December 18, 2024 – The U.S. Department of Justice has filed a civil lawsuit against CVS Pharmacy Inc. and its subsidiaries, accusing the company of knowingly dispensing controlled substances without legitimate medical purposes, in violation of the Controlled Substances Act (CSA) and the False Claims Act (FCA). CVS, the nation’s largest pharmacy chain, operates over 9,000 pharmacies across the United States.
The lawsuit, unsealed today in Providence, Rhode Island, alleges that from October 17, 2013, to the present, CVS filled prescriptions for controlled substances that were not valid or issued in the usual course of medical practice. Among the allegedly unlawful prescriptions were large quantities of opioids, early refills, and a dangerous combination of drugs known as “trinity” prescriptions—prescriptions for opioids, benzodiazepines, and muscle relaxants. CVS is also accused of filling prescriptions from “pill mill” prescribers who issued prescriptions without any legitimate medical need.
The complaint asserts that CVS ignored substantial warning signs, including evidence from its own pharmacists and internal data, that indicated its stores were dispensing unlawful prescriptions. It is also alleged that corporate policies prioritized profits over patient safety, setting staffing levels that were insufficient for pharmacists to properly review prescriptions and comply with legal obligations. The complaint further claims that CVS’ actions contributed to the opioid crisis and led to patient deaths from overdoses shortly after filling these prescriptions.
“We are seeking to hold CVS accountable for repeatedly filling prescriptions that were unlawful, endangering public health and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton. “The company’s actions have had a significant role in fueling the opioid crisis, and we will continue to take legal action against those who contribute to this epidemic.”
U.S. Attorney Zachary A. Cunha for the District of Rhode Island also commented, noting that the lawsuit targets CVS for failing in its critical role as a gatekeeper for prescription opioids and facilitating the illegal distribution of these highly addictive drugs. The lawsuit further emphasizes that when companies prioritize profits over patient care, the government will take every necessary action to hold them accountable.
The Justice Department alleges that CVS’ actions violated both the CSA and the FCA. If found liable, CVS could face substantial civil penalties for each unlawful prescription filled, as well as treble damages for each prescription reimbursed by federal healthcare programs. The government may also seek injunctive relief to prevent future violations and implement changes to CVS’ compliance programs.
“We will continue to hold accountable those who violate laws intended to protect public health, whether they are street-level drug dealers or large corporations like CVS,” said DEA Administrator Anne Milgram.
The whistleblower in the case, Hillary Estright, filed the original complaint under the qui tam provisions of the FCA in October 2019. These provisions allow private individuals to file lawsuits on behalf of the government and share in any recovery. The Justice Department’s intervention underscores its commitment to tackling healthcare fraud and protecting the public from unlawful distribution of controlled substances.
The case, United States ex rel. Estright v. Health Corporation et al., is being litigated in the District of Rhode Island. The investigation involved several law enforcement agencies, including the DEA, HHS-OIG, and DCIS.
As the case progresses, the claims made against CVS are still allegations, and no determination of liability has been made at this stage.