In recent years, many pharmaceutical class actions in Canada that have proceeded to a motion for certification have been certified. However, the recent case Batten v. Boehringer Ingelheim (Canada) Ltd. [Batten] is another welcome example of a Canadian court denying certification of a proposed pharmaceutical class action. The case involves the novel oral anticoagulant (NOAC), Pradaxa®.
Despite pleading many causes of action, the plaintiffs pursued only their “failure to warn” claim for certification. The allegation centred around the fact that, for the majority of the relevant time period, Pradaxa® (unlike the pre-existing commonly used anticoagulant, warfarin) did not have a specific antidote that could reverse its anticoagulant effect.
The plaintiffs requested that Perell J. find that the following key issues (among others) existed and were certifiable as common issues:
- Did any of the Defendants have a duty to warn the Class Members of the risks of harm, namely from the lack of an antidote for Pradaxa®?
- Can the lack of an antidote for Pradaxa® give rise to or exacerbate dangerous or life-threatening events for persons who have ingested Pradaxa®?
Justice Perell ultimately found that there was no basis in fact to support the existence of either as common issues.
A Reminder that Plaintiffs Must Show “Some Basis in Fact”
Justice Perell reminds readers in his decision that, despite a lowered evidentiary bar at certification, it is still the plaintiff’s burden to show that there is some basis in fact that the proposed common issues exist:
 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.
 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… 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 [citations omitted].
 In particular, there must be a basis in the evidence before the court to establish the existence of common issues [citations omitted].
No Basis in Fact to Support a Duty to Warn
In relation to the first question, Perell J. found that there was no basis in fact to conclude that a common issue about a duty to warn about the absence of an antidote exists. He noted that there was a lack of evidence that a patient on Pradaxa® who experiences a bleeding event is at a greater risk of unstoppable bleeding due to the lack of an antidote than a patient on warfarin who experiences a bleeding event.
Perell J. further concluded that the evidence showed the lack of an antidote was not an “undisclosed hazard”, as it was not a hazard at all, based on the following evidence:
- There is no increased risk for developing life-threatening injuries for patients who are prescribed Pradaxa® rather than warfarin; and
- 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.
No Basis in Fact to Support Commonality
Justice Perell also found that there was no basis in fact to conclude that the question of whether the defendants had a duty to warn about the absence of an antidote could be answered in common across the class of persons who ingested Pradaxa® because:
- A patient’s risk 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 to treat bleeding would depend on patient-specific factors;
- The nature of a patient’s specific bleeding event would depend upon patient-specific factors;
- The need for 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.
Justice Perell explained that, since the alternative for a patient to taking a NOAC like Pradaxa® would be to take warfarin, knowing about the lack of antidote for Pradaxa® ought not to affect a patient’s decision to take it, as warfarin has a longer half-life and, therefore, takes longer to reverse itself.
Justice Perell concluded that the absence of commonality is inherent in the nature of this case. He noted that most duty to warn cases 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; however, in this case, the absence of commonality arises from the particular nature of the duty to warn problem: 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.
A Lack of Methodology to Prove General Causation for the Class
The second common issue that the plaintiffs requested be certified was classified by Perell J. as their general causation question. Justice Perell found that it failed as a common issue for the same reasons as the first question and for two additional reasons:
- 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; and
- 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 and the plaintiffs provided no such evidence.
Batten provides an excellent precedent for defendants of future pharmaceutical class actions. A few key takeaways are:
- While the evidentiary burden on a certification motion of “some basis in fact” is low, it exists for a reason. In order for a class action to be certified, plaintiffs must be able to satisfy a judge that there is a sufficient evidentiary basis for the facts on which the claims of the class members depend, i.e. that the common issues exist and are, in fact, common.
- There are some cases where commonality will be impossible to prove. Where a plaintiff alleges that a defendant failed to warn a learned intermediary about something that is neither a hidden defect of the product nor a material risk across the class, defendants should seriously consider resisting certification on that issue.
- The general causation principle in Pro-Sys Consultants v Microsoft holds true for pharmaceutical class actions: where a plaintiff seeks to certify questions of causation, there must be some evidence of a methodology that will enable the plaintiff to prove causation on a class-wide basis.