CHARLESTON – As the landmark federal opioid trial concluded its fifth week, an opioid abuse epidemiologist shared data connecting causation between prescription opioids and opioid use disorder.
The trial opened June 11 with U.S. District Judge David Faber granting plaintiffs three additional days at the end of June to present their case.
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.
Farrell
Attorney Paul Farrell Jr., representing the City of Huntington called Katherine Keyes, substance abuse epidemiologist, to the stand as an expert witness.
Keyes specializes in opioid use, opioid use disorder, data trends and related fields. She has been deemed an expert witness in other litigations. She is a principal investigator in various projects, several published peer-reviewed journals and has been noticed as top in her field in different regards.
Keyes said she believes there is a causal connection to prescription opioids and heroin that has been established factually in medical literature. The biggest piece of literature Keyes would reference is from a consensus developed by the Association of Schools and Programs of Public Health.
“I believe that the evidence in the medical literature is overwhelmingly supports the validity of this statement,” Keyes said.
Keyes said she compared the data trends overtime between Cabell County and nationwide and saw an enormous increase nationally of prescription opioids supply, West Virginia saw a larger increase than the nation and Cabell County saw the largest increase of the three.
“They all point in one direction and that’s [the] increase to the supply of prescription opioids cause harms in Cabell County,” Keyes said.
Keyes said harms caused by exposure/supply are opioid use disorder, diversion & nonmedical use, hospitalization and overdoses, transition to other opioids – particularly heroin and fentanyl – death, neonatal abstinence syndrome and bloodborne diseases.
A 2014 referenced as the Edmund study showed the relation of dose and duration of opioids to OUD. The study was based off the study used to connect smoker’s risk of lung cancer. The study found smokers were 13x more likely to develop lung cancer than nonsmokers.
Edmund’s study showed if someone took a low dose prescription opioid for 90 days, the OUD is 15 times more likely to be developed. Taking a medium dosage for 90 days, the OUD is 26 times more likely. Taking a high dose of prescription opioids for 90 days, the OUD is 122 times more likely.
“I have rarely seen [a risk] in the literature as high as 122,” Keyes said.
Keyes said Gherter analysis examined the data on amount of prescription opioids distributed by each county and the correlation to hospitalizations across the country. She said studies want to establish the cause precedes the effect.
“This study showed more supply, more hospitalizations,” Keyes said. “There are people who have used heroin who have never used prescription opioids, just like some who have used prescription opioids and don’t use heroin. It’s a risk factor.”
Keyes said the greatest risk factor relates to the strength of associations and is availability and price of prescription opioid.
Keyes said economic conditions play a relatively small role in opioid related harms seen across the nation. Less than 10 percent of the U.S. overdose trend across the nation is economic related.
There is no literature that Keyes is aware of that would dispute her data and conclusions.
A demonstrative graph showing CDC data on overdose rates of all drugs was presented showing West Virginia being greater than the nation and Cabell County being greater than West Virginia.
“Cabell County, I believe is in the top five counties in terms of overdose death [in country],” Keyes said.
Data presented by Keyes showed West Virginia had substantially higher NAS rates than the nation and Cabell was higher than the state. 62.3 per 1,000 births in Cabell County had NAS, 56.2 per 1,000 births in West Virginia had NAS and 7 per 1,000 births in the nation in 2016.
Keyes said the prevalence of OUD in Cabell County is 8.9 percent.
Keyes said there is a definite causal association between the use of prescriptions of opioids and the use of heroin, as well as the causal association between the increased supply of prescription opioids to Cabell County and OUD.
Cross-examination of Keyes will continue Monday morning.
Earlier in the day, attorney David Ackerman, representing the City of Huntington, continued questioning expert witness, Jakki Mohr, professor of marketing with University of Montana as an expert witness.
Mohr is an expert in several areas of marketing, including distribution channels.
“This was some of the most sophisticated marketing that I have seen,” Mohr said.
Several documents – between 1995 to approximately 2017 – were presented to show how Mohr developed her opinions. Mohr regularly mentioned services that “touched” consumers – something Mohr says is called, touchpoints, interaction or communication between parties.
“All of my opinions are based on documents that I have used,” Mohr said
An internal memorandum from Purdue Pharma that included McKesson, Cardinal Health and AmerisourceBergen.
“This document shows the important role in the distribution marketing success of manufacturing products,” Mohr said. “This was a critical time period according to perdue… The new programs would be critical to their success”
The three distribution companies had “glimmer buttons” – a paid search, where a pharmacy searched for competing products, they could click the button on the distribution company’s website and an oxycontin advertisement would appear, Mohr said.
She noted her surprise in the timing of this button being 1995.
“These people were already inventing what we would be relying on in the future, pay-per-click advertising,” Mohr said.
Mohr also said she discovered “triangulated values proposition segments” during her review – the company targets three areas simultaneously.
“I have never seen this in my marketing career,” Mohr said.
Mohr described and explained several different areas of marketing through her testimony.
“Communication with customers is marketing,” Mohr said. “Anything designed to give financial incentive to customers is considered promotion.”
Mohr said she reviewed thousands of pages through hundreds of documents to conclude all three defending companies did participate in marketing different opioids.
Before starting the cross-examination, attorney Shannon McClure, representing AmerisourceBergen, motioned to strike Mohr’s testimony from the record because, “the existence of marketing proves nothing.”
McKesson and Cardinal Heath joined in the motion.
McClure said the testimony has no relevance and is out of geographical scope and there was no evidence showing the distribution companies marketing was tied to any sales or misconduct.
The defense argued it was a known truth that companies across the globe engaged in marketing.
Faber ruled not to strike the testimony due to his understanding the plaintiffs are attempting to show the defending companies increased demand of opioids and said the court would see what happened during the cross-examination.
McClure started the cross-examination with a line of questioning on Mohr’s background and educational knowledge on any healthcare or pharmaceutical related marketing and her expertise on Food and Drug Administration (FDA) labeling requirements or the role physicians have when prescribing. Mohr had none.
Tensions between the defending lawyer and witness were tangible when Mohr answered in ways, she believed to be correct, but McClure did not believe were the answers to her questions.
McClure asked Mohr several questions regarding her research on where the marketing took place, the veracity of the documents she used, and her knowledge on distribution company’s targeted geographical areas or implementations of opioids or evidence of sales increases.
“I was asked to determine whether or not the distributors engaged in marketing of opioids,” Mohr said.
Attorney Timothy Hester, representing McKesson, asked a pattern of questions on global marketing, the depth of product lines being unusual for companies and advertising awareness.
Hester argued that advertising can be done to assist patients and not just sale, something Mohr disagreed. She said in the grand scheme, all marketing is used to funnel into some type of sales.
Attorney Jennifer Wicht, representing Cardinal Health finished the cross-examination with questions referring to Mohr’s knowledge of the distribution company prior to this case and promotional program knowledge.
Ackerman had no questions for 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)
