CHARLESTON – As the landmark federal opioid trial entered its fourth week, plaintiffs jumped into McKesson Corporation’s threshold guidelines and due diligence process.
During testimony on May 24, McKesson Corp. Director of Regulatory Affairs Michael Oriente testified that the Controlled Substance Monitoring Program was being developed as he transitioned into the DRA position.
Under CSMP, a threshold system was created for all schedule two through five substances. Oriente said customers only were permitted to receive up to the threshold number and then they would be blocked. McKesson had a three-level review process to determine if the order was suspicious.
Faber
McKesson distribution centers are sectioned into four districts and have five DRA positions, according to Oriente.
Emails between 2008 and 2013 were presented containing conversations between McKesson’s DRAs about having inadequate resources to complete the job.
“At certain times, the workload was heavy,” Oriente said.
In 2017, Cabell County and the City of Huntington sued the three largest pharmaceutical distribution companies – AmerisourceBergen, Cardinal Health and McKesson Corp. – 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.
Oriente said threshold change requests increased toward the end of the month as customers more than likely were reaching the threshold and had blocks.
“I needed backup yesterday,” David Guston, director regulatory affairs with territory covering the West Virginia area wrote in one email. “It is not possible to be truly diligent and handle that kind of volume.”
In the email, Guston also said he believed he had 190 emails and around 80 increases in the south. He also said it was difficult for them to be thorough and error free.
“We need to think of a solution to the tsunami at the end of the month,” Oriente wrote.
Each DRA had a section of the country with one extra person making it a team of six. When someone on the team had time off, the others would cover their territory.
Emails from 2011 showed the group again talking about the volume of work and need for additional help.
An email thread from 2008 showed Guston addressing the number of threshold increases for McKesson.
“Regulatory team, something needs to be addressed. All of these. I believe had already gotten increases in the past week, one was done yesterday,” Guston wrote. “We are giving a lot of automatic increases that would not fly for independent retailers without level twos.”
Oriente said the company never did automatic threshold increases; all requests were reviewed.
In 2013, the reporting process for McKesson changed from reporting only during a level three review to reporting anytime a customer attempted to exceed threshold.
When asked his understanding of Drug Enforcement Administration’s expectations of McKesson blocking any orders that were deemed suspicious Oriente said, “requirement as I understood to report suspicious orders which started blocking and report would be done when level three review conducted”
Oriente also testified he understood McKesson’s obligation was to monitor, block and report suspicious orders.
“Once identified as suspicious, it would go under a three level process,” Oriente said. “If we would have identified an order as potential diversion, we would block that order. There’s a difference between a diverted order than a suspicious order.”
Plaintiffs presented a slide from a demonstrative that said, “CDC currently classifies prescription drug abuse as an epidemic,” then asked Oriente if he agreed, and he said he did. They then asked if he had an understanding there still is a drug epidemic in the country.
“My understanding is the prescription epidemic has declined in the past few years,” Oriente said.
Oriente said he believed it was other drugs fueling the epidemic.
Plaintiffs presented another demonstrative slide with a quote from Joseph Rannazzisi, deputy assistant administrator of DEA office of diversion control, that “illicit pain clinics, the pharmacies that fill their scripts, and the wholesale distributors who supply pharmacies without due diligence” had posed an “imminent threat to public health and safety” by providing millions of oxycodone and other controlled substances. Defendants objected to the use of the slide on grounds of hearsay.
“I think it goes beyond that,” said U.S. District Judge David Faber, overseeing the bench trial. “It’s an opinion of a DEA agent. I’m going to sustain the objection.”
Faber allowed the exhibit to be admitted, but said the court would not be considering it for anything.
Documented emails were presented by the plaintiffs of requests from the chain pharmacy, Rite Aid, opting out of the threshold limits.
Oriente said Rite Aid has its own internal monitoring program and was the reason they asked to be opted out of the program or to have it modified to prevent supply cut off.
Another email string was presented from a CVS customer service agent asking for a 30 percent “buffer” for the chain pharmacies, like was done for Rite Aid.
“I need to have Don approve that CVS will be ‘tweaked’ like Rite Aid was,” Oriente wrote in reply.
Oriente said not all Rite Aids received that additional buffer. He said if an individual pharmacy of the chain requested it, they would review, and he was unsure of the number of pharmacies given a buffer.
“I would have been the one to review them,” Oriente said. “The decision would have been Don Walker. I just don’t recall what was eight years, how many.”
When asked about a threshold reduction initiative, Oriente testified another team member did most of the work and reviews himself.
Plaintiffs asked Oriente if it was ever appropriate to adjust a threshold above the requested number. He said he did not believe there were restrictions to increasing the threshold.
“10 percent buffer when thresholds first established because of variability in purchasing,” Oriente said. “I could see Dave doing that in his region if he wanted to do that.”
Oriente said the retail pharmacies were only treated differently because they had their own regulatory teams.
“Go from local store to chain corporation," Oriente said. "They would review through their regulatory team. They would then send to McKesson to be reviewed by myself."
Cabell Country had three of four Rite Aids with a 50 percent increase of all level two controlled substances. The plaintiffs presented a document called “Rite Aid All” regarding threshold changes in August 2008.
“Reason for change is Rite Aid has DEA monitoring program in place at corporate level,” according to the document. “As a result, Rite Aid Corp and McKesson agreed to increase all C2 base codes by 50 percent.”
Oriente only recalled one of the pharmacies receiving a 50 percent increase specifically.
Defendants objected due to geographic scope; Faber sustained based on witness testimony that “Rite Aid All” did not mean all the Rite Aids.
Plaintiffs questioned Oriente on his part in documenting increases and reviews. A list of internal audits for McKesson distribution centers were presented stating several to no documentation was filed for Washington Court House, Ohio, and New Castle, Pennsylvania, – both serving West Virginia.
Oriente testified that McKesson Corp had “refrain from using the words ‘suspicious’ in communication,” written in their policies.
“’Customers of interest’ action would have to be taken when considered suspicious,” Oriente said.
He said the company did not want to use the term suspicious for customers who had not been deemed suspicious, but when it was “we took action.”
McKesson has had more than five violations of the controlled substance act equaling more than $15.3 million in fines according to violationtracker.org.
During May 21 testimony, Dr. Joseph Werthammer, pediatric neonatologist at Cabell-Huntington Hospital, explained neonatal abstinence syndrome, a syndrome the Centers for Disease Control and Prevention’s website states “is a withdrawal syndrome that can occur in newborns exposed to certain substance, including opioids, during pregnancy.”
West Virginia’s Department of Human Resources released a report in April 2018 that stated, “data for 2017 showing overall incidence rate of NAS was 50.6 cases per 1,000 (5.06 percent) for West Virginia residents.”
Cardinal Health salesman Jesse Kave also testified Friday that while he had had access to Cardinal’s purchase report trends, it was not something he often checked. He also said prescriptions for the abused drugs had been declining. Plaintiffs argued large volume orders of the substances should have been an instant red flag.
Scott Lemley, the former criminal intelligence analyst for the police department and the Mayor’s Office of Drug Control Policy, testified Friday about the rapid increase of the opioid epidemic, resulting in increased drug seizures, increased overdoses and the crisis moving from low dosage opioids to high dosage opioids and heroin. Lemley, who is now the current director of innovations for Huntington, said The Medical Shoppe and Safescript were early indicators of the crisis, but he also stated the county did try to handle the situation and went to state delegates to initiate programs to help reduce the abuse of prescription pills.
The defense argued that Huntington’s problem started long ago with the closure of several factory and manufacturing jobs leaving many citizens unemployed and a downward effect that left the city vulnerable.
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)
