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Attorney General Mike DeWine...
$40 Million
Settlement for Ohio Medicaid
(COLUMBUS, Ohio) -- Attorney General Mike DeWine announced today that
Ohio and various other states and the federal government have reached
an agreement in principle for the largest healthcare fraud settlement
in U.S. history.
Under the terms of the settlement, GlaxoSmithKline (GSK) has agreed to
pay $3 billion to resolve allegations that GSK engaged in various
illegal schemes related to the marketing and pricing of drugs it
manufactures. As part of the settlement, GSK will pay to the
states and the federal government a total of $2 billion in damages and
civil penalties to compensate various federal healthcare programs,
including Medicaid, for harm allegedly suffered as a result of the
illegal conduct.
“GlaxoSmithKline illegally marketed several prescription drugs for
ailments the medications were not intended to treat,” said Ohio
Attorney General Mike DeWine. “The medicines were then
overprescribed and paid for with Ohio taxpayer dollars. Today I’m
happy to say that we are getting that taxpayer money back.”
As part of this settlement, Ohio Medicaid will receive a total of
$40,255,498.34 in recoveries from GSK. The federal share of that
settlement amounts to $23,541,015.87, while Ohio’s share is
$16,714,482.47.
In addition, GSK has agreed to plead guilty to federal criminal charges
relating to drug labeling and FDA reporting and has agreed to pay a $1
billion criminal fine in connection with those allegations.
The state and federal governments alleged that GSK engaged in a pattern
of unlawfully marketing certain drugs for uses for which the drugs were
not approved by the Food and Drug Administration (FDA); making false
representations regarding the safety and efficacy of certain drugs;
offering kickbacks to medical professionals; and underpaying rebates
owed to government programs for various drugs paid for by Medicaid and
other federally-funded healthcare programs. Specifically, the
government alleged that GSK engaged in the following activities:
• Marketing the depression drug Paxil for off-label uses, such as use
by children and adolescents;
• Marketing the depression drug Wellbutrin for off-label uses, such as
for weight loss and treatment of sexual dysfunction, and at
higher-than-approved dosages;
• Marketing the asthma drug Advair for off-label uses, including
first-line use for asthma;
• Marketing the seizure medication Lamictal for off-label uses,
including bipolar depression, neuropathic pain, and various other
psychiatric conditions;
• Marketing the nausea drug Zofran for off-label uses, including
pregnancy-related nausea;
• Making false representations regarding the safety and efficacy of
Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug
Avandia;
• Offering kickbacks, including entertainment, cash, travel, and meals,
to healthcare professionals to induce them to promote and prescribe
Paxil, Wellbutrin, Advair, Lamictal, Zofran, the migraine drug Imitrex,
the irritable bowel syndrome drug Lotronex, the asthma drug Flovent,
and the shingles and herpes drug Valtrex; and
• Submitting incorrect pricing data for various drugs, thereby
underpaying rebates owed to Medicaid and other federal healthcare
programs.
As part of the settlement, GSK has also agreed to plead guilty to
criminal charges that it violated the federal Food, Drug, and Cosmetic
Act (“FDCA”) in connection with certain activities. The
government alleges that GSK introduced Wellbutrin and Paxil into
interstate commerce when the drugs were misbranded, meaning containing
labels that were not in accordance with their FDA approvals, and that
GSK failed to report certain clinical data regarding Avandia to the FDA.
The settlement is based on four qui tam actions brought by private
individuals pursuant to state and federal false claims acts and filed
in or transferred to the United States District Court for the District
of Massachusetts, as well as investigations conducted by the U.S.
Attorney’s Office for the District of Massachusetts and the Civil
Frauds Division of the U.S. Department of Justice.
A National Association of Medicaid Fraud Control Units team
participated in the investigation and analysis of the claims and
conducted the settlement negotiations with GSK on behalf of the
settling states. Team members included representatives from Ohio,
Massachusetts, California, Colorado, and New York.
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