Endo Health to pay $39 million over fluoride labeling claims
Endo Health to pay $39 million over fluoride labeling claims
NEW YORK | BY SUZANNE BARLYN AND NATE RAYMOND
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.........
Customers might be relieved hearing this that the fluoride amount wasn't as stated. But it shows the duplicity of drug companies.
NEW YORK | BY SUZANNE BARLYN AND NATE RAYMOND
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.........
Customers might be relieved hearing this that the fluoride amount wasn't as stated. But it shows the duplicity of drug companies.
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9:28 AM
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