As she went through a timeline of state and federal regulatory decisions, an attorney for giant drug distributor Cardinal Health told a federal judge that the huge numbers of opioid painkillers shipped to Cabell County were never “unreasonable.”
For a second and final day, attorneys representing the “Big Three” drug distributors made closing arguments that the companies — AmerisourceBergen, Cardinal Health and McKesson — should not be held responsible for the opioid epidemic that plagued West Virginia’s fourth-largest county and one of its largest cities, Huntington.
“The number of pills we distributed [to Cabell County] was exactly the number of pills prescribed,” Cardinal Health lawyer Enu Mainigi said, disputing claims from Cabell County attorney Paul Farrell Jr. that the 81 million pills shipped by distributors over eight years into a county with about 100,000 people was “unreasonable” and caused public harm.
“The plaintiffs started their case by saying there was something unreasonable about all of our suspicious order monitoring systems,” Mainigi said. “But when that didn’t pan out with the company witnesses, their entire case became about volume, your honor. Their entire case became about volume and volume alone.”
In 1998, she noted, West Virginia’s Legislature passed the Manageable Intractable Pain Act, which protected doctors from lawsuits for prescribing opioids to patients in pain. In 2001, the state Board of Pharmacy issued a policy statement encouraging the use of opioids for pain. By 2005, she said, the pharmacy board was telling doctors they could get in trouble for underprescribing pain medication.
As for the sheer number of pills that went to West Virginia, including Huntington and Cabell County, Mainigi pointed to testimony from former state Health Officer Dr. Rahul Gupta, who described the state’s high rates of pain-causing conditions. In a 2016 report from Gupta on the state’s public health landscape, the state led the nation in its prevalence of arthritis and cancer
Throughout the trial, lawyers for the distributors and for the city and county have gone back and forth as to how effective opioids are at treating pain versus covering it, referring to scientific journals and articles that support their stances.
But to doctors in the early 2000s, federal and state medical leaders were calling for more opioids, and doctors were acting in good faith, Mainigi said.
Surveillance and due diligence
Expert witnesses for the city and county, like former U.S. Drug Enforcement Administration official James Rafalski, said earlier in the trial that the distributors failed to create and operate programs to stop prescription painkillers from being diverted and sold illegally.
Rafalski said in late May he believed most of the distributors’ orders should’ve been blocked. But to hold back orders or to send less out, Mainigi said, distributors like Cardinal Health would’ve been interfering with doctor-patient relationships and patients who might really need their drugs. It was up to doctors, she said, to weigh the risks and benefits of prescribing opioids.
“Doctors must make the decision on how to strike that balance,” Mainigi said. “Distributors cannot unilaterally decide to stop shipping an FDA-approved medication simply because a certain portion of the population may experience what is a known risk.”
And all the while, Cardinal Health’s surveillance monitoring system was in compliance with state and federal law, said Mainigi. Until 2008, the DEA allowed distributors to report suspicious orders after they had been shipped.
Distributor attorneys highlighted that all their clients’ customers were licensed — including, for Cardinal Health, the Huntington Medicine Shoppe that came up earlier in the trial for suspicious orders.
Mainigi pointed in her closing arguments to several investigations, from 2012 to 2016, that showed no evidence of diversion.
“Your honor, as I stand here today, Medicine Shoppe remains a licensed pharmacy in good standing with the state of West Virginia and the DEA,” Mainigi said. “There is no evidence that Cardinal Health acted unreasonably in that context.”
McKesson attorney Timothy Hester was the final attorney to speak on behalf of the defendants on Wednesday.
While Hester echoed other points made by attorneys for the drug distributors, he also disputed that prescription opioids were still driving substance use in Cabell County.
Calling it a “gateway” effect, attorneys for Huntington and Cabell County have argued distributors are also responsible for the use of heroin and fentanyl, both of which are illegal under the Uniform Controlled Substances Act. Expert witness Corey Waller, a specialist in treating addiction, testified earlier in the trial that all opioids, prescribed or synthetic, have the same chemical compositions and effect on the brain.
But Hester argued that distributors can’t be held responsible for the misuse of products when their customers — the pharmacies — are meeting all legal licensing requirements.
“Licensed pharmacy distributors had nothing to do with the decisions and these actions taken entirely by criminal actors,” Hester said.
Rather, he pinned illegal use of prescription use on the individuals themselves, and the rising use of illicit drugs on “cartels and drug dealers.”
“It has shifted to the abuse and misuse of heroin and fentanyl, and fentanyl analogues. It’s a crisis of heroin and fentanyl abuse,” Hester said.
Like Mainigi and attorney Bob Nicholas for AmerisourceBergen, who testified Tuesday, Hester disagreed with the city and county’s request for abatement.
The plaintiffs want $2.5 billion for a four-part plan focused on responding to opioid use disorder and its ripple effect on the community. But much of that money covers the actual treatment of addiction, which the city and county wouldn’t oversee.
The plan also consists of caring for people who have opioid use disorder in the future, and which wouldn’t be directly caused by the product that distributors sent into the community.
“Treatment of harms is not proper abatement,” Hester said.