The Justice Department, along with the Drug Enforcement Administration (DEA), Friday announced a $50 million settlement with Walmart Incorporated to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA).
The government’s complaint — filed on Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of individuals on its compliance team and the knowing actions of its pharmacists. They alleged that members of Walmart’s compliance team knew that certain prescribers were operating as “pill mills” but filled invalid prescriptions written by those prescribers anyway. Members of the compliance team allegedly knew of the prescribers’ egregious conduct because Walmart’s own pharmacists reported the conduct to Walmart’s corporate compliance team, including through thousands of “refusal-to-fill” forms. The compliance team, however, prioritized other goals over CSA compliance. As one director on the compliance team acknowledged in an email, rather than analyzing the refusal-to-fill reports, the compliance team viewed “[d]riving sales and patient awareness,” as “a far better use of our market directors and market manager’s time.”
Walmart pharmacists also allegedly filled prescriptions they knew were invalid. The pharmacists knew these prescriptions were invalid because they were either written by a known “pill mill” prescriber or the prescriptions had obvious red flags such as dangerous combinations of opioids, “cocktails” of opioids and non-opioids, excessively repeated fills of high-dosages of often-abused opioids, or repeated requests for early fills of often-abused controlled substances.
“Today’s settlement proves this Department is committed to putting Americans’ flourishing first,” said Associate Attorney General Stanley Woodward. “Congress enacted laws to promote responsibility and accountability for companies who dispense controlled substances to protect Americans.”
In addition to the monetary payment, Walmart has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires Walmart to establish a hotline for both employees and patients to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.
“This $50 million settlement makes clear that pharmacies have a responsibility to identify and prevent the unlawful dispensing of controlled substances,” said DEA Assistant Administrator Cheri Oz. “Filling illegitimate opioid prescriptions puts patients and communities at risk and undermines the safeguards designed to prevent the diversion and misuse of potentially addictive medications.
The settlement addresses past conduct while establishing compliance obligations designed to strengthen safeguards and help prevent these failures from happening again, according to Oz.
