CHARLESTON – All three major drug distribution companies objected to Cabell County and Huntington attorneys bringing in an expert witness with a U.S. Drug Enforcement Administration background to examine opioid data.
The City of Huntington and Cabell County sued three of the largest distribution companies – AmerisourceBergen, Cardinal Health and McKesson Corp – in 2017, seeking the parties be held responsible for shipping over 81 million prescription pain pills into the area of 100,000 residents. Five of 77 pharmacies in Cabell County and Huntington, received over 23.2 million pills between 2006 and 2014 according to the data released by DEA.
Attorney Paul Farrell Jr., representing Cabell County, called James Rafalski, a former DEA official to the stand May 26. Rafalski investigated registrants, collect due diligence files and put together reports to determine effective controls to prevent diversion on behalf of the DEA.
Farrell
“My experience has been that they’re sometimes voluminous files between time frames,” Rafalski said. “Back then they were a lot of paper, some were electronic. Most would have a chronology of what they had done [in reference to customers].”
Rafalski said he would put together a report once he reviewed all the company and files and then submit the file to the chief counsel in Washington D.C, where the counsel would review the report and confirm or not confirm Rafalski’s findings for “systematic long-term issue.”
Farrell asked for Rafalski to be presented as an expert witness with objection from the defendants claiming “some of what has been articulated from Mr. Rafalski is opinion” and “causation to the extent that he has opinion on whether or not failure of effective control.”
US District Judge David Faber said he would conditionally admit Rafalski’s testimony, subject to later determination if it meets “standards of expert.”
“I’ll go ahead and hear the testimony and reserve the ruling on that,” Faber said. “I think I ought to hear it before I make that decision.”
Two demonstratives were presented with 12 guidance materials and eight reliance materials of the three companies Rafalski used for his testimony.
“Guidance material, it kind of gives a road map to me of some history of what the guidance was to the defendants,” Rafalski said. “There were some important rulings there.”
Rafalski said the data reports he reviewed were from the companies and all specific to Cabell County.
Data given to Rafalski on the distribution companies varied in length of time period.
Between 2004 and 2018 McKesson Corp. had 18,900 sales transactions of hydrocodone and oxycodone equaling 7.7 million dosage units. Cardinal Health had 92,900 sales transactions equaling 35.1 million dosage units. AmerisourceBergen had 77,400 sales transactions equaling 35.4 million dosage units.
A Cardinal report from May to April 2007 for The Medicine Shoppe in Huntington was presented to communicate “ingredient limits” which Rafalski said leads to “the actual trigger or threshold that they’ve [distribution center] created.”
Rafalski explained that the document showed Cardinal used a 12-month average and multiplied it by four to determine the benchmark for a customer’s order to be flagged.
The Medicine Shoppe document showed the pharmacy’s oxycodone product limit being 104g and that 157g of oxycodone was shipped to The Medicine Shoppe before being reported to the DEA.
Faber asked Rafalski if he was able to discern from the companies’ policies and procedures what should happen to future orders once system is triggered.
“They should be held, your honor. Stopped,” Rafalski said.
Rafalski said any drug related to the drug family of the flagged order should be held, no matter the size. He explained the orders should be shipped once cleared of diversion and blocked if the distribution center is unable to dispel the potential for diversion.
Rafalski testified there was no golden rule on what the trigger should be or guidance on how high or low to make the number.
“That determination is for the company or the registrants,” Rafalski.
In reference to the Suspicious Order Monitoring system, Rafalski said there is many different systems for different customers. He said a vet would need a smaller volume compared to a hospital.
“Regulation allows flexibility of registrants to meet their business needs and their customers,” Rafalski.
Rafalski testified that he took numbers from information provided by the defendants and data presented by an earlier analyst expert, Craig McCann, to run numbers through six different methodologies to find the average orders the distribution companies should have flagged.
Based on those numbers, 20-98 percent, most towards the higher mark, of orders should have been flagged “given diversion not dispelled.”
Documentation was also shown that between 2007 and 2018, ABDC made 45 pre-shipment reports. Cardinal made 307 post-shipment reports between 1996-2018 with the first discovered in 2018. McKesson had 79 post-shipment reports between 1996 and 2018 with the first being shown in 2013.
Farrell asked Rafalski several questions involving his findings after review of documents for the three companies and if he had an opinion on the subject presented.
Defendants objected each question, eventually asking for a continuous objection line involving questions to be noted and examined during redirect.
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)
