Vytorin is a combination of Zetia and the statin Zocor. It has been under the microscope since the ENHANCE study was released in January 2008. ENHANCE found that the drug was no better than a cheaper, generic statin in preventing clogged arteries, and raised serious questions about the effectiveness of both Vytorin and Zetia. What’s more, Merck and Schering-Plough delayed releasing ENHANCE for more than a year, even though the trial was actually completed in 2006.
The ENHANCE debacle spawned scores of lawsuits against Merck and Schering-Plough. Many accused the companies of marketing Vytorin and Zetia in a misleading fashion and failing to disclose the results of ENHANCE in a timely manner. According to Reuters, the $41.5 million settlement will resolve all the class-action lawsuits that seek economic damages related to the purchase of the two drugs. About 145 such suits are pending, Reuters said.
This is the second Vytorin settlement announced by the companies this summer. In July, we reported that Merck and Schering-Plough had agreed to pay $5.4 million to 35 states and the District of Columbia to settle allegations they delayed the release of negative information from ENHANCE. The attorneys general from the states involved in the settlement had alleged that before the drug makers released any of the negative study results, both Merck and Schering-Plough conducted intense marketing of Vytorin through direct-to-consumer advertising.
Neither settlement announced this summer requires the companies to admit any wrongdoing or liability.
Despite the settlements, Merck and Schering-Plough’s Vytorin troubles are far from over. According to The Wall Street Journal, the companies still face a U.S. Department of Justice investigation, as well as lawsuits alleging securities-law violations. The Justice Department is investigating whether the companies’ promotion of Vytorin caused false claims to be submitted to federal health-care programs, the Journal said.