DOJ, Purdue Reach $8B Global Settlement Over Opioid Fraud

On Wednesday, the Department of Justice announced that it had reached an extensive global resolution with Purdue Pharma regarding ongoing civil and criminal investigations into the OxyContin manufacturer’s marketing and role in the nation’s opioid epidemic. In total, the settlement will amount to more than $8 billion, including a $3.544 billion criminal fine, $2 billion criminal forfeiture, and a $2.8 billion civil settlement pursuant to False Claims Act violations. Members of the Sackler family have also agreed to $225 million in civil damages under the FCA.

The criminal plea acknowledges the fraud perpetrated by Purude in misleading DEA on its anti-diversion program and efforts to further support improper or unlawful prescribing and dispensation of opioid mediation. Additionally, Purude admitted to Anti-Kickback Statute violations within its doctor speaker program and ongoing relationship with Practice Fusion and notifications in the electronic health records system. Under the FCA charges, it is recognized that Purdue was responsible for false claims to be submitted t federal health care programs for their OxyContin product following the improper promotion of the product. The Sacklers were also found to have encouraged expansion of the OxyContin market beyond what was considered a legitimate medical use ultimately leading to gross overprescribing and subsequent misuse, abuse, diversion and death.

The global resolution, which remains subject to approval by a New York bankruptcy court, would also oversee the transition of Purdue Pharma, following bankruptcy proceedings, from its current operations into a public benefit company. The new entity would be overseen by a trust and operate to benefit the American public and focus on safe and legitimate prescription drug distribution along with the provision of naloxone and MAT products at steep discounts or at-cost.

The settlement agreement does not release any of the defendants, including the Sacklers or Purdue executives, of any criminal charges they may face as part of the investigation.

Articles & Resources

Department of Justice Justice Department Announces Global Resolution of Criminal and Civil Investigations with Opioid Manufacturer Purdue Pharma and Civil Settlement with Members of the Sackler Family

Department of Justice – Remarks by Deputy Attorney General Jeffrey A. Rosen on the Resolution of Civil and Criminal Investigations into Purdue Pharma and the Sackler Family

Walmart Sues DOJ in Preemptive Move Around Epidemic Culpability

On Thursday, the world’s largest retailer Walmart sued the Department of Justice and Drug Enforcement Administration in the Eastern District of Texas to better clarify the roles of pharmacists under the Controlled Substances Act. The lawsuit is an attempt to preempt any future civil litigation brought by the Department of Justice against Walmart and other retail pharmacies around improper dispensing of controlled substances and lack of refusal to fill prescriptions.

According to a release from the retailer, Walmart indicated that they “are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs.” The retailer notes the uncomfortable position that they are in, fixed between the DEA, state health agencies/regulators, and patients.

The lawsuit follows reports of a previously dropped case that originated in the Eastern District of Texas against the retailer but was allegedly quashed by federal law enforcement officials.

Articles & Resources

Walmart Newsroom – Walmart Sues DOJ and DEA Seeking Clarity for Pharmacists in Dispensing Prescription Opioids

Wall Street Journal – Walmart Files Pre-Emptive Lawsuit Against Federal Government in Opioid Case

Bloomberg – Walmart Opioid Lawsuit a Long Shot to Thwart Federal Enforcement

CNN – Walmart Files Lawsuit Seeking to Prove Its Pharmacists Are Not Responsible for Opioid Crisis

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

Bloomberg Law – Anti-Opioid Prescription Rules Stymie Access for Black Patients

Pew Charitable Trust – Expanded Access to Naloxone Can Curb Opioid Overdose Deaths

Associated Press – NYU to Remove Sackler Name Following Purdue Pharma Deal

Washington Post – Purdue Pharma Agrees to Plead Guilty to Federal Criminal Charges in Settlement Over Opioid Crisis

NPR – Purdue Pharma Reaches $8B Opioid Deal With Justice Department Over OxyContin Sales

Wall Street Journal – ‘White Market Drugs’ Review; Addiction by Prescription

Texarkana Gazette – Drug Diversion by Health Care Workers is a Serious Problem

DEA Newsroom – DEA Announces 19th National Prescription Drug Takeback Day

NIH Newsroom NIH Study Tests Comprehensive Model Intervention to Reduce Opioid Overdose Deaths in Hard-Hit Communities

Massachusetts AG Maura Healy – AG Healey Sues National Addiction Treatment Center Chain for Ordering Medically Unnecessary Drug Tests and Violating Self-referral Laws

Substance Abuse and Mental Health Services Administration – The Opioid Crisis and the Hispanic/Latino Population: An Urgent Issue

Department of Justice – Pain Clinic Owner Sentenced for Role in Operating Pill Mills in Tennessee and Florida

U.S. Attorney for the Western District of Virginia – Suboxone Manufacturer Indivior’s Former Chief Executive Officer Sentenced to Jail Time in Connection with Drug Safety Claims

U.S. Attorney for the Central District of California – Houston Woman Sentenced to 5 Years in Federal Prison for Role in Opioid Pill Mill that Shipped Narcotics from California to Texas

U.S. Attorney for the District of New Hampshire – Hudson Woman Pleads Guilty to Tampering with Consumer Products and Unlawfully Obtaining Controlled Substances

U.S. Attorney for the District of Massachusetts – Former VA Hospice Nurse Pleads Guilty to Diverting and Tampering with Morphine Meant for Dying Veterans

This Week’s Calendar

The House and Senate have no opioid-related hearings or events scheduled at this time as they continue to address several pressing topics including a Supreme Court nomination, coronavirus pandemic relief and the forthcoming presidential election. In the instance that there are any changes to the schedule for this week, we will make additional information available.

  • White House Office of National Drug Control Policy
    White House Virtual Roundtable on Making Prescription Drug Take Back Day Every Day
    Thursday, October 29th, 1:00pm – 2:30pm ET; Register Here

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