![]() ![]() Ryan is a former Endo sales representative whose sales territory included upstate New York. The settled Lidoderm civil allegations include those originally brought by whistleblower Peggy Ryan in the first of three qui tam lawsuits now pending in federal court in the Eastern District of Pennsylvania. Under qui tam (whistleblower) provisions of the federal False Claims Act, certain private citizens may bring civil actions on behalf of the United States and may share in any recovery. Of the $171.9 million that Endo has agreed to pay to resolve these civil claims, the company will pay $137,700,172 to the United States and $34,209,981 to various States and the District of Columbia. The civil settlement resolves allegations under the False Claims Act that, between March 1999 and December 2007: (1) Endo knowingly promoted Lidoderm for treatment of non-FDA-approved (off-label) conditions, including lower back pain and chronic pain (2) because uses of the product for those conditions were not medically accepted indications, federal health care programs did not cover such uses and (3) Endo’s off-label promotion caused providers to submit false reimbursement claims for such non-covered uses to Medicare, Medicaid, and other federal health care programs. Lidoderm was FDA approved only for relief of pain associated with post-herpetic neuralgia (“PHN”), a painful condition that affects some individuals with a history of shingles. Ĭivil Settlement in Eastern District of Pennsylvania. Separately handled and announced today by the Department of Justice and the Office of the United States Attorney for the Northern District of New York is Endo Pharmaceuticals Inc.’s additional deferred prosecution agreement to pay $20.8 million in criminal forfeiture and fines to resolve related criminal liability. The civil resolution is the result of whistleblower allegations filed in the Eastern District of Pennsylvania and was announced today by the Department of Justice and United States Attorney Zane David Memeger. (Endo), which is headquartered in Malvern, Pennsylvania, have agreed to pay $171.9 million to resolve civil allegations of off-label marketing of their adhesive pain patch Lidoderm. and its subsidiary Endo Pharmaceuticals Inc. PHILADELPHIA - Specialty pharmaceuticals company Endo Health Solutions, Inc.
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