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Endo Pharmaceuticals to Pay $172.9 Million to Resolve Off Label Marketing Allegations

by
SD Attorney General Marty Jackley
SD Attorney General Marty Jackley

PIERRE, SD (KELO AM) – Attorney General Marty Jackley announced that South Dakota 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 $172,916,967 to the states and federal governments and a $20,000,000 dollar criminal fine. Between March 1999 and December 2007, Endo knowingly promoted the sale and use of Lidoderm for use in connection with lower back and chronic pain which were not medically accepted indications and were not covered by the state Medicaid program. South Dakota’s will receive $98,800 as part of the settlement, of that amount $64,787 is the Federal Medicaid share.  

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