CPAP Litigation Updates:
Philips Respironics offered a partial settlement for their faulty breathing machines worth $479 million in September. The agreement covers only monetary reimbursements to users of the devices and vendors who might have financed replacements for consumers. This, however, does not address other significant claims in the plaintiffs’ cases involving personal injury or the cost of medical care related to use of the breathing machines.
The FDA is showing more concerns over significant health hazards linked to more than 70,000 Philips Trilogy Evo Ventilators. These ventilators have been recalled due the device potentially introducing debris into the airways, creating life-threatening risks for patients. Recently, the FDA escalated this recall to Class I status following the occurrence of at least one fatality and two critical injuries associated with the product.
Since April of 2021, Philips has been consistently issuing recalls on a variety of respiratory related devices. With close to 5.5 million recalled CPAPs and other devices, this is shaping out to be one of the largest recalls in U.S. history.
The Food and Drug Administration (FDA) released an update stating more than 105,000 defective CPAP machine reports from consumers, as well as 385 reported deaths related to the Philips’ CPAP products. The main source of the defects stem from exposure to toxic sound abatement foam inside the sleep apnea machines.
After recalling millions of CPAP devices last year, Philips was forced to issue another recall. This one is for their magnetic facemasks used with its CPAP machines (both new and old). They received complaints from consumers stating that the magnets in the masks were causing nearby medical devices like pacemakers to stop functioning. The FDA designated this to be a Class I recall, meaning it poses the risk of severe injury or death to consumers.
What is Sleep Apnea?
As most of us learned in health class (or just from life experience), sleep is an important part of developing a healthy lifestyle. According to Sleep Foundation, “Sleep is an essential function that allows your body and mind to recharge.” Healthy sleep is important for the body to remain healthy and fight off illness. It is a necessity that we sometimes treat as a luxury. When busy schedules make getting a good night’s sleep difficult, some of us unfortunately must deal with illnesses that make sleep labored and more complicated to obtain. One example is of those who suffer from sleep apnea.
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. It’s a potentially serious disorder with symptoms involving snoring loudly and feeling tired even after a full night’s sleep.
The main types of sleep apnea are:
- Obstructive sleep apnea, a common form that occurs when throat muscles relax
- Central sleep apnea, which occurs when your brain doesn’t send proper signals to the muscles that control breathing
- Complex sleep apnea syndrome, which occurs when someone has both obstructive sleep apnea and central sleep apnea
It’s estimated that 25 million Americans have sleep apnea and according to SoClean CEO Bob Wilkins, more than 8 million people in the U.S. use Continuous Positive Airway Pressure (CPAP) machines. This number is steadily increasing by 8-9% each year as more people get diagnosed with obstructive sleep apnea. Unfortunately, this is not a condition that should go untreated. Obstructive sleep anea can not only cause extreme fatigue, high blood pressure and heart problems, but it can worsen or lead to other life-threatening illnesses.
After speaking with a healthcare professional, we typically assume the treatment that is being prescribed is going to add positive benefits to our overall health (like getting a CPAP machine). In some cases, however, this ideal is tested. A great example to this is the recent recall issued by Philips Respironics.
PHILIPS RECALL FACTS YOU NEED TO KNOW
- Philips issued a recall for CPAP and Bilevel PAP devices due to a defect in the sound abatement foam in the devices.
- Interior foam degraded into particles may have been ingested or inhaled by the user.
- Off-gassing of chemicals from the foam could have been inhaled as well.
- Fleming | Nolen | Jez is a law firm that focuses on standing up against companies that create products that harm the public.
These Risks Include:
- Airway irritation or inflammation
- Breathing difficulty
- Lung Damage
- New or worsening asthma
- Lung cancer
- Kidney cancer
- Liver cancer
- Colon cancer
- Heart attack/heart failure
- Respiratory failure
- Liver disease
- Kidney disease
The CPAP Recall
Philips Respironics issued a recall for Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices after potential health risks were identified. Most of these risks are associated with the sound abatement foam within the devices. This foam is a polyester-based polyurethane (PE-PUR) designed to reduce machine noise, making them quieter when in use. According to a notice send from Philip Respironics, this foam has been shown to degrade into tiny particles that may be ingested or inhaled by the user. These particles may also cause off-gassing from certain chemicals which could lead to a range of illnesses, including chemical poisoning, asthma, pulmonary fibrosis, and liver damage.
Do you have a Philips CPAP Device?
If you are curious about whether your device may be affected by the recall, a sign you can look for is the presence of black debris or particles within the airpath circuit. This can be in the humidifier, tubing or mask of the device. Philips estimates that 3 to 4 million devices may be affected, with the majority being first-generation DreamStation products sold before April 2021. How do you know if your device was affected? Well, you may have received a notice in the mail. If you think you have been affected, you may be eligible to file a claim against the manufacturer. Here is a list of all the devices that were manufactured before April 26, 2021:
CPAP and BiLevel PAP
- Continuous Ventilator, Non-life Supporting
- DreamStation ASV
- DreamStation SV, ST, AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- Non-continuous Ventilator
- SystemOne Q series
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation Go CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- E30 (Under Emergency Use Authorization)
- Continuous Ventilator
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP V30 Auto Ventilator
Have You Been Affected?
If you believe you were affected, it’s important to not panic. If you do not have a replacement device, do not stop using the device without first consulting your doctor or a healthcare professional. Second, it’s important to figure out what your legal options are. If you’ve already paid a large amount of medical bills, or have been suffering in silence, you may be able to receive financial help. Our firm is well experienced in the personal injury field and will typically ask questions to get a better idea of your case. Knowing how long you’ve used the device, the model of your device and any injuries experienced are all useful information to share if you choose to reach out to our firm for help. Even if you were not injured by a CPAP machine but were advised by a health care professional to stop using it, you may be eligible to file a claim due to the impact it has and will continue to have while you wait for the device to be fixed.
If you or a loved one used a Philips brand CPAP or Bilevel PAP machine manufactured before April 26, 2021, and suffered side effects or injuries, you may be eligible to file a claim against the manufacturer. For a free claim review, simply fill out our online form.