Merck to pay $950 mil­lion in Vioxx suit, plead guilty

Modern Healthcare - - LATE NEWS -

Merck agreed to pay $950 mil­lion to re­solve crim­i­nal charges and a law­suit al­leg­ing that the com­pany il­le­gally mar­keted Vioxx, the painkiller that was pulled from the mar­ket in 2004. Merck, based in White­house Sta­tion, N.J., will plead guilty to a mis­de­meanor for il­le­gal pro­mo­tion ac­tiv­ity re­lated to Vioxx and pay a $321.6 mil­lion crim­i­nal fine. In an agree­ment with pros­e­cu­tors, Merck ad­mits mis­brand­ing Vioxx by pro­mot­ing the drug to physi­cians as a treat­ment for rheuma­toid arthri­tis dur­ing a three-year pe­riod in which it was not ap­proved by the Food and Drug Ad­min­is­tra­tion for that in­di­ca­tion. Vioxx was ap­proved by the FDA in 1999; it was ap­proved as an in­di­ca­tion for rheuma­toid arthri­tis in 2002. The com­pany also will en­ter a $628.4 mil­lion civil set­tle­ment agree­ment that re­solves al­le­ga­tions of off-la­bel mar­ket­ing and false state­ments about the drug’s safety. The U.S. will re­cover $426 mil­lion from the civil set­tle­ment and the re­main­ing $202 mil­lion will be dis­trib­uted to the Med­i­caid pro­grams that par­tic­i­pated in the suit. Merck will en­ter a cor­po­rate in­tegrity agree­ment with the HHS’ in­spec­tor gen­eral’s of­fice. Top ex­ec­u­tives will be re­quired to com­plete an­nual com­pli­ance cer­ti­fi­ca­tions, and Merck will be re­quired to post in­for­ma­tion about physi­cian pay­ments on its web­site, ac­cord­ing to the news re­lease. Merck said in a news re­lease that the “civil set­tle­ment does not con­sti­tute any ad­mis­sion by Merck of any li­a­bil­ity or wrong­do­ing.” The com­pany said Vioxx lit­i­ga­tion with seven states re­mains out­stand­ing.

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