Media Center

Attorney General J.B. Van Hollen Announces Settlement with Endo Pharmaceuticals to Resolve Off-Label Marketing Violations
 

MADISON — Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states and the federal government in a global settlement with Endo Pharmaceuticals, a wholly owned subsidiary of Endo Health Solutions (Endo), a manufacturer of pharmaceutical products.  The settlement resolves civil allegations of unlawful marketing practices aimed at promoting the drug Lidoderm for conditions not approved by the Food and Drug Administration (FDA).  According to the qui tam, or whistleblower lawsuit, Endo unlawfully marketed Lidoderm for use in connection with lower back pain or chronic pain.  The FDA approved Lidoderm only for the treatment of pain associated with post-herpetic neuralgia, more commonly known as “shingles.”

 

Under the terms of the civil settlement, Endo will pay the state $405,760 as part of a total $1,310,940 attributable to Wisconsin Medicaid.  The state and federal governments jointly fund Medicaid – a medical insurance program for the needy and disabled.  That amount is part of a total $472,916,967 to the states and federal governments. 

 

Endo also will pay a $20.8 million criminal fine, and enter into a Deferred Prosecution Agreement with the Northern District of New York and 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, including Wisconsin’s.

 

Between March 1999 and December 2007, Endo knowingly promoted the sale and use of Lidoderm for uses that were not medically accepted indications and not covered by Wisconsin Medicaid, causing false and/or fraudulent claims to be submitted and paid.