WILMINGTON, Del. (Legal Newsline) - The U.S. Justice Department filed a long-anticipated lawsuit against Walmart, accusing the retailer of filling “hundreds of thousands” of suspicious opioid prescriptions that it should have blocked or reported to federal authorities.
The 160-page complaint filed in U.S. District Court in Delaware accuses Walmart of violating the Controlled Substances Act by failing to intercept prescriptions that bore “red flags” indicating they were written for improper purposes or destined for illegal diversion. The government also accuses Walmart of failing to inform federal authorities of suspicious order patterns in the wholesale distribution business that formerly served its more than 5,000 retail pharmacies.
Walmart has been expecting the lawsuit for some time and two months ago filed a preemptive suit in Texas, where the Justice Dept. investigation originated, seeking a declaratory judgment on its legal duties under the CSA. Federal law doesn’t identify any specific “red flags” pharmacists must heed other than that prescriptions must be written by a Drug Enforcement Administration-licensed practitioner.
The government’s lawsuit doesn’t accuse Walmart of filling any prescriptions by unlicensed doctors, and Walmart called the case a misguided attempt to turn its pharmacists into “DEA’s own `doctor police.’”
The government’s view of the law would force pharmacists “to come between doctors and their patients in a way Congress never intended, and federal and state health regulators say isn’t allowed,” the company said in a strongly worded response on its website. “Pharmacists aren’t doctors and don’t write opioid prescriptions.”
In its lawsuit, the Justice Dept. says Walmart facilitated opioid diversion and abuse by failing to implement a companywide system to alert individual pharmacists about prescribers who had been tagged as suspicious by regulators or other Walmart pharmacies. The government also accuses Walmart of operating a deficient suspicious-order monitoring system in its wholesale division that failed to detect order patterns from its own pharmacies that suggested illegal activity. Walmart ceased wholesale distribution of opioids in 2018.
“For years, Walmart kept in place a system that it knew was failing to adequately detect and report suspicious orders,” the Justice Dept. complaint says. “Walmart periodically considered fixing its system, but time and time again it chose not to spend the time, money, and effort needed to bring its process into compliance.”
The lawsuit repeatedly accuses Walmart of violating the CSA and includes descriptions of some 20 practitioners it Walmart should have identified as writing suspicious prescriptions. The “red flags” the government cites included scrips for too many pills at excessive doses, opioids prescribed in combination with other narcotics it dubbed dangerous “trinities,” and allowing patients to pay in cash. Some patients also were rejected at one Walmart pharmacy only to have their prescription filled at another one, the government says, a problem it says Walmart could have stopped by issuing nationwide halt orders on specific prescribers.
The complaint is careful to describe Walmart as filling “invalid prescriptions,” instead of “illegal prescriptions.” The term appears to encompass any prescription the government considers to have been excessive or not in the patient’s best interest.
In its Declaratory Judgment Act suit, Walmart says the government is seeking to enforce duties on its pharmacists that appear nowhere in the law, and in many cases contradict their obligations under state law and regulations. Pharmacists who refuse to fill prescriptions by licensed physicians, for example, can face liability or enforcement actions by state regulators for the unauthorized practice of medicine. Walmart faces at least two class action lawsuits accusing it of depriving customers of needed medicine.
During the same time Walmart is accused of aggravating the opioid crisis, the DEA nearly tripled the production quotas for oxycodone and hydrocodone and had unique visibility into where every pill was produced and distributed through its nationwide ARCOS database. Walmart also says nearly 70% of the practitioners the Justice Dept. has identified as suspicious still hold DEA licenses to prescribe narcotics.
While the government acknowledges practitioners are prohibited from writing prescriptions for improper purposes, the lawsuit says the CSA imposes a “corresponding responsibility” on pharmacists to “independently determine that the prescription is valid.” That responsibility includes “identifying and attempting to resolve red flags,” documenting how the “red flag” is resolved and refusing to fill a prescription if it is not. Pharmacists “cannot rely exclusively on the fact” a prescription was written by a licensed doctor, the government says; the pharmacists “must consider any signs that a prescription may be invalid or that the controlled substances may be abused or misused.”
Walmart complains this gives the government far too much leeway to punish practices which in hindsight it finds improper. For example, the government now claims the “classic trinity” of opioids, benzodiazepine and a muscle relaxer is presumptively suspicious, yet doctors routinely prescribe this combination for severe pain. Medicare and Medicaid still pay for these prescriptions and the Justice Department’s opposition to the “trinity” is contradicted by other federal agencies, Walmart says.
In its declaratory judgment suit, Walmart describes the government’s investigation and long-threatened lawsuit as an attempt to extract a multibillion-dollar settlement from the company. In its complaint, the government pegs potential penalties at more than $67,000 per violation, totaling tens of billions of dollars.
Walmart doesn’t appear to be in a settling mood, however. In its news release responding to the lawsuit, the company called it “misguided and misleading.”
“It is wrong on the law and riddled with factual inaccuracies, mischaracterizations and cherry-picked documents taken out of context,” Walmart says. “And it is outrageous the Department is trying to shift blame for DEA’s own well-documented failures in policing the very doctors it gave permission to prescribe opioids.”