November 22nd, 2011

Merck Pleads Guilty and Pays $950 Million for Illegal Promotion of Vioxx

The US Department of Justice announced today that Merck, Sharp & Dohme will plead guilty to illegal promotion of Vioxx (rofecoxib) and will pay a $950 million in fines and penalties to the US government and individual states.

The criminal plea is tied to Merck’s off-label promotion of rofecoxib for rheumatoid arthritis (RA) from 1999 until 2002, since the drug did not have an indication for RA at that time. The civil settlement is tied to a broader range of allegedly illegal conduct by Merck, including statements about the cardiovascular safety of rofecoxib made by Merck representatives. The company will also enter into an expansive corporate integrity agreement with the government.

In its own press statement, Merck said that the civil portion of the settlement “does not constitute any admission by Merck of any liability or wrongdoing.” Merck also said:

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.

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