The U.S. Justice Department, together with the Drug Enforcement Administration (DEA), last week announced a $50 million settlement with Walmart Inc. 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, according to a news release from the Justice Department.
The United States 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.”
In addition to the monetary payment announced last week, 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, according to the release.
Additional information about the enforcement and affirmative litigation branch and its enforcement efforts can be found at https://tinyurl.com/4kuezd9d.
