.R. (3d) 161 (B.C.C.A.); McKenna v. Gammon Gold Inc., 2010 ONSC 1591 (CanLII), [2010] O.J. No. 1057 (S.C.J.) at para. 126, leave to appeal granted 2010 ONSC 4068 (CanLII), [2010] O.J. No. 3183 (Div. Ct.), varied 2011 ONSC 3882 (Div. Ct.).

[178]      The common issue criterion presents a low bar: Carom v. Bre-X Minerals Ltd. (2000), 2000 CanLII 16886 (ON CA), 51 O.R. (3d) 236 (C.A.) at para. 42; Cloud v. Canada (Attorney General), supra, at para. 52; 203874 Ontario Ltd. v. Quiznos Canada Restaurant Corp., 2009 CanLII 23374 (ON SCDC), [2009] O.J. No. 1874 (Div. Ct.), aff’d 2010 ONCA 466 (CanLII), [2010] O.J. No. 2683 (C.A.), leave to appeal to S.C.C. refused [2010] S.C.C.A. No. 348.

[179]      An issue can be a common issue even if it makes up a very limited aspect of the liability question and even though many individual issues remain to be decided after its resolution: Cloud v. Canada (Attorney General) supra. A common issue need not dispose of the litigation; it is sufficient if it is an issue of fact or law common to all claims and its resolution will advance the litigation for (or against) the class: Harrington v. Dow Corning Corp., supra.

[180]      In the context of the common issues criterion, the some-basis-in-fact standard involves a two-step requirement that: (1) the proposed common issue actually exists; and (2) the proposed issue can be answered in common across the entire class: Hollick v. Toronto (City), supra; Fulawka v. Bank of Nova Scotia, 2012 ONCA 443; McCracken v. Canadian National Railway Company, supra; Williams v. Canon Canada Inc., supra; Martin v. Astrazeneca Pharmaceuticals PLC, 2012 ONSC 2744; Good v. Toronto Police Services Board, 2014 ONSC 4583 (Div. Ct.); Dine v. Biomet, 2015 ONSC 7050, aff’d 2016 ONSC 4039 (Div. Ct.).

[181]      In their Notice of Motion, Mr. Batten, the Hamilton Estate, and Ms. Nelson propose the following common issues:

[182]      In their factum, Mr. Batten, the Hamilton Estate, and Ms. Nelson propose a different set of common issues, which for convenience of analysis, I have re-ordered as follows:

[183]      With the narrowing of the Plaintiffs’ claim to the duty to warn claim, I shall analyze the proposed common issues from the factum.

[184]      This question is no longer applicable to the narrowed duty to warn claim, and has been supplanted by the more specific and focused Question 2, to which I now turn. 

[185]      In my opinion, Question 2 fails the common issues criterion. In the immediate case, there is no basis in fact to conclude that a common issue about a duty to warn about the absence of an antidote actually exists. And, if this duty to warn did exist, there is no-basis-in-fact for concluding that the question of whether the Defendants had a duty to warn about the absence of an antidote can be answered in common across the class of persons who ingested Pradaxa®.

[186]      Recognizing that Boehringer has a duty to warn of dangers inherent in the use of Pradaxa® of which it has knowledge or ought to have knowledge and without doing an analysis of the merits of the breach of the duty to warn claim; i.e., without assessing the merits of Mr. North’s argument that the information in the OVERDOSAGE section of Part I of the Product Monograph was inadequate and instead applying the very low threshold test of some-basis-in-fact for the existence of a duty to warn claim, there is no basis in fact for concluding that the failure to warn about the absence of an antidote for Pradaxa® is a source of harm and there is no-basis-in-fact for concluding that - as a class - persons who ingested Pradaxa® would suffer any harm from not being warned about the absence of an antidote for Pradaxa®.

[187]      There is no basis in fact for concluding that a patient on Pradaxa® who experienced a bleeding event was at a greater risk of unstoppable bleeding because of the lack of an antidote than a patient on warfarin who experienced a bleeding event. The evidence was that there was no increased risk for developing life-threatening injuries for patients prescribed Pradaxa® rather than warfarin. Indeed, the evidence is that regardless of the prescribed anticoagulant, the physician treating a patient for excessive bleeding would use conventional methods to abate the bleeding and would resort to an antidote or reversal agent as a last resort, because a reversal agent to an anticoagulant carries the very serious risk of precipitating a devastating and perhaps life-ending stroke. For persons on anticoagulants, the same treatments for the known risk of bleeding would be used for persons on warfarin as for patients on Pradaxa®. The evidence, however, was that the patient presenting with bleeding who was on Pradaxa® without an antidote was in a preferable position to patient presenting with bleeding who was on warfarin. 

[188]      There was no-basis-in-fact to conclude that that the bleeding of a patient on Pradaxa® was more difficult to stop by conventional means than the bleeding of a patient on warfarin. The evidence was that in the overwhelming majority of cases, an antidote was not necessary for Pradaxa®, because unlike the much longer lasting warfarin, the effect of Pradaxa® would simply wear off and rarely would it be necessary to hasten that wearing-off process by a reversal agent. The evidence suggested that it takes longer to reverse the longer-lasting anticoagulant effect of warfarin by the administration of vitamin K, than it takes Pradaxa® to lose its anticoagulant effect because of the shorter biological half-life of Pradaxa®. If a patient had taken Pradaxa® in the previous one to two hours before being treated for bleeding, activated charcoal might be given to absorb any free remaining drug in the stomach or intestines, but the vast majority of patients could receive conventional treatments and safely wait till the anticoagulant effect of Pradaxa® had worn off.

[189]      What the evidence establishes is that inherently all anticoagulants propagate bleeding and while there is a reversal agent for warfarin and until recently there was no reversal agent for Pradaxa®, for the very rare patient for whom it would be safe to reverse an anticoagulant (with the attendant risk of precipitating a blood clot and a stroke), the patient on Pradaxa®, unlike the patient on warfarin, would not need an antidote because unlike warfarin, the anticoagulant effect of Pradaxa® would likely have already worn off. Save for very few cases, an emergency room physician would stop the administration of the anticoagulant but would not apply a reversal agent because of the risks associated with doing so. There is no-basis-in-fact for concluding that the failure to warn about the absence of an antidote for Pradaxa® was a potential cause of harm and there is no-basis-in-fact for concluding that the failure to warn was a potential cause of harm across the class of patients prescribed Pradaxa®.

[190]      There is no-basis-in-fact for concluding that the absence of an antidote for Pradaxa® created any undisclosed hazard for patients. The evidence was that the absence of an antidote was not an undisclosed hazard, because it was not a hazard for the reasons already expressed. And, it was common knowledge among the medical profession that the drug did not have an antidote. The evidence was that prescribing physicians treating patients for AF and emergency room physicians already knew about the absence of an antidote.

[191]      Moreover, save in a few individual cases, for cardiologists prescribing an anticoagulant, the absence of an antidote for Pradaxa® was not a reason for not prescribing Pradaxa® or for favouring a prescription of warfarin. There is no-basis-in-fact for concluding that across the class of patients prescribed Pradaxa®, the Class Members would not have used Pradaxa® because of the absence of an antidote.

[192]      In any event, if there was a failure to warn about the absence of an antidote, there was no-basis-in-fact for concluding that the failure applied commonly across a class of persons ingesting Pradaxa®. What was common to the class was that a physician had prescribed an anticoagulant that by its nature propagates bleeding but which was being prescribed to diminish the very grave risk of a stroke. However, the decision to prescribe an anticoagulant and the selection of the type of anticoagulant is based on patient-specific facts. The risks that a patient has of experiencing a stroke and his or her risk of experiencing a bleeding event, of which there is a wide range of variance in nature and intensity, are patient-specific. The need for an antidote for bleeding would depend on patient-specific factors, and the nature of a patient’s specific bleeding event would depend upon patient-specific factors. The need of a patient to be told about reversal agents or the absence of them is patient-specific and very much a matter of physician judgment on a case-by-case basis.

[193]      If there was a common failure to warn, there is no common harm across the class because the individual Class Members would not be harmed by the absence of a warning because the absence of an antidote would not and ought not to have affected their decision to take Pradaxa® because their alternative would be to take warfarin which although it had an antidote, would take longer to reverse itself than it would take for Pradaxa® to naturally lose its operative effect.

[194]      The case at bar is not like Parker v. Pfizer Canada Inc., 2012 ONSC 3681, where I certified a products liability failure-to-warn-action against the manufacturer of a smoking cessation drug that had a long list of neuropsychiatric adverse events including suicidal and homicidal ideation. In that case, the long list of neuropsychiatric adverse events did not eradicate a common complaint about a failure to warn. However, in the case at bar, there is no-basis-in-fact to conclude that the absence of an antidote was a danger in the ordinary use of Pradaxa®, and if the absence of an antidote was a danger in ordinary use, there is no-basis-in-fact to conclude that the absence of an antidote was a danger common to the Class Members. The case at bar is not a case where it could be said that there is some-basis-in-fact for concluding that all Class Members needed to be told by their physicians that that the drug they were taking had no antidote, and this is particularly true when the alternative of warfarin, which did have a reversal agent, would in most cases be less than the optimum choice of anticoagulant and might be disadvantageous and (more) harmful to the patient.          

[195]      I conclude that Questions 1 and 2 do not qualify as common issues.

[196]      I wish to be clear that the conclusions in the immediate case are an application of existing principles to the particular circumstances of the immediate case. Although the standard is low, in the immediate case, based on their own evidence, the Plaintiffs did not satisfy me that there was some-basis-in-fact for the existence of common issues 1 and 2. In the immediate case, the absence of commonality arises from the particular nature of a duty to warn problem that involves an alleged failure to warn a learned intermediary about the absence of an antidote when there is no-basis-in-fact for concluding that the absence of an antidote was a hidden defect or that the absence of an antidote posed a common and material risk across the class. In contrast to the immediate case, most duty to warn cases simply involve an alleged failure by the defendant to warn about a hidden defect or potential risk of harm caused by the use of the product.       

[197]       Question 3 is apparently meant to be a general causation question, but it fails for the same reasons that questions 1 and 2 fail and for two additional reasons.

[198]      The first additional reason is that there was no common class-wide potential injury or risk of injury arising from the absence of an antidote. The evidence is that Pradaxa® (or warfarin) does not give rise to dangerous or life-threatening events for persons who have ingested Pradaxa® (or warfarin) because, strictly speaking, anticoagulants do not cause dangerous or life threatening events; they are prophylactics prescribed to prevent dangerous life-threatening events, like a stroke from AF. However, as foreshadowed earlier, it can be said Pradaxa® (or warfarin) does exacerbate some life-threatening events; namely excessive bleeding, in the sense that anticoagulants by their nature interfere with the coagulation meant to stop bleeding. Nevertheless, across the class of persons taking Pradaxa® the absence of a reversal agent does not further exacerbate this problem, any more than the presence of vitamin K better ameliorates the problem across the class of persons taking warfarin. The point is that there is nothing generalized, i.e., common across the class, about the circumstances of a life-threatening bleeding event and the absence of an antidote, and whether the patient on Pradaxa® (or warfarin) needs a reversal agent is a patient-specific circumstance. Indeed, considerable care must be taken before administering a reversal agent to an anticoagulant because doing so may bring on the dangerous or life-threatening event for which the anticoagulant was meant to be prophylactic.   

[199]      The second additional reason why the causation issue in the case at bar fails the commonality tests is the absence of a methodology to prove general causation. Where a plaintiff seeks to address questions of causation on a class-wide basis as the foundation for his or her class action, there must be some evidence of a methodology that will enable the plaintiff to prove causation on a class-wide basis: Charlton v. Abbott Laboratories Ltd., 2015 BCCA 26, rev’g 2013 BCSC 1712; Chadha v. Bayer Inc., supra, at para. 52, aff’g (2001), 2001 CanLII 28369 (ON SCDC), 54 O.R. (3d) 520 (Div. Ct.), leave to appeal refused, [2003] 2 S.C.R. vi. Where no such methodology is put forward by the plaintiffs, there is not sufficient evidence before the court to show that the resolution of the proposed general causation common issue will efficiently advance the claim: Charlton v. Abbott Laboratories Ltd., supra at para. 84; Pro-Sys Consultants Ltd. v. Microsoft Corporation, supra at para. 115; AIC Limited v. Fischer, 2013 SCC 69 at para. 43.

[200]      In Chadha v. Bayer Inc., supra, which was a competition conspiracy action, the Court of Appeal denied certification because there was no evidence that liability could be proved on a class-wide basis and thus there was no common issue. In Charlton, the defendants manufactured an antidepressant that contained sibutramine. There was some-basis-in-fact that sibutramine increased blood pressure and the risk of heart attacks and strokes in persons with a pre-existing cardiovascular condition. The plaintiffs, who as individuals had suffered strokes and heart attacks after being prescribed with drugs containing sibutramine, brought a proposed class action on behalf of patients prescribed with the drug. The expert evidence established that there was no methodology to establish that sibutramine had the potential to harm other than those with a pre-existing cardiovascular condition. Reversing the motions judge, the British Columbia Court of Appeal concluded that he had erred in certifying the class action.

[201]      In the case at bar because of the particular nature of the duty to warn problem, there was no evidence of a methodology that would enable the Plaintiffs to prove causation on a class-wide basis, and this is another reason to conclude that question 3 is not certifiable.     

[202]      Putting aside that question 4 is ambiguous, unclear, and cryptic, in my opinion, the meaning that can be deciphered from it relates to the individual situations of the Class Members and is also dependent on the various legislative schemes of the provinces and territories. It is not a common issue. And, apart from being essentially an individual issue, assuming question 4 was amenable to class-wide treatment, it would add almost nothing to moving the action forward.

[203]      Question 4 fails the test for certification as a common issue.

[204]      As drafted in the factum, question 5 is not certifiable as a common issue.  However, a question about punitive damages is certifiable as a common issue. The appropriate question is: Does the conduct of the Defendants deserve an award of punitive damages if the other prerequisites for such an award were satisfied?

[205]      In Waldman v. Thomson Reuters Corp., 2012 ONSC 1138, leave to appeal to Div. Ct. refused, 2012 ONSC 3436 (Div. Ct.), I explained that although a claim for the assessment of punitive damages will not be suitable for a common issue when the court cannot make a rational assessment about the appropriateness of punitive damages until after individual assessments of the compensatory losses of class members has been completed, nevertheless, the question of whether the defendant’s conduct was sufficiently reprehensible or high-handed to warrant punishment is capable of being determined as a common issue. This approach was endorsed in Chalmers (Litigation guardian of) v. AMO Canada Co., 2010 BCCA 560 and in other cases.

[206]        Although the question of whether the conduct of the Defendants deserves an award of damages is an appropriate question for certification, nevertheless, in the immediate case, I would not certify the question because the certification of a question about punitive damages presupposes that there are common issues about the Defendants’ predicate liability and in the immediate case, there are no such questions. Put differently, a common issue about punitive damages is not certifiable in the absence of other certifiable common issues. If there are no common issues about liability, it is nonsensical to certify a common issues about the extent of the remedies.  

[207]      I, therefore, conclude that question 5 fails the test for certification.

[208]      And, I conclude that the common issues criterion is not satisfied in the immediate case.

[209]      Since the case at bar fails the common issues criterion, it is axiomatic that it also fails the preferable procedure criterion. See O’Brien v. Bard, 2015 ONSC 2470.

[210]      Since the case at bar fails the common issues and preferable procedure criterion, the issue of whether the Plaintiffs have satisfied the fifth and final criterion for certification is also unsatisfied. The fifth and final criterion for certification as a class action is that there is a representative plaintiff who would adequately represent the interests of the class without conflict of interest and who has produced a workable litigation plan.

[211]      The representative plaintiff must be a member of the class asserting claims against the defendant, which is to say that the representative plaintiff must have a claim that is a genuine representation of the claims of the members of the class to be represented or that the representative plaintiff must be capable of asserting a claim on behalf of all of the Class Members as against the defendant: Drady v. Canada (Minister of Health), 2007 CanLII 27970 (ON SC), [2007] O.J. No. 2812 (S.C.J.) at paras. 36-45; Attis v. Canada (Minister of Health), [2003] O.J. No. 344 (S.C.J.) at para. 40, aff'd [2003] O.J. No. 4708 (C.A.).

[212]      Provided that the representative plaintiff has his or her own cause of action, the representative plaintiff can assert a cause of action against a defendant on behalf of other Class Members that he or she does not assert personally, provided that the causes of action all share a common issue of law or of fact: Boulanger v. Johnson & Johnson Corp., [2002] O.J. No. 1075 (S.C.J.) at para. 22, leave to appeal granted, [2002] O.J. No. 2135 (S.C.J.), varied (2003), 2003 CanLII 45096 (ON SCDC), 64 O.R. (3d) 208 (Div. Ct.) at paras. 41, 48, varied 2003 CanLII 52154 (ON CA), [2003] O.J. No. 2218 (C.A.); Matoni v. C.B.S. Interactive Multimedia Inc., 2008 CanLII 1539 (ON SC), [2008] O.J. No. 197 (S.C.J.) at paras. 71-77; Voutour v. Pfizer Canada Inc., [2008] O.J. No. 3070 (S.C.J.); LeFrancois v. Guidant Corp., [2008] O.J. No. 1397 (S.C.J.) at para. 55.

[213]      Whether the representative plaintiff can provide adequate representation depends on such factors as: his or her motivation to prosecute the claim; his or her ability to bear the costs of the litigation; and the competence of his or her counsel to prosecute the claim: Western Canadian Shopping Centres Inc. v. Dutton, supra at para. 41.

[214]      In the immediate case, the Plaintiffs do not have claims that are representative of the claims of all Class Members for the reasons expressed above about the failure of the common issues criterion.

[215]      I conclude that the representative plaintiff criterion is not satisfied. 

[216]      For the above reasons, the certification motion is dismissed without costs.