Department Of Justice Joins Lawsuits Filed Over Alleged Illegal Marketing Of Heart Failure Medication Natrecor

Main Category: Cardiovascular / Cardiology
Also Included In: Litigation / Medical Malpractice;  Heart Disease
Article Date: 23 Feb 2009 - 0:00 PDT

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The Department of Justice on Thursday announced plans to join two whistleblower lawsuits filed against Johnson & Johnson subsidiary Scios over allegations that the company illegally marketed the heart failure medication Natrecor for unapproved uses and defrauded Medicare and other federal health care programs, the San Francisco Chronicle reports. FDA in 2001 approved Natrecor for use in hospital patients who experienced shortness of breath caused by acute congestive heart failure (Egelko, San Francisco Chronicle, 2/20).

According to the lawsuits, filed in 2005 in U.S. District Court for the Northern District of California by former Scios sales managers Joe Strom and Jeffrey Smith, the company since 2001 has marketed Natrecor for use in outpatients who have less severe heart failure. In court documents unsealed on Thursday, the plaintiff in one of the lawsuits alleges that "upper management has always permitted and encouraged active off-label marketing" (Wang/Kendall, Wall Street Journal, 2/20). Marcella Auerbach, an attorney for one of the plaintiffs, said that Scios and J&J have collected hundreds of millions of dollars in reimbursements from Medicare and other federal health programs for unapproved uses of Natrecor (San Francisco Chronicle, 2/20).

Charles Miller, a spokesperson for the civil division at DOJ, said, "Our investigation showed what we believed to have been off-label usage," adding, "As a result, we've joined the suit."

Ernie Knewitz, a spokesperson for J&J, said that the company had "reviewed the allegations thoroughly and will be prepared to address them through the courts" (Wall Street Journal, 2/20).

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