Within 2 weeks of Merck & Co.'s decision to withdraw the anti-arthritis drug rofecoxib (Vioxx) because of its cardiovascular risks, lawyers filed 10 class-action lawsuits collectively representing several thousand plaintiffs in Canada against the firm and its Canadian subsidiary, Merck Frosst Canada (CMAJ 2004;171[7]:1027-8).
Four suits were filed in Ontario, 2 in Quebec, and 1 each in BC, Saskatchewan, Manitoba and Newfoundland and Labrador. A 7-province action filed in the Federal Court of Canada also named the federal government as co-defendant. More suits are expected in the coming months.
The claims could coalesce into a unified suit, or a bid in a single province could be certified as a class action and eventually advertise for victims, absorbing under its umbrella all Canadians who claim to have suffered side-effects from rofecoxib, says Tony Merchant of the Regina-based Merchant Law Group.
Merck Frosst Canada public affairs manager Marlene Gauthier declined comment except to say “we believe we have strong and meritorious defences to the lawsuits brought against us.”
Although it often takes years for class-action suits to coalesce, lawyers say there's nothing surprising about the alacrity with which they've been filed. Nor will there be a shortage of potential plaintiffs; IMS Health reports that 3.3 million rofecoxib prescriptions worth $196.6 million were filled in Canada in 2003. Lawyer Jim Poyner, of Vancouver-based Poyner Baxter, said his firm received 800 complaints from BC residents within days.
Most suits are against only Merck and its associates, for allegedly failing to undertake adequate safety testing on rofecoxib while continuing to market it. Rofecoxib was withdrawn when preliminary results from the 3-year APPROVe (Adenomatous Polyp Prevention on VIOXX) trial showed almost double the risk of cardiovascular incidents among trial subjects taking the drug for more than 18 months, compared to patients taking placebo.
Pfizer Inc., manufacturers of the similar COX-2 medication celecoxib (Celebrex), announced Oct. 18 they are starting a clinical trial in 2005 to assess its drug in osteoarthritis patients at high risk for cardiovascular disease. — Wayne Kondro, CMAJ
Figure. The legal fallout began mere days after rofecoxib was removed from the market Sept. 30. Photo by: Canapress, A. Sancetta