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DOJ and Merck reach settlement agreement in Vioxx suit

Merck & Co [corporate website] reached a settlement agreement Tuesday with the US Department of Justice (DOJ) [official website], agreeing to pay $950 million in criminal and civil penalties. The agreement [text, PDF] includes $321 million in criminal fines and $628 million in civil fines as well as submitting a guilty plea to an information [text, PDF] filed by the US Attorney's Office for the District of Massachusetts (USAO) [official website]. The one-count information was filed against Merck for promoting Vioxx [JURIST news archive] for use against rheumatoid arthritis before receiving FDA [official website] approval. Merck has also entered into a corporate integrity agreement through which procedures will be put into place to prevent and detect any violations of company policy or law. Merck said the settlement does not constitute an admission of any liability or wrongdoing [press release] and the company believes they "acted responsibly and in good faith in connection with the conduct at issue." The USAO said [press release] they "will continue to work with law enforcement partners to aggressively investigate and prosecute pharmaceutical companies—no matter how large—when they improperly market their products."

Vioxx was pulled from the market in September 2004 after it was discovered that it led to an increased risk of heart attack. In June 2010, a federal judge in Louisiana found for Merck [JURIST report] in a lawsuit over reimbursements for the prescription painkiller Vioxx filed by the Louisiana Attorney General's Office [official website] and joined [JURIST report] by the state of Florida in 2008. Other lawsuits were filed in Louisiana, California, New Jersey and Texas [JURIST reports]. In April 2010, the US Supreme Court [official website] ruled [JURIST report] that a securities fraud claim filed against Vioxx had not passed its statute of limitations and could proceed. In September 2007, the New Jersey Supreme Court [official website] dismissed a class action lawsuit [JURIST report] filed against Merck, reversing a lower court's decision to grant nationwide class certification in the case. In November 2007, Merck said that it had agreed to pay $4.85 billion to settle [JURIST report] all pending lawsuits regarding its marketing and distribution of Vioxx.

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