Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and Olmetec Plus (together, Olmetec), which are allegedly designed, manufactured, distributed and marketed by the Defendants.
The motion for authorization to bring a class action contemplates a national class that includes all persons who were prescribed and have ingested Olmetec. Though the motion for authorization makes a passing defective design allegation, the defective design claim does not seem to be seriously advanced. Rather, the claim centers around the defendants' alleged failure to warn of gastrointestinal side effects associated with Olmetec.
According to the motion for authorization, the alleged side effects of Olmetec include, among others, diarrhea, vomiting, nausea, weight loss, dehydration, malnutrition, and sprue-like enteropathy (or celiac-like symptoms).
The Olmetec product monograph prepared on November 5, 2013, states that Olmetec is indicated for the treatment of mild to moderate essential hypertension. The same monograph, under "Warnings and Precautions", indicates that sprue-like enteropathy has been observed in patients taking Olmetec. According to the motion for authorization, this information "made its first appearance" in November 2013, though the drug has been available in the US since 2002. It is not clear from the motion when the drug first became available in Canada.
According to the Consumer Law Group website, side effects may develop months or years after taking the drug suggesting that there may be complex limitation issues associated with each individual claim.
To date, this appears to be the only proposed class proceeding relating to Olmetec products in Canada, though parallel litigation is proceeding in the U.S. pursuant to the multi-district litigation procedure.
Health Canada issued restrictions concerning the use of Olmetec and other medication used to treat high blood pressure as recently as February 4, 2014, however, the restrictions are limited to the recommended use of the product. Interestingly, the FDA currently takes the position that the benefits of Olmetec continue to outweigh its potential risks. Olmetec has not been recalled in either Canada or the U.S.
The matter is in its early stages and it is thus far too early to predict its outcome, but we will watch carefully to see what happens next.