CPAP Machine Recall Lawsuit Information.
You Think Your CPAP Machine Is Helping You Breathe... But Is It Making You Sick?
CPAP and Bi-PAP machines are heralded as "the gold standard" of treatment for common yet serious conditions such as sleep apnea and emphysema. However, Philips, by far the world's largest maker of such devices, recently issued a recall of millions of CPAP and BiPAP machines over serious health concerns. So, how safe is your CPAP or Bi-PAP device?
Sleep Apnea Is a Serious Condition with Serious Impacts on Health and Wellbeing
Research shows that obstructive sleep apnea, or OSA, is a fairly common disorder that impacts anywhere from 3% to 9% of the population. This means that millions of people in the United States alone are suffering from an affliction that not only hinders proper sleep but also increases risk of hypertension, cardiovascular disease, and neurological disease. Aside from these serious health risks, individuals suffering from OSA also experience measurable negative impacts on their economic outcomes and even have an increased risk of being involved in car accidents!
CPAP Is the "Gold Standard" of Sleep Apnea Treatment
Clearly, obstructive sleep apnea (OSA) is a serious condition impacting practically every factor that influences an individual's wellbeing. Thankfully, treatments are available that mitigate many of the negative effects of obstructive sleep apnea. According to the American Association of Sleep Medicine (AASM), continuous positive airway pressure—popularly known by the acronym CPAP—"should be considered both first-line and gold-standard treatment for OSA," a statement that is supported by much medical evidence.
"When used as prescribed, CPAP reduces daytime sleepiness, normalizes sleep architecture, and improves numerous OSA-specific health outcomes," reported a 2016 study published in the Journal of Otolaryngology - Head and Neck Surgery. "The sense of CPAP being considered gold standard of therapy has become so entrenched within health that many North American renumerating agencies, be they government insurance or private plans, as well as the medicolegal world, have adopted the position that patients must undergo a trial of CPAP prior to being considered for any other more invasive intervention." Thus, not only are CPAP devices considered the "front-line" and "gold standard" of obstructive sleep apnea treatments, in many instances, governments, insurers, and similar stakeholders require a patient to at least attempt CPAP prior to approving other treatments.
Further, in addition to being recognized as the primary treatment method for obstructive sleep apnea, CPAP, BiPAP, and similar devices also are widely used by individuals who have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as emphysema.
But How Safe Is Your CPAP Machine?
The medical literature demonstrates a strikingly uniform view that CPAP machines offer the best available treatment for those experiencing obstructive sleep apnea. Importantly, "'optimal' adherence rates in the literature range from 4 to 6 h per night," meaning that individuals treating their OSA with CPAP will be inhaling air passing through their CPAP device for anywhere from one-sixth to one-fourth of their total day. Further, it is not uncommon for chronic OSA sufferers to use CPAP on a nightly bases for many years. Such patients ultimately spend a significant portion of their lives breathing through these devices.
This duration and regularity of use has become a matter of significant concern in light of recent revelations that insulation foam used in popular CPAP and BiPAP machines emit toxic gases and even degrade to the point that small particles of foam enter the air tubes of these breathing devices. While the full extent of the health risks that these revelations pose to individuals using affected CPAP and BiPAP machines remains unclear at this time, the potential for harm already has led the dominant player in the CPAP and BiPAP markets, Philips Respironics, to recall millions of devices.
Philips Respironics Dominates the Global CPAP / BiPAP Market
In the 2000s, consumer electronics giant Philips made a major push to expand its presence in the lucrative health-care market with the purchase of Pennsylvania-based Respironics Inc for $5.1 billion. At the time, Reuters called the move Philips' "largest deal to date in an aggressive expansion in the fast-growing health-care sector."
At the time of the 2007 deal, Philips already was the world's largest maker of electronic lighting, a top-three global provider of hospital equipment, as well as the biggest consumer electronics brand in Europe, per Reuters.
In terms of market dominance in the CPAP and BiPAP arena, Philips multi-billion-dollar Respironics gambit certainly paid off. According to a 2019 survey conducted by market analysts Needham, prior to the coronavirus pandemic, Philips Respironics accounted for nearly two-thirds of the "flow generator" market, which includes CPAP and BiPAP devices. According to Needham, Philips Respironics controlled 62.8% of the market, with its next largest competitor ResMed coming in at 32.2%.
The Philips Respironics Recall
Having only two companies account for such an enormous proportion of the market (95%) for these essential and increasingly used medical devices creates the risk that problems encountered with a device or devices made my one of these dominant market players would have far-reaching implications for patient health. Unfortunately, that concern recently became a reality with Philips announcing the recall of millions of CPAP and BiPAP machines due to problems with insulation foam used in a wide range of the company's flow generator models.
On June 14, 2021, Phillips announced a global recall "for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component of these devices."
The problem with the foam, according to Philips, is two-fold: First, the PE-PUR foam can emit toxic gases that enter the air tube, where they are inhaled by the patient. Second, the foam can deteriorate to the point where small particles of the foam also enter the air tube, where they similarly are inhaled into the patient's lungs. While there is little scientific research specifically investigating the health risks posed by inhaling actual particles of the foam (largely due to it being such an uncommon risk under most circumstances), there is a much greater body of evidence indicating the serious health risks posed by the gases produced by the PE-PUR foam.
With patients breathing only air that has passed through their CPAP or other flow generator device for anywhere from four to six hours every day, any exposure to harmful gases or solids produced by those devices is likely to be significant as well as recurring.
What Is PE-PUR Foam?
One of the great tragedies in PE-PUR foam posing a health risk to users of certain Philips CPAP and Bi-PAP devices is that the foam itself is not essential to their functioning. Although known to emit toxic gases, PE-PUR foam is still used across a number of industries for its sound-dampening qualities. For example, it is used by auto manufacturers to reduce road noise in vehicles. PE-PUR foam also is used as an insulation material when attempting to "soundproof" a room.
In these uses, humans are extremely unlikely to inhale the toxic fumes put off by PE-PUR foam in an amount large enough to pose health concerns. However, despite the known risks, Philips chose to use PE-PUR foam in many of its CPAP and BiPAP devices as a noise-reducing material. How a giant, well-funded company like Philips could overlook the potential health risks of putting foam known to emit toxic gases into respiratory devices is one of the great still-unanswered questions surrounding the whole tragic situation.
Toxic Gases Produced by PE-PUR Foam
Two different toxic gases have been identified as emanating from the PE-PUR foam used in many of Philips' CPAP and BiPAP devices. Both of these gases are classified as Volatile Organic Compounds (VOCs) and are known to be harmful to human health.
"Lab testing performed for and by Philips has also identified the presence of VOCs which may be emitted from the sound abatement foam component of affected device(s)," Philips wrote in a June 14 notice titled Clinical Information for Physicians. "VOCs are emitted as gases from the foam included in the CPAP, BiLevel PAP and MV devices and may have short- and long-term adverse health effects."
According to Philips, the "potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects."
Specifically, PE-PUR foam has been found to "outgas" two VOCs known to be hazardous to human health: dimethyl diazine and phenol. According to Philips, "VOCs may cause irritation and airway inflammation" which "may be particularly important for patients with underlying lung diseases or reduced cardiopulmonary reserve."
In addition to the shorter-term side effects of inhaling dimethyl diazine, the VOC also is known to cause damage to the kidneys and liver, which are responsible for filtering dimethyl diazine from the body. The medical literature indicates that dimethyl diazine exposure is associated with a number of maladies involving these vital organs, including total organ failure and cancers of the liver and/or kidneys.
Phenol, the other VOC identified as "out-gassing" from Philips' PE-PUR foam, also is known to be highly dangerous to human health. According to the United States Environmental Protection Agency (EPA), "Phenol is considered to be quite toxic to humans."
"Anorexia, progressive weight loss, diarrhea, vertigo, salivation, a dark coloration of the urine, and blood and liver effects have been reported in chronically (long-term) exposed humans," the EPA further states. "Animal studies have reported reduced fetal body weights, growth retardation, and abnormal development in the offspring of animals exposed to phenol by the oral route."
Even short-term exposure to phenol can be problematic for human health, whether inhaled or brought into contact with the skin: "Phenol is highly irritating to the skin, eyes, and mucous membranes in humans after acute (short-term) inhalation or dermal pressures," according to the EPA.
The EPA's conclusions are supported by a great deal of medical research, which shows a wide range of serious health impacts associated with either dermal (on-the-skin) exposure or inhalation of phenol.
"In one study, muscle pain, weakness, enlarged liver and elevated levels of liver enzymes were found in an individual after inhalation and dermal exposure to phenol and a few other chemicals," reports the EPA. Further, "Cardiac arrhythmias have also been reported in humans exposed to high concentrations of phenol."
The Dangers of Inhaling Foam Particles
Compared to the serious health risks associated with inhalation of the VOCs outgassed by Philips' PE-PUR foam, the effects of inhaling actual particles of the foam are much less well known. However, this does not mean that inhaling the foam particles is any less dangerous.
Judging from how the lungs are affected by the inhalation of other forms of particles, they are likely to respond to the polyester-based polyurethane foam particles by attempting to encapsulate them. While encapsulation is a natural defense against foreign objects in the lungs, it increases the risk of cancer at the site of the encapsulation. Encapsulation involves encircling the particle with a thin layer of tissue in order to shield it off from the rest of the body. This is the same process that takes place following the inhalation of asbestos fibers, which can lead to mesothelioma, a particularly deadly form of lung cancer.
National Cancer Institute (NCI). Encapsulated. NCI Dictionaries
If the lungs fail to encapsulate the PE-PUR foam particles inhaled via a Philips device, the particles simply will remain in the lungs, where they will continue to degrade over time, leaching whatever toxic substances they may contain into the bloodstream, through which they will travel to every cell and vital organ in the entire body.
So What Can You Do?
If you or someone you know has been using a recalled Philips CPAP or BiPAP machine, it is important to consult a physician immediately for advice on finding an alternative treatment. Only your doctor can help you decide if it is appropriate to discontinue treatment immediately or whether treatment should be continued until a suitable alternative has been identified and obtained.
Many experts believe that it is only a matter of time before lawsuits begin to be filed against Philips over the PE-PUR foam in many of its CPAP and Bi-PAP machines. With millions of devices having been recalled, the number of lawsuits easily could run into the many thousands.
Make sure you stay tuned to TheLawFirm.com for the latest legal updates on the Philips CPAP recalls!
Chee, Foo Yun and Niclas Mika. (20 December 2007). Philips in $5 billion Respironics deal. Reuters
Taylor, Nick Paul. (28 January 2020). Philips and ResMed may lose shar in growing market for sleep tech: survey." MedTechDive
Philips. (14 June 2021). Sleep and Respiratory Care update: Clinical information for physicians
United States Environmental Protection Agency (EPA). (Accessed 25 June 2021). Phenol
National Cancer Institute (NCI). Encapsulated. NCI Dictionaries
Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.