Walmart Inc. of Bentonville has asked a federal judge to throw out the Department of Justice’s lawsuit against it over allegations that its pharmacists unlawfully dispensed opioids, fueling the national opioid crisis.
In December, the DOJ sued Walmart in U.S. District Court in Delaware over claims that Walmart, starting in June 2013, knowingly filled thousands of controlled substance prescriptions that were not issued for legitimate medical purposes, according to a DOJ news release.
Walmart operates more than 5,000 pharmacies nationwide and until 2018 acted as a wholesale distributor of controlled substances for its own pharmacies, the DOJ’s lawsuit said.
The complaint also alleges that, as the operator of its distribution centers, “Walmart received hundreds of thousands of suspicious orders that it failed to report as required to by the [Drug Enforcement Administration],” the news release said.
The Justice Department is seeking civil penalties, which could total in the billions of dollars.
“Walmart’s systematic failure, for years, to comply with its legal obligation to detect and report each of its suspicious orders thus created a major obstacle to efforts to combat the prescription drug abuse epidemic,” the DOJ said.
Walmart has denied the allegations of wrongdoing. In October, about two months before the DOJ filed its suit, Walmart preemptively sued the Justice Department and asked a judge to clarify the roles and responsibilities of pharmacists and pharmacies under the Controlled Substances Act. For example, Walmart wanted U.S. District Judge Sean Jordan to say that the CSA doesn’t require pharmacists to second-guess a doctor’s decision that a prescription serves a legitimate purpose.
A federal judge dismissed Walmart’s case in February, saying the court didn’t have the authority to rule on it. Walmart appealed the decision to the U.S. Court of Appeals for the Fifth Circuit, where the case is pending.
‘Difficult Position’
Walmart is in a difficult position when a patient comes to a pharmacist with an opioid prescription, the company said in court filings.
“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,” the retailer said.
But either decision puts the pharmacist and pharmacy at “great risk,” Walmart said. The pharmacist who fills a valid opioid prescription risks a federal investigation, civil liability or criminal prosecution if, in hindsight, the prescription the pharmistict believed was legitimate should not have been filled.
“On the other hand, a pharmacist who refuses to fill such a prescription risks having her license stripped for the unauthorized practice of medicine, not to mention the potential harm to patients in need of their medicine,” Walmart said.
Walmart said it has refused to fill “hundreds of thousands of problematic” prescriptions, and has faced state investigations and suits accusing it of interfering with doctor-patient relationships.
Several groups filed friend-of-the-court briefs for Walmart in the DOJ case.
“This case seeks to hold a company responsible for the acts of its employees in filling allegedly improper prescriptions without any allegation that the employees who filled the prescription possessed knowledge of irregularities in the prescriptions,” said the joint filing by the U.S. Chamber of Commerce, the National Retail Federation and the Washington Legal Foundation. The DOJ “exposes companies to staggering liability — even where no one, identifiable employee knowingly engaged in any wrongdoing,” the filing said.
The National Association of Boards of Pharmacy told Arkansas Business states don’t require pharmacists to dispense prescriptions that, in the pharmacist’s judgment, may harm patients.
“It is critical for pharmacists and prescribers to work together to address any medication concerns in the best interest of the patient,” NABP Executive Director Lemrey “Al” Carter said in an email to Arkansas Business.
A pharmacist could decide not to fill the opioid prescription, Carter said.
The amount of due diligence required by the pharmacist depends on the circumstances, including the quantity of the drug and how the prescription was received, Carter said.
Consulting “with the patient about their medical condition and why the medication was prescribed are good due diligence tools, particularly if a pharmacist still has questions after gathering preliminary information,” Carter said.
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