Canada: B.C. Court Confirms Plaintiffs Must Provide Workable Causation Methodology To Certify Product Liability Class Proceedings

In Charlton v. Abbott Laboratories, Ltd., 2015 BCCA 26 (Charlton), the British Columbia Court of Appeal clarified the evidentiary threshold plaintiffs must satisfy at the certification stage in the context of product liability class actions. In particular, the Court confirmed that plaintiffs alleging that a product causes adverse effects or injury must adduce evidence of a workable methodology to demonstrate that the product in question was capable of causing adverse effects on a class-wide basis. In so ruling, the Court reiterated the principles articulated by the Supreme Court in the 2013 "indirect purchaser trilogy," and affirmed their application to the product liability context. Ultimately, the plaintiffs in Charlton failed to adduce sufficient evidence of general causation, which proved fatal to the certification of the action.


In 2011, a class action was commenced against Abbott Laboratories, Ltd. (Abbott) and Apotex, Inc. (Apotex) on behalf of all individuals in Canada who were prescribed a drug containing sibutramine, on the basis that ingestion of sibutramine allegedly caused or contributed to adverse cardiovascular health, including heart attacks, strokes, increased blood pressure, increased heart rate and irregular heartbeat. The plaintiffs pleaded various causes of action, including negligence, failure to warn and breaches of the B.C. Business Practices and Consumer Protection Act and the Competition Act, in addition to seeking damages pursuant to the doctrine of waiver of tort.

Notably, some of the members of the class reported suffering from cardiovascular events like heart attacks or strokes after being prescribed sibutramine, while others had not. Furthermore, it was unclear from the evidence how many class members (if any) had a pre-existing history of cardiovascular illness.

Expert Evidence at Certification

The plaintiffs filed two medical expert reports in support of their application for certification, and the defendants filed two responding expert reports. After considering the expert evidence as whole, the Court of Appeal summarized the evidence as follows:

  • There was some evidence of increased risk for cardiovascular events in individuals with pre-existing heart problems.
  • The Canadian product monograph cautioned against prescribing sibutramine to patients with a history of cardiovascular disease.
  • There was no evidence presented to suggest that the drugs in question had in fact been prescribed to individuals with pre-existing conditions.
  • The extent of the risk for individuals with no history of cardiovascular disease had not been studied, and the statistical evidence that was available did not demonstrate a measurable increase in the risk for patients with no history of cardiovascular disease.

The B.C. Supreme Court's Decision on Certification

The certification judge found the claim met the test for certification in all respects and certified the class, which was defined as "[a]ll persons in Canada who were prescribed and ingested [sibutramine] ... ."

Among the various common issues certified by the certification judge was the issue of whether sibutramine causes or contributes to heart attacks, strokes and irregular heartbeat in relation to all Canadian patients who were prescribed and ingested drugs containing sibutramine, whether or not they had a pre-existing cardiovascular condition.

The appellants appealed the certification decision, arguing that the certification judge erred in principle by certifying the proceedings. The appellants focused their argument on the asserted failure of the plaintiffs to lead evidence of a methodology for establishing general causation on a class-wide basis.

B.C. Court of Appeal Overturns Certification

Relying on the Supreme Court of Canada's 2013 trilogy of cases in the indirect purchaser context,1 the B.C. Court of Appeal reiterated the principle that a class action should not be certified where a plaintiff fails to adduce some evidentiary basis for a methodology that could be used by the Court to answer the common questions. In this regard, the Court observed that the question of class-wide general causation should not be certified as a common issue without evidence of a methodology to prove such causation in respect of the class as a whole. In so commenting, the Court drew a distinction between certain prior pharmaceutical class actions in which causation had been held to be sufficiently established on the basis of evidence of a general increase in risk to the class caused by using the drug in question and the case before it, where no such generalized risk data was available.

The Court ultimately concluded that the lack of a methodology for demonstrating general causation was an insurmountable evidentiary hurdle:

[t]here was no evidence of a methodology for establishing that the class as a whole, as opposed to those who were wrongly prescribed sibutramine despite a history of disease, was affected or put at risk by its use of sibutramine. ...

While there is no dispute that those with pre-existing cardiopulmonary disease are at a statistically increased risk of adverse cardiac events, this is not a case where the experts disagree on the extent of the risk, but rather, a case where the experts are uncertain whether there is a risk to the class as a whole and cannot describe a methodology for addressing that question.

The remaining common issues hinged upon a finding of general causation on a class-wide basis. Accordingly, absent a workable methodology for addressing causation, the Court concluded that certification should not have been granted and set aside the certification order of the trial judge.

Notably, in denying certification, the B.C. Court of Appeal also harmonized an apparent inconsistency between the trial judge's decision in Charlton and a parallel proceeding in Québec in which certification had been denied (though admittedly in the context of a different legal regime). In particular, the Québec Superior Court was presented with a similar evidentiary record to that in Charlton, and held in a decision released in 2012 that the evidence put forward by the plaintiffs in that case was insufficient to meet the test for class action authorization pursuant to section 1003 of the Québec Code of Civil Procedure.

Implications: A Stricter Approach to Certification?

The appellate decision in Charlton represents a clear affirmation of the recent judicial statements to the effect that class action plaintiffs bear the burden of establishing causation on a class-wide basis. In particular, the case illustrates the fact that causation cannot simply be presumed, nor is it sufficient for plaintiffs to simply argue that a product could – in the abstract – cause injury to certain consumers. Rather, the plaintiffs must adduce some evidence – or at least a workable methodology at the certification stage – in order to satisfy the courts that some manner of class-wide conclusions regarding causation could reasonably be drawn.

Moreover, the case is also reflective of the increased willingness on the part of the courts to intervene at the certification stage where the underlying merits of the proceedings are somehow problematic. In particular, as discussed in a previous Osler Update, the courts appear to have moved away from a rigid application of the certification criteria to a broader consideration of the proceedings as a whole. Although the certification test is not intended to be a test of the merits of the action, the decision in Charlton nonetheless demonstrates the crucial importance of the evidentiary record, even at the certification stage. In the wake of the Supreme Court of Canada's reaffirmation that certification should serve as a "meaningful screening device"2, courts are now carefully considering the inter-relationship between the definition of the class, the common issues and the available evidence to determine not only whether the certification test has been met, but also whether the matter should be allowed to proceed more generally.


1. Pro-Sys Consultants Ltd. v. Microsoft Corporation, 2013 SCC 57 [Pro-Sys], Sun-Rype Products Limited v. Archer Daniels Midland Company, 2013 SCC 58, and Infineon Technologies AG v. Option consommateurs, 2013 SCC 59.

2. Pro-Sys, supra at para. 103.

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

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

In association with
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

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