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First Vioxx Ruling

By Janice G. Inman
August 30, 2005

Merck & Co., founded in 1891, has a slogan — what it calls its “guiding philosophy.” That philosophy is, “patients first.” In the first of many Vioxx trials expected to be litigated in state and federal courts across the country, the jury wasn't buying it. On Aug. 19, after a month-long trial, ten out of 12 jurors — the number needed to return a verdict of guilty — found Merck liable to the plaintiffs, survivors of a man who took Vioxx for pain relief. The damages award was staggering: $24.5 million in economic losses and compensation for mental anguish and $229 million in punitive damages.

One of Company's Leading Products May Be Its Undoing

Vioxx, the trade name of the generic drug rofecoxib, gained FDA approval in May 1999 for the treatment of osteoarthritis, menstrual pain and the management of acute pain in adults. The original safety database included approximately 5000 patients on Vioxx and did not, according to the FDA, show an increased risk of heart attack or stroke. www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm. Merck later conducted a study it called VIGOR (VIOXX GI Outcomes Research), which was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding. The results of that study, submitted to the FDA in June 2000, did indeed show that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID. It also turned up another, less fortuitous piece of news for Merck: Participants on Vioxx experienced a greater number of heart attacks than those not taking that medication.

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