Qualitest Pharmaceuticals, a generic drug manufacturing arm of Endo Health Solutions, will pay $39 million to settle a whistleblower lawsuit accusing the drugmaker of falsely labeling and selling multivitamin tablets that contained less than half the amount of advertised fluoride.
Dr. Stephan Porter filed the lawsuit against Qualitest in March 2013 under the whistleblower provisions of the False Claims Act, which allow individuals with original knowledge of fraud and other wrongdoing to sue on behalf of the U.S. government and share a percentage of any recovery their case brings.
Dr. Porter determined through testing that the Qualitest multivitamins contained about 45 percent of the amount of fluoride stated on the product’s labeling. This amount of fluoride, he said, was less than the amount of fluoride recommended by the American Dental Association for the prevention of tooth decay and cavities.
“Rather than using sufficient amounts of the 2 percent sodium fluoride solution to provide the amounts of fluoride ion in each tablet indicated on the drug labels, defendants purposely or recklessly used less than half the necessary amounts,” the complaint asserted.
Backing Dr. Porter’s claims, federal prosecutors claimed that those who took the tablets were likely put at a higher risk of cavities and other health problems. Qualitest mislabeled the vitamins from about 2007 to July 2013, the lawsuit claimed.
The mislabeled vitamins also amounted to a submission of false claims by Qualitest because it sold the federal Medicaid program a product that was falsely labeled and marketed, the complaint alleged.
“Companies have an obligation to accurately report the ingredients in the drugs they market,” New York Attorney General Eric T. Schneiderman said in a statement. “My office will continue to work to ensure that patients and health care providers can rely on drug labels being accurate.”
The $39-million settlement will be shared between the federal government and 47 states, scoring a major recovery of Medicaid funds. It was not determined how much of the recovery would be awarded to Dr. Porter for his role in exposing the mislabeled vitamins, but he could receive up to 30 percent, or $11.7 million, under the rules of the False Claims Act.