Qui Tam

Botox maker Allergan pleads guilty and agrees to pay $600 Million fine for illegal off-label promotion

By LaBovick Law

American pharmaceutical manufacturer Allergan Inc. has agreed to plead guilty and pay $600 million fine. This will resolve Allergan's criminal and civil liability arising from the unlawful promotion of Botox® Therapeutic, for uses not approved  by the Food and Drug Administration (FDA). The resolution includes a criminal fine and forfeiture totaling $375 million and a civil settlement with the federal government and the states of $225 million to resolve claims that its unlawful marketing practices caused false claims to be submitted to government health care programs.

The civil settlement resolves three lawsuits filed in federal court in the Northern District of Georgia under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. The following whistleblowers – Dr. Amy Lang, Charles Rushin, Cher Beilfuss, Kathleen O'Conner-Masse, and Edward Hallivis – will receive $37.8 million from the federal share of the settlement amount.

Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, and Sally Quillian Yates, U.S. Attorney for the Northern District of Georgia, filed charges against Allergan for promoting Botox® for headache, pain, spasticity and juvenile cerebral palsy – not approved by the FDA. According to the criminal charges, Allergan made it a top corporate priority to maximize sales of Botox® for such off-label uses.

Allergan's off-label marketing tactics included calling on doctors who typically treat patients with off-label conditions. In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops on billing for off-label uses, conducted detailed audits of doctors' billing records, and provided a Botox® Reimbursement Hotline.

This settlement is part of the government's emphasis on combating health care fraud.  Since January 2009, the False Claims Act has helped the Justice Department recover approximately $3.1 billion in cases involving fraud against federal health care programs.  The Justice Department's total recoveries in False Claims Act cases since January 2009 have topped $4 billion.

Click on the following link to read more on the Allergan settlement:
Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox® - DOJ
 
Allergan Will Pay Fine, Plead Guilty to Misdemeanor - Bloomberg

Allergan To Pay $600 Million To Resolve Off-label Marketing Allegations, Agrees To Drop First Amendment Suit - Thompson

Full post as published by Whistleblower Law Blog on September 16, 2010 (boomark / email).