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