‘Pharmacies are supposed to be the last line of defense’: Albertsons on trial for allegedly fueling Washington’s opioid crisis

One of Washington’s largest pharmacy networks, Albertsons, is on trial, accused of lax controls that Washington State Attorney General (AG) Nick Brown believes led to millions of opioid pills being funneled into the black market.

The trial will determine whether a private company is responsible for helping fuel the opioid addiction epidemic, and whether it should pay to abate a crisis that the AG’s Office said has claimed 7,400 lives in the form of overdoses in the last three years alone.

Judge Janet Helson in King County Superior Court heard opening arguments from the state that painted a bleak picture of a strained system of overwhelmed pharmacy and safety professionals with due diligence that came too little, too late.

Attorneys for Albertsons argued that doctors bear the true responsibility for over-prescribing and that the state places conflicting burdens on the pharmacists: a legal “duty to dispense” with a high bar for denial, and increasing requirements to investigate potential diversion and fraud with murky standards.

Breaking down the state’s case

One of the assistant attorneys general framed the case around a single number he asked the judge to remember: over 16 years, from 2006 to 2022, Albertsons dispensed 641 million opioid pills into Washington. Those pills, the attorney said, represented over 9.6 billion morphine milligram equivalents, including more than 283 million hydrocodone and 252 million oxycodone tablets.

“Pharmacies are supposed to be the last line of defense against potent addictive medication being misused or diverted into the illegal drug market,” counsel for the state attorney general’s office told the judge.

The state alleges more than 6.5 million of those prescriptions were “red-flagged,” meaning they bore warning signs that the drugs could be misused or diverted, and that 96% had “no or insufficient due diligence” performed before they were dispensed.

The state used real patient examples to illustrate how that staggering number added up. One attorney showed the judge a table in which a single customer walked into an Albertsons pharmacy in SeaTac on April 7, 2009, and walked out with 1,440 opioid pills.

“One patient, one visit, same store, one pharmacy owned by Albertsons,” he said.

The customer returned month after month, in May, June, July, August, October, November, December, and January of the following year, receiving similar volumes each time.

“That’s 48 opioid pills a day, every day for 10 months,” he noted.

He then showed a second example from a store on Washington Avenue in Kent, where a single customer received 5,014 oxycodone pills in a single month. In May 2010 alone, that customer visited the same store 10 times to pick up OxyContin, with some fills amounting to 147 pills per day, and others reaching as high as 158 pills per day.

A compliance team ‘overwhelmed’ by theft and loss

An attorney for the plaintiff walked the judge through the history of Albertsons’ Pharmacy Controlled Substance Analytics Team (PCAT), which was created in response to a prior Drug Enforcement Administration (DEA) investigation. The team, consisting of a manager and six analysts, was originally designed to handle a wide portfolio: controlled substance dispensing, corresponding responsibility compliance, and identifying outlier prescribers.

But the state argued that the team was quickly consumed by a single function, processing theft-and-loss reports, to the exclusion of nearly everything else. By 2018, the attorney said, PCAT was receiving 3,000 to 4,000 loss reports per month from stores around the country, rendering the team unable to perform its other duties.

The attorney quoted a 2016 email from Tony Provenzano, Albertsons’ vice president of compliance, writing: “I continue to have very strong concerns over the ability of PCAT to manage workload, putting our DEA settlement at risk.”

Despite years of complaints, the state argued, the team remained at six analysts from 2015 through 2020.

“What Albertsons did was treated compliance like a spotlight,” the attorney for the plaintiff said. “They shone the light only on theft and loss reporting, and left things like controlled substance dispensing, corresponding responsibility, outlier prescribers, left all those in the dark, and left the pharmacist in the store defenseless to deal with the opiate epidemic that was raging across the state.”

Reactive, not proactive

The state argued that Albertsons’ compliance efforts were reactive — spurred not by concern for patients, but by fear of DEA enforcement. The attorney for the plaintiff showed the judge a 2018 email in which Provenzano saw a news headline warning that the DEA was “coming for pharmacies who are dispensing an unusual or disproportionate amount of drugs.”

In response, Provenzano directed his compliance director to identify the stores the DEA was most likely to target and review them “ASAP.”

“They knew they had problems; they just weren’t doing anything about it till they thought the DEA was coming,” the attorney said.

It was only after this scare, the state argued, that Albertsons began taking steps to address its pharmacists’ readiness: for the first time discussing a comprehensive controlled substance training course, for the first time talking about mandatory continuing education on appropriate dispensing and opioid abuse, and for the first time discussing training pharmacists on how to use the state’s Prescription Drug Monitoring Program (PDMP).

Pharmacies as profit centers

The state sought to undermine any suggestion by Albertsons that its pharmacies were merely a convenience for grocery shoppers or a loss leader. An attorney for the plaintiff cited internal Albertsons analysis showing that a pharmacy customer was more than three times more valuable to the company’s bottom line than a non-pharmacy customer. Pharmacy sales in 2014 for the Seattle division alone exceeded $450 million.

The state portrayed the company as relentlessly demanding more of its pharmacists — pushing flu shots, shingles vaccinations, counseling sessions, text-alert signups, autofill programs, mobile app registrations, and promotional coupons — all in addition to the core task of evaluating and dispensing prescriptions.

The attorney read from an email by a pharmacist in Spokane describing her work environment as “stressful, chaotic, unsafe, and hostile.”

She wrote: “I don’t get lunch breaks. My staff doesn’t get breaks either.”

Corporate employees were simultaneously calling her, one about patient counseling sessions, another about flu shots, another wanting whooping cough displays.

“It cannot all be done,” she wrote. “We are drowning.”

The state showed additional pharmacist complaints from across the years: “My job is chronically stressful,” one wrote.

“Twelve-hour shifts without breaks,” another stated.

“Don’t even get to use the bathroom,” another read.

And, from 2022: “I almost passed out, vomiting due to exhaustion, dehydration, and hunger.”

The attorney for the plaintiff also took aim at Albertsons’ relationship with GoodRx and other discount card companies. One Albertsons pharmacist had written to management that the GoodRx relationship “made Albertsons the low-cost provider of opioids,” and that “people were coming into our stores expecting less scrutiny and expecting to pay less money.”

Another pharmacist wrote: “Discount cards are aiding the spread of opioids. Instead of helping our communities, we are harming them indirectly.”

The pharmacist added: “Safeway will be on the wrong side of history as it relates to the opioid epidemic.”

According to the state, when these complaints reached senior leadership, the company’s current president of pharmacy declined to change course: the answer was no policy change, and to keep accepting discount cards.

The state also cited a 2019 email in which Provenzano, reading an article about Narcan, the opioid reversal drug, not being prescribed often enough alongside opioids, circulated the article to other executives with the comment: “This is a sales opportunity.”

“Not ‘we can get more Narcan into the hands of high-risk patients,'” the attorney said. “Not ‘we can save some lives.’ But Narcan, from Albertsons’ perspective, from the VP of Compliance, was a sales opportunity.”

The abatement plan

Counsel for the state told the judge that the state would present testimony from Dr. Ted Miller, described as an urban planner, operations research analyst, and health economist with more than 55 years of experience. Dr. Miller will present an abatement plan covering four areas: treatment, harm reduction, primary prevention, and system coordination. The state noted that Albertsons would not be presenting an alternative abatement plan, and would instead simply attempt to attack Dr. Miller’s proposal.

“At the conclusion of this trial, the evidence will overwhelmingly show that Albertsons substantially contributed to the creation of this condition, this opioid crisis, and allowed it to metastasize,” the attorney said.

Albertsons’ defense: “A mirror, not a driver”

Lawyers for Albertsons opened with a tone of measured acknowledgment before pivoting to a vigorous defense.

“We know and understand the great damage that Washington has experienced from opioid abuse,” counsel for the respondent told the judge. “Our grocery stores are in these communities. Our pharmacists live here, raise their families here, and serve their neighbors across the counter.”

But the defense’s core argument was straightforward: Albertsons is a pharmacy that fills lawful prescriptions written by licensed doctors, and the dramatic rise in opioid dispensing was driven not by Albertsons but by a wholesale transformation in the national standard of care for treating pain, a transformation championed by the state of Washington itself.

The evolving standard of care

Lawyers for Albertsons devoted substantial time to what they described as the most critical backdrop to the case: the decades-long evolution in the medical community’s approach to pain treatment.

“The state refers to us as the last line of defense, and other times you will hear them refer to us as gatekeepers, and that is partially correct,” the attorney for the respondent told the judge. “But the part that the state always leaves out is doctors hold the only key. Without a doctor’s prescription, the gate does not open.”

Counsel for Albertsons walked the judge through a detailed timeline:

In 1993, Washington passed the Intractable Pain Act, telling doctors that prescribing narcotics for chronic pain was appropriate, making it one of the first states to do so.

In 1996, the Washington Department of Health and Medical Commission jointly issued guidelines concerned that patients had “inadequate access to opioids” and that under-treatment of chronic pain “may be affecting the public health, safety, and welfare.” The same year, the FDA approved OxyContin.

In 1998, the Federation of State Medical Boards issued revised model guidelines saying “opioids may be essential in the treatment of acute and chronic pain,” and the DEA endorsed them.

In 1999, the Washington Medical Commission issued a rule specifically telling doctors they need not fear disciplinary action for prescribing opioids to treat acute, chronic, and intractable pain.

In 2001, the DEA and 21 health organizations, including the American Medical Association and the American Cancer Society, issued a joint statement calling under-treatment of pain “a serious problem” and urging doctors to treat it aggressively with opioids. That same year, the Joint Commission began requiring hospitals to assess pain in all patients, treating it as “the fifth vital sign.”

In 2005, the Washington Attorney General, the same office now bringing this lawsuit, joined 20 other state attorneys general in writing a letter criticizing the DEA for hindering access to opioids.

In 2006, the DEA responded with a policy statement telling doctors they need not worry about investigation or discipline for prescribing opioids, declaring: “Nearly every prescription issued by a physician in the United States is for a legitimate medical purpose.”

“So when doctors wrote more prescriptions, pharmacies like ours received more prescriptions to be filled,” the lawyer for Albertsons said. “But that’s not evidence that we dispensed medication that we should not have.”

The defense then traced the pendulum swinging the other direction: voluntary state guidelines in 2007, more restrictive guidance in 2010, repeal of the permissive 1999 rule, the Federation of State Medical Boards’ dramatically revised model policy in 2013, and the CDC’s seminal 2016 chronic pain guidelines. Through each step, the defense argued, Albertsons’ dispensing tracked the evolving standard of care.

Notably, the lawyers for Albertsons pointed out that even as the standard was tightening, Washington continued to defer to doctors’ discretion. As late as 2019, the state Department of Health clarified that its prescribing rules “do not limit the daily dose of opioids a doctor can prescribe,” and expressed concern that patients on chronic opioid therapy were “unable to find providers willing to care for them.”

“It does not matter, in hindsight, whether we in this courtroom agree with the change in the standard of care or whether we now think doctors prescribed too much,” counsel for the respondent said. “For purposes of this lawsuit, what matters is the historical fact that the standard of care evolved, causing a dramatic rise in the number of opioid prescriptions that doctors wrote, which of course meant that dispensing of those prescriptions rose as well.”

Red flags: ‘Made for litigation’

Lawyers for Albertsons mounted a frontal assault on the state’s red flag analysis, which is the basis for the claim that more than 60% of Albertsons’ opioid prescriptions bore warning signs of potential misuse. The defense argued that the state’s expert, a former executive director of the National Association of Boards of Pharmacy, developed a list of red flags “specifically for opioid litigation”— a list “that has never been endorsed by any government or regulatory body anywhere, let alone in Washington” and has “never been used outside the courtroom.”

The defense contrasted the expert’s litigation red flags with the guidance his own organization issued while he was its executive director. In the real world, the lawyer said, the organization’s red flag guidance was “far more nuanced and context dependent,” advising pharmacists to look at factors like high doses and unusual prescriber distances in the context of each patient’s circumstances, not against rigid predetermined thresholds.

The defense offered specific examples of how the state’s approach could sweep in legitimate prescriptions: A cancer patient treated by an oncologist an hour away in Seattle would trigger the 25-mile distance red flag. A chronic pain patient who refills a monthly prescription even one day early would trigger the state’s threshold for excessive days’ supply.

“You won’t find the state’s red flag list anywhere outside of this courtroom,” the lawyer for Albertsons said.

The defense also pointed to what the state’s own expert will not testify to: that red flags mean a prescription was illegitimate, that they resulted in diversion, or that there is any statistical link between red-flagged prescriptions and actual harm. The state, the defense said, has stipulated to these limitations.

The compliance program

Counsel for Albertsons pushed back strongly against the state’s characterization of its compliance program, presenting it instead as a system that evolved appropriately with changing standards and improving technology.

The defense traced Albertsons’ compliance efforts year by year: a 2005 Safeway dispensing policy requiring extra scrutiny for controlled substances; a 2010 update specifically addressing red-flag-type concerns (though the term was not yet in widespread use); a 2013 training developed by the company’s compliance director emphasizing red flags; a 2014 training video prepared by the National Association of Boards of Pharmacy; quarterly field evaluations beginning in 2015; a revised controlled substance dispensing policy in 2016 tracking national guidance from the NABP; a 2018 requirement that pharmacists check the state’s Prescription Drug Monitoring Program when they had concerns about a prescription, which the defense noted was three years before the state itself mandated PDMP checks in 2021; and mock DEA audits beginning in 2019.

The defense specifically addressed the 2017 DEA settlement, which the state had repeatedly referenced.

The settlement “had nothing to do with our dispensing,” the lawyer said. “It was about whether Safeway was reporting thefts to the DEA on time.”

But the defense argued that what came out of the settlement was significant: Albertsons agreed to provide the DEA annual summaries of its entire compliance program, covering store reviews, field evaluations, internal audits, and training.

“They didn’t respond with any concerns,” the lawyer said, “because, as the evidence will show, our program worked.”

“Is our system better today than it was in 2020? Yes. Better in 2020 than 2012? Yes,” counsel for Albertsons acknowledged. “But that does not mean Albertsons’ prior policies were unreasonable or unfair under the law.”

The AG’s office said it has already recovered more than $1.3 billion for state and local governments from drug manufacturers and distributors in prior opioid cases. The outcome of this trial could add significantly to that total, or, if the defense prevails, draw a line around the liability of pharmacies in America’s opioid crisis.

The trial continues Tuesday morning and is scheduled to continue until sometime in September.

Read more of Jillian Raftery’s stories here.