Date: 11-24-2020

Case Style:

Case Number: 20-cr-****

Judge: Madeline Cox Arleo

Court: United States District Court for the District of New Jersey (Essex County)

Plaintiff's Attorney: United States District Attorney’s Office, Newark, New Jersey

Defendant's Attorney:

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Description: Newark, New Jersey white collar criminal defense lawyers represented Purdue Pharm, L.P., which was charged with conspiracies to defraud the United States by violating the Food, Drug, and Cosmetic Act, and violate the Federal Anti-Kickback Statute.

“Purdue admitted that it marketed and sold its dangerous opioid products to healthcare providers, even though it had reason to believe those providers were diverting them to abusers,” Attorney for the United States Rachael A. Honig, District of New Jersey, said. “The company lied to the Drug Enforcement Administration about steps it had taken to prevent such diversion, fraudulently increasing the amount of its products it was permitted to sell. Purdue also paid kickbacks to providers to encourage them to prescribe even more of its products.”

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” said Deputy Attorney General Jeffrey A. Rosen. “Today’s guilty pleas to three felony charges send a strong message to the pharmaceutical industry that illegal behavior will have serious consequences. Further, today’s convictions underscore the Department’s commitment to its multi-pronged strategy for defeating the opioid crisis.”

“As today's plea to felony charges shows, Purdue put opioid profits ahead of people and corrupted the sacred doctor-patient relationship,” Christina Nolan, U.S Attorney for the District of Vermont, said. “We hope the company's guilty plea sends a message that the Justice Department will not allow big pharma and big tech to engage in illegal profit-generating schemes that interfere with sound medicine. We hope, also, that this guilty plea will bring some sense of justice to those who have suffered from opioid addictions involving oxycodone and some vindication for families and loved ones of those who did not survive such addiction."

“This case makes clear that no company, including Purdue Pharma, whose actions harm the health and safety of the American public, is beyond the reach of law enforcement,” Assistant Director Calvin Shivers of the FBI's Criminal Investigative Division said. “The opioid epidemic continues to spread across the United States impacting countless Americans and harming communities. Together with our law enforcement partners, the FBI is committed to investigating and holding criminals accountable for the roles they play in fueling this crisis.”

As part of today’s guilty plea, Purdue admitted that from May 2007 through at least March 2017, it conspired to defraud the United States by impeding the lawful function of the Drug Enforcement Administration (DEA). Purdue represented to the DEA that it maintained an effective anti-diversion program when, in fact, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids. Purdue also reported misleading information to the DEA to boost Purdue’s manufacturing quotas. The misleading information comprised prescription data that included prescriptions written by doctors that Purdue had good reason to believe were engaged in diversion. The conspiracy also involved aiding and abetting violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose, and thus without lawful prescriptions.

Purdue also admitted it conspired to violate the federal Anti-Kickback Statute. Between June 2009 and March 2017, Purdue made payments to two doctors through Purdue’s doctor speaker program to induce those doctors to write more prescriptions of Purdue’s opioid products. Also, from April 2016 through December 2016, Purdue made payments to Practice Fusion Inc., an electronic health records company, in exchange for referring, recommending, and arranging for the ordering of Purdue’s extended release opioid products – OxyContin, Butrans, and Hysingla.

Under terms of the plea agreement, Purdue agreed to the imposition of the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. For the $2 billion forfeiture, the company will pay $225 million within three business days following the entry of a judgment of conviction in accordance with the Plea Agreement. The Department is willing to credit the value conferred by the company to state and local governments under the Department’s anti-piling on and coordination policy if certain conditions are met.

Purdue has also agreed to a civil settlement that provides the United States with an allowed, unsubordinated, general unsecured bankruptcy claim for recovery of $2.8 billion to resolve its civil liability under the False Claims Act. Separately, the Sackler family will pay $225 million in damages to resolve its civil False Claims Act liability.

The criminal and civil resolutions, which were announced on Oct. 21, 2020, do not include the criminal release of any individuals, including members of the Sackler family, nor are any of the company’s executives or employees receiving civil releases.

On Nov. 17, 2020, the bankruptcy court in the Southern District of New York approved the financial terms of the global resolution with the company. The resolution includes the condition that the company cease to operate in its current form and instead emerge from bankruptcy as a public benefit company (PBC) or entity with a similar mission designed for the benefit of the public. The proceeds of the PBC will be directed toward state and local opioid abatement programs. Based on the value that would be conferred to state and local governments through the PBC, the Department is willing to credit up to $1.775 billion against the agreed $2 billion forfeiture amount. The Department looks forward to working with the creditor groups in the bankruptcy in charting the path forward for this PBC to best accomplish public health goals.

The global resolution does not resolve claims that states may have against Purdue or members of the Sackler family, nor does it impede the debtors’ or other third parties’ ability to recover any fraudulent transfers.

Today’s announcement was made by First Assistant U.S. Attorney for the District of New Jersey Honig; Deputy Attorney General Rosen; Acting Assistant Attorney General of the Civil Division Clark; and U.S. Attorney for the District of Vermont Nolan. The criminal investigation was conducted by the U.S. Attorney’s Offices for the Districts of New Jersey and Vermont, the Consumer Protection Branch of the Department of Justice’s Civil Division, and the FBI’s Washington, D.C., and Newark Field Offices, with assistance by DEA. The civil settlements were handled by the Fraud Section of the Commercial Litigation Branch of the Department of Justice’s Civil Division, and the U.S. Attorney’s Offices for the Districts of New Jersey and Vermont, with assistance from the Department of Health and Human Services, Office of General Counsel and Office of Counsel to the Inspector General; the Defense Health Agency; and the Office of Personnel Management. The Purdue bankruptcy matter is being handled by the U.S. Attorney’s Office for the Southern District of New York and the Civil Division’s Commercial Litigation Branch, Corporate/Finance Section.

The government is represented in the District of New Jersey by Deputy Chief of the Criminal Division Nicholas Grippo, Chief of the Opioids Unit Melissa Wangenheim, Chief of the Health Care Fraud Unit Lee M. Cortes Jr., and Assistant U.S. Attorneys J. Stephen Ferketic, Sean Sherman, Marihug P. Cedeño and Nicole Mastropieri.

IN FORMATIO NThe defendant having waived in open court prosecution by indictment, the Attorney for the United Statescharges:COUNT ONE (Conspiracy to Defraud the United States of AmericaandtoViolatethe Federal Food, Drug, and Cosmetic Act)1.At all times relevant to this Information:a.The defendant, PURDUE PHARMA L.P. (“PURDUE PHARMA,” the “Defendant,” or “the Company”), a privately-held Delaware limited partnership headquartered in Stamford, Connecticut, manufactured, sold, and distributed opioids, including its branded opioid medications OxyContin (oxycodone HCl), Butrans (buprenorphine), and Hysingla ER (hydrocodone bitartrate).b.Beginning in or around February 2002 through in or around July 2017, PURDUE PHARMA occupied a research and development (“R&D”) facility in Cranbury, New Jersey, at which it conducted non-clinical discovery science research. Beginning in or around at least 2002 and continuing through
2the first half of 2015, PURDUE PHARMA sold and distributed OxyContin extended-release tablets within the United States that were manufactured by The P.F. Laboratories Inc. at a facility in Totowa, New Jersey. Between in or around 2005 and in or around 2010, PURDUE PHARMA leased office space in West Paterson, New Jersey from a third party, which was used as overflow office space for personnel associated with the Totowa manufacturing operations.From in or around March 2017 through in or around September 2019, PURDUE PHARMA began leasing a smaller R&D facility in Princeton, New Jersey.c.Purdue Pharma Inc. (“PPI”) was the general partner of PURDUE PHARMA, and the Board of Directors of PPI managed PURDUE PHARMA and its wholly owned subsidiaries (collectively, the “Purdue Entities”). PURDUE PHARMA was the main operating entity of the various Purdue Entities.d.The United States Drug Enforcement Administration (“DEA”) was a United States federal law enforcement agency that enforced the controlled substances laws and regulations within the United States.

Outcome: Except to the extent of Purdue’s admissions as part of its criminal resolution, the claims resolved by the civil settlements are allegations only. There has been no determination of liability in the civil matters.

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