J&J's Scios to plead guilty, pay $85M in Natrecor case

Johnson & Johnson's ($JNJ) legion of legal problems is one less strong. The company agreed to pay $85 million and plead guilty to a misdemeanor charge in a Justice Department probe of its Natrecor marketing. The company had been accused of promoting the heart drug, approved to treat congestive heart failure patients in hospitals and emergency rooms, for off-label use as a routine, outpatient infusion.

The plea agreement involves a single charge of misbranding a drug. It puts Scios under three-year probation, but it also releases the company from prosecution on other offenses related to Natrecor marketing, the Justice Department said in a court filing. The agreement awaits final approval by a San Francisco court and is scheduled for a hearing Sept. 28.

The settlement doesn't exempt Scios or J&J from separate civil claims in a pending False Claims Act suit, Bloomberg reports. That lawsuit, originally filed by a Scios whistleblower, alleges J&J marketed Natrecor for "serial outpatient infusions" that weren't FDA-approved. The whistleblower claims J&J had calculated that off-label use could boost Natrecor sales as high as $930 million, BNet Pharma reports.

Meanwhile, J&J lost a bid to dismiss a Risperdal marketing case. A judge has decided the state-court lawsuit in Arkansas will go forward with a trial expected sometime next year. A similar case is scheduled for trial in Texas in November, while a J&J appeal in a West Virginia case is also pending. The company reached a tentative settlement in a federal probe of its Risperdal marketing last month; J&J agreed to plead guilty to a misdemeanor charge in the years-old investigation. The settlement amount hadn't yet been determined.

- read the Reuters news
- get more from Bloomberg
- see the BNet Pharma piece
- check out another Bloomberg story

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