Vioxx Lawsuit Help

Vioxx Litigation

Vioxx litigation could result in high liability risk for Merck & Co., amounting to $10 billion or more, according to a SG Cowen & Co. analyst. Merck has said it is creating a reserve to cover potential Vioxx litigation. A high number of Vioxx lawsuits are anticipated , and there is great anticipation for the trial results with the first case set to go to an Alabama federal court in December 2004. Some attorneys have compared the potential Vioxx litigation costs for Merck to be similar to the costs incurred by Bayer AG after its cholesterol-lowering drug Baycol was taken off the market. Others disagree, believing evidence against Merck is sure to create a flood of strong cases that could result in crippling Vioxx litigation costs.

Generally, lawsuits involving drug side effects are difficult to prove with the burden on the patient to show without a doubt the use of the drug was directly responsible for the adverse condition(s). Vioxx litigation has been viewed differently by many and has been assumed to have a higher chance of delivering costly decisions for Merck because of the magnitude of the situation. Over 20 million people have taken Vioxx since it was first launched in 1999. In 2003, total sales for Vioxx reached $2.5 billion despite safety concerns that gained momentum in recent years.

Up until a month before Merck abruptly withdrew Vioxx from the market, the company had continued to claim there were no safety problems with the drug despite the studies showing cardiovascular events were being suffered . It is expected that Vioxx litigation will be heavily based on the now-seized FDA eight-page letter to Chief Executive Raymond Gilmartin that directly criticized Merck in September 2001. The Vioxx recall was one of the largest drug industry moves that surprised many, but was described by the acting director of the FDA’s Center for Drug Evaluation and Research to be “not a total surprise” since “we have been concerned and aware of the potential for cardiovascular effects for the last few years.”

Many people are fed up with the laissez faire attitude that the FDA has been accused of having , and Vioxx litigation is sure to highlight some concerns with the agency’s failure to adequately respond to decisions made by Merck. Included in the eight-page letter are accusations that Merck continued to promote Vioxx while minimizing potentially serious cardiovascular findings. Until the Vioxx recall, Merck had continued to claim that the higher incidence of cardiovascular events observed in a study comparing Vioxx and naproxen was really because naproxen has heart benefits, but the letter sent by the FDA pointed a finger at Merck saying, “You fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence.”

Merck had been spending over $100 million a year in direct-to-consumer advertising while minimizing the links between Vioxx and cardiovascular events, an argument that will carry some weight in upcoming Vioxx litigation. When Merck sponsored the three-year study comparing Vioxx to a placebo, the company could no longer continue to defend its blockbuster drug and had to pull the study after just 18 months. Patients , angry that they were kept unaware of the risks for cardiovascular events , are fed up with the drug industry’s ability to spin events to favorably promote drugs that may be life-threatening. Upcoming Vioxx litigation is sure to increase focus on federal regulation and the ability of large drug companies to manipulate market presence.

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For more information on Vioxx litigation, please contact us to confer with an attorney.

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