Justice Department files nationwide lawsuit against Walgreens
On Friday late afternoon, the Justice Department announced that in a civil complaint filed Jan. 16 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 and then sought reimbursement for many of these prescriptions from various federal healthcare programs in violation the False Claims Act.
“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.”
“Today’s announcement demonstrates that we are doubling down on our commitment to both combat the opioid crisis and enforce corporate accountability,” said First Assistant U.S. Attorney Maya D. Song for the Eastern District of Virginia. “We will continue to work with colleagues across the nation to confront these issues and deter pharmacies from failing to honor their obligation to ensure that these powerful drugs are provided only 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 Inspector General Christi A. Grimm of the Department of Health and Human Services Office of Inspector General. “Outstanding teamwork on this case and other collaborations with our law enforcement partners demonstrates HHS-OIG’s unwavering commitment to combating health care fraud and prosecuting providers who abuse the public’s trust.”
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).
A Walgreens spokesperson provided Drug Store News with the following comment: "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. We 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. Walgreens has long been a leader in providing education and resources, as well as implementing best-in-class policies and procedures, to help combat opioid misuse and abuse.
Walgreens added, "We look forward to the opportunity to defend the professionalism and integrity of our pharmacists."
