Par Pharmaceutical Company 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.
The whistleblower learned of Par’s plan to promote Megace ES to an off-label patient population — long-term care facilities — just weeks into her employment.
However, the drug poses a serious risk of deep vein thrombosis in elderly patients, particularly residents of LTC facilities, due to sedimentary lifestyle. Thompson immediately voiced her concerns verbally and in writing to the most senior Par executives, including the compliance officer. “When her internal complaints were repeatedly rebuffed, she made the choice to blow the whistle,” said Deming.
Among the numerous key documents and information Thompson provided to the government included executive-level emails — including messages from Senior Vice President of Sales, Rick Painter — directing managers and the sales force to aggressively promote Megace ES in LTC facilities.
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 relentless pursuit of those profits led to the lawsuit that ended up costing Par Pharmaceutical company, Inc. $45 million.
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