Deeply Disturbing Claims Against CVS in U.S. Justice Dept. Lawsuit

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Deeply Disturbing Claims Against CVS in U.S. Justice Dept. Lawsuit

IMAGES: CVS and DOJ

 

The United States Justice Department’s lawsuit against Rhode Island-based pharmacy giant CVS is fundamentally different than the plethora of lawsuits that the company previously faced for its role in the opioid crisis — a crisis that has devastated families.

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If the claims by the Justice Department are proven true; they unveil a perverse, profit-driven strategy implemented by the corporation that not only violated the health standards but constructed a system that required pharmacists to ignore “red flags” and to fill as many opioid prescriptions as possible.

READ MORE ABOUT THE LAWSUIT HERE

The number of deaths tied to the epidemic is staggering. According to the CDC, from 1999–2019, nearly 500,000 people died from an overdose involving prescription and illicit opioids. The first wave of overdose deaths began with increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids increasing since at least 1999.

The causes of the opioid crisis are varied, but what continues to be unveiled is that corporate actors repeatedly traded for profits.

Intertwined into this prosecution of CVS by the Justice Department is Rhode Island politics. Former CVS president Helena Foulkes, who ran for governor of Rhode Island in 2022 and lost by fewer than 5,000 votes to Dan McKee in the Democratic primary, has been gearing up for another run in 2026.

She has raised hundreds of thousands of dollars and attended hundreds of community events.

Foulkes’s bio reads, “I spent 25 years at CVS Health, most recently as President of CVS Pharmacy and EVP of CVS Health. I led the strategic vision as well as the operations for all aspects of the company’s retail business and was an architect of the company’s move to becoming a recognized leader in healthcare. Over the course of my time with the company, we were able to grow CVS to become the largest pharmacy health care provider in the United States, from 1,400 stores and roughly $4B in sales to 10,000 pharmacies with $180B in sales and over 200,000 employees.”

Helena Foulkes, former CVS President PHOTO: Campaign
She served in top management positions during the opioid epidemic and she served as president of CVS from 2014 to 2018. The Justice Department lawsuit overlaps with her leadership as the Justice Department's case cites violations beginning in 2014. When asked why the government only went back to 2014, Zachary Cunha, the U.S. Attorney for the District of Rhode Island, said that the two statutes only allow for ten-year look-backs.

This lawsuit was not the only bad news for CVS. On Tuesday, CVS was linked to secret payments from opioid manufacturer Purdue Pharma.

CVS is one of the companies implicated in taking “secret” payments from Purdue Pharma in exchange for removing safety restrictions, according to a major investigation released by the New York Times.

“For years, the benefit managers, or P.B.M.s, took payments from opioid manufacturers, including Purdue Pharma, in return for not restricting the flow of pills. As tens of thousands of Americans overdosed and died from prescription painkillers, the middlemen collected billions of dollars in payments,” wrote the Times.

As part of the government’s lawsuit, top law enforcement officials voiced disgust with the CVS corporate strategy.

“Simply put, they put profits over their obligation to keep their customers safe,” said Drug Enforcement Agency Administrator Anne Milgram on Wednesday. “A pharmacy is the final step in the pharmaceutical distribution process that is in place to keep customers safe. 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.”

 

One of the Examples Outlined in the Justice Department Lawsuit Against CVS:

Prescriber Raymond Kraynak: “A pill pusher, and a drunk”; “[Kraynak] was a doctor of osteopathic medicine, who operated a family medicine practice in Mount Carmel and Shamokin, Pennsylvania. In 2014, 2015, and 2016, he was the top prescriber of opioids in Pennsylvania. From January 2014 to July 31, 2017, Kraynak prescribed approximately 9.5 million units of oxycodone, hydrocodone, oxycontin, and fentanyl to his patients.

It was common knowledge in Mount Carmel and Shamokin that patients could easily get narcotics from Kraynak. As one former patient explained, Kraynak was the “go to” for pain pills. Some patients referred to him as “the Maniac” or the “candy man” because of the large number of controlled substance prescriptions he wrote. A police detective from Coal Township, which surrounds Shamokin, reported in mid­ 2015 that Kraynak had prescribed most of the narcotic pills that ended up being sold and used on the streets of the township.

CVS was alerted to Kraynak’s inappropriate prescribing at least as early as 2014 but continued to fill his prescriptions for years before finally blocking him in 2017, well after CVS learned that DEA had raided Kraynak’s office.

By July 2014, CVS also knew about a public internet review of Kraynak’s practice that stated: “This doctor writes scripts without seeing patients. He will refill without questioning why a patient needs an addictive drug due to supposed lose [sic].”

CVS was repeatedly made aware that Kraynak was engaged in unlawful prescribing. Before July 2017, pharmacists and other business units escalated Kraynak to CVS GCR for review 17 times, more times than any other prescriber in the entire country. [GCR is de facto how CVS required pharmacists to justify denying a prescription]

 

Kraynak escalations to GCR included the following:

On or about April 28, 2014, two CVS stores separately reported a concern that Kraynak was writing a high volume of prescriptions.

On or about July 27, 2015, a CVS business unit noted that Kraynak’s prescribing was “questionable” due to his writing of “large amounts of controls.” On or about November 2, 2015, that same business unit noted Kraynak was “questionable” because he “writes for high qtys [quantities] of high strengths of oxycodone.”

On or about May 31, 2016, a CVS pharmacist reported that Kraynak “is a prescriber of concern” who “often writes prescriptions for frequencies above what is recommended and only has office hours daily from 6am­9am.”

On or about August 29, 2016, a CVS pharmacist reported that Kraynak was “under investigation by DEA” and that another chain pharmacy “made a corporate wide decision not to fill his scripts anymore.”

In October 2016, a CVS manager reported to GCR that “at least 5” of his pharmacists had separately reached out to the manager with concerns about Kraynak, as well as reporting that another chain pharmacy had “suspended filling as a company for this prescriber.” One pharmacist “had already expressed concern with this prescriber prior to the decision [by another chain pharmacy to cease filling Kraynak’s prescriptions] but now the influx of patients and prescriptions is unbelievable. They have refused to fill a ton of prescriptions and what they are filling still seems excessive.”

On or about October 7, 2016, a CVS pharmacist reported that Kraynak’s patients were pharmacy shopping; that one patient lied about their insurance coverage; and that two other pharmacy chains had stopped filling Kraynak’s Schedule II prescriptions.

On or about October 18, 2016, a CVS business unit reported “regulatory concerns” with Kraynak; that two national pharmacy chains, and a third local pharmacy were refusing to fill for him; that Kraynak was steering his patients to CVS because it would fill his prescriptions; that patients were showing up with multiple hard copies for multiple strengths of the same Schedule II controlled substances; and that the “DEA office has been to this store location.”

On or about October 27, 2016, a CVS pharmacist reported that Kraynak “gives patients multiple hard copies and guides them to pharmacy shop”; “writes for multiple short active and long active pain reliever” at the same time; and provides “incorrect diagnostic codes.” This pharmacist also reported that two national pharmacy chains and another local pharmacy had stopped filling for Kraynak, and that pharmacists were “receiving threats via social media” for refusing to fill for Kraynak.

On or about January 24, 2017, a CVS pharmacist reported having “concerns with the excessive amount of Narcotics, controlled substances and cocktail shares prescriptions from [Kraynak]. The prescriber writes for the same drugs, same dosage and qty and keeps patients on these drugs on a long term.”

On or about April 28, 2017, a CVS business unit reported that Kraynak “[w]rites for large quantities, too many too much,” and “higher strengths than standard practice in the area.”The reporting pharmacist did “not feel these are totally valid.”

On or about June 2, 2017, a business unit reported that Kraynak prescribed a “[l]arge amounts of pain meds” and that he had faced Pennsylvania medical board action in 2012 for  prescribing  “large  quantities  of  controls  for  multiple  patients  without  proper indications/documentation/drug screening.”

 

CVS pharmacists also wrote notes in patient profiles indicating that Kraynak was engaged in unlawful prescribing. These notes were available to GCR for review. Despite these notes, pharmacists continued to fill Kraynak’s prescriptions, even in some instances for the very same patients in whose profiles the warning notes appeared. The following chart shows examples:

 

SOURCE: Department of Justice Lawsuit

 

CVS interviewed Kraynak three times regarding his prescribing habits. During all three interviews, GCR staff expressly noted the enormous volume of opioid prescriptions Kraynak was writing. Before its first interview with Kraynak in 2014, GCR noted that Kraynak was in the 100th percentile chainwide for volume for both oxycodone and hydrocodone. During a second interview, in December 2016, interviewers addressed, but did not resolve, Kraynak’s high volume score. Finally, a May 2017 CVS analysis identified Kraynak as in the 100th and 99th percentiles for volume of oxycodone and hydrocodone prescribing, respectively.  

Moreover, before the third interview, GCR was alerted to an online review of Kraynak’s practice that stated: “He is a pill pusher, and a drunk. I was able to obtain Adderall and Xanax by answering five questions. I can bet shortly he will be locked up. . . .” 

Despite CVS’s documented awareness of Kraynak’s unlawful prescribing, it did not block his controlled substance prescriptions until June 2017, shortly before he was indicted. 

In December 2017, Kraynak was indicted for, among other things, unlawful distribution and dispensing of controlled substances, including violations resulting in the death of five patients. On September 23, 2021, Kraynak pled guilty and admitted that Schedule II opioid drugs that he prescribed resulted in the deaths of five patients. He was sentenced to fifteen years’ incarceration.  

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