Canada: Successful Resistance Of Certification In A Pharmaceutical Class Action

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.1 [Batten] is another welcome example of a Canadian court denying certification of a proposed pharmaceutical class action.2 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:

  1. 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®?
  2. 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:

[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... 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].

[162]     In particular, there must be a basis in the evidence before the court to establish the existence of common issues [citations omitted].3

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:

  1. 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
  2. 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.

Practical Takeaways

Batten provides an excellent precedent for defendants of future pharmaceutical class actions. A few key takeaways are:

  1. 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.
  2. 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.
  3. The general causation principle in Pro-Sys Consultants v Microsoft4 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.

Footnotes

1. 2017 ONSC 53

2. Certification was also denied in Martin v AstraZeneca, 2012 ONSC 2744, aff'd 2013 ONSC 1169 (Div. Ct.)

3. Batten, 2017 ONSC 53 at paras. 160-162

4. Pro-Sys Consultants v Microsoft, 2013 SCC 57 at para. 115

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions