Attorneys General Sue Walgreens Over Dangerous Prescription Practices

The Department of Justice (DOJ) has filed a civil lawsuit against Walgreens (Walgreens Boots Alliance, Walgreen Co, and various subsidiaries) over allegations it violated the Controlled Substances Act and the False Claims Act. This news comes on the heels of reports about hundreds of Walgreens stores closing by the end of 2025, along with approximately 2000 locations that shuttered within the past 10 years.¹

As of December 29, 2024, Walgreens was the third largest pharmacy chain in the US, with 8475 locations, behind CVS with 9165 locations and Express Scripts with 45,948 locations.² Together, the trio accounts for 85% of the largest 10 pharmacies in the US.

The lawsuit, United States ex rel. Novak v. Walgreens Boots Alliance Inc., focuses on the filling and reimbursement of millions of prescriptions over nearly 13 years (from August 2012 to the present).¹ The DOJ alleged these prescriptions were unlawful because they involved excessive amounts of dangerous opioids and other controlled substances, early refills, and a combination of high-risk drugs often abused together, such as opioids, benzodiazepines, and muscle relaxants commonly used for pain management.³ When taken, the synergistic effects of these drugs are an increase in dopamine and capability to depress respiration.⁴

The financial fine against Walgreens could be massive if it is found liable, with $80,850 being the maximum amount handed down per unlawful prescription and potential for treble damages. | Image Credit: © Douglas-stock.adobe.com

“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, in a statement.¹ The DOJ noted in its filing that Walgreens exerted pressure on its pharmacists to fill the prescriptions but not to determine their validity. Additionally, Walgreens was said to have withheld that information from the pharmacists, including warnings from other pharmacists about potential illegal prescriber activity.

The lawsuit was filed on the January 16 in the US District Court for the Northern District of Illinois by attorneys general from the Middle District of Florida, Northern District of Illinois, District of Maryland, Eastern District of New York, and Eastern District of Virginia, with investigation assistance from government agencies that include the FBI, Drug Enforcement Administration, and Department of Labor Office of Inspector General. This action followed the original filing of 4 lawsuits by whistleblowers against Walgreens, which were consolidated under the False Claims Act.

Overdose-related deaths from synthetic opioids and stimulants in the US outpaced other countries as recently as 2023, climbing to over 100,000 for a third consecutive year that year and totaling 324 per 1 million population in 2022.⁵ More recent data show a 12-month drop from June 2023 to June 2024 of opioid overdose deaths: 86,401 to 70,655.⁶

A recent move by the FDA in October seeks to provide an alternative pain management solution for patients with severe pain: it approved oxycodone hydrochloride (RoxyBond), which is formulated with SentryBond abuse-deterrent technology that encompasses the ability to “maintain the intended release profile of extended-release products and to delay the release of immediate-release products.”⁷

In certain instances, also alleged in the DOJ’s lawsuit, unlawfully filled opioid prescriptions picked up at Walgreens directly led to overdose-related deaths.¹ The financial fine against Walgreens could be massive if it is found liable, with $80,850 being the maximum amount handed down per unlawful prescription and potential for treble damages—or triple the amount of actual damages.⁸

Actions under this lawsuit and the eventual decision’s ramifications could trickle down to have an adverse impact on Americans with prescription drug coverage under Medicare, Medicaid, and public health care programs if Walgreens is found to have willfully disregarded federal law, the suit stresses, noting that putting profits ahead of patients endangers their health.

References

1. Justice Department files nationwide lawsuit alleging Walgreens knowingly filled millions of prescriptions that lacked a legitimate medical purpose. News release. Department of Justice. January 17, 2025. Accessed January 20, 2025. https://www.justice.gov/opa/pr/justice-department-files-nationwide-lawsuit-alleging-walgreens-knowingly-filled-millions

2. 10 largest pharmacies in the United States in 2024. ScrapeHero. Updated December 29, 2024. Accessed January 20, 2025. https://www.scrapehero.com/location-reports/10-largest-pharmacies-in-the-usa/

3. Labonville S. The holy trinity of medications: high risk combinations. Injured Workers Pharmacy. Accessed January 20, 2025. https://www.iwpharmacy.com/blog/the-holy-trinity-of-medications-high-risk-combinations

4. Horsfall JT, Sprague JE. The pharmacology and toxicology of the 'holy trinity.' Basic Clin Pharmacol Toxicol. 2017;120(2):115-119. doi:10.1111/bcpt.1265

5. Steinzor P. US overdose deaths outpace other countries, report finds. AJMC®. January 9, 2025. Accessed January 20, 2025. https://www.ajmc.com/view/us-overdose-deaths-outpace-other-countries-report-finds

6. Bonavitacola J. Deaths due to opioid overdose fall for the 12th consecutive month. AJMC®. November 14, 2094. Accessed January 20, 2024. https://www.ajmc.com/view/deaths-due-to-opioid-overdose-fall-for-the-12th-consecutive-month

7. RoxyBond, featuring SentryBond abuse-deterrent technology. Prescribing information. Protega Pharma; 2024. Accessed January 20, 2024. https://www.roxybond.com/reduce-abuse

8. Treble damages. Cornell Law School. Accessed January 20, 2024. https://www.law.cornell.edu/wex/treble_damages