On May 7, 2012, the Ontario Superior Court of Justice released its decision in Martin v. AstraZeneca Pharmaceuticals PLC (Martin), dismissing the plaintiffs' motion for certification of a class proceeding related to the pharmaceutical medicine Seroquel® for the reasons summarized below. This is the first case in Ontario to deny certification of a proposed class action involving a pharmaceutical medicine.
In Martin, the plaintiffs sought to certify a class consisting of "all persons in Canada who were prescribed and who consumed" the pharmaceutical medicine Seroquel®, an atypical antipsychotic drug. It was first approved in 1997 by Health Canada for the treatment of schizophrenia and bipolar disorder.
The plaintiffs in Martin alleged that Seroquel® caused various health risks to users including weight gain, diabetes "and/or related metabolic disturbances", that the defendants had failed to warn members of the proposed class about those health risks and that the defendants had been negligent in the design, development, testing, manufacturing, distribution, marketing and sale of Seroquel®. The plaintiffs also alleged that the defendants had committed the tort of conspiracy by unlawful means and had unlawfully marketed Seroquel® for off-label (not approved by Health Canada) uses. The plaintiffs sought a disgorgement remedy (waiver of tort), punitive damages and special damages on behalf of the proposed class. The defendants denied each of the allegations against them and opposed certification.
Test for Certification
Applying the test from the Class Proceedings Act, 1992 (the CPA), the Court reviewed the available evidence, considered its admissibility and ultimately held that the plaintiffs had failed to establish each of the requirements for certification.
Evidentiary Standard on Certification
The Court confirmed the well-known proposition that certification motions are "procedural in nature and not intended to provide the occasion for an exhaustive inquiry into factual questions that would fall to be determined at trial." It also confirmed that a plaintiff's evidentiary burden on certification is low; the plaintiff needs only show some "basis in fact" to meet the requirements for certification. However, it held that the Court must consider the admissible evidence, including the evidence filed by the defendants, when deciding whether the plaintiffs have met the certification criteria. Further, while the evidentiary threshold is low at certification, the Court must perform a gatekeeper function. While it is not the role of the certification judge to assess and weigh evidence or to resolve conflicts in the evidence, there is no relaxed standard as to admissibility on the certification motion – the evidence tendered must satisfy the usual criteria for admissibility.
Evidence Admissibility Issues
At the certification hearing, the defendants challenged significant portions of the evidence filed by the plaintiffs as being inadmissible, including portions of the affidavits filed from the representative plaintiffs and by a lawyer at the plaintiffs' law firm. The defendants also challenged the admissibility of affidavit evidence from the plaintiffs' expert, Dr. Laura Plunkett, a U.S.-based "pharmacologist", "toxicologist", "FDA regulatory specialist" and "consultant." The defendants argued that statements made by Dr. Plunkett in her evidence were outside her area of expertise, were bald, conclusory and made without requisite foundation in fact.
Noting that the motion for certification failed regardless of the admissibility issues (and therefore it was not necessary to engage in a detailed analysis of the admissibility of the plaintiffs' evidence), the Court nevertheless considered the admissibility of Dr. Plunkett's evidence. The Court found significant portions of her evidence to be inadmissible, including opinion evidence regarding the adequacy of the Canadian warnings. The Court noted in particular that the case was about the marketing, sale and use of Seroquel® in Canada and not in the U.S. Likewise, it was Health Canada's approval of Seroquel® and the Canadian warnings that were relevant and in issue and not the actions of the FDA in the U.S. Dr. Plunkett had no Canadian training or experience and "to the extent" she had any regulatory expertise, it was "purely American". Further, the Court found that there was no evidence that Dr. Plunkett's U.S.-based expertise was transferrable to drug regulation in Canada.
Failure to Disclose a Cause of Action – Section 5(1)(a)
of the CPA
Following a well-known line of cases in Ontario, the Court confirmed that the plaintiffs' pleading must be read generously to allow for inadequacies due to drafting frailties and the plaintiffs' lack of access to key documents and discovery information at the time of pleading. It confirmed that s. 5(1)(a) of the CPA will be satisfied unless the claim has a radical defect or it is plain and obvious that it cannot succeed.
In the circumstances, however, the Court found that the plaintiffs' pleading offended the most basic rules governing pleadings and that it was plain and obvious that the plaintiffs' claims were bound to fail. Specifically, it found the plaintiffs' statement of claim suffered from two fundamental problems: the pleading was inconsistent in how it described the activities of each defendant; and it "lumped" the defendants together as a single enterprise and did not attempt to particularize how each defendant was liable to the proposed class for each of the causes of action alleged.
With respect to the first of these problems, the Court found that the plaintiffs' pleading created confusion and suffered from a lack of clarity as to "which defendant did what in relation to Seroquel®." Noting generally that defendants are entitled to know the precise nature of what they have allegedly done, it also found this problem was compounded by the plaintiffs' failure to identify the specific acts undertaken by each defendant.
As a matter of proper pleading, the Court held that it is inappropriate for plaintiffs to "lump" defendants together as a single enterprise, absent a pleading of material facts that would justify doing so. Here, the plaintiffs failed to identify the specific acts undertaken by each defendant with respect to each cause of action.
The Court found numerous flaws relating to each cause of action alleged and found that it was "plain and obvious" that they could not succeed. While non-exhaustive:
- The Court held that the plaintiffs' pleading offended
the Rules of Civil Procedure by failing to acknowledge the
difference between the various forms of negligent activity alleged
(negligent design, development, testing, manufacturing,
distribution, marketing and sale). By lumping these distinct types
of negligence together, the plaintiffs' pleadings were
"muddled" and "confused".
- The plaintiffs failed to draw a factual distinction between
approved and off-label uses of Seroquel®. The Court found the
pleadings with respect to off-label use were vague, commenting that
"unclear" allegations of off-label use had been
"simply ... dropped into the negligence pleading."
- With respect to the plaintiffs' allegations of
negligent design, development and testing, the Court found that the
plaintiffs failed to identify the alleged design defect. It further
held that the plaintiffs did not meet the requirements for
liability for negligent development and testing by failing to plead
that "a safer and economically more feasible alternative to
Seroquel® would have been adopted, but for the
- With respect to the allegations of negligent manufacture, the
plaintiffs failed to plead anything about what was allegedly
negligent about the manufacturing process. Further, there was a
"complete lack of material facts in the pleading" to
support this allegation.
- With respect to the allegations of negligent distribution,
marketing and sale, the plaintiffs failed to plead that
Seroquel®'s "alleged propensity to injure
outweighed the value of its use." Many of the
plaintiffs' allegations in this regard were also
essentially claims of negligent misrepresentation, for which the
plaintiffs had failed to plead particulars of reliance or the
damages suffered as a result.
- The plaintiffs failed to provide sufficient particulars
regarding the defendants' alleged breach of their duty to
warn. There was no indication of which particular defendant
allegedly breached its duty to warn, or which defendant owed such a
duty by virtue of having manufactured Seroquel®. The plaintiffs
had also failed to plead what warnings were given, how they were
inadequate, and whether or how they could have been improved.
- The allegations of conspiracy were similarly problematic. They lacked clarity, precision, and the material facts necessary to support each of the elements of the cause of action of conspiracy.
Identifiable Class – Section 5(1)(b) of the
With respect to s. 5(1)(b) of the CPA, the Court held that the plaintiffs had failed to provide evidence of an identifiable class.
In support of the existence of a class, the plaintiffs relied on a lawyer's affidavit to establish that the plaintiffs' firm had been contacted by more than 30 potential class members who had consumed Seroquel® for both approved and off-label uses. The lawyer's affidavit referred to similar class actions in Alberta, British Columbia and Quebec in support of the existence of a class.
The Court found this evidence to be insufficient to establish an
"air of reality" regarding the existence of the class.
The plaintiffs had failed to lead any evidence regarding the nature
of their contact with class counsel. There was also no evidence to
show that any of the 30 people wished to have their common
complaint heard (assuming there to be a common complaint) through a
class proceedings process.
The proposed class definition was also problematic because it failed to identify the time period in issue. As such, there was no way to assess whether the proposed class was defined more widely than necessary.
Common Issues – Section 5(1)(c) of the
The plaintiffs proposed 13 common issues for trial, none of which were held to meet the threshold for certification.
With respect to the proposed general causation issue – "Can Seroquel® cause weight gain, diabetes and/or related metabolic disturbances as well as secondary injuries flowing therefrom?" – the Court questioned the meaning of "metabolic disturbances as well as secondary injuries flowing therefrom", noting that this terminology was unclear and that the plaintiffs had been unable to explain what it meant. It held that the fact that a similar common issue had been certified in another case involving a similar medicine (Zyprexa®) was not a sufficient answer. Likewise, it held that the plaintiffs could not defer this question to trial on the basis that it would be explained through expert evidence. A certification judge cannot perform the task of assessing a common issue if it is unclear what it means.
The Court also considered whether a general causation issue relating to weight gain and diabetes could be assessed in common. Noting that the defendants warned regarding the risk of weight gain and diabetes, and that the answer to this question would not determine whether Seroquel® in fact caused diabetes or weight gain in any individual class member, it found that the determination of this question would mark "only the beginning of the inquiry." The plaintiffs had not provided any evidence to show that a methodology involving general population data (or some other approach) could be used to assess this issue in common and arrive at an answer that would be of any use to the class. In these circumstances, the proposed common issue constituted a "scientific question of interest" only, and was rejected.
With respect to the proposed common issue relating to off-label promotion, marketing, etc., of Seroquel®, the Court concluded that the plaintiffs had failed to lead any evidence that the defendants had promoted, marketed, etc., Seroquel® for off-label uses in Canada. The Court noted that off-label use and prescription is a common and necessary practice among physicians and patients in certain circumstances. It also held that the plaintiffs could not rely on a Settlement Agreement reached in U.S. litigation in which claims of "unapproved" use were settled by one of the named defendants. The U.S. settlement was entered into without any admission of liability on the part of the defendants and involved off-label promotion allegations in the U.S., not Canada. As such, it could not serve as "some evidence" to support certification of such a common issue in Canada.
The Court held that even if there was some evidence to support a common question relating to the plaintiffs' allegations of negligence (though there was no evidence in the Court's view), the question, as framed by the plaintiffs, was overly broad. The Court held that each of the different allegations (negligent design, development, researching, testing, recommending, advertising, promoting, and/or marketing of Seroquel®) would require an inquiry into the defendants' activities over a 14-year period. In essence, "it is a common issue that asks multiple questions". In these circumstances, the Court refused to certify the issue on the basis that it was too broad.
The Court also rejected the plaintiffs' proposed common issues related to the duty to warn. The common issue put forward by the plaintiffs assumed that a single duty to warn arose on the part of the defendants at a specific period of time. The Court held that such an assumption ignored that the defendants' duty to warn was ongoing, and would have changed over time. Further, the evidence established that the warnings in the product labelling had changed for both diabetes and weight gain over time, and were treated differently on the label over time. As such, it found that a single answer to the proposed common issue that would be common to all members of the proposed class over time was not possible. Further, even if certified, determination of this issue would result in an answer, "so general it would have no impact on the litigation."
With respect to the allegation of conspiracy, the Court found that the evidence relied on by the plaintiffs in support of this allegation was insufficient to constitute "some evidence" for the purposes of certifying a common conspiracy issue.
With respect to the remaining proposed common issues, the Court noted that each of the proposed common issues were remedial and focused on the class's entitlement to damages. Given the lack of any evidence to support any of the liability common issues, the Court found that there was no evidence to support certification of any common remedial issues. Notwithstanding this finding, the Court went on to reject each of the proposed remedial common issues on the basis that there was either no evidence to support such a common issue (waiver of tort), or that they were not appropriate in the circumstances of this case (punitive damages).
Preferable Procedure – Section 5(1)(d) of the
Having found that there was no single common issue that would significantly advance the litigation for the proposed class and/or that each of the liability common issues collapsed because the issues did not have a basis in fact and lacked commonality, the Court found there was no basis on which to conclude that a class action would be a fair, efficient and manageable method of advancing the claim.
The Representative Plaintiff and a Workable Litigation
Plan – Section 5(1)(e) of the CPA
The Court found that the plaintiffs had failed to put forward a suitable representative plaintiff. Based on the evidence, it had "serious" concerns as to whether the proposed representative plaintiffs had a sufficient level of interest and understanding of the action. It also found a lack of evidence demonstrating that their claims were "anchored in" the class actions, given their individual medical histories. These medical histories provided no evidence that their weight gain and diabetes had been caused by Seroquel®. Further, there was no evidence that the warnings in the product label were inadequate with respect to the weight gain and diabetes allegedly experienced by the proposed representative plaintiffs.
While the Court noted that the plaintiffs' work plan provided much of the usual detail that the Court expects to see, it described the work plan as a work of fiction "because there are no common issues that have been accepted".
The Martin decision will be helpful in opposing certification of a proposed pharmaceutical class action, especially where the product has not been recalled and remains on the market with Health Canada's approval. It remains to be seen whether this decision represents the beginning of a trend away from the certification of pharmaceutical class actions in Ontario, or whether it will be viewed as a decision that turned on the specific manner in which the claim was pleaded.
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.