WHITEHOUSE STATION, N.J., Nov. 22, 2011 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced it has reached a resolution with federal and state authorities regarding a previously disclosed investigation concerning Vioxx. Merck voluntarily withdrew Vioxx from the market in September 2004. The company previously recorded a charge of $950 million in October 2010 in anticipation of today’s agreements.
The company pleaded guilty to the criminal charge of violation of the US Food Drug and Cosmetic Act for promoting rofecoxib for the treatment of rheumatoid arthritis for approximately three years before that use was approved by the FDA. For this, the firm will pay a $321.6 million criminal fine, the US Department of Justice said yesterday.
Merck will also pay $628.3 million as part of a civil settlement, which covers, amongst other things, allegations that company representatives made “inaccurate, unsupported, or misleading statements” about rofecoxib’s cardiovascular safety to increase sales. Approximately a third of that civil settlement will be distributed to Medicaid agencies from 43 states and the District of Columbia. In November 2007, Merck entered into an agreement to resolve myocardial infarction and stroke claims filed as of that date in the US, paying out $4.85 billion to resolve more than 99.9% of eligible claims. (Our Note -LLF)
Previously disclosed litigation with seven states remains outstanding. The civil settlement does not constitute any admission by Merck of any liability or wrongdoing.
“We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. Separately, the company agreed to plead guilty to a misdemeanor under the Federal Food, Drug, and Cosmetic Act arising out of the marketing of Vioxx by company representatives to physicians in the United States for the treatment of rheumatoid arthritis before the FDA’s approval of that indication in April 2002. The company will pay a fine of approximately one-third of the reserved amount to the federal government as part of the plea agreement. As part of the plea agreement, the United States acknowledged that there was no basis for a finding of high-level management participation in the violation. The government also recognized Merck’s full cooperation with its investigation.
Merck also has entered into a new corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. This agreement replaces Merck’s current CIA and builds upon the company’s existing comprehensive compliance program. Merck’s compliance program includes specific policies and procedures governing the company’s interactions with healthcare professionals and is designed to help prevent, detect and resolve potential violations of company policy or law. “Merck recognizes the importance of robust compliance programs and is committed to adhering to the law and to our fundamental values and standards. We believe that the settlement of this lengthy investigation is in the best interests of our stakeholders, and we look forward to focusing on our mission to save and improve lives around the world,” said Kuhlik.
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Go on, tell them how you feel.
Posted by: David M. Schwadron, Esquire