Par Pharmaceutical Pays $45 Million To Settle Whistleblower Off-Label Claims
PHILADELPHIA, March 6, 2013 /PRNewswire/ -- Par Pharmaceutical Company has agreed to pay $45 million to settle civil and criminal allegations that the company launched a long term care ("LTC") sales force to promote Megace ES for off-label uses including weight loss in elderly patients. The FDA approved Megace ES in July 2005 for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome.
Christine Thompson was a key whistleblower in the case against Par. Brian Kenney and Tavy Deming of the Philadelphia-area firm Kenney & McCafferty, P.C. represented Ms. Thompson.
"Christine is the ideal whistleblower. She worked for Par as one of just ten Regional Business Manager, so she was able to provide top notch evidence and information revealing a nationwide off-label promotional scheme to the government," according to Kenney. Among the numerous key documents and information Thompson provided to the government included executive level emails - including emails from Senior Vice President of Sales Rick Painter - directing managers and the sales force to aggressively promote Megace ES in LTC facilities.
"Even more remarkable, our client came to the government with powerful evidence of corporate knowledge of the fraud yet she had clean hands, because she never participated in Par's fraud. Just weeks into her employment, during her training, she discovered Par's plan to promote Megace ES to an exclusively off-label patient population – elderly residents of long-term facilities. She immediately voiced her concerns verbally and in writing to the most senior Par executives, decided to blow the whistle," said Deming.
Par's unlawful scheme not only illegal and cost taxpayers tens of millions of dollars, but the company consciously ignored serious patient safety issues because, according to Kenney, "there was little profit to be made by marketing the drug lawfully, due to advancements in HIV and AIDs treatments which drastically reduced the on-label patient population." The most serious risk posed by the use of Megace ES in the elderly patient population, particularly residents of LTC facilities, is deep vein thrombosis, due to that patient population's sedimentary lifestyle. "Our client only worked for Par for a few months, and in just those few months, a physician in her territory stopped using Megace ES due to a patient developing a deep vein thrombosis which the physician attributed to Megace ES therapy," said Kenney.
"Christine was being groomed for a management position with another pharmaceutical company when Par recruited her away with an immediate management opening. Par told her she would be marketing a drug to treat an underserved often marginalized patient population: HIV and AIDs patients. It seemed like the perfect job, because helping people in need is part of who Christine is. Added Kenney, "Christine has an extensive background volunteering for various non-profit disaster relief organizations. She would take vacation time to volunteer with these organizations all across the globe.
The federal investigation into Par's marketing practices was conducted through a collaborative effort of the U.S. Department of Justice, and the U.S. Attorney's Offices for the District of New Jersey. The New York State Assistant Attorney General's Office led the investigation on behalf of the states and the National Association of Medicaid Fraud Control Units ("NAMFCU").
Case Caption: United States ex rel. Thompson et al. v. Pharmaceutical Companies, Inc., et al., Civil Action No. CV-09-3526 (D.N.J.).
About Kenney & McCafferty, P.C.:
Kenney & McCafferty, PC is the one of the most successful national law firms specializing in representing qui tam, tax, and SEC whistleblowers. Kenney & McCafferty's qui tam lawsuits have recovered more than $6 billion in civil and criminal fines and penalties for federal and state governments, resulting in the payment of hundreds of millions of dollars in whistleblower rewards to Kenney & McCafferty clients.
Additional information about the firm is available at http://www.quitam-lawyer.com and http://www.tax-fraud.net.
Document Links:
To read the full complaint filed on behalf of Ms. Thompson, click here.
SOURCE Kenney & McCafferty, P.C.
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