The United States (US) Department of Justice (DOJ) has filed a “nationwide lawsuit” against pharmacy multiple CVS, alleging its “actions helped to fuel the opioid crisis”, it announced yesterday (December 18).
The civil complaint alleges that 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)”.
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Principal deputy assistant attorney general of the DOJ’s civil division Brian M. Boynton, said “the practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct”.
He added that CVS “pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity”.
Profits over safety
The lawsuit explains that “CVS’ violations resulted from corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety”.
It added low staffing levels for pharmacists made it difficult for them to meet performance metrics, and CVS also prevented “pharmacists from warning one another about certain prescribers” to stop filing unlawful prescriptions.
The lawsuit says in some “tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS”.
“Shifting standard for pharmacy”
A CVS spokesperson told C+D that “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”.
It added it “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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Those “largely resolved” claims saw CVS agree to pay nearly $5 billion as “to substantially resolve all opioid lawsuits and claims” but it “is not an admission of any liability or wrongdoing”.
The CVS spokesperson also told C+D that “the government’s lawsuit seeks to impose a shifting standard for pharmacy practice” because “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”.
“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,” it said.
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CVS added it has been “an industry leader in developing innovative programs to fight opioid misuse” including pioneering “a first-of-its-kind program to block controlled-substance prescriptions written by doctors of potential concern” alongside blocking “more than 1,250 practitioners, including nearly 600 prescribers who the government continues to license”.
It said the lawsuit “intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few” and referred to its “opioid response” notice for how it is fighting opioid misuse.
“Candy man” and “like McDonald’s”
District of Rhode Island US attorney Zachary A. Cunha said CVS failed in its “critical role as gatekeeper of dangerous prescription opioids” and “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,” he added.
The lawsuit alleges CVS Pharmacy Inc. and various subsidiaries – 59 others in total – since October 17, 2013, to the present, “knowingly filled prescriptions … that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice”.
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It added that a large number were filled “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”.
The DOJ allege that CVS also “filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices”, an approach where prescribers issue large numbers of prescriptions “without any medical purpose”.
According to the lawsuit, it reveals CVS “ignored substantial evidence” including from its own pharmacists and internal data that unlawful prescriptions were being dispensed.
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One employee had warned CVS in writing about safety issues with performance and staffing levels which meant they felt “rushed to fulfil an order like McDonald’s” amid an “assembly line style of medication preparation”.
The lawsuit also details how the Ohio Board of Pharmacy previously “fined CVS and placed eight stores on probation due to inadequate and unsafe staffing levels” as well as pharmacists walking out to protest “unsafe working conditions”.
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The full complaint details allegations against seven pill mill prescribers, two of which were both called the “candy man” by either patients or other healthcare staff, and an additional document that shares all the false claims for prescriptions written by the seven pill mill prescribers.
Another document shares nearly 400 pages of false reimbursement claims to federal healthcare programs Medicare Part D, Medicaid, and TRICARE.
Whistleblower
The lawsuit mentions that CVS is the largest pharmacy chain in the US with over 9,000 pharmacies and a reported $116 billion revenue for 2023.
It says between 2015 and 2020, CVS “sold over twelve billion doses of opioids in the United States, many of which were paid for by federal healthcare programs”.
A previous CVS employee turned-whistleblower Hillary Estright filed the action on October 17, 2019, under the FCA and the Drug Enforcement Administration (DEA), Department of Health and Human Services (HSS) and the Defense Criminal Investigative Service (DCIS) investigated, alongside support from multiple government agencies including the (Federal Bureau of Investigation) FBI.
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If CVS is found liable of filling unlawful prescriptions for controlled substances, and of seeking reimbursement from federal healthcare programs – which violate the Controlled Substances Act (CSA) and the False Claims Act (FCA) respectively – it could “face civil penalties for each unlawful prescription filled in violation of the CSA” and “treble damages and applicable penalties for each prescription reimbursed … in violation of the FCA”.
Eastern District of Virginia US attorney Jessica D. Aber said: “we will pursue whatever legal action is necessary to stop any enterprise, regardless of size, that places profit over the safety of our citizens”.
DEA administrator Anne Milgram added it 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”.
It comes as four US senators and representatives introduced the Patients Before Monopolies Act last week (December 11) to “prohibit a parent company of a PBM or an insurer from owning a pharmacy business” and “require that a parent company in violation of the PBM Act divest its pharmacy business within three years”.
The act explains that “the three largest PBMs – CVS Caremark, Express Scripts, and Optum Rx – manage 80% of prescription drug claims”.
The legislation will “address this unacceptable conflict of interest, allows corporate giants to put profits over the interests of patients, taxpayers, employers, and independent pharmacies”.
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Last week, C+D reported that US President-elect Donald Trump has called for an investigation into the link between vaccines and autism – a debunked claim – and has said his health secretary Robert F Kennedy Jr will be “working with” drug companies to find out “what’s happening”.
Earlier this month, a study found almost 30% of US retail pharmacies closed in the decade between 2010 and 2021.
And Boots’ parent company Walgreen Boots Alliance revealed that in the US, some 1,200 “future expected store closures” will happen amid a 10% year-on-year pharmacy sales growth from Boots UK.
