August 6, 2009 – Merck & Co. Schering-Plough Corp. and the companies' cholesterol joint venture, Merck/Schering-Plough Pharmaceuticals (MSP), this week announced they entered into agreements to resolve class-action litigation currently pending against the companies relating to the purchase or use of VYTORIN and ZETIA.
VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet. However, VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone. Also, unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks.
The companies said a settlement is being resolved for a total fixed amount of $41.5 million. The agreements were reached with plaintiffs seeking to represent proposed classes of consumers, insurers and other entities and with a separate group of independently represented health plans that purchased, used or paid money towards the purchase of VYTORIN or ZETIA from the time of the products’ introduction to the market.
"These agreements will allow the companies to avoid continuing defense costs and remain focused on discovering, developing and delivering novel medicines and vaccines," said Bruce N. Kuhlik, executive vice president and general counsel of Merck.
The settlement will resolve all of the class-action lawsuits (including claims for attorneys' fees, costs and nongovernmental liens) that seek economic damages related to the purchase of VYTORIN and ZETIA. The companies have disclosed previously more than 140 such lawsuits pending in the U.S. District Court for the District of New Jersey. Those lawsuits make allegations regarding the safety and efficacy of VYTORIN and ZETIA based upon the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) clinical trial, the results of which were released by the companies in January of 2008.
The companies said the agreements are not an admission by the companies of any misconduct or liability in connection with the marketing or sale of VYTORIN or ZETIA or plaintiffs' allegations relating to the ENHANCE study. The agreement with the proposed classes is subject to court approval and certain conditions related to participation. The agreement with the independently represented health plans is not a class settlement and does not require court approval.
"We continue to believe that VYTORIN and ZETIA in addition to a healthy diet can provide important benefits for physicians in helping their patients with high cholesterol reach their cholesterol goals," said Thomas J. Sabatino, executive vice president and general counsel of Schering-Plough.
For more information: www.vytorin.com, www.ZETIA.com