Merck, Schering-Plough and the companies' cholesterol joint venture, Merck/Schering-Plough Pharmaceuticals (MSP), have entered into agreements to resolve, for a total fixed amount of $41.5 million, civil class action litigation currently pending against the companies relating to the purchase or use of Vytorin and Zetia.
The MSP joint venture recorded these charges in the 2009 second quarter fiscal results.
The agreements, announced Aug. 5, 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 (ezetimibe/simvastatin) or Zetia (ezetimibe) 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 the Whitehouse Station, N.J.-based Merck.
According to the companies, 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, including paying $5.4 million to settle with 35 states. 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 in January of 2008.
MSP said this settlement is not an admission of any misconduct or liability in connection with the marketing or sale of Vytorin or Zetia.