J&J’S Scios or­dered to pay $85 mil­lion for mis­brand­ing

Modern Healthcare - - LATE NEWS -

A sub­sidiary of John­son & John­son pleaded guilty to mis­de­meanor drug mis­brand­ing and was or­dered to pay an $85 mil­lion crim­i­nal penalty for pro­mot­ing reg­u­lar in­tra­venous use of its heart-fail­ure drug Na­trecor. A fed­eral judge in San Fran­cisco or­dered the unit, called Scios, to pay the fine as part of a ne­go­ti­ated plea deal, un­der which the drug­maker ad­mit­ted il­le­gally mar­ket­ing the drug be­tween 2001 and 2003 by not in­clud­ing in­struc­tions for how to ad­min­is­ter Na­trecor for the use ap­proved by the Food and Drug Ad­min­is­tra­tion. A state­ment from Sun­ny­vale, Calif.-based Scios said the com­pany ad­mits guilt but de­nies know­ingly mis­brand­ing the drug. Typ­i­cally, mis­de­meanor vi­o­la­tions of the Food, Drug and Cos­metic Act do not in­volve in­tent to com­mit a crime, govern­ment of­fi­cials say in court records. The plea leaves un­re­solved a par­al­lel law­suit filed by a former em­ployee, and joined by the govern­ment, ac­cus­ing both Scios and John­son & John­son of caus­ing Medi­care and other govern­ment pro­grams to be billed for un­ap­proved uses of Na­trecor be­tween 2001 and 2005.

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