The outcome of a landmark federal opioid trial in West Virginia that reached closing arguments this week rests on two legally thorny questions.
Was it "unreasonable" for three of America's biggest corporations — the drug wholesalers AmerisourceBergen, Cardinal Health and McKesson — to ship roughly 81 million highly addictive opioid pills to pharmacies in one small Rust Belt city on the Ohio River?
If that was a reckless thing to do, does the addiction crisis in Huntington and surrounding Cabell County, W.Va., amount to a "public nuisance" that the companies must help remedy?
The answers to those questions will now be decided by U.S. District Judge David Faber in Charleston, W.Va.
His ruling, not expected for at least a month, could set legal precedents that shape corporate accountability for the opioid epidemic raging in thousands of communities across the United States.
According to the Centers for Disease Control and Prevention, more than 500,000 Americans have died since companies began aggressively marketing and distributing prescription pain pills in the late 1990s.
Experts believe the flood of opioid medications served as a kind of gateway, igniting a deadly second wave of addiction and overdose deaths linked to heroin and the synthetic opioid fentanyl.
In his closing arguments, attorney Paul Farrell, who lives in Huntington and represents Cabell County, said evidence is clear that the companies' business practices caused serious harm.
"It was a blowout," Farrell said. "We had 81 million pills that came flooding into our community. And it wasn't by accident. Somebody delivered those pills here."
According to federal data made public during the trial, the pills were shipped to the community from 2006 through 2014, years when America's opioid epidemic was surging.
Officials in Huntington and Cabell County are asking Faber to award them up to $2.5 billion in damages, money they would use to help ease the opioid crisis.
The companies deny any wrongdoing and say the huge shipments of pills — which they acknowledge occurred — reflected trends in opioid prescribing practices by doctors, which were out of their control.
"We're a mirror of what's happening in health care," Enu Mainigi, an attorney representing Cardinal Health, said in her closing arguments. "We reflect it. We do not drive it."
Public health experts say the ruling in this landmark federal case will define the public health response to the opioid crisis in hard-hit West Virginia for decades to come.
It could also shape the legal strategies of thousands of communities across the U.S. currently suing the drug industry over companies' role in making, distributing and selling highly addictive opioid medications.
Over the next 150 days, those communities will decide whether to accept a $21 billion national settlement offered by AmerisourceBergen, Cardinal Health and McKesson.
Joe Rice, an attorney with Motley Rice who represents dozens of governments suing the drug industry over opioids, including the city of Huntington, said the outcome of the West Virginia case could influence those decisions.
"People are going to watch what happens in Huntington and Cabell," Rice said.
He noted, however, that the opioid epidemic in West Virginia has been more destructive than in other parts of the U.S., which makes this case unique.
"Huntington and Cabell are one of the hardest-hit areas of the country, so [other communities] will have to measure the facts they have to put forward in what they decide to do in the settlement process or through a trial," Rice told NPR.
This is a community where 1 in 10 people is opioid dependent
Over the course of this trial, attorneys for Huntington and Cabell County argued that the companies failed to implement adequate monitoring systems to detect oversupply of opioids. The firms all dispute those claims.
Public health experts testified that the impact of that "tsunami" of pills has been profound on this community of roughly 91,000 people. One in 10 residents of Cabell County is now believed to be opioid dependent.
According to data presented during the trial, more than 2,500 children have been born with developmental challenges linked to opioid use by their mothers. Over the last five years, 6,400 people have experienced overdoses.
The community has also seen a related crisis of HIV/AIDs and hepatitis because of contaminated-needle use.
In his closing arguments, Farrell said the opioid epidemic could be overcome with adequate funding.
"We're trying to create treatment programs that can make a difference and save lives and be a shining example for the nation of how to get out of this problem," he said.
Drug distributors blame doctors and regulators
Attorneys representing AmerisourceBergen, Cardinal Health and McKesson acknowledged shipping tens of millions of opioid pills to Huntington and Cabell County. They also agreed that an addiction crisis is ravaging the community.
But during closing arguments, attorneys for the three firms argued that the companies acted responsibly, shipping pain pills only on the basis of legally written prescriptions to licensed pharmacies.
They also downplayed the significance of the large quantities of opioids distributed to pharmacies in the community.
"Volume does not equal wrongdoing," said Mainigi, from Cardinal Health's legal team. "What caused the increase in volume was the change in the standard in care. Doctors prescribed more opioids to treat pain. The evidence shows they wrote those prescriptions in good faith."
"Licensed physicians chose to prescribe more opioid medications," said Robert Nicholas, an attorney representing AmerisourceBergen. "Distributors did not second-guess these judgments. ... They weren't qualified to do that. It wasn't their place to do that."
At one point, however, Faber questioned whether the magnitude of opioid shipments delivered to the community might trigger some legal liability.
"Is there some point at which the number would be so great that it would be unreasonable?" Faber asked.
Attorneys representing the firms noted that national quotas for opioid production are regulated by the U.S. Drug Enforcement Administration (DEA).
"The DEA permits this volume of pills," said attorney Timothy Hester, representing McKesson. "It cannot be possible to call that distribution of pills unreasonable."
For the corporations, tens of billions of dollars in potential liability are at stake, along with potential harm to their reputations as cornerstones of America's for-profit health system.
While the federal case in West Virginia nears conclusion and states weigh whether to join the national opioid settlement involving the drug distributors, a wider legal reckoning is unfolding in courtrooms around the U.S. over corporate America's role in the opioid crisis.
State opioid trials are underway in California and New York, with another major federal opioid trial against pharmacy chains now scheduled for October in Ohio.
A confirmation hearing for the bankruptcy of Purdue Pharma, maker of OxyContin, is scheduled for Aug. 9 in New York.
SCOTT SIMON, HOST:
There were closing arguments this week in a landmark federal opioid trial in West Virginia. A judge will now decide whether it was reasonable for three of America's biggest corporations to ship 81 million opioid pills to one small city. Behind the complex legal arguments in the case, there is outrage and despair in West Virginia at the continuing destruction caused by the opioid epidemic as NPR addiction correspondent Brian Mann reports.
BRIAN MANN, BYLINE: Speaking on the steps of the federal courthouse in Charleston, W.Va., attorney Paul Farrell voiced fury this week at the tsunami of pain pills that hit his hometown, Huntington.
(SOUNDBITE OF ARCHIVED RECORDING)
PAUL FARRELL: There is no new evil in the world. We just recreate new ways to experience it.
MANN: Farrell leads the legal team representing Huntington and surrounding Cabell County, located about an hour from Charleston. The community sued three of the nation's biggest drug distributors - AmerisourceBergen, Cardinal Health and McKesson. Farrell told reporters evidence presented during the trial shows the companies acted recklessly.
(SOUNDBITE OF ARCHIVED RECORDING)
FARRELL: How you can sell 81 million pills into a town of 100,000 people and then walk away and not only deny any responsibility, but then pretend like there's no fallout...
MANN: The companies deny any wrongdoing and say they acted properly. But two basic facts in this case aren't in dispute. Federal records show the companies did ship that many pills during a nine-year period when West Virginia's opioid epidemic was spiraling out of control. The second fact not in dispute is that Huntington, which stretches along the Ohio River, is in big trouble; 1 in 10 residents here now struggle with opioid use disorder. Drug overdose deaths surged again last year across West Virginia, up 40%. Robert Davis lives on the street in Huntington. His drug of choice is methamphetamines laced with the synthetic opioid fentanyl.
ROBERT DAVIS: I just did that, Narcan'ed (ph) somebody.
MANN: Narcan is a medication that revives people overdosing on opioids.
DAVIS: Just happened to been right by the dude, man. I didn't know he was even on heroin. And next thing I know, bam, he plopped. I told a dude, it's like, man, he's so deep.
MANN: Talking to people in Huntington, I hear stories like this over and over. Amanda Coleman heads a day shelter and social service program for homeless people with addiction called Harmony House.
AMANDA COLEMAN: It's been staggering, and it's been really hard on the staff who work here seeing people overdose, losing people to overdose, or having people come in and say, oh, I OD'd three times this weekend.
MANN: In their lawsuit, local leaders are demanding $2.5 billion from the drug companies. They say the money would go to expand programs like Harmony House. But Coleman says she stopped believing help is on the way.
COLEMAN: I don't have a whole lot of hope that our society is going to change the things that need to be changed in order to dramatically reduce this problem. It's demoralizing as somebody who's working in this field.
MANN: The three drug distributors have agreed to a tentative national settlement for their opioid practices worth $21 billion. But West Virginia has opted out of that deal. In closing arguments this week, attorneys for the companies said they played no role in the deadly epidemic unfolding in Huntington. They said they only shipped pain pills to licensed pharmacies based on prescriptions written by doctors. They pointed out their opioid shipments to Huntington were monitored by state and federal regulators. The companies also argued the crisis with heroin and fentanyl has no link to those millions of opioid pain pills.
Legal experts interviewed by NPR say those arguments may well prevail. This case is anything but a slam dunk. Whatever the outcome, journalist Eric Eyre, who won a Pulitzer reporting on West Virginia's opioid crisis, says the trial was important.
(SOUNDBITE OF ARCHIVED RECORDING)
ERIC EYRE: Everybody here in West Virginia, we wanted to have our day in court, you know, try to hold these companies accountable. You know, we found out about those hillbilly emails that made fun of West Virginians.
MANN: He's referring to internal emails shared by executives at AmerisourceBergen made public during the trial that mocked people with opioid addiction as pillbillies (ph) and described prescription pain pills as hillbilly heroin. Eyre says one frustration during the trial was that Judge David Faber only allowed evidence that focused on opioid shipments directly involving Huntington and Cabell County, excluding data that showed companies also sent massive shipments of pain pills to other rural counties nearby.
EYRE: It was like a faucet, and they turned the faucet on, you know, full open, way more than medical need in one of those small communities.
MANN: A ruling in this case isn't expected for at least a month. Thousands of communities across the U.S. hit hard by the addiction crisis will watch closely to see whether Huntington prevails as they weigh whether to continue their own lawsuits against the drug companies or take the national settlement offer now on the table. Brian Mann, NPR News, Huntington, W.Va.
(SOUNDBITE OF MUSIC) Transcript provided by NPR, Copyright NPR.