In a sweeping move to hold corporations accountable in the ongoing battle against the opioid crisis, the U.S. Department of Justice (DOJ), alongside the Drug Enforcement Administration (DEA) and the Department of Health and Human Services Office of Inspector General (HHS-OIG), announced a landmark $300 million civil settlement with Walgreens Boots Alliance and its subsidiaries.
The national pharmacy chain stands accused of knowingly filling millions of invalid prescriptions for opioids and other controlled substances in violation of federal law — and then billing federal health care programs like Medicare for these prescriptions. According to officials, this is one of the largest Controlled Substances Act (CSA) settlements in history.
“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. “We will continue to hold accountable those entities and individuals whose actions contributed to the opioid crisis.”
A Decade of Violations
The government’s complaint, originally filed in January and amended in April in the Northern District of Illinois, alleges that from August 2012 through March 2023, Walgreens filled unlawful prescriptions, including those for dangerously high quantities of opioids, early refills, and drug combinations commonly abused as a “trinity.”
Pharmacists allegedly filled these prescriptions despite glaring red flags indicating that many were not medically necessary or legally valid. Internal pressure to fill prescriptions quickly, combined with corporate-level failures to provide compliance support, allowed the unlawful activity to continue unchecked, the DOJ said.
In some cases, Walgreens allegedly refused to share internal data on problematic prescribers with pharmacists and even blocked pharmacists from warning one another about them.
Government Response and Reform
As part of the settlement, Walgreens will pay $300 million based on its ability to pay, and an additional $50 million will be owed if the company is sold or merged before 2032. The agreement includes a seven-year compliance mandate with the DEA and a five-year Corporate Integrity Agreement with HHS-OIG to ensure improved oversight and staff training in the future.
“These agreements 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 of the Northern District of Illinois.
DEA Acting Administrator Derek Maltz emphasized the responsibility of pharmacies to prevent diversion of controlled substances. “When one of the nation’s largest pharmacies fails at this obligation, they jeopardize the health and safety of their customers and place the American public in danger,” he said.
Whistleblower Lawsuits Spark Government Action
The case originated from four whistleblower (or qui tam) lawsuits filed by former Walgreens employees under the False Claims Act (FCA). These whistleblowers will collectively receive over 17% of the federal recovery, equating to roughly $51.75 million.
Acting Inspector General Juliet T. Hodgkins of HHS-OIG said, “Pharmacies that neglect their legal duties and instead exploit these programs for market advantage squander taxpayer dollars and put patient safety at risk.”
The investigation involved extensive collaboration across multiple federal agencies and U.S. Attorneys’ Offices in Illinois, Florida, Maryland, New York, Virginia, and beyond. The FBI, Department of Veterans Affairs, Department of Labor, and Department of Defense were among the many involved in gathering evidence and building the case.
“Strict compliance with the law is essential to safeguarding the public,” said U.S. Attorney Erik S. Siebert for the Eastern District of Virginia. “Medically unnecessary prescriptions are a cost ultimately borne by the taxpayers and consumers.”
As the legal dust settles, Walgreens must now undertake significant reforms. But for federal prosecutors and investigators, the message is clear: the fight against opioid misuse—and those who profit from it—is far from over.
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