Why drug distributors won WV opioid trial

West Virginians have seen opioid addiction decimate their families and their communities for years.

During last year’s landmark trial in Charleston against the nation’s largest drug distributors, they heard again about millions upon millions of pills shipped to a community too small to need or handle them.

They also heard how executives at one of the companies made fun of the people using the drugs, calling them “pillbillies” in a parody of the theme song to “The Beverly Hillbillies.”

As a result, many West Virginians were incredulous when, nearly a year after the trial ended, Senior US District Judge David Faber ruled in favor of the drug distributors and against Cabell County and the city of Huntington.

In the conclusion to his 184-page-ruling, Faber acknowledged the “considerable toll” taken on residents by the opioid epidemic, but — in a line present in most news accounts of the ruling — said cases “must be decided not based on sympathy , but on the facts and the law.”

Lawyers for both sides agreed before the trial that the judge could decide the case himself, without a jury. So what were the facts, and the law, that led Faber to let the huge companies that had supplied so many pills to so few people off the hook?

What was the argument against the distributors?

Early in his ruling, Faber wrote that both sides agreed that there is an opioid epidemic, in Huntington and Cabell County as well as the entire country, and that “the epidemic was fueled, at least in part, by prescription opioids.”

The city and county argued that the drug distributors — AmerisourceBergen, Cardinal Health and McKesson — had caused the epidemic by flooding the area with pills, and should have to pay to fix the problem. As the judge wrote, they were seeking “relief in the form of abatement” of the problem.

As distributors, the companies serve essentially as a middleman between drug manufacturers and the pharmacies where drugs are sold. In this role, they’re also expected to monitor for suspicious orders of controlled substances and work with authorities, including the US Drug Enforcement Administration, to prevent them from being diverted to the streets.

The heart of Cabell and Huntington’s argument was that the distributors failed in their role as watchdogs. Over eight years, 81 million opioid painkillers were delivered to Cabell County, which has fewer than 100,000 residents. As a result, plaintiffs argued, overdoses and crime rates spiked, families were torn apart, and the fabric of the communities was irrevocably changed.

Plaintiffs’ lawyers argued that the companies’ oversight measures weren’t good enough. If they had been in the city and county said, the flood of easily abused opioids could have been avoided, along with the increased overdoses and crime rates, and the damage to families and communities.

The city and county also wanted to prove that executives at the companies knew about the damage they were causing, and continued to ship massive quantities of opioids into the region anyway. That’s where lawyers used the “pillbillies” emails in their arguments.

But Faber blocked lawyers from using a 2018 bipartisan US House of Representatives report that cited the distributors’ “failures that contributed to the worsening of the opioid epidemic,” saying it was “inherently political.” His ruling contradicted a previous one by the federal judge in charge of opioid litigation across the nation, who allowed the report to be introduced.

Why did the judge find their arguments inadequate?

As middlemen between pharmacies and manufacturers, the drug distributors argued, they neither created and marketed the pills, nor wrote prescriptions for them. All they did was fill pharmacies’ orders in good faith, while using DEA-approved methods for flagging suspicious orders. Even when orders for opioids skyrocketed, they argued that it was not their place to question the judgments of doctors.

The defense was able to present their entire argument in only five days of the six weeks granted to them, and Faber found their arguments compelling

“There is nothing unreasonable about distributing controlled substances to fulfill legally written prescriptions,” the judge wrote. And in great detail, he described how changes in the field of medicine — some of which, albeit, were pushed by opioid manufacturers — had doctors rethinking their approach to pain management, with many seeing opioids like OxyContin as possible solutions with relatively low risks of addiction.

Moreover, the companies followed DEA guidelines by establishing automated systems to look for suspicious orders of the controlled drugs, the judge wrote. The DEA even called AmerisourceBergen’s method of identifying these shipments a new “industry standard” in 2007.

What about this “public nuisance” stuff?

The only charge that Cabell County and Huntington brought against the distributors was creating a “public nuisance.” That essentially means that the companies’ actions, they argued, prevented residents from exercising their rights and living safely and peacefully.

Historically, public nuisance charges have been an effective means of punishing industries that have done harm to large swaths of the population in America. For example, the $206 billion tobacco industry settlements of the 1990s came after public nuisance charges were brought against many of the industry’s largest companies by individual states and territories. In West Virginia, such charges have been brought against companies that have harmed the environment in ways that damaged residents’ health.

But even before the trial began in early May 2021, Faber had made clear that his interpretation of public nuisance was a relatively narrow one.

When the drug distributors’ lawyers argued the case should be thrown out because public nuisance laws didn’t apply to them, Faber shot them down and said the case could move forward.

In doing so, though, he drew a distinction: while it would be extremely difficult to bring a nuisance case against a lawfully operating business that local officials soured on, Cabell and Huntington’s lawyers were arguing that the drug distributors had broken the law when they failed to stop massive and suspicious shipments of pills to the area. That, Faber wrote, would be grounds for a nuisance case if it could be proved.

Ultimately, that part of the Cabell/Huntington case fell apart in Faber’s eyes.

Faber’s analysis of public nuisance cases in West Virginia concluded that the public nuisance law could not be applied to the legal sale and marketing of products. And moreover, the plaintiffs couldn’t prove that the companies directly impacted property or public resources.

Faber’s ruling here is contrary to the finding of a panel of West Virginia circuit judges who ruled on the legitimacy of a similar case in West Virginia, where dozens of cities and counties were suing the same drug distributors. The distributors tried to have the case thrown out on the grounds that West Virginia’s public nuisance law could not be applied to them.

In an order signed by Circuit Judges Alan Moats and Derek Swope, the judges wrote, “the Panel finds and concludes that West Virginia public nuisance law encompasses Plaintiffs’ opioid claim.” They pointed to other circuit cases in West Virginia — which Faber said were “not persuasive” — as well as rulings by the federal judge overseeing opioid litigation, and courts in 22 other states, to back up their ruling.

What were Cabell County and Huntington asking for?

Cabell and Huntington lawyers asked the court to award them $2.5 billion over 15 years. The number was based on an abatement plan devised by a Johns Hopkins researcher laying out the services and funding required to effectively combat the opioid epidemic in the area.

The defendants argued that the number was unnecessarily high, and Faber ultimately agreed with them.

Faber wrote that little in the plan directly addressed stemming the number of opioid pills flooding Huntington and Cabell, and instead focused on the effects of addiction. “It is readily apparent that what plaintiffs seek is not relief from wrongful conduct,” he wrote. “Instead, plaintiffs’ ‘Abatement Plan’ seeks recovery for the extensive harms of opioid abuse and addiction.”

What about the big plaintiffs’ witness?

After months of silence, the first hint at what Faber’s ultimate decision might be came last month, one week before he issued his ruling. The judge partially granted a defense motion to dismiss testimony from one of the plaintiffs’ star witnesses.

James Rafalski, a former DEA investigator, had decades of experience working to prevent the diversion of prescription drugs to the black market. He tested that he believed the drug distributors’ methods for identifying suspicious opioid shipments weren’t good enough. The calculations they used, he said, allowed massive shipments of pain pills to move ahead without question.

Rafalski demonstrated a number of alternative methods that he believed would have alerted the companies and the DEA that an abnormally large number of opioids were being sent to Cabell County.

Faber allowed that testimony, but he did take issue with Rafalski’s retrospective conclusion that the drug distributors’ efforts to stop drugs from entering the black market were insufficient. In the nearly 30 pages of his ruling that he dedicated to parsing the evidence in favor of and against Rafalski’s criticisms, Faber wrote, ”Mr. Rafalski did not evaluate whether any pharmacies within plaintiffs’ borders were neglecting their legal obligations with regards to effective controls against diversion.”

Because of this, the judge threw out Rafalski’s testimony linking the companies’ order monitoring system to the opioid crisis in Cabell County, deeming it just the former DEA investigator’s opinion, and inadmissible as evidence.

In his ruling a week after he disallowed part of Rafalski’s testimony, Faber wrote that while in retrospect it might be clear that the companies flooded the area with an unreasonable number of pills, there was nothing unreasonable about the companies’ behavior and attempts to prevent that .

What happens next?

Lawyers for Huntington and Cabell County have 30 days from Faber’s ruling to appeal the case to the 4th US Circuit Court of Appeals. An appeal could cost both sides a lot of money, so a settlement is still a possibility.

Faber’s ruling was filed with the court late on the afternoon of July 4, hours before another trial against the drug distributors was to start. That trial, in circuit court rather than federal court, involved more than 100 West Virginia cities, towns and counties. Plaintiffs’ lawyers asked for a delay in that trial, and Swope, the circuit judge who is overseeing the trial in Kanawha County, granted it.

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