Sleep apnea is a condition that has affected many people in the country. It is estimated that one in fifteen adults suffers from sleep apnea, which equals eighteen million people. Since it is a prevalent problem, the healthcare industry and researchers continue to work round the clock to find solutions. There are currently several treatment options for sleep apnea, including the use of BiPAP and CPAP machines.
However, many of these machines have been discovered to be ineffective and have since been recalled from the market. People who have used the devices have also complained of sustaining injuries and are moving to seek compensation. If you’re one of the people adversely affected or injured after BiPAP or CPAP use, you could also be eligible for compensation.
At Consumer Alert Now, our top priority is warning the public about defective products that have found their way into the market. We’ll inform you why CPAP and BiPAP machines were recalled and the dangers you may be exposed to should you continue using the recalled devices. Apart from alerting you, we’ll also help you find a lawyer if you’ve been injured by any defective products, to help you obtain just compensation from the product manufacturer or any other liable party. Thus, if you have sustained an injury after CPAP or BiPAP use, reach out to us right away to start your journey to damage recovery.
What are BiPAP and CPAP Machines?
BiPAP and CPAP are ventilators most patients use in treating different types of breathing issues. Patients suffering from obstructive sleep apnea use CPAP machines to improve their condition. Sleep apnea is a disorder whereby an individual’s breathing is disrupted while sleeping, making them snore loudly. Breathing could become shallow or cease entirely temporarily. People with sleep apnea are usually fatigued during the day. In severe cases, sleep apnea could cause a stroke, heart attack, and high blood pressure.
CPAP is the short form for continuous positive airway pressure. The machine has an adjustable pressure setting. On the other hand, BiPAP stands for Bilevel positive airway pressure. The ventilator has two pressure settings (IPAP and EPAP).
Effective CPAP and BiPAP therapy treat sleep apnea by delivering a steady flow of oxygen through a mask into a sleep apnea patient’s nose and mouth as they sleep. BiPAP and CPAP devices elevate air pressure in a patient’s throat, which, in turn, keeps the airway open when the individual is inhaling. A BiPAP machine increases air pressure during inhalation but decreases it during exhalation. Apart from sleep apnea, CPAP and BiPAP are also used to treat conditions like pneumonia, COPD (chronic obstructive pulmonary disorder), and more.
People suffering from sleep apnea can also opt for a surgical procedure for treatment. Lifestyle changes like abstinence from alcohol consumption, stopping smoking, and losing weight may also ease symptoms.
CPAP, mechanical ventilator, and BiPAP machines are manufactured and sold by the Dutch medical equipment manufacturer, Philips. The full name of this company is Koninklijke Philips N.V, translating to Royal Philips. This company has 65 percent of shares in the CPAP and BiPAP market. The company acquired Respironics in 2008, which makes the DreamStation products. And in 2020, it made approximately twenty billion in revenue, and 49 percent of what it sold was from respiratory care machines.
Recalling of BiPAP and CPAP Devices
As we mentioned, most patients with breathing problems use Philips BiPAP and Philips CPAP ventilators to treat their illnesses. However, on 30th June 2021, the United States Food and Drug Administration (FDA) alerted the public that Philips Respironics CPAP and BiPAP ventilators had been recalled because of possible health risks. Ever since the recall, most people are claiming to have suffered injuries from these devices and are bringing multiple suits that may lead to multi-district litigation.
On 14th June, Philips voluntarily retracted four million mechanical ventilators, BiPAP, and CPAP devices. Ventilators help patients who face difficulty breathing on their own, usually in a clinical setting. A ventilator could be utilized during surgeries and helps critically ill patients or those in a coma. The recalled devices include:
- Non-continuous Ventilator— REMstar SE Auto, Dorma 500, Dorma 400, DreamStation Go, DreamStation, and SystemOne (Q-series)
- Continuous Ventilator, Non-Life Supporting— OmniLab advanced, C-Series S/T and AVAPS, C-Series ASV, SystemOne ASV4, DreamStation ST AVAPS, and DreamStation ASV,
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use— Respironics E30
- Mechanical ventilator, continuous, non-Life Supporting: A-Series BiPAP A30, A-Series BiPAP A40
- Mechanical ventilator, continuous minimum ventilatory support, facility use— A-Series BiPAP V30 AutoVentilator, A-Series BiPAP Hybrid A30 (not marketed in the United States)
- Continuous ventilator, non-life supporting— Aeris, Garbin Plus, LifeVent, Trilogy 200, Trilogy 100
All the recalled devices were made before 26th April 2021. This recall applies to all serial numbers for the above-listed device models.
The FDA categorizes this as a Class 1 recall, that is, the most serious. The United States Department of Veterans Affairs had supplied about 300,000 (three hundred thousand) of the recalled machines to veterans.
Keep in mind that these Philips devices are still deemed safe and haven’t been recalled:
- Airway clearance devices
- Respiratory drug delivery devices
- Oxygen concentrators
- REMStar SE
- Dorma 200
- Dorma 100
- DreamStation 2
- BiPAP A40 Pro
- BiPAP A40 EFL
- Trilogy 202
- Trilogy EV300
- Trilogy Evo OBM
- Trilogy Evo
Why They Were Recalled
The manufacturers for CPAP, BiPAP, and mechanical ventilators use a unique material known as polyester-based polyurethane (PE-PUR) to manufacture these machines— specifically used to make sound abatement foam liners. The significant reason the machines were recalled is because of this special material. The material can disintegrate into smaller particles that the patient may inhale/ingest, resulting in serious harm. The machines don’t have filters that can prevent ingestion or inhalation. PE-PUR also emits carcinogenic and toxic chemicals when in use, which the patient eventually breathes directly. These chemicals include:
- Phenol, 2,6-bis, also known as carbonic acid— the gas is used in making other chemicals.
- Dimethyl diazene, also called Azomethane— is a gas used in manufacturing other chemicals.
- Diethylene glycol— this is a chemical solvent that’s toxic if ingested. It could also irritate the eyes, mucous membrane, and skin.
- Toluene diamine— it’s a component of color dyes, polyurethane, explosive sensitizers, and hydraulic fluid. This chemical may cause skin problems, cancer, organ injuries, infertility, and congenital disabilities.
- Toluene diisocyanate— this is an ingredient of coatings and foams. Inhalation could lead to eye injuries, cancer, respiratory irritation, skin problems, and even death.
Additionally, high humidity or heat could lead to further degradation of the PE-PUR foam. Some patients have reported noticing black particles in their breathing tubes, which is visual proof of degradation of PE-PUR foam.
Unapproved cleaning procedures like ultraviolet or ozone light can worsen the foam degradation situation (Philips doesn’t consider SoClean an approved cleaning process). High temperatures and high humidity in the places where the machines are stored may also worsen foam degradation.
In essence, Philips machines meant to alleviate people’s sleep apnea symptoms are otherwise contaminating their airways. The recalled Philips machines are faulty products, which are unreasonably hazardous and pose a high cancer risk.
Symptoms and Side Effects of Using Defective BiPAP and CPAP Machines
Users of Philips products have reported symptoms and side effects like:
- Sore throat
- Sinus infections
- Chest pressure
- Chronic headaches and dizziness
- Adverse effects to the kidneys or liver
- Irritation of the skin around the mouth and nose, upper airway, eyes, and respiratory tract
Injuries the Recalled BiPAP and CPAPs Machines Can Cause
Multiple Philips Respironics devices users have reported that tiny black fragments of foam infiltrated one or several components of the devices, including the tubing and face masks. Exposure to PE-PUR particulates could cause the following injuries:
- Cancer of the kidney, liver, and lungs
- Liver damage
- Kidney damage
- Respiratory problems like asthma
- Lung injury
- Upper respiratory infections
- Lung inflammation,
- Irritation of the upper airway, nose, and eyes
- Pulmonary fibrosis
If you’re a Philips Respironics user, you should talk to your doctor as soon as possible should you experience any of the above injuries, symptoms, or other related adverse effects.
Are There Lawsuits?
After a defective product recall, many people usually bring lawsuits because of claims of suffering injuries. Since CPAP and BiPAP were recalled, many people are bringing suits against numerous manufacturers for different injuries. The involved manufacturers include:
- Philips RS North America LLC
- Philips North America LLC
- Koninklijke Philips N.V.
On 29th June 2021, a class-action suit was brought in federal court in Massachusetts (Shelton v. Koninklijke Philips N.V). The plaintiffs allege that the BiPAP and CPAP manufacturers had prior knowledge concerning the faultiness of their machines but did not warn the consumers on time. They claim that patients were using the recalled devices daily, but without the class-action suit, the manufacturers didn’t have plans to replace the affected machines any time soon.
It is worth noting that a second class-action suit was brought against Philips manufacturers by a commercial truck driver based in Oregon. The driver seeks compensation since they were compelled to interrupt their treatment for sleep apnea. They aim to represent everybody facing this problem but particularly people residing in Oregon. The complainant was diagnosed with sleep apnea in 2020, and their doctor prescribed them a BiPAP machine from Philips to treat their disorder. Since they don’t have any replacement for their faulty device and Philips hasn’t provided one, the complainant was forced to stop working because they can’t be a commercial driver with untreated sleep apnea disorder.
As of now, litigation is still in the initial stages, and there’s a possibility that thousands or even more complainants throughout the country will file more cases. It’s anticipated that federal multidistrict litigation (MDL) for BiPAP and CPAP lawsuits will be formed. An MDL speeds up the court process by consolidating all personal injury lawsuits filed against one defendant during pre-trial proceedings. Unlike it is with class action suits, MDL complainants’ cases stay separate.
Once multidistrict litigation is formed, the class action lawsuit’s purpose will likely be limited to reimbursing for medical checkups or monitoring and compensating uninjured complainants who paid out-of-pocket for their recalled BiPAP or CPAP machines. Most patients are given their machines free of charge through private insurance, the VA, Medicaid,
Apart from the failure to caution consumers, there are other several claims against CPAP and BiPAP manufacturers, including claims for:
- Deceptive trade practices/consumer fraud
- Negligence per se
- manufacturing defect
- Defective design (negligence and strict product liability)
- Breach of express and implied warranties
- Negligent misrepresentation
- Fraudulent misrepresentation
- Fraudulent concealment
- Gross negligence
Possible Compensation to the Victims
Victims of recalled sleep apnea devices are seeking to recover the following damages:
- Lost wages for missing work due to being too sick
- Medical bills, including costs for doctor’s appointments, hospital stays, new breathing machines for replacing the recalled ones, and medications
- Pain and suffering
- Loss of future earning capacity if the recalled machines caused the plaintiff to be overly ill in that they can’t work in the future
In other cases, the judge might also award complainants punitive damages if they find that Philips manufacturers acted shockingly or maliciously. Courts may grant punitive damages where the complainants can prove that Philips was aware of the PE-PUR degradation risks and hazards but didn’t do anything about it.
Proof that Philips May Have Had Prior Knowledge of the Faultiness of their CPAP and BiPAP Machines
Among the primary aspects of holding Philips responsible in any suit brought for harm that their faulty devices caused is establishing whether they had constructive or actual knowledge about the faultiness of their machines. If the complainants show that the company knew or should’ve been aware of the PE-PUR foam problem in their devices and the health hazards linked to exposure, Philips can be responsible for negligently failing to warn.
There’s some relevant proof supporting the claim that Philips company had known for a lengthy period that their ventilators and machines had a problem before recalling them. These include:
The company disclosed problems with the retracted machines to investors prior to the recall. Many weeks before Philips issued the recall press release; they notified corporate investors of the issues the DreamStation and CPAP devices had. On 21st April 2021, the company released the quarterly report to its investors. But, under the section titled ‘Regulatory Update,’ Philips wrote to investors all the things they knew concerning the issues their machines had, including the risk of exposure to degraded PE-PUR foam. Also, the report assured the investors that the company had already launched new generation DreamStation devices that wouldn’t have defects.
The Company manufactured and launched the DreamStation 2 just before they issued a recall. Perhaps the most compelling evidence to show Philips had known of the problems or PE-PUR foam for a lengthy period is that they launched a new, safer alternative to their DreamStation in April 2021. This device doesn’t have any safety problems involving PE-PUR foam that’s prone to disintegration.
Many weeks after releasing DreamStation 2, the company informed consumers that the older devices were faulty. Finally, on 14th July 2021, they issued the recall. Without any doubt, the company didn't design or make the new generation of DreamStation devices overnight since manufacturing any new product takes many months and even years. This shows that Philips had been aware of the defectiveness of their previous machines long before they recalled them.
The company received several complaints from CPAP and BiPAP Users Who’d Been inhaling black particles. The complainants in the class action suits allege that they were defrauded because they spent a lot of money on BiPAP and CPAP machines that are, in the real sense, worthless. Additionally, they claim that the manufacturer had been receiving complaints from CPAP and BiPAP consumers for several years, claiming they were inhaling dust or foam particles from the machine.
As a result, there’s abundant pertinent proof that Philips opted to hide the fact that their current generation of sleep apnea at the time was faulty. Inhaling PE-PUR foam particles and the chemicals or gases it emits could result in severe health issues, including multiple forms of cancer.
What to DO If Your Philips BiPAP CPAP Machine Was Recalled
Doctors and other medical providers have been informed of the requirement to explore other options for sleep apnea patients using ventilators. In many cases, an alternative treatment option might not be worthwhile. If that’s the case, patients who need life-supporting or continuous ventilation ought to be treated with inline infection to minimize the risks of chemical or particulate exposure.
BiPAP and CPAP users are at a lower risk of harm should they discontinue using a faulty Philips machine right away. However, you must still take these steps soon enough:
Talk to Your Physician
COPD, sleep apnea, and other illnesses are severe. Even though Philips recommends stopping using the defective machines right away, it’s critical to inquire from your doctor about alternative respiratory treatment options. Your physician may establish that the advantages of continued use of the device surpass the risks. You want to make an informed decision with an expert health care provider. The alternative treatment options your physician may suggest if CPAP or BiPAP machine is hazardous include:
- Surgery— some minors have sleep apnea since their adenoids or tonsils are too large. A surgical procedure to extract them can usually solve the problem. In grownups, surgery is not always as effective since it may be challenging to identify the location of the blockage that causes the disorder. Still, some surgical procedures have worked for some patients, including MRTA (modified radiofrequency tissue ablation).
- Exercise and nutritional therapies— obesity is a risk factor for particular forms of sleep apnea. Exercising more frequently and changing your diet could help you shed weight and lower the seriousness of your symptoms.
- Neural stimulation— if you suffer from given forms of central sleep apnea, you could be implanted with a device that can convey impulses through your phrenic nerve, stimulating your diaphragm. This, in turn, helps initiate breathing when you are sleeping.
- Hypoglossal nerve stimulation— a surgically implanted appliance can deliver the exact electric stimuli to the nerves in your airway. This helps improve your airways’ muscle tone, helping the airways to stay open.
- Oral devices— appliances such as an orthodontic retainer or mouth guard can help to keep your airways open by exerting pressure on your tongue.
- Changing your sleeping position— we have individuals who only suffer from sleep apnea whenever they sleep on their back. Some products can help keep you on your side by preventing you from rolling over. The doctor may also suggest that you try tying a tennis ball to the back of your sleepwear.
Keep Your Machine
If you choose to stop using your BiPAP or CPAP ventilator from Philips, don’t dispose of it or return it to the manufacturers to be refunded. Philips advises that the customers register the machine online at www.philips.com/src-updates to receive more notifications regarding the status of the recall and the next steps.
For your lawsuit to be successful, hired experts and your lawyer must inspect the device for proof that it is faulty. Thus, you must have the BiPAP or CPAP machine with you and avail it when your attorney requests to see it.
Reach Out to a Lawyer
Claims that involve faulty medical devices are usually complex. Even though Philips Respironics machines have been recalled, this doesn’t mean you automatically have the right to compensation. It’s critical to talk to a skilled attorney right away to help you protect your legal rights and start building your lawsuit. As we've seen, exposure to chemicals and particulates from defective Philips BiPAP, CPAP, and other ventilator machines can result in permanent impairment, serious injury, or even death. You don’t want to lose the chance to seek damages for these traumatic losses.
Talk to a Philips CPAP & Philips BiPAP Lawsuit Attorney Near Me
If you’ve sustained an injury after using a CPAP or BiPAP sleep apnea machine, you want to talk to a skilled attorney to determine if you qualify for a lawsuit or joining a class-action suit. At Consumer Alert Now, our priority is alerting consumers of any dangerous product in the market and helping them seek compensation if the product has harmed them in any way. We’ll link you with a skilled lawyer who will protect your rights and walk you through the process of obtaining fair compensation. Contact us at 800-511-0747 if you need legal representation or want to know more about the recalled Philips CPAP and BiPAP devices, and we’ll help you irrespective of where in the United States you are contacting us from.