After a week of interrogation of AmerisourceBergen Drug Corp. employees, attorneys for the city of Huntington and Cabell County turned the spotlight on that company’s competitor, Cardinal Health, as they continue their attempt to prove distributors knowingly fueled the area’s opioid crisis.
The turn in testimony occurred Thursday at a federal court trial in Charleston in which the municipalities accuse the “Big Three’’ drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of sending an excessive 127.9 million opiate doses into the county from 2006 to 2014 before a reduction in the pills shipped made users turn to illicit drugs.
The defendants point to the U.S. Drug Enforcement Administration, doctors and West Virginians’ poor health as the culprits.
While the last week of testimony centered on AmerisourceBergen and its distribution relationship with Safescript, a problematic downtown Huntington pharmacy, Cabell County attorney Mike Fuller said the closure of the pharmacy by the DEA and the end of its relationship with AmerisourceBergen did not mitigate opioid abuse, it just made its customers find a new pharmacy with a different distributor.
Fuller presented an internal email from Cardinal Health from 2012 that indicated T and J Enterprises, doing business as the Medicine Shoppe at 2402 Adams Ave., in Huntington, saw a large uptick in opioid sales after the closure of SafeScript. The email did not identify the shuttered pharmacy by name, but timing suggests it was Safescript.
Information from the investigation detailed in the email said the pharmacy experienced a significant growth of opioid sales after the closure of a Huntington pharmacy by the DEA. DEA data shows the pharmacy received an average of 18,600 dosage units of opioids per month from 2006-14, about 3.7 times the national average.
A Cardinal Health employee had questioned a pediatrician prescribing a high rate of pills, but no action came from the investigation.
Thursday’s testimony came from Michael A. Mone, a licensed pharmacist and lawyer who worked for Cardinal Health from 2007 to 2020. In 2007, he moved to the anti-diversion program and, in 2012, he became vice president associate general counsel of its regulatory department.
When Mone joined Cardinal Health, he said, he was tasked with revamping its suspicious-order monitoring system. The 2007 system set for tracking suspicious orders was similar to that of AmerisourceBergen’s.
Thresholds were established through an analysis of unique characterizations of a segment of customers — such as whether they were a hospital or public pharmacy — and then by other business analytics. The businesses were then categorized into large, medium and small categories and an average amount of pills purchased was set. The threshold was three times that amount.
While Fuller called the threshold a limit of the number of pills that could be ordered, Mone disagreed.
“The threshold, I agree with you, is a number; it is not, however, a limit,” he said.
When an order came in over the pill allowance threshold, it would be evaluated and the pharmacy was contacted to do a questionnaire to justify why the pills were needed. The order could then be released or reported to the DEA. Termination of the account was possible.
Mone said Cardinal Health wanted to integrate into its process what the pharmacies received from other distributors, but the DEA would not provide that information, stating that it was proprietary.
Cardinal Health training exhibits shown Thursday said that, if a threshold is not increased, the order size would be cut down to meet the threshold. If the order was not justified, a report would be sent to the DEA and a block would be applied to any remaining controlled substance orders of that customer.
He said there should be documentation each time a suspicious order was suspected and the justifications made to increase the threshold. The DEA did not provide any guidance on what those thresholds should be, though.
A Cardinal Health training presentation from 2007 shown Thursday said the company was told reporting suspicious orders to the DEA did not relieve a distributor of its duties. Its duties went beyond just reporting the orders, it said.
“If you report suspicious orders, yet fill them, you are failing to maintain effective control,” the slide said Cardinal Health was told. Mone said he didn’t agree with the DEA’s interpretation.
“The obligation is to report suspicious orders. The regulation says develop the system, implement the system to report suspicious orders,” he said.
The number of suspicious orders triggered by the computer and those found to actually be suspicious after review varies drastically. In June 2008, the system flagged 421 suspicious orders, but only two were reported to the DEA after a human investigation. In July, there were 793 flags, but only six were reported. There were more than 1,000 in August, September and October combined, but none were reported.
Asked how many suspicious orders they reported in Cabell County, Huntington and West Virginia, Mone said he did not know. Fuller used a spreadsheet that showed no orders sent to Cabell County had been flagged after August 2012. Mone said the DEA never complained about its shipments to Cabell County, nor did it alert Cardinal Health of any wrongdoing by pharmacies there.
Mone said in September 2007 that his co-workers attended a DEA conference in which AmerisourceBergen presented its new electronic suspicious-order monitoring program that the DEA wanted others to implement. The DEA now wanted them to hold suspicious orders, he said.
“The language itself hasn’t changed. It had to be a change in expectations [by the DEA],” he said.
At the questioning of Cardinal Health attorney Enu Mainigi, Mone said that, to his knowledge, Cardinal Health never shipped a suspicious order.
After the conference, by November 2007, its Washington distribution center was shut down. Two more in Florida and New Jersey followed in December, and a show-cause order was issued in January 2008 for its Texas facility. Mone said that, at that point, Cardinal Health had already made changes the DEA had sought at the conference.
Cardinal Health reached a settlement with the DEA in 2008 in which there was no admission of liability or findings of wrongdoing. The distribution centers soon reopened.
The DEA made a weeklong visit to Cardinal Health’s headquarters in 2009, during which agents reviewed the company’s systems, files and facilities to make sure they were following guidelines, Mone said.
Cardinal Health agreed to a second settlement with the DEA again in May 2012, which resulted in a two-year suspension of its Florida distribution center. In December 2016, it again settled for $44 million over more allegations that it violated the Controlled Substances Act in Maryland, Florida and New York.