NY AG ANNOUNCES $173 MLN SETTLEMENT WITH ENDO PHARMACEUTICALS

(The following is a reformatted version of a press release issued by New York Attorney General Eric T. Schneiderman and received via e-mail. The release was confirmed by the sender.) "*News from   A.G. SCHNEIDERMAN ANNOUNCES $173M SETTLEMENT WITH PHARMACEUTICAL GIANT TO  RESOLVE OFF-LABEL MARKETING ALLEGATIONS*  "Endo Pharmaceuticals Will Return $25M To New York Medicaid Program "  "A.G. Schneiderman: My Office Will Protect Precious Medicaid Dollars; Work To  Ensure Pharmaceutical Companies Play By The Rules "  NEW YORK - Attorney General Eric T. Schneiderman announced today that New York  has joined with other states and the federal government in a $173 million  global settlement with Endo Pharmaceuticals, a wholly owned subsidiary of Endo  Health Solutions, a manufacturer of pharmaceutical products, to resolve civil  allegations of unlawful marketing practices aimed at promoting the drug  Lidoderm for conditions not approved by the Food and Drug Administration.   New York led the national team representing the states in the investigation and  subsequent settlement. According to the qui tam, or whistleblower lawsuit, Endo  unlawfully marketed Lidoderm for use in connection with lower back pain or  chronic pain. The FDA approved Lidoderm only for the treatment of pain  associated with post-herpetic neuralgia, more commonly known as shingles.  “Illegally marketing drugs off-label puts patient lives at risk and rips off  New York taxpayers and the state by defrauding Medicaid and other programs,”  *Attorney General Schneiderman* said. “Pharmaceutical companies, no matter how  large, are not above the law, and my office will continue to ensure that  prescriptions are written based on sound medical judgment – and that drug  manufacturers are held responsible for pushing their products for uses not  approved by the FDA.”  Under the terms of the civil settlement, Endo will pay $172,916,967 to the  states and federal government and pay a criminal penalties and forfeitures of  almost $21 million . Endo will also enter into a Deferred Prosecution  Agreement with the Northern District of New York and enter into a Corporate  Integrity Agreement with the Department of Health and Human Service’s Office of  the Inspector General. The lawsuit was filed in the Eastern District of  Pennsylvania under the provisions of the federal False Claims Act and analogous  state False Claims statutes. The New York Medicaid program will receive more  than $25 million in the settlement.  As outlined in the settlement agreement, between March 1999 and December 2007,  Endo knowingly promoted the sale and use of Lidoderm for use in connection with  lower back and chronic pain that were not medically accepted indications and  were not covered by the state Medicaid program. Endo’s alleged unlawful conduct  caused false or fraudulent claims to be submitted to the state Medicaid  program. A copy of the New York settlement with Endo can be found here [  http://www.ag.ny.gov/pdfs/New_York_Settlement_Agreement.pdf ].  A team from the National Association of Medicaid Fraud Control Units worked  with the federal government on the investigation and conducted settlement  negotiations with Endo on behalf of the states. Representatives from the states  of New York, Florida, Texas and Oregon comprised the team. Leading the team was  Jay Speers, Counsel to the New York Medicaid Fraud Control Unit; Stacey Millis,  Supervising Special Auditor Investigator; Michael LaCasse, Chief Auditor, and  Matthew Tandle, Senior Special Auditor Investigator. New York's Medicaid Fraud  Control Unit, led by Acting Director Amy Held, is part of the Criminal Justice  Division, led by Executive Deputy Attorney General Kelly Donovan.  (rml) NY