Johnson & Johnson Pleads Guilty to Misbranding Natrecor; Still Faces FCA Case

Johnson & Johnson’s Scios unit, which manufactures the congestive heart failure drug Natrecor, agreed to pay an $85 million penalty and plead guilty to a misdemeanor count of misbranding medication due to inadequate directions on Natrecor’s label.  The agreement also resolves any potential offenses based on Johnson & Johnson’s sale and marketing of Natrecor.

Johnson & Johnson still faces a pending False Claims Act case which alleges that that they marketed the drug for off-label uses without FDA approval, causing any claims for Medicare payments for such use of Natrecor to be false.

Last month, Johnson & Johnson settled a misdemeanor criminal charge related to Risperdal, an anti-psychotic drug.