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Vytorin Named in 100+ Lawsuits, Justice Department Investigation

Dec 2, 2008 | Parker Waichman Alonso LLP

Nearly a year after an important Vytorin study raised serious doubts about its effectiveness, Merck and Schering-Plough are facing an increasing number of lawsuits over the controversial cholesterol -lowering drug, the Associated Press Reports.  In a filing with the Securities and Exchange Commission (SEC), Merck also said that the marketing of Vytorin was the subject of a Justice Department investigation.

Vytorin is a combination of the statin Zocor and the cholesterol-lowering drug Zetia.  Vytorin has been under the microscope since the ENHANCE study, which found the drug was ineffective in preventing clogged arteries, was released last January.    Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics have likened to fraud.  The delay prompted a Congressional investigation into the way Merck and Schering-Plough handled the ENHANCE findings.

According to Merck's SEC filing, the controversy over ENHANCE has resulted in more than 140 class action lawsuits that name Merck and its partner, Schering-Plough, as defendants.  According to the Associated Press, some of the lawsuits allege consumer fraud, while others involve claims for personal injury or seek medical monitoring for people who used Vytorin.

The SEC filing also confirms that the companies' promotion of Vytorin is the subject of a Justice Department investigation.  According to the Associated Press, that probe is focusing on whether the companies' promotions made false claims to federal health care programs.

News of the lawsuits and investigation is only the latest bad news involving Vytorin, which once promised to be a blockbuster for Merck and Schering-Plough.  Vytorin took another hit over the summer, when the SEAS study was released.  SEAS was designed to see if the drug helped people with aortic stenosis avoid heart attacks.  Not only did SEAS show that Vytorin offered no additional heart attack prevention, but Vytorin patients enrolled in the study had higher rates of cancer than those taking a placebo. Congress recently expanded its Vytorin investigation to include the handling of SEAS.