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the action
Parties to proposed pharmaceutical class proceedings will want to take note of the recent decision in Martin v AstraZeneca.1 Martin is one of the few proposed Canadian class actions regarding a pharmaceutical product in which the Court refused to allow the plaintiffs to prosecute their claim as a class action. In Martin, Madam Justice Horkins of the Ontario Superior Court denied certification of a claim based on use of the drug Seroquel. Seroquel is an "atypical antipsychotic." It is approved by Health Canada to treat certain psychiatric illnesses such as schizophrenia and bipolar disorder. The plaintiffs also claim that physicians often prescribe Seroquel "off-label" (for uses that are not approved by Health Canada) to treat anxiety, sleep disorders, depression and dementia-related psychosis. Since the time it was first available on the Canadian market, Health Canada has never suspended or withdrawn its approval of Seroquel. Seroquel has never been the subject of any voluntary or mandatory recall action. The proposed plaintiff "Patient Class" in this action was defined as all persons in Canada who were prescribed and who consumed Seroquel, whether for approved or off-label uses. The plaintiffs also proposed a separate "Family Class" comprised of certain family members of the Patient Class. In their claim, the plaintiffs alleged that the defendants were jointly responsible for a number of serious adverse health risks 1 Martin v AstraZeneca Pharmaceuticals Plc, 2012 ONSC 2744 ["Martin"]. associated with both approved and off-label uses of Seroquel. The proposed defendants in Martin were a group of related AstraZeneca companies. The plaintiffs framed their principal claims very generally under "negligence and failure to warn." The plaintiffs allege that the defendants designed, developed, manufactured, promoted, distributed and sold Seroquel in Canada for the approved uses, and marketed Seroquel for off-label uses. The plaintiffs also advanced a claim for "unlawful means" conspiracy. The defendants denied all of the allegations against them and pleaded that Seroquel is safe and effective when used as directed to treat approved conditions. class action certification in Ontario
Class actions are regulated by statute. In Ontario, an action cannot proceed as a class action unless and until it has first been "certified" by the court under the Class Proceedings Act.2 As part of the certification test, plaintiffs are required to demonstrate that the allegations in their pleading give rise to a legal cause of action.3 The purpose of this requirement, as in an individual suit, is to eliminate those actions which are clearly frivolous or unfounded. Plaintiffs do not face an onerous task in meeting this criteria of the certification test; this element will be satisfied unless it is "plain and obvious" from the pleading that the plaintiff's claim has no chance of success. the certification motion
Justice Horkins refused to certify the claim in Martin as a class proceeding on the basis that the plaintiffs failed to advance any valid cause of action. In general, she characterized the plaintiffs' pleadings as "muddy and vague."4 She found the plaintiffs failed to identify the specific acts alleged to have been done by each defendant to support the causes of action advanced. In addition, she found that the plaintiffs failed to particularize which defendant was alleged to have done what in relation to Seroquel. Furthermore, she found the plaintiffs' approach of advancing a general claim in "negligence and duty to warn" to be flawed since the activities which formed the bases of these claims were distinct such that they could not be "thrown into one single cause of action." This lack of particularity was compounded since the plaintiffs also did not explain how the defendants' alleged negligent activity related to both approved and off-label uses of Seroquel, even though different material facts were required to support these distinct allegations. In analyzing the negligence cause of action, Justice Horkins found that the plaintiffs actually pleaded three different types of negligence: (1) negligent design, development and testing; (2) negligent manufacturing; and (3) negligent distribution, marketing and sale. She denied certification in respect of each of these categories.55 First, Justice Horkins found the plaintiffs did not plead sufficient material facts to support a cause of action for negligent design, development and testing. In asserting a cause of action for negligent design, a plaintiff must identify a risk in the product resulting from its design. Generally, the plaintiff must then demonstrate that the defendants could have reduced or eliminated this risk through adopting an alternative design or through providing appropriate warning information. In Martin, Justice Horkins found the plaintiffs failed to identify any alleged design defect in Seroquel and failed to identify a safer, economically-feasible design that the defendants could have used, but for their negligence. She also found that the allegation that the defendants "designed, developed and tested" Seroquel for off-label uses simply didn't make any sense. Second, the Court found that the plaintiffs' cause of action for negligent manufacturing failed because their pleading contained a complete lack of material facts to support this cause of action. Specifically, the plaintiffs failed to provide any information about what was allegedly negligent about the defendants' manufacturing process and failed to clearly identify which of the defendants was the manufacturer of Seroquel. Finally, the motions judge found that the plaintiffs' cause of action for negligent distribution, marketing and sale was also deficient. With respect to approved uses, the plaintiffs did not plead that Seroquel's harmful effects outweighed its benefits. Justice Horkins could therefore find no basis for their claim that the defendants were negligent in choosing to distribute the drug. With respect to off-label uses, Justice Horkins found "the defendants did not have a duty to ‘ensure' that Seroquel was not distributed, marketed or sold for off-label uses." The Court noted that physicians in Canada are at liberty to prescribe pharmaceuticals for off-label uses as they see fit, and pharmaceutical companies have no ability or right to interfere with this lawful conduct. Moreover, although the plaintiffs alleged that the defendants misrepresented information about Seroquel as part of a negligence simpliciter claim, Justin Horkins held that these allegations were "effectively allegations of negligent misrepresentation." The requisite elements of a successful negligent misrepresentation claim include pleading the particulars of the alleged misrepresentation at issue and demonstrating that the plaintiffs relied on these representations to their detriment. Justice Horkins held the plaintiffs failed to meet the pleading standard in both these respects and so could not sustain their cause of action in negligent misrepresentation. The Court refused to certify the plaintiffs' remaining causes of action of duty to warn and conspiracy. With respect to duty to warn, the plaintiffs failed to identify the defendant who was the manufacturer of Seroquel and who therefore had the legal duty to provide appropriate warning information. The plaintiffs also failed to plead what warnings the defendants actually provided, how they were inadequate and whether or how these warnings could have been improved. Similarly, Justice Horkins found the claim for conspiracy to be "fraught with problems;" it lacked clarity and precision and failed to plead any of the material facts required to support the constituent elements of such a claim. Justice Horkins also noted that the plaintiffs would not have been successful on other elements of the certification test. For example, she found the plaintiffs were unable to produce sufficient information to establish an identifiable class of two or more persons that could be represented by the plaintiff. Moreover, she found that the proposed common issues lacked the commonality necessary to be resolved via the procedural mechanism of a class proceeding. Defendants to proposed pharmaceutical class actions will want to follow how Martin is interpreted and applied in future certification hearings. It is possible that Martin may signal a shift in the law that signals courts may be willing to more rigorously apply existing certification standards. by Adrienne Boudreau and Anna Tombs, student at law For more information on this topic, please contact: The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained. McMillan LLP  Vancouver  Calgary  Toronto  Ottawa  Montréal  Hong Kong  mcmillan.ca

Source: http://lmls.com/Files/143398_certification%20denied%20in%20pharmaceutical%20case.pdf

Doi:10.1016/s0967-5868(03)00010-9

Journal of Clinical Neuroscience (2003) 10(3), 338–339ª 2003 Elsevier Science Ltd. All rights reserved. doi:10.1016/S0967-5868(03)00010-9Treatment of painful peripheral neuroma by vein implantationR.J. Mobbs BSc(MED) MB BS, M. Vonau MB BS FRACS, P. Blum MB BS FRACSDepartment of Neurosurgery, Institute of Neurological Sciences, The Prince of Wales Hospital, Sydney, AustraliaSummary Painful n

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