The drug manufacturer Merck will reimburse $950 million to resolve investigations into its marketing of the painkiller Vioxx, U.S. Department of Justice said Tuesday.
The bureau said Merck will give $321.6 million in criminal fines and $628.4 million as a civil resolution contract. It will also pray culpable to a wrong charge that it marketed Vioxx as a treatment for rheumatoid arthritis before getting U.S. Food and Drug Administration endorsement.
Merck discontinued selling Vioxx in 2004 after proof showed the drug doubled the risk of heart attack and stroke. In 2007, the company paid $4.85 billion to resolve around 50,000 Vioxx-related grievances.
The Justice Department said the settlement resolves claims that Merck made false, unverified, or deceptive statements about Vioxx’s safety to boost sales and made false statements to Medicaid agencies about its protection.
According to Merck, the agreement does not comprise an admittance of any legal responsibility or wrongdoing, and it said the government admitted that there was no foundation to wrap up that Merck’s upper-level management was involved in the defiance.
Merck also penetrated into a contract about its sales, marketing, publication and government pricing activities. According to the Justice Department, agreement makes stronger lapse of the company. It will oblige top officials to complete annual fulfillment certifications, and the company will situate information about physician imbursements on its website.
In the third quarter of 2010, the company took a accuse of $950 million to cover up the anticipated agreement payments.
Vioxx was endorsed by the FDA in 1999, but the government did not primarily approve the drug for use in rheumatoid arthritis. That destined doctors could write prescriptions for Vioxx for rheumatoid arthritis patients, but Merck could not sponsor the drug to make use of. The Justice De! partment said Merck promoted Vioxx for rheumatoid arthritis for three years and prolonged to do so after getting an FDA warning letter in 2001. The drug was granted as a treatment for rheumatoid arthritis in 2002.
The government will acquire $426.4 million from the agreement, and $202 million will be handed out to state Medicaid programs for 43 states and the District of Columbia.
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