A Johnson County man blames his sleep apnea machine for giving him lung cancer and is suing the manufacturer, which last year recalled the machine and several other breathing-aid devices.
Philips Respironics issued a voluntary worldwide recall for the machines last June because of possible health risks related to noise-abatement foam inside them. The foam can break down and release possible cancer-causing particles that a user might inhale or swallow, the Food and Drug Administration said last year.
Last month the FDA announced it had received more than 100 reports of deaths associated with the recalled devices, though no connection has been made between the deaths and the machines.
Robert Dix of Prairie Village began using one of the now-recalled machines in 2016, according to a lawsuit filed in the US District Court of Kansas in April.
In late 2019 he was diagnosed with lung cancer, suffering “serious and substantial life-altering injuries” as a result of the company’s conduct, the lawsuit says.
It accuses Philips of knowing about the problems with the machines before last year’s recall and failing to warn users of a defect “that created a significantly increased risk of cancer, among other health impacts.” The company also failed to warn doctors who recommended the machines to their patients, the suit says.
Philips does not comment on litigation, Mario Fante, senior press officer in the company’s global press office, said in an email to The Star.
The recall is massive, involving as many as 3 million to 4 million devices worldwide, according to the company. The FDA defined it as a Class 1 recall, the most serious category for products that can lead to possible serious injury or death.
Most of the recalled devices are the company’s first-generation DreamStation machines.
The parent company, Dutch health care conglomerate Royal Philips NV, is a defendant in Dix’s lawsuit and is taking heat from officials in the United States and its home country of the Netherlands over its handling of the recall.
Last month, lung specialist Monique Klaaver told a Dutch TV news program that the company’s communication with patients and doctors about the recall and the health risks associated with the machines has been “deplorable.”
“We are talking about an essential medical aid here, not a vacuum cleaner,’ she said.
Philips officials say most machines should be replaced or repaired by the end of the year.
“I would like to emphasize that I fully understand the concerns of patients,” Philips medical director Jan Kimpen told Dutch media last month.
“We also apologize for this at all times. In all fairness, we have to say that we are both on the side of accelerating the production of the devices and in the area of the information flow to the patients have had a slow start due to the complexity and the large numbers.”
Patients are sounding off
Thousands of users of the recalled machines have joined Facebook support groups where they are venting anger and frustration. One group was started by a man who writes that his father, a nonsmoker, was diagnosed with cancer on his vocal cords after using one of the devices.
Many worry that the machines they connected on to help them sleep safely have made them sick, while some are waiting for replacements for their machines nearly a year after the recall was announced.
“I still haven’t gotten a new one,” said a female patient in one of the Facebook support groups. “I’ve tried changing brands they are no where to be found. So, my choice, die from a stroke, or use the (darn) thing. I’ve had one for 13 years. All recalled.”
Patients are sounding off on Twitter as well.
“I have sleep apnea and must use a CPAP device to sleep properly. Almost a year ago Philips issued a recall for loads of their devicesincluding mine, because they can cause cancer,” Twitter user @AlecJohnson4TX tweeted Thursday.
“Last December I was told that I was on a list to get a replacement. Today I get in touch and they have no idea when my replacement might arrive. So if I wind up getting cancer as a result of this inaction, are they going to say they’re sorry!!!”
Legal news publications report hundreds of class action and personal injury lawsuits have been filed citing the company’s “failure to warn.” Legal observers expect more lawsuits given the number of machines recalled.
The lawsuits alleviate a long list of illnesses caused by inhaling the foam particles, from several forms of cancer to heart failure, liver disease and chemical poisoning.
Black debris, particles
The recall mostly affects CPAP (continuous positive airway pressure) and BiPAP (bilevel positive airway pressure) machines that help people breathe by pushing air into their lungs through a mask or nasal cannula.
They’re used most often to treat sleep apnea and other health conditions that cause people to briefly stop breathing while they sleep.
Left untreated, sleep apnea can put a person at risk for serious health problems, including heart damage and strokes. Some people waiting for replacement machines are still using their recalled devices because they can’t sleep without them.
The FDA says the polyurethane foam inside the recalled machines, designed to reduce sound and vibration, can degrade through exposure to heat and humidity, but also from unapproved cleaning methods such as ozone and UV light cleaning products.
In its recall, Philips said exposure to the foam particulates can cause a slew of health problems — headaches; irritated eyes, skin and respiratory tract; breathing issues and possible toxic and carcinogenic effects.
It has also disclosed that lab testing found that the foam might also emit volatile organic compounds — VOCs — a gas that can cause similar health problems.
According to an FDA report late last year, the company knew about potential problems with the foam as early as November 2015. One of its subsidiaries had done “preventative maintenance” on a different machine, a ventilator device, because of a similar foam issue, but did nothing to investigate whether it affected “any Philips sleep and respiratory care products,” the FDA said.
“Additionally, no further preventive maintenance servicing procedures were implemented,” by the company, the FDA said.
The Dix lawsuit says Philips has not disclosed when it first received reports from users “regarding the presence of black debris/particles” in their machines.
“However, given how long ago the first of the recalled devices came to market, it is unlikely that defendants only recently learned of these issues.”
And yet, the suit says, the company continued to make, market and sell the recalled devices “with such awareness for a significant period of time.”
‘DNA damage and lung cancer’
Dix was prescribed the use of a Philips Respironics DreamStation Auto CPAP device — one of the machines recalled — around March 2016, the lawsuit says.
He used it daily for several years for sleep apnea following manufacturer’s instructions, the suit says.
As a result of using the device, Dix “has suffered personal injuries including harm to his respiratory system, cellular damage, DNA damage, and lung cancer,” the lawsuit says.
He was diagnosed with lung cancer in December 2019 and now faces some permanent disability, the suit says. Using the CPAP “caused or significantly contributed to his development and progression of lung cancer, which has permanently changed his life,” the suit says.
It describes how he’s undergone significant treatment, including a lobectomy — major surgery to remove one of the lobes of the lung — and “now requires constant and continuous medical monitoring and treatment due to the defective nature of the subject device and/or defendants’ wrongful driver.”
The lawsuit requests unspecified compensatory damages and a trial by jury.
Dix’s Kansas City lawyers said they did not want him to comment and did not return requests for further information.
The feds are watching
The FDA has received more than 21,000 medical device reports, known as “MDRs,” from April 2021 through April 30, 2022 concerning foam breakdown inside the recalled Philips Respironics sleep apnea and ventilator devices.
The reports are mandatory from a company when information “reasonably suggests” their device might have caused or contributed to a death or serious injury, and voluntary from health care professionals, consumers and patients.
The reported health problems associated with the recalled devices are wide in scope, including chest pain, asthma, cancer, dizziness and difficulty breathing.
The FDA notes that an MDR report is not evidence that a device has caused or contributed to a problem, and the cause can’t usually be determined through this reporting method alone.
Model names and numbers for the recalled devices can be found on the FDA’s website. Philips said it sent letters to users with instructions for registering devices to have them repaired or replaced. Recall information and updates are on the Philips website. You can also call 877-907-7508.
The company recommends talking to your health care provider to decide what to do next, which could include stopping use of the device, or continuing to use it if your doctor decides the benefits outweigh the risks the company outlined in the recall notification.
Using a similar device that’s not part of the recall, or using an alternative treatment for sleep apnea, could also be options, the company says.
This story was originally published June 6, 2022 5:00 AM.