Merck, Schering-Plough Resolve Investigation Under State Consumer Protection Statutes

Merck & Co., Schering-Plough and their cholesterol joint venture – Merck/Schering-Plough Pharmaceuticals, have reached a civil settlement with a multistate group of attorneys general representing 35 states and the District of Columbia. They investigated whether the companies violated state consumer protection laws in connection with the Enhance clinical trial, or by their promotion and marketing of Vytorin and Zetia.

As part of the resolution, the companies agreed to reimburse the investigative costs of the 35 states and the District of Columbia, which totaled $5.4 million. The settlement agreement does not require the companies to make any other payment, and does not require or include any admission of misconduct or liability by the companies.

In the settlement, the companies agreed to continue to comply with the Food, Drug and Cosmetic Act, the US Food and Drug Administration Amendments Act, and other laws requiring the truthful and non-misleading marketing of pharmaceutical products. They also made other voluntary assurances of compliance related to the promotion of Vytorin and Zetia.

Bruce Kuhlik, executive vice president and general counsel of Merck, said: Today’s agreement is consistent with our belief that the companies conducted the Enhance trial in good faith and that their promotion of Vytorin and Zetia was in compliance with the law.