The Justice Department announced today that the United States has filed a complaint in intervention in a whistleblower lawsuit brought under the False Claims Act (FCA) against Rite Aid Corporation and various subsidiaries (collectively Rite Aid) alleging that Rite Aid knowingly filled unlawful prescriptions for controlled substances. In addition to alleging claims under the FCA, the government’s complaint also alleges violations of the Controlled Substances Act (CSA). Rite Aid is one of the country’s largest pharmacy chains, with over 2,200 pharmacies in 17 states.
“The Justice Department is using every tool at our disposal to confront the opioid epidemic that is killing Americans and shattering communities across the country,” said Attorney General Merrick B. Garland. “That includes holding corporations, like Rite Aid, accountable forknowinglyfillingunlawful prescriptions for controlled substances.”
“We allege that Rite Aid filled hundreds of thousands of prescriptions that did not meet legal requirements,” said Associate Attorney General Vanita Gupta. “According to our complaint, Rite Aid’s pharmacists repeatedly filled prescriptions for controlled substances with obvious red flags, and Rite Aid intentionally deleted internal notes about suspicious prescribers. These practices opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores.”
“The opioid crisis has exacted a heavy toll on communities across the United States,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Today’s complaint is an important reminder that the Justice Department will hold accountable any individuals or entities, including pharmacies, that fueled this terrible crisis.”
“Pharmacies, physicians, corporations, and other health care entities that have contributed to the proliferation of opioids in our communities and the tragic loss of life from overdose deaths must answer for their role in the crisis we now face,” said First Assistant U.S. Attorney Michelle M. Baeppler for the Northern District of Ohio. “This complaint is a continuation of the Justice Department’s commitment to hold accountable those entities that aggravated and profited from the opioid crisis.”
The government’s complaint alleges that, from May 2014 through June 2019, Rite Aid knowingly filled at least hundreds of thousands of unlawful prescriptions for controlled substances that lacked a legitimate medical purpose, were not for a medically accepted indication, or were not issued in the usual course of professional practice. These unlawful prescriptions included, for example, prescriptions for the dangerous and highly abused combination of drugs known as “the trinity,” prescriptions for excessive quantities of opioids, such as oxycodone and fentanyl, and prescriptions issued by prescribers whom Rite Aid pharmacists had repeatedly identified internally as writing illegitimate prescriptions. The government alleges that Rite Aid pharmacists filled these prescriptions despite clear “red flags” that were highly indicative that the prescriptions were unlawful. The government further alleges that Rite Aid not only ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from certain pharmacists, its distributor, and its own internal data, but compounded its failure to act by intentionally deleting internal notes about suspicious prescribers written by Rite Aid pharmacists and directing district managers to tell pharmacists “to be mindful of everything that is put in writing.” By knowingly filling unlawful prescriptions for controlled substances, the government alleges that Rite Aid violated the CSA and, where Rite Aid sought reimbursem*nt from federal healthcare programs, also violated the FCA.
Along with Rite Aid Corporation, the government’s complaint names as defendants the following Rite Aid subsidiaries: Rite Aid Hdqtrs, Corp.; Rite Aid of Connecticut, Inc.; Rite Aid of Delaware, Inc.; Rite Aid of Maryland; Rite Aid of Michigan; Rite Aid of New Hampshire; Rite Aid of New Jersey; Rite Aid of Ohio; Rite Aid of Pennsylvania; and Rite Aid of Virginia.
“The action supported today by the Drug Enforcement Administration (DEA) should serve as a warning to those in the pharmacy industry who choose to put profit over customer safety,” said Special Agent in Charge Orville O. Greene of the DEA.
“Pharmacies are required to ensure prescription drugs are only dispensed based on valid prescriptions,” said Special Agent in Charge Maureen Dixon of the Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “Prescriptions which are not medically necessary, and not for a medically accepted indication, will not be paid for by Medicare and Medicaid. HHS-OIG will continue to work with our law enforcement partners and the Department of Justice’s Civil Division to recover improperly paid funds through the FCA.”
Whistleblowers Andrew White, Mark Rosenberg, and Ann Wegelin, who all previously worked for Rite Aid at various pharmacies, filed an action in October 2019 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 the lawsuit, as it has done here in part. Those who violate the Act are subject to treble damages and applicable penalties. The case is captioned United States ex rel. White et al. v. Rite Aid Corp., et al., No. 1:21-cv-1239 (N.D. Ohio).
The United States’ intervention in this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).
This matter is being handled by the Civil Division’s Commercial Litigation Branch (Fraud Section) and the U.S. Attorney’s Office for the Northern District of Ohio. The DEA Cleveland Field Division, FBI Cleveland Field Office, and HHS-OIG provided substantial assistance in the investigation.
The United States is represented in this matter by Senior Trial Counsel Christopher Wilson of the Civil Division’s Fraud Section and Assistant U.S. Attorneys Patricia Fitzgerald and Elizabeth Berry for the Northern District of Ohio.
The Justice Department is committed to holding responsible those who have fueled the opioid crisis by violating the law. Last week, 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), the Drug Enforcement Administration, and other Department components. The Task Force will steer 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.
As an expert with in-depth knowledge of legal matters and a focus on healthcare compliance, I can attest to the significance of the recent announcement by the Justice Department regarding the intervention in a whistleblower lawsuit against Rite Aid Corporation. The case involves allegations of violations under the False Claims Act (FCA) and the Controlled Substances Act (CSA), highlighting the government's commitment to addressing the opioid epidemic.
The Justice Department's intervention is a strategic move to combat health care fraud, emphasizing the use of the FCA as a powerful tool. The FCA allows private parties to sue on behalf of the United States for false claims, with the government intervening in this case. The whistleblowers, Andrew White, Mark Rosenberg, and Ann Wegelin, who formerly worked for Rite Aid, filed the lawsuit under the qui tam provisions of the FCA. This legal mechanism enables private individuals to expose fraudulent activities and share in any financial recovery.
The core allegations against Rite Aid are that the company knowingly filled hundreds of thousands of unlawful prescriptions for controlled substances between May 2014 and June 2019. These prescriptions were said to lack a legitimate medical purpose, were not for a medically accepted indication, or were not issued in the usual course of professional practice. The substances included the dangerous combination known as "the trinity" and excessive quantities of opioids like oxycodone and fentanyl.
The government's complaint asserts that Rite Aid's pharmacists ignored clear "red flags" indicating that the prescriptions were unlawful. Furthermore, Rite Aid allegedly deleted internal notes about suspicious prescribers intentionally, exacerbating the flow of millions of illegal opioid pills from its stores. The intentional actions of the corporation are claimed to violate both the CSA and, where reimbursem*nt was sought from federal healthcare programs, the FCA.
The subsidiaries of Rite Aid, including Rite Aid Hdqtrs, Corp.; Rite Aid of Connecticut, Inc.; Rite Aid of Delaware, Inc.; and others, are also named as defendants in the complaint.
The involvement of the Drug Enforcement Administration (DEA) and the Department of Health and Human Services, Office of the Inspector General (HHS-OIG), underscores the severity of the allegations. Special Agent in Charge Orville O. Greene of the DEA and Special Agent in Charge Maureen Dixon of HHS-OIG both emphasized the importance of prioritizing customer safety over profit in the pharmacy industry.
The Justice Department's creation of the Opioid Epidemic Civil Litigation Task Force further demonstrates a comprehensive approach to holding entities accountable for contributing to the opioid crisis. This task force involves various components, including U.S. Attorneys’ Offices, the Civil Division’s Consumer Protection Branch and Commercial Litigation Branch (Fraud Section), the Drug Enforcement Administration, and others.
In conclusion, the Justice Department's intervention in this case reflects a commitment to addressing the opioid epidemic through legal channels, emphasizing accountability for entities, like Rite Aid, accused of contributing to the crisis. The claims made against the defendants are allegations, and no determination of liability has been reached at this point.
