Merck & Co. reaches settlement deal in Vytorin study results lawsuit

Merck & Co. settled a lawsuit over claims that the company delayed the release of clinical trial data that questioned the efficacy of Vytorin (ezetimibe/simvastatin). The settlement ends a case filed in 2008 that alledged that the company delayed announcing data from the ENHANCE trial for 21 months amid concerns that it would hurt future sales of the cholesterol drug.

As part of the legal settlement, Merck & Co.’s drug research arm is now required to provide an annual report to Merck's board describing any clinical trials with results that haven't been reported within 12 months of completion, including the reasons for the delay and any corrective action taken. The clinical trials subject to this policy are for Merck-sponsored studies of products marketed in the US. Merck will retain this change in its corporate governance for at least three years, unless a majority of the independent directors deem it no longer in the best interest of Merck.

The settlement ends a component of the litigation that alleged that Merck and its then partner Schering-Plough delayed the 2008 release of results from the ENHANCE trial, which was completed in 2006 in order to protect sales growth for both Vytorin and its related drug Zetia (ezetimibe). The companies claimed that the delay was needed to adequately analyse issues with data quality. The settlement does not require Merck to make any monetary payments beyond attorneys' fees and expenses for the plaintiff of $5.1 million.

"We feel the settlement is an appropriate resolution of the case," remarked Merck spokesman Ron Rogers, adding that the company has made no admission of wrongdoing or liability. Merck has previously settled other lawsuits related to the Enhance trial, though some litigation continues.

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