For the first time, a Quebec court has refused to authorize a class action proposed after a drug manufacturer announced a voluntary withdrawal. The proposed class action concerned sibutramine, a weight-loss drug for obese patients. From 2000 to 2010, sibutramine was manufactured by Abbott Laboratories and marketed in Canada as the patent medicine Meridia®. Apotex also marketed a generic version, Apo-Sibutramine, in 2010. Both companies voluntarily withdrew the drug in October 2010 at Health Canada's recommendation, after a study linked sibutramine with increased risk of heart attack and stroke in patients with a history of cardiovascular problems. The proposed class action was commenced four days later. The Quebec Superior Court held that the plaintiff had no cause of action against Apotex, and had alleged insufficient facts to warrant authorizing the class action against Abbott.
Sibutramine is an appetite suppressant, formerly prescribed to obese patients as a weight-loss aid. In 2010, the Sibutramine Cardiovascular Outcome Trial (SCOUT), a long-term, large-scale clinical study, found an increased risk of non-fatal heart attacks and strokes in certain patients taking sibutramine who were already at high risk for cardiovascular disease. This study prompted the European Medicines Agency to suspend the marketing authorization for sibutramine, while American and Canadian health authorities recommended a voluntary withdrawal. Both Abbott Laboratories and Apotex followed Health Canada's recommendation to withdraw the drug.
The representative plaintiff, Brent MacMillan, had been prescribed Meridia® by his family doctor in June 2004. Mr. MacMillan alleged that he had suffered a frightening episode that he believed to be a heart attack in the fall of 2005 and immediately stopped taking Meridia®. When the voluntary recall occurred in October 2010, Mr. MacMillan's doctor called him to advise him that he could contact a lawyer if he wished to commence a class action. Mr. MacMillan brought the application for authorization of a class action four days later. He alleged that Abbott and Apotex misrepresented the efficacy of sibutramine in causing weight loss, failed to warn patients of the risk of cardiovascular problems, and marketed the drug despite a risk to benefit ratio that was too high.
Quebec courts apply a four-part test in determining whether to authorise a class action. The representative plaintiff must establish each of the following:
- the proposed class members' actions raise identical, similar, or connected issues;
- the facts alleged appear to support the conclusions sought (the claim has the "appearance of right");
- the composition of the plaintiff group makes it difficult or impractical to proceed otherwise; and
- the person seeking authorization can adequately represent all members.
In this case, the proposed action failed all but the first element.
The claim against Apotex failed immediately: Justice Roy applied the rule, now well-established in both Ontario and Quebec, that in a class action against multiple defendants, there must be at least one representative plaintiff with a claim against each defendant. In this case, Mr. MacMillan was the only plaintiff, and he had never taken the Apotex product.
As against Abbott, the judge held that the facts alleged by the plaintiff were either insufficient or contradicted by the plaintiff's own evidence. First, the plaintiff had brought the action against the Canadian company, Abbott Laboratories Ltd.; however, the evidence showed that an American company, Abbott Laboratories, was the manufacturer, and the plaintiff failed to bring evidence linking the two entities.
Second, the judge noted that the plaintiff relied for scientific evidence exclusively on the SCOUT study. However, that study was done primarily in patients who took sibutramine against the manufacturer's indications, namely patients with a history of cardiovascular disease, who were over 65, and/or who took the drug for periods much longer than a year. The drug monograph, approved by Health Canada, cautioned against use in each of these circumstances. The study moreover found an increase in heart attack and stroke risk only in patients with a history of cardiovascular problems, for whom the drug was not recommended.
The judge acknowledged that the SCOUT study had affected health authorities' estimate of the risk to benefit ratio for sibutramine. On one hand, the study showed that long-term weight loss from sibutramine was modest and reversible. On the other hand, taking sibutramine increased the risk of heart attack and stroke for patients who already had a history of cardiovascular problems, which is common among obese persons. The SCOUT study did not show, however, that the drug, rather than the patients' obesity, was the cause of any heart attacks or strokes.
The judge noted that, in similar product liability cases in which Quebec courts authorized class actions, the representative plaintiffs had submitted scientific studies or medical records establishing at least an apparent link between the medication and the alleged harmful side-effect. In this case, there was no evidence that persons taking the drug according to the manufacturer's indications were exposed to any increased risk of heart attack or stroke.
Mr. MacMillan also failed to establish an appearance of right in his own case. He admitted having lost more than 5% of his body mass while taking the drug – more than average loss indicated in the drug monograph. Although he regained that weight after stopping treatment with sibutramine, he did not claim to have made any lifestyle changes, which the monograph indicated were necessary to maintain the weight loss.
As regards his alleged heart attack, the judge was even more critical. The judge noted that Mr. MacMillan had never investigated whether he had really experienced a heart attack in fall of 2005, and had made no efforts to verify his hypothesis that that episode was caused by the drug. Medical records showed that Mr. MacMillan took the drug contrary to several indications in the drug monograph. Finally, there was no evidence supporting his allegations that he was still at risk of future problems after discontinuing the drug.
The judge also found that the proposed class definition – all persons who had purchased and/or taken the drug, and their heirs and relatives – was too broad. First, the class had to be restricted to persons who had had heart attacks or strokes after taking the drug, as other persons taking sibutramine would not have suffered any harm. Second, class actions may only be authorized on behalf of relatives of directly injured class members if there is a representative plaintiff for the relatives, which was not the case here. Finally, the SCOUT study had shown an increase in non-fatal heart attacks and strokes only, but not in overall mortality, so there was no reason to include patients' heirs in the class.
The claim also failed the next element of the authorization test, concerning the composition of the plaintiff group. As the plaintiff failed to show that even a single sibutramine patient (including himself) had suffered a heart attack or stroke, the court could not conclude that there was a group of persons who could form a class at all.
On the last element of the test, the judge held that Mr. MacMillan was not an appropriate representative plaintiff, based on his handling of the claim to date.
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