Source: United States Attorneys General
In a civil complaint filed yesterday in the U.S. District Court for the Northern District of Illinois, the Justice Department alleges that Walgreens Boots Alliance, Walgreen Co. and various subsidiaries (collectively, Walgreens) dispensed millions of unlawful prescriptions in violation of the Controlled Substances Act (CSA) and then sought reimbursement for many of these prescriptions from various federal health care programs in violation the False Claims Act (FCA). Walgreens is one of the country’s largest pharmacy chains, with over 8,000 pharmacies across the United States.
“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.”
The government’s complaint alleges that, from approximately August 2012 through the present, Walgreens knowingly filled millions of prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice. Among the millions of unlawful prescriptions that Walgreens allegedly filled were prescriptions for dangerous and excessive quantities of opioids, prescriptions for early refills of opioids and prescriptions for the especially dangerous and abused combination of drugs known as the “trinity,” which is made up of an opioid, a benzodiazepine and a muscle relaxant.
The complaint alleges that Walgreens pharmacists filled these prescriptions despite clear “red flags” that indicated that the prescriptions were highly likely to be unlawful. Walgreens allegedly ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from its own pharmacists and internal data.
The complaint further alleges that Walgreens systematically pressured its pharmacists to fill prescriptions quickly without taking the time needed to confirm each prescription’s validity. Walgreens also allegedly deprived its pharmacists of crucial information, including by preventing pharmacists from warning one another about certain prescribers.
The complaint alleges that by knowingly filling unlawful prescriptions for controlled substances, Walgreens violated the CSA and, where Walgreens sought reimbursement from federal health care programs, also violated the FCA. The complaint alleges that Walgreens’s actions helped to fuel the prescription opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at Walgreens. 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 and treble damages and applicable penalties for each prescription paid by federal programs in violation of the FCA. The court also may award injunctive relief to prevent Walgreens from committing further CSA violations.
“As alleged in the complaint, Walgreens continually disregarded its obligations under the Controlled Substances Act and False Claims Act by illegally dispensing powerful controlled substances and unlawfully seeking reimbursement from federal health care programs,” said Acting U.S. Attorney Morris Pasqual for the Northern District of Illinois. “These laws are critically important in protecting our communities from the dangers of the opioid epidemic. 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.”
“The damage caused by the opioid crisis continues to reverberate in the Middle District of Florida and around the country,” said U.S. Attorney Roger B. Handberg for the Middle District of Florida. “The filing of this civil complaint is a major step in our continued effort to confront those responsible for the harm they have done to our communities.”
“Pharmacies play a critical role in ensuring that only lawful controlled substance prescriptions are dispensed – Walgreens failed to do just that,” said U.S. Attorney Erek Barron for the District of Maryland. “We are committed to holding Walgreens accountable for its role in the opioid epidemic that has devastated communities across the country, including in Maryland.”
“This country is in the midst of a serious opioid epidemic, and New York is no exception,” said Acting U.S. Attorney Carolyn Pokorny for the Eastern District of New York. “Walgreens, which operates one of the largest pharmacy chains in the United States, including nearly 300 pharmacies in the Eastern District of New York during the relevant time period, repeatedly ignored its obligations to ensure that these drugs did not fall into the wrong hands. My office will continue to work with others in the Justice Department to combat the opioid crisis by holding pharmacies that fill unlawful prescriptions accountable.”
“The Justice Department has prioritized both combating the opioid crisis and upholding corporate accountability, and the action we are announcing today affirms our resolve,” said First Assistant U.S. Attorney Maya D. Song for the Eastern District of Virginia. “My office is pleased to partner with our colleagues from across the nation to confront these issues and deter pharmacies and pharmacists from failing to honor their obligation to ensure that these dangerous drugs are only provided to those with a true medical need.”
“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.”
“Millions of Americans enrolled in Medicare, Medicaid, and other public health care programs count on pharmacies to dispense drugs responsibly. When pharmacies disregard federal laws and put profits ahead of patients, they endanger Americans’ health and compromise taxpayer dollars,” said Deputy Inspector General Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG remains diligent in pursuing entities involved in unlawful behavior that abuses the public’s trust in health care services.”
Four different whistleblowers who previously worked for Walgreens in various parts of the country filed whistleblower actions under the qui tam provisions of the FCA. Those provisions authorize private parties to sue on behalf of the United States for false claims and share in any recovery. The Act permits the United States to intervene and take over such lawsuits, as it has done here. The four cases have been consolidated and are captioned United States ex rel. Novak v. Walgreens Boots Alliance Inc. No. 18 C 5452 (NDIL).
The United States’ intervention in this matter underscores the government’s commitment to combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to HHS, at 800-HHS-TIPS (800-447-8477).
The United States is represented in this matter by Assistant Director Amy DeLine, Senior Litigation Counsel Donald Lorenzen and Trial Attorney Nicole Frazer of the Justice Department’s Civil Division’s Consumer Protection Branch and Assistant Director Natalie Waites and Trial Attorney Joshua Barron of the Civil Division’s Commercial Litigation Branch, Fraud Section, as well as Assistant U.S. Attorney Valerie R. Raedy for the Northern District of Illinois, Chief of the Civil Division Randy Harwell and Assistant U.S. Attorney Carolyn Tapie for the Middle District of Florida, Chief of the Civil Division Thomas Corcoran for the District of Maryland, Assistant U.S. Attorney Elliot M. Schachner for the Eastern District of New York and Assistant U.S. Attorney Clare Wuerker for the Eastern District of Virginia.
The U.S. Attorneys’ Offices for the District of Colorado and the Southern District of California, the DEA, HHS-OIG, Defense Criminal Investigative Service, Defense Health Agency (DHA), Office of Personnel Management (OPM), Department of Labor (DOL) Office of Inspector General and FBI Chicago Field Office provided substantial assistance in the investigation.
The Justice Department is committed to holding responsible those who have fueled the opioid crisis by violating the law. In March 2023, the Associate Attorney General announced the creation of the Opioid Epidemic Civil Litigation Task Force, which formalizes and enhances coordination of the department’s existing work and will consider new initiatives. Because of the scope and duration of the crisis, the Task Force includes U.S. Attorneys’ Offices, the Civil Division’s Consumer Protection Branch and Commercial Litigation Branch, Fraud Section, DEA and other department components. The Task Force steers the department’s civil litigation efforts involving actors alleged to have contributed to the opioid epidemic, including by diverting prescription opioids.
The claims asserted against defendants are allegations only and there has been no determination of liability.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.
Additional information about the Fraud Section of the Civil Division and its enforcement efforts can be found at www.justice.gov/civil/fraud-section.
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For information about the federal agencies involved in this investigation and their work to combat the opioid crisis and federal health care fraud, visit: