DOJ sues Walgreens for alleged role in fueling opioid crisis

The U.S. Justice Department has filed a civil lawsuit against Walgreens and its subsidiaries, accusing the pharmacy giant of illegally dispensing millions of prescriptions for controlled substances and seeking federal health care reimbursements for these prescriptions.

According to the statement released by the Justice Department on Friday, Walgreens Boots Alliance violated the Controlled Substances Act (CSA) and the False Claims Act (FCA), contributing to the ongoing opioid epidemic. The nationwide lawsuit was filed on Thursday in the U.S. District Court for the Northern District of Illinois.

“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. “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.”

“Walgreens systematically pressured its pharmacists to fill prescriptions, including controlled substance prescriptions, without taking the time needed to confirm their validity,” Boynton added. “These practices allowed millions of opioid pills and other controlled substances to flow illegally out of Walgreens stores.”

The Justice Department alleges that since 2012, Walgreens filled “millions of unlawful prescriptions” for opioids and other controlled substances that were either lacking a legitimate medical purpose, were invalid or not issued in the usual course of professional practice.

The prescriptions included “dangerous and excessive” amounts of opioids, early refills, and the abused “trinity” drug combination of an opioid, benzodiazepine, and a muscle relaxant.

Walgreens pharmacists allegedly ignored “clear red flags” that indicated that the prescriptions were highly likely to be unlawful, with Walgreens ignoring substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions.

The lawsuit also claims Walgreens pressured its pharmacists to prioritize speed over thoroughness, undermining their ability to verify the validity of prescriptions. Walgreens also allegedly deprived its pharmacists of crucial information, including by preventing pharmacists from warning one another about certain prescribers.

The complaint alleges that the company’s actions helped to fuel the prescription opioid crisis and that, in some instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at Walgreens.

If found liable, Walgreens could face significant financial penalties, including up to $80,850 for each one of the millions of unlawful prescriptions and damages for federal health care claims. The court also may award injunctive relief to prevent Walgreens from committing further violations.

“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.”

This lawsuit follows whistleblower reports from four former Walgreens employees. FCA provisions allow private parties to sue on behalf of the United States for false claims and share in any recovery, with the U.S. being able to intervene and take over the lawsuit. The four cases have been consolidated and are captioned United States ex rel. Novak v. Walgreens Boots Alliance Inc.

Walgreens has responded in a statement, saying that “We are asking the court to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary “rules” that do not appear in any law or regulation and never went through any official rulemaking process.” Adding that Walgreens Boots Alliance “will not stand by and allow the government to put our pharmacists in a no-win situation, trying to comply with “rules” that simply do not exist.”

“Walgreens stands behind our pharmacists, dedicated healthcare professionals who live in the communities they serve, filling legitimate prescriptions for FDA-approved medications written by DEA-licensed prescribers in accordance with all applicable laws and regulations,” the statement said. “We look forward to the opportunity to defend the professionalism and integrity of our pharmacists.”