Scios, Inc., a biopharmaceutical company, engages in the discovery, development, and marketing of treatments for cardiovascular and inflammatory diseases. It markets Natrecor (nesiritide) for the treatment of acutely decompensated congestive heart failure. In addition to Natrecor, the company has two product research and development programs, p38 kinase, directed to the development of inhibitors of p38 kinase, an enzyme responsible for increased production of various proteins that cause inflammation; and TGF-beta, directed to the development of inhibitors of TGF-beta, a signaling protein that is implicated in a range of diseases characterized by unregulated scarring and eventual organ failur...
820 West Maude Avenue
Sunnyvale, CA 94085
Founded in 1981
Nolan Auerbach & White Announces Conclusion of its Client's Civil False Claims Act Case against Johnson & Johnson and Scios
Nov 4 13
Nolan Auerbach & White announced the conclusion of its client's 8-year-long civil False Claims Act case against Johnson & Johnson and its subsidiary Scios, Inc. The qui tam case was brought in July 2005 by Joe Strom, a former Scios Area Manager. Both Defendants will pay $184 million to resolve civil allegations that they unlawfully promoted their cardiac drug Natrecor for unapproved uses. In addition, in 2011, Scios agreed to pay an $85 million criminal fine and to plead guilty to a misdemeanor charge of introducing misbranded Natrecor into interstate commerce. This settlement was announced by the United States as part of a $2.2 billion global settlement between the government and Johnson & Johnson. The Food & Drug Administration (FDA) only approved Natrecor for a specific use, namely, as a treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. Mr. Strom's Complaint alleges that Johnson & Johnson and Scios broadly marketed the drug to physicians for off-label uses, including the treatment of chronic congestive heart failure patients with serial, scheduled outpatient infusions. Sales tactics identified by Mr. Strom and the government in legal filings, included organizing third-party continuing medical education programs that were actually controlled, promoted and designed by Scios; distributing third-party articles; touting the off-label benefits of Natrecor, while not disclosing that the article was funded in part or in full by Defendants; and educating physicians on Medicare reimbursement codes for off-label uses. The legal filings further described that Defendants paid grant funds and provided other resources to health care providers to use in starting outpatient infusion clinics, provided health care professionals with their Heart Failure Clinic Marketing Resource Kit, which included, inter alia, form press releases for outpatient clinics to announce their activities, and a Clinical Resource Compendium which provided contact information for medical supplies, equipment, and reimbursement consultants.