CLEVELAND, Ohio — Four Ohio residents, including two doctors and two drug company representatives, were named in a federal indictment that say the doctors received kickbacks from the representatives to increase prescriptions for a medication that treats a neurological condition.
The crimes centered on the prescription drug Nuedexta. The drug treats PseudoBulbar Affect, a neurological disorder that arises as a result of other conditions or a brain injury that causes exaggerated and uncontrollable crying and laughing episodes. In addition to the indictment, the drug’s manufacturer Avanir Pharmaceuticals has agreed to pay more than $116 million in criminal penalties, forfeiture and settlement proceeds.
Drs. Deepak Raheja and Bhupinder Sawhny, as well as pharmaceutical representatives Gregory Hayslette and Frank Mazzucco, were named in an 83-count, 104-page indictment filed in Cleveland that says the quartet worked together in a years-long scheme, the U.S. Attorney’s Office said in a news release.
Hayslette and Mazzucco worked for Avanir, which is based in Aliso Viejo, California. The quartet’s crimes led patients who did not have PseudoBulbar Affect to receive the medication, according to federal prosecutors.
A grand jury handed up the indictment on Sept. 18, following an investigation led by the FBI. It was unsealed Thursday morning after agents arrested Raheja, Sawhny and Hayslette.
Raheja, 63, of Hudson, is a neurologist whose primary office was on West 14th Street in Cleveland. Sawhny, 70, of Gates Mills, is a neurosurgeon whose practice was on Ridge Road in Parma. He was licensed to practice in Ohio in 1982.
Hayslette, 43, of Aurora, worked as a pharmaceutical sales representative for Avanir from June 2015 through September 2016 and worked to market Nuedexta in Northern Ohio. Mazzucco, 41, of Dublin, was a regional business manager and supervised Hayslette until Hayslette left the company in September 2016, according to prosecutors.
Avanir promoted Nuedexta through a speaker’s bureau where company representatives reach out to doctors to speak about and promote the drug. A typical engagement involved a dinner at an expensive restaurant where a doctor presented information about the drug through a slideshow provided by the company, according to the U.S. Attorney’s Office. An Avanir sales representative invited the attendees and was present.
Raheja, who was licensed to practice medicine in Ohio in 1993, joined Avanir’s speaker’s bureau in February 2011. He gave more than 200 presentations between October 2011 and April 2016 and Avanir paid him $331,500, according to prosecutors.
Hayslette and Mazzucco worked to give doctor’s incentives to write prescriptions for the drug and make more money for themselves. They arranged for speaker’s bureau programs, often with little or no educational value to those in attendance, for Raheja, Sawhny and other medical professionals, according to authorities.
They organized payments for honoraria and other expenses to Raheja. Hayslette also allowed false sign-in sheets from speaking engagements to be turned in to justify the events and large payments to both doctors, officials said.
Hayslette also offered free and illegal firearms training and office equipment to Sawhny, and plied Raheja with coffee and meals, according to prosecutors. He also promoted uses and dosages of the drug that were not approved by the U.S. Food and Drug Administration, accessed patient health information without authorization and helped to submit false diagnoses for PseudoBulbar Affect to Medicaid programs, officials said.
The doctors took steps in return for the money and items, according to officials. This included writing more Nuedexta prescriptions and allowing bills sent to Medicare and Medicaid for patients that did not have the disorder. Between October 2011 and April 2016, Raheja wrote 10,088 prescriptions for Nuedexta, the most of any doctor in the country, prosecutors said.
Raheja also falsely diagnosed patients with the disorder, and Sawhny permitted unauthorized access to patient health records, authorities said.
In addition to the charges for the Ohio defendants, Avanir admitted in court filings in a case in a federal court in Georgia that it paid a doctor to increase the amount of Nuedexta he prescribed. The company’s agreement calls for it to pay a $7.8 million penalty and forfeit more than $5 million and the Justice Department agreed not to prosecute the company for three years to allow it to comply with the agreement. The company had cooperated with the federal investigation.
The company will likely be excluded from participating in federal health-care programs like Medicare and Medicaid for at least five years, according to a news release from the Justice Department.
The company also agreed to pay more than $95 million to resolve two False Claims Act lawsuits filed related to how it marketed Nuedexta. The cases were initially brought by former Avanir employees in Akron and in Georgia. The federal government later got involved.
In those cases, the government said Avanir marketed Nuedexta for elderly long-term care facilities to be used for conditions other than PseudoBulbar Affect, which the FDA had not approved, the Justice Department said.
Avanir said in a statement Thursday morning that “these two individuals are no longer employed at Avanir Pharmaceuticals” and that the company does not comment on former employees beyond confirming they worked there. A news release put out later in the day put the total it agreed to pay for state and federal inquiries at $116 million and its CEO Wa’el Hashad said the company was pleased to resolve the issues.