CHARLESTON – As they began arguing their case, the three drug distributor defendants in the bellwether federal trial continued to rest blame on others for fueling the opioid epidemic.
After more than six weeks of testimony, the City of Huntington and Cabell County rested their case July 1. That meant defendants AmerisourceBergen, Cardinal Health and McKesson started arguing the companies’ side July 2.
Huntington and Cabell County sued the distribution companies 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.
Farrell
Attorney Paul Schmidt, representing McKesson, first called Christopher Gilligan to testify as an expert in the field of pain management, risks and benefits of prescription opioids.
Gilligan moved from surgery to work with pain management when he saw the way patients were treated in one area compared to the other.
“I realized in pain medicine there was an element where we could do the same thing for patients, try to develop better, safer [and] easier procedures to manage pain management,” Gilligan said.
Gilligan said he agreed that in his experience, distributors do not have a role in deciding who needs prescription opioids or how much is needed. Later he said, “I’m not an expert in healthcare distributors and their business,” in reference in the distributor’s work.
Gilligan said patients with severe pain are unable to work, exercise, or participate in regular life activities.
“For a lot of those patients, their pain is severe, so their suffering is severe,” Gilligan said. “Not only do they have suffering from the pain, but they have their life taken away from them.”
Gilligan said chronic pain is defined as pain lasting six to 12 weeks or longer. Acute pain arises quickly, usually from an injury. Gilligan agreed that pain is one of the most frequent reasons for patient so see a doctor and said, “chronic pain is almost a condition.”
A growing population, an older population and increase in people with a heavier weight are a few things that contribute to increased pain levels, according to Gilligan.
While nonprescription pain relief options – acupuncture, physical therapy and psychological techniques – are available, Gilligan said each patient should have the benefits of pain medication reviewed to determine if the benefits outweigh the risks, something he said every medication has.
“In the United States, many pain experts agree that physicians should prescribe opioids, when necessary, regardless of outside pressures,” Gilligan said.
Gilligan said doctors should carefully review each patient’s tests and records carefully because “you can’t determine if a medication was appropriate without that information.” He said the patient’s addiction risk and condition severity should be accessed, as well as the extent that a nonopioid can give relief before an opioid is prescribed – referred to as “opioid risk stratification.”
“I think the FDA approval of those medications reflect the consensus … the benefits outweigh the risks,” Gilligan said.
Gilligan said the risk of addiction, abuse and misuse varies with each patient.
“It boils down to largely, risk vs benefits,” Gilligan said. “Someone who is abusing and misusing a drug, might get addicted but they might not. You can say, not with perfect accuracy, but with meaningful action on patient is high risk, medium risk and is low risk.”
Gilligan clarified the difference between addiction, abuse and misuse.
“[The patient] develops a compulsive, self-destructive use of a substances addiction,” Gilligan said. “Abuse and misuse on the other hand is just taking the medication for nonmedical use.”
Gilligan said black box warnings are added to medications when there is a specific series risk, they want doctors to be particularly aware of and is typically on the front of a box.
Schmidt presented a CBHSQ Data Review study that shows heroin use in people ages 12-49 years old by demographic and geographic characteristics and prior drug use within a five-year period following the first nonmedical pain reliever use.
The study showed that the 1.1 percent of participants using heroin had no prior illicit drug use or abuse/misuse of prescription pain relievers, leaving 98.9% of participants having prior illicit drug use or misuse/abuse of prescription pain relievers.
“It’s a broader substance abuse problem, where some individual cases there is a misuse and abuse of prescription opioids, but it’s a broader substance abuse problem,” Gilligan said.
Gilligan said doctors have education, training and authority that gives the prescribers a responsibility to make an accurate decision on prescribing pain medications.
“I can’t think of another party that has that level of information for a patient,” Gilligan said.
Gilligan testified that prescribers are given guidance for dosages, monitoring and when and how to appropriately use opioids for chronic pain.
“There are patients who have severe, crippling pain we can’t treat with anything but opioids,” Gilligan said.
Various documents were presented to discuss and explain how the standard of care has changed over time, with an emphasis on undertreatment of pain and exaggeration of potential risk of opioids to an awareness of the adverse effects and needed emphasis on risks to the continued use of the medications while being more conservative.
“Standard of care is [the] quality of care, thoroughness, safety of care a doctor expects to maintain in their field,” Gilligan said. “What you’re expected to do and that can apply to anything.”
Gilligan said it was important and made known to physicians to recognize that if giving a patient a significant dose of opioids over a significant period will make the body dependent and more tolerate of the medication. He said this is not the same as addiction.
“They set measuring pain as the fifth vital sign. To add pain as the fifth vital sign is a very clear message of how important JCAHO [The Joint Commission] felt treating pain was,” Gilligan said in reference to the group’s pain standards.
“I think the great majority of overprescribing was well-intended,” Gilligan said. “I don’t think distributors had an influence on doctors prescribing prescriptions.”
Paul Farrell Jr., representing Cabell County, led the cross-examination.
Farrell presented a McCabe article on the correlation of heroin and prescription opioid use. The article said while most of the prescription opioid exposure does not lead to heroin, those who reported nonmedical prescription opioid misuse were more prevalent to use heroin.
“I think some people are more likely to use other forms of opioids before injection,” Gilligan said.
Farrell asked Gilligan if he believed in the current medical state that four out of five users began using prescription opioids before using heroin. Gilligan did agree and said he had “no reason to dispute.”
Gilligan said large numbers of prescriptions anywhere will lead to diversion.
“I think if there are a large number of prescriptions in any area, there will be a number diverted and misused,” Gilligan said.
Farrell asked Gilligan if he agreed and embraced the gateway theory.
“I think there is a direct relationship with the abuse and misuse of opioid, along with other factors, that can lead to the initiation of heroin,” Gilligan said.
A slide deck from a presentation previously created and presented by Gilligan was introduced and showed that an increase in prescriptions of opioids in an area equated to an increase in deaths. Farrell quoted Gilligan’s presentation where he connected heroin and fentanyl use to prescription opioid use, as well as the opioid epidemic trends in West Virginia.
David Ackerman, representing the City of Huntington, asked a pattern of questions around the documents presented throughout the day that not only clarified earlier testimony, but showed in 2009 that half of all opioid prescription patients filled a second opioid prescription within 30 days.
He also presented reports that said opioids as pain relievers over a long period of time are not always effective. A course of 67 studies showed 3 percent of chronic, noncancer patients taking opioids regularly established an abusive relationship with the medication.
Schmidt’s rebuttal pointed to several of the reports and the relationship between doctors and prescribing prescription opioids to patients excludes distributors.
The trial will resume July 7 with the next witness from the defense.
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)