Augusta, Maine - Attorney General William J. Schneider announced today that Maine has received payment of more than $1.1 million in a nationwide settlement with pharmaceutical manufacturer Merck Sharp & Dohme Corp. (Merck) involving allegations of off-label marketing and failure to disclose potential adverse health effects of the painkiller Vioxx.
The settlement agreement, reached with the United States and 43 states and the District of Columbia in November 2011, resolved allegations that Merck marketed it drug Vioxx for uses not approved by the United States Food and Drug Administration (FDA), misrepresented the cardiovascular safety issues related to the drug and otherwise made false and misleading representations about Vioxx.
Merck paid the states and the federal government a total of $615 million in civil damages and penalties to resolve claims on behalf of the Medicaid, Medicare and other federally-funded healthcare programs.
Vioxx (generic name rofecoxib) is a non-steroidal anti-inflammatory medication that was approved by the FDA in 1999 for the treatment of osteoarthritis, acute pain conditions and dysmenorrhea. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in the FDA-approved product label. These uses are also known as unapproved or "off-label" uses.
On September 30, 2004 Merck voluntarily withdrew Vioxx from the market worldwide, citing an increase in the incidence of heart attacks and strokes in patients taking Vioxx. This settlement resolves allegations that Merck marketed Vioxx for the treatment of rheumatoid arthritis before the FDA approved the drug for that use and that Merck made inaccurate, misleading and unsupported statements about Vioxx's cardiovascular safety in order to increase sales of the drug.
The misleading representations caused physicians to write prescriptions for Vioxx that they otherwise would not have written, resulting in Medicaid paying for prescriptions that should not have been submitted for reimbursement.
"The big payout by Merck follows multi-year investigations and extensive civil and criminal litigation," said Attorney General Schneider. "Especially where patient safety is at risk, we will work diligently with our state and federal partners to hold drug makers accountable for fraud and abuse and safeguard the taxpayer dollars that fund essential healthcare services for our most needy citizens."
Assistant Attorney General Michael Miller, Director of Attorney General Schneider's Healthcare Crimes Unit, handled this matter.
The Healthcare Crimes Unit is the Medicaid Fraud Control Unit for the State of Maine charged with investigating and prosecuting financial fraud and other crimes committed by MaineCare providers or their employees, and investigating and prosecuting abuse, neglect or exploitation of elderly and dependent persons that occurs in health care facilities or by health care providers.
To learn more about the Office of the Attorney General Healthcare Crimes Unit, go to: http://www.maine.gov/ag/crime/crimes_we_prosecute/healthcare_crimes.shtml
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