Purdue Pharma, Sackler families boost contribution in opioid settlement to $7.4 billion
Purdue Pharma headquarters; Victor J. Blue/Bloomberg via Getty Images
(NEW YORK) — The company and once-prominent family behind the drug OxyContin agreed Thursday to increase their financial contribution to resolve mass opioid litigation.
The Sacklers and Purdue Pharma boosted their settlement contribution to $7.4 billion after the U.S. Supreme Court overturned a prior settlement in June 2024. If approved, the new plan would end the costliest corporate bankruptcy resulting from the U.S. opioid crisis.
Purdue, under the leadership of the Sackler families, invented, manufactured and aggressively marketed opioid products for decades, according to the lawsuits. States and cities across the country said it fueled waves of addiction and overdose deaths.
The pharmaceutical company introduced OxyContin, a brand name of oxycodone, in the 1990s and filed for chapter 11 bankruptcy in 2019 after the company was sued thousands of times.
Under the settlement terms, the Sacklers’ control of Purdue Pharma ends. The $7.4 billion will go directly to communities across the U.S. — including states, counties, cities and territories — over the next 15 years to support opioid addiction treatment, prevention, and recovery programs.
“Families throughout New York and across the nation are suffering from the immense pain and loss wrought by the opioid crisis,” said New York Attorney General Letitia James, whose office helped negotiate the settlement agreement.
“The Sackler family relentlessly pursued profit at the expense of vulnerable patients, and played a critical role in starting and fueling in the opioid epidemic,” she continued. “While no amount of money will ever fully repair the damage they caused, this massive influx of funds will bring resources to communities in need so that we can heal.”
Purdue Pharma planned to exit bankruptcy last year under terms that gave the Sacklers a full release from all civil opioid claims even though they themselves were not declaring bankruptcy. In return, the Sacklers agreed to pay $6 billion.
The Supreme Court rejected the attempt by the Sacklers to use Purdue Pharma’s bankruptcy to shield themselves from liability.
Under the new terms, a significant amount of the settlement funds will be distributed in the first three years, with the Sacklers paying $1.5 billion and Purdue paying nearly $900 million in the first payment, followed by $500 million after one year, an additional $500 million after two years, and $400 million after three years.
A board of trustees selected by participating states in consultation with the other creditors will determine the future of the company. Purdue will continue to be overseen by a monitor and will be prevented from lobbying or marketing opioids.
“This story is about a family of cruel billionaires who believed they were above the law, pursued by states who never backed down,” Connecticut Attorney General William Tong said Thursday. “Today, we are forcing Purdue Pharma and the Sackler family to pay $7.4 billion for their role in igniting one of the most devastating public health crises in American history.”
Purdue Pharma said in a statement to ABC News, “We are extremely pleased that a new agreement has been reached that will deliver billions of dollars to compensate victims, abate the opioid crisis, and deliver treatment and overdose rescue medicines that will save lives. We have worked intensely with our creditors for months in mediation, and we are now focused on finalizing the details of a new Plan of Reorganization, which we look forward to presenting to the bankruptcy court.”
(NEW YORK) — Federal health officials have begun collecting samples of aged raw cow’s milk cheese across the U.S. to test for bird flu, the Food and Drug Administration announced.
Sample collection started at the end of this month and is expected to be completed by the end of March 2025, the FDA said Monday. If needed, the agency said it will extend the collection period.
It comes after the U.S. Department of Agriculture issued a federal order earlier this month that raw milk samples nationwide would be collected and shared with the agency to be tested for bird flu.
The FDA said it plans to collect 300 samples of raw cow’s milk cheese that has been aged for at least 60 days from warehouses and distribution centers across the country.
Samples will be tested with a PCR test, which looks for genetic material from the virus, and will be completed within one week of collection, according to the FDA. Samples that indicate the presence of the virus will undergo viability testing.
Viability testing will be done by injecting part of the virus into an embryonated egg and analyzing if it grows or multiplies.
Raw milk cheese is made with unpasteurized milk. In the U.S., cheese can be made from raw milk but must be aged a minimum of 60 days to lessen the risk of any pathogens that may be present, per the FDA.
Samples that test positive for viable virus will be “evaluated on a case-by-case basis,” the FDA said, and the agency may issue actions “such as a recall, follow-up inspection or other possible responses to protect public health.”
The FDA has previously warned of the dangers of drinking raw milk, which does not undergo pasteurization — a process that kills viruses and bacteria. The agency currently considers unpasteurized soft and hard cheeses, as well as other products made from unpasteurized milk, a “high-risk choice.”
Past studies from federal health officials have shown that pasteurization effectively kills the bird flu virus. Nearly all, or 99%, of the commercial milk supply produced on dairy farms in the U.S. follows a national pasteurization program.
Pasteurization has been a practice in the U.S. for more than 100 years and kills harmful bacteria and viruses by heating milk to a specific temperature over time, the FDA notes.
The U.S. has been facing an outbreak of bird flu, or avian influenza, since April, when the first human case was reported.
Almost all confirmed cases have had direct contact with infected cattle or infected livestock. Most bird flu cases in the U.S. have been mild, and patients have typically recovered after receiving antiviral medication.
(WASHINGTON) — During his confirmation hearings two weeks ago to lead the Department of Health & Human Services (HHS), Robert F. Kennedy Jr. repeated several unfounded claims about autism.
Kennedy, an environmental lawyer who has made money through books, speeches and lawsuits while sharing vaccine skepticism, refused to say that vaccines don’t cause autism despite many high-quality studies finding no such link.
He stated during the hearing that autism rates have “have gone from 1 in 10,000 … and today in our children, it’s one in 34.” His claims have been repeated by President Donald Trump on Truth Social.
It’s unclear where Kennedy got his 1 in 10,000 statistic. In 2000, approximately 1 in 150 children in the U.S. born in 1992 were diagnosed with autism compared with 2020, during which one in 36 children born in 2012 were diagnosed, according to data from the Centers for Disease Control and Prevention.
Some psychiatrists and autism experts told ABC News it’s important to highlight the rising rates of autism, and that at least Kennedy is putting a spotlight on it.
“On the bright side, I think it is really important to place an emphasis on these very high rates, it’s kind of great putting a spotlight on autism, these increased rates,” Dr. Karen Pierce, a professor in the department of neurosciences at the University of California, San Diego and co-director of the UCSD Autism Center of Excellence, told ABC News. “We need more funding. We need more infrastructure to support everybody who is now recognized as on the spectrum. So, I think that that’s actually a really good thing.”
However, the experts said Kennedy and others are missing important context about why autism rates are increasing. They say reasons may include a combination of widening of the definition of the spectrum and of types of symptoms associated with autism spectrum disorder (ASD) as well as people having children at older ages, better awareness and access to diagnostic testing.
“With the rates increasing, there certainly are valid reasons for that,” Pierce said. “There’s better awareness, and doctors can find autism a lot easier than they could before in the past…. and I think a very big reason is just better record keeping nowadays and easier access to reviewing records.”
What is autism?
ASD is a developmental disability caused by differences in the brain, according to the CDC.
People with ASD often communicate, interact, behave and learn differently, the CDC says. ASD symptoms typically begin before age 3 and can last a lifetime, although symptoms may change over time.
“There can be differences in how one is reading social cues and interpreting them, and then there’s also certain behaviors that we see,” Dr. Anna Krasno, clinical director of the Koegel Autism Center at the University of California, Santa Barbara, told ABC News.
“So those include a preference for sameness, a difficulty with transitioning, some cognitive and behavioral rigidity,” she continued. “We also see intense interests, so topics that people are super, super into and want to research, repetitive speech and motor movements. And then we also see really significant sensory differences as well.”
ASD is a spectrum, which means symptoms vary by person — some need little support in their daily lives and some may need a great deal of support in performing day-to-day activities. Some may have advanced conversation skills and others may be nonverbal.
Wider recognition, better understanding
Experts told ABC News there is a wider recognition and a better understanding of what is now understood as autism/ASD.
Traits of what is now known as ASD are built on early observations in the 1940s from Austrian-American psychiatrist Dr. Leo Kanner and Austrian physician Dr. Hans Asperger.
A 1943 paper from Kanner described 11 children who presented with “inborn autistic disturbances of affective contact” while Asperger’s 1944 report focused on boys who had marked social difficulties; unusual, circumscribed interests; and good verbal skills.
It was not until 1978 that autism was recognized as a developmental disorder distinct from schizophrenia by the World Health Organization. It was also in the 1970s that psychologists and psychiatrists first came to describe autism as a spectrum.
“When autism was first described, it was new to people understanding that there was a condition that included social communication difficulties and restricted and repetitive behavior, and people primarily only recognized it when it was at its most extreme,” Dr. Jeremy Veenstra-VanderWeele, division director in child and adolescent psychiatry at Columbia University, told ABC News.
“And so, if you go back and read the initial descriptions today, those are kids who we would recognize in the waiting room, recognize in the grocery store, in whom autism would be very obvious and would not require much assessment in order to diagnose,” he continued.
Better diagnostic tools
Experts say another reason for the increase in rates is having better diagnostic tools than what was available decades ago.
There is no single tool used as the basis of an ASD diagnosis. Typically, tools rely on descriptions from parents or caregivers of a child’s development and a professional’s observation of a child’s behavior, according to the CDC.
Currently, the Autism Society encourages all children to be screened for signs of autism by their family pediatrician three times by the age of three — at nine, 18, and 24 or 30 months. If a child shows symptoms of ASD, more rigorous diagnostic testing can be carried out by a specialist including a full neuropsychological exam.
Additionally, the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) provides standard criteria for helping diagnose autism.
Under DSM-5, a child meets the criteria if they have deficits in three areas of social communication and interaction and at least two of four types of restricted, repetitive behaviors.
While the first edition of DSM came out in 1952, it was not until the third edition, DSM-3, in which autism was listed under an entirely new “class” of conditions — the Pervasive Developmental Disorders.
Veenstra-VanderWeele said the change in the criteria is another reason why the number of those diagnosed with autism rose. He likened it to changing the definition of what it means to be tall.
“To just use a crude example, if you would define somebody as tall if they were over six-foot-six, and then 30 years later, say that somebody is tall if they’re over five-foot-10, you’d get very, very different numbers, and that’s part of what’s happened here,” he said.
Pierce added that because of limited knowledge and awareness in the past, there may have been many children who were underdiagnosed and misdiagnosed.
“It’s understandable that people wouldn’t even necessarily think that somebody has autism, because nobody knew what really autism was,” she said. “So, you know, large numbers of people were just put in the books as just having special education needs, maybe as a language delay or of having a cognitive impairment.”
Older reproductive age
Some studies have suggested that people who become pregnant at an older age have an increased risk of giving birth to a child with autism.
A 2012 review and meta-analysis of 16 papers from researchers in New York, London, Israel and Sweden found an association between advanced maternal age and the risk of autism.
Advanced paternal age may also be a risk factor. A 2006 study conducted jointly by researchers in New York, London and Israel found that men who were above age 40 were 5.75 times more likely to have a child with ASD compared to men younger than age 30 after controlling for other factors.
However, questions still swirl about whether or not there is a risk from the age of parents, and not all researchers are convinced.
“I know that there is some research looking at maternal and paternal age with regard to autism, and there’s research around environmental causes,” Krasno said. “I think where I always firmly land is that it is inherited, and it is genetic. So, I don’t know the exact correlation between age and diagnostic rate, but we do know that genetics are highly associated with diagnosis.”
Environmental risk factors
Researchers are also divided over whether or not environmental risk factors play a role in causing autism.
The National Institute of Environmental Health Sciences says the “clearest evidence” involves events before and during birth, including prenatal exposure to air pollution or pesticides; maternal obesity or diabetes; extreme prematurity; and periods of oxygen deprivation to the brain during birth.
“But these factors alone are unlikely to cause autism. Rather, they appear to increase a child’s likelihood for developing autism when combined with genetic factors,” NIEHS states on its website.
Pierce said from the studies she’s read, evidence suggests autism is a genetic condition. She added the environmental factors may play a role but “to a small degree.”
Myth that vaccines cause autism
The myth that vaccines cause autism was born out of a fraudulent 1998 study, hypothesizing that the measles, mumps, rubella vaccine caused intestinal inflammation, which, in turn, led to the development of autism.
The paper has since been discredited by health experts, retracted from the journal in which it was published, and its primary author, Andrew Wakefield, lost his medical license after an investigation found he had acted “dishonestly and irresponsibly” in conducting his research.
More than a dozen high-quality studies have since found no evidence of a link between childhood vaccines and autism.
However, Kennedy has held fast to this claim, saying during a 2023 interview on Fox News that he believes autism comes from vaccines.
During the HHS confirmation hearings, Kennedy said he was not “anti-vaccine” but “pro-safety.” At the same time, Kennedy repeatedly refused throughout the hearings to say that vaccines were not linked to autism, while still insisting he supports vaccination in general.
Experts told ABC News there is no evidence to suggest a link between vaccines and autism, and perpetuating the myth can be dangerous.
“Once there’s a lie and it’s spread, it doesn’t matter that it’s a lie. Once people hear it, then they believe that it’s true despite all of the Herculean efforts to disprove it and debunk it,” Pierce said. “There’s no evidence for it whatsoever, and there’s actually extremely, as far as scientific evidence is concerned, there’s extremely strong evidence to suggest absolutely not.”
Christopher Banks, president and CEO of the Autism Society of America, said the false claim that vaccines cause autism can divert financial resources from much-needed research.
“Instead of advancing support and therapies, time and funding are wasted disproving a debunked theory,” he said. “This misinformation also fuels stigma, implying that autism is something to be feared rather than understood and supported, leading to discrimination against autistic individuals.”
ABC News’ Dr. Jade Cobern, Cheyenne Haslett and Will McDuffie contributed to this report.
Jessie Owen was left paralyzed nearly 12 years ago when a tree fell on a car in which she was a passenger. Via ABC News.
(NEW YORK) — Nearly 12 years ago, Jessie Owen’s life changed forever.
“My family was going over a mountain pass and a tree fell on our car. In that moment, my parents passed away, my siblings were severely injured, and I became quadriplegic,” Owen said. “I lost my independence. I lost my job. I lost my apartment. I lost my autonomy and the life that I dreamed for myself.”
Like Owen, more than 300,000 people live with spinal cord injuries in the United States, with an estimated 18,000 new cases each year, data shows.
Motor vehicle accidents account for the majority of spinal cord injuries and are closely followed by falls, acts of violence and sports activities, according to the National Spinal Cord Injury Statistical Center.
For years, options for recovery have been limited, but a newly FDA-cleared external spinal stimulator, ARC-EX Therapy, which received clearance on Dec. 19, may offer hope for people like Owen.
“ARC-EX is simply electrodes attached to skin on the back of the neck,” explained Chet Moritz, M.D., a professor of rehabilitation medicine at the University of Washington. “It allows us to pass current through the skin to activate the sensory nerves as they enter the spinal cord. Now, those sensory nerves make direct connections to the motor nerves which help people to move.”
Owen, who participated in the Up-LIFT study, a clinical trial focusing on the health benefits of ARC-EX Therapy, saw a life-changing impact.
“I was wildly surprised and pleased to see that it was making meaningful change in my life. I can now paint with my hands. I can open a jar of peanut butter. I can tie my shoes. It [used to] take me 30 minutes to get dressed. Now it takes 12. [I used to require] 20 caregiving hours a week and I was able to move down to about eight.”
The Up-LIFT study produced promising results.
Of the 60 patients with cervical spinal cord injuries studied, 72% saw improvements in hand strength and function. Participants also reported fewer muscle spasms, better sleep, less pain, and improved independence during daily activities.
“The success of [this] study of people with spinal cord injuries is phenomenal,” noted Moritz. “There are essentially no current therapies for chronic spinal cord injury, and so having the majority of patients respond in both strength and function measures [is] just an outstanding result.”
With FDA approval, ARC-EX Therapy is expected to become more accessible.
“Patients can work with their local rehabilitation clinics to see a therapist and work with them in the clinic at first to tune the device,” Moritz said. Results may appear quickly — some participants noticed changes within just a few sessions, he added.
While the device is currently cleared for improving hand strength, function and sensation, Moritz noted other benefits: “Some people will have modest improvements in their bladder function, heart rate, or blood pressure control.”
Leah Croll, M.D., vascular neurologist at Maimonides Health and assistant professor of neurology at SUNY Downstate, shared the excitement over the device.
“The idea that ARC-EX Therapy may accelerate or augment neurologic recovery is really exciting. Any improvement in neurologic function is meaningful and has far-reaching impact in the daily lives of these patients and their families,” she said.
The road to recovery after a spinal cord injury is grueling, Croll said.
“After emergency and ICU care is completed, the mainstay of treatment is working closely with physical therapists, occupational therapists and other rehabilitation professionals to support neurologic recovery,” said Croll. “Patients may also need medications and certain procedures, depending on their unique symptoms.”
For Owen and others, ARC-EX Therapy represents a renewed sense of hope and an exciting change in the way these patients can be treated.
“[With ARC-EX Therapy], I continued to gain function back, and I found I was able to pour more into other people,” Owen said. “The first indicator of success that I noticed was my own happiness. It works, and it gives us hope and passion.”
Natalie S. Rosen, M.D., is a physician in the Hematology & Oncology Department at New York-Presbyterian Columbia and a member of the ABC News Medical Unit.
