NEW YORK (Reuters) - A generic drug maker owned by Endo International Plc has reached a $39 million settlement with the U.S. government and 47 states stemming from the unlawful labeling of multivitamins that contained fluoride.
New York Attorney General Eric Schneiderman announced the settlement on Wednesday. The case stemmed from a 2013 whistleblower lawsuit filed under the False Claims Act in which the U.S. Department of Justice and state attorneys general later intervened.
A spokeswoman for Endo and the generic drug maker unit, Qualitest Pharmaceuticals, declined to comment.
Qualitest’s misleading labels caused healthcare professionals to submit false reimbursement claims to Medicaid and federal health care plans, who then paid for vitamins that did not contain the fluoride amount stated on the label, the New York attorney general said.
What’s more, patients were exposed at higher risks of cavities and related health problems, the attorney general said.
Qualitest labeled and promoted that the vitamins contained an amount of fluoride recommended by the U.S. Food and Drug Administration (FDS). The vitamins, in fact, contained half that amount, the attorney general said.
The misrepresentations came to light after a whistleblower, Stephan Porter, a dentist in Florida, tested tablets that Qualitest made between 2008 and 2013 and learned of the actual fluoride amounts, according to New York Attorney General Eric Schneiderman.
The FDA and Endo, which bought Qualitest in 2010, confirmed those findings, according to Schneiderman. The settlement includes $5 million resolving claims related to New York’s Medicaid program.
In 2010 alone, New York paid out more than $984,000 in reimbursements to healthcare providers who submitted claims for the fluoride tablets for Medicaid beneficiaries, according to a lawsuit filed in the case by Manhattan U.S. Attorney Preet Bharara.
Qualitest stopped distributing the fluoride tablets by October 2013. Vintage Pharmaceuticals, a company that is now also part of Endo, also distributed the tablets under its brand, according to the lawsuit.
The case is U.S. ex rel. Porter, et al. v. Vintage Pharmaceutical, U.S. District Court, Southern District of New York, No. 13-1506.
Reporting by Suzanne Barlyn and Nate Raymond in New York; Editing by Bernard Orr