WEST PALM BEACH, Fla., Dec. 18, 2015 (GLOBE NEWSWIRE) -- Pharmaceutical giant Endo Pharmaceuticals Inc., and seven of its subsidiaries, will pay $39 million to settle a whistleblower qui tam lawsuit alleging the company manufactured and sold chewable fluoride multivitamins containing less than half the labeled dosage. Fluoride is critical to the dental health of children living in communities without fluoridated drinking water.
Dr. Stephan Porter, a Florida dentist, filed suit in 2013 under the provisions of the False Claims Act after discovering that one of the major fluoride supplements on the market, Qualitest, contained less than half of the amount of fluoride indicated on its label. According to the lawsuit, from 2007 to July 2013, Endo and its subsidiaries manufactured sub-potent chewable fluoride tablets under the Qualitest brand name and as a result, pediatricians, dentists, and parents unwittingly gave their children less than half of the fluoride advocated by the American Dental Association.
Ryon McCabe, a partner at McCabe Rabin, P.A. a West Palm Beach law firm that handles whistleblower litigation, represented Dr. Porter, and praised his client’s hard work and fortitude throughout the course of the investigation. “The most important thing to Dr. Porter was to remove the defective product from circulation, which this lawsuit accomplished,” said McCabe. “Dr. Porter is pleased with the result, but continues to be concerned that children who received insufficient fluoride as a result of this product will suffer unnecessary dental cavities and related problems in the future.”
Doctors and pediatricians commonly prescribe fluoride supplements to children under the age of 16 who live in communities without fluoridated drinking water. The American Dental Association and the American Academy of Pediatrics publish fluoride guidelines to assist doctors and pediatricians to prescribe correct dosages of fluoride based on a child’s age and the level of fluoride in their drinking water. Pharmaceutical companies manufacture these fluoride supplements in dosages of 1 mg, .5 mg and .25 mg to coincide with these official recommendations.
“Today’s settlement was a result of the robust public-private partnership that defines the False Claims Act,” said McCabe. “Assistant United State Attorney Li Yu of the Southern District of New York, as well as Jay Speers, Counsel to the National Association of Medicaid Fraud Control Units worked tirelessly with Dr. Porter to bring this case to settlement.”
The False Claims Act authorizes private individuals, known as relators, to bring a qui tam lawsuit on behalf of the federal government to recover money lost due to fraud. Since 1986, the United States has recovered nearly $52 billion in taxpayer funds because of the False Claims Act. In this case, the federal government, as well as the state Medicaid programs of 26 different states will share the recovery.
The lawsuit and Stipulation and Order of Settlement and Dismissal is available on PACER at U.S. ex rel Porter v. Endo Pharmaceuticals, et al, 13-Civ-1506, United States District Court, Southern District of New York.