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Merck hit over warnings on Vioxx

ANGLETON, Texas -- Merck & Co.'s top epidemiologist took some verbal punches yesterday as the plaintiff's lawyer in the nation's first Vioxx-related lawsuit to go to trial said the company downplayed the drug's safety for years before taking it off the market in 2004.

The trial centers on the May 2001 death of Robert Ernst, a 59-year-old Texan who ran marathons. According to the plaintiffs, he took Vioxx for about eight months to relieve pain in his hands, and died in his sleep.

Nancy Santanello, executive director and head of Merck's department of epidemiology and the company's representative at the trial, was the first witness to testify.

''It's important that your company never minimize the risk of your drugs?" demanded Mark Lanier, the plaintiff's lawyer.

''I think all the risks should be provided," Santanello replied.

Lanier highlighted warning letters Merck received from the Food and Drug Administration about misrepresenting or downplaying concerns about Vioxx's safety in aggressive marketing efforts that included glitzy television ads.

''Would you agree the letter says you guys were doing something you shouldn't be doing?" Lanier asked.

''According to the FDA letter, yes," Santanello replied.

After two years of wrangling with the FDA, Merck added warnings about cardiovascular risks to Vioxx's label in 2002.

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