Acting Attorney General John J. Hoffman announced today that New Jersey will receive a total of $2.7 million as a result of its participation in a global settlement with Qualitest Pharmaceuticals Inc. that resolves civil allegations the company mislabeled its multivitamin-with-fluoride tablets to indicate they were richer in fluoride than they actually were.
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.
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.