Canada: Product Liability: Superior Court Refuses Authorization For A Class Action Against A Drug Manufacturer

On July 4, 2011, the Quebec Superior Court dismissed a motion filed by Option consommateurs (Petitioner) for authorization to institute a class action against one of our clients, Merck Canada Inc. and Merck & Co., Inc. (Merck).1

The class action was being sought on behalf of all natural persons who, in Quebec, had purchased or taken a drug marketed under the name FOSAMAX®, which is prescribed for treating and preventing osteoporosis. The Petitioner accused Merck of being negligent and failing in its duty of safety and its duty to inform in marketing the drug, the use of which is linked to osteonecrosis of the jaw (ONJ), a rare condition disclosed in the product monograph. The Petitioner also alleged that the drug could increase the risk of atypical fractures. It was seeking reimbursement of the price paid for the drug as well as punitive and compensatory damages.

The Superior Court dismissed the motion because the Petitioner failed to show that the criteria in article 1003 of the Code of Civil Procedure (CCP) were satisfied.

Existence of common questions (article 1003 (a) CCP)

The court found that individual questions concerning the existence of harm, a causal relationship and exculpatory grounds were so numerous and substantial that the test in article 1003 (a) CCP was not met.

The proposed action required the examination, for each group member, of a host of individual questions, including: the existence of harm (diagnosis of ONJ or an atypical fracture); the connection between the harm sustained and use of the drug in light of all relevant risk factors; the information received from the physician or dentist; and the advisability of taking the drug despite the alleged risk of ONJ and atypical fractures given the member's particular situation (i.e. a benefit/risk analysis). As a result, only the question of fault (negligence, manufacturing defect or breach of the duty to inform) could have been decided on a common basis.

In this, the Superior Court mirrored Goyette c GlaxoSmithKline Inc., in which the Court of Appeal determined that a class action should not be authorized when the question of the existence of harm sustained by each group member cannot be determined collectively.2 Our firm represented GlaxoSmithKline Inc. in that case.

Colour of right (article 1003 (b) CCP)

The Superior Court considered the particular case of the designated person to determine whether the allegations in the motion for authorization to institute a class action warranted the conclusions sought. In keeping with prevailing case law, the court did not accept as if proven allegations in the motion that were contradicted by the evidence in the record. The court found that the Petitioner had not met the minimum burden of raising facts giving rise to a good colour of right. The Petitioner had not alleged that the designated person had suffered from ONJ, but rather that she had shown symptoms consistent with the condition. No diagnosis of ONJ had ever been made. Moreover, the designated person's dental records showed she did not exhibit symptoms characteristic of ONJ. In addition, her pharmacological profile showed she had continued taking the drug after the motion for authorization to institute a class action had been filed, even though she had been made fully aware of the risks of ONJ. Further, there was no allegation in the motion that the designated person had suffered from atypical fractures.

The court also took into account recent notices from Health Canada stating the drug is effective in treating and preventing osteoporosis and its benefits outweigh the risks when used as directed in the product monograph.

Composition of the group (article 1003 (c) CCP)

The Superior Court found that the Petitioner did not meet its burden of demonstrating that the composition of the group made the application of articles 59 or 67 CCP difficult or impracticable. The motion did not provide any indication of the number of individuals who had suffered from ONJ or atypical fractures after taking the drug. It only alleged that a very large number of individuals are prescribed the drug each year in Quebec. The scientific literature submitted by the Petitioner stated that ONJ and atypical fractures are very rare phenomena, which made it very difficult for the court to assess the size of the group.

Adequate representation (article 1003 (d) CCP)

The Superior Court found that the Petitioner was not in a position to provide adequate representation of the members of the group given (1) the absence of a good colour of right for the designated person, (2) the failure of the designated person to inform the Petitioner that she had suffered from dental problems long before taking the drug, (3) the designated person's failure to inform the Petitioner that she had continued taking the drug after the motion for authorization to institute a class action had been filed, contrary to what she had alleged in this proceeding, and (4) the designated person's intention to move to Germany.


Option consommateurs c Merck Canada Inc., in keeping with Goyette, establishes that a motion for authorization to institute a class action against a drug manufacturer should not be allowed when the only questions that can be decided collectively relate to the fault of the manufacturer.

These two cases are consistent with the recent ruling by the Supreme Court of Canada in Bou Malhab v Diffusion Métromédia CMR Inc.,3 which states that a class action must be dismissed if the existence of personal injury for each member of the group cannot be concluded from the evidence. In that case, the court also expressed the opinion that the examination of the question of the existence of personal injury (as opposed to its quantification) cannot be conducted as part of the procedure provided in articles 1037 to 1040 CCP, which sets out the rules for determining individual claims when a class action is accepted.

Option consommateurs c Merck Canada Inc. also illustrates the importance for the courts of allowing appropriate evidence so that the seriousness of vague or general factual allegations contained in a motion for authorization to institute a class action may be ascertained. In this case, it became apparent from the designated person's dental and pharmacological records and from the examination of the Petitioner's representative that the designated person's personal claim did not meet the colour of right test, and that the Petitioner and the designated person were not in a position to adequately represent the members of the group.


1 Option consommateurs c Merck Canada inc., 2011 QCCS 3447.

2 Goyette c GlaxoSmithKline inc., 2010 QCCA 2054 (Goyette).

3 Bou Malhab v Diffusion Métromédia CMR inc., 2011 SCC 9.

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