Attorney
General Mike DeWine
Ohio
to Receive More than $5 Million in Endo Pharmaceuticals Case
(COLUMBUS,
Ohio) -- Attorney General Mike DeWine announced today that Ohio has
joined with several other states and the federal government in a
global settlement with the pharmaceutical product manufacturer Endo
Pharmaceuticals.
The
$172,916,967 settlement resolves civil allegations of unlawful
marketing practices aimed at promoting the drug Lidoderm for
conditions not approved by the Food and Drug Administration, which
then caused false and/or fraudulent claims to be submitted to
Medicaid.
Ohio's
portion of the settlement is $5,064,222.
"This
company made millions deceiving patients who were in pain, and then
billing taxpayers for a product that was not intended to be used this
way," said Attorney General DeWine. "Promoting the sale of
a pharmaceutical drug for uses not approved by the FDA is not only
illegal, but it is also extremely dangerous."
According
to the whistleblower lawsuit, Endo unlawfully marketed Lidoderm for
use in connection with lower back pain or chronic pain between March
1999 and December 2007. The FDA approved Lidoderm only for the
treatment of pain associated with post-herpetic neuralgia, more
commonly known as “shingles.”
The
settlement also includes a $20 million fine, and Endo will be
required to enter into a Deferred Prosecution Agreement with the
Northern District of New York and 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. 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.
Endo
Pharmaceuticals is a wholly owned subsidiary of Endo Health
Solutions.
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