TAKING ON BIG PHARMACY

Federal opioid trial focuses on big pharmacy chains’ alleged role in epidemic

“We are working together in ongoing efforts to battle the opioid epidemic and protect our friends, neighbors, and loved ones.” — Lake County Commissioner John R. Hamercheck

Attorneys representing Lake County in its federal opioid epidemic case allege that large pharmacy chains “not only failed to be the last line of defense against a flood of opioids but also accelerated the supply of opioids into the communities.”

Lake and Trumbull counties are scheduled for trial May 24, 2021, in the Northern District of Ohio federal court in Cleveland for cases involving pharmacy chains CVS, Walgreens, Walmart, Rite Aid and Giant Eagle.

U.S. District Court Judge Dan

Polster ruled in April that the two counties should be the plaintiffs in a test case to be tried in his courtroom. At issue will be both pharmacy chains’ roles in distributing powerful prescription painkillers to their own stores and dispensing them to patients.

Polster is overseeing more than 2,000 opioid cases filed by government entities across the country. Lake County first filed its suit in December 2017.

“The people in this county are resilient and united in our cause,” Lake County Commissioner John R. Hamercheck said in a statement. “We are working together in ongoing efforts to battle the opioid epidemic and protect our friends, neighbors, and loved ones.

“We look forward to our day in court to seek accountability and pursue the resources needed to ensure our law enforcement, medical services, and treatment facilities have what they need to help us recover and rebuild.”

Ohio is among the hardest hit states by the opioid epidemic. Lake County has seen hundreds of opioid-related overdose deaths over the past decade. While those deaths are largely attributed to drugs like heroin and illicit fentanyl, Lake County’s attorneys argued that overdoses from non-prescription opioids are “directly related to prescription pills.”

“According to the American Society of Addiction Medicine, 80 percent of people who initiated heroin use in the past decade started with prescription painkillers — which, at the molecular level and in their effect, closely resemble heroin,” the attorneys wrote in a court filing. “In fact, people who are addicted to prescription painkillers are 40 times more likely to become addicted to heroin, and the CDC identified addiction to prescription pain medication as the strongest risk factor for heroin addiction.”

The attorneys argue that the defendants “contributed greatly” to the opioid epidemic by “by selling and distributing far greater quantities of prescription opioids than they know could be necessary for legitimate medical uses, while failing to report, and to take steps to halt suspicious orders and sales, thereby exacerbating the oversupply of such drugs and fueling an illegal secondary market.”

The Washington Post last year collected and shared data from the Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System, known as ARCOS.

Obtained information now includes county-level data from 2006 to 2014. In that time period, nearly 83.2 million prescription oxycodone and hydrocodone pills were distributed in Lake County.

That’s enough for 40 pills per person in Lake County per year. Stores owned by the companies named in the lawsuit received four of the five highest pill distribution totals in Lake County over that period.

A Willoughby CVS received more than 4.5 million pills, a Painesville Rite Aid received nearly 4.3 million pills. Those locations received the most pills, according to information in the database. The Eastlake Walmart received the fifth-most with more than 3.2 million pills.

The 209-page complaint against the five companies was recently unsealed.

The chains are accused of dragging their feet when it came to setting up systems to monitor suspicious orders. CVS, for example, did not have a suspicious order monitoring, or SOM, until 2010. That policy was put into place the day after a DEA audit, according to the complaint.

As of Nov. 21, 2013, the company had only reported seven suspicious orders across all its distribution centers and pharmacies in the U.S.

The complaint also alleges that the volume of opioids Walgreens shipped into Lake County was “so high as to raise a red flag that not all of the prescriptions being ordered could be for legitimate medical uses.”

But Walgreens did not timely report any suspicious orders in the county between 2007 and 2014, according to the complaint.

Elsewhere in the complaint, Rite Aid is accused of conspiring with drug distributor McKesson to avoid suspicious order reporting. McKesson was Rite Aid’s exclusive wholesaler of Schedule II substances, including opioids, at that time.

One example of the alleged collaboration to avoid suspicious order reporting took place in Ohio involving Akron doctor Adolph Harper, who in 2015 was sentenced to 10 years in prison for illegally prescribing hundreds of thousands of doses of painkillers and other pills to customers for no legitimate medical purpose, even after at least eight customers died from overdose-related deaths.

The complaint alleges Rite Aid worked with McKesson to “ensure an increase in the amount of opioids Rite Aid could order from McKesson specifically to meet the illegitimate demand from Dr. Harper. Neither Rite Aid nor McKesson reported any of these orders as suspicious.”

The complaint alleges that Walmart’s pressure on pharmacists “to fill more prescriptions quickly was at odds with a culture and practice of compliance.” “Even when Walmart pharmacists suspected diversion based on an individual prescriber’s prescribing practices, for years, Walmart did not allow its pharmacists to request blanket refusals to fill. Walmart, however, had always had the ability to do so,” the complaint alleges.

“Finally, in 2017, Walmart implemented a policy by which individual pharmacists could request such blanket refusals, which would permit the pharmacist to refuse to fill future prescriptions from that prescriber without evaluating each prescription individually.”

The complaint alleges that Giant Eagle failed to maintain effective controls against diversion from its pharmacies.

The attorneys argue that red flags should have been apparent given that the Ohio Board of Pharmacy found that in a Chardon Giant Eagle in neighboring Geauga County, the company “failed to provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs” between May 2009 and January 2011. The most diverted drug was hydrocodone.

The board found “[t]he drugs were stolen by an inadequately supervised technician who admitted to a Board agent that the drugs were diverted to her addicted husband and also sold to another individual.”

“These figures demonstrate Giant Eagle’s knowledge of and failure to prevent diversion,” the complaint states.

A CVS spokesperson said in a statement, “Opioids are made and marketed by drug manufacturers, not pharmacists. Pharmacists dispense opioid prescriptions written by a licensed physician for a legitimate medical need. Over the years, we have made significant investments in technology and procedures to support our pharmacists in exercising their professional obligations.”

“The plaintiffs’ use of small portions of decadesold documents without context is misleading and does not change the facts,” the spokesperson said in the statement. “We will continue to vigorously defend the company in these matters.”

Spokespeople for Giant Eagle and Rite Aid declined to comment on pending litigation. Walgreens and Walmart did not respond to messages seeking comment.