Merck & Co. and Schering-Plough will pay $41.5 million to settle class-action lawsuits filed by patients taking their shared cholesterol drugs Vytorin and Zetia, the companies said Wednesday.
The joint venture, Merck/Schering-Plough Pharmaceuticals (MSP), recorded these charges in the second quarter 2009 to cover the settlement's cost, a spokesman for Merck said.
The lawsuits involved allegations stemming from the Enhance clinical trial, whose results in January 2008 cast doubt on the efficacy of Zetia (ezetimibe) and Vytorin (simvastatin).
Vytorin is a combination drug made up of Merck’s Zocor, a statin drug, and Schering-Plouugh’s Zetia, a newer cholesterol lowering drug.
The settlement resolves some 145 lawsuits pending in U.S. District Court for the District of New Jersey that were seeking class-action status to represent consumers and insurers who purchased, used or paid money toward the purchase of Vytorin or Zetia.
The settlement is not an admission of liability or misconduct in connection with the marketing or sale of Vytorin or Zetia or plaintiffs' allegations relating to the Enhance study.
The agreement involves two settlements - one with insurers and the other with consumers who purchased, used or paid money toward the purchase of Vytorin and Zetia. The consumer settlements require court approval.
The Enhance study found Vytorin was no better at reducing plaque buildup then generic brand Zocor which has been on the market for more than two years.
In July, the companies agreed to pay $5.4 million to 35 states to settle claims they had violated consumer-protection laws by delaying negative findings from the Enhance study.
Zytorin was approved by the Food and Drug Administration in 2002, on the basis of drug trials involving 3,900 patients for 12 weeks, not long enough to determine if the drug reduced heart attacks or cardiovascular disease. #