Merck & Co, Inc and Schering-Plough Corporation and the companies' 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 who investigated whether the companies violated state consumer protection laws in connection with 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 or by their promotion and marketing of Vytorin and Zetia.
As part of the resolution of the multistate investigation, the companies agreed to reimburse the investigative costs of the 35 states and the District of Columbia which totalled $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 and made other voluntary assurances of compliance related to the promotion of Vytorin and Zetia.
"This 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," said Bruce N Kuhlik, executive vice president and general counsel of Merck.
"Resolving these inquiries for an amount equal to the states' investigative costs is in the interests of all stakeholders," said Thomas J Sabatino, executive vice president and general counsel of Schering-Plough.
In addition to the District of Columbia, the 35 states participating in the agreement are: Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
The companies previously disclosed the multistate investigation in filings with the US Securities and Exchange Commission.