DOJ files lawsuit against CVS alleging controlled substances violations

The Department of Justice (DOJ) has sued CVS Health, accusing the pharmaceutical giant of contributing to the opioid crisis by knowingly filling unlawful prescriptions to boost corporate performance metrics.

"The practices alleged contributed to the opioid crisis and opioid-related deaths, and today's complaint seeks to hold CVS accountable for its misconduct," Brian M. Boynton, head of the Justice Department's Civil Division said in a statement.

In the civil complaint unsealed Wednesday, the government alleges that the company knowingly filled prescriptions for controlled substances that lacked a legitimate medical purpose from Oct. 17, 2023, to the present day. 

Officials believe that low staffing levels amid a lack of information made pharmacists susceptible to faulty prescribers who issued fake prescriptions.

"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," said U.S. Attorney Zachary A. Cunha for the District of Rhode Island, where the complaint arose.

"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," he added.

The DOJ said CVS not only violated the Controlled Substances Act but also sought reimbursement from federal health care programs for unlawful prescriptions in violation of the False Claims Act.

However, CVS maintains that all prescriptions filled by the company were lawful.

"The government's lawsuit seeks to impose a shifting standard for pharmacy practice. Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance," a CVS spokesperson told The Hill.

"Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized, and empowered to write controlled-substance prescriptions," they added.

They also confirmed that CVS is developing innovative programs to fight opioid misuse.

However, the discrepancies have earned a scathing response from law enforcement agencies.

"Simply put, they put profits over their obligation to keep their customers safe. A pharmacy is the final step in the pharmaceutical distribution process that is in place to keep customers safe," Administrator Anne Milgram of the Drug Enforcement Administration (DEA) said. 

"In the fight against the opioid epidemic, DEA will continue to be relentless in holding those accountable who violate our drug laws and place our communities in danger whether they are a criminal cartel or large pharmacy chain," she continued.

This is not the company's first time receiving federal pushback over prescriptions.

Earlier this month, House members launched an investigation into CVS Caremark for potential antitrust violations.

In 2011, CVS paid a $17.5 million settlement for submitting inflated prescription claims to the government by billing the Medicaid programs in Alabama, California, Florida, Indiana, Massachusetts, Michigan, Minnesota, New Hampshire, Nevada and Rhode Island for more than what CVS was owed for prescription drugs dispensed to Medicaid beneficiaries.