Will Your Dog Get Dementia? A Large New Study Offers Clues.

The risk of canine cognitive dysfunction, a.k.a. “doggy dementia,” is far greater in dogs who don’t get enough exercise, researchers found. Their risk factors echo some in humans, whose homes they share.Around the time Dante turned 8, he started to seem a little off. The 70-pound Bernese mountain dog would pace his family’s home in Interlaken, N.Y., like a caged bear. Then he might stand stock still, staring trance-like at the pedals of the family’s organ. Or at a corner of a room. In the middle of the night, he would wake up and begin barking incessantly, for no obvious reason.Then the indoor incontinence began.A brain scan confirmed that Dante had canine cognitive dysfunction, colloquially known as doggy dementia. It is often described as the dog’s analog to Alzheimer’s disease. Some studies have found it can occur in at least 14 to 35 percent of older dogs. But because the symptoms resemble those in other diseases, its true prevalence is difficult to confirm.A large new study of 15,019 dogs enrolled in the Dog Aging Project, an ongoing investigation into canine illness and aging, published Thursday in the journal Scientific Reports, identifies the top factors associated with a dog’s risk of getting the disease.A key finding: Exercise may play a significant preventive role. The odds of a cognitive dysfunction diagnosis were 6.47 times higher in dogs reported as not active compared with those reported to be very active, researchers at the University of Washington found. But they also said that the disease itself could lead to lack of exercise, emphasizing that the study results, which are based on observations by owners, suggest correlation, not causation.Odds of getting the disease also appear to increase in dogs that have neurological disorders, or impaired hearing or sight. Annette Fitzpatrick, a co-author of the study and a University of Washington research professor with expertise in dementia in people as well as canines, commented, “When you don’t get stimulation from the outside world, it seems to increase the risk of our not even being able to use our brains as well.”The study, she said, “shows that there may be other things we can be aware of, to try to reduce the onset of cognitive dysfunction.”And certainly age matters. A dog’s life expectancy often depends on breed, size and body mass: think mastiff (six to 12 years) versus Chihuahua (12 to 20 years). During the later years of a dog’s projected life span, each successive year contributed to the potential for disease onset, the study found.In fact, the researchers noted, risk factors that correlate with canine cognitive dysfunction mirror some of the factors for humans with dementia, including Alzheimer’s disease.Earlier studies of canine cognitive dysfunction often drew from veterinary assessments in smaller populations of older dogs; this one is culled from dogs who range in age from puppyhood to mid-20s. In the coming years, as these dogs grow older, the project, which has enrolled more than 40,000 dogs and hopes to reach 100,000, will issue more complex findings on cognitive dysfunction and other diseases.In this study, the prevalence of canine cognitive dysfunction among all the dogs, young and old, was 1.4 percent. But the average age of the dogs was just 6.9 years, and only 19.5 percent of the dogs analyzed were in the last quarter of their life span.“This study compares dogs with cognitive dysfunction to those that don’t have it,” Dr. Fitzpatrick said. “But as the years progress, we can look at the same dog who maybe had great cognitive function but then declined.”Matt Kaeberlein, a co-director of the Dog Aging Project, with Dobby, his 12-year-old German shepherd, in their Seattle backyard.Grant Hindsley for The New York TimesDobby and Dr. Kaeberlein’s late dog Chloe keep inspiring him to research causes of canine aging.Grant Hindsley for The New York TimesThe results were derived from just one baseline accounting by owners of their dog’s health and lifestyle experience between 2019 and 2020, and a particularly high-threshold cognitive function questionnaire.Among the questions:How often does your dog pace up and down, walk in circles and/or wander with no direction or purpose?How often does your dog get stuck behind objects and is unable to get around?How often does your dog walk into walls or doors?How often does your dog have difficulty finding food dropped on the floor?If the study findings have a familiar, even intuitive ring, that may be because the Dog Aging Project, which receives funding from the National Institute on Aging, a branch of the federal National Institutes of Health, may shed insight into factors that affect the life span of humans well as the dogs who share their homes.Unlike laboratory animal subjects such as fruit flies and mice, companion dogs are affected by their owners’ environmental and social factors, such as secondhand cigarette smoke, lawn pesticides and access to health care.“Estimates of human longevity say that about 75 percent is due to environment and 25 percent is genetic,” said Matt Kaeberlein, a biogerontologist at the University of Washington who is a co-director of the Dog Aging Project. “So companion dogs give us the opportunity to really understand the role of that environmental variability in the biological aging process.”Moreover, because dogs age much more rapidly than humans, the studies underway within the project provide opportunities along an expedited timeline for insights into human and canine aging.Dr. Kaeberlein’s motivation derives not only from his professional background but also from his many years as a dog owner. He shared stories of Chloe, his lively, loving, now-deceased keeshond, who began to stare blankly and get tangled in furniture, stricken with canine cognitive dysfunction. Or Dobby, his current inspiration, the family’s longhaired German shepherd who “is just a special dog,” but who, at 12 years old, has already beat back cancer once and can no longer cavort in the backyard to chase wand soap bubbles.“I would really like it if my dogs could live longer,” Dr. Kaeberlein said. “And I would really like it if I could help other people’s dogs live longer.”The trials now underway within the project, which began in 2014 and has researchers from the University of Washington and Texas A&M, as well as from the Cornell University College of Veterinary Medicine and other universities, includes those for potentially life-expanding drugs and a biobank of tissue donated by owners of deceased dogs. It released a study that is shaking the dog world, because of its finding that better health in dogs is correlated with a single daily feeding.(As Dr. Kaeberlein discussed that association during a phone interview, two small, highly food-motivated canines who had been snoozing at this reporter’s side sat up abruptly, whining and howling in protest. Dr. Kaeberlein hastened to add that the study’s observation is more likely a comment on obesity and morbidity than it is a prescription for feeding frequency, which is in keeping with the latest study’s positive correlation with exercise.)Dante with his owner Lisa Mitchell, who worked with one of her other dogs, Rook, on obedience at Cass Park in Ithaca.Heather Ainsworth for The New York TimesCanine cognitive dysfunction is difficult to pinpoint. A dog’s seeming ignorance of a commonplace command could indicate deafness or old-age stubbornness rather than an atrophying brain. Symptoms that look like cognitive dysfunction could actually be from stroke, brain inflammation, diabetes or Cushing’s disease, said Dr. Nicole Ehrhart, a veterinarian and director of the Columbine Health Systems Center for Healthy Aging at Colorado State University. Veterinarians rely initially on keen owner observation, she said, and then perform diagnostic tests.“Look at your dog looking into your eyes and see how long they hold your gaze, especially if you have a treat by your face,” she said. “Because as dogs get dementia, they can’t focus on things they would normally focus on.”Dr. Ehrhart, who was not involved in the Dog Aging Project study, called the new research “wonderful confirmation of something that we know across all species: that exercise is good for healthy aging and that lifelong habits of exercise can be preventive for Alzheimer’s disease and other cognitive issues.”In fact the average life expectancy for Bernese mountain dogs is six to eight years; Dante is now 11. But he had been particularly active in his younger years: He had the physical and mental acuity to gleefully navigate complex obstacle course competitions and leap imperviously off top stairs at a single bound.But now, the typically love-seeking Berner shies away from his household pack — three Golden retrievers and two doting, worried humans. Instead, he prefers to plop down under his favorite lilac bush, even in the pouring rain.“I used to try to make him come inside to be with us,” said Lisa Mitchell, his owner. “But after a year I thought, ‘Tomorrow might be his last day and maybe he’s more comfortable there.’ So we’ve just given over to letting him stay outside alone, if that’s where he wants to be.Although there are medicines and diets that can ameliorate the dog’s cognitive dysfunction for a time, Dr. Ehrhart said, owners needed to be sensitive to their dog’s increasing disorientation. Don’t disrupt their routines. Don’t move around furniture. Secure your yard, so the dog can’t wander away and get lost. If you want to host a loud dinner party with unfamiliar humans, put the dog in a comforting environment that is not so stimulating.And know that dogs, like older humans, can get “sundowner syndrome”: increased anxiety and disorientation as the day comes to a close.“It turns out that probably the best model for human aging has been aging alongside of us for hundreds and hundreds of years,” Dr. Ehrhart said. “This is a two-way street: Anything we’re going to be doing to improve our dogs’ health and life span is likely to improve ours, and anything we’re doing for humans is very likely to improve our dogs’. And who doesn’t want that?”

Read more →

Allergan Reaches Tentative $2.37 Billion Deal to Settle Opioid Suits

If finalized, the agreement, along with a companion deal reached by Teva earlier this week, would send as much as $6.6 billion to communities harmed by the opioid epidemic.A bipartisan group of state attorneys general announced Friday morning that it had struck an agreement in principle with the pharmaceutical company Allergan for $2.37 billion to resolve more than 2,500 opioid-related lawsuits brought by states, local governments and tribes nationwide who have suffered during the ongoing opioid epidemic.The company did not immediately respond to requests for comment, but a quarterly earnings report on Friday by Allergan’s parent company, AbbVie, characterized the amount as “a charge related to a potential settlement of litigation involving Allergan’s past sales of opioid products.”The proposed settlement is a companion agreement to a $4.25 billion deal in principle announced earlier in the week from Teva Pharmaceuticals. If a significant majority of states and communities sign on, the combined deal, when finalized, could be worth $6.6 billion, said lawyers familiar with the negotiations. That is higher than a nationwide settlement struck with Johnson & Johnson or an offer from Purdue Pharma, opioid manufacturers with much higher public profiles.The deals are linked largely because, in 2016, Teva bought Allergan’s generic drug portfolio, including its substantial opioid business. Teva made this week’s settlement contingent in part on Allergan reaching its own deal for opioid liability.“We’ve worked hard to get the best result for Americans harmed by the opioid crisis, and it’s rewarding to take another step in the right direction,” said Tom Miller, the attorney general for Iowa, whose office led the bipartisan group in the negotiations with Allergan and Teva. “We continue to make it a priority to hold manufacturers responsible, while ensuring victims of this epidemic receive the help they need.”Unlike Teva’s deal, under which plaintiffs can elect to receive a portion of the payout in overdose drug reversal and addiction treatment medication rather than cash, Allergan’s offer is all cash with no product, lawyers familiar with the negotiations said. Teva’s payments to states and communities would be disbursed over 13 years, while Allergan’s would be over six years. The amounts of both pharmaceutical companies presumably include the settlement figures that were already struck over the past year with a handful of states and counties.Both Allergan and Teva sold branded as well as generic opioid painkillers. Lawyers for thousands of entities asserted that these manufacturers, like so many others, exaggerated the benefits of opioids to doctors and the public and downplayed the drugs’ addictive properties. In addition, although the companies are required to report suspicious orders to authorities, both failed to do so, lawyers said.Teva had said that the potential agreement was not an admission of wrongdoing.The deals still have a ways to go before money actually starts flowing to communities. Issues such as allocation of funds, tighter monitoring of suspicious orders and the creation of a public repository of internal documents have yet to be resolved.Josh Stein, the North Carolina attorney general, commented on the arc of the opioid epidemic and the litigation to emerge from it. “In 2020, nine North Carolinians died each day from opioid overdose,” he said. “There is no amount of money that could ever repair that kind of loss. But there is hope in recovery, and, thanks to our ongoing work to hold these companies accountable, people across this state are getting the treatment and support they need to get healthy. And we’re still not done.”

Read more →

Teva Reaches Tentative $4.25 Billion Settlement Over Opioids

The deal would end thousands of lawsuits against one of the largest producers of opioid painkillers during the height of the opioid epidemic.Teva Pharmaceuticals, one of the country’s biggest manufacturers of generic opioids, announced a settlement in principle with some 2,500 local governments, states and tribes over the company’s role in the deadly, ongoing opioid epidemic.The deal — worth up to $4.25 billion — came after a series of blistering trials and previous settlements in individual cases across the country over the past year.Though much lesser-known, Teva, an Israeli company, and its affiliates produced far more prescription opioids during the peak years of the crisis than marquee-name opioid manufacturers such as Johnson & Johnson did. Its production of both generic and branded painkillers dwarfed the output of Purdue Pharma, the maker of OxyContin, the medication most immediately associated with setting off an avalanche of overdoses and deaths.Under the deal, Teva would make payouts over 13 years, directed to state, local and tribal programs to ease the opioid crisis, which has only deepened during the coronavirus pandemic. The $4.25 billion total included the nearly $550 million in settlements the company had already struck as trials got underway in San Francisco as well as in Florida, West Virginia, Texas, Louisiana and Rhode Island.States and communities can choose to accept a portion of their payouts in overdose reversal medications, rather than cash.Fentanyl Overdoses: What to KnowCard 1 of 5Devastating losses.

Read more →

Few Parents Intend to Have Very Young Children Vaccinated Against Covid

In a new survey, 43 percent of parents of children ages 6 months through 4 years said they would refuse the shots for their kids. An additional 27 percent were uncertain.Barely a month after the Food and Drug Administration authorized Covid-19 vaccines for very young children, the prognosis that large numbers of them will actually get the shots looks bleak, according to a new survey of parents released on Tuesday by the Kaiser Family Foundation, which has monitored vaccine attitudes throughout the pandemic.A majority of parents polled said they considered the vaccine a greater risk to their children than the coronavirus itself.For children in the age group, 6 months through 4 years, parental apprehension has so far resulted in the administration of scarcely a trickle of Covid shots. Since June 18, when they became eligible, just 2.8 percent of those children had received shots, the foundation found recently in a separate analysis of federal vaccine data. By comparison, 18.5 percent of children ages 5 through 11, who have been eligible for Covid shots since October, had been vaccinated at a similar point in the rollout of their shots.The new survey found that 43 percent of parents with children under 5 said they would “definitely not” have them vaccinated. About 27 percent said they would “wait and see,” while another 13 percent said they would have their children vaccinated “only if required.” Even some parents who were themselves vaccinated against Covid said they would not give permission for their youngest children.The new analysis of parents’ views comes as vaccine uptake for older children has been slowing markedly. To date, only 40 percent of children 5 to 11 have been vaccinated. In the new survey, 37 percent of parents said they would “definitely not” get a Covid vaccine for their child in that age group.The parents’ chief concerns were about potential side effects of the vaccine, its relative newness and what they felt was a lack of sufficient research. Many parents said they were prepared to let their children take the risk of contracting Covid rather than getting a vaccine to prevent it. Experts on childhood vaccination said they viewed the parents’ hesitation with alarm, coming at a time when Covid cases are once again soaring and expected to worsen during the cold weather months, and as the possibility of new and potentially more dangerous coronavirus variants remains.Although a vast majority of children who come down with Covid get over it easily, “some kids get very, very ill from it and some die,” said Patricia A. Stinchfield, the president of the National Foundation for Infectious Diseases. She was not involved in the Kaiser study.How a child will fare with Covid is unpredictable, added Ms. Stinchfield, a nurse practitioner who coordinated vaccine administration for Children’s Minnesota, a children’s hospital system in St. Paul and Minneapolis. “We have no marker for that,” she said. “Half the kids who come down with severe Covid are healthy kids, with no underlying conditions. So the idea of saying ‘I’m going to skip this vaccine for my kid, we’re not worried about Covid’ is really to take a risk.”This latest report is based on an online and telephone survey from June 7 to June 17 of 1,847 adults, 471 of whom had a child under 5. The margin of error was plus or minus 3 percentage points for the full sample, and plus or minus 8 percentage points for parents with a child under 5.Perhaps unsurprisingly, the partisan divide was especially sharp around vaccination for children, with Republican parents three times as likely as Democratic parents to say they will “definitely not” have their child vaccinated.A majority of parents said they found information from the federal government about the vaccine for their children to be confusing. Yet 70 percent said they had not yet discussed the shots with a pediatrician. Just 27 percent of those parents who are considering the vaccine said they would make an appointment to have that conversation.Parents who might be predisposed to having their children get Covid shots said that lack of access was a significant barrier, a concern expressed by more Black and Hispanic parents than white parents. About 44 percent of Black parents worried about having to take time off from work to have their children vaccinated or to care for them if the children had side effects. Among Hispanic parents of young children, 45 percent said they were worried about finding a trustworthy location for the shots, and about a third feared they would have to pay a fee.Ms. Stinchfield said she understood their concerns: Her own daughter had to take off work to get vaccinations for Ms. Stinchfield’s grandchildren, ages 1 and 3. Ms. Stinchfield went to a clinic with them. “The message to clinics is, Make the vaccine for kids available in the evenings and on weekends,” she said.Did her grandchildren have any side effects? No, Ms. Stinchfield said with a chuckle. “They felt so good that we put them in a little kiddie pool,” she said. “And now my granddaughter’s got a tan line from the Band-Aid from the shot on her leg.”

Read more →

Soaring Overdose Rates in the Pandemic Reflected Widening Racial Disparities

A new federal report found that fatal overdoses jumped 44 percent among Black people, twice the increase among white people, from 2019 to the end of 2020.The pandemic’s devastating impact on drug overdose deaths in the United States hit people of color the hardest, with rates among young Black people rising the most sharply, according to a federal report that was released on Tuesday and that analyzed overdose data by race, age and income.Overall, overdose deaths jumped 30 percent from 2019 to 2020, the report from the Centers for Disease Control and Prevention said. Deaths among Black people rose 44 percent, about twice the increase in deaths among white people (22 percent) or Hispanic people (21 percent). Deaths among American Indians and Alaska Natives increased 39 percent.Measured as a portion of the population, in 2020, deaths among Black people were higher than in any other racial or ethnic group — 39 per 100,000, compared with 31 for white people, 36 for American Indian and Alaska Native people and 21 for Hispanic people.“The disproportionate increase in overdose death rates among Blacks and American Indian and Alaska Native people may partly be due to health inequities, like unequal access to substance use treatment and treatment biases,” said Dr. Debra Houry, acting principal deputy director of the C.D.C.The racial breakouts were based on data from Washington, D.C., and 25 states that had completed analyses. The study included data from some states where overdose death rates rose, such as Georgia, Kentucky and Maine, but not from others with high rates, like Florida, New York and Michigan. C.D.C. researchers said that, nonetheless, the trends they saw in this data mirrored statistical racial breakouts across the country.Nationwide, overdose deaths have continued to rise since 2020, although the rate has slowed somewhat. The impact on different races became even more striking when age was factored in. In 2020, the death rate from overdoses in men 65 and older was nearly seven times greater for Black men than for white men. In Black people ages 15 to 24, the overdose death rate rose 86 percent from 2019 to 2020.Authors of the study said the deaths were driven largely by illicitly produced fentanyl, with some triggered by the combination of other drugs with the opioids, such as methamphetamine and cocaine.The pandemic exacerbated the spiral, the authors said. With people young and old isolated from social services, peers, family and treatment centers, to say nothing of a drop in income for many, drugs became a distraction and a solace.The results showed in harsh relief the racial divide with respect to access to treatment for substance abuse. Although the data showed that treatment was sparse among all those who died, the portion of people who had received treatment for substance abuse was smallest among Black people (8.3 percent), or about half that of white people who had sought treatment and later died.Income inequality also deepened that chasm, the report said.Perhaps surprisingly, the report said that overdose death rates generally were higher in counties with more treatment services and mental health care providers. Again, the impact varied according to race. Among American Indian and Alaska Native people and Black people, for example, the rate in 2020 in counties with at least one opioid treatment program was more than twice that in counties that lacked such services.Among counties with comparatively more treatment options than others, overdose death rates from 2019 to 2020 increased 49 percent among Black people, compared with 19 percent among white people.“Just because there’s the availability of services doesn’t mean that those services are actually accessible,” said Mbabazi Kariisa, the lead author of the report and a health scientist with the Division of Overdose Prevention at the C.D.C. She noted that limited transportation and insurance options could be problematic. In addition, she said, fear of being stigmatized and a pervasive mistrust of the health care system could also be significant factors.The report also noted that in counties that were geographically large, a treatment center might be located in a dense population center, which would make access challenging for those in far-flung areas. But it is difficult to pinpoint a causal relationship between the presence of a clinic and death rates: A county with high rates of drug abuse and overdose deaths might simply be more likely to have a clinic.

Read more →

The New Abortion Bans: Almost No Exceptions for Rape, Incest or Health

Most of the state abortion prohibitions that would go into effect if Roe v. Wade is overturned do not contain carve-outs that were once widely supported by abortion opponents.In the years before Roe v. Wade, some states that had outlawed abortion began permitting it in limited circumstances: in cases of rape or incest, or to save the life or health of the woman.And for decades after the Roe ruling guaranteed the right to abortion throughout the United States, abortion opponents from Ronald Reagan to Donald J. Trump generally supported those exceptions, even as they worked to undo Roe.Exceptions for rape, incest and life endangerment are codified in the Hyde Amendment as the only reasons the federal government will pay for abortions through Medicaid. For decades, surveys have shown that large majorities of Americans support these carve-outs, even in heavily Republican states.But if the Supreme Court overturns Roe, as expected, many state abortion bans would take effect that do not include most of the exceptions.There are no allowances for victims of rape or incest in Alabama, Arkansas, Florida, Kentucky, Louisiana, Missouri, Oklahoma, Ohio, South Dakota, Tennessee or Texas. Mississippi, whose law banning abortion after 15 weeks is at the center of the case the Supreme Court will rule on this month, permits an abortion in cases of rape but does not specify incest.While all bans allow an exception to save the life of the woman, those in some states, such as Idaho, South Dakota and Arkansas, do not also cite protection of her health.The state senator who sponsored the Arkansas legislation, Jason Rapert, a Republican who is president of the National Association of Christian Lawmakers, said that his faith drove his views on abortion. He said he had heard testimony from rape and incest victims who expressed “the mental anguish they went through when they dealt with the fact they terminated the life of their own baby,” and who now oppose abortion.Arkansas’s only abortion exception is to save the woman’s life in “a medical emergency.” Mr. Rapert called exceptions to protect a woman’s health “an open door you could drive a truck through. You could describe anything that way.”Anti-abortion signs outside the Jackson Women’s Health Organization in Mississippi.Rory Doyle for The New York TimesMany of the new bans are set up as so-called trigger laws in 13 Midwestern and Southern states, intended to take effect swiftly if Roe falls. At least nine more states are weighing similar bans — some of which have been paused by courts — or could revive pre-Roe abortion prohibitions. The outcomes will depend on the details of the Supreme Court’s decision and the politics of each state.“I think we are heading in a direction of increasing absolutism and punitiveness,” said Reva Siegel, a Yale Law School professor who is a co-author of an equal protection amicus brief in the Mississippi case before the Supreme Court. She noted that even as Mississippi legislators restricted abortion access, they refused to expand postpartum Medicaid coverage.The move away from exceptions reflects the Republican Party’s shift to the right, said Mary Ziegler, a legal historian at the University of California, Davis, Law School and author of “Dollars for Life,” a book to be published this month about the anti-abortion movement and the Republican Party.Candidates are increasingly jockeying for far-right support in primaries in Republican-dominated states, she said, aware not only that turnout typically consists of the most fervent voters but also that national anti-abortion groups are searching for local standard-bearers to fund.Much of that rightward shift has been propelled by Mr. Trump. But during the 2016 and 2020 campaigns, Mr. Trump said in tweets that he supported exceptions to allow abortion for pregnancies resulting from rape and incest, or to protect the life of the mother. A spokesman for Mr. Trump declined requests from The New York Times to describe the former president’s current position on exceptions, or his reaction to the state bans that don’t include them.Though embracing limited exceptions might have once seemed politically expedient, the aims of the anti-abortion movement have grown increasingly unconditional. As the composition of the Supreme Court became more conservative, Ms. Ziegler said, there has been “a sense that the movement could pretty much get whatever it wanted without alienating the court.”Now, anti-abortion groups are debating whether to accept any exception to a ban.Students for Life, an anti-abortion organization, distinguishes between exceptions for rape or incest, and one to save the life of the woman, said Kristan Hawkins, the group’s president. How a child was conceived, she said, is irrelevant to the value of that child’s life: “We see them as valuable, worthy of love, and welcome.”Kristan Hawkins of Students for Life speaking at the University of Virginia in Charlottesville in April.Julia Rendleman for The Washington Post, via Getty ImagesThe group does, however, support exceptions for a lifesaving abortion. “That is not an act of abortion,” she said, “as the intent of abortion is to end life, not intervene to save life if possible.”But some groups, like Pro-Life Wisconsin and those affiliated with the abortion abolition movement, reject all exceptions, as does Doug Mastriano, the Republican nominee for governor of Pennsylvania, who calls abortion “science-denying genocide.”Some abortion rights supporters argue that focusing on exceptions is misguided. When people express shock that the new laws do not allow exceptions for rape and incest, “they seem to suggest that if those exceptions are granted, the new restrictive laws are more reasonable,” said Leslie J. Reagan, a historian of American medicine and public health at the University of Illinois at Urbana-Champaign. Whether or not there are exceptions, some state bans include criminal penalties, which Dr. Reagan, author of “When Abortion Was a Crime,” called “a step backwards to the century of criminalized abortion that the U.S. has already lived through.”The history of exceptions stretches back decades. In 1959, the American Law Institute, an independent group of legal scholars, lawyers and judges, began drafting model legislation to modify the crime of abortion. It proposed that termination be permitted if a physician decided there was grave risk to the health of the woman, or to the fetus, or if the pregnancy was the result of rape or incest.Two threats to a fetus were then of profound concern. One was the morning sickness drug thalidomide, tested on American women in the 1950s, that could cause severe birth defects or stillbirths. Another was rubella, commonly known as German measles, that could result in stillbirth or in life-threatening effects on the baby (a vaccine was approved in 1969).Over the next 14 years, at least 13 states would adopt some of those exceptions. Ms. Ziegler said that abortion opponents saw the exceptions as a compromise, acknowledging these were “hard cases, a fight not worth having because the country wasn’t there yet.”The idea behind the rape and incest exceptions in particular, she added, “was that people who had been sexually assaulted had not chosen to have sex, so you could legalize abortion in those cases without encouraging promiscuity, which was something the authors were worried about.”A pin on the wall of Trust Women Clinic in Oklahoma City. Oklahoma is one of several states where trigger laws carry no allowances for victims of rape or incest.Evelyn Hockstein/ReutersAllowing an abortion to save the woman’s life was encoded in abortion bans throughout the country for nearly a century before the Roe ruling. Police enforcement of the bans waxed and waned over the decades, depending on local political, social and economic factors.By the 1940s, police were raiding offices of licensed physicians who performed abortions, compelling patients to testify against their doctors. To offer doctors criminal liability shields, hospitals set up committees to evaluate which cases qualified for “therapeutic” abortions. But though hospital-sanctioned abortions provided a legal alternative to back-alley abortions, they were expensive and rarely authorized by the committees.Although the exceptions in the new abortion bans are scant, states nonetheless require doctors as well as patients to supply substantial documentation to justify the need.Florida’s law banning abortion after 15 weeks of gestation, scheduled to take effect July 1, says doctors must record the medical necessity for an abortion to save the woman’s life or to “avert a serious risk of imminent substantial and irreversible physical impairment of a major bodily function of the pregnant woman other than a psychological condition, and another physician is not available for consultation.”Many doctors see the statutory language that only permits abortion to prevent death or severe injury as putting them in violation of their professional oaths to their patients. Though states are often vague about thresholds such as life or “medical emergency,” they often require extensive documentation to justify the procedure, including gestational age of the fetus, indication of cardiac activity and medical records attesting to, as Oklahoma says, “the medical condition of the pregnant woman that prevented compliance with this act.”Yet the impact of the documentation requirements can cut both ways. Some state laws suggest that ample records can serve to defend the doctor against criminal conviction.“If doctors in these states are going to perform abortions, they will be checking with a hospital lawyer first,” said Elizabeth Nash, a policy analyst at the Guttmacher Institute, a reproductive health rights group that supports abortion.In essence, abortion exceptions that, decades earlier, were an attempt by lawmakers to keep pace with medical practice, have now come full circle: “The physical health of the woman will become more of a legal question than a medical one,” Ms. Nash said.

Read more →

Seeking Pills, Young People Head to Social Media, With Deadly Results

The soaring drug fatalities in the U.S. are being fueled partly by fentanyl-tainted pills bought by teenagers and young adults on Snapchat, Instagram, TikTok and other social media apps.Shortly after Kade Webb, 20, collapsed and died in a bathroom at a Safeway Market in Roseville, Calif., in December, the police opened his phone and went straight to his social media apps. There, they found exactly what they feared.Mr. Webb, a laid-back snowboarder and skateboarder who, with the imminent birth of his first child, had become despondent over his pandemic-dimmed finances, bought Percocet, a prescription opioid, through a dealer on Snapchat. It turned out to be spiked with a lethal amount of fentanyl.Mr. Webb’s death was one of nearly 108,000 drug fatalities in the United States last year, a record, according to preliminary numbers released this month by the Centers for Disease Control and Prevention. Law enforcement authorities say an alarming portion of them unfolded the same way as his: from counterfeit pills tainted with fentanyl that teenagers and young adults bought over social media.“Social media is almost exclusively the way they get the pills,” said Morgan Gire, district attorney for Placer County, Calif., where 40 people died from fentanyl poisoning last year. He has filed murder charges against a 20-year-old man accused of being Mr. Webb’s dealer, who pleaded not guilty. “About 90 percent of the pills that you’re buying from a dealer on social media now are fentanyl,” Mr. Gire said.The phenomenon has led to disturbing new statistics:Overdoses are now the leading cause of preventable death among people ages 18 to 45, ahead of suicide, traffic accidents and gun violence, according to federal data.Although experimental drug use by teenagers in the United States has been dropping since 2010, their deaths from fentanyl have skyrocketed, to 884 in 2021, from 253 in 2019, according to a recent study in the journal JAMA.A Drug Enforcement Administration fact sheet shows authentic prescription pills and counterfeit ones.Drug Enforcement AdministrationRates of illicit prescription pill use are now highest among people ages 18 to 25, according to federal data.Much as drug dealers in the 1980s and ’90s seized on pagers and burner phones to conduct business covertly, today’s suppliers have embraced modern iterations — social media and messaging apps with privacy features such as encrypted or disappearing messages. Dealers and young buyers usually spot each other on social media and then often proceed by directly messaging each other.The platforms have made for a swift, easy conduit during the coronavirus pandemic, when demand for illicit prescription drugs has jumped, both from anxious, bored customers and from those already struggling with addiction who were cut off from in-person group support.The Opioid CrisisFrom powerful pharmaceuticals to illegally made synthetics, opioids are fueling a deadly drug crisis in America.Origins of an Epidemic: Purdue Pharma knew OxyContin was widely misused, but continued to promote the painkiller as less addictive.An Unrelenting Surge: ​​Deaths from drug overdoses again rose to record-breaking levels in 2021, nearing 108,000, according to the Centers for Disease Control and Prevention.A Settlement: Purdue Pharma reached a deal with a group of states that long resisted the structure of the original bankruptcy plan. Here is what the agreement means.Detailing Tragedies: As part of the settlement, families who lost loved ones to opioid addiction were allowed to address the owners of Purdue Pharma in court.How Opioids Work: Through interviews with users and experts, we created a visual representation of how these drugs hijack the brain.Supplies of tainted pills, crudely pressed by Mexican cartels with chemicals from China and India, have escalated commensurately. Fentanyl, faster and cheaper to produce than heroin and 50 times as potent, made for a highly addictive filler. Last year, the federal Drug Enforcement Administration seized 20.4 million counterfeit pills, which experts estimate represent a small fraction of those produced. Its scientists say that about four out of 10 pills contain lethal doses of fentanyl.The result is that new waves of customers are swiftly becoming addicted, said Dr. Nora Volkow, director of the National Institute on Drug Abuse. “When you are putting fentanyl in pills that are sold as benzodiazepines or for pain, you are reaching a new group of customers that you wouldn’t have if you were just selling fentanyl powder.”A photo of Mr. Webb from a vacation he took in Kauai, Hawaii.Brandon Thibodeaux for The New York TimesZachariah Plunk, 17, of Mesa, Ariz., died after buying a counterfeit Percocet from a dealer he reached through Snapchat.via Wendy PlunkIn a two-month span in the fall, the D.E.A. identified 76 cases that involved drug traffickers who advertised with emojis and code words on e-commerce platforms and social media apps. The agency has included a feature in its One Pill Can Kill public awareness campaign: a poster called “Emoji Drug Code: Decoded,” with images of drug symbols.“There are drug sellers on every major social media platform — that includes Instagram, Facebook, Twitter, Snapchat, Pinterest, TikTok and emerging platforms like Discord and Telegram,” said Tim Mackey, a professor at the University of California San Diego who runs a federally funded start-up that developed artificial intelligence software to detect illicit online drug sales. “It’s an entire ecosystem problem: As long as your child is on one of those platforms, they’re going to have the potential to be exposed to drug sellers.”At around 1:30 a.m. on Aug. 15, 2020, Zachariah Plunk, 17, a star high school football player from Mesa, Ariz., contacted a dealer through Snapchat, seeking a Percocet.As footage from the family’s home security camera would reveal, the dealer dropped off drugs around 3 a.m. Zach went outside, swallowed a pill and fell to the curb. At 5 a.m., a 15-year-old neighbor found him dead.To Wendy Plunk, Zach’s mother, the ease with which dealers can evade detection is particularly devastating. The man who sold her son the fatal pill remains on Snapchat, she said, adding, “I keep an eye on the guy. Every time he gets kicked off, he changes his name a bit and gets on again, with the same picture.”In January, parents of children as young as 13 who had died from pills protested in front of Snapchat’s headquarters in Santa Monica, Calif., with signs accusing the company of being an accomplice to murder. One speaker was Laura Berman, a relationship therapist and television host. In February 2021, her 16-year-old son, Sam, bought what he thought was a Xanax through a Snapchat connection, ingested it and died at home of fentanyl poisoning.Facing a barrage of criticism from law enforcement and grieving parents, social media platforms have been stepping up policing on their sites, shutting down dealers’ accounts and redirecting drug seekers to addiction services.In January, family and friends of young people who died after taking counterfeit pills protested outside Snapchat’s headquarters in Santa Monica, Calif.Apu Gomes/Agence France-Presse — Getty ImagesOn Monday, the Ad Council announced a wide-ranging campaign to roll out this summer, funded by three tech companies — Snap, Meta and Google — to alert teenagers and young adults about the dangers of fentanyl. Social media platforms like Twitter, TikTok, Twitch and Reddit are expected to provide landing zones for the warnings.Snap, the parent company of Snapchat, and Meta, the parent of Instagram and Facebook, report they are increasingly interrupting drug exchanges. Snap said it took action on 144,000 drug-related accounts in the United States from July to December last year. That figure doesn’t include the 88 percent of drug-related content that was pre-emptively detected by artificial intelligence software, which monitors terms that could signify drug deals.Now, when Snapchat users search for “fenta,” “xanax” or other drug language, the results are blocked. They are redirected to an in-app video channel with content from nonprofit groups and the C.D.C. that addresses “fentapills” — the dangers of purported OxyContin, Percocet, Xanax and Adderall.According to Facebook’s latest community standards report, it took action on four million drug-related exchanges worldwide in the fourth quarter of 2021. Instagram took action on 1.2 million, figures which represent alerts from both users and pre-emptive detection technology.On Instagram, one recent search for Percocet did set off an automatic warning and an offer of help. But it also yielded numerous results, including an account that posted photos of the pills and contact information, with phone numbers on the encrypted messaging apps Wickr and WhatsApp.And when companies remove dealers from their platforms, many sellers simply leapfrog to another.“We detect about 10,000 new drug-related accounts a month,” said Dr. Mackey, whose software company detects illicit online drug trafficking for private and public organizations.Most drug seekers will not baldly search for a drug by name, he said. They may use a hashtag with a celebrity associated with it. Enterprising dealers troll comments for customers, inserting themselves in online exchanges among seekers of pain relief.During the pandemic, drug use has surged as mental health among young adults and teenagers has deteriorated, studies show. Young people tend to eschew heroin, not only because of its addictive properties but also because of a skittishness about syringes, say experts in adolescent behavior. Pills, with the false imprimatur of medical authority, appear safer. Moreover, to their generation, prescription medications — for anxiety, depression and focus — have become normalized.Ed and Mary Ternan of Pasadena, Calif., in their son Charlie’s bedroom.Michael Tyrone Delaney for The New York TimesCharlie Ternan died after taking what he thought was a Percocet he bought from a dealer through Snapchat.Michael Tyrone Delaney for The New York Times“By the time the kid goes to college, his friends all have prescription bottles in their backpacks — they’re used to sharing pills,” Ed Ternan said. “The drug traffickers know that.” In May, 2020, his 22-year-old son, Charlie, three weeks away from college graduation, bought what he thought was a Percocet for back pain from a dealer he connected with on Snapchat. Thirty minutes after ingestion, Charlie, 6-foot-2 and 235 pounds, was dead from fentanyl poisoning.Rather than sue Snap for wrongful death, Mr. Ternan and his wife, Mary, asked the company to step up monitoring.“I said: ‘If the kids were buying real Percocet on Snapchat, they wouldn’t be dying. You guys need to escalate this problem right up to the same level as child sex trafficking,’” Mr. Ternan said.The Ternans formed Song for Charlie, one of many organizations of families who have lost children to fentanyl. Mr. Ternan has met with federal officials and has connected Snapchat with digital and drug treatment experts. His group creates cautionary content for TikTok and Snapchat.The rules of engagement in the war on drugs have shifted, Mr. Ternan said, adding: “It’s now about chemistry and social media distribution and encryption. We need different kind of generals, a more collaborative approach between Big Tech and the government.”To fine-tune prevention messaging, Snap commissioned Morning Consult, the digital market research firm, to conduct a survey of drug knowledge. The results, from a random sample of 1,449 Snapchat users ages 13 to 24, underscore their vulnerability to misusing prescription drugs. They expressed feeling overwhelmed, anxious and depressed but also fearful of the stigma surrounding mental health challenges. “Coping with stress” was the top reason to turn to illicit pills, they said.But only half the respondents overall, and 27 percent of the teenagers, knew that fentanyl could be in counterfeit pills. When asked to rate the danger posed by certain drugs, nearly two-thirds were likely to rank heroin and then cocaine as “extremely dangerous,” but scarcely a third put fentanyl in that category. Overall, 23 percent didn’t even know enough about fentanyl to rank its danger level, including 35 percent of adolescents.That ignorance is what drove Wendy Thomas, a substitute third-grade teacher from Sanford, N.C., to repurpose her grief over the 2020 death of her son from a counterfeit Percocet, and use it to reach teenagers. With her nonprofit, Matthew’s Voice, she has written health-class curriculums about fentanyl for high school freshmen and seventh-graders that are currently under final review by a large North Carolina school district.Signs showing photos of people who died after being poisoned by pills containing fentanyl, before a protest outside Snap in June 2021.Patrick T. Fallon/Agence France-Presse — Getty ImagesIt also motivates anguished parents like Elizabeth Dillender, who is Kade Webb’s mother and the grandmother of his newborn daughter, Indigo Kade. “I’m not naïve enough to think that social media is going away,” she said. “We have to work in conjunction with social media to get the word out to these kids.”Ms. Dillender has taken her campaign to Spotify, where she has a fentanyl awareness podcast, and to social media platforms like TikTok and Facebook.Recently, her podcast featured Laura Didier, another mother from Mr. Webb’s hometown, Rocklin, Calif. A year before Mr. Webb died, Ms. Didier’s former husband found their 17-year-old son, Zach, in his bedroom slumped lifeless over his computer keyboard. Zach had bought what he thought was a Percocet from a dealer on Snapchat.“You think if there’s a problem, you’ll see red flags — their grades are dropping, their disposition and friends are changing,” Ms. Didier reflected recently. “But that’s old thinking about drug behavior. This can happen so quickly without your ability to predict. I just don’t want families to be complacent and think, It can’t happen to us.”To underscore that message, at least one harm reduction network, the Santa Clara Opioid Overdose Prevention Project in California, has been promulgating the darkly instructive warning: #ExpectFentanyl.

Read more →

Were These Doctors Treating Pain or Dealing Drugs?

The Supreme Court will hear from two convicted pill mill doctors in cases that could have significant implications for physicians’ latitude to prescribe addictive painkillers.For years, Dr. Xiulu Ruan was one of the nation’s top prescribers of quick-release fentanyl drugs. The medicines were approved only for severe breakthrough pain in cancer patients, but Dr. Ruan dispensed them almost exclusively for more common ailments: neck aches, back and joint pain. According to the Department of Justice, he and his partner wrote almost 300,000 prescriptions for controlled substances from 2011 to 2015, filled through the doctors’ own pharmacy in Mobile, Ala. Dr. Ruan often signed prescriptions without seeing patients, prosecutors said.Dr. Ruan has been serving a 21-year sentence in federal prison, convicted in 2017 for illegally prescribing opioids and related financial crimes. To collect millions of dollars in fines, the government seized houses, beach condos and bank accounts belonging to him and his business partner, as well as 23 luxury cars, such as Bentleys, Lamborghinis and Ferraris.On Tuesday, lawyers both for Dr. Ruan and for Dr. Shakeel Kahn, who is serving 25 years on charges related to pill mill clinics in Arizona and Wyoming will argue before the Supreme Court of the United States that the criminal standard the physicians faced is applied inconsistently among the federal circuits. In asking that the doctors’ convictions be overturned, they want the court to establish a uniform standard that permits doctors to raise a “good faith” defense. Juries could then consider whether doctors subjectively believed they were using their best medical judgment.The likelihood of these two doctors being set free is small, legal experts believe, but the court’s decision on the broader legal questions could have significant implications for the latitude doctors can take in prescribing potentially addictive painkillers and other restricted medications.The cases confront an uneasy relationship between law and medicine. In an era when overdose deaths are soaring, how should the law balance letting physicians exercise their best judgment with stopping egregious outliers?At issue is the reading of the language of the Controlled Substances Act of 1970. The act permits doctors and pharmacists to dispense certain drugs such as opioids and amphetamines, categorized by their potential for abuse and medical value, even as it prohibits everyone else from doing so. It says that a prescription for one of these medications “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”Prosecutors, through the office of the U.S. Solicitor General, argue that the criminal standard in the act is straightforward and well-established, with a baked-in good-faith defense that affords doctors ample leeway. Even if the Supreme Court were to adopt a new framework and order that the doctors be retried, they argue, a jury could not conclude that the doctors were relying on their good-faith medical judgment.The evidence, they wrote, “overwhelmingly demonstrated that petitioners acted as drug dealers disguised as medical professionals, dispensing addictive drugs that endangered their patients simply to line their own pockets.”Lawyers for the government and the doctors declined to comment or did not respond to requests to do so.For many in medicine, the case is not about whether Drs. Ruan and Kahn were bad doctors.“It’s about all the other doctors in the country who intend to do the right thing, but are dealing with difficult cases,” said Dr. Stefan Kertesz, a professor of medicine at the Heersink School of Medicine at the University of Alabama at Birmingham and an addiction researcher. “Are we all at risk of criminal investigation based on making decisions that involve difficult medical trade-offs?”Some legal experts say they presume that the court picked two cases from different circuits in order to examine legal distinctions and disjunctions, and that it may well emerge with a clarifying rule. But it is difficult to predict how the justices will rule, they say, because the issues do not fit tidily into liberal and conservative boxes.The cases are being argued during a period when investigations of prescribing habits have increased, in an effort to curb the rise in overdose deaths that began more than 20 years ago, as prescription painkillers became readily available. Authorities saw doctors as a significant source of the problem.State regulators imposed an array of punishments for excessive prescribing, such as fines, license revocation and imprisonment. In recent years, the prescribing of opioids fell sharply. Even so, overdoses and deaths hit a record last year. A majority of those deaths were not from prescribed opioids but from illegal ones.Dr. Shakeel Kahn was sentenced to 25 years in prison in 2019.Tom Morton, K2radio.comDr. Xiulu Ruan has been serving a 21-year sentence, convicted in 2017 for illegally prescribing opioids and related financial crimes.Dr. Xiulu RuanSome studies see a connection between the drop in prescriptions and the rise in overdose deaths. An article published recently in The New England Journal of Medicine reported that high-dose chronic pain patients who were abruptly dismissed from doctors’ practices have experienced surges in emergency room visits, addiction to illegal drugs and even suicide.To what extent has the increased surveillance of doctors led to an overcorrection in prescribing? A 2019 survey in the journal Pain of 452 primary care clinics in nine states found that nearly half would not prescribe opioids to new primary care patients who said they were already being prescribed the painkillers.Dr. Samer Narouze, president of the American Society of Regional Anesthesia and Pain Medicine, said that he knew of doctors who had lost licenses or were jailed, and that it could be hard to understand the basis on which different sanctions were meted out. In the current risk-averse, litigious climate, his hospital’s opioid oversight committee has, on occasion, sought legal counsel before making decisions in difficult cases involving the drugs, said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.The outcome of the Supreme Court cases is also being closely monitored by representatives of chronic pain patients.“We definitely want to catch doctors who are behaving like large-scale drug pushers,” said Kate Nicholson, executive director of the National Pain Advocacy Center, which filed a brief arguing that fear of criminal prosecution deterred doctors from using good medical judgment to treat pain.“Our issue is the chilling effect the current standards have on good doctors, who fear that even when they are exercising their best medical judgment, they will be subjected to oversight and enforcement,” said Ms. Nicholson, a former government disability rights lawyer who was bedridden for 18 years and relied on high-dose opioids.Some years ago, she moved to Colorado to start post-surgical rehabilitation and needed to find a doctor to help her safely wean off opioids. But her new doctor, she said, told her that he had stopped prescribing opioids and that “you won’t find anyone else in this area willing to, either.”Yet other patients, whose opioid addictions were initiated by doctors’ prescriptions, still want to see prescribers more tightly reined in and punished. Dr. Kahn based his rates on the number of pills prescribed; his brother, the office manager, would meet patients in parking lots to exchange the doctor’s signed prescriptions for cash, prosecutors said. Two days after a young patient paid him $1250, she died of an overdose of oxycodone.The Supreme Court’s analysis of the Ruan and Kahn cases will likely involve a close reading of Congress’s text and a discussion about canons of criminal law.In the last 15 years, as federal agents raided pill mills and prosecutions increased, the language around “legitimate medical purpose” and “professional practice” has been interpreted differently by different federal appellate courts. Those readings direct how a judge instructs a jury on what it must find to convict or acquit the prescriber.In a brief asking for a clear legal standard, health-law and policy professors argue that several appeals courts — including the U. S. Court of Appeals for the 11th Circuit, which upheld Dr. Ruan’s conviction, and the U. S. Court of Appeals for the 10th Circuit, which upheld Dr. Kahn’s — permit doctors to be convicted if they deviate from accepted medical practice, without a jury also having to find that the doctor did so “without a legitimate medical purpose.” That standard, they say, lacks a critical component of criminal law: intent.That element, the professors wrote, distinguishes well-meaning, possibly negligent doctors from criminal ones. Without the requirement of intent, the Controlled Substances Act “has been weaponized against practitioners in reaction to the overdose crisis,” they said. Prosecutions have increased, they said, while the standards for conviction have “steadily eroded.”The professors argue that this broad standard can ensnare doctors who determine that an individual patient requires a prescription of opioids that exceeds conventional limits. Doctors who prescribe medications off-label, a common practice, could also fall under that standard.Conversely, other circuits require that prosecutors prove beyond a reasonable doubt that doctors knew not only that they were deviating from accepted medical practice but also, and crucially, that they were prescribing without a legitimate purpose.But how far can a good-faith defense be stretched? Does it suffice for doctors to simply argue that they believed the prescriptions served a legitimate medical purpose?“Good faith,” then, would seem to be a subjective standard; “legitimate medical purpose,” an objective one. If so, the two would inherently be in conflict.Prosecutors argue that at the very least, doctors must show they made reasonable efforts to learn the medical norms upon which they based their good-faith judgment. A mistake in understanding those norms, they say, would not rise to the level of criminal conduct.Recently, the Centers for Disease Control and Prevention took steps to give physicians more leeway in prescribing opioids. In a draft of the new recommendations, the agency bluntly states that prescribers should almost always seek alternative pain therapies rather than opioids. But it also says that doctors can rely on their best medical judgment, especially when treating “legacy” patients — typically, chronic pain patients who are already on high opioid doses.The good-faith argument shouldn’t be read as a “get out of jail free” card, said Kelly Dineen, who teaches health law at Creighton University School of Law in Nebraska and who is a co-author of the health-law professors’ brief. “The jury still has to assess their credibility,” she said. “But doctors should be allowed to bring that defense.”Sheelagh McNeill

Read more →

Companies Finalize $26 Billion Deal With States and Cities to End Opioid Lawsuits

The first checks could be cut in April. The money — from the nation’s three major pharmaceutical distributors and Johnson & Johnson — will be used for addiction treatment and prevention.The nation’s three largest drug distributors and a major pharmaceutical manufacturer announced Friday that a supermajority of states and localities had accepted the terms of their $26 billion offer to settle thousands of civil claims related to the deadly opioid crisis. The first checks are expected to go out in early April.Through its pharmaceutical division, Janssen, Johnson & Johnson will pay $5 billion, broken into annual payments over nine years. McKesson, Cardinal Health and AmerisourceBergen, the distributors, will pay a combined $21 billion over 18 years. At least 85 percent of the payments will be dedicated to addiction treatment and prevention services. By signing onto the deal, thousands of local governments as well as states have agreed to drop their opioid lawsuits against the companies and also pledge not to bring any future action.In its sweep and bottom line, the deal is second only to the Big Tobacco settlement of the late 1990s as a multistate agreement.The total amount includes almost $2 billion that will cover fees and costs for the platoons of lawyers nationwide who represented local governments as well as some states and built much of the legal strategy in the cases. Those payments will go out over roughly seven years.There are no separate funds to compensate families and individual victims of the opioid crisis.The announcement is a milestone in the nationwide opioid litigation, which began in 2014 with a few cities and counties filing lawsuits against five drug manufacturers. But as thousands of governmental plaintiffs eventually filed claims, the cases reached across the pharmaceutical industry, to distributors and retailers as well. The actions gelled into a modern legal behemoth that is still far from fully resolved, featuring, most prominently, the cases against Purdue Pharma.The crisis continues to take a terrible toll: More than 500,000 Americans have died from overdoses to prescription and illegal street opioids since 1999, according to federal data.The distributors and Johnson & Johnson released statements Friday morning, noting that the deal is not an admission of wrongdoing and that they strongly dispute the allegations. The distributors said in a joint statement that they believed that “the implementation of this settlement is a key milestone toward achieving broad resolution of governmental opioid claims and delivering meaningful relief to communities across the United States that have been impacted by the epidemic.”Johnson & Johnson also added that it would “continue to defend itself against any litigation that this final settlement agreement does not resolve,” noting that it no longer sells prescription opioid medication in the United States.When Johnson & Johnson, the distributors and a smaller group of states announced their proposed settlement in July, the companies said they required an unspecified majority of plaintiffs to sign on, to guarantee an end to litigation. The announcement Friday morning signals that a sufficient threshold has been reached, or at least 90 percent of those governments eligible to participate, and 46 of 49 eligible states for the distributors and 45 for Johnson & Johnson. Courts in each state will now have to sign off on the agreements, a process that is expected to go relatively smoothly and swiftly.According to the agreements, a state will get its full allocation if all its local governments sign on to the deal. For example, all 100 North Carolina counties and 47 municipalities have agreed, and the state will get its allotment of $750 million.“North Carolina communities will begin to receive money this year to help people struggling with substance abuse,” said Josh Stein, the state’s attorney general and a leader of a bipartisan coalition of states that negotiated with the companies and local governments for nearly three years. “The treatment, recovery, prevention and harm reduction services that will be available across the state will help people regain control over their lives and make North Carolina safer.”A few holdout states and localities still remain against either the distributors or Johnson & Johnson, including Washington, Oklahoma and Alabama. But legal experts say that stance could be perilous: The outcomes from a few completed trials point to favorable resolutions for the companies, suggesting that continuing to do battle with those governments who declined the deal is a risk the companies are willing to take.This month, the same companies announced a tentative settlement with Native American tribes that have suffered disproportionately high addiction and death rates during the opioid epidemic. In combination with a $75 million deal that distributors struck with the Cherokee Nation last fall, the 574 federally recognized tribes could receive $665 million in payouts over nine years. An overwhelming majority of tribes are expected to sign on to the proposal.A major theme coursing throughout the opioid litigation has been the aggressive marketing of the drugs, which went all but unchecked for years. Distributors almost never sent up warning flares when pharmacy clients took deliveries of quantities of opioids that were wildly disproportionate to the local population. A central feature of the new deal is that the distributors must set up an independent clearinghouse to track and report one another’s shipments, a mechanism intended to raise red flags immediately when outsize orders are made.During the settlement negotiations, a secondary series of talks between the states and the local governments over the allocation of the funds was also unfolding. By now, about two dozen states have worked up their own distribution plans with local cities and counties that also sued the companies.The executive committee of lawyers, including Joe Rice, Elizabeth Cabraser and Jayne Conroy, who negotiated for local governments, released a statement saying, “We arrived at this moment after years of work by community leaders across the country who committed themselves to seeking funds they need to combat the opioid epidemic.”They continued, “While this is a vital step, it is only one of the many that are necessary to put an end to this crisis.”

Read more →

Sacklers Raise Their Offer to Settle Opioid Lawsuits by More Than $1 Billion

But they continue to insist on protection from civil liability claims over opioids, an unusual and controversial measure that derailed a previous deal.Members of the billionaire Sackler family have sweetened their cash offer to settle thousands of opioid-related lawsuits against them and their company, Purdue Pharma, offering up to $6 billion, an increase of more than $1 billion from an earlier offer, according to a mediator’s report filed Friday afternoon in bankruptcy court.But the deal is not done. The Sacklers have not budged from the line they drew in the sand at the outset of the case. In exchange for their billions, they are continuing to demand an end to all civil claims against them related to Purdue and opioids, and that future such claims be prohibited.Legal experts and the public have criticized efforts by the Sackler family to seek personal protection from liability. It is a shield typically granted to companies seeking bankruptcy restructuring, as Purdue is, but rarely extended to owners who do not file for personal bankruptcy. Eight states and the District of Columbia refused to sign on to an earlier proposal because of the Sackler liability shields.The mediator, Judge Shelley Chapman, a federal bankruptcy judge, said in her report that a “supermajority” of those states had now agreed to the new offer. But holdouts remain and the deal is not yet done.The earlier offer included a pledge from the Sacklers of $4.55 billion, including a $225 million federal settlement, to be paid out over roughly nine years. Under the new offer, the Sacklers would pay a total of $5.5 billion, with an additional contribution of up to $500 million, contingent on the sale of their international pharmaceutical companies. The Sacklers would have 18 years to make payments of the additional $1 billion.The bankruptcy plan requires that the Sackler money, plus billions more from Purdue, be given to funds for states, municipalities and tribes dedicated to the treatment and prevention of opioid addiction, and to compensate victims.Known as “the Nine,” the holdouts, including Connecticut, Washington, California and Maryland, have been at the mediation table with Purdue and the Sacklers since January.While negotiations continue, a stay against all litigation against both Purdue and the Sacklers, which has been in place since September 2019, was extended this week and is now set to expire on March 3.A representative of one branch of the family, descendants of Mortimer Sackler, declined to comment; representatives of another branch, descendants of Raymond Sackler, did not respond to a comment request.Judge Chapman has requested an extension of the deadline for mediation talks through February 28. Noting that the “unanimous acceptance” that the Sacklers require has not yet been achieved, she suggested that further talks could either reach that end or craft a different set of plans that would not necessitate unanimity.In the meantime, Purdue, whose plan was rejected by U.S. District Judge Colleen McMahon in December, is pursuing an appeal in the Second Circuit Court of Appeals. Oral arguments are expected in April.Purdue released a statement saying: “We remain focused on achieving our goal of providing urgently needed funds to the American people for opioid crisis abatement. We believe a global settlement is the swiftest and most cost-effective exit path from Chapter 11 and we will continue working to build consensus as we proceed through the appeal process with the United States Court of Appeals for the Second Circuit.”

Read more →