Quebec Court of Appeal Confirms the Decision to Deny Certification of a Drug Related Class Action

Different times call for different measures, and the jurisprudence governing Quebec class actions is no exception to this rule. While 2011 and the beginning of 2012 brought waves of decisions in favour of certification, the end of 2012 seemed to bring more circumspection.

This trend seems to continue in 2013, notably in a decision rendered in January in the case of Option Consommateurs v. Merck & Co. Inc. The Court of Appeal of Quebec followed a guarded approach in this drug related class action, refusing certification because there was insufficient evidence to demonstrate occurrences of a known, but rare side-effect, either with the Plaintiff or amongst the broader group of consumers who used the product.



This class action concerns Fosamax®, a drug used in the treatment and prevention of osteoporosis. The Plaintiff asserted that the Respondent was negligent and failed to respect its duty of safety by marketing an unsafe product with latent defects. Patients who had consumed one of the ingredients (biphosphonate), had sometimes developed undesirable conditions (osteonecrosis of the jaw, bone weakening or skeletal degeneration).

The consumer organization acting as the Plaintiff claimed that these were side effects caused by the drug. The designated individual representing the proposed Plaintiff class claimed to suffer from osteonecrosis of the jaw as a result of having consumed Fosamax®, although she had received no medical diagnosis to establish this.

Medical literature showed that osteonecrosis of the jaw had occurred in one to four patients out of 100,000 who used biphosphonates.

The Decision

The Court of Appeal maintained the conclusions of the Superior Court, and dismissed the proposed class action.

The Court concluded that the Plaintiff had not shown any colour of right. The absence of a medical diagnosis was detrimental to the certification of the class action. The Court refused to content itself with “hypotheses”, when medical literature showed very rare occurrences of the side effects complained of, and could not establish a definite causal link with the use of biphosphonates.

The Court also doubted that there were sufficient members of the proposed group to justify a class action. The drug had been prescribed to around 100,000 patients and Respondent’s market share was 40%. Therefore, medical literature supported the conclusion that there did not even exist one occurrence of damages that could be attributed to the Respondent.

The Court was not impressed, either, with the designated individual and the Plaintiff’s capacity to represent the members.

Potential Significance

Considering that the Plaintiff’s only burden at the certification level is to “demonstrate” their cause of action, which can prove to be a light burden in most circumstances, many plaintiffs have tried to present cases based on the fact that it was “possible” that they suffered damages.

This decision confirms that it is insufficient for the Plaintiff to claim, in health related class actions, that damages “appear” to have occurred: convincing medical evidence must be advanced to establish the actual occurrence in the individual Plaintiff and in the population that is the object of the class action, of side effects caused by the use of the product.

In the absence of such evidence, the Court will likely refuse to play doctor: it will not agree to make a diagnosis, nor will it agree to weigh scientific evidence in a legal forum, to arrive at conclusions which the medical community has not yet reached.

Case Information

Option Consommateurs v. Merck & Co. Inc., 2013 QCCA 57

Quebec Court of Appeal Docket: 500-09-021902-119; 500-06-000402-079

Date of Decision: January 16, 2013

Court of Appeal of Quebec drug related class action drug safety Fosamax health related class action



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