The U.S. Justice Department (DOJ) filed a civil complaint in federal court alleging CVS Pharmacy filled unlawful prescriptions in violation of the Controlled Substance Act (CSA) and False Claims Act (FCA).
The government's complaint targets the country's largest pharmaceutical company with over 9,000 stores nationwide, alleging it "knowingly filled 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."
The DOJ alleges the drugstore giant continued its unlawful practice from Oct. 17, 2013, to the present.
The Department of Justice alleged CVS filled excessive and dangerous quantities of opioids, early fills of opioids and "trinity prescriptions" illegally.
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"Trinity prescriptions" are a combination of prescription drugs that includes an opioid, a benzodiazepine and a muscle relaxant.
The complaint also claims CVS filled prescriptions written by prescribers it knew to engage in "pill mill practices," which was when prescribers issue large quantities of drugs without any medical purpose.
"According to the complaint, CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions," the DOJ said.
The Justice Department accuses CVS of violating the acts due to performance metrics, compensation incentives and staffing policies.
"CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations," the complaint said.
It additionally withheld crucial information from pharmacists that could have prevented the amount of unlawful prescriptions filled, the DOJ alleged.
The DOJ also alleged that CVS, through its malpractice, helped fuel the continuing opioid crisis in the U.S.
"This lawsuit alleges that CVS failed to exercise its critical role as gatekeeper of dangerous prescription opioids and, instead, facilitated the illegal distribution of these highly addictive drugs, including by pill mill prescribers," U.S. Attorney Zachary Cunha said.
"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 said.
The DOJ said CVS could face civil penalties for every single unlawful prescription filled in violation of the CSA, penalties for each prescription reimbursed by federal health care programs and injunctive relief to prevent CVS from committing further violations.
In a statement to Fox News Digital, a spokesperson for CVS Pharmacy said CVS officials "strongly disagree" with the allegations and "false narrative" presented by the DOJ.
"We have cooperated with the DOJ’s investigation for more than four years, and we strongly disagree with the allegations and false narrative within this complaint," the company said. "We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state attorneys general.
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"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," CVS added. "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."
The CVS Pharmacy spokesperson pointed to its history of being an industry leader in developing ways to fight the opioid crisis.
"As one example, 12 years ago, CVS Pharmacy pioneered a first-of-its-kind program to block controlled-substance prescriptions written by doctors of potential concern. To date, we have blocked more than 1,250 practitioners, including nearly 600 prescribers who the government continues to license," CVS said.
"This program is not required by any statute or regulation, and CVS Health repeatedly has defended lawsuits from those alleging we go too far in blocking opioid prescribers.
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"The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids and too few."
