Vytorin Lawsuit Over Delayed Release of Bad Study Data Settled by Merck

Merck & Co. has reportedly reached an agreement to settle a Vytorin lawsuit that accused the drug maker of delaying the release of study results that cast their blockbuster cholesterol drug in an unfavorable light. 

The lawsuit was filed by shareholders who said the company sat on a report for 21 months that showed Vytorin was no better than Zocor at reducing plaque buildup.

The drug maker has agreed to pay $5.1 million to cover plaintiff fees and the company is required to report any delayed test result to the research committee of the company’s board of directors that exceeds one year. The company will have to file the reports for the next three years.

Vytorin is a cholesterol drug that combines Zetia (ezetiminbe) with Zocor (simvastin). It was approved by the FDA in 2004 and was heavily marketed as part of a joint venture between Merck and Schering-Plough.

In August 2009, Merck & Co. and Shering-Plough Corp., which jointly market the drug, agreed to pay $41.5 million to settle Zetia and Vytroin class action lawsuits filed for consumers who alleged that the companies hid data for two years that showed the drug to be less effective than advertised. The companies also paid $5.4 million in July to resolve investigations by numerous states into whether they acted illegally in the handling of an effectiveness study, a clinical trial known as ENHANCE. The latest settlement deals with claims brought by shareholders who say that the company made itself look more valuable by sitting on the data.

Questions were raised about the companies’ actions months before the data was released, when the drug makers indicated that they were going to change the ENHANCE study’s measure of effectiveness a year and a half after the study had been concluded. These actions also led to a congressional investigation into whether the drug makers were trying to manipulate scientific data.