![]() ![]() “Under our CIA Endo agrees to promote its products legally, while board members and top executives are specifically held accountable for compliance.” “By marketing Lidoderm for uses not covered by Federal health care programs, Endo profited at the expense of taxpayers and could have put patients at risk,” said Daniel R. The CIA requires Endo to implement measures designed to avoid or promptly detect conduct similar to that which allegedly gave rise to this matter, including measures requiring: (1) an internal risk assessment and mitigation program (2) numerous internal and external reviews of promotional and other practices (3) key executives and individual Board members to sign compliance certifications and (4) public reporting of information about Endo’s financial arrangements with physicians. Department of Health and Human Services (“HHS”). agrees to enter into a Corporate Integrity Agreement (“CIA”) with the Office of Inspector General of the U.S. As part of the settlement, Endo Pharmaceuticals Inc. “We will hold accountable those who circumvent that process in pursuit of financial gain.”Ĭorporate Integrity Agreement. Delery, Assistant Attorney General for the Civil Division of the United States Department of Justice. “FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Stuart F. This obligation takes precedence over the company’s bottom line,” said Memeger. Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses. “Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear and honest judgment of doctors that their patients rely on and trust. The whistleblower share of the settlement has not yet been determined. 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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