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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Looking to resolve litigation over Vioxx (rofecoxib), Merck & Co reached an agreement to settle the vast majority of Vioxx claims for $4.85 billion.
Whitehouse Station, NJ (Nov. 9)-Looking to resolve litigation over Vioxx (rofecoxib), Merck & Co reached an agreement to settle the vast majority of Vioxx claims for $4.85 billion. Merck voluntarily withdrew Vioxx, a COX-2 selective nonsteroidal anti-inflammatory drug, from the market in 2004 following safety concerns that the drug increased the incidence of strokes and heart attacks and has since faced thousands of lawsuits over the product.
“This is a good and responsible agreement that will allow the company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines,” said Richard T. Clark, chairman, president and chief executive officer of Merck, in a company release. “The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding Vioxx product liability claims in the United States for a fixed amount.”
Merck signed the agreement with the law firms that comprise the executive committee of the Plaintiffs’ Steering Committee of the federal multidistrict Vioxx litigation as well as representatives of plaintiffs’ counsel in state-coordinated proceedings to resolve state and federal myocardial infarction (MI) and ischemic stroke claims already filed against Merck in the United States. The agreement, which also applies to tolled claims, was signed by the parties after meeting with three of the four judges overseeing the coordination of more than 95% of the current claims in the Vioxx litigation.
As of Oct. 9, 2007, in the United States, Merck had been served or was aware that it had been named as a defendant in approximately 26,600 lawsuits, filed on or before Sept. 30, 2007, which include approximately 47,000 plaintiff groups, alleging personal injuries resulting from the use of Vioxx, and in approximately 264 putative class actions alleging personal injuries and/or economic loss.
Under the agreement, Merck will pay a fixed amount of $4.85 billion into a settlement fund for qualifying claims that enter the resolution process. Claims will be evaluated on an individual basis. The agreement is open only to those cases filed or tolled on or before Nov. 8, 2007, and is subject to certain conditions. These conditions are:
Merck expects to record a fourth-quarter 2007 pretax charge in the amount of $4.85 billion to cover the cost of the agreement. “This agreement is the product of our defense strategy in the United States during the past three years and is consistent with our commitment to defend each claim individually through rigorous scientific scrutiny. Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine if they qualify for payment,” said Bruce N. Kuhlik, senior vice-president and general counsel of Merck. “This agreement also makes sense for the company because since 2004, we have reserved approximately $1.9 billion for defending Vioxx litigation and, absent this agreement, could anticipate that the litigation might stretch on for years.”
Merck may begin making payments to individual qualifying claimants as early as August 2008.