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Department of Justice sues Walmart alleging unlawful opioid dispensing

Pharmacists are in the untenable position of being held liable for a doctor's prescription, Walmart said in its own lawsuit.

Susan Morse, Managing Editor

In a civil complaint filed Tuesday, the Department of Justice charged Walmart with unlawfully dispensing controlled substances, specifically opioids, from pharmacies it operates across the country and unlawfully distributing these drugs to its pharmacies throughout the height of the prescription opioid crisis. 

The complaint said this resulted in hundreds of thousands of violations of the Controlled Substances Act. The Justice Department seeks civil penalties, which could total in the billions of dollars, and injunctive relief.

If Walmart is found liable, it could face civil penalties of up to $67,627 for each unlawful prescription filled and $15,691 for each suspicious order not reported.  

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"It has been a priority of this administration to hold accountable those responsible for the prescription opioid crisis.  As one of the largest pharmacy chains and wholesale drug distributors in the country, Walmart had the responsibility and the means to help prevent the diversion of prescription opioids," said Jeffrey Bossert Clark, acting assistant attorney general of the Civil Division.  

"Instead, for years, it did the opposite – filling thousands of invalid prescriptions at its pharmacies and failing to report suspicious orders of opioids and other drugs placed by those pharmacies. This unlawful conduct contributed to the epidemic of opioid abuse throughout the United States."  

WHY THIS MATTERS

The DOJ is holding Walmart responsible as the operator of its pharmacies and wholesale drug distribution centers, based on a multiyear investigation by the department's Prescription Interdiction and Litigation Task Force.

The complaint, filed in the U.S. District Court for the District of Delaware, alleges that Walmart knowingly filled thousands of controlled substance prescriptions that were not issued for legitimate medical purposes or in the usual course of medical practice, and that it filled prescriptions outside the ordinary course of pharmacy practice.

The complaint also alleges that, as the operator of its distribution centers, which ceased distributing controlled substances in 2018, Walmart received hundreds of thousands of suspicious orders that it failed to report as required by the Drug Enforcement Administration.  

Together these actions helped to fuel the prescription opioid crisis, the DOJ said. 

WALMART'S LAWSUIT AGAINST THE DOJ

On October 22, Walmart filed its own civil action against the Department of Justice in the U.S. District Court in the Eastern District of Texas.

Walmart is seeking a judicial declaration to resolve a dispute with the U.S. Department of Justice and the U.S. Drug Enforcement Administration about the obligations of pharmacists and pharmacies under the Controlled Substances Act. 

"The DOJ and DEA are placing pharmacists and pharmacies in an untenable position by threatening to hold them liable for violating DOJ's unwritten expectations for handling opioid prescriptions – expectations that are directly at odds with state pharmacy and medical practice laws, the expert judgment of federal health agencies, and even DEA's own public statements," Walmart said in the lawsuit.

"When a patient presents a pharmacist with an opioid prescription written by a doctor who is licensed by a state medical board and credentialed by DEA to prescribe controlled substances, the pharmacist must make a difficult decision. The pharmacist can accept the doctor's medical judgment and fill the opioid prescription, or second-guess the doctor's judgment and refuse to fill it – a decision the pharmacist must make without the benefit of a medical license, examining the patient, or having access to medical records."

Walmart asked that the court declare that pharmacists be liable under the CSA and its regulations only when they fill a prescription that they know was not issued for a legitimate medical purpose, and it listed other reasons.

Pharmacies do not have an affirmative obligation under the CSA and its regulations to impose corporation-wide refusals-to-fill for particular doctors, Walmart said.

The DOJ filed a motion to dismiss. Walmart's response is due no later than January 6, 2021, and the DOJ's reply is due nine days after that, U.S. District Judge Sean Jordan ordered on December 18.

Also, at 11 a.m. on January 28, 2021, a hearing on a multidistrict litigation notice is scheduled in the Thurgood Marshall Federal Judiciary Building in Washington, D.C. 

THE LARGER TREND
 
The DOJ pursued Purdue Pharma, a company it believed contributed to the nation's opioid crisis.

On November 24, the DOJ announced that opioid manufacturer Purdue Pharma had pleaded guilty in federal court in Newark, New Jersey, to three felony offenses of conspiracies to defraud the United States and to violating the 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,"  said Rachael A. Honig, first assistant U.S. Attorney for the District of New Jersey. 

Purdue continued to market its opioid products to more than 100 healthcare providers whom the company had good reason to believe were diverting opioids, the DOJ said. 

The DOJ claimed Purdue also 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 the terms of the plea agreement, Purdue agreed to the imposition of one of the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.5 billion and an additional $2 billion in criminal forfeiture. 

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 has agreed to pay $225 million in damages to resolve its civil False Claims Act liability.

As part of that settlement, Purdue Pharma also agreed to close down the company.

Also, last February, the United States Attorneys' Offices sent letters to more than 180 Wisconsin physicians, physician assistants and nurse practitioners advising that a review of their prescribing practices showed that they were prescribing opioids at relatively high levels compared to evidence-based prescribing guidelines.

The letters warned that these prescribing practices could be contributing to the flow of prescription opioids into illegal markets and could lead to civil and criminal enforcement actions.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com