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. Paladin Labs Announces the Canadian Launch of Emtrix®įor complete list of press releases click Here.PHILADELPHIA - Specialty pharmaceuticals company Endo Health Solutions, Inc. Paladin Labs Announces the Canadian Launch of Zincofax® Spray Announces the Launch of Unisom® Snore Relief, the Only Natural Health Product Throat Spray Available in Canada to Help Relieve Symptoms Associated with SnoringĪRIAD and Paladin Announce Commercial Distribution Agreement for Iclusig (Ponatinib) in Canada Announces Launch of New Indication for XIAFLEX® (Collagenase Clostridium Histolyticum), Broadening Its Use to the Treatment of Appropriate Patients with Peyronie's Disease Announces Approval of Envarsus PA TM (tacrolimus prolonged-release tablets) in Canadaīioprojet and Endo Jointly Announce Agreement for Paladin Labs Inc. Helsinn and Endo Announce Agreement for Paladin Labs Inc. Movapo® (apomorphine hydrochloride) for Patients with Advanced Parkinson's Disease Now Reimbursed in Most Canadian Provinces to Commercialize Abaloparatide in CanadaĮnvarsus® PA Once-daily Immunosuppressive Therapy for Kidney and Liver Transplant Patients is Now Reimbursed in Ontario, Quebec, Manitoba and Saskatchewan Announces Approval of Wakix® (pitolisant) in CanadaĪDVANZ PHARMA and Endo Announce Partnership for Paladin Labs to Commercialize Xydalba® (dalbavancin hydrochloride) in CanadaĮndo Announces Licensing Agreement for Paladin Labs Inc. Announces the Launch of Xydalba® (dalbavancin for injection) in Canada Paladin Labs Announces Health Canada’s Filing Acceptance of Cenobamate Tablets as an Adjunctive Therapy for the Management of Partial-Onset Seizures in Adults with Epilepsy
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