Fluoride Action Network

Qualitest: Vitamin maker agrees to $39 million settlement on fluoride content

Source: Daily Business Review | December 18th, 2015 | By Celia Ampel
Industry type: Pharmaceuticals

A West Palm Beach attorney obtained a $39 million settlement with a pharmaceutical company whose chewable vitamins allegedly contained less than half the promised amount of fluoride.

Endo Pharmaceuticals Inc. and seven subsidiaries agreed Thursday to pay the federal government and 26 state Medicaid programs, including Florida’s, to settle a whistleblower suit filed by dentist Stephan Porter of West Palm Beach.

Porter discovered the deficiency in the Qualitest fluoride supplements by conducting a chemical analysis of the vitamins while working for a competitor.

“The most important thing to Dr. Porter was to remove the defective product from circulation, which this lawsuit accomplished,” said Porter’s attorney, Ryon McCabe of McCabe Rabin in West Palm Beach.

“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,” he said.

Porter filed the qui tam case in the Southern District of New York in March 2013 under the False Claims Act, alleging Endo caused pharmacies to submit false claims to federal health care programs.

The Pennsylvania-based company pulled the children’s vitamins five months later after the whistleblower lawsuit called the problem to the attention of the U.S. government.

“Once the company knew they were under investigation for this, they pulled it off the shelf,” McCabe said.

The federal government spent the next several months examining company records and interviewing witnesses about the fluoride supplements, which were prescribed to children who live in communities without fluoridated drinking water to prevent tooth decay.

The investigation determined children who took Qualitest once a day received only about 44 percent of the daily fluoride intake recommended by the American Dental Association and the American Academy of Pediatrics.

Endo accepted responsibility for that finding as part of the settlement agreement. The company also admitted it knew Medicaid was paying claims for the Qualitest vitamins.

Porter will receive $4.7 million of settlement money from the federal government, $2.8 million from the states plus 21 percent of the accrued interest for his role as a whistleblower.

The next step is to recover funds for any consumers who paid for the Qualitest vitamins out of pocket rather than through Medicaid. McCabe filed a separate consumer class action against Endo in the Southern District of New York to pursue those claims.

Although he will not be a member of the class, McCabe said the issue is “near and dear” to him.

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See also

Dec 16, 2015: Manhattan U.S. Attorney announces $39 million civil fraud settlement against Qualitest Pharmaceuticals for selling half-strength fluoride supplements

Dec 17, 2015: Endo Health to pay $39 million over fluoride labeling claims

Dec 18, 2015: Vitamin maker agrees to $39 million settlement on fluoride content

Jan 2, 2016: Qualitest Pharmaceuticals settles with N.Y., other states in fluoride labeling case

Jan 14, 2016: Idaho getting $87K from pharmaceutical agreement

Jan 20, 2016: New Jersey to receive $2.7 million in multistate settlement

Jan 26, 2016: Michigan to get nearly $700K over false vitamin claims