United States Sues Walgreens Over Violations of the Controlled Substances Act and False Claims Act
The United States recently filed a lawsuit against Walgreens Boots Alliance, Walgreen Co., and subsidiaries (collectively, Walgreens) alleging that they dispensed millions of unlawful prescriptions in violation of the Controlled Substances Act (CSA), followed by reimbursement for many of the prescriptions from federal health care programs in violation of the False Claims Act (FCA).
The complaint specifically alleges that from August 2012 through the present, Walgreens knowingly filled millions of prescriptions for controlled substances without a legitimate medical purpose, or that were not valid and/or were not issued in the usual course of professional practice. This includes prescriptions for early refills of opioids and prescriptions for the combination of drugs known as the “trinity” – an opioid, a benzodiazepine, and a muscle relaxant.
According to the complaint, Walgreens pharmacists filled the prescriptions at issue despite clear “red flags” that indicated the prescriptions were likely to be unlawful. The lawsuit also alleges that the company ignored substantial evidence from multiple sources – including its own pharmacists and internal data – that its stores were dispensing unlawful prescriptions.
Not only did Walgreens ignore its pharmacists who raised concerns about illegal prescriptions, it allegedly systematically pressured pharmacists to quickly fill prescriptions, without taking the time to confirm validity of each prescription. Walgreens also allegedly deprived its pharmacists of relevant information, including preventing pharmacists from warning one another about certain prescribers.
If Walgreens is found liable, it could face civil penalties of up to $80,850 for each unlawful prescription filled in violation of the CSA in addition to treble damages and applicable penalties for each prescription paid by federal programs in violation of the FCA. Injunctive relief may also be awarded to prevent Walgreens from committing further violations of the CSA.
The lawsuit was initially filed by four different whistleblowers who previously worked for Walgreens in some capacity under the qui tam provisions of the False Claims Act. The United States intervened and took over, and the cases have been consolidated.
“This lawsuit seeks to hold Walgreens accountable for the many years that it failed to meet its obligations when dispensing dangerous opioids and other drugs,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Our complaint alleges that Walgreens pharmacists filled millions of controlled substance prescriptions with clear red flags that indicated the prescriptions were highly likely to be unlawful, and that Walgreens systematically pressured its pharmacists to fill prescriptions, including controlled substance prescriptions, without taking the time needed to confirm their validity. These practices allowed millions of opioid pills and other controlled substances to flow illegally out of Walgreens stores.”
“Walgreens and its pharmacists have an obligation to ensure that every prescription they fill is legitimate and issued responsibly. As this lawsuit alleges, Walgreens failed in this obligation, and many times ignored the red flags that warned of suspicious prescribing practices,” said DEA Principal Deputy Administrator George Papadopoulos. “Walgreens placed the public in danger by disregarding their responsibility. DEA will continue to pursue any individual or corporation that chooses profit over patient safety and we will hold them accountable.”
Other Walgreens Settlement
In the fall of 2024, Walgreens reached a $106.8 million settlement with the Department of Justice to resolve allegations that the company violated the False Claims Act and various state statutes for billing government health care programs for prescriptions that were never dispensed.
Similar Lawsuits Filed by the DOJ
The lawsuit filed by the DOJ against Walgreens for violations of the CSA and FCA is similar to a lawsuit filed in December 2024 by the DOJ against CVS Pharmacy and various subsidiaries. The CVS lawsuit covers similar behavior from October 2013 to the present, where CVS pharmacists were filling prescribing a dangerous number of opioids, early fills of opioids, and “trinity” prescriptions. According to that complaint, CVS staffing levels were insufficient to allow pharmacists the ability to meet performance metrics and comply with legal obligations. Similar to the Walgreens accusations, CVS allegedly prevented pharmacists from warning one another about certain prescribers, which may have reduced the overall number of illegal prescriptions filled.
The DOJ sued Rite Aid for similar allegations in 2023, alleging that Rite Aid knowingly filled unlawful prescriptions for controlled substances in violation of the FCA and CSA. In that instance, Rite Aid allegedly ignored evidence from sources that its stores were dispensing unlawful prescriptions and went a step further by intentionally deleting internal notes about suspicious prescribers written by Rite Aid pharmacists and directing district managers to tell pharmacists “to be mindful of everything that is put in writing.”