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.
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