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Merck to Pay $58 Million in Vioxx Settlement
Merck to Pay $58 Million in Vioxx Settlement
Thursday, 22 May 2008, 02:58 PM
Merck has agreed to pay $58 million to 29 states and the District of Columbia to settle claims that it allegedly broadcast misleading DTC ads for Vioxx.
Merck has agreed to pay $58 million to 29 states and the District of Columbia to settle claims that it allegedly broadcast misleading DTC ads for Vioxx. In a statement on the company's Web site, Merck said it believes it "acted in good faith and that [its] activities in support of Vioxx were intended to fully comply with relevant regulations."
The plaintiffs charged that television advertisements for Vioxx – which aired until 2004 when Merck withdrew Vioxx from the market – downplayed the increased risks of heart attack and other cardiovascular problems. According to The Gazette, a daily newspaper in Iowa, Iowa attorney general Tom Miller said, "We allege Merck's aggressive early direct to consumer promotion of Vioxx drove hundreds of thousands of consumers to seek prescriptions of Vioxx before its risks were fully understood."
As part of the agreement with the attorneys general, Merck will:
- register clinical trials and submit results to the registry and results data bank as required by the FDA Amendments Act
- accurately provide information, not make any false or misleading claims, promotional or otherwise
- agree for 10 years to delay any DTC television ads for pain relievers after FDA approval, if the director of the Center for Drug Evaluation recommends it, and for however long the director recommends
- agree for seven years to submit all new DTC television ads for pre-review by the FDA, wait for the FDA's response, modify if necessary, and then begin airing its campaigns.
The $58 million will be distributed among the 29 states and Washington, D.C., "in an amount to be designated by a multi-state executive committee." The 29 states include: Arizona, Arkansas, California, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.
Click here to view the full 22-page Texas judgment.
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