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Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees. Merck withdrew Vioxx in 2004 after a study showed it doubled the risk of heart attacks and strokes. The company won 11 of 16 Vioxx suits at trial before agreeing in 2007 to create a $4.85 billion settlement fund to resolve thousands of injury claims over the drug. Plaintiffs' experts said Merck distorted the health risks of Vioxx in medical literature, advertisements and statements to doctors by sales representatives. The settlement, which won preliminary approval from a New Jersey state judge on Feb. 8, would resolve all so-called derivative lawsuits, which are for the benefit of the company rather than just shareholders. An approval hearing is scheduled for March 22 in Atlantic City, New Jersey. The settlement, which covers federal and New Jersey state shareholder cases, isn't an admission of wrongdoing on the part of Merck or the executives named in the suit, Rogers said. The company will be required to make corporate governance changes and "supplement existing policies and procedures," he said. In testimony videotaped in 2006 for the Vioxx trials, Harvard Medical School professor Jerome Avorn said Merck failed to conduct adequate studies of Vioxx's risks before launching it in 1999 as an alternative to painkillers that caused more stomach bleeding. Merck also misled doctors about a 2000 study that showed Vioxx caused five times more heart attacks than another painkiller, naproxen, he said. The Advantage study, was a trial of 5,557 patients started in 1999, just as Vioxx was cleared for sale. The study, which recruited 600 doctors, was crafted by Merck's marketing department, according to researchers who reviewed 100 internal company memos and reports. The Advantage study "was marketing masquerading as science," the lead author of the Annals report, Kevin Hill of Harvard Medical School in Boston, said in a 2008 interview. "They went about this in a very analytic way, picking doctors who would be most influential, who will talk to other doctors and recommend Vioxx to them, and thus increase prescriptions in the area, planting the seeds of additional Vioxx use." Under the settlement announced yesterday, Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party. To read this article in it's entirety visit, http://www.bloomberg.com/apps/news?pid=newsarchive&sid=agszHuubt9EM
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