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India's Largest Generic Drugmaker Ranbaxy Pays $500 Million to Settle Systemic Generic Drug Manufacturing Fraud
Date:5/13/2013

tion of a court-ordered seal and confidentiality, and receive a percentage of the amount recovered in a successful case.

Mr. Thakur's lawsuit, which was joined by the Department of Justice and participating States, alleges wide-ranging manufacturing violations in Ranbaxy's facilities in India and the United States, including inadequate testing to ensure that the drugs were safe, effective, free of cross-contamination, and manufactured in compliance with their approved specifications. Moreover, Mr. Thakur alleges that Ranbaxy falsified information about the drugs, including backdating tests and submitting false data where no tests were performed. The pervasive violations are alleged to have adulterated dozens of generic drugs purchased by government healthcare programs such as Medicare and Medicaid, as well as generic antiretroviral drugs purchased by the United States under the President's Emergency Plan for AIDS Relief.

As a result of today's $500 million settlement, the government will obtain approximately $350 million in civil penalties and $150 million in criminal penalties. Mr. Thakur will receive 21 percent of the federal and participating Medicaid States' civil recoveries. Ranbaxy USA, Inc. has entered a plea of guilty to six felony counts in a criminal information filed by the United States, including introducing into commerce adulterated or misbranded drugs.

Andrew Beato , head of the False Claims Act and Whistleblower Practice Group at Stein Mitchell Muse & Cipollone and counsel to Mr. Thakur, stated that "This case was fueled by the extraordinary courage of Dinesh Thakur . Without expectation of gain and at great risk, he reported the fraud to ensure that patients' health was not compromised by the quality of Ranbaxy drugs." Mr. Beato said that
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SOURCE Stein Mitchell Muse & Cipollone LLP
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