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United States Joins Suits Against Scios and Johnson & Johnson
Date:2/19/2009

s not cover drugs used for off-label uses unless such off-label use is established to be medically necessary. The federal health care programs -- in particular, Medicare -- paid substantial amounts for the serial outpatient off-label use of Natrecor.

In mid-2005, a panel of leading cardiologists told Scios that it should stop promoting the scheduled, serial outpatient use of Natrecor. Scios subsequently sent a letter to healthcare providers in which it acknowledged that there was insufficient clinical evidence supporting the safety and efficacy for scheduled, serial outpatient use of the drug. In 2007, Scios released the results of a clinical study that showed no significant benefits of serial outpatient Natrecor infusions.

The two separate civil False Claims Act suits -- called qui tam actions -- were filed by former Scios sales managers against Scios and Johnson & Johnson in the Northern District of California. The False Claims Act allows for private persons to file whistleblower suits to provide the government information about wrongdoing. Under the statute, if it is established that a person has submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and $5,500 to $11,000 for each false or fraudulent claim filed. If the government is successful in resolving or litigating its claims, the whistleblower who initiated the action can receive a share of between 15 percent to 25 percent of the amount recovered.

The qui tam or whistleblower actions contain additional allegations. However, the United States is only intervening with regard to allegations that Scios marketed the drug Natrecor for serial infusions in the outpatient setting.

The investigation was conducted by the Civil Division of the U.S. Department of Justice, the U.S. Attorney's Office for the Northern District of California, the Federal Bureau of In
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SOURCE U.S. Department of Justice
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