New Jersey-based Merck and Co. Inc., which maintains no wrongdoing, announced Thursday it would pay between $21.8 million and $37 million to settle a class action lawsuit with Canadians who say they experienced heart trouble after taking Vioxx.
The settlement — which has yet to receive court approval — includes about $10 million in fixed costs and legal fees. The rest will be determined based on the number of eligible claimants.
Mike Peerless, a lawyer with London, Ont.-based Siskinds LLP, who helped lead negotiations with Merck, said between 1,000 and 2,000 Canadians may be eligible to be compensated under the settlement.
He praised the deal as a satisfactory ending to a difficult case.
"This has been a very long and complicated case to work our way through. It was hard-fought at every step, but we're certainly very pleased on behalf of the plaintiffs to have come to a resolution," Peerless said in a telephone interview.
The Canadian settlement is the latest chapter in a more than decade-long saga involving Vioxx, which has been off the market for seven years as a result of the ongoing controversy surrounding it.
Merck touted the drug as a treatment for rheumatoid arthritis starting in 1999 despite the fact the U.S. government had not approved its use for that purpose.
While doctors were permitted to write prescriptions for the drug, Merck was forbidden from marketing it as a treatment for that condition.
The U.S. Justice Department alleged Merck promoted Vioxx for rheumatoid arthritis for three years and continued to do so after getting a warning letter from the Food and Drug Administration in September 2001.
The drug was approved as a treatment for rheumatoid arthritis in April 2002, but evidence later surfaced suggesting it doubled the risk of heart attack and stroke.
Vioxx was ultimately pulled from the market in 2004.
Since then, Merck has been embroiled in legal negotiations with plaintiffs who say they suffered heart attacks or other cardiac episodes while on the drug. The company paid US$4.85 billion to settle nearly 50,000 lawsuits in 2007.
Last November, the U.S. justice department ordered the company to pay a further US$950 million to resolve investigations of the way Vioxx was marketed.
Throughout the legal wrangling, however, Merck has steadfastly maintained it did no wrong and said the various settlements it negotiated are in no way a statement of liability.
The company reiterated that point when announcing the terms of the Canadian suit.
"Merck continues to believe that the evidence shows the company acted responsibly with Vioxx, from the careful study in clinical trials involving about 10,000 patients before its approval by regulatory authorities around the world, through the careful safety monitoring while Vioxx was on the market, right up through the decision to voluntarily withdraw the medicine in September 2004," Merck said in a statement.
The company also said it will be examining individual claims to determine who qualifies for its settlement amounts.
"Claims for myocardial infarction and sudden cardiac death will be evaluated on an individual basis by an independent administrator based on objective criteria related to various factors, including duration of Vioxx use, age and presence of risk factors," Merck said. "Individual awards for ischemic stroke claims will be a uniform amount not to exceed C$5,000."
Peerless praised Merck for its willingness to negotiate a settlement despite its assertion of innocence.
"Merck certainly does not say they did anything wrong, in fact they deny they ever did, but I still think they need to be commended for coming forward and putting enough money on the table that we think those people who have been injured by this product when it was on the market can get fairly compensated."
The Canadian class action lawsuit is being handled by a consortium of 18 lawfirms across the country, Peerless said, adding that anyone who feels they may be eligible for compensation should come forward as soon as possible.