If you’re a patient who depends on a CPAP (Continuous Positive Airway Pressure) breathing machine as part of your nightly routine, there’s a good chance you’ve seen a targeted ad or heard a news report about some of the recent CPAP medical lawsuit settlements. While it’s easy to overlook one or two medical device settlements, the number of settlements has been on the rise over the past couple of years. In this post from personal injury attorney Tim Gilpin, we’re taking a deep dive into the recent surge in CPAP settlements to help you decide if you might be owed damages.

CPAP Breathing Machines

For patients who rely on CPAP (Continuous Positive Airway Pressure) machines to treat their sleep apnea or another condition, these medical devices are a trusted lifeline. CPAP machines work by generating a gentle flow of pressurized air into patients’ lungs through the hose and mask system. This helps to provide airway support while preventing airways from narrowing or even collapsing while patients sleep, which in turn prevents sleep apnea. 

By delivering a consistent flow of air pressure to patients while they sleep, CPAP machines do much more than just protect patients against potentially life-threatening conditions. They also help patients experience a more peaceful night’s sleep, which can lead to an overall increase in health and general well-being. 

The benefits to patient health are significant, including:

• Lower blood pressure
• Diabetes glucose level improvement
• Reductions in snoring
• Improved cognitive function
• Headache improvement
• Reduced chance of stroke 
• Reduced chance of heart failure

Around 33 million Americans rely on CPAP machines to maintain their health including a U.S. president — which is why it’s vital that the manufacturers behind these products be held accountable for producing medical devices they can trust. 

Philips Respironics CPAP Lawsuit

Every medical device manufacturer has a responsibility to protect the patients who trust in their products. But when CPAP manufacturer Philips Respironics started getting reports of problems with their CPAP machines in 2010, shortly after redesigning their CPAP machine, the company failed to react, according to a bombshell investigative report produced in 2023 as part of a joint investigation between the Pittsburgh Post-Gazette,ProPublica, and Amsterdam-based Mediahuis NRC.

CPAP-related Health Concerns

The problem with Philips CPAP machines stemmed from a type of foam used as a sound-dampening material. As anyone who has shared a bedroom with a CPAP user can likely attest, CPAP machines can be loud. To help stifle the noise in their bi-level positive airway pressure (BPAP) and continuous positive airway pressure (CPAP) machines, Philips used an industrial foam called polyester-based polyurethane (PE-PUR) foam— a foam not originally intended for medical use — that was supplied by a polyurethane foam manufacturer as an abatement material. 

 

As complaints of this black foam starting to break down began to roll in, mounting from dozens to thousands, Philips continued manufacturing the product. According to the joint investigation, these complaints involved “dirt and dust,” “black particles,” “black shavings in the chamber,” “contamination,” and even an “oily-like” chemical described in another complaint as an “unknown sticky substance.” 

The FDA would eventually find that exposure to PE-PUR, including inhalation or swallowing, could cause a number of health risks such as:

• Inflammatory response
• Hypersensitive immune or allergic reaction
• Asthma
• Skin irritation
• Eye irritation
• Nose and airway irritation
• Headache
• Dizziness
• Nausea or vomiting
• Toxic effects
• Cancer

Philips Sold a Faulty CPAP Machine

Far from alerting the public to the risk, for more than a decade, Philips chose to address their complaints on a case-by-case basis. According to the Pittsburgh Post-Gazette, the company managed to keep a lid on 3700 complaints for 11 years. Long after these complaints continued to mount, drawing scrutiny from the U.S. Food and Drug Administration (FDA), Philips Respironics was pressured to take action, leading to additional testing and the company eventually pulling these products altogether. 

In the two months leading up to the product recall and even after putting a halt on shipping, CEO Roy Jakobs of the Philips Respironics parent company Royal Philips told distributors to keep pushing these products while the company continued to assess the risks. 

The company would eventually come to acknowledge that over time, the foam inside their ventilators could begin to degrade and emit harmful chemicals like volatile organic compounds (VOCs), particularly with exposure to heat and humidity or the use of certain cleaning products — causing the crumbled foam particles to end up in patients’ mouths, noses, throats, and even lungs. According to court records, this foam breakdown was found to pose “unacceptable” and potentially “life-threatening” risks including concerns over “permanent impairment.” 

Recalling Philips CPAP Products

In June 2021, the FDA issued a statement announcing the sweeping recall of millions of breathing devices including the following PE-PUR-containing Philips devices manufactured between 2009 and April 26, 2021:

• E30
• Dreamstation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C-Series ASV 
• C-Series S/T and AVAPS 
• OmniLab Advanced+
• SystemOne (Q-Series) 
• DreamStation 
• DreamStation Go 
• Dorma 400 
• Dorma 500 
• REMstar SE Auto
• Trilogy 100 
• Trilogy 200 
• Garbin Plus
• Aeris
• LifeVent
• A-Series BiPAP Hybrid A30 (not marketed in US) 
• A-Series BiPAP V30 Auto
• A-Series BiPAP A40 
• A-Series BiPAP A3

The same year as the Philips Respironics recall, a class-action lawsuit was initiated to help patients recover economic losses associated with replacing their recalled CPAP machines and other medical or related expenses. Philips settled the lawsuit in 2023 for $479 million to be distributed among Philips users affected by the recall. 

Continued FDA Concerns

After conducting extensive testing, Philips Respironics would later claim that their independent research found no long-term health risks associated with the recalled CPAP machines. However, the FDA urged continued research and monitoring, noting, “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices.” 

What CPAP Users Need to Know

If you’re a CPAP user with a recalled device, the FDA recommends the following:

1. Talk to your healthcare provider before stopping or changing ventilators. 
2. Ask your provider about inline bacterial filters that may be used to help filter out PE-PUR foam particles (although this has not yet been proven). 
3. Register your ventilator on the Philips voluntary recall website. 
4. Call 1-877-907-7508 to learn about replacements or get updates on the recall. 
5. If you experience health issues believed to be associated with a recalled CPAP device, speak with your provider and file a report through the MedWatch voluntary report site.

Contact a Personal Injury Attorney

Sadly, the Philips CPAP settlement is just the latest in a long line of examples of unscrupulous companies putting profits and the corporate bottom line over patient health. While it took more than a decade and the power of the U.S. federal government to force the Dutch company to prioritize patient health, not every patient sees that kind of justice. 

If you’ve been injured due to a bad medical device or another form of medical malpractice, personal injury attorneys like Tim Gilpin who are passionate about patient rights can help level the playing field. Contact Tim today to get the professional legal assistance you need.