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 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.
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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)
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