The agency said Merck will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. It will plead guilty to a misdemeanor charge that it marketed Vioxx as a treatment for rheumatoid arthritis before getting Food and Drug Administration approval.
Among other things the Department of Justice charged that false claims about the safety and effectiveness of Vioxx caused Medicare and Medicaid to pay for drugs that they would not have bought but for the misrepresentation.
Merck stopped selling Vioxx in 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007, the company paid $4.85 billion to settle around 50,000 Vioxx-related lawsuits."
Merck's misconduct also led to a 2008 $650 million settlement of charges that Merck failed to pay rebates owed to Medicare and Medicaid, and made illegal payments to providers to induce them to prescribe Zocor Vioxx. Those were qui tam actions brought by whistleblowers.
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