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Case Details for "Merck & Co. and Schering-Plough Corp"
Merck and Schering-Plough settle investigation relating to Zetia and Vytorin
Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle a multistate investigation that the companies delayed the release of test results casting doubt on the effectiveness of two blockbuster cholesterol drugs.
The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on allegations the companies kept quiet the results from an unfavorable study, violating consumer protection laws. Merck and Schering-Plough will pay back the costs of the investigation, but don't have to make other payments or admit wrongdoing or liability.
In January 2008, the companies released study data showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older, much-cheaper drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.
The study compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin's ingredients. Zocor is available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.
Kentucky Attorney General Jack Conway said the companies agreed to get advance Food and Drug Administration approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.
The state of Kentucky where the agreement was filed will receive $100,000 in the settlement.
The settlement does not resolve all the lawsuits and investigations involving the drugs, however. In a May regulatory filing, Merck disclosed that subcommittees from the U.S. Senate and House of Representatives have asked the company and Schering-Plough to interview employees and examine documents related to Zetia and Vytorin. Merck also disclosed that the Justice Department is investigating the companies' conduct in selling the drugs, and the possibility that they may have submitted false claims to federal health care programs as they promoted Vytorin.
Merck said it was then aware of 145 civil class action lawsuits related to the drugs.
The 35 states involved in Wednesday's settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
Posted on:2009-07-15
Company: Merck & Co. and Schering-Plough Corp
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Scope: Nationwide
Type of Case: Consumer
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