Pharmaceutical company Merck agreed in 2007 to pay nearly $5 billion to settle lawsuits of injury and wrongful death linked to the drug Vioxx. The U.S. Justice Department recently announced that the company must now pay an additional $950 million for marketing the pain killer as a treatment for rheumatoid arthritis without proper approval from the U.S. Food and Drug Administration.
The drug was recalled in 2004 after studies showed an increased risk of strokes and heart attacks among Vioxx users. Merck has pleaded guilty to charges that it marketed Vioxx without FDA approval as an arthritis pain treatment. The $950 million fine will be split -- with $321.6 million to be paid in criminal fines and $628.4 million going toward settlement of civil lawsuits. Merck's attorneys announced that settlement of the civil lawsuits did not constitute any admission of wrongdoing.
As part of the settlement, Merck also agreed to more oversight of the company, complete annual compliance reports and certifications and the posting of all payments made to doctors on the company's website. Merck also entered into an agreement that will monitor the sales, publication, pricing and marketing of the drugs it manufactures.
Vioxx was one of three drugs referred to as cox-2 inhibitors, which included Celebrex and Bextra. The painkillers were known for their effectiveness without harsh gastrointestinal side effects. Merck has since halted the production of Bextra. Celebrex is still prescribed as a treatment for muscle and joint pain.
Source: U.S. News & World Report, "Merck to pay $950m to settle probe of Vioxx marketing" Nov. 22, 2011
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