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Subpotent Fluoride Tabs Results in $4.7 Million Whistleblower Award

United States Justice Department officials and regulators have settled Medicaid fraud charges against Vintage Pharmaceuticals (doing business as Qualitest Pharmaceuticals), its parent Endo Pharmaceuticals and several other affiliates. All of the charges relate to fluoride supplements sold by Qualitest.

Court documents reveal that Qualitest sold chewable fluoride tablets that were labeled as containing 1.0 mg, 0.5 mg or 0.25 mg of fluoride ion per tablet. Residents in much of the United States live in rural areas that don’t have fluorinated public water. The American Dental Association believes that fluoride supplements help prevent tooth decay, especially among adolescents.

According to a whistleblower lawsuit filed by Dr. Stephan Porter and later confirmed by regulators, the pills often contained less than half of the API listed on the labels.

Dispensing subpotent pharmaceutical products violates the U.S. Food and Drug Act. Because these supplements were often paid by government Medicaid and the Federal Employees Health Benefits Program, the case was prosecuted by the Department of Health and Human Services and not the FDA.

Under a Civil War era statute called the False Claims act, private citizens can file a complaint on behalf of the government when there is a fraud involving federal dollars or programs. The person filing the complaint – called a “relator” or whistleblower – can receive up to 30% of whatever the government collects from those responsible for the wrongdoing.

Here, the federal government will receive $22.4 million with an additional $16.5 million going to the states. The Medicaid program relies on both state and federal dollars.

For his efforts in filing the case and bringing the subpotent tablets to the government’s attention, Dr. Porter will collect a whistleblower award of $4,710,000.00.

In announcing the settlement against Qualitest and Endo, a government spokesperson said, “It is shocking that a pharmaceutical company would knowingly distribute diluted fluoride meant to provide preventative dental benefits to children as if it were full strength. We remain committed to investigating companies that put greed over their professional obligations to serve their customers and honestly bill for their products.”

Another spokesperson 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 agree! Subpotent drugs are a real problem in the U.S. and have reached epidemic levels in many developing countries. We hope that by paying whistleblowers to step forward, regulators can stop contaminated, adulterated, subpotent and superpotent drugs from entering our hospitals and home medicine cabinets.

The False Claims Act is a fraud statute. That means Qualitest can’t claim the subpotent drugs were an isolated issue or manufacturing defect. While the law doesn’t extend to most drug sales outside the U.S., these cases help regulators worldwide identify wrongdoers and shine a light on drug potency problems.

The Pharmaceutical Integrity Coalition’s mission is to stop bad pharma, hold drug companies accountable for their misdeeds and empower individual whistleblowers to step forward and stop corporate greed. We help match whistleblowers with qualified lawyers and never charge for our services. We can also help publicize bad pharma when would be whistleblowers decide not to step forward.

If you know of subpotent drugs or API in the marketplace, contact us. We can help.

Important note to our readers both inside and outside the United States: Whistleblowers need not by U.S. citizens to be eligible for an award.

Medicare and Medicaid fraud awards are not paid to those who report fraud using FDA, FBI or Medicare fraud hotlines. There are very specific procedures that must be filed to collect an award. We can help steer you to a qualified lawyer.

Related topics: Qualitest