) ) ALBERT C. BATTEN v. THE ESTATE, 2017 ONSC 6098

CITATION : Batten v. Boehringer Ingelheim (Canada) Ltd., 2017 ONSC 6098 DIVISIONAL COURT FILE NO.: 61/17 DATE: 20171103 ONTARIO SUPERIOR COURT OF JUSTICE DIVISIONAL COURT Morawetz R.S.J., Swinton and DiTomaso JJ. BETWEEN: ) ) ALBERT C.

BATTEN and THE ESTATE OF MARGARET JANE HAMILTON, on behalf of her Estate Representative Wendy Nelson, and WENDY NELSON, personally Plaintiffs (Appellants) – and – BOEHRINGER INGELHEIM (CANADA) LTD., BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BOEHRINGER INGELHEIM PHARMA GMBH & CO KG, and BOEHRINGER INGELHEIM INTERNATIONAL GMBH Defendants (Respondents) ) ) ) ) ) ) ) ) ))))))))) Daniel E.H. Bach and Ronald Podolny , for the Plaintiffs (Appellants) J.

Scott Maidment, Calie Adamson and Anna Tombs , for the Defendants (Respondents) ) ) ) HEARD at Toronto: September 25, 2017 Swinton J.: Overview [ 1 ] The appellants, plaintiffs in a proposed class proceeding, appeal from the order of Perell J. dated January 5, 2017, in which he dismissed their motion for certification.

The motions judge found that the duty to warn there was no antidote for the drug Pradaxa® was not a common issue. [ 2 ] The appellants submit that the motions judge erred in principle by improperly considering the merits of the proceeding in determining whether the common issues criterion had been met. I disagree, and for the reasons that follow, I would dismiss the appeal. Factual Background [ 3 ] Boehringer Ingelheim (Canada) Ltd. (“BICL”) is the Canadian manufacturer of Pradaxa®, an anti-coagulant drug used to treat stroke prevention in patients with atrial fibrillation (“AF”), among other conditions.

Those with AF are at risk of having the flow of blood slow or stagnate in areas of the heart. This may result in the formation of blood clots, which leads to an increased risk of stroke. Anti-coagulants reduce the risk of clot formation and thus reduce the risk of strokes. However, while anti-coagulants do not cause bleeding, they do create an increased risk of prolonged or persistent bleeding in patients who experience bleeding because of another disease state – for example, a bleeding ulcer. [ 4 ] Pradaxa® was introduced by BICL in 2008 as an alternative to warfarin, a drug which has been in use since 1954.

The evidence filed by the respondents for the certification motion described in detail the differences between warfarin and Pradaxa®. [ 5 ] Warfarin acts as a Vitamin K antagonist. For warfarin to be effective, the patient must maintain an International Normalized Ratio (“INR”) between 2 and 3. INR is a measure of how long it takes a clot to form. It is difficult to maintain a stable INR, because INR fluctuates due to patient-specific factors. Those using warfarin must observe dietary restrictions and undergo frequent blood monitoring and frequent dose adjustments.

There is an antidote for warfarin, through the administration of Vitamin K, but it is rarely used because of associated risks, including an increased risk of stroke. [ 6 ] Pradaxa® has a fixed dosing regimen, minimal interactions with other drugs and no food interactions. It has a predictable anti-coagulant response, with a rapid onset and faster decline of effectiveness. There is no need for monitoring INR in patients taking

Pradaxa®. As well, Pradaxa® has a significantly lower risk of intra-cranial bleeding (“ICH”) than warfarin. However, prior to 2016,there was no approved antidote for Pradaxa®. [7] The appellants initially sought to certify a class proceeding alleging negligence in the design and manufacture of Pradaxa®. However, at the time of the certification motion, they sought to certify only with respect to the issue of an alleged breach of the duty towarn that there was no antidote for Pradaxa®. The Decision of the Motions Judge [8] The motions judge determined that the question relating to the duty to warn did not meet the common issues criterion in s.5(1)(

c) of the Class Proceedings Act,1992, S.O. 1992, c. 6 (the CPA”). He concluded that there was no basis in fact to conclude that thefailure to warn about the absence of an antidote for Pradaxa® was a common issue. Alternatively, if there was a duty to warn about theabsence of an antidote, there was no basis in fact to conclude that the failure to warn could be answered in common across the proposedclass of patients who had taken Pradaxa® (Reasons, paras. 185-196).

More precisely, he stated (at para. 186): … 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 andthere is no-basis-in-fact for concluding that – as a class – persons who ingested Pradaxa® would suffer any harm from not being warnedabout the absence of an antidote for Pradaxa®. The Issue on Appeal [9] The appellants argue that the motions judge erred in principle in applying the common issues criterion for certification,because he engaged in a merits-based analysis and weighed competing expert evidence.

They ask this Court to overturn the decision andto grant certification. Analysis [10] In this proposed class proceeding, the appellants allege that the respondents breached a duty to warn that there was no antidotefor Pradaxa® that could stop excessive bleeding. They submit that the respondents breached the duty to warn because of the allegeddeficiency in the Product Monograph for Pradaxa®: the information that there was no antidote for Pradaxa® was found in the sectiondealing with Overdosage, and not in the warnings

section or the

section addressed directly to consumers. [11] Before the motions judge, the appellants proposed common issues concerning the duty to warn, causation and punitivedamages. The question relating to the duty to warn was framed as whether any of the defendants had a duty to warn the class membersof the risks of harm, namely from the lack of an antidote for Pradaxa®.

While the appellants have rephrased their proposed commonissues in their factum for this appeal (as set out in para. 34 of the factum), in my view, this has no impact on the result of the appeal. [12] The motions judge set out the governing legal principles to be applied in a motion for certification at paras. 161 through 164of his Reasons. In particular, he instructed himself that he was not to assess the merits of the plaintiffs’ claim in a motion forcertification.

Rather, with respect to the common issues criterion, he must determine whether there is some basis in fact that establishesthere is an issue or issues common to all class members.

He was aware that the evidentiary threshold is low, stating at para. 164: The some-basis-in-fact test sets a low evidentiary standard for plaintiffs, and a court should not resolve conflicting facts and evidence atthe certification stage or opine on the strengths of the plaintiff’s case; the focus at certification is whether the action can appropriately goforward as a class proceeding ... [13] The motions judge also set out the governing legal principles for determining whether the common issues criterion in s. 5 ofthe CPA had been met at paras. 174-180 of his Reasons. [14] The appellants suggested, in oral argument but not in their factum, that the motions judge erred by stating that the commonissues test requires a two-step inquiry: “(1) the proposed common issue actually exists; and (2) the proposed issue can be answered incommon across the entire class” (at para. 180).

They rely on a recent decision of Belobaba J. in Kalra v. Mercedes Benz Canada Inc.,2017 ONSC 3795 where he rejected a two stage analysis (at paras. 45 - 46), although he had applied the two stage analysis in the past. He stated that he preferred a one stage analysis that focused on class-wide commonality. [15] I see no conflict between the common issues test as applied by the motions judge in the present case and the existingjurisprudence. For example, the Ontario Court of Appeal stated in Fulawka v.

Bank of Nova Scotia, 2012 ONCA 443 at para. 79 thatthere must be some evidentiary basis to show that a common issue exists beyond a bare assertion in the pleadings. There is no conflictbetween his approach and that in Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 , [2013] 3 S.C.R. 477. Thatcase does not directly address a one stage versus a two stage inquiry. Rather, it emphasizes that “the factual evidence required at thisstage goes only to establishing whether these questions are common to all the class members” (at para. 110).

In my view, the motionsjudge applied the governing legal principles. [16] The major argument of the appellants is that despite the correct enunciation of the governing legal principles, the motionsjudge actually engaged in the weighing of evidence and entered into a consideration of the merits when he dealt with the common issuescriterion. As this was an error in principle, the appellants argue that his decision is subject to review on a standard of correctness. [17] In support of their argument, the appellants point to the following statement at para. 120 of the motions judge’s Reasons, “Ifound Dr.

Sommer’s evidence unhelpful and unconvincing, and I very much prefer the evidence of Dr. Wulffhart and Dr. Chopra set outbelow.” Dr. Sommer, a specialist in emergency medicine, was an expert for the appellants, while Dr. Wulffhart, a cardiologist, and Dr.Chopra, head of emergency medicine at University Health Network in Toronto, were experts for the respondents. [18] It is important to note that this sentence is found in the

section of the Reasons where the motions judge was summarizing theevidence, and in my view, that statement had no impact on the outcome of the motion. When one turns to the

section of the Reasons

dealing with the common issues criterion, it is clear that the motions judge did not impermissibly weigh the evidence of the appellants’ experts against that of the respondents and prefer the latter where there was conflict. Nor did he, as the appellants assert, determine that the appellants’ claim could not succeed on the merits.

Rather what he did was to consider the evidence of all the expert witnesses and apply the “some basis in fact” test. [ 19 ] It was permissible for the motions judge to rely on the evidence filed on behalf of the respondents on matters that were not directly addressed by the appellants’ evidence.

As the Supreme Court of Canada stated in Pro-Sys , above, a motion for certification is to be a “meaningful screening device”: The standard for assessing evidence at certification does not give rise to a ‘determination of the merits of the proceeding’ ( CPA , s. 5(7)); nor does it involve such a superficial level of analysis into the sufficiency of the evidence that it would amount to nothing more than symbolic scrutiny. (at para. 103) [ 20 ] The motions judge assessed the evidence of the main witnesses for the appellants, Dr. Sommer and Stanley North, a consultant in regulatory affairs who is not a doctor.

He then looked to the evidence of the respondents’ medical experts to fill in significant gaps in the appellants’ evidence concerning the relevance of antidote information in a dialogue between a patient and a physician about the use of warfarin versus Pradaxa®, the role that an antidote would play in the choice of an anti-coagulant, and the management of excessive bleeding in patients who are taking Pradaxa®.

The respondents filed undisputed medical evidence to show that any relationship between the alleged failure to warn and the alleged harm from the lack of an antidote for Pradaxa® is patient- specific and not subject to determination on a common basis. [ 21 ] The motions judge recognized that the respondents had a duty to warn of dangers inherent in the use of Pradaxa® of which it had knowledge or ought to have knowledge (at para. 186).

However, after he assessed the evidence before him, he concluded that there was no basis in fact for concluding that the failure to warn of the lack of an antidote was a potential cause of harm. [ 22 ] In reaching this conclusion, the motions judge relied on undisputed evidence establishing that the absence of an antidote for Pradaxa® is not a relevant matter for the majority of individuals who take Pradaxa® (see para. 187). There was no basis in fact to conclude that patients taking Pradaxa® were at an increased risk of life-threatening injuries when compared to patients taking warfarin.

The evidence showed that patients presenting with increased bleeding would be treated using conventional methods. An antidote would be rarely used, because of the risks associated with it. For example, ceasing to use the drug is a valuable treatment option because Pradaxa® has a half-life of approximately 12 to 14 hours, and its anti-coagulant effect wears off within 12 to 24 hours after cessation.

The evidence showed that it would take longer to reverse the anti-coagulant effect of warfarin with Vitamin K than it takes Pradaxa® to lose its anti-coagulant effect, because the latter has a shorter biological half-life. [ 23 ] Ultimately, the motions judge concluded that there was no basis in fact to conclude that the absence of an antidote for Pradaxa® created any undisclosed hazard for patients (at para. 190).

He also concluded that there was no basis in fact to conclude that across the class, members would not have used Pradaxa® because of the absence of an antidote (at para. 191). [ 24 ] Moreover, the motions judge concluded that even if there was a failure to warn about the absence of an antidote, there was no basis in fact to conclude that there would be a common harm across the class from the failure to warn.

He relied on undisputed expert evidence that the circumstances in which the antidote to Pradaxa® is appropriate are rare, and the need for a patient to be told about antidotes or the lack thereof is patient-specific (at para. 192).

As he stated at para. 194: 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 [sic] 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. [ 25 ] In my view, the motions judge applied the “some basis in fact” test, as he was required to do.

He did not weigh competing evidence, but relied on undisputed evidence in support of his conclusions that the low threshold for common issues had not been met. The appellants have not demonstrated any palpable and overriding error in his treatment of the evidence. [ 26 ] I turn now briefly to the proposed question on causation – namely, whether the lack of an antidote for Pradaxa® can give rise to dangerous or life threatening events for persons who have ingested the drug.

I agree with the motions judge’s conclusion that there was no common class-wide potential injury or risk of injury arising from the absence of an antidote. As he stated at para. 198: 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.

As well, he found that the causation issue was not a common issue because the appellants had failed to show that there was a methodology that would prove causation of harm on a class-wide basis. [ 27 ] Finally, the motions judge appropriately refused to certify a question dealing with punitive damages, given the absence of other certifiable common issues. Conclusion [ 28 ] The motions judge’s decision on certification is entitled to substantial deference, absent an error of principle or a palpable and overriding error of fact ( Markson v. MBNA Canada Bank , 2007 ONCA 334 at para. 33 ).

The appellants have failed to demonstrate any error in principle or fact, and accordingly, the appeal is dismissed. [ 29 ] The parties have agreed that there will be no costs of the appeal.

_______________________________ Swinton J. I agree _______________________________ Morawetz R.S.J. I agree _______________________________ DiTomaso J. Released: November 3, 2017 CITATION : Batten v. Boehringer Ingelheim (Canada) Ltd., 2017 ONSC 6098 DIVISIONAL COURT FILE NO.: 61/17 DATE: 20171103 ONTARIO SUPERIOR COURT OF JUSTICE DIVISIONAL COURT Morawetz R.S.J., Swinton and DiTomaso JJ. BETWEEN: ALBERT C.

BATTEN and THE ESTATE OF MARGARET JANE HAMILTON, on behalf of her Estate Representative Wendy Nelson, and WENDY NELSON, personally Plaintiffs (Appellants) – and – BOEHRINGER INGELHEIM (CANADA) LTD., BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., BOEHRINGER INGELHEIM PHARMA GMBH & CO KG, and BOEHRINGER INGELHEIM INTERNATIONAL GMBH Defendants (Respondents) REASONS FOR JUDGMENT Swinton J.

Released: November 3, 2017