MARYLAND AG GANSLER SECURES SETTLEMENT WITH GLAXOSMITHKLINE

(The following is a reformatted version of a press release
issued by the Office of Maryland Attorney General Douglas F.
Gansler and received via electronic mail. The release was
confirmed by the sender.) 
AG Gansler Secures Settlement with GlaxoSmithKline
Pharmaceutical company pays $3.6 million to resolve Medicaid
fraud allegations 
Baltimore, MD (January 3, 2013) - Attorney General Douglas F.
Gansler announced today that Maryland has entered into a
settlement agreement with GlaxoSmithKline LLC (GSK) to resolve
allegations that the pharmaceutical company engaged in various
illegal schemes related to the marketing and pricing of drugs it
manufactures. Under the terms of the settlement, GSK paid
$3,620,452 to the Maryland Medicaid program. 
“Consumers have the right to expect drug manufacturers are
upfront and honest about their products,” said Attorney General
Gansler. “When a pharmaceutical company engages in marketing
outside the scope for which a drug was approved, it
unnecessarily drives up prescription costs, which this office
will not stand for.” 
The State 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); 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 State 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 and Zofran. 
·         Offering kickbacks, including entertainment, cash,
travel and meals, to healthcare professionals encouraging them
to promote and prescribe Paxil, Wellbutrin, Advair, Lamictan,
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. 
The settlement is related to a $3 billion settlement with the
federal government and other states announced in July. 
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 Fraud Division of the
U.S. Department of Justice. 
A team from the National Association of Medicaid Fraud Control
Units (NAMFCU) 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 Massachusetts, California, Colorado, New
York, and Ohio. In announcing the settlement, Attorney General
Gansler thanked Assistant Attorney General Shelly Marie Martin
and Medicaid Fraud Control Unit Chief Auditor Ruth Jarrell for
their work on this matter. 
CONTACT:
David Paulson - 410-576-6357
dpaulson@oag.state.md.us 
Alan Brody - 410-576-6956
abrody@oag.state.md.us 
(bjh) NY 
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