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Friday, April 26, 2024

Distributors object to Gupta's testimony on transition from prescription to street drugs

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CHARLESTON – During the third day of a federal trial against three major opioid distributors, lawyers for the City of Huntington and Cabell County sought to make the case that the ongoing drug crisis was predictable, as well as tied to the use of prescription painkillers.

On May 5, attorneys called David Courtwright, a historian of opioid use and drug policy, as well as Dr. Rahul Gupta, who was West Virginia’s health officer and commissioner of the state’s Bureau for Public Health from 2015-2018, to testify in the bench trial at the Charleston federal courthouse.

Gupta testified, at one point, that there was not “one iota of doubt” that prescription drug use led to illegal drug use. Defendants have said there is no proof of a direct causal link and objected to his testimony dozens of times.


Gupta

Courtwright testified about three principal opioid epidemics that preceded the ongoing crisis. The first opium and morphine epidemic, in the late 1900s, was followed by a heroin epidemic in the late 1940s-early 1950s, followed by a heroin epidemic in the late 1960s-early 1970s, he said.

The City of Huntington and Cabell County sued the “Big Three” drug distributors – McKesson, AmerisourceBergen, and Cardinal Health – in 2017 over their role in the overdose crisis,  after more than 80 million doses of the drugs were sent to the area in an eight-year period.

Plaintiffs have sought to make the case that prescription painkiller use is tied to illicit drug use, which became a greater problem statewide and regionally in recent years. Tuesday, Dr. Corey Waller, an Michigan doctor with expertise in pain and substance use disorder, testified that people who take prescription painkillers and those who use opioids illegally see identical changes in their brain chemistry

Courtwright confirmed, under questioning Wednesday from plaintiffs’ attorney Paul Farrell Jr. that supply was a substantial factor giving rise to the prior opioid epidemics in the United States.

Courtwright, who wrote "The Age of Addiction: How Bad Habits Became Big Business," said the first epidemic, in the late 1900s, came from widespread medicinal use of opioids.

“To be precise, per capita consumption of medicinal opiates in the United States tripled between 1870 and 1890, which was right in the heart of the first epidemic,” he said.

Senior U.S. District Judge David Faber asked if that epidemic was related to the Civil War. Courtwright said that belief is a myth. He said surveys show women made up 60-70 percent of addicted people.

"What do we know about women?" he said. "They seek out medical care, and they were exposed to the administration of these drugs by physicians, disproportionately to men. I think that explains the gender difference."

Vulnerable, young people were most affected by the second and third epidemics, he said, following an increase in the supply of heroin following World War II, and again in the late 1960s, 

Courtwright testified that those crises waned after stories in newspapers and angry speeches from public officials, followed by action, including reform within the medical profession and the passage of statutes.

Following the first epidemic, governments passed prescription laws and the Harrison Narcotics Tax Act of 1914, Courtwright said. Courtwright said the "purpose was to make sure that all narcotic transactions were confined to legitimate medical channels."

Following the late 1960s-early 1970s epidemic, President Richard Nixon waged the "war on drugs." 

The Controlled Substances Act of 1970 was a major part of that, Courtwright said. That law is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of drugs is regulated, and includes drug scheduling categories.

The Harrison Narcotics Tax Act, he said, "deputized the registrants to help prevent the problem of diversion."

"There are half a million people who are registered under the Controlled Substances Act," he said. "The government did not have enough agents to oversee every narcotic transaction. It needed help and that's why the law's written the way it is."

Monday, the defense had argued that they were under no government obligation to refuse to ship suspicious orders.

Gupta, who left West Virginia for the March of Dimes, testified about several reports the state Department of Health and Human Resources prepared during his tenure.

The defendants had sought to preclude, then limit his testimony, as well as preventing the use of four studies that informed his opinions.

Gupta, while explaining his background in public health, explained that the field is important because social determinants of health relating to where a person was born, lives, works and worships affect their health more than clinical care. He also stressed that public health work addressing addiction is important because addiction affects the community.

Plaintiffs are seeking to make the case that the shipments of pills to the region created a public nuisance for the area.

Anne McGinness Kearse, a lawyer for Huntington, questioned Gupta about work informing DHHR reports on overdose deaths and infectious disease, as well as the findings of those reports.

Defendants objected dozens of times, seeking to preclude Gupta from offering opinion about those reports’ implications, frequently on grounds that Gupta was relying on hearsay and hadn't directly observed events.

They argued that Gupta’s opinions were based on review of events that occurred before he moved to the state, and that questions were leading.

Faber said, at times, he would let Gupta speak and sort out later whether he’d consider the testimony in his ruling. While he said that “you have to do a little bit of leading to get to the subject,” he also told Gupta not to editorialize. 

Gupta referred to an analysis of 2016 overdose deaths released in 2018, among other DHHR reports.

In the report, health officials reviewed 818 deaths and found 33% of decedents tested positive for a controlled substance, but had no record of a prescription at their time of death, indicating diversion of a controlled substance prescription, and 91% of all decedents had a documented history within the controlled substances monitoring program.

Kearse asked if the investigation found a relationship between prescription drug use and heroin.

Gupta said that DHHR found through the 2018 report that people who died had interactions with the controlled substance monitoring program, but were less likely to have done so within the four months preceding the death, indicating a transition from prescription opioids to IV drugs. He also said that when they contacted people with HIV and Hepatitis C, they found those people had used prescriptions.

“And now because the supply has reduced, they have to transition to street drugs, predominantly heroin," he said.

He also said a crackdown in pill mills sent people turning to emergency rooms for pain pills, and some of them wanted the cheaper, alternative treatment on the street.

National studies on the link are consistent with DHHR’s findings, he said, “and there's not an iota of doubt” that’s what happened.

Defendants objected to Gupta’s testimony on the linkage, saying Gupta had told them during deposition that his opinion on the linkage was based on a study he didn’t conduct, and that this was the first they were hearing of the pill mill crackdown and contact tracing as basis for his opinion. 

“I think the thing to do is to hear what he has to say and, in all likelihood, I’m not going to consider it,” Faber said, adding that he was presiding over a bench trial, so no jury was present.

While Enu Mainigi, for the defense, asserted during cross-examination that Gupta was relying on one outside study, Gupta shook his head no and asked Faber to correct the mischaracterization, but the judge told him to just answer the questions.

In a series of questions focused on each report during cross-examination, Mainigi asked Gupta to confirm that each did not include any recommendation to focus on drug distribution. 

Mainigi is lead and national counsel for Cardinal Health in multi-district, nationwide opioid litigation spanning several years.

"Are you familiar with the fentanyl analogue called, and I may mispronounce it, so you can correct me, carfentanyl?" Mainigi said, emphasizing the "an" in the word.

"How do you pronounce that?" she said.

"And you're aware that carfentanyl does not come from Cardinal Health, ABC, or McKesson," she added.

Gupta pronounced the word correctly.

"Maybe one of the reasons I'm very familiar with spelling and speaking carfentanyl is I see that a lot," he added.

Gupta’s testimony resumes Thursday.

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)

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