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

Rhode Island to Recover More Than $200,000 for Medicaid Budget

Attorney General Peter F. Kilmartin announced today that Rhode Island 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 government and a $20.8 million dollar criminal fine. Rhode Island will recover $213,126 for the state's Medicaid budget.

"Pharmaceutical companies continually engage in off-label marketing, defrauding states' Medicaid programs tens of millions of dollars each year. The FDA requires strict procedures to bring drugs to market for good reason to protect the health and safety of patients. To skirt the FDA's rules and regulation in exchange for profits is too big a lure for many companies. This practice is unethical, illegal and potentially dangerous," said Attorney General Kilmartin.

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.

Related links

Department or agency: Department of the Attorney General

Online: http://www.riag.ri.gov/

Release date: 02-21-2014

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