Drug Maker Ranbaxy Settles Whistleblower Case for $500 MillionMay 16, 2013
Generic drug maker, Ranbaxy Laboratories, just settled an eight-year whistleblower case for $500 million with the U.S Food and Drug Administration (FDA). The case is considered the highest profile generic drug violation in the United States.
Whistleblower, Dinesh Thakur, was director and global head of Research Information and Portfolio Management at Ranbaxy Laboratories from 2003 through 2005, according to Money Control.
In 2005, Thakur reported to management that Ranbaxy’s Ponta Sahib and Dewas plants were falsifying data. When nothing was done, he advised the FDA about falsified records and U.S. drug manufacturing rules violations. According to Money Control, civil and criminal charges were filed against Ranbaxy and some of its senior directors.
Eight years later, Ranbaxy pleaded guilty to felony charges and agreed to pay a massive $500 million fine to settle the criminal and civil cases; Thakur received a $48.5 million payment under the U.S. False Claims Act’s Whistleblower Provision. Thakur’s identity as a whistle blower was just revealed by the U.S. Department of Justice once the settlement was reached, Money Control said.
Based in India, Ranbaxy is one of the 10 largest generic drug producers in the world and has been operating in the United States since 1995.
Thakur says it took eight years of collaboration with the U.S. government to work through the complex paper trail of fallacious data and unsafe manufacturing processes that could have potentially compromised drug safety and quality, explained Money Control.
Over the course of the investigation, Ranbaxy was banned from importing over 30 drugs to the U.S. for three years; received no new FDA drug approvals until it signed a Consent Decree in 2011; forfeited 180-day exclusivity on three drugs, which cost Ranbaxy some $300 million in lost opportunity; had to surrender 27 new drug applications; was fined $500 million; and had gains nullified gains from blockbuster U.S. launches, such as atorvastatin, a generic version of Lipitor, according to Money Control.
A whistleblower is an employee, a former employee, or a member of an organization—especially a business or government agency—who reports misconduct to people or entities with the power and presumed willingness to take corrective action.
Generally, the misconduct is a violation of a law, rule, regulation, and/or the misconduct presents a direct threat to public interest, such as fraud and corruption or, as seen in this case, health/safety violations.
Whistleblower complaints focus on conduct prohibited by a specific law and that may cause damage to public safety, that may waste tax dollars, or that may violate public trust in an honest, accountable government.