Ohio has joined with several other states and the federal government in a global settlement with the pharmaceutical product manufacturer Endo Pharmaceuticals, Attorney General Mike DeWine announced.
The $172,916,967 settlement resolves civil allegations of unlawful marketing practices aimed at promoting the drug Lidoderm for conditions not approved by the Food and Drug Administration, which then caused false and/or fraudulent claims to be submitted to Medicaid.
Ohio's portion of the settlement is $5,064,222.
"This company made millions deceiving patients who were in pain, and then billing taxpayers for a product that was not intended to be used this way," DeWine said. "Promoting the sale of a pharmaceutical drug for uses not approved by the FDA is not only illegal, but it is also extremely dangerous."
According to the whistleblower lawsuit, Endo unlawfully marketed Lidoderm for use in connection with lower back pain or chronic pain between March 1999 and December 2007. The FDA approved Lidoderm only for the treatment of pain associated with post-herpetic neuralgia, more commonly known as “shingles.”
The settlement also includes a $20 million fine, and Endo will be required to enter into a Deferred Prosecution Agreement with the Northern District of New York and into a Corporate Integrity Agreement with the Department of Health and Human Service’s Office of the Inspector General.
The lawsuit was filed in the Eastern District of Pennsylvania under the provisions of the federal False Claims Act and analogous state False Claims statutes. A team from the National Association of Medicaid Fraud Control Units worked with the federal government on the investigation and conducted settlement negotiations with Endo on behalf of the states.
Endo Pharmaceuticals is a wholly owned subsidiary of Endo Health Solutions.