The Justice Department closed out 2015 by intervening and settling a healthcare fraud qui tam action alleging that a pharmaceutical manufacturer knowingly sold defective drug products for use by the pediatric population. Specifically, in December 2015, Endo Pharmaceuticals subsidiary Qualitest Pharmaceuticals agreed to pay the federal and state governments over $39 million for allegedly selling government healthcare programs chewable fluoride tablets that contained less than half the amount of fluoride ion indicated on the drug label.

These allegations were raised only two years ago in a False Claims Act qui tam action filed by a Florida dentist. According to his qui tam complaint, Qualitest’s fluoride supplements allegedly contained less than half the amount of fluoride indicated on the label.

Chewable fluoride tablets are routinely prescribed to children living in communities without fluoridated water supply to prevent tooth decay. In fact, since at least 1994, guidelines issued by the American Dental Association and the American Academy of Pediatrics recommended that, to prevent tooth decay, fluoride supplements be prescribed to children living in communities without fluoridated water supply in doses of 1.0 mg, 0.5 mg, or 0.25 mg of fluoride ion per day, depending on a child’s age and the local water fluoridation level.

However, as Qualitest admitted to the Southern District of New York, its manufacturing processes were not even designed to produce chewable fluoride tablets that would contain 1.0 mg, 0.5 mg, and 0.25 mg of fluoride ion per tablet. Indeed, soon after the government started investigating the whistleblower’s allegations, Qualitest ceased all production of its fluoride supplement.

In announcing the resolution of this case, the U.S. Attorney for the Southern District of New York released the following statement: “The integrity of federal healthcare programs like Medicaid depends on manufacturers telling the truth about their drugs and producing and labelling their drugs accurately.  When companies violate that critical obligation, as Qualitest did here by distributing diluted fluoride and then causing health care programs to pay for the full strength tablets, we will pursue them, make them pay damages and admit to their violations.”

The government also highlighted that relator received a handsome whistleblower reward  of nearly $5 million. Hopefully, this pharmaceutical fraud case will encourage others to step forward and expose manufacturers who knowingly produce products that differ from their labels.

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