OPIOID CRISIS

For the families of the roughly 400,000 Americans who have died of opioid drug overdoses since 1999, a legal drama scheduled to unfold in an Ohio courtroom in October may feel like a true shot at justice.

After downplaying the risks of dangerous and highly addictive prescription narcotics, and of profiting from their spiraling misuse, the purveyors of prescription painkillers could be forced to reckon with the consequences of their actions.

The civil trial promises to expose evidence suggesting that dozens of companies made deceptive claims about opioids, flooded the market with their products, engaged in shady record-keeping and lucrative self-dealing, and looked the other way as the body count mounted.

For their role in seeding and supplying an epidemic of addiction, a jury could hold the companies liable for billions of dollars in damages.

Equally important, a trial in the case known as Multidistrict Litigation 2804 would explore some of the thorniest questions in America today: Who bears responsibility for addiction? Can businesses be blamed if government agencies fail to enforce the law? And when profits drive the companies that deliver American health care, where does that leave patients?

Questions like these "require a broad conversation," said Thomas Cooke, a professor of business law at Georgetown University. But the companies in the Ohio case would "rather not have that conversation."

And U.S. District Judge Dan Aaron Polster, who presides over MDL 2804, doesn't think a Cleveland courtroom is the place to resolve such conundrums. Polster has leaned hard on all sides to settle the case and avert a trial.

Purdue Pharma and the Sackler family that controls it could pave the way. The MDL suits accuse them of engaging in a deceptive campaign to market OxyContin, and in September they announced a deal to have the Sacklers pay $3 billion and steer all of Purdue's future profits to states, counties, cities and federal territories that sign on to the settlement. Purdue says the payout could be worth more than $10 billion over time.

Neither the Sacklers nor Purdue would acknowledge any wrongdoing.

Whether deals like this deliver justice will be in the eye of the beholder. But they could bring swift resolution to a case that otherwise threatens to grind on for years. With opioids claiming an average of 130 lives a day in the United States, those who favor a settlement argue that time and money are better spent fighting the epidemic than debating who's to blame for it.

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Addiction to prescription opioids — including oxycodone, hydrocodone, fentanyl, morphine and codeine — now rules the lives of roughly 1.7 million Americans. Some 652,000 Americans use heroin, and roughly 80% of them are thought to have started down that road by misusing prescription narcotics. Opioid-related overdoses claimed the lives of 47,600 people in 2017.

And it will get worse. On its current trajectory, the epidemic could kill close to 82,000 people a year by 2025, according to one recent projection.

The White House Council of Economic Advisers estimated that opioid abuse cost the nation $504 billion in 2015 alone — not only for treatment and policing, but also for the lost economic potential of those ensnared by the drugs.

The case in Cleveland is the largest civil action in U.S. history. It consolidates some 2,000 suits brought by thousands of counties, cities and tribal entities against dozens of defendants. The plaintiffs include consumers, hospitals knocked on their heels by the opioid epidemic, and insurance plan administrators.

In a separate case, 49 states — all except Nebraska — are suing the companies that have made, marketed, distributed and dispensed opioids. That action is also driving toward a massive settlement, and it could muddle the Ohio proceedings even more.

"It's diabolically complicated," said Mike Moore, an attorney representing four states and a handful of cities and counties in the MDL 2804 suits.

The plaintiffs charge that corporate greed trumped the public's health at every turn.

Greed drove opioid manufacturers to oversell and overproduce the drugs, the lawsuits allege. Greed drove companies that distribute prescription drugs to oversupply pharmacies, they add. And greed drove pharmacies to over dispense the drugs to patients who were becoming hooked, to criminals who were diverting them to the black market, and to addicts shopping for a fix.

The evidence for some of these charges is not hard to find. Nor, in many cases, is it contested.

In a 2003 letter to Purdue Pharma, the Food and Drug Administration warned that its advertisements "grossly overstate the safety profile" of OxyContin and charged that the company was promoting it for unauthorized uses.

In a criminal case four years later, Purdue and three top executives pleaded guilty to misleading regulators, doctors and patients about the drug's addiction risks. The company paid $634 million in fines, but no one served jail time.

But in the years since, Purdue continued its efforts to make pain a "vital sign" to be routinely treated, urged doctors to prescribe OxyContin more freely, and targeted patients with ads that portrayed the drug as a lowrisk balm.

In 2008 and again in 2017, drug distribution giant McKesson paid millions to settle federal claims that it was supplying pharmacies with suspicious quantities of opioids. Another distributor, Cardinal, settled similar charges in 2008.

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Some of the cases swept into MDL 2804 accuse the defendants of fraud, corruption and "unjust enrichment." Others claim the companies have run what amount to illegal drug enterprises.

But virtually all agree on this: The collective actions of manufacturers, distributors and pharmacies have led to the social equivalent of an oil spill or a nuclear accident — and the resulting "public nuisance" has foisted steep costs upon cities, counties and tribes.

Moore calls it a "pill spill." And just as BP was required to clean up the oil that gushed from its Deepwater Horizon rig, the makers and distributors of opioids need to clean up the mess they made too.

"You marketed this stuff as nonaddictive, and you got us addicted," said Paul Farrell, a Hungtington, West Virginia, attorney who represents several cities and counties in MDL 2804. "You were supposed to monitor transactions to ensure only medical needs were being fulfilled. Instead, you poured enough opioids into places like West Virginia to supply every American man, woman and child with 67 prescription pain pills a year. ... Clean it up."

That legal argument — that an addiction epidemic can be treated like an environmental disaster — is "incredibly unique," Cooke said.

In August, a court in Oklahoma gave that novel theory some heft. Judge Thad Balkman ruled that opioid maker Johnson & Johnson breached the state's "public nuisance" law and ordered the company to pay the state $572 million in damages. (Johnson & Johnson plans to appeal the ruling.)

The MDL 2804 defendants say this use of public nuisance laws is an overreach.

The defendants also argue they are blameless because they adhered to the complex laws that govern their operations.

Manufacturers say they briefed doctors on opioids' risks as they were understood at the time and produced the drugs under the watchful eyes of the FDA and the Drug Enforcement Administration.

Distributors maintain that they followed DEA rules as they warehoused the drugs, recorded their volumes and whereabouts, and shipped them to drugstores as they were needed to fill prescriptions. Pharmacies say they dispensed the drugs as ordered by doctors and under rules dictated by state legislatures and pharmacy boards.

If any of the defendants had failed to comply with laws and regulations, they assert, the government should have stepped in and stopped them.

Detecting and acting on signs of an addiction epidemic, they say, was the responsibility of police departments, county public health offices, hospitals, state medical and pharmacy boards, the DEA and the FDA.

The argument puts some of the plaintiffs on the defensive, but it's not clear whether it will work in court, legal experts said.

The defendants "have 100% responsibility for what they create and what they put into the marketplace," Cooke said. "A potential juror would see blaming the government as an effort to deflect responsibility."

This line of defense is also undercut by the litany of penalties imposed by government regulators over the years.

The defendants, for their part, have pointed the finger of blame at one another, at the physicians who wrote opioid prescriptions, and at the people who took the drugs and became addicted.

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