The Justice Department, together with the Drug Enforcement Administration (DEA) and Department of Health and Human Services Office of Inspector General (HHS-OIG), has announced a $300 million settlement with Walgreens Boots Alliance, Walgreen Co., and various subsidiaries (collectively, Walgreens) to resolve allegations that the national chain pharmacy illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA) and then sought payment for many of those invalid prescriptions by Medicare and other federal health care programs in violation of the False Claims Act (FCA).
The settlement amount is based on Walgreens’s ability to pay. Walgreens will owe the United States an additional $50 million if the company is sold, merged, or transferred prior to fiscal year 2032.
The government’s complaint, filed on Jan. 16 and amended April 18 in the U.S. District Court for the Northern District of Illinois, alleges that from approximately August 2012 through March 1, 2023, Walgreens, one of the nation’s largest pharmacy chains, knowingly filled millions of unlawful controlled substance prescriptions.
These unlawful prescriptions included prescriptions for excessive quantities of opioids, opioid prescriptions filled significantly early, and prescriptions for the especially dangerous and abused combination of three drugs known as a “trinity.”
Walgreens pharmacists allegedly filled these prescriptions despite clear red flags indicating a high likelihood that the prescriptions were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice.
The complaint further alleges that Walgreens pressured its pharmacists to fill prescriptions quickly and without taking the time needed to confirm that each prescription was lawful.
Walgreens’s compliance officials also allegedly ignored substantial evidence that its stores were dispensing unlawful prescriptions and even intentionally deprived its own pharmacists of crucial information, including by refusing to share internal data regarding prescribers with pharmacists and preventing pharmacists from warning one another about certain problematic prescribers.
In light of Friday’s settlement, the United States has moved to dismiss its complaint. Walgreens will also move to dismiss a related declaratory judgment action filed in the U.S. District Court for the Eastern District of Texas.
“Pharmacies have a legal responsibility to prescribe controlled substances in a safe and professional manner, not dispense dangerous drugs just for profit,” said Attorney General Pamela Bondi. “This Department of Justice is committed to ending the opioid crisis and holding bad actors accountable for their failure to protect patients from addiction.”
“This settlement resolves allegations that, for years, Walgreens failed to meet its obligations when dispensing dangerous opioids and other drugs,” said Deputy Assistant Attorney General Michael Granston of the Justice Department’s Civil Division. “We will continue to hold accountable those entities and individuals whose actions contributed to the opioid crisis, whether through illegal prescribing, marketing, dispensing or distributing activities.”
“Importantly, Walgreens’s agreements with the DEA and HHS-OIG provide swift relief in the form of monitoring and claims review that will improve Walgreens’s practices immediately,” said U.S. Attorney Andrew S. Boutros for the Northern District of Illinois. “Our office will continue to work with our law enforcement partners to ensure that opioids are properly dispensed and that taxpayer funds are only spent on legitimate pharmacy claims.”
“This landmark civil settlement is the largest Controlled Substances Act resolution in our district’s history and once again confirms the high priority our office has placed upon confronting those responsible for the opioid crisis here,” said U.S. Attorney Gregory W. Kehoe for the Middle District of Florida.
“With the power to dispense potentially harmful substances comes the responsibility to ensure that every prescription is legitimate before it is filled,” said U.S. Attorney Kelly O. Hayes for the District of Maryland. “When pharmacies fail that responsibility, this office will work with others across the country to hold accountable those who put patients and communities at risk.”
“This settlement holds Walgreens accountable for failing to comply with its critical responsibility to prevent the diversion of opioids and other controlled substances,” said U.S. Attorney John J. Durham for the Eastern District of New York.
In addition to the monetary payments announced today, Walgreens has entered into agreements with the DEA and HHS-OIG to address its future obligations in dispensing controlled substances. Walgreens and the DEA entered into a memorandum of agreement that requires the company to implement and maintain certain compliance measures for the next seven years.
Walgreens must maintain policies and procedures requiring pharmacists to confirm the validity of controlled substance prescriptions prior to dispensing controlled substances, provide annual training to pharmacy employees regarding their legal obligations relating to controlled substances, verify that pharmacy staffing is sufficient to enable pharmacy employees to comply with those legal obligations, and maintain a system for blocking prescriptions from prescribers whom Walgreens becomes aware are writing illegitimate controlled substance prescriptions.
Walgreens has also entered into a five-year Corporate Integrity Agreement with HHS-OIG, which further requires Walgreens to establish and maintain a compliance program that includes written policies and procedures, training, board oversight, and periodic reporting to HHS-OIG related to Walgreens’s dispensing of controlled substances.
The civil settlement resolves four cases brought under the qui tam, or whistleblower, provisions of the FCA by former Walgreens employees. The FCA authorises whistleblowers to sue on behalf of the United States and receive a share of any recovery.
It also permits the United States to intervene and take over such lawsuits, as it did here. The relators will receive a 17.25% share of the government’s FCA recovery in this matter.
