DOJ Lawsuit Alleges CVS Helped Fuel Opioid Epidemic Through Unlawful Opioid Prescriptions

In a lawsuit unsealed on December 18, the US Department of Justice (DOJ) alleged that over the last decade, CVS knowingly filled and dispensed unlawful prescriptions in violation of the Controlled Substances Act.¹

The lawsuit alleges that the company knowingly violated both the Controlled Substances Act and the False Claims Act. | image credit: Rosshahizal Amri - stock.adobe.com

“Opioid deaths remain a scourge on communities across Rhode Island and the nation, robbing families of loved ones and leaving pain and devastation in their wake,” said US Attorney Zachary A. Cunha for the District of Rhode Island. “This lawsuit alleges that CVS failed to exercise its critical role as gatekeeper of dangerous prescription opioids and, instead, facilitated the illegal proliferation of these highly addictive drugs, including by pill mill prescribers.”

“When corporations such as CVS prize profits over patient safety and overburden their pharmacy staff so that they cannot carry out the basic responsibility of ensuring that prescriptions are legitimate, we will use every tool at our disposal to see that they answer for it,” Cunha continued.

In addition to “dangerous and excessive quantities” of opioids, early opioid fills, and trinity prescriptions for an opioid, a benzodiazepine, and a muscle relaxant, the lawsuit alleges that CVS also filled large quantities of controlled substance prescriptions “written by prescribers it knew to be engaged in ‘pill mill practices.’”

READ MORE: In the Opioid Epidemic, Treatment Challenges Still Persist

In a statement made to ABC News,² CVS spokesperson Amy Thibault described the suit as “misguided,” adding that CVS officials “strongly disagree with the allegations and false narrative” presented by the DOJ.

These practices contributed to the opioid crisis and fueled opioid-related deaths, said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division.¹ “Today’s complaint seeks to hold CVS accountable for its misconduct.”

In addition to Controlled Substance Act violations, the lawsuit alleges that CVS sought reimbursement from federal health care programs for these unlawful prescriptions,¹ violating the False Claims Act, which protects the federal government from both being overcharged or from being sold “shoddy goods or services.”³

Whistleblower and former CVS employee Hillary Estright filed an action in October 2019 under qui tam provisions of the False Claims Act,¹ one of the strongest whistleblower protection laws in the US.⁴

If found liable, CVS could face civil penalties ranging from $5500 to $23,607 for each false claim filed to a federal health care program, civil penalties, and treble damages.⁵

Companies that have played a role in the opioid epidemic are continuing to face legal action. In August 2024, McKesson, Cardinal Health, and Cencora (formerly AmerisourceBergen) agreed to pay $300 million in a class action settlement for the role the companies played in fueling the opioid epidemic.⁶ More recently, consulting firm McKinsey agreed to pay $650 million to resolve civil and criminal investigations into the firm’s consulting work with OxyContin manufacturer Purdue Pharma to “turbocharge” OxyContin sales.⁷

Although CDC data show that opioid-related overdose deaths decreased between 2022 and 2023⁸—the first time a decrease has been seen since 2018—overdose deaths remain high. Illicit synthetic opioids including fentanyl and fentanyl analogs, as well as stimulants such as methamphetamine and cocaine, are currently fueling the fourth wave of the opioid epidemic.⁹

READ MORE: Law and Advocacy Resource Center

References

1. Justice Department files nationwide lawsuit alleging CVS knowingly dispensed controlled substances in violation of the Controlled Substances Act and the False Claims Act. News release. US Department of Justice. December 18, 2024. Accessed December 19, 2024. https://www.justice.gov/opa/pr/justice-department-files-nationwide-lawsuit-alleging-cvs-knowingly-dispensed-controlled

2. Pezenik S. CVS knowingly dispensed “massive” amount of invalid opioid prescriptions: DOJ lawsuit. ABC News. December 18, 2024. Accessed December 19, 2024. https://abcnews.go.com/US/cvs-knowingly-dispensed-massive-amount-invalid-opioid-prescriptions/story?id=116927855

3. Fraud and abuse laws. US Department of Health and Human Services Office of Inspector General. Accessed December 19, 2024. https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/

4. False Claims Act (qui tam) whistleblower FAQ. National Whistleblower Center. June 10, 2020. Accessed December 19, 2024. https://www.whistleblowers.org/faq/false-claims-act-qui-tam/

5. United States ex rel. Estright v. Health Corporation, et al., No. 1:22-cv-222 (D.R.I). Accessed December 19, 2024. https://www.justice.gov/opa/pr/justice-department-files-nationwide-lawsuit-alleging-cvs-knowingly-dispensed-controlled

6. Nowosielski B. Major drug distributors to pay $300 million in opioid epidemic settlements. Drug Topics. September 5, 2024. Accessed December 19, 2024. https://www.drugtopics.com/view/major-drug-distributors-to-pay-300-million-in-opioid-epidemic-settlements

7. Justice Department announces resolution of criminal and civil investigations into McKinsey & Company’s work with Purdue Pharma L.P.; former McKinsey senior partner charged with obstruction of justice. News release. US Department of Justice. December 13, 2024. Accessed December 19, 2024. https://www.justice.gov/opa/pr/justice-department-announces-resolution-criminal-and-civil-investigations-mckinsey-companys

8. US overdose deaths decrease in 2023, first time since 2018. News release. CDC. May 15, 2024. Accessed December 19, 2024. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2024/20240515.htm

9. Ciccarone D. The rise of illicit fentanyls, stimulants, and the fourth wave of the opioid overdose crisis. Curr Opin Psychiatry. 2021;34(4):344-350. Doi:10.1097/YCO. 0000000000000717