CHARLESTON — As the landmark federal opioid trial entered its third week, testimony focused on two AmerisourceBergen employees who oversaw regulations involving diversion control.
The City of Huntington and Cabell County sued the nation’s “Big Three” drug distributors — AmerisourceBergen, Cardinal Health and McKesson — over their involvement in the ongoing opioid crisis after shipping more than 100 million doses of opioid variants to the area, from 2006 to 2014.
During the first half of Monday’s testimony, AmerisourceBergen continued cross-examination of David May, vice president of Corporate Security and Diversion Control of the drug distribution company.
Farrell
The cross-examination, led by attorney Shannon E. McClure, focused on AmerisourceBergen’s policy and regulations put in place to monitor the distribution of both controlled and non-controlled substances and the ability to flag suspicious ordering of controlled substances with what they call diversion control.
According to testimony, AmerisourceBergen monitors ordering with a program that instantly reviews all orders electronically and automatically flags any suspicious orders. The order then is reviewed by a human. If the threshold has been surpassed, the order automatically is held until further review. Potential red flags can lead to engagement from the distributor sending an email to ordering a site visit.
Orders deemed suspicious can be canceled and reported to the DEA. Orders deemed not suspicious are “picked, packed and shipped” where they are added back into queue, the order then has an electronic notification sent to find it and put it back on the shelf to be shipped to the pharmacy.
McClure presented excerpts of customer dashboards that AmerisourceBergen has developed to monitor a customer’s order history, amount of controlled and non-controlled substances, a customer risk matrix and several other pieces of customer information.
These documents and dashboards are a part of the company’s Diversion Control Program which is made of five buckets- due customer due diligence component, order monitoring program, ongoing due diligence, policies and procedures and training- to help monitor drug distribution and catch red flags.
McClure asked for these documents to be withheld from the public with objection from the plaintiff. Overseeing the case, U.S. District Judge David Faber allowed the withholding for now.
McClure used the documents to argue that the company goes above and beyond Drug Enforcement Administration (DEA) required regulations.
Before ending cross-examination, McClure shared names of customers across Cabell County served by AmerisourceBergenranging from 2006 to 2018.
The number of customers varied over the 12-year span, ranging from as many as 18 to as little as few as six, with the number mostly decreasing over time.
During the redirect, attorney Mark Pifko presented documents from prior witness Craig McCain, a data analyst. The document showed AmerisourceBergen had distributed close to 2,600,000 opioids to just two pharmacies in Cabell County.
May said he had not familiarized himself with distribution numbers enough to confirm.
After May was dismissed, attorney Paul T. Farrell Jr. called Steve Mays, vice president of Regulatory Affairs, to the stand.
Farrell, representing Cabell County, presented documents presented to Mays during a meeting with the DEA on August 10, 2005. Mays confirmed he was presented the material at that time and told to read when time permitted and that he later relayed the information to the Diversion Control team.
Mays also confirmed he had a follow-up call with the DEA that included AmerisourceBergen’s legal counsel and Zimmerman.
Mays said he could not recall the exact details of that call, but said it was “basically [the] same as meeting [he had with the DEA]. He also said he informed the DEA that they were in the process of updating policies.
Farrell asked Mays about the monitoring of AmerisourceBergen’s customer base and if they compared those patterns and purchases with customer trends.
“That’s how our system was designed,” Mays said.
AmerisourceBergen had a settlement agreement with the DEA in 2007 that required the company to develop a new monitoring program.
“An enhanced program, that is correct,” Mays said.
Another part of the settlement was that AmerisourceBergen would report all sales of narcotics to the DEA every 48 hours.
Mays said comparisons of customers were based within their peer groups but did not have drugs abused in different geographical areas incorporated into the company’s monitoring database.
When it comes to what results as a flag for suspicious activity, Mays said a customer is flagged when they order above their normal threshold, which is the customer’s monthly average and varies each month.
New customers are held at a minimal threshold that varies per customer and is determined by their size and the amount of business they do.
Mays said these numbers are calculated using a customer’s purchase of all prescription drugs.
During the last part of Monday’s examination, Mays confirmed that AmerisourceBergen runs the diversion control program within all of its hubs.
He also said he could not recall the company relying on CDC overdose numbers for monitoring, but the company did look at historical ordering records.
Mays testimony will resume Tuesday.
During last week’s testimony, emails from an AmerisourceBergen executive were presented showing exchanges within the company making jokes and mocking Appalachians.
One email included a parody song with lyrics about West Virginia using words like “pillbillies” and “Oxycontinville” sung to the tune of the “Beverley Hillbillies” TV show theme song, to describe the state
According to a published report, there was an email forwarded by a corporate investigator with the title “Oxycontin for kids.”
There were also emails referring to stricter laws for opioids in Florida driving “pillbillies” north, mockery of Kentuckians ability to read and a reference to increased shipments to the areas with a note that read, “There is a whole lot of pain in the Appalachian area.”
Chris Zimmerman, senior vice president of Corporate Security and Regulatory Affairs, testified and said the emails were for “business purposes only and to vent frustration from their tireless work to keep the supply chain safe,” according to a published report.
Zimmerman also said the company had a high-grade culture and apologized for the inappropriate language used in the emails while assuring the court he understood the importance of patients receiving needed medication.
