It is well accepted by most everyone involved in the landmark opioid trial that has taken place in Charleston over the past few months that there is a substance abuse epidemic in Huntington and Cabell County.
Also not up for debate is that local officials are doing the work to alleviate the suffering of drug-addicted residents, their families and the area’s social structure, as a whole.
Identifying who or what caused the problem, and who ultimately should pay the projected nearly $2.6 billion price tag to fix it, is where the disagreement lies.
Senior U.S. District Judge David Faber is now left to answer those questions after closing arguments ended Wednesday in the first-of-its-kind trial that began May 3.
The city of Huntington and the Cabell County Commission claim three drug distribution companies — AmerisourceBergen Drug Corp., Cardinal Health and McKesson — played a substantial role in fueling the substance abuse epidemic in their communities by distributing millions of pills to pharmacies in the area and failing to flag what the local governments said were unusual or suspect orders for such large quantities of pills compared to the population of the area.
Attorneys for the drug distributors argued that their clients have complied with federal laws and U.S. Drug Enforcement Administration regulations, and aren’t liable for the epidemic.
Faber did not indicate Wednesday when he might hand down his decision. Final briefs from each party in the case are set to be filed in the next two weeks.
Attorneys for Cardinal Health and McKesson made their final case to Faber Wednesday morning and early Wednesday afternoon, saying there is no evidence that indicated the companies engaged in unreasonable conduct.
Bob Nicholas, representing AmerisourceBergen, presented his closing argument Tuesday afternoon.
The drug companies’ attorneys argued that the plaintiffs have proven only that there was a large volume of pills shipped to the area and that there is a substance abuse epidemic there. They also argued that the city and county have not proven the distribution of pills led to the illegal use of prescription opioids or subsequent use of illegal drugs, including heroin.
That’s because they all were following the same standards of care, which changed in the 1990s to determine that pain is a vital sign health care professionals should gauge when treating patients, Enu Mainigi, representing Cardinal Health, and Timothy Hester, representing McKesson, argued Wednesday.
“The illegal drug crisis could not have been foreseeable to distributors when every health care and regulatory system in this country encouraged increased prescribing without ever thinking it would lead to a heroin and fentanyl crisis,” Hester said.
Responding to those arguments, Anthony Majestro, representing Huntington, said the whole point of the federal Controlled Substance Act was to regulate addictive products, including opioids, derived from opium, which has been noted for centuries for its pain-killing and addictive qualities.
“To pretend that the supply of opium doesn’t create addiction and demand totally ignores the entire premise of why we’ve regulated this drug,” Majestro said. “It is a metastatic cancer on our body politic and will continue to grow. It has been around since the Byzantine era. It has toppled governments. You can’t get opioid addicts without a supply of opium.”
Huntington and the Cabell County Commission claim the drug distributors played a substantial role in fueling the substance abuse epidemic in their communities by distributing millions of pills to the area. In their initial lawsuit, the local governments claimed the drug distributors delivered more than 81 million pills to the area between 2006 and 2014. The area’s population at the time was between 90,000 and 100,000 people.
Data presented as evidence during the trial showed that as many as 127.9 million pills were shipped to Huntington and Cabell County during those years.
Attorneys for the local governments argued that the influx of opioid pills was a catalyst for substance abuse disorder among residents, which led to them later using other illegal drugs, including heroin, when opioids weren’t easily accessible.
The epidemic has been a drain on the governments’ resources, straining their finances and their workforce, particularly the first responders who are treating people suffering from overdoses and investigating the public health and criminal ripple effects of substance abuse.
Dr. Caleb Alexander, a professor at the Johns Hopkins Bloomberg School of Public Health, testified that it would take almost $2.6 billion to enact a plan to abate the epidemic in the city and county.
If Faber finds the drug distributors are liable for the epidemic and should pay for the damages Huntington and the Cabell County Commission have suffered, he will determine how much money they would receive.
The drug distributors collectively have argued they are not to blame for the substance abuse disorder epidemic.
Their attorneys said the evidence indicates that they distributed opioids in accordance with prescriptions written in good faith by local doctors and filled by local pharmacists. The attorneys have argued that the doctors and pharmacists were acting in accordance with medical standards of care, and state and federal regulations.
They also have argued that the companies’ systems to monitor drug distribution complied with DEA standards.
On behalf of Cardinal Health, Mainigi on Wednesday recapped the history of opioid distribution during her closing arguments.
During the 1980s and most of the 1990s, opioids most commonly were used for end-of-life care and chronic pain. However, the changes to standards of care in the late 1990s led to a greater acceptance in treating a wider range of pain using opioids, leading to the state Board of Medicine, attorney general and Legislature adopting policies and laws in 1997 and 1998 that opened the door for doctors to prescribe more opioids.
Subsequently, there was an increase in opioid prescriptions in the late 1990s and early 2000s, Mainigi said.
Mainigi referred to data charts presented during the trial that showed opioid prescription trends in Cabell County, Huntington and West Virginia matched nationwide trends.
What caused Cabell and Huntington to have a higher opioid prescription rate per capita was that West Virginia already had a higher overall per capita rate for prescription medications before opioids were commonly prescribed, Mainigi said.
West Virginia ranks No. 1 in the country for total prescriptions per capita, Mainigi said, meaning doctors in the state prescribed more medications overall before opioids became more common.
“The bottom line is that the same number of opioid prescriptions would have been written and filled in Cabell and Huntington even if Cardinal had not existed,” Mainigi said.
She turned to testimony from former state health officer Dr. Rahul Gupta, who said West Virginia has an older population, which tends to suffer from more pain-causing conditions. Additionally, the state’s economy is heavily reliant on physically demanding jobs that lead to more work-related injuries, Gupta testified.
“West Virginia and, particularly Cabell and Huntington, have higher rates of pain-causing conditions and, therefore, higher rates of prescribing,” Mainigi said. “That’s always been the case, or been the case for a significant amount of time.”
Mainigi, Hester and Nicholas argued during the past two days that their companies’ respective drug monitoring systems did appropriately flag suspicious orders when they occurred, but did not stop orders because doing so could have left patients who needed medicine without it.
Hester noted that Gupta also testified that doctors often would overprescribe opioids to ensure patients didn’t experience pain but that no longer is the standard.
“Even today, after all this attention that’s been given to prescription opioids over the last decade or more, opioids continue to be recommended and approved,” Hester said. “They’re extensively prescribed, even today, for treating pain.”
As substance abuse disorder became more widespread, the standards for prescribing opioids changed to allow for fewer prescriptions. Hester again referred to testimony from Gupta, who said there was a 52% decline in prescribing opioids between 2014 and 2019.
Hester argued that, if there were a crisis created by the volume of prescription opioids, it ended years ago.
The only evidence of opioid pills leading to illegal drug use is when unused prescription opioids were diverted by family or friends or were stolen, he said.
“Medicine cabinet diversion is not something distributors created,” Hester said. “This all happens outside the closed system, after the opioids leave the pharmacy.”
Majestro said the defendants’ arguments completely ignored legal precedent, particularly what he described as a materially similar case before the U.S. Supreme Court from 1943.
That case, Direct Sales Co. vs. United States, Majestro said, involved a South Carolina town with a population of about 2,000 people receiving 6,000 doses of morphine sulphate per month. The morphine sulphate distributor argued then that it was just filling prescriptions written by local doctors, who also were criminally convicted in the case.
That’s the same argument the drug distributors are making in Charleston, West Virginia, in 2021, Majestro said.
The Supreme Court ruled against the distributor in that case, Direct Sales Co., saying, “it could be inferred that the seller not only knew the physician was selling the drug illegally but intended to cooperate with him therein.”
“These three companies are continuing to say the same thing: It is not their duty,” Majestro said. “What that tells me, your honor, is ... they would do it again.”
Wrapping up his closing arguments, Majestro presented a photo of the Summersville Dam, which holds back part of the Gauley River in Nicholas County, to create Summersville Lake, the largest lake in West Virginia.
Majestro asked Faber to compare the dam to the closed distribution system for prescription medicine, particularly opioids. He compared the water to opioids, and equated an engineer at the dam with the opioid distributors.
“[The defendants] are standing up above the water and they’re looking down,” Majestro said. “The volume of water that comes out is under their control. This isn’t an issue of the safety valve failed ... somebody had to turn it on. Someone had to turn it open.”