CHARLESTON – Tables turned as an expert witness for Cardinal Health had his professional reputation challenged during his testimony at the bellwether federal opioid trial.
Enu Mainigi, representing Cardinal Health, called local physician Timothy Deer as an expert in pain management and the standard of care for pain management.
Deer testified that he was asked to look at the standard care in West Virginia between 1994 and 2021, the change of opioid prescribing and “what really happened” in West Virginia.
Mainigi
Huntington and Cabell County sued the three large distribution companies – AmerisourceBergen, Cardinal Health and McKesson – in 2017, seeking the parties be held responsible for their part in the opioid epidemic. Five of 77 pharmacies in Cabell County and Huntington, received over 23.2 million pills between 2006 and 2014 according to DEA data.
Deer defined standard of care as “what a reasonable doctor would do in certain situations, some are written, and some are understood.”
“Over time standard of care changes,” Deer said. “Based on new information, you have to change with it.”
Deer said he is extremely involved in the national society, as well as West Virginia and felt confidents in the national overview and his impression of how things changed in West Virginia.
Deer said there have been three main factors that impacted the prescribing of opioids over time. The liberalization of prescribing opioids for basically anyone who complained of pain in West Virginia, in the late 1980s. He said prescribing changed dramatically in 1996, as new drugs came along that were said to be less addictive, primarily OxyContin, and most doctors has no reason to disagree.
Deer treats chronic pain in Charleston at The Spine and Nerve Centers of the Virginias. He said as the 1990s progressed; the clinic saw a sizeable increase of patients with large dosages of prescription opioids. This resulted in helping patients move off the opioids and finding new forms of long-term care.
In the early parts of 2000, Deer said he believed the treatment timeline and the “less addictive” opioids were better, as Purdue Pharma was educating it to be.
“I really thought the teachings around the country was correct, until I saw what was happening,” Deer said.
Deer said he heard a Purdue doctor say that no opioid was addictive, the pain was just undertreated.
Deer started to change his beliefs at this point, finding other treatments for pain and he no longer said opioids were not addictive.
He was not the only one. Deer said between 2010 and 2015 there was noticeable push back when doctors were not sure it was right to continuously increase opioid prescriptions for treatment.
“Based on their knowledge base and their options, they were [prescribing appropriately] based on the information,” Deer said.
One piece of this knowledge base was the implementation of pain as the fifth vital sign, where asking about pain became routine screening.
Deer said opioids were not prescribed often, doctors usually opting for the short-term pain medications. He said there was a fear of over-prescribing and revocation of medical licenses. After the push for more pain treatment and a 1997 West Virginia State Board of Medicine document that eased the fear of too many pain reliever prescriptions, undertreatment of pain became a fear.
In 1998, West Virginia Legislature passed the Intractable Pain Act, consistent with the board of medicine’s message the prior year, that if pain did not dissipate with reasonable attempts of normal treatment, opioids and other controlled substances were to be used.
“I think the intent, at the time, was reasonable and felt to be in need,” Deer said.
The act said noncancer patients with chronic pain should be treated the same as cancer patients with pain.
“Guidelines had not caught up with current standard treatment of care, that’s how I took it at the time,” Deer said. Citing the belief that patients had the right to be treated for pain.
The Management of Pain Act was passed as a revision to the Intractable Pain Act in 2001. This revision emphasized that physicians should access and treat pain properly and note that tolerance and physical dependence are “normal consequences” of prolonged opioid use and not the same as addiction.
U.S. District Judge David Faber, who is overseeing the bench trial, asked Deer to explain the difference in physical dependence and addiction.
“Physical dependence means that if you’re [patient] taking a medication and you quit taking the medication, they [patient] have a seizure or feel bad, that’s physical dependence. Once they go through that phase, they don’t crave that drug,” Deer said. “If they’re addicted, they take it for other reasons than [needed] they crave it.”
A joint policy statement, adopted in 2001 and readopted in 2010, encouraged opioid prescribing in Deer’s opinion.
“As these acts became law, you saw more and more opioids,” Deer said. “I think at the time, the vast majority of those doctors were acting reasonable in the standard of care.”
While other experts have testified that West Virginia demographics did not play a large role in the opioid epidemic, Deer disagreed.
“I believed it [demographics] had a large impact of prescribing in West Virginia than other places,” Deer said.
Deer said there were four major demographics he believed to play a role. He said West Virginians have higher rates of chronic pain, leading the country in levels of arthritis and obesity were given examples. He said the state is an average of four years older than other states leading to a greater death rate and many younger people are leaving the state for better jobs. Deer said the state has more physically demanding jobs and a “blue collar workforce that works hard,” but adds to more injuries. He also insurance policies play a role in limiting what physicians can do.
“Many specialists don’t accept West Virginia Medicaid and can’t get approval for innovative management,” Deer said. Something he said he experienced and the reason why he accepts the insurance.
In 2012, legislation was passed that required doctors to check the Controlled Substance Monitoring Program before prescribing opioids to decrease/eliminate doctor shopping.
The CDC released the first federal guidelines in 2016 giving prescribers guidance on prescribing and proper dosages.
In 2018, the Opioid Reduction Act was passed, limiting refills and the time between refills without re-assessment.
“I think it was a major factor in changing the standard of care in West Virginia in a positive light,” Deer said.
Deer estimated 50-100 patients in 2001 came in with an opioid prescription. He said in 2018, few being seen with a prescription and even less the past few years.
Deer said the standard of care changes when physicians hold each other accountable proper research is conducted on various opinions.
“West Virginia has made an effort to change things as a whole and we’ve evolved,” Deer said. “Hopefully we continue to evolve to make progress.”
Bob Fitzsimmons representing the plaintiff led the cross-examination.
Fitzsimmons wasted no time throwing questions at Deer to prove his lack of knowledge for Cabell County data.
Fitzsimmons asked if there is a written standard of care for opioid prescriptions and where the information Deer used for his testimony.
“I do not think that is something [standard of care] in writing due to the evolution of it,” Deer said. “There’s things I think were important, like the legislation we’ve seen today [guidelines, acts, statements].”
Defendants offered continuous objections to Fitzsimmons' cross-examination, citing it was out of scope and/or improper.
Deer said he had no direct knowledge of doctors being reprimanded in Cabell County for inappropriately prescribing opioids, but believed those doctors existed.
“I think there were some doctors who prescribed inappropriately. One is too many in West Virginia, in my opinion,” Deer said.
Fitzsimmons questioned Deer’s early demographic response, citing West Virginia is the 15th lowest state with constituents over 65 years old. He also said in terms of blue-collar jobs Deer mentioned – coal mining, timbering – have been nonexistent in Cabell County in at least 20 years.
A peer-reviewed paper Deer co-wrote was presented that said, “the abuse of controlled prescription drugs was foreshadowed by dramatic increases in their manufactures and distributors and the number of prescriptions written and filled.”
Deer said he did not write the entire paper and was not an expert on every piece, but he did trust the colleague who wrote the paper with him. He said there should be a citation of who wrote each piece, but that person would have been an expert and he does not have reason to disagree as he has no expertise in diversion.
Deer’s prescribing history between 1997 and 2017 was presented, showing him ranked in the top five opioid prescribers in Kanawha County. He was the top two/three prescriber of MME for 12 years and then dropped to number five after a drastic change in 2017. Deer was also shown as the top prescriber of three prescription fentanyl.
Deer argued he was probably the only one in the area treating cancer patients for pain.
When a graph titled, “Physician dosage units compared to specialty averages – Timothy Deer” was presented showing Deer prescribing significantly more than others and Fitzsimmons compared it to an earlier graph referenced as “pill mountain,” Deer became visibly frustrated and argued that the data was incorrect but did show the success of his team.
“We follow referral patients. I think this is a misrepresentation of data,” Deer said. “Having said that, going back to the graph, we are the lowest in 2017. I think we have taken the most [patients] off opioids in West Virginia, maybe the country.”
During the redirect, Mainigi clarified that Deer was unaware of this graph and/or where the data originated. He also testified that there are only about six full-time professionals like him in the state.
Representing McKesson, Timothy Hester called James Hughes to the stand as an expert witness in health economics and health insurance related to prescription medicines.
Hughes testified that he was asked “to examine the role of payers [Cigna, Medicaid, Medicare, WVPEIA, etc.] in the prescribers of opioids in West Virginia.”
Hughes said through data from the Kaiser Family Foundation in 2018, 1.6 million (93.8 percent) West Virginians have some form of medical insurance. 26.45 percent of those are on Medicaid and 6.17 percent are uninsured.
“I would expect the percentage of people covered by Medicaid to be high in Cabell County/Huntington,” Hughes said.
He said this was due to the poverty level in Cabell/Huntington, estimating 30 percent or more were at least eligible for Medicaid.
From 2019 prescription payment by payer count data, again from Kaiser, showed 32.2 million prescriptions in West Virginia. 40.89 oercent of those prescriptions were paid for by commercial insurance, 29.41 percent were Medicare, 25.44 percent were covered by Medicaid and 4.25 percent were paid for with cash.
Hughes said he would expect a higher fraction of prescription opioids paid for by Medicaid.
Prior authorization allows an extra step of accountability, Hughes said. He also said the doctor may not want to complete the prior authorization and will switch from an opioid. Prior authorization has reduced opioid prescriptions by about 52 percent, he said.
“The process [of] prior authorization is basically the chance for two things to happen,” Hughes said. “For the doctor to reflect on the prescription he or she is writing to make sure it fits patient needs and check on doctor to make sure they are adhering to the standard of care set.”
Hughes said he was unaware of distributors having any influence in prescription coverage or authorizations.
Cross-examination will continue July 8.
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)