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.”

This article originally appeared in

$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.

Now, an inventive plan to jump-start negotiations, recently put forth by lawyers for the nearly 2,000 cities and counties that have brought cases, is facing attacks from an unlikely source. Pushback that could torpedo it is coming less from the corporate defendants than from the localities’ uneasy allies: the states.

It is a struggle over power, politics and money. And in an arena filled with outsized egos, the fight is also very much about who will get to claim credit for resolving a public health crisis that has killed more than 200,000 people since 1999 and sunk many more into debilitating addiction.

A hearing on the proposal is scheduled for Tuesday in Cleveland before the federal judge who is overseeing the cases, Dan A. Polster.

The plan was devised to address a major sticking point: The defendants, including manufacturers that developed and made the drugs, Fortune 20 companies that distributed them and national pharmacy chains that sold them, want an end to the constant stream of lawsuits.

So lawyers for the plaintiffs suggested allowing all 34,000 towns, cities and counties in the country to vote on settlement offers. After an offer is approved, they will be bound by the outcome and can bring no further suits. All voting communities affected by the crisis would get a portion of the payout.

But a letter signed by a bipartisan coalition of 39 state attorneys general raises arguments that could topple the ambitious proposal and further slow talks.

Rather than myriad cities and counties, they contend, it is the states, through law enforcement and regulatory authority, that can efficiently wrest a high-impact national agreement. They maintain that this plan goes behind the backs of the states pursuing cases brought by their own attorneys general, who are elected or appointed. By contrast, local governments are using private lawyers, who work on contingency fees.

The states also fear that the plan would corral money for the cities and counties that they should control. And because this “negotiation class” is untested, they argue, it is likely to be appealed, delaying remedies for everyone.

“In my view, it’s the plaintiffs’ lawyers using local governments to hijack the sovereignty of the states and create ‘city states,’” said Dave Yost, the Ohio attorney general, who filed a letter critical of the plan. “But this is not the United City-States of America.”

The plaintiffs also intend their proposal to be a course correction to the Big Tobacco settlement, as well as a possible template for future resolutions in such public welfare areas as firearms, climate change and environmental pollution.

The 1998 Master Tobacco Settlement, which resulted in payouts of some $250 billion, was struck between five cigarette manufacturers and 46 states seeking reimbursement for their Medicaid programs for treating tobacco-related illnesses. But much of the money went to discretionary funds of state legislatures. Especially in the wake of the 2008 financial crisis, hefty amounts were redirected to balancing budgets and fixing potholes, rather than to local prevention and treatment programs.

Still bitter about those outcomes, communities whose coffers had been depleted by the opioid crisis decided to sign with private lawyers, circumventing the states.

Since 2013, when Chicago filed its opioid lawsuit, platoons of these private lawyers have taken more than 500 depositions, filed thousands of motions, read through more than 50 million pages of documents and analyzed raw code from the Drug Enforcement Administration about pill distribution. At Polster’s direction, they have shared their trove with the states.

“None of the attorneys general complained while we were doing all that,” said Paul Geller, an attorney whose opioid clients include Los Angeles. “It kind of makes you wonder why seeking to organize for negotiation purposes all of a sudden crosses the line for them.”

Strictly speaking, the states, whose cases are in state court, have no say in the federal litigation. While all are suing some manufacturers, fewer are going after the deep-pocketed distributors, and fewer still have named pharmacy chains. With the exception of some states, including Oklahoma, Massachusetts and New York, opioid litigation by many attorneys general lags behind the federal cases.

But mindful that the conclusion of federal and state cases likely depends on each other, Polster has regularly solicited input from the attorneys general.

So how do they really feel? The states bluntly say that the negotiation plan usurps a role that is properly theirs.

Under the legal doctrine called “parens patriae” — parent of the nation — states, in a wide swath of cases, often assume the role of vindicating the interests of vulnerable citizens.

“We have a vision of the state attorneys general as being preferable because they’re insulated from money,” said Adam Zimmerman, who teaches complex litigation at Loyola Law School, Los Angeles.

“But they’re not insulated from politics,” he added, noting that the position is often a steppingstone to higher political office.

Yost, the Ohio attorney general, and others argue that these cases should be resolved from the top down, not the bottom up. But each state’s relationship with local government, enshrined in its constitution and laws, varies. Funding sources for the diverse costs of the opioid crisis, whether local or state, also differ from state to state.

And so the states say they should disburse the money. The fly in that ointment is that many states preclude attorneys general from distributing settlement money, because their legislatures control such funds.

Rather than approving the plaintiffs’ plan, Yost said, Polster could ascertain each state’s relationship with its municipalities. He could then encourage those with similar laws and interests to negotiate in groups. That process, Yost predicted, would be more streamlined than this proposal.

“If I were a defendant, I’d be very wary of dealing with the cities and counties, knowing that the state attorneys general were still gunning for me,” said Elizabeth C. Burch, a law professor at the University of Georgia who closely follows the litigation. “I’d be more inclined to do a global deal with them that preempts the city and county cases.”

Yost said that if the states oversaw negotiations, private lawyers would still get paid — any settlement would include a separate money bucket for them. “But I think that’s a one-gallon bucket for washing the car and they think it should be an oil tanker.”

There’s a love-hate relationship between the states and private lawyers, he said. While a government’s use of private lawyers dates to early English common law, the biggest boost to that practice came during the tobacco litigation itself, when state attorneys general, strapped for resources, turned to them.

Some of those very same lawyers are now in the opioid litigation, working for cities and counties — and, indeed, a handful of states. Geller’s opioid clients include Maryland’s Montgomery County in federal court and Maryland itself, in state court.

While that dual representation may prompt skepticism, Geller said that it served the interests of time and coordination, because so much material overlaps.

At the outset of the litigation, Polster established two parallel tracks. One is to prepare for trial, the first of which is set for Oct. 21 in Cleveland.

The second is to pursue negotiation, to bring remedies as soon as possible. That track has sputtered along, mostly because the defendants have pointed fingers at each other, disputed liability and faulted the federal government’s role in overseeing the sale and distribution of drugs.

The concept for this negotiation group was developed by several law professors, who now have roles in the opioid litigation, and refined by the plaintiffs’ lawyers. (The group would not include other parties like tribes and third-party payers.)

It uses an allocation map that shows each municipality what share to expect from a settlement, calculated with federal data about pill distribution, opioid-related overdoses and deaths.

“All the political entities have gotten notice about this plan,” said Samuel Issacharoff, a law professor at New York University who worked on the proposal, referring to the cities and counties, “and it’s noteworthy that we’ve heard no substantial opposition to it.”

If Polster does certify the proposal, it is unclear whether the states or even the defendants can appeal.

The manufacturers’ motion says that they “take no position on whether the court should grant plaintiffs’ motion,” a possible indication of their willingness to negotiate.

But the distributors are fighting hard. The plaintiffs responded by saying, essentially, that the plan is not about the distributors — it is only about how to organize the plaintiffs. If the distributors do not like the plan, the plaintiffs’ lawyers wrote, “fine. Don’t negotiate with it. Don’t settle with it.”

Nonetheless, added Geller, who represents Los Angeles, “It’s time to try to land the plane.”

This article originally appeared in <a href="https://www.nytimes.com/2019/08/05/health/opioids-litigation-settlement.html" id="c6568152-b58d-3d5d-ae87-b5bd349f0ea6">The New York Times</a>.

States Clash with Cities Over Potential Opioids Settlement Payouts

Over the past 18 months, progress toward a settlement in the massive federal opioid litigation has stalled, even as the costs of the crisis continue to mount.

The new research confirms what has long been widely accepted in the scientific community, and it echoes findings of a 2002 study by members of the same team of scientists about the vaccine, known as MMR because it protects against measles, mumps and rubella.

But the findings come at a moment of resurging suspicion about vaccine safety, that has been promulgated at the far edges of the internet and on mainstream sites such as Amazon, Facebook and Pinterest. Many of those companies have taken steps in recent weeks to remove anti-vaccine content, but Monday, the president of the American Academy of Pediatrics, Dr. Kyle E. Yasuda, wrote to the chief executives of Google, Facebook and Pinterest, urging further action in “an urgent request to work together to combat the dangerous spread of vaccine misinformation online.”

In emphatic language, the researchers, who followed 657,461 Danish children born between 1999 and 2010, stated in the Annals of Internal Medicine: “The study strongly supports that MMR vaccination does not increase the risk for autism, does not trigger autism in susceptible children, and is not associated with clustering of autism cases after vaccination.”

Denmark offers a national vaccination program that is free and voluntary. At regular intervals, a team led by Dr. Anders Hviid, who is with the department of epidemiology research at Statens Serum Institut in Copenhagen, followed the children, 31,619 of whom remained unvaccinated.

The researchers further broke out subgroups of children according to other inoculations, and whether they had siblings with autism.

In time, 6,517 children received a diagnosis of autism. These researchers found no greater proportional incidence of the diagnosis between the vaccinated and unvaccinated children. This conclusion echoes a finding in their 2002 study of 537,303 Danish children, published in The New England Journal of Medicine.

Noting that measles outbreaks are becoming more commonplace in the United States as well as Europe, Hviid said: “U.S. researchers concluded that even a 5 percent reduction in vaccination coverage would triple measles cases, with significant health economic costs. A main reason that parents avoid or are concerned about childhood vaccinations has been the perceived link to autism.”

The results of his study, he said, offered both reassurance and reliable data that no such link exists.

In an editorial accompanying the study, Dr. Saad B. Omer, a public health researcher at Emory University, and Dr. Inci Yildirim at the Emory School of Medicine, pointed out that it has been nearly a decade since the small study that set off alarms about a possible link between the vaccine and autism has been refuted and retracted. Yet resources are being continually poured into studies such as this latest one, to underscore the inaccuracy of that original misfire.

“In an ideal world,” they wrote, “vaccine safety research would be conducted only to evaluate scientifically grounded hypotheses, not in response to the conspiracy du jour.”

They said that doctors and public health officials needed to firmly label the association “a myth.”

“Debunking a myth is tricky,” said Dr. Sean T. O’Leary, a spokesman for the American Academy of Pediatrics and an associate professor of pediatrics at the University of Colorado at Denver. When you repeat the myth, he said, “you risk reinforcing it. All that parents remember about your complicated explanation about why vaccines don’t cause autism is that they’re somehow linked. So pediatricians should focus on the diseases we’re trying to prevent, and if you have to address a myth, be clear that’s exactly what it is. “

O’Leary, who researches immunization delivery challenges, said that particularly because clinicians are pressed for time, they need to be able to have solid information for parents who want to look further into the issue.

“It can be hard for parents to sort out what’s real and what’s not,” he said.

This article originally appeared in <a href="https://www.nytimes.com/2019/03/05/health/vaccines-measles-autism.html" id="87f1ef02-8241-3e47-a022-dd42b0853cc7">The New York Times</a>.

At a time when measles outbreaks are mounting among clusters of unvaccinated children, notably in Washington state, New York and Texas, a new large study published this week found no association between the measles vaccine and autism — a reason often given by parents for rejecting inoculation.

Jan Hoffman

Articles written by the author

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

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

What to Know About the Landmark Opioid Trial Starting Monday

Opioid Settlement Talks Teeter as Trial Looms

Judge Summons Drug CEOs for Talks on Sweeping Opioid Settlement

Drug Giants Pursuing $50 Billion Settlement of Opioid Cases

Drug Giants Seeking Settlement of Opioid Cases for $50 Billion

States Clash with Cities Over Potential Opioids Settlement Payouts

One More Time, With Big Data: Measles Vaccine Doesn't Cause Autism

Teenagers Can't Stop Vaping Nicotine. Experts Struggle to Help.

How to Help Teenagers Quit Vaping

Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting

Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting

Study Shows Big Rise in Teen Vaping This Year

Purdue Says Sacklers May Walk From Opioid Deal if Judge Does Not Block Cases

How Anti-Vax Sentiment Took Hold in the United States

What would giving health care to unauthorized immigrants mean?

Pillsbury flour cases are recalled over salmonella trace

One more time, with big data: Measles vaccine doesn't cause autism

Opioid lawsuits are headed to trial, and the stakes are high