NOTICE: This is an archived press release. Information contained on this page may be outdated. Please refer to our latest press releases for up-to-date information.


Post date: December 16 2015

A.G. Schneiderman Announces $39 Million National Settlement In Principle With Qualitest Pharmaceuticals For Violation Of The False Claims Act

NY Leads Team of States in Settlement After Qualitest Sold Falsely Labeled Drugs that Contained Less than 50% of the Advertised Active Ingredient

Schneiderman: My Office Will Work To Make Sure That Patients and Health Care Providers Can Rely On Drug Labels Being Accurate

NEW YORK – Attorney General Eric T. Schneiderman announced today that New York has joined with up to 47 states and the federal government in an agreement in principle with Qualitest Pharmaceuticals, Inc., a manufacturer of generic pharmaceutical products, and its parent company, Endo Health Solutions, to resolve civil allegations of unlawful labeling practices. According to the whistleblower lawsuit, Qualitest unlawfully labeled and marketed multivitamin tablets with fluoride as containing the American Dental Association (ADA) recommended amount of fluoride, when the tablets actually contained less than half that amount. Under the settlement in principle, Qualitest has agreed to pay over $5 million resolving claims relating to New York's Medicaid program.

“Companies have an obligation to accurately report the ingredients in the drugs they market,” Attorney General Schneiderman said. “My office will continue to work to ensure that patients and health care providers can rely on drug labels being accurate.”

Physicians, dentists, and pharmacists rely on the fluoride strength indicated on the label that accompanied the multivitamin with fluoride tablets.  The whistleblower in this case, Dr. Stephan Porter, tested various fluoride tablets manufactured by Qualitest between 2008 and 2013 and determined that, on average, they contained about 45% of the amount of fluoride ion indicated on the product label.  This was later confirmed by the FDA, and Endo, which had purchased Qualitest in 2010, stopped distributing the multivitamin with fluoride products by October 2013.

By mislabeling the strength of its fluoride products, Qualitest caused these healthcare providers to submit false reimbursement claims to Medicaid and various federal health care plans.  The government plans paid for a multivitamin with fluoride product that did not contain the amount of fluoride ion indicated on the label and their clients were likely exposed to a higher risk of cavities and related health problems.

New York would like to thank whistleblower Dr. Stephan Porter for initiating this case, which resulted in the product being removed from the market; he will receive a portion of the settlement.  Endo is headquartered in Malvern, Pennsylvania; Qualitest Pharmaceuticals’ corporate name is Generics International (US Parent), Inc., which is a wholly-owned subsidiary of Endo.  The case is captioned U.S. ex rel. Porter, et al. v. Vintage Pharmaceutical, No. 13-CIV-1506, and was filed in the United States District Court for the Southern District of New York. 

The case was handled by the Medicaid Fraud Control Unit, which worked closely with the U.S. Attorney's Office for the Southern District of New York and a multi-state team that included representatives of New York, Texas, Washington, Florida and Oregon.  Of the $5 million related to the New York Medicaid program, about $2.8 million will go to New York and $2.2 million will go to the federal government.  

New York led the national team; the matter was handled by Counsel to the NY MFCU Jay Speers and Special Assistant Attorney General David G. Abrams.  Special Auditor-Investigators Matthew Tandle and Deowattie Persaud served as members of the state team. Investigator Lisa McDonald also handled the case. The Medicaid Fraud Control Unit is led by Acting Director Amy Held and Assistant Deputy Attorney General Paul J. Mahoney.  The Division of Criminal Justice is led by Executive Deputy Attorney General Kelly Donovan.     

Groups audience: