Jan Hoffman

Judge Dan A. Polster of the Northern District of Ohio announced from the bench Monday morning that the deal was struck around 1 a.m.

People familiar with the discussions said a settlement to resolve thousands of other cases brought by local governments and states could be announced later in the day by state attorneys general, but Polster confirmed only the settlement of this first landmark trial.

To settle the case, the drug distributors — McKesson, Cardinal Health and AmerisourceBergen — will pay $215 million to the two Ohio counties that brought the case, people familiar with the agreement said. Teva, the Israel-based manufacturer of generic drugs, is expected to pay $20 million in cash and donate $25 million worth of addiction treatment drugs.

The settlement is the latest in a flurry of agreements reached by drug companies to avoid the landmark federal trial, which was to serve as a test case for legal arguments and evidence in a yearslong attempt to hold the pharmaceutical industry accountable for an epidemic of addiction to opioid painkillers that has killed hundreds of thousands of Americans.

Other companies who already reached a settlement to avoid that trial include Johnson &amp; Johnson; Mallinckrodt Pharmaceuticals, one of the biggest manufacturers of generic opioids; and Purdue Pharma, which has been widely blamed for igniting the opioids crisis with misleading marketing of its drug OxyContin.

The ultimate goal of all companies is to reach a so-called global settlement to resolve all the cases still on the runway in federal and state courts. Purdue reached a tentative settlement to do just that in September — a deal that involves a cash payment of up to $4.5 billion from its owners, members of the Sackler family, and a restructuring of the company into a public entity that would donate all profits to cities, counties and states to compensate for costs associated with the epidemic. But that deal is mired in a long bankruptcy court process.

On Monday morning, the drug distributors, Teva and other companies were still working to reach a global deal worth nearly $50 billion in cash and donated addiction treatments. Talks to do so had reached an impasse Friday, but people familiar with the negotiations said Monday that they were continuing.

In announcing the settlement of the Ohio trial in court Monday morning, Polster appeared to nudge the parties to keep working. “I did not encourage the settlement of this trial only,” he said, noting that the parties and negotiators were in the courthouse all day Friday and into the evening to discuss the larger settlement.

He said he understood that the parties will keep trying, adding that he hoped that “we don’t lose the momentum that was created.”

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$260 Million Opioid Settlement Reached at Last Minute With Big Drug Companies

CLEVELAND — The three major drug distributors and an opioid manufacturer have reached a settlement worth $260 million to avoid the landmark first federal opioid trial that was set to begin here Monday.

The deal, which is a combination of cash payouts and donations of addiction treatments, could become a model for a nationwide settlement of thousands of similar cases brought in an attempt to hold the pharmaceutical industry accountable for an epidemic of addiction that has killed hundreds of thousands of Americans.

In the settlement, the drug distributors — McKesson, Cardinal Health and AmerisourceBergen, which distribute about 90% of all the medicines to pharmacies, hospitals and clinics in the United States — agreed to pay $215 million to the two Ohio counties that brought the lawsuit. Teva, the Israel-based manufacturer of generic drugs, agreed to pay $20 million in cash over three years and donate $25 million worth of addiction treatment drugs such as a generic Suboxone, which blunts cravings for opioids.

“We hope it provides a bench mark for a national resolution for other communities to have the resources to do what is necessary to abate the epidemic,” said Peter H. Weinberger, a Cleveland lawyer who represents some Ohio counties.

Even as the two-county settlement was being announced, the drug distributors and other corporate defendants in the trial were pursuing a global deal, worth $48 billion in cash and donated addiction treatments, to resolve all opioid lawsuits against them.

On Monday afternoon, four state attorneys general — from North Carolina, Pennsylvania, Texas and Tennessee — announced a step toward that much more ambitious goal, saying they had reached a tentative agreement to settle the cases against the three distributors, Teva, and Johnson &amp; Johnson. But they not only have to sell the deal to the rest of the states, but also to the cities and counties, who have been pushing for more money paid out in a shorter time frame.

Settlement Is Reached as an Opioids Trial Was Set to Begin in Ohio

CLEVELAND — The three major drug distributors and an opioid manufacturer have reached a $260 million settlement with two Ohio counties to avoid the landmark first federal opioid trial that was set to begin here Monday.

The weekend impasse highlighted the tensions over money, control and optics between the states that, through their attorneys general, filed opioid lawsuits in state courts and the counties, cities and tribes nationwide whose thousands of cases are assembled before a federal judge in Cleveland.

This jury trial, brought by two Ohio counties, is the local governments’ turn to show their hand and throw down their best evidence, witnesses and lawyers. It’s considered a litmus trial, in which the plaintiffs want to tell a national story so stark, and land a verdict so whopping, that these pharmaceutical defendants and others will settle.

But if the posture taken during 10 hours of talks on Friday in courthouse caucus rooms filled with their chief executives is any indication, the companies believe they have a viable defense.

The defendants include three major drug distributors, McKesson, Cardinal Health and AmerisourceBergen; Walgreens; and Teva, an Israeli drug manufacturer. Five drugmakers, including Purdue Pharma and Johnson &amp; Johnson, already settled with the two counties, as did a small distributor over the weekend.

Monday is the day that the judge, Dan A. Polster of the Northern District of Ohio, said he wished would never come. Most opioid cases nationwide were transferred to Polster by a judicial panel. When he first addressed lawyers for what was then several hundred lawsuits — now more than 2,300 — he said he wanted to avoid protracted wrangling and settle within a year, to get emergency relief to hurting communities.

Hundreds of depositions and many millions of discovery documents later, the national federal opioid litigation is being called the most complex in U.S. legal history.

Here is a guide to issues in the trial, which, if the cases are not settled, could last about two months.

— Why the Ohio counties first?

Efficiency. Polster’s court is in Cleveland, the seat for Cuyahoga County, one of two counties suing. (The other is Summit, which includes Akron.) In 2017, Ohio had the second-highest rate of opioid-related overdose deaths in the country. Because of his familiarity with the issues, Polster will oversee these cases, combined into one trial.

— Prescriptions for opioids are dropping. Isn’t the problem easing?

Not if you ask Laura Beal, a nurse practitioner at MetroHealth Medical Center in a battered neighborhood on Cleveland’s west side. The area right around the county hospital has the highest overdose rate in the city; in 18 months, the MetroHealth police intervened in 46 overdoses just on the health system’s properties.

On Saturday, as settlement negotiations continued, Beal was at the hospital’s Office of Opioid Safety. There, she identifies patients in the emergency department who might be willing to detox and try rehab, including taking Suboxone, the maintenance medication she can prescribe before they leave the hospital. MetroHealth contracts with a peer-support team that will transport patients directly to treatment, and follow up after discharge. That team may see up to 70 new patients in the hospital weekly and regularly visits the troubled county jail.

Beal estimates that two-thirds of her heroin-addicted patients began their descent with prescription opioids. Her office runs a needle-exchange program and educates doctors about tapering pain patients off opioids. She gives patients who leave with an opioid prescription a treated bag that dissolves leftover pills.

After overdose patients recover, Beal supplies them with Narcan, the overdose reversal drug, to carry with them and a test strip for fentanyl so they can at least make sure their street drugs are free of the deadly substance.

— One of the most significant changes she has seen doing this work?

A 4-milligram dose of Narcan can reverse an overdose, Beal said, “but on some patients now, we have to use 20 milligrams.”

— The drug manufacturers have largely settled. Who is left?

The defendants with the deepest pockets are drug distributors. McKesson and AmerisourceBergen are on Fortune’s Top 10 list of companies; Cardinal Health is 16th. The pharmacy chain Walgreens is accused of lapses in its distribution of opioids.

Last year, these five companies had combined total revenues of more than half a trillion dollars.

— What will the plaintiffs try to prove?

Seeking $8 billion, the plaintiffs claim the distributors conspired to flout the federal law that requires them to monitor sales and report outliers. They say they will argue that the distributors lobbied members of Congress for favorable legislation and not only cast a blind eye on supersize orders but rewarded sales teams that brought them in.

They also intend to show the devastation that unfolded from the yearslong pill dump: how addiction ate into every sector of county life, crippling budgets for law enforcement, foster care and first-responder squads. Expect testimony from addiction medicine specialists as well as testimony from people who have struggled with opioids.

— What will the defendants argue?

Causation is a critical question. The distributors are expected to say they were simply delivering medication made by the drug manufacturers, approved by the government and prescribed by doctors. Their defense may include a recent report from a federal watchdog that accuses the Drug Enforcement Administration of lax oversight of opioids.

The defense also intends to describe a shifting medical culture: In the late ’90s, when OxyContin first appeared, prescribers were urged to focus on undertreated pain with new, supposedly nonaddictive drugs. The prescribing of opioids changed — from using them for end-stage cancer to making them the go-to drug for acute and chronic pain.

— In the courtroom

For the plaintiffs: Mark Lanier, long recognized as one of the country’s best tort trial lawyers. With his native Texas drawl, the boyish energy of a man who built and runs a train on his 40-acre estate, and a preacher’s conviction, Lanier has exacted giant-killer jury verdicts from Johnson &amp; Johnson and Merck. On Sunday, Lanier turned 59 and, as he usually does when working out of town, flew back to Houston on his private plane to deliver his Sunday Bible study lecture, typically attended by hundreds. His firm has just taken on Juul, on behalf of a New Jersey teenager.

If anyone can make the tangled-vine narratives of the opioid crisis accessible, Lanier, a master storyteller, may be the one. He is nimble and canny, and has used courtroom props like brightly colored Ping-Pong balls and water balloons to illustrate complex science. He studies jurors’ questionnaire responses, learning their favorite television shows, and has presented summations with titles like “Desperate Executives” and “CSI: Angleton (Tx).”

Lanier is also a popular lecturer in legal academia. Among his YouTube instructional videos: “What Makes a Great Trial Judge.”

For the defense: Many lawyers, featuring luminaries with deep experience defending Big Pharma against full-bore attacks. Of particular interest is Enu Mainigi of Williams and Connolly, who represents Cardinal Health, the drug distributor, and is one of the few women among the defense’s lead trial lawyers.

Mainigi, who immigrated to the United States from India when she was 5 and was elected student president at Harvard Law School, is known as a savvy strategist with a jury-friendly presence.

She largely prevailed recently for CVS Health, turning aside accusations of Medicaid fraud in Texas. After the trial, she took some female jurors out to lunch for a debriefing. Gradually, the talk comfortably turned to the Sisyphean challenges of hair maintenance in the Austin summer humidity.

Mainigi, 49, is also a longtime behind-the-scenes Republican adviser. Fresh out of law school, she became head of policy issues and research for Bob Dole’s 1996 presidential campaign and represented Rick Scott, the senator from Florida, when he was a health care executive whose company paid a $1.7 billion fine for health care fraud. Mainigi facilitated Scott’s resignation, and when he was later elected governor, she led his transition team.

The judge: Polster, a Cleveland native who has been on the federal bench since 1998, is presiding over a trial he tried to avert. So did others.

The attorney general of Ohio fought to block it.

The defense sought to disqualify him, accusing him of bias because he had mused publicly about settling the case. Appellate judges did urge Polster to be more circumspect but sided with him, noting that settlement is a traditional judicial goal.

Polster contested the defense’s assertions.

“Publicly acknowledging this human toll does not suggest I am biased,” he wrote. “It shows that I am human.”

What to Know About the Landmark Opioid Trial Starting Monday

CLEVELAND — Two decades after the onset of an opioid epidemic that led to the deaths of 400,000 Americans, the first landmark federal opioid trial is set to begin Monday, after furious, last-minute settlement talks between two powerful groups of plaintiffs and five drug industry defendants faltered.

Paul Hanly, a lead lawyer for the municipal governments, said late Friday afternoon that, “We have had a long day of discussions with the attorneys generals and the distributors and with the judge who is, as usual, extremely helpful.”

But, he said, “There is no settlement,” adding that a trial set to begin Monday was still on course.

Chief executives for the three major drug distributors were summoned to the Federal Reserve courthouse here in Cleveland today by Judge Dan A. Polster, who was attempting to wrest a last-minute, comprehensive settlement to resolve thousands of cases filed by local governments as well as those filed by state attorneys general in state court.

Under discussion was a deal worth nearly $50 billion in cash and addiction treatment medicine and services. It would require the three distributors to pay $18 billion over 18 years.

It was unclear at day’s end how far apart the sides were, and informal discussions might continue over the weekend. People familiar with the talks said that the state attorneys general viewed the offer more favorably than did the plaintiffs. The states’ lawyers would not comment.

Hanly characterized the offer as too little and over too long a period of time. But he was one of the few engaged directly in the negotiations who would speak publicly.

Adding to the pressure-cooker atmosphere was the specter of 12 jurors, whom Polster had sworn in Thursday, in anticipation that opening statements would begin as scheduled Monday. Inexorable moves such as these can often prod the sides to the desired result: settlement.

Friday’s extraordinary sessions included not only top executives from the drug distributors, which are Fortune Top 20 companies, but state attorneys general from Texas, Pennsylvania, North Carolina and Tennessee; lawyers for more than 2,300 opioid lawsuits filed by cities, counties and tribes nationwide; and delegates from cities large and small that have been devastated by the two-decade long epidemic. More than 400,000 people have died in that time.

Also in court were executives representing Walgreens, the pharmacy chain; Teva, the Israeli-based manufacturer of generic drugs; and Henry Schein Medical, a small drug distributor.

Companies reached for comment either declined to do so or did not respond to messages.

Other people familiar with the negotiations said that discussions with Teva had so far yielded a “small cash contribution” of several hundred million dollars.

Paul Farrell, another lawyer on the plaintiffs’ team, said that discussions with Walgreens, which is being sued in the forthcoming trial for its role as a distributor of opioids to its own pharmacies, “were not fruitful.”

The case at the center of Monday’s trial was brought by two Ohio counties, Cuyahoga and Summit, although the negotiations contemplated a settlement that would resolve thousands of other cases around the country. The Ohio trial is considered a powerful litmus test for all the parties.

The defendant distributors — AmerisourceBergen, Cardinal Health and McKesson — along with other companies had been mulling a megadeal that earlier this week was estimated at nearly $50 billion.

There are many more drug industry defendants, including the pharmacy chains Walmart, Rite Aid and CVS, in the far-flung web of litigation. But now that Purdue Pharma’s tentative deal is caught up in a lengthy bankruptcy court review, a global settlement would be the first in the national opioid litigation.

Plaintiffs’ lawyers say a wide-ranging settlement could have a domino effect on the remaining defendants, encouraging them to reach a comprehensive deal too.

But people familiar with the state of play Friday in Cleveland suggested that the existing obstacles could lead to a much narrower outcome, with only the Ohio cases settling, rather than a global resolution.

A major sticking point, said some members of the local governments’ legal team, was that the distributors would not estimate the losses suffered by West Virginia communities, saying that the state itself had already settled with the three distributors for about $73 million.

A signature tension in the talks to date is how to allocate any money from the settlement, with local governments wary of ceding that power to the states.

Farrell said that, “the attorneys general are deciding among themselves how to allocate the money.” He and Hanly turned aside the question of whether their own fees were a stumbling block, a conflict raised in private by other parties.

“That hasn’t even come up yet,” Hanly said.

But another person familiar with the talks disputed that account, saying that states and counties were intent on working toward getting money to distressed communities.

Another issue in the talks is public transparency: If the companies reach a settlement, plaintiffs’ lawyers want to ensure that records of what transpired during the years of one of the country’s greatest public health crises are unsealed.

Throughout the day, parties caucused in separate rooms on two floors, as negotiators, including Polster shuttled among them.

Clusters of lawyers and public relations managers paced back and forth, muttering in hallways, cellphones glued to their ears. They would have jaunty expressions, radiating confidence, but then a phone would ring and faces would abruptly turn dour. Then another phone would ring.

Steve Williams, the mayor of Huntington, West Virginia, a small city staggered by opioids, seemed frustrated.

“We put drug dealers in the alleys in jail, and there are these drug dealers sitting here in board rooms and now we’re just talking about money? We’re angry in Huntington,” Williams said. “If there was not a single tablet distributed again and not another gram of heroin, we would still be dealing with the aftereffects for four decades.”

Opioid Settlement Talks Teeter as Trial Looms

CLEVELAND — Despite a day of fervent negotiations between major drug industry corporations and the thousands of cities and counties suing them for their roles in the opioid epidemic, plaintiffs’ lawyers said that talks had stumbled but would continue.

The distributors — AmerisourceBergen, Cardinal Health and McKesson — along with other companies are trying to strike a megadeal that would release them not only from the immediate trial, brought by two Ohio counties, but the rest of the cases. Most of the cases are being supervised by Polster, but several hundred are percolating in just about every state court.

There are many more drug industry defendants, including the pharmacy chains Walmart, Rite Aid and CVS, in the far-flung web of litigation. But with Purdue Pharma’s tentative deal caught up in a lengthy bankruptcy court review, the six corporate defendants in this trial could be the first in the national opioid litigation to reach a so-called global settlement. Plaintiffs’ lawyers say they hope such a deal would have a domino effect on the remaining defendants, encouraging them to reach a comprehensive deal too.

Four people familiar with the settlement discussions characterized them as “fluid.” While parties had been talking about a deal worth nearly $50 billion, lawyers for thousands of small governments whose cases are before Polster said they wanted more money, the timeline for payments to shorten and specific guarantees on how those funds would be distributed.

The six defendants appearing at Polster’s request include the three giant drug distributors; a small distributor; Teva, which makes generic drugs; and Walgreens, the pharmacy chain.

Officials from New York City; Boston; Chicago; Nashville, Tennessee; Broward County, Florida; Delaware County, Pennsylvania; and Huntington, West Virginia, are in the courthouse as are the attorneys general from Tennessee, North Carolina, Pennsylvania and Texas.

The parties either did not respond to messages or declined to comment.

As fevered negotiations continued in Cleveland hotel rooms and on cross-country conference calls, Polster on Thursday swore in 12 jurors, in anticipation that opening statements would begin as scheduled Monday. Inexorable moves such as these can often prod the sides to the desired result: settlement.

People knowledgeable about the negotiations said that a sticking point was the fees for the private lawyers who represent the small governments. To prepare for the trial and the cases at large, which has taken years, lawyers from 21 law firms have taken over 450 depositions, compiled millions of documents, and spent millions of dollars on expert witness reports and data analysis, said a person familiar with the processes.

Friday is unfolding as a dynamic, daylong exercise in “shuttle diplomacy.” The day began with a brief gathering of the parties in Polster’s courtroom, after which they decamped to separate rooms.

Polster’s special masters — litigation experts who, from the outset of the filings, have had daily responsibilities marshaling the cases and acting as liaisons to the judge — will move among the rooms, working offers and counteroffers, and reporting back. A lawyer said that the judge himself had, on occasion, been stepping into the caucus rooms.

As of Thursday evening, no one familiar with the discussions could predict with confidence whether Friday will conclude with a deal or a directive for opening statements to begin Monday morning.

In January 2018, Polster held an initial gathering of these parties in his courtroom. There were only several hundred opioid cases on his docket then — there are now more than 2,300 — and the assembly was intended to give the parties and the judge himself a foreshadowing of what was at stake. At that time, mayors, county executives and chiefs of police showed up, to offer the judge a ground’s-eye view of their communities’ devastation by opioids. Several recounted bitter family experiences.

One executive there that day was Mayor Steve Williams of Huntington, who is expected to be in court Friday. His city of 48,000 was featured in the Oscar-nominated documentary “Heroin(e)” and is often described as the epicenter of the opioid epidemic.

He stood against a hallway window, watching as groups of lawyers milled about. “I’m fighting drug dealers in white coats,” he said quietly. “We need the resources to clean up this mess and make sure it never happens again.”

Judge Summons Drug CEOs for Talks on Sweeping Opioid Settlement

CLEVELAND — A mayor of a small West Virginia city brought to its knees by opioids and representatives of large cities and counties left reeling by the epidemic are gathering in federal court here Friday to sit side by side with chief executives from the country’s largest drug distributors. Along with four state attorneys general, they were summoned by Judge Dan A. Polster, who is trying to wrest a far-reaching, last-minute agreement to resolve thousands of lawsuits before the start of the fir...

Three people familiar with the negotiations said that cities and counties across the country are tentatively supporting the broad parameters of the deal but are negotiating over its total value as well as attorneys’ fees. They warned that details could change and the deal could still fall apart before Monday, when opening statements are to begin in the first federal trial to determine responsibility for the opioid epidemic.

The agreement would release AmerisourceBergen, Cardinal Health and McKesson, which together distribute about 90% of the country’s medicines, along with Johnson &amp; Johnson and Teva, the Israeli-based manufacturer of generic medicines, from a rapidly growing list of more than 2,300 lawsuits that they face in federal and state courts.

All of the companies either did not return requests for comment or declined to do so.

Pennsylvania, North Carolina, Tennessee and Texas are leading the talks for the states, along with lawyers for thousands of cities and counties whose cases are in federal court.

Since the late 1990s, more than 400,000 people in the United States have died from overdoses of prescription painkillers and illegal opioids, including heroin and fentanyl. The epidemic is considered one of the greatest public health crises in the country’s history.

The three drug distributors and Teva are defendants in the first trial, brought by two Ohio counties. With thousands of somewhat similar governmental lawsuits on the national runway, the Ohio suit is considered an important showcase that will test the strength of both sides’ witnesses and legal arguments before 12 jurors.

Even as discussions continue, so does the selection of a jury, in anticipation of the start of the trial should talks collapse.

Johnson &amp; Johnson recently settled with the two Ohio counties for about $20.4 million, but the company is named in many of other suits, as well.

Many drug manufacturers and pharmacy chains also have been named as defendants in federal and state opioids cases, but they are apparently not involved in these negotiations.

The maker of OxyContin, Purdue Pharma — which is currently in bankruptcy court — has a tentative and much-disputed agreement with lawyers for thousands of municipal suits in federal court and nearly two dozen states that, if finalized, would remove the company from most opioids cases as well.

According to people familiar with the talks, the combined value of the current deal breaks down as follows: $20 billion to $25 billion in cash to be divided among the states and localities to help pay for health care, law enforcement and other costs associated with the epidemic; and another $25 billion to $30 billion in addiction-treatment drugs, supplies and delivery services.

People familiar with the negotiations said many details are still being debated, including the timetable for when the money would be paid.

Whether the amount will be considered sufficient by all the plaintiffs remains to be seen. A new report by the Society of Actuaries projects the costs related to the opioid epidemic at $188 billion in 2019 alone, including health care, child and family assistance programs, criminal justice activities and lost wages.

People familiar with the talks said that a sticking point in negotiation is how much money will go toward attorneys’ fees for the private lawyers who represent governments in the overwhelming majority of cases and work on contingency.

Those lawyers filed the first opioid lawsuits in 2014 and have since conducted hundreds of depositions and compiled many millions of documents.

Drug Giants Pursuing $50 Billion Settlement of Opioid Cases

CLEVELAND — As a critical trial deadline bears down, lawyers for states and the three largest drug distributors in the country, along with two manufacturers, have agreed on a framework for a deal to resolve thousands of opioid cases with a settlement worth nearly $50 billion in cash and addiction treatments.

The agreement would release AmerisourceBergen, Cardinal Health and McKesson Corp., which together distribute about 90% of the country’s medicines, along with Johnson &amp; Johnson and Teva, the Israel-based manufacturer of generic drugs, from a rapidly growing list of more than 2,300 lawsuits that they face in federal and state courts.

Although the states have agreed in principle to the framework, cities and counties across the country have not yet fully embraced it, said lawyers for a committee that represents thousands of municipal governments. They are seeking more information about how the money will be distributed, whether it will be directed to relief measures or end up in general funds for state legislatures, and “when they could expect the financial support to start,” the lawyers said in a statement.

The companies either did not respond to messages or declined to comment.

Some of the largest drugmakers, pharmacy chains and distributors have been fighting with state and local governments in the courts for nearly two years, as the nation searches for accountability for one of the worst public health crises in America’s history.

The parties are under extreme pressure to reach a deal by Monday, when opening statements are set to begin in the first federal trial to determine responsibility for the opioid epidemic, which has led to 400,000 deaths in the United States over the past two decades.

The three drug distributors and Teva are defendants in the first trial, brought by two Ohio counties. With thousands of similar governmental lawsuits on the national runway, the Ohio suit is considered an important showcase that will test the strength of both sides’ witnesses and legal arguments before 12 jurors.

The drug distributors are not nearly as well known as some of the other corporate players implicated in the opioid crisis, like Purdue Pharma, whose misleading marketing of the drug OxyContin is thought to have set off the epidemic. But the distributors are bigger and richer than the manufacturers — all three are among the top 20 companies in the United States by revenue — and numerous lawsuits have pointed to evidence that they routinely evaded regulators and helped pharmacies and manufacturers circumvent limits on orders of opioid painkillers.

Lawyers for the plaintiffs in the trial starting Monday have said that the distributors conspired through their trade organization to flout the federal law, which obliged them to monitor sales and report outliers. They said that the distributors not only cast a blind eye on extraordinary orders, but lashed and rewarded their teams to sell greater volumes of opioids.

In New York state alone, the distributors sold 1.6 billion oxycodone pills to pharmacies between 2010 and 2018. It was distributors, said the office of Attorney General Letitia James of New York, who “jammed open the floodgates.”

The distributors have said they were simply delivering medication that was approved by the Food and Drug Administration and prescribed by doctors.

Pennsylvania, North Carolina, Tennessee and Texas are leading the settlement talks for the states, along with lawyers for thousands of cities and counties whose cases are in federal court.

According to people familiar with the talks, the combined value of the deal breaks down as follows: $20 billion to $25 billion in cash to be divided among the states and localities to help pay for health care, law enforcement and other costs associated with the epidemic; and another $25 billion to $30 billion in addiction-treatment drugs, supplies and delivery services.

Many details are still being debated, including the timetable for when the money would be paid, people familiar with the negotiations said.

Whether the amount will be considered sufficient by all the plaintiffs remains to be seen. A new report by the Society of Actuaries projects that the costs related to the opioid epidemic — including health care, child and family assistance programs, criminal justice activities and lost wages — will hit $188 billion in 2019 alone.

“It’s not an accident these offers are coming out on the eve of trial,” said Abbe R. Gluck, a professor of health policy and law at Yale Law School. “But I think the question will be if this number is going to be enough to get a sufficient number of local governments to sign on.”

People familiar with the talks said that one sticking point in the negotiations is how much money will go toward attorneys’ fees for the private lawyers who represent governments in the overwhelming majority of cases and work on contingency.

This proposed deal is considerably larger than the tentative settlement negotiated by Purdue Pharma earlier this fall, not least because it involves five large companies instead of one. Under the Purdue agreement, Purdue’s owners, members of the Sackler family, would pay between $3 billion and $4.5 billion over seven years. The company would be restructured into a public corporation, with profits from drug sales going toward the plaintiffs. Purdue has also agreed to donate addiction-treatment medication.

The Purdue deal is being vigorously opposed by about two dozen states who contend that the Sacklers are not paying enough money and have not yet fully disclosed how much they have earned from OxyContin sales.

Johnson &amp; Johnson recently settled with the two Ohio counties for about $20.4 million, but the company is named in many of the other suits, as well.

On Wednesday, even as negotiations continued, jury selection was underway in the federal courthouse in Cleveland. Because the trial is expected to be heavily steeped in testimony about illegal drug use, addiction, crime and rehab, prospective jurors were interviewed in private in Judge Dan A. Polster’s chambers, so that lawyers could determine whether they had a glancing acquaintance with any of those topics.

The atmosphere in the courtroom was solemn and portentous, with lawyers proceeding exactly as if the trial will indeed begin on Monday, should talks collapse.

Drug Giants Seeking Settlement of Opioid Cases for $50 Billion

CLEVELAND — The nation’s three largest drug distributors and two manufacturers have agreed with multiple states on a framework to resolve thousands of opioid cases with a settlement worth nearly $50 billion in cash and addiction treatments, according to three people familiar with the negotiations.

Comen, an oncologist who has treated patients for cancers related to the human papillomavirus that a vaccine can now prevent, replies emphatically: Absolutely.

She never imagined she would be getting such queries. Yet these playground exchanges are reflective of the national conversation at the end of the second decade of the 21st century — a time of stunning scientific and medical advances but also a time when the United States may, next month, lose its World Health Organization designation as a country that has eliminated measles, because of outbreaks this year. The WHO has listed vaccine hesitancy as one of the top threats to global health.

As millions of families face back-to-school medical requirements and forms this month, the contentiousness surrounding vaccines is heating up again, with possibly even more fervor.

Though the situation may seem improbable to some, anti-vaccine sentiment has been building for decades, a byproduct of an internet humming with rumor and misinformation; the backlash against Big Pharma; an infatuation with celebrities that gives special credence to the anti-immunization statements from actors like Jenny McCarthy, Jim Carrey and Alicia Silverstone, rapper Kevin Gates and Robert F. Kennedy Jr.; and now, the Trump administration’s anti-science rhetoric.

“Science has become just another voice in the room,” said Dr. Paul A. Offit, an infectious disease expert at Children’s Hospital of Philadelphia. “It has lost its platform. Now, you simply declare your own truth.”

The constituents who make up the so-called vaccine resistant come from disparate groups, and include anti-government libertarians, apostles of the all-natural and parents who believe that doctors should not dictate medical decisions about children. Labeling resisters with one dismissive stereotype would be wrongheaded.

“To just say that these parents are ignorant or selfish is an easy trope,” said Jennifer Reich, a sociologist at the University of Colorado Denver, who studies vaccine-resistant families.

It remains true that the overwhelming majority of American parents have their children vaccinated. Parent-driven groups like Voices for Vaccines, formed to counter anti-vaccination sentiment, have proliferated. Five states have eliminated exemptions for religious and philosophical reasons, permitting only medical opt-outs.

But there are ominous trends. For highly contagious diseases like measles, the vaccine rate to achieve herd immunity — the term that describes the optimum rate for protecting an entire population — is typically thought to be 95%. The Centers for Disease Control and Prevention found that the vaccination rate for the measles, mumps and rubella (MMR) injection in kindergartners in the 2017-18 school year had slipped nationally to 94.3%, the third year in a row it dropped.

Seven states reported rates for the MMR vaccine that were far lower for kindergartners, including Kansas at 89.1%; New Hampshire, 92.4%; the District of Columbia, 81.3%. (The highest is West Virginia at 98.4%.)

Almost all states have at least one anti-vaccine group. At least four have registered political action committees, supporting candidates who favor less restrictive vaccine exemption policies.

Public health experts say that patients and many doctors may not appreciate the severity of diseases that immunizations have thwarted, like polio, which can affect the spinal cord and brain — because they probably have not seen cases.

“Vaccines are a victim of their own success,” said Offit, a co-inventor of strains of rotavirus, which can cause severe diarrhea in young children, that led to a vaccine. “We have largely eliminated the memory of many diseases.”

The growth of vaccine doubt in America coincides with several competing forces and attitudes.

Since the early 2000s, as the number of required childhood vaccines was increasing, a generation of parents was becoming hypervigilant about their children and, through social media, patting each other on the backs for doing so. In their view, parents who permitted vaccination were gullible toadies of status quo medicine.

In 2011, Dana Fuqua, of Aurora, Colorado, pregnant with her first child, felt that irresistible pull of groupthink parenting.

She had just moved to the area, so she reached out to mothers’ groups on Facebook. Colorado, with a kindergarten vaccination compliance rate of 88.7%, has a rambunctious vaccine-resistant movement. Fuqua’s new friends urged her to have a drug-free birth, use cloth diapers and never to let a drop of formula pass her baby’s lips. Vaccines, it followed, were anathema.

The women intimidated her. They had advanced degrees; she had only a Bachelor of Science and a nursing background.

“I didn’t argue with them,” Fuqua said. “I was so desperate for their support that I compromised by delaying the vaccine schedule, so I wouldn’t get kicked out of the group.”

But when her second child was born prematurely, susceptible to illness, the group’s approval was not as important as her baby’s safety. Her position, she said, shifted from, “‘I can’t hang out with you if you had a vaccine because you could be shedding a virus’” — a common, false belief among the vaccine resistant — to, “‘If you haven’t had a vaccine, I will not associate with you.’”

She had both children fully vaccinated.

There have been anti-vaccination movements at least since 1796, when Edward Jenner invented the smallpox vaccine. But many experts say that the current one can be traced to 1982, when NBC aired a documentary, “DPT: Vaccine Roulette,” that took up a controversy percolating in England: a purported tie between the vaccine for pertussis — a potentially fatal disease that can cause lung problems — and seizures in young children.

Doctors sharply criticized the show as dangerously inaccurate. But fear spread. Anti-vaccination groups formed. Many companies stopped making vaccines, which were considered loss-leaders and not worth the corporate headache.

Then, in 1998, Andrew Wakefield, a British gastroenterologist, published a Lancet study (since discredited and withdrawn), associating the MMR vaccine with autism.

Faced with risking autism or measles, some parents thought the answer was obvious. Most had never seen measles, mumps or rubella because vaccines had nearly eliminated them. But they believed they knew autism.

And most people are notoriously poor at assessing risk, say experts in medical decision-making.

Many stumble on omission bias: “We would rather not do something and have something bad happen, than do something and have something bad happen,” explained Alison M. Buttenheim, an associate professor of nursing and health policy at the University of Pennsylvania School of Nursing.

People are flummoxed by numerical risk. “We pay more attention to numerators, such as ‘16 adverse events,’ than we do to denominators, such as ‘per million vaccine doses,’” Buttenheim said.

A concept called “ambiguity aversion” is also involved, she added. “Parents would like to be told that vaccines are 100% safe,” she said. “But that’s not a standard we hold any medical treatment to.”

Relatively few people are absolutists about refusing all vaccines. “But if you’re uncertain about a decision, you’ll find those who confirm your bias and cement what you think,” said Rupali J. Limaye, a social scientist who studies vaccine behaviors at the Johns Hopkins Bloomberg School of Public Health.

Nowhere is that reinforcement more clamorous than on social media, Limaye added. “You may only see your pediatrician a few times a year but you can spend all day on the internet,” she said.

People tend to believe an individual’s anecdotal narrative over abstract numbers. By 2007, when McCarthy, the actress, insisted that vaccines caused her son’s autism, thousands found her to be more persuasive than data showing otherwise. A nascent movement took hold.

At the same time that these powerful attacks on vaccine confidence were underway, a constellation of trends was emerging.

The definition of a good parent was becoming fraught with the responsibility for overseeing every aspect of a child’s life.

“As we adopted a culture of individualistic parenting, public health became a hard sell,” Reich said.

The primary reason for healthy people to get the flu shot is to protect those with compromised immune systems, like infants and older adults, from getting sick. But altruism isn’t a great motivator for parents, Buttenheim said. “They are much more concerned about protecting their own child at all costs,” she said.

Contrast that attitude with the collective goodwill of the 1950s, say medical sociologists, when American parents who had seen President Franklin D. Roosevelt’s wheelchair as a debilitating symbol of polio patriotically sought to vaccinate their children to help eradicate the disease worldwide.

By 2014, studies showed that parental confidence in authorities like the CDC and in pediatricians was dropping, especially around vaccines. Mistrust of Big Pharma was even more pronounced.

By then, Donald Trump was offering support on Twitter for the discredited link between autism and vaccination. As president-elect, he met with leaders of the anti-vaccination movement, although as measles cases surged, he endorsed vaccination.

As parenting became rife with orthodoxy, the Marcus Welby model of the paternalistic doctor retreated. Patients asserted autonomy, brandishing internet printouts at doctors. Shared decision-making became the model of doctor-patient engagement.

Pediatricians offered to stagger vaccine schedules. Some were even flexible about vaccinations altogether.

In 2011, shortly after Emma Wagner had given birth in Savannah, Georgia, a pediatrician on the ward examined the baby. “He asked me if I was interested in the hepatitis B vaccine,” she said of an inoculation typically done at birth.

He replied, “‘That’s fine, because your 2-day-old daughter isn’t a prostitute and isn’t using IV drugs, so hep B isn’t at the top of my worries.’”

Wagner said she “swallowed the anti-vax Kool-Aid. I was motivated by fear. I thought, ‘Until I know for certain that these are safe, I won’t do it. The pediatrician said, ‘I will support your decision and in a few years we’ll talk about exemptions for school.’”

She has since become a staunch supporter of immunization.

Libertarianism also courses through vaccine hesitation, with parents who assert that government should not be able to tell them what to put in their bodies — a position often marketed as “the right to choose.”

“Having the government order them to do something reinforces conspiracy theories,” said Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins. “And people perceive their risk to be higher when it’s not voluntary.”

In reality, he said, one’s risk of harm is greater while driving to an airport than it is being on the airplane itself. But driving is voluntary and gives the illusion of control. People fear flying because they cannot control the plane. By extension, many childhood vaccines are not voluntary, which rattles those who prefer to believe they can control their health.

With so many different but deeply held convictions, public health experts struggle to design vaccine-positive campaigns.

In 2017, researchers applied the six values of “the moral foundations theory” to vaccine attitudes, surveying 1,007 American parents.

The results were intriguing. Those most resistant to vaccines scored highest in two values: purity (“my body is a temple”) and liberty (“I want to make my child’s health care decisions”).

A third, said Saad B. Omer, director of Yale’s Global Health Institute and an author of the study, was also telling: deference to authority — a score indicating whether one was likely to adhere to the advice of experts like a pediatrician or the CDC.

Salmon’s team at Johns Hopkins is working on an app to capture parents’ vaccine attitudes and to tailor information to persuade them to vaccinate their children.

Pediatricians are front-line persuaders, he said, and they should be compensated for the time it takes to educate parents.

Most experts note that physicians themselves, never mind parents, have no idea about the federal vaccine monitoring systems, which have been in place for more than 20 years.

“We ask parents in the first two years of their child’s life to protect them against 14 diseases, that most people don’t see, using fluids they don’t understand,” Offit said. “It’s time for us to stand back and explain ourselves better.”

The question is often whispered, the questioners sheepish. But increasingly, parents at the New York playground where Dr. Elizabeth A. Comen takes her young children have been asking her: “Do you vaccinate your kids?”

Jan Hoffman

Articles written by the author

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