The U.S. Department of Justice has filed a lawsuit against CVS Pharmacy Inc., claiming that the company improperly filled illegal prescriptions and sought reimbursement from federal health programs for these wrongful medications.

As the largest pharmacy chain in the nation, CVS operates around 9,000 pharmacies and is accused of knowingly filling prescriptions for controlled substances that lacked a legitimate medical basis, were invalid, or were issued outside of standard professional practice, according to a statement from the Justice Department.

The complaint, which was revealed in a Rhode Island court, alleges that CVS filled numerous illegal prescriptions, including those for “dangerous and excessive amounts of opioids, premature refills of opioids, and ‘trinity’ prescriptions.” Trinity prescriptions consist of an opioid, a benzodiazepine (a type of sedative), and a muscle relaxant, and are known to be particularly harmful and frequently misused.

In response to the lawsuit, a CVS spokesperson said in an email to YSL News, “We have been cooperating with the DOJ’s investigation for over four years and we firmly disagree with the allegations and flawed narrative presented in this complaint.”

“We will robustly defend ourselves against this misdirected federal lawsuit, which emerges after years of litigation on similar issues by state and local authorities—claims that have largely been settled through a comprehensive agreement with the participating state Attorneys General,” the spokesperson added.

CVS allegedly overlooked pill mills and evidence from its own staff

The U.S. Attorney’s Office alleges that CVS filled substantial amounts of prescriptions for controlled substances written by doctors who were known to engage in “pill mill practices.”

Pill mills refer to illegal pharmacies that prescribe high volumes of controlled substances to individuals without any legitimate medical reasons, according to the National Library of Medicine.

The lawsuit asserts that CVS had substantial evidence from various sources, including its own pharmacists and internal data, yet overlooked the fact that its outlets were dispensing illegal prescriptions.

“When lives are ruined or lost due to opioid abuse, it doesn’t matter whether the supplier is a street dealer, a pill mill, or a large corporation,” U.S. Attorney Jessica D. Aber for the Eastern District of Virginia stated in the news release. “Our regulations regarding the distribution of opioids and other controlled substances are explicit and apply universally. We will take whatever legal measures are necessary to halt any entity that prioritizes profit over the safety of our communities.”

DOJ: ‘CVS’ actions helped to fuel the opioid crisis’

By allegedly ignoring clear evidence and breaching both the Controlled Substances Act (CSA) and the False Claims Act (FCA), CVS reportedly achieved corporate performance goals, received incentive pay, and followed staffing guidelines that “placed corporate profits over patient safety,” the Justice Department claimed.

The U.S. Attorney’s Office also noted that CVS’s staffing levels were inadequate for pharmacists to meet their performance targets while fulfilling their legal obligations and that they “deprived their pharmacists of essential information,” which included not informing them about certain prescribers.

“The complaint claims that CVS’s conduct contributed to the opioid crisis and that, in some heart-wrenching cases, patients died from overdosing on opioids shortly after filling those illegal prescriptions at CVS,” according to the Justice Department’s statement.

Whistleblower brought allegations against CVS to light

The Justice Department regards Hillary Estright, a former CVS employee, as a whistleblower after she brought allegations of wrongdoings to light by filing a complaint on October 17, 2019. She utilized the qui tam provisions of the FCA, which empower private individuals to sue on behalf of the U.S. for false claims and partake in any financial recovery, the Justice Department stated.

The U.S. government has decided to step in and take control of lawsuits filed under the qui tam provisions, which they have done in this instance.

CVS States Prescriptions Called ‘Unlawful’ Were for FDA-Approved Opioids

CVS has asserted that the lawsuit from the government is attempting to enforce “an inconsistent standard for pharmacy practices.”

The company’s statement claims that “many of the legal arguments in the complaint have no basis in existing statutes or regulations, and address issues the government has refused to clarify.”

Furthermore, CVS pointed out that the prescriptions deemed “unlawful” by the Justice Department were for an opioid medication that is approved by the FDA and prescribed by a licensed practitioner “whom the government itself has authorized to prescribe controlled substances.”

According to CVS, they established a pioneering program 12 years ago designed to prevent doctors who may pose a risk from prescribing controlled substances. Since then, they have blocked over 1,250 practitioners, including 600 whose licenses are still upheld by the government.

CVS added, “This initiative is not mandated by any laws or regulations, and we have repeatedly defended against lawsuits from individuals who claim we excessively restrict opioid prescribers.” They shared that the government’s lawsuit adds complexity to the challenges pharmacists face as they are criticized for both dispensing excessive and insufficient amounts of opioids.