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Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that it has entered into an agreement to resolve all claims related to Vioxx® in Canada. The agreement was signed by Merck and plaintiffs' representatives and is pending approval by courts in Canada's provinces.
"This agreement is structured to provide certainty and finality toward resolving Vioxx cases in Canada for a fixed amount," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine qualification."
If the agreement is approved and specified conditions are met, Merck will pay a total amount of at least C$21,806,250 but not more than C$36,881,250. This would resolve all Vioxx certified class actions, putative class actions, other litigation and claims related to Vioxx in Canada.
The amount to be funded for Vioxx users in Canada will be between C$11,306,250 and $26,381,250 and will be determined by the final number of eligible claimants. 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. Individual awards for ischemic stroke claims will be a uniform amount not to exceed C$5,000.
The resolution also includes fixed costs of C$6,000,000 for class counsel fees, C$3,500,000 for Canadian provinces and territories and C$1,000,000 for administrative expenses involved in the implementation of the resolution. Should administrative expenses or approved fees exceed these amounts, any excess will be paid from the amount to be funded for eligible Vioxx users.
Merck's decision to resolve this litigation is based upon the specifics of the Canadian lawsuits and the Canadian legal system. This resolution only applies to litigation in Canada and has no impact on pending litigation in any other country.
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.
This agreement in Canada does not include any statement to the contrary and does not constitute any admission of liability.
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The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).