The Department of Justice announced that Avanir Pharmaceuticals, a pharmaceutical manufacturer based in Aliso Viejo, California, was charged for paying kickbacks to a physician to induce prescriptions of its drug Nuedexta.

The Northern District of Ohio also announced indictments of four individuals, including former Avanir employees and one of the top prescribers of Nuedexta in the country, who were involved in the kickback scheme.

Avanir has also agreed to pay over $95 million to resolve civil False Claims Act allegations of kickbacks as well as its false and misleading marketing of Nuedexta to providers in long term care facilities to induce them to prescribe it for behaviors commonly associated with dementia patients, which is not an approved use of the drug.

In addition to the $95,972,017 being paid to resolve the United States’ civil claims, Avanir will pay an additional $7,027,983 to resolve state Medicaid claims.

Prosecutors alleged Avanir violated the Anti-Kickback Statute by paying a doctor to induce him to become a high prescriber of Nuedexta to beneficiaries of federal healthcare programs, offering him financial incentives to write additional Nuedexta prescriptions for beneficiaries of federal healthcare programs, and inducing him to recommend that other physicians prescribe Nuedexta to beneficiaries of federal healthcare programs.

Nuedexta is approved by the Food and Drug Administration for the treatment of pseudobulbar affect (PBA), which is characterized by involuntary, sudden, and frequent episodes of laughing or crying, and occurs secondary to a neurologic disease or brain injury.

The Northern District of Georgia also announced a deferred prosecution agreement resolving the charge, under which Avanir admits that it paid the doctor to induce him to not only maintain, but increase his prescription volume. Under the agreement’s terms, Avanir will pay a monetary penalty in the amount of $7,800,000, and a forfeiture in the amount of $5,074,895. The United States will defer prosecuting Avanir for a period of three years to allow the company to comply with the agreement’s terms. The agreement will not be final until accepted by the court.

Named in the 83-count indictment are: Deepak Raheja, 63, of Hudson; Gregory Hayslette, 43, of Aurora; Frank Mazzucco, 41, of Dublin, and Bhupinder Sawhny, 70, of Gates Mills. All four are charged with conspiracy to solicit, receive, offer and pay health care kickbacks. Avanir has agreed to cooperate in the prosecution of these individuals.

The civil settlement resolves lawsuits filed by former employees of Avanir, under the qui tam or whistleblower provisions of the False Claims Act. Kevin Manieri will receive $12,389,823 of the civil settlement, and Duane Arnold and Mark Shipman will receive $5,365,000 of the civil settlement.