KV Pharmaceutical Reaches Settlement with the Department of Justice for $17 Million

KV Pharmaceutical (KV), the parent company for Ethex Corporation (Ethex), this month agreed to pay $17 million to settle claims that Ethex of violated the False Claims Act when it allegedly reported false information to the Centers for Medicare and Medicaid Services (CMS).

According to the complaint filed by the Department of Justice (DOJ), Ethex falsified Food and Drug Administration (FDA) certifications of two products, Nitroglycerin ER and Hyoscyamine Sulfate ER, to CMS, thereby allowing the company to sell these unapproved drugs to Medicare patients.  The Food, Drug, and Cosmetic Act requires that all drugs must be approved by the FDA for safety and effectiveness before they can be marketed for mass consumption.  Neither drug has received FDA approval, which potentially places consumers at risk.  Ilisa Bernstein, acting director of the Office of Compliance for the FDA, outlined the seriousness of this violation, stating, “This settlement sends a strong message to those who seek to put the health of American patients at risk by distributing and promoting drugs which have not been approved by the FDA.”

To settle the case, KV has agreed to pay the federal government $10,158,695 and $6,841,305 to the state Medicaid Services.  The whistleblower who reported the company’s unlawful actions received $1,523,804 of the federal share and additional amounts from the state share.

Tagged: Enforcement Bodies, False Claims Act (FCA), Occupational Safety and Health Administration (OSHA), Whistleblower Laws (Federal), Whistleblower Protection Act (WPA)