(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 [
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.
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