CHARLESTON – As the landmark federal opioid trial entered its sixth week, tensions rose as defendants spent the day trying to discredit a report by a substance use disorder epidemiologist.
The City of Huntington and the Cabell County Commission sued three of the nation’s top pharmaceutical distribution companies – AmerisourceBergen, Cardinal Health and McKesson – in 2017 seeking compensation over claims the companies helped fuel the opioid epidemic by sending more than 81 million controlled substances to the county between 2006 and 2014.
On June 14, attorney Timothy Hester, representing McKesson, continued cross-examination of Katherine Keyes, a substance abuse epidemiologist.
Keyes
Hester opened the morning with questions to Keyes regarding the exact definition of exposure/supply and of opioid use and need. Keyes said there are many arguments on the practices of opioid prescribing for certain circumstances and the inappropriateness.
“The legitimacy of opioids for any particular [reason] has been controversial,” Keyes said. “It would really depend on what the purpose is.”
Hester referenced several of Keyes’ peer-reviewed articles and statements that did not align perfectly with what she testified.
“I think I would provide a little more context if written today," Keyes replied. "I think most epidemiologists would not make such a blanket statement.
“At the time write, [I] believed to be a true statement … a statement based on the literature.”
Hester questioned Keyes' analysis and asked if she personally investigated the number of people who take or who had a need for pain medications in Cabell County or if she specifically evaluated any of the defending companies – McKesson, AmerisourceBergen or Cardinal Health – by name.
Keyes said she did not know the specifics of the numbers for the county and did not do the specific analysis of each company but did have an opinion based on her report.
“I do know I have an opinion about that,” Keyes said. “I can point to literature to form an answer to that question.”
Hester questioned Keyes on her diversion numbers. Keyes said her report used the definition of diversion.
“Any opioids that are used by someone that they are not prescribed for,” Keyes said. “Illicit diversion source would be any way [of] getting opioids without [a] prescription.”
Hester asked a pattern of questions based off a peer-reviewed article that Keyes was an author off and mentioned West Virginia. He argued that the article referenced rural areas had more elderly, obese and hard manual labor that may lead to a higher need of pain medications.
Keyes would not directly agree because she said the paper was focused more on Kentucky and that was not her expertise, so she did not feel comfortable in comparing it to West Virginia to make an opinion.
“Just because there is opioid prescribing, does not necessarily mean there is appropriate opioid prescribing,” Keyes said.
Hester questioned Keyes several different ways on the doctor’s overprescribing of opioids being the “principal foundation” of the opioid crisis.
“I think it’s a major foundation of the prescribing and what we saw subsequent with the opioid epidemic,” Keyes said.
When Hester later directed blame back to doctor’s prescribing, Keyes said she believed the majority were doing what they believed to be best.
“They are acting on good faith based on the information [drug literature] given,” Keyes said.
Hester argued about the development of opioid use disorder with specific questions requiring a yes or no answer. Keyes answered each question with clarification to context.
Motions were made, and granted, to strike several of her answers from the record for being “nonresponsive.”
As a part of Keyes’ report, she used a methodology to determine and give an estimated number of the OUD population. Hester tried to break down the methodology for a length of time.
The witness’ agitation was showing as she raised continued issue with the method Hester was trying to use, Hester replied, “just work with me.”
Hester and Keyes did not come to an agreed conclusion before moving on.
Hester said he was changing course to the “gateway theory” of drug use and was immediately interrupted by Keyes with objection.
“It’s not a theory," Keyes said. "There’s data. It’s a gateway effect."
Hester questioned the definition of causation and broke down the epidemiological terminology Keyes used during her report. He questioned opioid use disorder having a cause due to the fact it is a multifactored disorder.
“There is one necessary cause and then there is other contributing causes,” Keyes said.
Hester probed Keyes about any of her written articles stating that there is a gateway cause from prescription opioid use to heroin use. When Keyes said she could not recall if the specific sentence was in her reports, Hester said there was no articles specifically stating there is a causal relationship, to which Keyes adamantly disagreed.
Keyes said there is not one study that can sufficiently show a causal relationship.
“There is sufficient consensus across the materials I relied on there is a dependent relationship,” Keyes said.
Hester finished the day with questioning data regarding the use of other drugs, not including prescription opioids, prior to heroin. He also noted several peer-review articles Keyes relied on, have authors who are being used as expert witnesses for opioid litigations, including this hearing.
Hester’s cross-examination will continue Tuesday morning.
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)