Fraudulent Labeling: Pharma Company Settles Fraud Charges for Half-Strength Supplements

The Government recently announced a $39 million settlement against Vintage Pharmaceuticals, LLC, d/b/a  QUALITEST PHARMACEUTICALS; Vintage’s corporate parent Endo Pharmaceuticals, Inc.; and seven of their corporate subsidiaries or affiliates (collectively, “QUALITEST”) in a civil fraud lawsuit.  The qui tam complaint alleged that QUALITEST violated the False Claims Act by knowingly manufacturing and selling understrength chewable fluoride tablets that were prescribed to children living in communities without fluoridated water supply to prevent tooth decay. More specifically the complaint alleges that from 2007 to July 2013 these tablets contained less than half the amount of fluoride ion that was indicated on the drug label which was less than half the amount of fluoride ion recommended by the American Dental Association and American Academy of Pediatrics guidelines. These actions caused Medicaid and the Federal Employees Health Benefits Program to pay millions of dollars for these understrength tablets.

Of note in this case, Qualitest admitted that its manufacturing processes were not designed to produce the indicated amount of fluoride ion per tablet.  The company further admitted that instead of using the amount of sodium fluoride that would result in the tablets containing the correct amount of fluoride ion, QUALITEST used less than half the appropriate amount of sodium fluoride.

OPM Inspector General Patrick E. McFarland said: “Qualitest’s actions are unconscionable and put the health and wellbeing of children at risk.  I am proud that we were able to work with our law enforcement partners to hold Qualitest accountable for its offenses.  We remain committed to ensuring that the health of Federal employees and their families are protected and that such unscrupulous behavior is caught and punished.

More information for whistleblowers is located at the Nolan Auerbach & White website.