The Department of Justice (DOJ) has filed a nationwide lawsuit against Walmart Inc. According to a civil complaint the DOJ filed, Walmart pharmacies across the country unlawfully dispensed controlled substances. At the height of the country’s prescription opioid crisis, Walmart unlawfully distributed such drug to their pharmacies, according to the complaint.
Walmart could ultimately pay civil penalties in the billions of dollars for their alleged unlawful conduct, which, as per the DOJ, represented hundreds of thousands of Controlled Substances Act (CSA) violations.
Standards Set by the Controlled Substances Act
With the CSA, all controlled substances became regulated under existing federal law. Each drug is classified into one of five schedules, depending upon the substance’s potential for abuse, safety or risk for dependence, and medical use.
The CSA also establishes rules of compliance that pharmacies must follow before filling any prescription for a controlled substance, as follows:
- A pharmacist must confirm that the prescription was issued for a legitimate medical purpose and in the “usual course of professional practice.”
- The pharmacist must uphold professional pharmacist practice standards, which includes spotting and resolving “red flags.”
- When a pharmacy violates these rules, they risk civil penalties and other forms of recourse.
As an operator of pharmacies, Walmart is bound by these rules.
Distributors of controlled substances also must adhere to specific standards set by the CSA. Specifically, they must detect and report suspicious pharmaceutical orders for controlled substances and report orders they find to be suspicious. Distributors who fail to abide by these rules subject themselves to civil penalties.
Because Walmart distributes controlled substances to its pharmacies, the corporation is also bound by these rules.
A Multi-Year Investigation
Over the course of several years, the DOJ’s Prescription Interdiction & Litigation (PIL) Task Force investigated Walmart’s adherence to the CSA. They discovered multiple violations connected to the corporation’s role as a wholesale drug distributor and manager of its stores’ pharmacies.
Specifically, the DOJ now accuses Walmart of knowingly filling prescriptions not issued for legitimate medical purposes or in the usual course of medical practice and outside standard pharmacy practice. These prescriptions numbered in the thousands.
Furthermore, the complaint raises concerns about the retail giant’s role as a controlled substances distributor. According to the DOJ, although Walmart stopped distributing controlled substances in 2018, it failed to report suspicious orders it received to the Drug Enforcement Agency (DEA). These orders numbered in the hundreds of thousands.
The combination of violations, according to the DOJ, facilitated a prescription opioid crisis that quickly grew to epidemic proportions.
“Today’s complaint is the culmination of a painstaking investigation by my office and our Department of Justice colleagues that uncovered years of unlawful conduct that did untold damage to communities around the country, including here in Colorado,” said U.S. Attorney for the District of Colorado Jason R. Dunn, as quoted in a DOJ press release. “We look forward to pursuing justice and holding the company accountable for its conduct.”
Complaints Falling on Deaf Ears
Walmart’s corporate personnel blocked its store pharmacists from complying with the CSA in many ways, according to the DOJ claim. Pharmacists were pressured by their managers to rush through the process of filling prescriptions and failed to inform them and authorize them to comply with CSA rules.
Although Walmart policy mandated that pharmacists detect and resolve “red flags,” the company prohibited any refusal to fill pill-mill prescriptions. Furthermore, when pharmacists did identify pill mills and other suspicious orders, they reported them to corporate, with no response.
Complaints regarding 20 prescribers that pharmacists sent up the chain of command include the following quotes:
- “95% of the prescriptions from this prescriber are for controlled substances”
- Prescribed “too many [drugs] for one person to take”
- “Filling for him is a risk that keeps me up at night;” “our concerns are falling upon deaf ears”
- “Gives patients what they want and [does] not practice real medicine”
- “Always writes excessive quantities for all of his patients”
- A “known pill mill doctor”
- “Many DEA red flags present”
- Filling prescriptions from this “pill mill” was “putting pharmacists and Walmart in a bad situation legally”
- “Customers that were under the influence tell me that this doctor will write whatever they want”
- “There is no way that many 25 year olds need 120 to 240 oxycodone per month”
- Prescribed “cocktails” and directed patients to fill their prescriptions at Walmart
The DOJ claim itemizes several glaring red flags that it failed to act on, including:
- Dangerous opioid combinations
- Dangerous opioid/non-opioid cocktails
- Repeated fills of extremely high dosages of opioids
- Unusually early filling of Schedule II substances
Walmart’s apparent disregard for CSA rules, for the peace of mind of its pharmacists, and the well-being of its customers made the company a clear subject of focus for entities investigating and attempting to resolve the nation’s opioid crisis.
Walmart Had the Means to Detect, Make a Difference
Not only did Walmart fail as a manager of its pharmacies, but it also fell seriously short in its role as a distributor of controlled substances. As the DOJ’s claim points out, it was well within the massive corporation’s means to detect problems with controlled substance orders and help its store pharmacies to deal with them in a safe, orderly manner that complied with CSA requirements.
It would have been entirely feasible for Walmart to design a suspicious-order-detection system, putting to use the volumes of data and information the company had amassed over the years. Such information includes extensive an invaluable data about orders and dispensing patterns.
Furthermore, the DOJ claims offers evidence that Walmart was aware that its policies and procedures for detecting suspicious orders were not working. Still, the company failed to correct these problems.
Walmart could have made a difference— especially as the prescription drug abuse epidemic was thriving beyond the country’s control, the DOJ asserts. Rather than abiding by CSA standards and protocols—steps that could have enabled a timely response to unlawful conduct—the corporation chose to line its pockets, filling order after order of opioids and dangerous drug combinations and pouring gasoline on the fire of abuse, addiction, and death.
Walmart Denies Liability
Walmart issued its response to the DOJ lawsuit on December 22, 2020. The “company line” is that “Walmart is helping fight the opioid crisis.” The company protests the DOJ’s allegations, saying that the lawsuit represents the DOJ’s tactics for shifting the blame for the DEA’s inadequacies in policing doctors permitted to prescribe opioids.
Walmart further suggests that by turning pharmacists into “doctor police,” the DOJ is forcing prescribers into a position between doctors and their patients—a practice prohibited by federal and state regulators.
They further assert that patients are now complaining about pharmacies refusing to fill prescription orders for medicine the patients need. The situation puts Walmart and other pharmacies in “damned if they do, damned if they don’t” situation, where any decision pharmacists make presents its own set of risks. One example of the outcome of such decisions is the class action lawsuit filed against CVS, Walgreens & Costco for not filling patients’ opioid prescriptions.
The company claims that the DOJ’s allegations are fraught with inaccuracies, which Walmart will counter with its own evidence in court.
How it Played Out
U.S. Attorney for the Eastern District of North Carolina Robert Higdon Jr. talked about the wreckage that opioid addiction has caused in countless communities across the country. He offered an example from his position as a prosecutor of how the corporation played into and enabled the opioid crisis.
According to Higdon, his office prosecuted a doctor for illegal opioid distribution. The man was convicted by a jury and sentenced to 20 years in prison. Reportedly the doctor specifically instructed his patients to have their opioid prescriptions at Walmart. Despite numerous reports from Walmart pharmacists alerting corporate of the suspicious prescriptions, Walmart failed to take action.
Potentially Massive Penalties
Walmart could pay a hefty price tag for its actions. If the DOJ succeeds in establishing the corporation’s liability for its CSA violations, it could cost the company as much as $67,627 for each prescription it unlawfully filled and $15, 691 for each unreported suspicious order.
“The misuse of prescription painkillers is a public health crisis,” remarked U.S. Attorney for the District of Delaware David C. Weiss in the DOJ press release. “DEA registrants must understand that licensure is a privilege, not a right. Whenever that privilege is abused, whether by the smallest local provider or the largest national chain, our office and the Department of Justice will take all necessary steps to enforce the law and keep the public safe.”
Holding Pharmacies Accountable
U.S. Attorney for the Middle District of Florida Maria Chapa Lopez is eager to hold Walmart accountable for its role in fueling the nation’s opioid problem.
“The opioid crisis has exacted a catastrophic human toll upon the residents of our district and upon our country,” Lopez explained in the DOJ press release. “National pharmacy chains must meet their legal obligations when dispensing and distributing these powerful medications. The filing of this complaint in collaboration with the Department of Justice and other United States Attorneys’ Offices demonstrates our firm commitment to enforcing these critical legal requirements.”
Lawyers from the Department of Justice Civil Division’s Consumer Protection Branch and from the U.S. Attorneys’ Offices for the District of Colorado, District of Delaware, Eastern District of North Carolina, Eastern District of New York, and Middle District of Florida will represents the United States in this national lawsuit.