They thought they were getting clean air from the lifelines at their bedsides, coveted nights of healthy sleep that for too long did not come easy.
Near Portland, Ore., Kim Binford’s sleep apnea machine helped him manage chronic pain. Outside Indianapolis, Connie Thompson was able to stay awake in class during her senior year of high school. In the suburbs of Atlanta, Debra Miller could put her grandchildren in the car and drive without fear.
But in June 2021, Mr. Binford, Ms. Thompson, Ms. Miller and millions of others learned that a defect in the breathing machines they relied on for years had the potential to inflict serious harm, including cancer, kidney and lung problems, and severe respiratory infections.
In announcing a massive recall of ventilators and sleep apnea machines, Philips Respironics acknowledged that an industrial foam placed inside the devices to reduce noise could break apart and send tiny particles and fumes into the noses, mouths and lungs of patients.
As many as 15 million devices from two Pittsburgh-area plants were made with the crumbling material, including the company’s popular DreamStation continuous positive airway pressure, or CPAP, machine used by those with sleep apnea. The disorder causes breathing to stop and start through the night.
Journalists spent more than a year probing what happened inside Philips Respironics after contaminants were found in its breathing machines.
Your questions answered.
Have you experienced health problems because of foam degradation in your Philips Respironics CPAP machine? Tell us your experience.
Since the recall, thousands of consumers have described unexplained illnesses while the reported death count linked to the recalled machines rose to more than 370. Some stopped using their devices altogether. Others bought secondhand machines, waited on a replacement from Philips or simply gambled, continuing to use their defective devices long after the recall.
Losses mounted quickly: lost sleep, lost money, lost nights spent worrying about a health threat that the U.S. government determined could cause severe illness or death.
Though it’s impossible to know what caused individual illnesses, or whether the machines were capable of advancing cancers that may have developed prior to use by patients, some medical experts say they fear long-term harm. The Food and Drug Administration has said the degrading foam, when inhaled or ingested, can lead to headaches, asthma, inflammatory conditions, respiratory tract problems and “toxic or cancer-causing effects to organs,” among other health complications.
Lawsuits against the company are ongoing in federal court in Pittsburgh, waged by families who say Philips should be held accountable for failing to warn customers about the risks years earlier.
In a statement, Philips said patient health and wellbeing is a top priority and that the company increased production amid supply chain challenges to send replacement devices to customers. The company added that some received entirely new machines while others received a CPAP motor that would work with existing components.
Since the recall, the company has walked back its initial assessment that the machines were potentially unsafe, saying new testing on the DreamStation and similar devices has shown that chemicals released by the foam are not at levels that can cause “appreciable harm.”
Medical experts and engineers familiar with the testing dispute that claim. Last month, the FDA announced that the company’s testing was inadequate and said that Philips had agreed to conduct additional assessments.
In the United States and beyond, families are still struggling.
“I worked my whole life to be pretty healthy,” said Ms. Miller, a retired elementary school teacher. “I didn’t want any debris in my lungs.”
In the middle of the night in June 2021, in a bedroom that overlooks landscaping projects that her husband never got to finish, Shawne Thomas scrolled through YouTube videos.
Rodney Thomas, a former Marine, had died a few days earlier from a rare form of nose and throat cancer after punishing rounds of chemotherapy and radiation. He was 51 and had recently retired, with plans to spend more time with their grandchildren.
An online post made Shawne Thomas stop cold: Philips had recalled millions of CPAPs and ventilators, saying the machines could send potentially “toxic and carcinogenic” material into the masks of users.
Ms. Thomas rummaged through her bedroom closet and found the machine that her husband had used for about 20 months. It was one of the recalled CPAPs, the widely used Philips DreamStation.
“I was amazed, hurt and angry all in one — and then I was furious,” she said.
Ms. Thomas, 53, met her husband in the late 1980s when they were both Marines and stationed in California as radio operators. He proposed on Valentine’s Day 1989, and the couple wed a few months later.
Married for 32 years, they lived on 20 acres in rural Louisiana across from a field of pecan trees. Rodney Thomas took care of the yard, the chores and his wife, who is disabled from a spinal cord injury sustained during military service.
Diagnosed with stage 4 cancer in early 2021, he underwent two surgeries, seven-hour chemotherapy sessions and radiation treatments.
He died in hospice, holding his wife’s hand, one week after the Philips recall was announced. Shawne Thomas threw a celebration to honor her husband’s life and then, like thousands of others, decided to join litigation against the company.
Ms. Thomas said that she and so many others should have been warned far earlier about the potential health hazards.
“I start to feel those thoughts and get angry and get into that dark place, and I have to remind myself I had 32 wonderful years with this man, and I am very lucky to have had that,” she said.
More than two years after her husband’s death, she said, she still has trouble sleeping. On cold nights, she lies under a quilt made of his T-shirts, next to a stuffed panda he gave her when he proposed years ago.
Jules Lee Jr. isn’t scared of much.
The 56-year-old Army veteran watched tanks explode, dodged bullets and swept through enemy bunkers during the Gulf War in the early 1990s. But when he learned in 2021 that the DreamStation that he had been using for three years to help him breathe at night had been recalled, Mr. Lee got scared.
His best friend, Rodney Thomas, who had also used a DreamStation, died from nose and throat cancer only days after the recall was announced. Like Mr. Thomas’ wife, Shawne, Mr. Lee said he fears the recalled CPAP was to blame.
Mr. Lee decided to stop using a breathing machine altogether.
“That really solidified me not using the machine — and not wanting to use any machine,” said Mr. Lee, who lives outside Baton Rouge.
He is not alone: Doctors surveyed for a study published in the Journal of Clinical Sleep Medicine said that 1 in 4 patients with sleep apnea stopped using their CPAP machines after the Philips recall. A majority of the doctors also reported that patients had lost trust in medicine.
Mr. Lee said he knows a CPAP machine will help control his sleep apnea, which, left untreated, can lead to strokes and heart problems. But he decided that he would rather die in his sleep than risk experiencing what his friend felt during months of cancer treatment.
Struggling with post-traumatic stress disorder, Mr. Lee said his depression worsened after Mr. Thomas died. On good days, Mr. Lee takes deer-hunting trips to Alabama and keeps up with a group of men who served together through basic training in Oklahoma and operations in the Middle East.
He said he worries about his health, his choice and what might come next, but he can’t bring himself to go back on a CPAP.
“I’m fearful and untrusting,” Mr. Lee said. “This is too fresh for me to want to start using a new machine.”
Kim Binford can’t remember the last time he felt like himself.
In the middle of the night, he wakes up in pain, with excruciating spasms near his heart or in his legs, arms and torso. He paces for long stretches and tries to go back to sleep.
Most nights, he just waits for morning.
The retired engineering manager who once ran marathons has sleep apnea as well as a rare condition known as benign cramp-fasciculation syndrome, which triggers severe muscle spasms.
He used a specialized Philips bi-level positive airway pressure, or BiPAP, machine for more than a decade to treat the conditions, but he stopped after learning in 2021 that his device and millions of others were recalled. Mr. Binford said he immediately called the company and registered for a new BiPAP.
Then he waited.
For several weeks after the recall, he said he managed to stay off his recalled machine altogether. But he stopped breathing one night and didn’t rouse quickly when his wife tried to jostle him awake at their home in the suburbs of Portland, where they live with two rescued Chihuahuas.
The father of two, who lives on a fixed income and could not afford to pay thousands of dollars for a new machine, started using his old one again.
“I’m kind of damned if I do, damned if I don’t,” he said. “Anything’s better than nothing. I’m just gonna roll the dice with my life.”
In September, more than two years after the recall, Mr. Binford said his insurance company finally sent him a refurbished machine.
“My condition was getting worse and worse and worse,” he said.
One year after Philips recalled millions of breathing machines, retired elementary school teacher Debra Miller decided she was tired of waiting for the company to send a replacement.
So she took matters into her own hands.
In June 2022, she emailed Philips, writing: “I’ve had a difficult year. I would like my machine as soon as possible.”
Three days later, Ms. Miller said, a box from Philips arrived at her two-bedroom home in the suburbs of Atlanta. It had a refurbished CPAP machine motor, she said, but no electrical cord or instructions for use.
“The components of the machine came, and they’re just dumped in a box,” said Ms. Miller, 70, who taught in public schools for 30 years.
Ms. Miller started using a CPAP machine in 2019 after she passed out driving her Ford Escape and crashed into three other cars, puncturing her liver. The other cars were totaled in the wreck; the drivers had minor injuries.
Ms. Miller was diagnosed with sleep apnea and daytime narcolepsy. The grandmother of three was not charged in the accident.
She got her first Philips machine soon after the diagnosis and used it every night.
After the recall, as she waited on a replacement from the company, she withdrew $1,000 from her retirement account to buy a new machine from a Philips competitor. Eleven months later, she received the refurbished CPAP from Philips — and stashed it in her bedroom closet.
“I literally got … half of an old machine,” she said.
Sheriff Brett Stassi figured the black particles that turned up in the CPAP machine he used every night for four years were harmless.
That changed in 2021 after the Philips recall, when Sheriff Stassi learned that an industrial foam embedded inside the devices could crumble and send debris and fumes into his lungs.
“You’re worried about dying in your sleep, and you come to find out that the machine might be doing more damage than the apnea,” he said.
Sheriff Stassi said he has good reason to worry.
One month before the recall, he was rushed into surgery after a routine visit to the doctor yielded an unexpected diagnosis: kidney cancer. His right kidney was removed, and he was treated with an immunotherapy drug.
Now in remission, the grandfather of five said he’ll never know if those black particles made him sick. But he’s suing Philips, he said, because the company should have alerted its customers to the health risks years before the recall.
In Iberville Parish outside of Baton Rouge, Sheriff Stassi tries not to dwell on the diagnosis. He keeps busy supervising 148 deputies and a jail filled with inmates.
His doctors have warned Sheriff Stassi that the cancer could return, possibly in his lungs or brain. For now, the scans are clear, and he’s hoping to finish a fourth term as sheriff. On a spring morning in an office filled with thank-you notes and photos of his children on their wedding days, Sheriff Stassi flipped through pictures of his infant grandson.
“See why I’m trying to stay alive?” he said.
Connie Thompson spends her days studying public safety, advocating for social and economic justice, and caring for her disabled mother.
At night, the 24-year-old races to the theater. She auditioned at an Indianapolis community theater for the first time last year and was cast in a production of “Little Women.” She has since moved on to the musical “Into the Woods.”
“It’s like, ‘Oh my God, I belong here,’” she said.
Ms. Thompson is busy mapping out plans for a future on stage but worries about the years ahead.
Diagnosed with sleep apnea as a teenager, she used a DreamStation for four years before learning about the recall and safety risks. Ms. Thompson said she fears that the prolonged use will one day impact her health.
“There’s so much that I want to do,” she said. “All of the opportunities that I’ve earned, I want to take them to their absolute fullest. The idea [that] I might not have a choice in that just shattered my world.”
Ms. Thompson first started using her CPAP machine in high school after excessive fatigue often kept her out of school. When her doctor told her in 2021 that her device had been recalled, Ms. Thompson said she had no choice but to continue to use her old one even though she often found black particles in her mask.
Unable to afford a new machine, she waited a year for Philips to send a replacement, cutting up surgical masks and wedging them into the tube that connects to her face mask to try to filter the debris. Lost sleep, she said, wasn’t an option. Her mother has rheumatoid arthritis and needs support around the house.
Ms. Thompson also takes classes at Ivy Tech Community College and has long considered herself a political activist, with views shaped in part by her experiences as a transgender woman.
She was recently cast in her first paid acting role and is preparing to audition for four-year conservatory programs to study musical theater. But she said insecurity about her health lingers.
“To know that I could get cancer or some other health effect from using a defective machine for so long brings me right back to square zero — the powerlessness of being completely incapacitated by health problems not under my control,” she said.
Just months before he was diagnosed with lung cancer, Carey Jenkins walked 60 miles over eight days in the mountains of Alaska on a bear-hunting trip.
Mr. Jenkins had always followed a strict exercise regimen. He had served as a deputy federal marshal for 16 years and was later appointed by former President George W. Bush as head marshal for the Middle District of Louisiana. Fitness was required for promotions: running a timed mile and a half, completing situps and pushups, and maintaining a low body fat ratio.
Mr. Jenkins went on to serve as an elected constable in his East Baton Rouge parish.
Everything changed, however, when his doctors found a spot on his lower right lung in the fall of 2019. Two years later, it had grown bigger.
The day he went to schedule surgery in 2021, he said he found a notice at the Louisiana home where he and his wife have lived for 30 years. It detailed the sweeping recall of breathing machines, including the DreamStation, which Mr. Jenkins used for several years to treat sleep apnea.
Like so many others, the 68-year-old grandfather of four said he worries the machine that helped him breathe at night instead imperiled his health.
With a malignant tumor on his lung removed, Mr. Jenkins is still working as a constable. But he said that even walking down his driveway to the mailbox is difficult, and he can no longer help his wife carry the furniture and crystal that she sells through her antique company. He sometimes takes supplemental oxygen with him to catch his breath.
“Before I do something, I know that there’s a limit that I have to stop at,” he said. ”I’m just doing everything I can do to get a deep breath … You have to work on it.”
In recent months, he’s been able to return to the gym with a trainer. Now, instead of exercising for his job in law enforcement, he’s keeping fit to try to live longer.
His goal: a hunting trip with his son next year.
In a church in St. Louis, hundreds of people gathered to honor Terry Flynn with a song: “When Irish Eyes Are Smiling.”
The father of four died in 2021, two weeks after he was diagnosed with esophageal cancer. He was 63 and had never made it to Ireland. A family friend planted a tree there in his memory.
“Before I even got engaged to Terry, one of the first things we did was attend a St. Patrick’s parade,” said Mary Ann Flynn, his wife of 35 years.
Terry Flynn used a recalled Philips machine for nine years to treat sleep apnea. His wife and children say they’ll never know if the device caused his illness, but they blame the company for not alerting patients to the potential health risks sooner.
Mary Ann Flynn said her husband, who went to the gym every morning before work at a law firm, would have immediately stopped using the machine.
“Had someone come to us … we would have been like, ‘Toss it out the window,’” she said. “It would have changed the scope of so many things.”
Terry Flynn was born and raised in St. Louis, where he coached soccer and baseball and liked to go fishing in local lakes. He met his wife in college, and they married shortly after graduation.
In 2021, the couple were planning a family vacation to Florida to celebrate the birthday of their twins, who were turning 21, and their older son, Sean, who had just been certified as a public accountant.
The trip never happened. Mr. Flynn was diagnosed with cancer that had spread from his esophagus to his liver and kidneys and died days later. Mary Ann Flynn said she and her family decided to sue Philips for failing to alert customers about the defective devices.
“It’s a machine to help you breathe by a reputable company,” she said, adding, “You kind of just trust.”
Pedram “Pedy” Ghaitani needed his sleep.
On most days, the driver for a medical company left his wife and young son in their apartment before sunrise to shuttle patients to appointments across the city. Mr. Ghaitani drove a limousine in his spare time, racing to airports, weddings and business meetings.
When he was diagnosed with sleep apnea in 2016, he became a faithful user of the DreamStation. He continued to use the machine even after doctors discovered in 2019 that he had a rare form of lymphoma. The 51-year-old Iranian immigrant died later that year.
“I always thought whenever he used to come home late, sometimes 2, 3 o’clock in the morning, ‘Thank God,’” said his wife, Ganna Kron. “He always came home. And then he didn’t.”
Ms. Kron is among thousands of people involved in litigation against Philips in Canada. Anger has swept the world, with lawsuits similar to those in the United States unfolding in several countries.
Ms. Kron said she’ll never know exactly what caused her husband’s illness but fears his recalled CPAP played a critical role. “Carcinogenic particles — it just baffles my mind,” she said.
Mr. Ghaitani fled Iran as a teenager and settled in New York. After he met Ms. Kron, he moved to Toronto. The couple married and had a son, Nash.
“He missed the chance to grow up with such a great man,” Ms. Kron said. “That is my heartbreak.”
Reporting was contributed by Debbie Cenziper of ProPublica; Michael D. Sallah and Michael Korsh of the Pittsburgh Post-Gazette; and Molly Burke, Aidan Johnstone and Bridgette Adu-Wadier of the Medill Investigative Lab.
Pittsburgh Post-Gazette: Michael Wereschagin, assistant managing editor of investigations and data; Jordan Anderson, reporter
Northwestern University’s Medill Investigative Lab: Molly Burke, Margaret Fleming, Susanti Sarkar, Nicole Tan, Claire Gardner, Bridgette Adu-Wadier and Grant Schwab