C.D.C. Urges Flu Shots to Reduce Strain on Health Care System

Lockdowns helped keep last year’s flu season historically mild in both the United States and around the world, but U.S. officials fear a more serious season this fall and winter, with unmasked people out and about far more, and nearly half of adults in a new survey saying they are unlikely to get a flu shot.At a news briefing to release the survey data on Thursday morning, top health experts said they were particularly concerned that, with the coronavirus still coursing around the country, nearly one in four people at higher risk for flu-related complications indicated they did not intend to get the flu vaccine.Dr. Rochelle P. Walensky, head of the Centers for Disease Control and Prevention, noted that while experts did not yet know how severely the flu would hit the United States this fall, other respiratory infections had already returned, including RSV, a common cause of pneumonia and bronchitis in babies and a serious threat to older adults. The C.D.C.’s latest weekly flu report shows that only one state, Wyoming, had reached a “moderate” level of flu cases.Because the flu was almost nonexistent last year, Dr. Walensky noted, people do not have the protective immunity they might have acquired if they had gotten sick, and she urged that everyone age 6 months and older be vaccinated. “The Covid-19 pandemic is not over, and the risk of both flu and Covid-19 circulating could put additional strain on hospitals and frontline health care professionals,” she said.The survey was commissioned by the National Foundation for Infectious Diseases, a nonprofit organization. Its medical director, Dr. William Schaffner, said that overall vulnerability to flu could be higher this year, “with relaxed Covid-19 mitigation strategies, increased travel and the reopening of schools.”For the survey, more than 1,110 respondents 18 and older from all 50 states and the District of Columbia answered questions in mid-August that explored attitudes about the flu; Covid-19; pneumococcal disease, which can cause pneumonia, sepsis and meningitis; and vaccination intentions.The answers revealed a tension between beliefs about the value of the flu vaccination and the intention to get one: 61 percent of respondents agreed that a shot was the best protection against the flu, but 44 percent said they were either unsure whether they would get one or did not intend to do so.The coronavirus pandemic, however, has had a positive effect on behaviors that could help lessen the impact of the flu. Nearly half of those surveyed said that because of the pandemic, they were more likely to stay home from work or school if they were sick, and 54 percent said they would wear a mask at least sometimes during the flu season.But there were racial disparities: 73 percent of Black respondents and 62 percent of Latinos said they would wear a mask during flu season, compared with only 46 percent of white respondents. Black and Latino respondents were also more likely to be worried about being infected with Covid and the flu simultaneously than white respondents.Dr. Walensky said that the flu vaccination rate nationally had held steady over the year before, at about 52 percent, but criticized what she called a “disparity gap” in flu vaccination: 56 percent for white people versus 43 percent among Black people. Patsy Stinchfield, a nurse practitioner at Children’s Minnesota, a pediatric health care system, and the president-elect of the infectious disease foundation, said that it was safe for people to get flu and Covid shots — including boosters — at the same time. Dr. Walensky also raised alarms about a decline in the flu vaccination rates among young children, to 59 percent from 64 percent the year before. In the 2019-2020 season, she said, 199 children died from the flu, about 80 percent of whom were not vaccinated.

Read more →

U.S. Parents’ Views Are Shifting on Vaccines, Poll Finds

About one in four U.S. parents report that a child of theirs had to quarantine at home because of a possible exposure to Covid-19 since the beginning of the school year, according to the latest findings of a monthly survey about vaccine attitudes by the Kaiser Family Foundation.That is even as two-thirds of parents say they feel that their school is taking appropriate measures to contain the spread of the coronavirus. The report suggests that many parents are conflicted about which courses of action will keep their children both healthy and educated.Even among parents who have received at least one vaccine dose, 18 percent do not think schools should require all staff and students to wear masks, a view held by 63 percent of unvaccinated parents. Overall, 58 percent of parents say that schools should have comprehensive mask requirements, 35 percent say there should be no mask mandates at all, and 4 percent believe that only unvaccinated students and staff should be compelled to wear masks, according to the report.Over the summer, the Centers for Disease Control and Prevention recommended that all students, teachers and staff members in elementary and secondary schools wear masks, regardless of their vaccination status, to allow as many students as possible to return to in-person instruction.Kaiser conducted a nationally representative survey of 1,519 people from Sept. 13 to Sept. 22 — a time of surging Covid deaths — and was mostly completed before Pfizer and BioNTech announced that their coronavirus vaccine was safe and effective for children aged 5 to 11. No vaccine is currently authorized in the United States for children under 12. Of all the people who were polled, 414 identified themselves as parents of children 17 or younger, and were included in the analysis of parents’ responses.The Pfizer vaccine, already in use for older children and adults, was authorized in mid-May for children aged 12 to 15, and the report suggests that over time, parents of children in that age group and older are slowly becoming more comfortable with it. By the time of the September interviews, 48 percent said that their children between the ages 12 to 17 had gotten at least one dose, up from 41 percent in July. According to federal data, 57 percent of that age group has received at least one dose.And perhaps prompted by a constellation of factors, including rising numbers of children hospitalized because of the Delta variant as well as seeing older vaccinated children remain healthy, parents of children aged 5 to 11 increasingly report favoring the vaccine as well..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-1kpebx{margin:0 auto;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-1kpebx{font-size:1.25rem;line-height:1.4375rem;}}.css-1gtxqqv{margin-bottom:0;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-19zsuqr{display:block;margin-bottom:0.9375rem;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}Thirty-four percent of those parents say now that they will have their children vaccinated as soon as they can, up from 26 percent in July. Commensurately, parental hesitation is beginning to melt: In September, with school open, 32 percent of parents of those younger children said they preferred to “wait and see” before making a decision about vaccinating them, down from 40 percent in July.Of note, the share of parents of children aged 5 to 17 who insist that they will “definitely not” vaccinate their children has scarcely budged in months, suggesting that they will be the most difficult to persuade. In April, 22 percent of parents of the older cohort, ages 12 to 17, said they would definitely not have their children get shots; in September, 21 percent reported holding the same view. Parents of younger children are similarly adamant: in July, 25 percent said “definitely not” position, and in September, 24 percent did.

Read more →

Fear of Delta, not rewards or mandates, is motivating Americans to get shots, a survey found.

The Delta variant was the main reason that people decided to get vaccinated against Covid-19 this summer and why most say they will get boosters when eligible, according to the latest monthly survey on vaccine attitudes by the Kaiser Family Foundation, released on Tuesday morning. But the survey indicated that nearly three-quarters of unvaccinated Americans view boosters very differently, saying that the need for them shows that the vaccines are not working.That divide suggests that while it may be relatively easy to persuade vaccinated people to line up for an additional shot, the need for boosters may complicate public health officials’ efforts to persuade the remaining unvaccinated people to get their initial one.Another takeaway from the Kaiser Family Foundation survey: For all the carrots dangled to induce hesitant people to get Covid shots — cash, doughnuts, racetrack privileges — more credit for the recent rise in vaccination goes to the stick. Almost 40 percent of newly inoculated people said that they had sought the vaccines because of the increase in Covid cases, with more than a third saying that they had become alarmed by overcrowding in local hospitals and rising death rates.“When a theoretical threat becomes a clear and present danger, people are more likely to act to protect themselves and their loved ones,” said Drew Altman, the Kaiser Family Foundation’s chief executive.The nationally representative survey of 1,519 people was conducted from Sept. 13-22 — during a time of surging Covid deaths, but before the government authorized boosters for millions of high-risk people who had received the Pfizer-BioNTech shot, including those 65 and over and adults of any age whose job puts them at high risk of infection.Sweeteners did have some role in getting shots in arms. One-third of respondents said that they had gotten vaccinated to travel or attend events where the shots were required.Two reasons often cited as important for motivating those hesitant to get a vaccine — employer mandates (about 20 percent) and full federal approval for the Pfizer-BioNTech vaccine (15 percent) — carried less sway.Seventy-two percent of adults in the survey said that they were at least partly vaccinated, up from 67 percent in late July. The latest numbers from the Centers for Disease Control and Prevention are even higher, reporting 77 percent of the adult population in the United States with at least one shot. The sharpest change in this month was in vaccination rates for Latinos: a jump of 12 percentage points since late July, to 73 percent, in the number of Latino adults who had received at least one shot.With the vaccination racial gap narrowing, the political divide has, by far, become the widest, with 90 percent of Democrats saying that they have gotten at least one dose, compared with 58 percent of Republicans.Perhaps reflecting pandemic fatigue, about eight in 10 adults said that they believed Covid was now a permanent fixture of the health landscape. Just 14 percent said that they thought “it will be largely eliminated in the U.S., like polio.”

Read more →

What to Know: Purdue Pharma Settlement

What to Know: Purdue Pharma SettlementJan HoffmanReporting on the opioid epidemicAbout 130,485 people who can prove they were harmed by OxyContin will each get between $3,500 and $48,000. Guardians of 6,550 children born with symptoms of opioid withdrawal will receive about $7,000. Over the past 20 years, more than 500,000 people in the U.S. died from prescription and illicit opioids. Federal economists said that the true cost of the epidemic — including law enforcement, healthcare and treatment — could run into trillions of dollars. During the pandemic, overdose deaths soared.

Read more →

Purdue Pharma Is Dissolved and Sacklers Pay $4.5 Billion to Settle Opioid Claims

The ruling in bankruptcy court caps a long legal battle over the fate of a company accused of fueling the opioid epidemic and the family that owns it.Purdue Pharma, the maker of the highly addictive painkiller OxyContin, was dissolved on Wednesday in a wide-ranging bankruptcy settlement that will require the company’s owners, members of the Sackler family, to turn over billions of dollars of their fortune to address the deadly opioid epidemic.But the agreement includes a much-disputed condition: It largely absolves the Sacklers of Purdue’s opioid-related liability. And as such, they will remain among the richest families in the country.Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., approved the settlement, saying he wanted modest adjustments. The painstakingly negotiated plan will end thousands of lawsuits brought by state and local governments, tribes, hospitals and individuals to address a public health crisis that led to the deaths of more than 500,000 people nationwide.The settlement terms have been harshly criticized for shielding the Sacklers. They are receiving protections that are typically given to companies that emerge from bankruptcy, but not necessarily to owners who, like the Sacklers, do not themselves file for bankruptcy.Several states, including Connecticut and Washington State, have already said they intend to appeal the judge’s ruling.In exchange for the protections, the Sacklers agreed to turn over $4.5 billion, including federal settlement fees, paid in installments over roughly nine years. Those payments, and the profits of a new drug company rising from Purdue’s ashes with no ties to the Sackler family, will mainly go to addiction treatment and prevention programs across the country.Judge Drain delivered his ruling orally from the bench in a marathon session that ran to six hours, meticulously working through his reasoning in a case he called the most complex he had ever faced. “This is a bitter result,” he said. “B-I-T-T-E-R,” he spelled out, explaining that he was frustrated that so much Sackler money was parked in offshore accounts. He said he had expected and wished for a higher settlement.But the costs of further delay, he said, and the benefits of an agreement he described as “remarkable” in its ability to help abate the epidemic, tilted toward approval.While the settlement serves as a benchmark in the nationwide opioid litigation aimed at covering governments’ costs and compensating families, it also means that a full accounting of Purdue’s role in the epidemic will never unfold in open court. Purdue pleaded guilty to federal criminal charges for drastically downplaying OxyContin’s addictive properties and, years later, for soliciting high-volume prescribers.But in a concession that made the bankruptcy plan more palatable to many plaintiffs, the company and the Sacklers agreed to make public more than 30 million documents, including confidential emails, that may reveal comprehensive marketing strategies.Just last month, Dr. Richard Sackler, a former president and co-chairman of the board, testified that neither the family, the company nor its products bore any responsibility for the opioid epidemic. Other Sacklers struck a more conciliatory note, saying they were horrified that a medication intended to alleviate pain had, in fact, caused pain to so many. But no one apologized or took personal responsibility.“I don’t think anybody would say that justice has been done because there’s just so much harm that was caused, and so much money that has been retained by the company and by the family,” said Dr. Joshua Sharfstein, a professor at the Johns Hopkins Bloomberg School of Public Health who developed a set of priorities for opioid settlement funds. “But this is what the legal system is going to produce. So at this point, the question becomes, how can those resources be used as effectively as possible?”A majority of states and other plaintiffs support the plan, reasoning that it is the best to help pay for a problem that has only grown worse during the pandemic, with a record number of opioid overdose deaths last year.Steve Miller, the chairman of Purdue’s board, said in a statement that the plan “ensures that billions of dollars will be devoted to helping people and communities who have been hurt by the opioid crisis.”The Mortimer Sackler branch and the Raymond Sackler branch each issued statements calling the resolution an important step in providing funds to address the public health crisis.Makeshift gravestones in protest against Purdue Pharma placed outside the White Plains courthouse during the bankruptcy proceedings. Seth Wenig/Associated PressThe Purdue settlement aligns with what some experts predicted from the outset: The money extracted through litigation will not be sufficient to cover the costs of the epidemic — including for law enforcement, treatment and social services — which some economists put in the trillions.Nor will the money gush forth. A recent deal with pharmaceutical distributors and Johnson & Johnson for $26 billion could take a year to be approved, and even then, payments would be doled out over 18 years.The Sacklers’ payments will come from their investments and from the sale of their international pharmaceutical companies, which they have seven years to complete. Purdue will make initial payments of roughly $500 million. Additional funds will come from anticipated profits from the new company’s drugs, including addiction-reversal medications as well as OxyContin.States will get money from a national opioid abatement trust, which they will distribute to their local governments. Native American tribes have their own fund.Another fund will compensate 130,485 individuals and families of those who suffered from addiction or died from an overdose, in amounts ranging from $3,500 to $48,000. Guardians of about 6,550 children with a history of neonatal abstinence syndrome may each receive about $7,000.“It was take it or leave it,” said Ryan Hampton, who resigned on Tuesday as co-chairman of a watchdog committee of plaintiffs, appointed by the federal government.OxyContin came on the market in 1996, at a time when doctors were being exhorted to recognize and treat pain, a symptom that the medical profession had tended to disregard as psychological or fleeting.Purdue’s sales troops fanned across the country, preaching the new pain relief gospel to thousands of doctors, who began prescribing OxyContin for both acute and chronic pain. By 2000, sales of the new drug had grown to almost $1.1 billion.But soon afterward, reports began surfacing of OxyContin pills being stolen from pharmacies and crushed and snorted. In 2007, the company and three executives pleaded guilty to federal criminal charges, paying a combined $634.5 million for minimizing the drug’s risk of addiction to doctors, regulators and patients.The nation was pounded by a spiraling epidemic of opioid abuse and overdose deaths. By 2014, local governments began filing lawsuits against Purdue. More plaintiffs followed, eventually suing other companies across the pharmaceutical supply chain. Members of the Sackler family became the personification of the epidemic’s villains. The Sacklers withdrew $10.4 billion from Purdue between 2008 and 2017. About half was paid to taxes.In September 2019, Purdue, facing 2,900 lawsuits, 628 of which named the Sacklers, filed for bankruptcy restructuring, which paused all claims.The most ferocious battle was fought over the extent to which the Sacklers would be released from Purdue-related lawsuits.Companies that emerge from bankruptcy restructuring are granted considerable legal protections. But federal appeals courts disagree over whether that shield can be accorded to owners, like the Sacklers. The prospect of Sacklers left relatively unscathed has led some members of Congress to introduce a bill that would prevent protections for owners in similar situations.Dr. Richard Sackler, a former president and co-chairman of Purdue’s board of directors, said that neither the family, the company nor its products bore responsibility for the opioid epidemic. via ProPublicaThe settlement does not preclude criminal prosecution. But realistically, say prosecutors, those cases are difficult to prove; no government entity has pressed a Purdue-related criminal charge against a Sackler. The Sacklers can still be held liable for some non-opioid related claims against Purdue, such as an environmental hazard or other Purdue drugs, if their conduct occurred before the bankruptcy plan takes effect.And opioid claims could be brought against the as-yet unnamed new company, which is independent of Purdue, if it breaches strict controls intended to closely monitor sales and distribution.During hearings last month, four Sacklers tried to put an arm’s length between their role as board members and that of Purdue’s executives, whom they said oversaw marketing and sales.But Dr. Kathe Sackler also testified, “I wouldn’t describe the board as passive listeners.” Rather, she said, they were “attentive listeners. Asked good questions, thoughtful questions, engaged in some debate over some questions from time to time.”Nine states objected to the plan, arguing that the shields would prevent them from exercising their police powers to prosecute the Sacklers for violating civil laws like consumer protection statutes.Washington State’s attorney general, Bob Ferguson, called the plan “morally and legally bankrupt,” because, he said, “it allows the Sacklers to walk away as billionaires with a lifetime legal shield.”Another objector was the U.S. Trustee, a program under the Department of Justice that monitors bankruptcy cases. Immediately after Judge Drain’s ruling, its lawyer said he would be requesting a stay of the order, pending an appeal.But Marshall Huebner, a bankruptcy lawyer who has shepherded Purdue through proceedings, had contended earlier that such objections would topple the Jenga tower-like deal and delay desperately needed funds.He characterized the governments’ terms as punitive toward the Sacklers and their company. “We will rip it out of your hands,” he said. “We will stomp it out of existence. We will transfer its assets to a trust for the benefit of the American people. It will have a monitor. We will pick the board. You will be barred. And you will have to sell all your overseas companies and give us over $4 billion.”A Congressional committee investigating the Sacklers last spring estimated the family fortune at about $11 billion.U.S District Court in White Plains in 2019, where Purdue Pharma’s bankruptcy case was argued. Seth Wenig/Associated PressDoses of OxyContin in a Massachusetts pharmacy in 2001.Darren McCollester/Getty ImagesJudge Drain had largely excluded the voices of victims during the two years. But at the conclusion of testimony in August, he pointedly acknowledged the families whose tragedies were entwined with Purdue’s drug.He spoke haltingly, his voice choking up. “I am very aware of the impact that this company’s products have had on hundreds of thousands of people,” he said.The letters families placed on the docket were eloquent and brave, he said. “If anyone doubts that impact, you should read them, not as advocates’ pieces but as evidence of the effect of this company’s products.”Judge Drain broke off in midsentence, overcome, and abruptly left the bench, ending the hearing.One letter he noted was from a Minneapolis widow with Stage 4 cancer. Years earlier, her firefighter husband was prescribed OxyContin for a back injury. He became addicted. Eventually he lost his job. Then the family lost its home. In September, he committed suicide.“I believe the Sackler family should know what their greed has caused,” the widow, Stephanie Lubinski, wrote. “They should know the name Troy Lubinski and the many, many others that have lost their lives to OxyContin.”

Read more →

Sacklers Threaten to Pull Out of Purdue Pharma Opioids Settlement

In a rare court appearance, David Sackler said he and his family would withdraw their pledge to pay $4.5 billion, unless they are granted broad legal immunity.A scion of the Sackler family, the billionaire owners of Purdue Pharma, vowed in court on Tuesday that the family would walk away from a $4.5 billion pledge to help communities nationwide that have been devastated by the opioid epidemic, unless a judge grants it immunity from all current and future civil claims associated with the company.Absent that broad release from liability, said David Sackler, 41, a former board member and grandson of one of the founders, the family would no longer support the deal that the parties have painstakingly negotiated over two years to settle thousands of opioids lawsuits brought by states, cities, tribes and other plaintiffs.“We need a release that is sufficient to get our goals accomplished, and if the release fails to do that, then we will not support it,” Mr. Sackler declared during the fourth day of fractious testimony in the confirmation hearing for the bankruptcy plan of Purdue Pharma, whose misleading marketing of the prescription painkiller OxyContin is widely seen as igniting the opioid epidemic.Instead, he said he believed the Sacklers would resume fighting all the cases “to their final outcomes” — a process that would be inordinately costly and protracted for everyone involved.The Sackler’s $4.5 billion pledge is the centerpiece of the settlement plan and, without it, the deal will almost certainly collapse. The money is to be paid over nine or ten years, to begin to cover the extraordinary costs of an addiction crisis that has contributed to the deaths of more than a half-million Americans since the late 1990s. Under the plan’s other major terms, Purdue would be remade into a new public benefit company, whose profits would almost all go to the settlement, and the Sacklers would renounce all involvement.They will, however, be allowed to remain involved in their considerable international pharmaceutical companies, through which they can continue to produce and market opioids for up to seven years, until the companies are sold, to seed the litigation payments.Another signature feature would be a public repository for more than 30 million documents from Purdue and the Sacklers “so that academics and scholars and families of victims and everyone can look at those documents and understand what can happen when there is a fraud and how intense and how long that fraud can go on,” said Jayne Conroy, a lawyer who began pursuing Purdue in 2002, and who testified on Monday in favor of the plan.A federal bankruptcy judge had been expected to confirm the plan at the end of these hearings, particularly after a majority of states that had earlier opposed the deal expressed support for it last month. But objections to the legal shield for the Sacklers have become the sharp focus of much of the testimony. The details of the Sacklers’ liability releases are so far-reaching that last week Judge Robert Drain himself said he had “some concerns about the breadth.”Mr. Sackler testified by video before Judge Drain, who sits in White Plains, N.Y. It is believed to be the first time that a member of the family has appeared in open court on a matter related to OxyContin, though some Sacklers have given depositions in cases over the years.He said the family anticipated that the liability shield would cover him, other members of his extensive family, and about 1,000 other individuals, including contractors and consultants, and protect them from lawsuits that had nothing to do with opioids. That means they would be forever immunized from any current and future lawsuits worldwide related not only directly to Purdue’s opioids but to other drugs the company makes, including drugs for addiction reversal, high cholesterol and even constipation as a result of taking prescription opioids.Purdue and the actions of Sackler family members, who as hands-on board members took a keen interest in the marketing of the company’s prescription opioids as nonaddictive, have been widely implicated in the opioid epidemic.The company has pleaded guilty to federal criminal charges twice, most recently in 2021, during which the Sacklers themselves paid related civil penalties.In his court appearance, Mr. Sackler refused to be pinned down by lawyers who sought to elicit an acknowledgment of family responsibility in the continuing tragedy, which saw a record-breaking number of overdose deaths last year during the pandemic. He continued to stoutly defend the company’s opioid medications as federally approved drugs to alleviate pain.The balance between “risk and societal benefit is, I think, beyond question,” Mr. Sackler said. “So I bristle at the notion that people are dying as the only barometer of these medications.”But at another moment during cross-examination, Mr. Sackler said, “I think because of the product we produced that has helped millions of people has also been associated with the opioid epidemic, we bear moral responsibility to try and help, and that’s what this settlement is designed to do.”At least 2,700 lawsuits and hundreds of thousands of claims have been registered against Purdue, beginning in 2014, when the opioid epidemic began to crest. The plaintiffs span a vast array including 48 states, local governments, tribes, hospitals, individuals and monitors of infants born with symptoms of withdrawal to opioids, all of whom have been ravaged and financially depleted by opioids.In more recent years, individual Sacklers themselves have been named in a growing number of the cases.Nearly two years ago, Purdue filed for bankruptcy restructuring, which put an automatic stay on those lawsuits. But the Sacklers themselves did not file for bankruptcy, although they insisted that they, too, benefit from the liability releases expected to be given to their company.The issue of releases for the Sacklers and other third parties is at the heart of the resistance to the bankruptcy plan now pursued by nine states, including Maryland, Washington and Connecticut. The District of Columbia, the federal Justice Department and U.S. Trustee, a program in the Justice Department that monitors bankruptcy cases, as well as some Canadian local governments and First Nations, have joined in the objections.According to current law in the First Circuit Court of Appeals, in which Judge Drain’s court is located, the judge can grant releases to the Sacklers and other third-party individuals who have not filed for bankruptcy. But, broadly speaking, the issue is unsettled.Other federal circuits prohibit it. The question has been taken up by members of Congress, and may well drive an appeal by the objectors, should Judge Drain confirm the plan. The hammering questions by objecting lawyers have so far been intended not only to raise questions about the plan, but to lay a foundation for such appeals.Alain Delaqueriere contributed research.

Read more →

Purdue Pharma’s Creditors Overwhelmingly Endorse Bankruptcy Plan

If approved by a judge next month, the plan would resolve thousands of lawsuits and set in motion the release of $4.5 billion to help cover costs from the opioid epidemic.A huge majority of more than 120,000 creditors of Purdue Pharma have voted to approve the company’s bankruptcy plan, a key step toward the eventual release of more than $4.5 billion dollars to help pay for the costs of the opioid epidemic and the resolution of thousands of lawsuits against the company and its owners, members of the billionaire Sackler family.Preliminary tabulation of voting by cities, states, tribes, insurers, families and caregivers of babies born with symptoms of withdrawal from being exposed to opioids in utero show that 95 percent favor the plan, the company said.Under the plan, the Sacklers would relinquish control of Purdue. The restructured company would re-emerge with a new name, and be run by an independently appointed board. Profits from sales of its signature prescription painkiller, OxyContin, and addiction-reversal drugs would flow into creditors’ trusts that would fund addiction prevention and treatment programs.The Sacklers, who have not filed for personal bankruptcy, would pay at least $4.5 billion of their personal funds over nine years (in addition to $225 million from a separate civil settlement with the Justice Department).Neither the company, nor the Sacklers, would admit to wrongdoing in connection with these lawsuits.Over the past two decades, more than 500,000 people in the United States have died from overdoses of prescription and illegal opioids, including a record annual number in 2020. Purdue, widely believed to have helped ignite the problem by downplaying the addictive potential of OxyContin and aggressively marketing the drug with misleading campaigns, pleaded guilty to two separate investigations by the Justice Department.For the complex plan to take effect, Judge Robert Drain of the U.S. Bankruptcy Court for the Southern District of New York, must sign off, a move long expected and now made even more likely by the full-throated results of the creditor vote. Purdue said it would release final voting tallies on Aug. 2, a week before a court hearing at which final objections will be aired, but the company does not anticipate that these results will change materially. The judge is expected to rule shortly after.Although a handful of states filed objections to the plan, as did the Department of Justice, those efforts seem unlikely to derail proceedings. Earlier this month, attorneys general for 15 states that had been among the most vociferous objectors, including Massachusetts and New York, said they had negotiated fresh terms that made the plan more palatable and now supported the plan.Among the new elements the states and Purdue reached during mediation was an agreement by the company to release more than 30 million documents to a public repository, including private communications with lawyers. Those documents are expected to unfurl the full story of the company’s and the Sacklers’ involvement in the selling of OxyContin.The Sacklers, long known for their philanthropy in the arts, would relinquish future naming rights to any institutions to which they donate until their contributions to the opioids settlement are paid in full.For nearly two years, the objecting states argued that they should be able to reach directly into the pockets of individual Sacklers, because they did not themselves file for bankruptcy protection. Under the terms of the Purdue plan, however, the Sacklers as well as their company have been released from all civil liability.Some members of Congress have introduced legislation to close a loophole in the bankruptcy code. It would permit states and possibly individuals to sue third-party owners of a company in bankruptcy who, like the Sacklers, have not themselves filed for bankruptcy. But if the legislation is passed, the Purdue plan and the status of the Sacklers will almost certainly have been long since resolved.

Read more →

Testing Britney Spears: Restoring Rights Can Be Rare and Difficult

To get out of conservatorship, the pop star will likely have to undergo a psychiatric evaluation, an uneasy melding of legal standards and mental health criteria.Her voice quaking with anger and despair, the pop star Britney Spears has asked repeatedly in court to be freed from the conservatorship that has controlled her money and personal life for 13 years. What’s more, she asked the judge to sever the arrangement without making her undergo a psychological evaluation.It’s a demand that legal experts say is unlikely to be granted. The mental health assessment is usually the pole star in a constellation of evidence that a judge considers in deciding whether to restore independence.Its underlying purpose is to determine whether the conditions that led to the imposition of the conservatorship have stabilized or been resolved.The evaluation process, which uneasily melds mental health criteria with legal standards, illustrates why the exit from strict oversight is difficult and rare. State laws are often ambiguous. And their application can vary from county to county, judge to judge, case to case.Isn’t Ms. Spears’s artistic and financial success proof she is self-sufficient?Yes and no. A judge looks for what, in law, is called “capacity.” The term generally refers to benchmarks in a person’s functional and cognitive ability as well as their vulnerability to harm or coercion.Under California law, which governs Ms. Spears’s case, a person deemed to have capacity can articulate risks and benefits in making decisions about medical care, wills, marriage and contracts (such as hiring a lawyer), and can feed, clothe and shelter themselves.Annette Swain, a Los Angeles psychologist who does neuropsychological assessments, said that because someone doesn’t always show good judgment, it doesn’t mean they lack capacity. “We all can make bad decisions at many points in our lives,” she said. “But that doesn’t mean that we should have our rights taken away.”Even so, Ms. Spears’s professional and financial successes do not directly speak to whether she has regained “legal mental capacity,” which she was found to lack in 2008, after a series of public breakdowns, breathlessly captured by the media. At that time, a judge ruled that Ms. Spears, who did not appear in court, was so fragile that a conservatorship was warranted.Judges authorize conservatorships usually for one of three broad categories: a severe psychiatric breakdown; a chronic, worsening condition like dementia; or an intellectual or physical disability that critically impairs function.Markers indicating a person has regained capacity appear to set a low bar. But in practice, the bar can be quite high.“‘Restored to capacity’ before the psychotic break? Or the age the person is now? That expression is fraught with importing value judgment,” said Robert Dinerstein, a disability rights law professor at American University.Records detailing grounds for the petition from Ms. Spears’s father, Jamie Spears, to become his daughter’s conservator are sealed. A few factors suggest the judge at the outset regarded the situation as serious. She appointed conservators to oversee Ms. Spears’s personal life as well as finances. She also ruled that Ms. Spears could not hire her own lawyer, though a lawyer the singer consulted at the time said he thought she was capable of that.Earlier this month, Los Angeles Superior Court Judge Brenda Penny said Ms. Spears could retain her own counsel.Does “capacity” differ among states?Yes. Some states, like California, detail basic functional abilities. Others do not. Colorado acknowledges modern advances like “appropriate and reasonably available technological assistance.” Illinois looks for “mental deterioration, physical incapacity, mental illness, developmental disability, gambling, idleness, debauchery, excessive use of intoxicants or drugs.”Sally Hurme of the National Guardianship Association noted: “You could be found to be incapacitated in one state but not in another.”Who performs the psychological assessment?Ideally, a forensic psychiatrist or a psychologist with expertise in neuropsychological assessments. But some states just specify “physician.” Psychiatrists tend to place greater weight on diagnoses; psychologists emphasize tests that measure cognitive abilities. Each reviews medical records and interview family, friends and others.Assessments can extend over several days. They range widely in depth and duration.Eric Freitag, who conducts neuropsychological assessments in the Bay Area, said he prefers interviewing people at home where they are often more at ease, and where he can evaluate the environment. He asks about financial literacy: bill-paying, health insurance, even counting out change.Assessing safety is key. Dr. Freitag will ask what the person would do if a fire broke out. “I’d call my daughter,” one of his subjects replied.Who chooses the evaluator?Ms. Spears has not been able to choose her evaluators in the past because the conservator has the power to make those decisions. However, if she moves to dissolve the conservatorship, she can select the evaluator, to help build her case. If the conservator, her father, opposes her petition and objects to her selection, he could nominate a candidate to perform an additional assessment. Ms. Spears would likely pick up both tabs as costs of the conservatorship.To avoid a bitter battle of experts and the appearance that an assessor hired by either camp would be inherently biased — plus the strain of two evaluations on Ms. Spears — the judge could try to get both sides to agree to an independent, court-appointed doctor.What impact does a mental health diagnosis have on an evaluation?Many states explicitly say that a diagnosis of a severe mental health disorder is not, on its own, evidence that a person should remain in conservatorship.Stuart Zimring, an attorney in Los Angeles County who specializes in elderlaw and special needs trusts, noted that he once represented a physician with schizophrenia and bipolar disorder who was under a conservatorship. The doctor’s rights were eventually restored after he proved he was attending counseling sessions and taking medication.“It was a joyous day when the conservatorship was terminated,” said Mr. Zimring. “He got to practice medicine again, under supervision.”The association between the diagnosis of a severe mental disorder and a determination of incapacity troubles Dr. Swain, the Los Angeles psychologist.“Whatever they ended up diagnosing Britney Spears with, was it of such severity that she did not understand the decisions that she had to make, that she could not provide adequate self-care?” she asked. “Where do you draw that line? It’s a moving target.”Does the judge have to accept an evaluator’s findings?No, but judges usually do.What standard does a probate judge apply to reach a decision?In most states, when a judge approves a conservatorship, which constrains a person’s autonomy, the evidence has to be “clear and convincing,” a rigorous standard just below the standard of “beyond a reasonable doubt.”But when a conservatee wants those rights restored, many experts believe the standard should be more lenient.Some states indeed apply a lower standard to end a conservatorship. In California, a judge can do so by finding it is more likely than not (“preponderance of evidence”) that the conservatee has capacity. But some states say that the evidence to earn a ticket out still has to be “clear and convincing.”Most states do not even set a standard.“There’s an underlying assumption that if you can get the process right, everything would be fine and we wouldn’t be depriving people of rights,” said Jennifer Mathis, deputy director of the Bazelon Center for Mental Health Law. “Our take is that the process is fundamentally broken and that we shouldn’t be using guardianship in so many cases.”If someone is doing well, isn’t the conservatorship no longer necessary?Yes and no. “Judges are haunted by people they have had in front of them who have been released and disaster happens,” said Victoria Haneman, a trusts and estates law professor at Creighton University. “So they take a conservative approach to freedom.”Describing the Kafkaesque conundrum of conservatorship, Zoe Brennan-Krohn, a disabilities rights lawyer with the American Civil Liberties Union, said: “If she’s doing great, the system is working and should continue. If she is making choices others disagree with, then she’s unreliable and she needs the system.”Or, as Kristin Booth Glen, a former New York State judge who oversaw such cases and now works to reform the system, put it, “Conservatorship and guardianship are like roach motels: you can check in but you can’t check out.”Can an evaluator recommend a less restrictive approach than a conservatorship?At times. Judge Glen once approved the termination of a guardianship of a young woman originally deemed to have the mental acuity of a 7-year-old. After three years of thoughtful interventions, the woman, since married and raising two children, had become able to participate fully in her life. She relied on a team for “supported decision making,” which Judge Glen called “a less restrictive alternate to the Draconian loss of liberty” of guardianship.A supported decision-making approach has been hailed by the Uniform Law Commission, which drafts model statutes. It has said judges should seek “the least restrictive alternative” to conservatorship.To date, only Washington and Maine have fully adopted the commission’s recommended model.Samantha Stark contributed reporting.

Read more →

States and Cities Near Tentative $26 Billion Deal in Opioids Cases

The agreement would end thousands of lawsuits against the three largest distributors and Johnson & Johnson and require them to pay billions for addiction treatment and prevention.The three largest pharmaceutical distributors and Johnson & Johnson are on the verge of a $26 billion deal with states and municipalities that would settle thousands of lawsuits over their role in the opioid epidemic and pay for addiction and prevention services nationwide.An agreement could be announced later this week, although several people with direct knowledge of the talks cautioned that there were still details being negotiated.The settlement would not conclude all of the multifaceted nationwide opioid litigation but would end legal action against some of the companies with the deepest pockets in the pharmaceutical supply chain: the country’s major medical distributors, Cardinal Health, McKesson and AmerisourceBergen, along with the pharmaceutical giant Johnson & Johnson.The distributors, which by law are supposed to monitor quantities of prescription drug shipments, have been accused of turning a blind eye for two decades while pharmacies across the country ordered millions of pills for their communities. Plaintiffs also allege that Johnson & Johnson, which used to contract with poppy growers in Tasmania to supply opioid materials to manufacturers and made its own fentanyl patches for pain patients, downplayed addictive properties to doctors as well as patients.Negotiations, which began more than two years ago, intensified this summer as trials opened in several states and overdose rates reached record levels.Unlike earlier settlement proposals, this one appears to have the critical backing of more than 40 states and a sweetener of $2 billion for plaintiffs’ attorneys. In recent weeks, many terms were nailed down and the fees for private lawyers in the cases — a previous sticking point — bumped up, prompting enthusiasm that an announcement was imminent, lawyers involved in the talks said.In a briefing with several reporters on Tuesday morning, lawyers for thousands of cities and counties were careful to use words like “optimistic” to describe the talks, saying that states had to agree first before local governments could even vote on the settlement. A statement from attorneys general of 10 states, including Pennsylvania, North Carolina and Tennessee, said the negotiations were “progressing well and potentially nearing their completion.”Cardinal Health declined to discuss the negotiations. The other distributors did not reply to requests for comment.Johnson & Johnson said in a statement, “There continues to be progress toward finalizing this agreement and we remain committed to providing certainty for involved parties and critical assistance for families and communities in need.”The company said the agreement would not be an admission of liability or wrongdoing and that it would continue to defend in cases brought by plaintiffs who were not part of the settlement.In court proceedings, the distributors have repeatedly argued that they were participants in the supply chain for drugs that were federally approved.A separate agreement between Native American tribes and the companies is still being negotiated.Even if the negotiators reach a deal, numerous steps are required before formal agreement, including voting by all of the thousands of plaintiffs. It includes carrot-stick incentives to induce more parties to come on board.The deal is contingent on agreement by a large majority of states. People involved in the talks say that eight or so states are still not on board, because they believe the amount of money the companies would pay is insufficient.“Their proposal can be described in three words — not good enough,” said Bob Ferguson, the attorney general of Washington, which has a September trial scheduled against the distributors. “It does not represent real accountability, and will not provide a transformative amount of money to help communities respond to the crisis they helped cause.”Another contentious issue in the proposed deal is what is known as “global peace” — the companies want assurance that a settlement would mean that plaintiffs would put down their litigating swords for good. They are asking that states ensure that local governments that have not brought cases against the companies, as well as those that have cases pending, refrain from future legal action against the companies over opioids.Once a state agrees to the deal, it would ask all of its local governments — even municipalities that have not filed lawsuits — to back it. Reimbursement would work on a tier: full payment is conditional on a state’s local governments signing on.For example, said Mr. Ferguson, most of the money that would be apportioned to his state would be contingent on Washington’s 39 counties and 281 cities signing on — a very high bar.Many major players in the prescription opioid industry have yet to settle cases against them. Some manufacturers, like Purdue Pharma and Mallinckrodt, have sought bankruptcy protection. Teva, Allergan and Endo are on trial. Cases against pharmaceutical chains, such as CVS Health, Walgreens and Walmart, are even further from resolution.According to lawyers familiar with negotiations, Johnson & Johnson, which ended its relationship with poppy growers and stopped making its fentanyl patch and other opioids, would pay $3.7 billion in the first three years and $1.3 billion over the next six years.Collectively the distributors would pay $21 billion over 17 years. The fees of lawyers, who pursued and financed the costly litigation for years, would be deducted from the total figure and are expected to be paid more quickly than some funds for addiction treatment.The distributors would establish a third-party monitor to track their own and their competitors’ drug shipments, intended to quickly alert red-flag pill sales.“It will provide an entirely new method of tracking narcotic drugs at a national level and will make data instantaneously available,” said Joe Rice, a lawyer for many local governments who is on the negotiating team.The negotiations for the states have been led by New York, North Carolina, Pennsylvania, Tennessee, Florida, Texas and California, among others.The negotiations were stalled for months over attorneys’ fees. Innumerable lawyers have contributed different amounts of work and have fought over who should get paid how much. Now, about $1.6 billion in fees and costs would be paid to private lawyers representing thousands of counties and municipalities, $50 million in costs and about $350 million to private lawyers who worked for states. (Many states are represented by their own salaried, government lawyers.)Another critical lever in advancing settlement terms has been the high-stakes gamble of a trial. The distributors have been locked in trial in a West Virginia federal court and in a New York state court. The West Virginia case is ongoing but on Tuesday, Letitia James, the attorney general for New York, announced a $1.179 billion settlement with the distributors that releases them from the case. That money would be deducted from the overall $26 billion settlement. Payments to New York could begin in two months, Ms. James said.A persistent tension in the talks has been over the division of funds among states and small governments, including cities and counties.The new settlement envisions a national formula for disbursing money to states and flexibility within each state to broker a deal with localities, so that the bulk of the funds is aimed at alleviating the opioid epidemic and preventing its recurrence.For months, states and counties elbowed each other, even as they fought with defendants. The distribution to each state now relies on extensive federal data and includes metrics like a state’s population, overdose deaths, opioid pill sales and disorders related to pain pill abuse.Most states will most likely work up their own disbursement plans. Ohio, North Carolina, Arizona, Texas, Florida and others have already brokered internal, state-specific formulas. Last month, the New York legislature passed bills that would ensure that all funds from the opioid litigation settlement would go into a “locked box,” to be used only to address the crisis.Johnson & Johnson is widely known as a company willing to try cases rather than settle, but it has faced rivers of adverse publicity recently: litigation over asbestos deaths related to its talcum powder, a recall of some sunscreens, and reports of rare adverse neurological events associated with its single-dose Covid vaccine. The company remains on trial in California state court but settled with the state of New York and two New York counties last month, on the eve of trial.The money for the New York settlement, $230 million, will be paid over nine years with an additional $33 million for lawyers’ costs and fees, and will be deducted from the national amount.

Read more →

15 States Reach a Deal With Purdue Pharma, Moving Toward a $4.5 Billion Opioids Settlement

The states, including Massachusetts and New York, agreed to drop opposition to the bankruptcy organization plan of the company, the maker of OxyContin.Fifteen states have reached an agreement with Purdue Pharma, the maker of the prescription painkiller OxyContin, that would pave the way toward a $4.5 billion settlement of thousands of opioid cases.The states decided late Wednesday to drop their opposition to Purdue’s bankruptcy reorganization plan, in exchange for a release of millions of documents and an additional $50 million from members of the Sackler family, the company’s owners.The agreement was contained in a late-night filing by a mediator in U.S. Bankruptcy Court in White Plains, N.Y.The settlement extracts concessions that will be added to a comprehensive proposal now being voted upon by more than 3,000 plaintiffs, including cities, counties, tribes and states, who sought to hold Purdue and its owners responsible for their role in the opioid epidemic, during which more than 500,000 Americans have died from overdoses of prescription and illegal opioids.Trials against other opioid manufacturers and drug distributors are underway.Nearly two years ago, the Sacklers had proposed paying $3 billion in cash. Both the company and family members had resisted releasing the full trove of documents, including hundreds of thousands of work emails and communications with attorneys, reaching back decades. According to last night’s filing, Purdue and the Sacklers will now release some 33 million documents, and the money has risen to $4.5 billion, plus an additional $225 million in a civil settlement with the Department of Justice.According to spokesmen, two branches of the Sackler family noted that the settlement included no finding of liability or wrongdoing. In a statement, they said: “This resolution to the mediation is an important step toward providing substantial resources for people and communities in need. The Sackler family hopes these funds will help achieve that goal.”The Sacklers will have nine years to make payments, but the new agreement includes an enhanced schedule.If Judge Robert Drain, who is presiding over the bankruptcy proceedings, certifies the plan after an August hearing, as is now widely expected, both the family and the company would be shielded from further opioid-related lawsuits.Maura Healey, the attorney general of Massachusetts, who was the first to sue individual Sacklers, said, “While I know this resolution does not bring back loved ones or undo the evil of what the Sacklers did, forcing them to turn over their secrets by providing all the documents, forcing them to repay billions, forcing the Sacklers out of the opioid business, and shutting down Purdue will help stop anything like this from ever happening again.”Another official in the pursuit of the Sacklers was Letitia James, the attorney general of New York.“For nearly two years, since Purdue Pharma declared bankruptcy, the company and the Sackler family have used every delay tactic possible and misused the courts — all in an effort to shield their misconduct,” she said. “While this deal is not perfect, we are delivering $4.5 billion into communities ravaged by opioids on an accelerated timetable and it gets one of the nation’s most harmful drug dealers out of the opioid business once and for all. ”Nine states and the District of Columbia continue to oppose the agreement. “While some progress has been made — especially around the public document depository — this plan is far from justice,” said William Tong, the attorney general of Connecticut. “Purdue and the Sacklers have misused this bankruptcy to protect their vast wealth and evade consequences for their callous misconduct. This deal alarmingly allows the Sacklers to still walk away with their personal wealth intact, and now allows funds already intended for charity to be included in this deal. We are evaluating all options to continue to fight this bankruptcy plan until all viable options are exhausted.”

Read more →