California Pharmaceutical Company to Pay $750,000 to Resolve False Claims Act Liability for Allegedly Paying Kickbacks to Induce Prescriptions of Opioid Products

NEWARK, N.J. – A California pharmaceutical company has agreed to pay $750,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims for certain opioids in violation of the federal Anti-Kickback Statute, U.S. Attorney Philip R. Sellinger announced today.

From Dec. 1, 2015, through Aug. 31, 2016, Sentynl Therapeutics Inc., of Solana Beach, California, a specialty pharmaceutical company, marketed and sold prescription opioids Abstral and Levorphanol Tartrate (Levorphanol).

The settlement resolves allegations that, during the relevant time period, Sentynl knowingly caused the submission of claims for Abstral and Levorphanol medications to Medicare in violation of the federal Anti-Kickback Statute. These allegedly false claims resulted from Sentynl’s alleged indirect payment of kickbacks to a physician. Specifically, the United States contends that Sentynl hired the girlfriend of a physician who was a top prescriber of Transmucosal Immediate Release Fentanyl (TIRF) medications to act as a sales representative in South Florida – the same region in which the physician practiced. Sentynl hired, employed, and made salary and bonus payments to the physician’s girlfriend to induce the physician to prescribe its Abstral and Levorphanol medications.

"Pharmaceutical companies that sold opioids are being held accountable for improper inducements offered to prescribers,” FBI – Newark Special Agent in Charge James E. Dennehy said. The Newark FBI and our law enforcement partners will continue our pursuit of those who continue to believe the rules don’t apply to them.”

“Pharmaceutical companies are not exempt from their responsibilities to operate within the confines of the law,” Special Agent in Charge Cheryl Ortiz of the Drug Enforcement Administration’s New Jersey Field Division said. “We are glad our diversion investigators were able to assist efforts to bring this matter to a resolution.”

“Some violations of the Anti-Kickback Statute, like those alleged here, can induce physicians’ imprudent prescribing of controlled substances,” stated Special Agent in Charge Naomi Gruchacz with the U.S. Department of Health and Human Services Office of Inspector General. “Individuals and entities that participate in the federal health care system are required to obey the laws meant to preserve the integrity of program funds and the provision of appropriate, quality services to patients.”

U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge James E. Dennehy in Newark; investigators of the U.S. Drug Enforcement Administration (DEA), under the direction of Special Agent in Charge Cheryl Ortiz; special agents of the U.S. Department of Health and Human Services Office of Inspector General, under the direction of Special Agent in Charge Naomi Gruchacz, with the investigation leading to the settlement.

The government is represented by Assistant U.S. Attorney Susan J. Pappy of the U.S. Attorney’s Office, District of New Jersey’s Health Care Fraud Unit and Robert L. Toll of the Office’s Opioid Abuse Prevention and Enforcement Unit, and Trial Attorney Douglas J. Rosenthal of the Department of Justice’s Civil Division, Commercial Litigation Branch (Fraud Section).

The government’s pursuit of this matter illustrates its efforts to combat healthcare fraud. One of the strongest tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).

The claims resolved by the settlement are allegations only and there has been no determination of liability.