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Drug Company Pays $39 Million In False Labeling Settlement

Children’s fluoride multivitamin tablet had half the fluoride listed on drug labels, shortchanging children and taxpayers

LANSING – Michigan Attorney General Bill Schuette today announced a $39 million national settlement with Qualitest Pharmaceuticals, Inc. which will bring $693,241.64 to the State of Michigan. Qualitest marketed multivitamin-with-fluoride tablets that contained less than 50% of the fluoride claimed on its labels to health care providers of children and families in Michigan. The mislabeling also caused health care providers to unknowingly submit incorrect claims to Medicaid and various federal health care plans, in violation of false claims laws.

“Parents, dentists and physicians rely on truthfulness in drug labeling and cannot take care of their children and patients when labels are not accurate,” said Schuette.

Qualitest was the largest distributor of multivitamin-with-fluoride tablets in the United States during the time period at issue in this case, October 1, 2007 through August 31, 2013. The lower dose of fluoride could expose children to greater risk of cavities and also led health care providers to unknowingly submit incorrect claims to Medicaid and various federal health care plans, in violation of false claims laws.

Details of the National Settlement with Qualitest Pharmaceuticals, Inc.

Under the settlement, Qualitest has agreed to pay $39 million to the United States and multiple states. Michigan will receive $693,241.64 under the settlement. The settlement stems from a whistleblower lawsuit, U.S., et al, ex rel. Porter v. Qualitest Pharmaceuticals Inc., et al., No. 13-CIV-1506, which was filed in the United States District Court for the Southern District of New York. Anyone with concerns regarding their dental health should consult a dentist.

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