Rodney Thomas was just 51 when he died of aggressive nasopharyngeal cancer, a rare form of head and neck cancer, after using a Philips sleep apnea machine.
His family were puzzled by his diagnosis at the time – Mr Thomas was not a smoker or heavy drinker and was in good health apart from a diagnosis of a sleep disorder.
To treat it, Mr. Thomas had started using a Philips Continuous Positive Airway Pressure (CPAP) machine, which was later found to release cancer-causing substances into users' airways, according to lawsuits against the company.
His wife Shawne Thomas – just one of many suing the medical device manufacturer – claims that its machine led to her husband's cancer and eventual death.
She told : “My husband didn't have to die.” That was completely unnecessary. We have lost our world.'
Ms. Thomas, from Louisiana, told this website that Rodney started using his sleep apnea machine in 2019 and the couple kept seeing black spots in the tube and mask, but didn't worry about it at the time.
Class action lawsuits later claimed that the particles were actually carcinogens that decomposed inside the machine and entered Rodney's respiratory tract.
Rodney Thomas was just 51 years old when he died of cancer in 2021 after using a Philips sleep apnea machine for several years
Rodney and his wife Shawne were married for 32 years and had three children together
Rodney Thomas' wife, Shawne, said the couple kept seeing black spots in the tubes and masks of Rodney's sleep apnea machine
About a year after using the device, Rodney developed a very “aggressive cough,” became more and more tired, and was unable to carry out his daily activities.
After noticing a large lump had formed in Rodney's throat, Ms Thomas encouraged him to go to the doctor, who initially thought Rodney had an infection and treated him with antibiotics.
When weeks passed with no improvement, Rodney underwent diagnostic imaging that revealed a tumor. He was diagnosed with nasopharyngeal cancer in January 2021.
He died just five months later – several days before Philips issued a recall of its devices.
It was only after her husband's death that Ms. Thomas found out about the recall when she saw a commercial announcing it on YouTube.
She immediately checked his machine's serial number and discovered it was included in the recall of millions of CPAP machines.
Ms Thomas told : “[I was] just traumatized. We were so shocked and then the shock turned into anger.
“That was completely unnecessary.”
The manufacturing giant first received complaints about faulty machines in 2010 after it redesigned its equipment. However, a ProPublica investigation found that Philips did not disclose the complaints even as the number grew from a few to dozens.
Users wrote to the company about “black shavings” in the CPAP machine chamber and reported that the devices were “contaminated with an unknown sticky substance.”
Almost 600 deaths have now been attributed to the machines in the last three years. According to the Food and Drug Administration, the deaths are alleged to be related to the foam and potentially toxic gases emitted into users' airways when the device is worn.
The deaths and illnesses are reported to the FDA through the agency's medical device reporting system. The system allows anyone – doctors, patients and family members – to submit adverse reactions that a person experiences after using a medical device or taking a medication.
The reports are not verified and the FDA states that reporting a death or injury does not constitute evidence of a causal relationship.
After learning of the recall, Ms. Thomas said she was “beyond angry.”
Ms. Thomas quickly got a lawyer and told this website that she had filed a lawsuit against the medical device manufacturer. As part of the lawsuit, she said her attorney sent Rodney's machine to a facility in Pennsylvania for testing.
The tests revealed the presence of a carcinogenic substance known to cause the type of cancer Rodney had, the lawsuit says.
A CPAP (Continuous Positive Airway Pressure) machine corrects sleep apnea, where sufferers stop and resume breathing during sleep, which can cause far more serious health problems
Indentations on President Joe Biden's face prompted the White House to tell reporters that he had started using a CPAP machine
Rodney is just one of hundreds of people whose deaths are allegedly linked to the use of the Philips CPAP machine – and thousands more are worried about their health.
Joel Pickett, a 79-year-old from Oregon, posted in a Facebook support group for people affected by Philips CPAP machines that he had developed tracheal cancer after years of using a recalled machine.
There are dozens of comments in the group from people reporting diagnoses of cancer, respiratory illnesses and infections, the deaths of family members they claim are linked to the use of the machines, and people expressing fear that they could develop life-threatening diseases through years of use.
Another poster said his symptoms of chest pain, muscle pain and rashes improved after he stopped using his CPAP machine.
Kelly Bush Fannerella of Pennsylvania reported that her son was diagnosed with non-Hodgkin's lymphoma after using the device.
In 2021, Philips sleep apnea machines were found to blow gas and foam into users' airways as they slept, putting them at increased risk of tumors.
The disruption led the company to recall more than 5 million machines in June 2021, but attempts to repair and replace affected machines have dragged on for years.
Most recently, the FDA, the Department of Justice and Philips agreed via consent decree that the manufacturer will stop selling its devices in the USA.
The manufacturer announced last month that it would stop selling its machines.
According to the FDA, since it initiated a recall of about 15 million devices in 2021, 561 CPAP users have died as a result of illnesses related to faulty devices, while thousands have struggled with other serious health problems.
The deaths were recorded in 116,000 medical device reports, the FDA's adverse event reporting database. From July to September 2023 alone, 111 deaths were registered, with a total of more than 7,000 medical device reports submitted in this short period.
The White House confirms Biden is using a breathing machine to treat sleep disorders
The White House said President Joe Biden, 81, was using a CPAP machine to treat his sleep apnea – after he had visible dimpling on his face.
Philips Respironics agreed to a $479 million partial settlement on September 8, 2023 to compensate people for financial damages related to the recall.
Approximately 30 million Americans suffer from sleep apnea, a condition characterized by pauses in breathing or shortness of breath during sleep that, over time, significantly increases the risk of heart attack and stroke.
It is estimated that 8 million people, including President Joe Biden, rely on a CPAP machine to sleep through the night, and given Philips' status as the market leader in CPAP machines, a large portion of those eight million machines are likely in this one Retrieve device included.
The problem stems from the type of foam used in the machine's headgear, which attaches around the head and connects to a snorkel-like device. It is intended to dampen noise and vibrations when the machine is operating.
However, the foam made from polyester-based polyurethane has been shown to break down and break down into tiny particles, releasing harmful chemical gases such as formaldehyde, benzene, methylene chloride, volatile organic compounds and solvents – all of which have been linked to various types of cancer and Respiratory diseases, according to several class action lawsuits.
Brett Stassi, a 62-year-old from Louisiana, battled kidney cancer after using his Philips sleep apnea machine every night for four years.
Terry Flynn of St. Louis, Missouri, died of esophageal cancer in 2021 just two weeks after being diagnosed. ProPublica reported that he used his CPAP machine for nine years.
And Mark Edwards, 58, suffered for years from recurrent respiratory infections and benign tumors that he believes were caused by the Philips DreamStation ventilator, he told ProPublica.
“It really blows my mind,” Ms Thomas told .
'[It’s] completely unnecessary. That's what really fascinates me about the whole thing. It didn't have to happen.'
In a statement to , Philips said: “Our thoughts and condolences go out to Mr. Thomas' family.” The health and well-being of patients is our top priority and we regret the heartache and concern caused by the Philips recall Respironics has caused the affected device users and their families.
“Importantly for patients and their caregivers, 13 independent epidemiological studies show no association between the use of continuous or bilevel positive airway pressure (PAP) devices, including Philips Respironics PAP devices, and an increased risk of cancer in people with obstructive sleep apnea. “
“In addition, Philips Respironics has carried out a comprehensive testing program for the PE-PUR foam together with five independent certified testing laboratories and qualified external experts.
“Based on the independent testing results to date, Philips Respironics has also concluded that the use of its sleep therapy devices is not expected to cause significant harm to patient health.”