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FOUR FROM THE U.S. ATTORNEY’S OFFICE IN ATLANTA GIVEN DOJ’s HIGHEST ATTORNEYS AWARD BY ATTORNEY GENERAL HOLDER AT CEREMONY TODAY IN WASHINGTON, D.C.

FOR IMMEDIATE RELEASE
October 19, 2011
http://www.jusice.gov/usao/gan/
CONTACT:  Patrick Crosby
(404)581-6016
FAX (404)581-6160

 WASHINGTON - Attorney General Eric Holder recognized four Assistant United States Attorneys from the Northern District of Georgia along with 340 other Department employees from offices across the country for their distinguished public service today at the 59th Annual Attorney General Awards Ceremony. Forty-four other individuals outside of the Department were also honored for their work.  Held at DAR Constitution Hall in Washington, D.C., this annual ceremony recognizes both Department employees and others for their dedication to carrying out the Department of Justice's mission.

“This year's award recipients have made significant contributions across, and far beyond, the Department of Justice and helped to protect the rights, safety and best interests of the citizens we are privileged to serve,” Attorney General Holder said. “I am grateful for the dedication and passion that these extraordinary public servants bring to their work, and I am honored to count them as colleagues.”

Assistant United States Attorney and Chief of Economic Crime Randy S. Chartash and Assistant United States Attorneys Douglas W. Gilfillan, Christopher J. Huber, and Sally B. Molloy from the Northern District of Georgia, along with Trial Attorney Edward C. Crooke with DOJ’s Office of Commercial Litigation, and Trial Attorney John W. Burke with DOJ’s Office of Consumer Protection Litigation, were awarded the John Marshall Award for Participation in Litigation for their outstanding work in obtaining a successful global resolution in the complex investigation of Allergan, Inc.’s illegal off-label promotion of Botox® as a treatment for headache, pain, spasticity, and juvenile cerebral palsy (JCP).  The John Marshall Awards are the Department of Justice’s highest awards offered to attorneys, for contributions and excellence in specialized areas of legal performance.

The Allergan global settlement, $600 million in total, was reached in September 2010.  At the time, it was the fifth largest recovery in an off-label marketing case; it had been resolved faster than any other off-label marketing case of comparable size; and it constituted a significant portion of Allergan’s revenues from Botox® for the period under investigation.  Specifically, Allergan pleaded guilty to misbranding Botox® in violation of the Food, Drug, and Cosmetic Act (FDCA), paid a $350 million criminal fine and forfeited an additional $25 million.  Allergan also paid $225 million to the federal government and the states to resolve its civil False Claims Act liability and to settle three qui tam actions. The civil settlement recovered monies for six federal health care programs: Medicare, Medicaid, TRICARE, the Federal Employees Federal Health Benefit Program (FEHBP), the Department of Veterans’ Affairs (VA), and the Department of Labor’s Office of Worker’s Compensation Programs (OWCP).

As part of the global resolution, Allergan entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services and also agreed to dismiss with prejudice the lawsuit Allergan filed against the FDA during the investigation challenging on First Amendment grounds the constitutionality of the FDCA and the FDA's implementing regulations.

To unravel Allergan’s massive off-label marketing scheme and to prove that Allergan’s illegal activities, not market demand, caused the skyrocketing growth in off-label Botox® sales required the prosecutors to review and organize millions of pages of subpoenaed documents, interview dozens of witnesses around the country, and analyze massive amounts of Botox® claims data for six federal health care programs.  The evidence showed that although Botox® was FDA-approved for only four rare conditions, Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses such as headache, pain and spasticity and demanded tremendous growth in off-label sales year after year.                   

                                                    
For further information please contact Sally Quillian Yates, United States Attorney, or Charysse L. Alexander, Executive Assistant United States Attorney, through Patrick Crosby, Public Affairs Officer, U.S. Attorney's Office, at (404) 581-6016.  The Internet address for the HomePage for the U.S. Attorney's Office for the Northern District of Georgia is www.justice.gov/usao/gan.

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