Ranbaxy USA Inc., a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty to charges relating to the manufacture and distribution of adulterated drugs made at two of its facilities. In addition to its guilty plea, Ranbaxy agreed to pay a criminal fine and forfeiture of $150 million, and also will pay another $350 million to resolve civil claims under the False Claims Act.
The whistleblower who initiated the lawsuit was a former Ranbaxy executive. According to the allegations he raised, Ranbaxy committed wide-ranging manufacturing violations in its 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. The whistleblower also alleged that Ranbaxy falsified information about the drugs, including backdating tests and submitting false data where no tests were performed. As a result of these practices, dozens of adulterated generic drugs were purchased by government healthcare programs such as Medicare and Medicaid.
As a reward for exposing Raxbury’s conduct through the filing of a False Claims Act lawsuit, the whistleblower will receive $48.6 million out of the federal government’s recovery.
For more information on this case, click here: http://www.justice.gov/opa/pr/2013/May/13-civ-542.html