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HomeEXTRAHEALTHU.S. Govt Files Nationwide Lawsuit Against CVS Over Controlled Substances Violation, False...

U.S. Govt Files Nationwide Lawsuit Against CVS Over Controlled Substances Violation, False Claims

In a civil complaint unsealed Wednesday in Providence, Rhode Island, the Justice Department alleges that CVS Pharmacy Inc. and various subsidiaries (collectively, CVS) filled unlawful prescriptions in violation of the Controlled Substances Act (CSA) and sought reimbursement from federal healthcare programs for unlawful prescriptions in violation of the False Claims Act (FCA).

CVS is the country’s largest pharmacy chain, with more than 9,000 pharmacies across the United States.

The government’s complaint alleges that, from October 17, 2013, to the present, CVS 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.

Among the large number of unlawful prescriptions that CVS allegedly filled were prescriptions for dangerous and excessive quantities of opioids, early fills of opioids, and “trinity” prescriptions, an especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant.

CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” — that is, prescribers who issue large numbers of controlled substance prescriptions 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 complaint alleges that CVS’ violations resulted from corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety. CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations.

CVS also allegedly deprived its pharmacists of crucial information (including by, for example, preventing pharmacists from warning one another about certain prescribers) that could have reduced the number of unlawful prescriptions filled.

The complaint alleges that CVS’ actions helped to fuel the opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS.

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct.”

U.S. Attorney Zachary A. Cunha for the District of Rhode Island further disclosed that the lawsuit alleged 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,” said Cunha.

The government alleges that by knowingly filling unlawful prescriptions for controlled substances, CVS violated the CSA and, where CVS sought reimbursement from federal healthcare programs, also violated the FCA. The complaint alleges that CVS’s actions helped to fuel the opioid crisis.

If CVS is found liable, it could face civil penalties for each unlawful prescription filled in violation of the CSA, as well as treble damages and applicable penalties for each prescription reimbursed by federal healthcare programs in violation of the FCA.

The court also may award injunctive relief to prevent CVS from committing further CSA violations, including ordering appropriate changes to corporate compliance programs and policies.

“When lives are destroyed or lost to opioid abuse, it doesn’t matter if the supplier is a street-level dealer, a pill mill, or a nationwide corporation,” said U.S. Attorney Jessica D. Aber for the Eastern District of Virginia.

“CVS is alleged to have dispensed large amounts of highly addictive opioid medications to persons they knew had no medical need for them,” said Administrator Anne Milgram of the Drug Enforcement Administration (DEA). “Simply put, they put profits over their obligation to keep their customers safe.”

Whistleblower Hillary Estright, who previously worked for CVS, filed an action on October 17, 2019, under the qui tam provisions of the FCA.

Those provisions authorise 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 such lawsuits, as it has done here.

The case is captioned United States ex rel. Estright v. Health Corporation, et al., No. 1:22-cv-222 (D.R.I.).

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