CHARLESTON – As the federal trial against three major opioid distributors continued, data showing pharmacies in Huntington and Cabell County were ordering well above the national average of controlled substances, some ordering more than five times the national average.
Cabell County and the City of Huntington sued the three largest pharmaceutical distribution companies – AmerisourceBergen, Cardinal Health and McKesson Corp. – in 2017 claiming the companies were largely responsible for the opioid crisis after the companies shipped more than 81 million hydrocodone and oxycodone pills to the county of just 100,000 residents between 2006 and 2014.
At the start of the May 18 testimony, officials from AmerisourceBergen and Cardinal Health objected to the number of documents the plaintiffs were presenting for possible use during examination the previous evening, stating it was unfair that the plaintiffs did not give a subset list of the known documents to be used during questioning.
Faber
“We are trying to anticipate every which way a witness shall go,” attorney Paul T. Farrell Jr., who is representing Cabell County, said.
The defendants, however, suggested the plaintiffs were trying to “bury” something within the numerous documents.
“I think it’s fair that you tell your opponents the ones you definitely plan to use,” U.S. District Judge David Faber told Farrell.
Faber, who is conducting the bench trial, ordered a subset list of documents that definitely will be used to be made known. Farrell listed the numbers of each document and mentioned a number of slides from a demonstration that would be used to the court.
Steve Mays, vice president of Regulatory Affairs of AmerisourceBergen (ABDC), then resumed his testimony from Monday.
Farrell presented a subset of ABDC’s Order Monitoring Program (OMP) history report where SafeScript Pharmacy #6, McCloud Pharmacy and Drug Emporium’s ordering information from 2008-2012 were in spreadsheet form.
The subset data showed that ABDC had a number of orders being flagged for exceeding the threshold between July 10 through July 12, 2007. It also showed the following monthly threshold changes over the months: July 12, 2007 – 10,600; Sept. 26, 2007 – 25,000; Sept. 27, 2007 – 30,000; April 2009 – 45,000; July 2011 – 40,200.
Farrell then pointed out that SafeScript alone had ordered about 360,000 controlled substances in one year for an area with a total population of 100,000 people. The data also showed only three suspicious orders being reported to the Drug Enforcement Administration (DEA). Mays said he did not believe these were the only ones reported.
Data was presented showing several pharmacies in Huntington/Cabell County had above average monthly shipments between 2006 and 2014.
In January 2006, the monthly average for hydrocodone was 6,091 and oxycodone was 3,424. Cabell County alone had data showing monthly orders from various pharmacies ranging from 12,600 to over 125,000.
Fruth Pharmacy was shown to average 46,000 of the two pills. That is six times the national average. Numbers showed Fruth ordering 124,000 hydrocodone in just one month.
In November 2006, the average was 3,649. SafeScript had an average monthly purchase of 35,551 of oxycodone pills.
The data shows that McCloud Pharmacy, Drug Emporium, four Fruth Pharmacies and Medical Park Family Health Center combined to exceed an average of 100,000 hydrocodone pills every month.
Farrell presented an investigation document that ABDC had conducted on SafeScript in June 2007 when the pharmacy was ordering an average of 33,000 pills a month, which was five times the national average. This investigation did not close until March 26, 2008. However, SafeScript’s orders still were being filled.
Earlier in Mays' testimony, Farrell went over the process ABDC uses to flag suspicious orders from customers, which Mays said the company has three different options – accept and approve, delete entire order or hold for further review.
Farrell also asked Mays how the bottom number threshold for customers is decided. Mays explained that it was a default threshold determined by numerous factors including the customer’s business activity, account size, the family dose and period groups in the monitoring program the company uses. He said it was updated “annually or a regular-basis,” but he was unsure of which is being currently used.
Mays said the company only report suspicious orders to the DEA if the drug is not released to the customer.
Farrell presented an email sent by Chris Zimmerman, senior vice president of Corporate Security and Regulatory Affairs, to Mays.
In the email, Zimmerman asked if Mays knew when the Healthcare Distribution Management Association (HDMA), now known as The Healthcare Distribution Alliance (HDA) published the Order Monitoring Program (OMP) trying to gauge if McKesson and Cardinal Health realized AmerisourceBergen had problems.
Mays said the guidelines were made in 2008, shortly after Cardinal Health had its license suspended, clarifying it was either late 2007 or early 2008. The document also said Cardinal had also had a license suspension in 2012.
All three of the defending pharmaceutical companies have had license suspensions at different distribution hubs in the past decade.
During the cross-examination, AmerisourceBergen attorney Shannon E. McClure discussed Mays’ history with the company, including training sessions, DEA investigations and visits with students to the Quantico facility.
Mays said he received an award from the DEA showing appreciation of the trainings ABDC had been doing over the years. McClure argued that the DEA had attended several of the trainings done by Mays and no protest was made.
The plaintiffs objected citing hearsay. Faber originally sustained but came back and allowed Mays to answer the question before moving on. Mays said he presented the same slideshow in full to diversion investigator students and could not recall any DEA supervisor saying the slides or presentation or information needed changed.
McClure presented an Internet Pharmacy Decision Questions document that was given to Mays during his meeting with the DEA. Mays said the questions were presented to help ensure new and current customers were not running an at-home, internet pharmacy. McClure asked if these questions were required to become routine.
“I did not take it that we were required to implement it [questionnaire], it was recommended,” Mays said, also testifying that he was never told that ABDC was doing anything wrong or that it should stop shipping suspicious orders.
Documents were presented showing Mays saying there are legal ways to have an internet pharmacy and that the company had an internet/mail order compliancy agreement for such customers to complete.
The cross-examination will continue Wednesday.
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)