Merck & Co. agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of Vioxx (rofecoxib), the U.S. Justice Department announced Tuesday. “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,” commented Bruce N. Kuhlik, the company’s executive vice president and general counsel.

 

Specifically, the drugmaker will pay a $321.6 million criminal fine and $628.3 million in civil penalties to settle allegations regarding the off-label marketing of Vioxx and statements regarding the drug’s cardiovascular safety.

 

While Kuhlik declined to comment on the criminal charge, Merck noted that the civil settlement “does not constitute any admission by Merck of any liability or wrongdoing.” Moreover, the company indicated that “the United States acknowledged that there was no basis for a finding of high-level management participation in the violation.”

 

Merck announced last October that it had set aside a $950-million reserve to cover the anticipated settlement payments related to the investigation. The company has also previously agreed to pay $4.9 billion to settle thousands of lawsuits brought by Vioxx users who alleged that they suffered injuries after taking the drug, as well as $1.9 billion in legal costs associated with the cases.

 

Morningstar analyst Damien Conover noted that the latest “settlement is potentially the final chapter in the Vioxx saga.”