Qualitest and Vintage: Fluoride Tablets at Less Than Half Strength

In the Qualitest Vintage fluoride settlement, the drugmaker agreed to pay $39 million over allegations that it sold chewable fluoride tablets containing less than half their labeled strength and caused government health programs to pay for them. The admissions in this pharmaceutical fraud case reached into the manufacturing process: too little sodium fluoride went into tablets sold for children. Someone who understood the formulation could see a problem that the label concealed.

Qualitest was the trade name of Vintage Pharmaceuticals, whose corporate parent was Endo Pharmaceuticals.

Why the Fluoride Strength Mattered

The labeled strengths matched the dosing guidance that Qualitest itself referenced. The company admitted that the amount delivered to children fell short of that guidance because its manufacturing process used too little of the ingredient needed to supply the fluoride ion.

Guidelines from the American Dental Association and the American Academy of Pediatrics had, since at least 1994, recommended fluoride supplements for children living in communities without fluoridated water to prevent tooth decay. The recommended daily dose depended on the child’s age and the local water fluoridation level. Qualitest’s labeling referenced those guidelines and stated strengths of 1.0 mg, 0.5 mg and 0.25 mg of fluoride.

Those numbers described what the child was supposed to receive. Qualitest admitted that its manufacturing processes were not designed to produce the stated amount of fluoride ion per tablet. It used less than half the appropriate amount of sodium fluoride, the ingredient needed to deliver that fluoride ion. The company also admitted the consequence: children taking the tablets received less than half the amount recommended by the guidelines.

The company sold a specified strength. Its own account of the process explained why the tablet could not deliver it. The shortfall began before a prescription was filled.

How Understrength Tablets Reached Government Claims

The government alleged that Qualitest caused Medicaid and the Federal Employees Health Benefits Program to pay millions of dollars for the understrength tablets. Qualitest admitted knowing that federal healthcare programs, including Medicaid, were a significant source of coverage for its fluoride products.

So the company knew who was paying. The government alleged that Qualitest knowingly sold the understrength tablets and caused the programs to pay for them as full strength. Children got less fluoride than the label promised, and taxpayers paid for the missing strength.

The pharmaceutical supply chain connects the manufacturer to a health care program’s payment through the dispensed product. A manufacturer can cause a false claim even when a pharmacy or physician submits it. In Qualitest’s case, the government traced the alleged payment fraud back to the strength of the tablets the company made and sold.

For an insider, those are connected business records. The label says what the company promises. The formulation and manufacturing records explain what it makes. Sales and payment records connect that product to the government program. Understanding the relationship between them is the value a manufacturing or quality employee can bring to a whistleblower case.

The Investigation and the End of Sales

Qualitest stopped making and selling its chewable fluoride tablets in August 2013, after the government began investigating the whistleblower’s allegations. The company admitted manufacturing and selling the tablets from 2007 through July 2013.

A whistleblower had brought a qui tam case under the False Claims Act earlier in 2013. That case brought the allegations to the government’s attention. The government investigated, then joined the lawsuit and settled its claims at the same time.

What Evidence Is Needed to Prove Fraud?

For a manufacturing case like Qualitest’s, we work out with you what your knowledge of the product and its government payments shows. We work with pharmaceutical whistleblowers who understand the formulation, the manufacturing decisions or the claims behind the medicine.

Public Citizen’s Health Research Group published the 2010 report Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010, which classified products that failed dosage specifications under poor manufacturing practices, separately from unlawful promotion. That distinction directs attention to the people who understand how the product was made and released for sale.

When the Plant’s Reports Contradict Its Findings

GlaxoSmithKline’s Cidra case shows another way those records can diverge, with a much larger civil settlement than Qualitest’s. Its October 2010 civil settlement provided $600 million to resolve allegations of false claims for drugs made at the plant. The whistleblower’s third amended complaint described reused manufacturing drums as a likely source of mix-ups between different tablets and strengths.

The complaint alleged that drums used for one type or strength of tablet were reused for another. It also described uncoated tablets of different types being mixed, leaving size or shape, rather than color, as the way to recognize a wrong tablet in a finished batch. That is the kind of production detail someone working with the product could understand.

The complaint also alleged that the plant blamed mix-ups on events outside the company’s control in reports to the Food and Drug Administration, despite mix-ups discovered at the site.

The comparison is the gap between the product and its description. Qualitest’s admissions explained an inadequate ingredient input. The Cidra complaint described alleged product mix-ups and contradictory reports. Each points to knowledge inside the plant that can explain why the medicine reaching patients differs from what the company represents.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In the Qualitest case, the federal government agreed to pay the whistleblower approximately $4.71 million.

You Know What Went Into the Tablet

If you know why a medicine’s contents differ from its label, speak to one of our whistleblower experts about the manufacturing decisions and government payments behind it. We build the case with you and bring in pharmaceutical fraud whistleblower lawyers who understand product quality and government-program claims. Bring us what you know about the tablets, and we will stay beside you to build your strongest pharmaceutical whistleblower case.