Opioid pills Opioid pills.Photo: Kimberly Boyles/Shutterstock.com

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Insys Therapeutics has agreed to pay $225 million to resolvecivil and criminal actions brought by the U.S. Department ofJustice over alleged kickbacks and marketing of its opioidpainkiller.

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Under the deal, announced Wednesday, Insys agreed to pay $195million to settle allegations in five separate whistleblowerlawsuits that it violated the False Claims Act. Its operatingsubsidiary also will plead guilty to five counts of mail fraud andpay a $2 million fine and $28 million in forfeiture. Both parts ofthe settlement center on Subsys, a fentanyl spray that Insysmanufactured and that the U.S. Food and Drug Administrationapproved in 2012 for the treatment of chronic pain in cancerpatients.

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Related: Opioid manufacturers: A publicnuisance?

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“The opioid epidemic has devastated communities and ravagedfamilies across this country,” said Assistant Attorney General JodyHunt of the Department of Justice's Civil Division, whichprosecuted the case along with the U.S. attorney's offices inMassachusetts and the Central District of California, as well asthe U.S. Department of Health and Human Services' Office ofInspector General. “The Department of Justice is committed to usingthe legal tools at our disposal to combat the illegal marketing anddistribution of opioids, including fentanyl. Today's settlementsends a strong message to pharmaceutical manufacturers that thekinds of illegal conduct that we have alleged in this case will notbe tolerated. I want to assure the families and communities ravagedby this epidemic that the Department of Justice will hold opioidmanufacturers accountable for their actions.”

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The agreement excludes cases brought by several cities, countiesand attorneys general against Insys, one of several opioidmanufacturers.

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The deal comes after Insys disclosed last month that it might filefor bankruptcy protection and could not afford the legal costsrelated to a Department of Justice's investigation.

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Under a charging document, prosecutors said Insys and itsoperating subsidiary began paying bribes and kickbacks to medicalprofessionals, under the guise of being “speaking programs,” toincrease marketing of Subsys from August 2012 to June 2015. Thedeferred prosecution agreement, expected to last five years, comesafter five former Insys executives, including billionaire founderJohn Kapoor, were convicted last month of charges relating to themarketing of Subsys.

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The civil portion of the agreement resolves lawsuits in whichthe United States had intervened alleging Insys violated the FalseClaims Act by paying kickbacks to physicians and nursepractitioners to prescribe Subsys to their patients.

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Amanda Bronstad

Amanda Bronstad is the ALM staff reporter covering class actions and mass torts nationwide. She writes the email dispatch Law.com Class Actions: Critical Mass. She is based in Los Angeles.