CHARLESTON – As the landmark federal opioid trial nears the end of its third week, testimony focused on Cardinal Health’s acknowledgement and regulations related to excessive controlled substance ordering.
The City of Huntington and Cabell County filed suit against three pharmaceutical distribution companies – AmerisourceBergen, Cardinal Health and McKesson – in 2017 seeking to hold the companies accountable for their alleged part in the opioid epidemic by sending more than 540,000 opioids each month to independent and chain pharmacies – excluding hospitals and/or hospital pharmacies – located in Cabell County.
On May 20, Michael Fuller, one of the lawyers representing Cabell County, resumed questioning of Michael Mone´, Cardinal Health's former vice president of anti-diversion. Mone´, a licensed pharmacist and lawyer, was employed by the distributor between 2006 and 2012 starting with Cardinal’s subdivision, Medicine Shoppe.
Mainigi
Mone´ said his role slightly shifted over time, but he said he was, “hired to assist franchise to adapt to regulatory changes or to provide education tools for regulatory appliance” and eventually took on a role to help improve Cardinal’s existing diversion control system used to identify suspicious orders from all customers of the company.
Fuller went over Cardinal Health’s due diligence program and the company’s electronic system used to monitor and flag suspicious orders of controlled substances from customers.
Fuller presented documentation showing Mone´ did have some concerns with the system in place and believed it could be expanded to better meet regulations. During his tenure, Mone´ assisted in not only expanding, but also implementing new measures in the Suspicious Ordering System (SOM).
“The manner of which we expanded due diligence was done when I came on,” Mone´ said. “The 'Know Your Customer' component of SOM system was something that was developed and expanded during my time.”
Mone´ said Cardinal Health had a team that consisted of a pharmacist(s) and staff that would review threshold numbers and suggestions for changes to determine if a customer’s request was justifiable or not. He said thresholds were determined from several factors of analysis of several subsets of data collected. That echoes what Steve Mays, vice president of Regulatory Affairs of AmerisourceBergen, had testified about his company's due diligence and order monitoring.
U.S. District Judge David Faber, who is conducting the bench trial, interrupted the examination to ask if the U.S. Drug Enforcement Administration (DEA) offered any guidelines on determining thresholds. Mone´ said to the best of his recollection the agency did not, but he said it did have an advisory committee that had a multiplier suggestion for list one chemicals.
“It is not necessarily applicable but does provide reasonable framework,” Mone´ said.
Fuller then moved into questioning about local pharmacies of The Medicine Shoppe franchise.
In an email exchange between Mone´ and Douglas Emma, manager QRA supply chain integrity of Cardinal Health, it stated a follow-up by LV-TAC was needed for a few “hot spots” and “black hole cases” that had “suspiciously high volumes of controlled substances.”
Mone´ testified that LV-TAC was a “large volume” group created to help compete due diligence.
“We’re continuously improving the program,” Mone´ said.
Fuller then moved into listings of two pharmacies and a pediatrician discussed in the email.
One of the pharmacies listed was in the town of Van in Boone County. It was discovered the pharmacy was dispensing opioids for out-of-state prescriptions from a drug clinic in Georgia for several months in 2012. Defendants objected to the use of the Van pharmacy on grounds of geographical scope.
Fuller questioned Mone´ on the Huntington-located The Medicine Shoppe, which is a franchise under Cardinal Health. An email showed the pharmacy claimed it experienced “significant growth from the stimulant drug families and new pain clinics.” The email showed a new pediatrician in Huntington prescribed several stimulants dispensed by The Medicine Shoppe, but nothing of significance was found under a DEA and license search.
Mone´ testified the diversion team broke the threshold factors for customers into subcategories and compared the information to external experts. He said after review he still believed “multiplying average by three” was a “good idea” to determine a customer’s threshold.
Fuller presented a spreadsheet of suspicious orders in Huntington/Cabell County and asked if Mone´ had any knowledge that the suspicious orders were reported to the DEA. Mone´ testified that he was not sure the number reported and that the reported ordered were not necessarily in the system.
“I don’t know the record retention policy of this record,” Mone´ said. “I’m not the IT guy, so I don’t know what the IT guys do.”
Attorney Enu A. Maingi, representing Cardinal Health, led the cross-examination.
Much of Maingi’s pattern of questions followed the same line as the plaintiffs earlier in the day and reiterated how Cardinal Health performed due diligence and reporting of suspicious orders.
Mone´’s predecessor, Steve Reardon, had reportedly attended the DEA conference where ABDC’s senior vice president of Corporate Security and Regulatory Affairs, Chris Zimmerman, presented ABDC’s enhanced electronic reporting system for suspicious ordered.
Mone´ testified Reardon also brought what he calls “the prongs of what we did – know your customer, OMP, investigation.”
Mone´ said the regulation adjusted to what he understood as suspicious orders were not to be shipped to customers. Prior to this, Cardinal Health would send monthly Ingredient Limit Reports to the DEA.
Maingi probed Mone´ about having access to the Cardinal Health system information prior to his employment, to which he said he did. She then asked if it was his belief Cardinal Health was complying to regulations.
“Yes, it would seem to me if a distribution center was proving an IRL to the DEA for all the years they were doing that and the regulation never changed, they would have to be complying,” Mone´ said.
Mone´ testified to a line of questions about his knowledge of Cardinal Health involving the sales team with threshold changes or DEA reporting, if Cardinal Health shipped to pharmacies in Cabell County and Huntington that were not licensed or that were filling illegally obtained prescriptions, if the West Virginia distribution centers had any license suspensions during his time, if Cardinal gave special treatment to one pharmacy over the other, if chain pharmacies were treated differently or if anyone from Cardinal would fill questionnaires out for customers – all of which Mone´ said “not to my recollection.”
A Cardinal Health questionnaire was presented for customers to complete periodically.
Faber asked how often the questionnaire was sent to be completed. Mone´ testified that the form was “initially paper and then electronically” but the form had no set schedule to be updated, it was periodical and “after threshold events.”
“We were engaged in a continuous improvement the entire time I was there,” Mone´ said.
Maingi inquired what would happen to medication ordered by the pharmacy and never filled.
“It just sits on the shelf,” Mone´ said.
Maingi then asked what would happen if a manufacturer shipped medications exceeding the DEA quota.
“It would be impossible to ship in excess of DEA quota,” Mone´ said. He said no amount over the DEA quota can be manufactured.
Mone´ said he had continuous contact with the DEA during his tenure.
Earlier in the day, Farrell proposed argument to Faber’s ruling on witness scheduling made on May 19, based on rules that Farrell states, “party has discretion to the party itself, subject of course general discussion itself” and a that it has a “cascade effect on other witnesses a lot of other witness that have different professional schedules and different lawyers scheduled to work with witnesses.”
Farrell argued that this was a “chicken and egg” problem and that the plaintiffs made the schedule in a “way that is most persuasive to your honor.”
Faber stated that he had thought a lot about the ruling made on Wednesday and said, “I think the plaintiffs do have a right to decide the order.”
In response, the defendants asked for leeway in cross-examination, to which Faber said, “we’ll cross that when we get there.”
Huntington is represented by Anne Kearse, Joseph Rice, Linda Singer and David Ackerman of Motley Rice and Rusty Webb of Webb Law Centre. Cabell County is represented by Paul Farrell Jr. of Farrell Law, Anthony Majestro of Powell & Majestro and Michael Woelfel of Woelfel & Woelfel.
AmerisourceBergen is represented by Gretchen Callas of Jackson Kelly and Robert Nicholas and Shannon McClure of Reed Smith. Cardinal Health is represented by Enu Mainigi, F. Lane Heard III and Ashley Hardin of Williams & Connolly. McKesson is represented by Mark Lynch, Christian Pistilli, Laura Wu and Megan Crowley of Covington & Burling.
U.S. District Court for the Southern District of West Virginia case numbers 3:17-cv-01362 (Huntington) and 3:17-cv-01665 (Cabell)
