The Wall Street Journal (2/20, Wang, Kendall) reports, "The U.S. Justice Department is joining two whistleblower lawsuits alleging that Johnson & Johnson [J&J] marketed its cardiac drug Natrecor [nesiritide] for a use that isn't approved by the Food and Drug Administration." The drug was approved in 2001 "for in-hospital use by patients with congestive heart failure." But, the prosecutors allege "that Scios, a subsidiary of J&J, launched an aggressive campaign to market Natrecor for patients with less-severe heart failure in an out-patient setting." In doing so, the company "caused 'false and fraudulent claims' to be submitted to federal healthcare programs, which could have led to 'damages in the hundreds of millions of dollars.'"
According to the AP (2/20), the company was advised "to stop promoting Natrecor for patients with less sever heart failure, including those who are no longer hospitalized," in 2005 by "a panel of leading cardiologists." J&J then "released results of a study that showed no medical benefit for those patients" in 2007. The company now faces two whistleblower suits "filed in the Northern District of California by former sales managers for J&J unit Scios Inc."
The Justice Department noted that "Medicare does not cover drugs used for off-label uses unless such off-label use is established to be medically necessary," but that it "paid substantial amounts for the serial outpatient off-label use," Bloomberg News (2/20, Blum) adds. As a result, prosecutors "could seek damages as much as triple the cost of the off-label medicines, as well as $5,500 to $11,000 for each false or fraudulent reimbursement claim filed." A J&J spokesman stated that the company "has 'reviewed the allegations thoroughly and will address them in the courts.'"
Modern Healthcare (2/20, Blesch) noted that "the Justice Department did not specify the cost of the alleged false claims and has not yet filed its version of the complaint." The San Francisco Chronicle (2/19, Egelko) and the Dow Jones Newswires (2/20, Kendall, Favole) also covered the story.
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