Nearly 108,000 Americans died of opioid overdoses in 2021. Back in 2017, the federal government declared opioids a public health emergency. But the National Center for Drug Abuse Statistics (NCDAS) is still reporting that 136 people are overdosing and dying each day. Calling pharmacies “critical gatekeepers against the unlawful dispensing... Read More »
Justice Department Charges Walmart with Filling and Failing to Report Suspicious Opioid Prescriptions
There is a tragic irony to Walmart’s advertising slogan that claims, “Save Money. Live Better.” The hundreds of thousands of people who filled their opioid prescriptions at Walmart’s pharmacies across the nation might have saved some money, but according to a new civil complaint filed by the Department of Justice, the retail giant’s unlawful conduct did not help its customers live better. It might even have cost them their lives.
The Justice Department’s (DOJ) complaint alleges that Walmart’s conduct during the nation’s opioid crisis violated the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act or CSA). This act regulates every outlet in the controlled substances supply chain. It requires pharmacies to assure that they fill only legitimate prescriptions and that they notify the Drug Enforcement Administration (DEA) about suspicious orders. On a nationwide basis, Walmart did neither.
If Walmart is found liable for violating the CSA, civil penalties of up to $67,627 could be given for each prescription that was filled unlawfully, and $15,691 could be imposed for each suspicious order that was not reported. Injunctive relief to prevent any future violations of the act is also being sought. The United States must prove these allegations if the case proceeds to trial.
DOJ’s charges against Walmart were filed in the U.S. District Court for the District of Delaware, the state of Walmart’s incorporation, on December 22. They are the result of a multi-year investigation by its Prescription Interdiction & Litigation (PIL) Task Force. The charges allege that Walmart’s Walmart-branded and Sam’s Club-branded outlets knowingly filled prescriptions that were not “issued for legitimate medical purposes.”
In addition, until 2018, Walmart acted as a wholesale distributor of controlled substances for its pharmacies. Throughout the opioid crisis, it received “thousands of suspicious orders” in its 5,000 plus stores that should have been reported to the Drug Enforcement Agency (DEA). Walmart’s failures “helped to fuel the prescription opioid crisis,” according to a press release issued by DOJ. These orders should have been identified because they showed a pattern of being larger and more numerous than normal. They were not.
The DOJ complaint states, “As both a pharmacy and a distributor, Walmart assumed critical gatekeeping responsibilities under the CSA. At two stages—when deciding whether to fill its pharmacies’ wholesale orders for controlled substances from its distribution warehouse, and when deciding whether to fill individuals’ prescriptions for controlled substances—Walmart was required by the CSA to take steps to prevent the diversion of the prescription drugs it sold.”
It continues, “As a nationwide dispenser and distributor of opioids, and given the sheer number of pharmacies it operates, Walmart was uniquely well positioned to prevent the illegal diversion of opioids. Yet, for years, as the prescription drug abuse epidemic ravaged the country, Walmart abdicated those responsibilities.”
According to the Centers for Disease Control, between 1999 and 2018, more than 232,000 people died in the United States from overdoses involving prescription opioids.
The CSA outlines the properties of controlled substances and explains what a pharmacist must do to monitor their use. It imposes a “corresponding responsibility on the pharmacist who must “independently determine that the prescription is valid and meets the first two requirements.”
The DOJ’s filing reiterated that Walmart’s pharmacists had the responsibility to “recognize, investigate, and resolve signs of a prescription’s invalidity— “red flags.” It states that Walmart routinely ignored “red flags” and that information they compiled about these warning signals were not efficiently shared with their pharmacists. Instead, Walmart’s managers actually pressured their pharmacists to fill high numbers of prescriptions, even from doctors they had reported for operating “egregious pill mills.” Sam’s Club even offered discounts on opioids at one point.
Managers refused to give their pharmacists the authority to refuse to fill suspect opioid orders or to issue blanket orders against “red flag” doctors. Instead, it required them to complete a “refusal- to-fill” form for every prescription issued by a suspect prescriber. Pharmacists complained this procedure was time-consuming, impractical, and prevented them from meeting CSA requirements. The complaint states, “Walmart impeded its pharmacists’ ability to comply with the legal requirements for dispensing controlled substances.” Pharmacists often complained of inadequate staff they would need to fulfill their CSA responsibilities. Their complaints were routinely ignored.
Walmart’s failures are even more shocking because, according to the DOJ complaint, “Walmart was well aware of the severity and scope of the prescription drug abuse epidemic.” It had acknowledged that drug overdoses were the number one cause of accidental deaths in the U.S. “Nevertheless, Walmart routinely ignored the very legal requirements that could have helped stem the epidemic,” the complaint stated.
Sadly, this week’s actions are not the first that were brought against Walmart. In 2009, DEA sought to revoke Walmart’s registration for one of its pharmacies that failed to comply with legal requirements related to filling prescriptions for controlled substances. In 2011, it entered into an agreement in which Walmart agreed to adopt a national compliance program and to collect reports from its pharmacists to further monitor prescription legality.
In reality, information was collected, but reports were not analyzed, nor was their information shared with pharmacists who could identify and stop filling prescriptions from “pill-mill prescribers.” Instead, managers were told to speed up the time it takes to fill prescriptions, were rewarded for high numbers, and were criticized for not meeting managers’ targets. Walmart’s promises to DEA were routinely ignored.
DOJ’s complaint summarizes, “Although Walmart knew its flawed system did not comply with the CSA, for years Walmart failed to use its ample resources to remedy these deficiencies.” The numbers are chilling. Out of an estimated 37.5 million controlled-substance orders to its pharmacies, only 204 were reported as suspicious. On the other hand, during the same period, Walmart’s backup distributor McKesson Corporation reported 13,000 suspicious orders to the DEA.
In the press statement, Deputy Assistant Attorney General Daniel J. Feith of the Civil Divisions’ Consumer Protection Branch stated, “For years, Walmart failed to meet its obligations in distributing and dispensing dangerous opioids and other drugs.” The release included similar statements by U.S. Attorneys for the Middle District of Florida, the Eastern District of New York, the District of Colorado, The District of Delaware and The Eastern District of North Carolina, demonstrating that Walmart’s alleged violations took place across the United States. The complaint contains 20 examples of “pill mill” prescribers.
Robert Higdon Jr, U.S. Attorney for the Eastern District of North Carolina, illustrated the scope of the problem by providing details of one typical case his office brought against a local doctor. He said, “For example, our office prosecuted a physician for illegal opioid distribution. A jury convicted him just last year, and he is currently serving a twenty-year prison sentence. As it turns out, that physician expressly directed patients to Walmart to have their opioid prescriptions filled. Walmart’s own pharmacists reported concerns about the doctor up the corporate chain, but for years, Walmart did nothing—except continue to dispense thousands of opioid pills.”
Someone should have been watching and acting with more urgency. There is a tragic irony in the statement by Jeffrey Bossert Clark, Acting Assistant Attorney General of the Civil Division, who is quoted in the DOJ press release about the new civic complaint. The complaint was issued in the last few weeks of the Trump Administration, yet Clark said, “It has been a priority of this administration to hold accountable those responsible for the prescription opioid crisis.”
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