Under terms of the settlement, Alabama-based Qualitest will pay 47 participating states and the federal government a total of $39 million to resolve the unlawful mislabeling allegations.
Qualitest was the subject of a qui tam or “whistleblower” lawsuit filed in 2013 by a Florida dentist who alleged that it unlawfully represented its multivitamin tablets as containing levels of fluoride recommended by the American Dental Association (ADA) when they did not.
Specifically, the lawsuit alleged that Qualitest marketed, sold and distributed multivitamins containing less than 50 percent of the fluoride represented on the label. According to the lawsuit, Qualitest engaged in the unlawful conduct between October 1, 2007 and August 31, 2013.
Since 1994, the American Dental Association and the American Academy of Pediatrics have recommended certain levels of fluoride in drinking water to prevent tooth decay, cavities and related issues. Both groups recommend supplemental fluoride for children whose drinking water contains an insufficient concentration of fluoride.
“At the end of the day, this kind of alleged health product mislabeling — and the false insurance claims it generates — costs us all,” said Acting Attorney General Hoffman.
“Working on our own and in collaboration with our state and federal partners, we are committed to identifying Medicaid fraud and abuse, and to holding those who engage in such conduct accountable,” Hoffman said.
A manufacturer of generic pharmaceutical products, Qualitest has its corporate offices in Hunstville, AL, and is a wholly-owned subsidiary of Endo Pharmaceuticals. Endo has its global headquarters in Dublin, Ireland, and its U.S. headquarters in Malvern, PA.
The 2013 whistleblower lawsuit alleged that Qualitests’s mislabeling of its multivitamins caused submission of false claims to state Medicaid programs. Filed in U.S. District Court in the Southern District of New York, the lawsuit contained allegations made under the federal False Claims Act and analogous state False Claims statutes.
Deputy Attorney General Nina D. Bonner of the Office of Insurance Fraud Prosecutor handled the Qualitest matter on behalf of the State.
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