Philips Lawsuit for CPAP, BiPAP and Ventilator Devices

Recall Identifies Health Risks Posed by Philips CPAP, BiPAP, and Ventilator Devices

On June 14, 2021, Philips Respironics issued a voluntary recall of certain PHILIPS CPAP, BiPAP and Ventilators citing potential cancer risk and other health conditions associated with the use of the devices. In their announcement, the company explains that the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in the affected devices, may break down and enter the device’s airpath circuit, including the device outlet, humidifier, tubing and mask.  If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. Currently, the recall primarily affects Philips DreamStation line of sleep and respiratory care devices manufactured between 2009 and April 26, 2021.

On June 30, 2021, the U.S. Food and Drug Administration (FDA) issued a safety bulletin alerting consumers of the recall of these devices and noted that   degradation may be accelerated in climates of high heat and humidity and/or as the result of using ozone-based device cleaners. Other factors like how long an individual has been using the machine and how many hours per day it is used, may also impact the rate and extent of component degradation.  

On July 22, 2021, the FDA gave the recall a Class I designation, the most serious type of recall designation.  A Class I recall is issued when there is a reasonable probability that the recalled device “will cause serious adverse health consequences or death.”

See Recall Notice Here: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. 

The health risks posed by the breakdown of these PE-PUR chemicals can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention.

The potential risks of PE-PUR particulate exposure include:

• cancer
• toxic exposure
• organ damage (e.g. kidneys and liver)
• asthma
• chronic headache
• inflammatory response
• chronic upper airway irritation, cough, chest pressure and recurring sinus infections 

If you or a loved one has been prescribed a Philips sleep apnea device and is still using it, you must remain vigilant in observing any new side effects and new symptoms.  Inspect the device for any evidence of degradation, specifically black debris.  If you observe any black debris in the device, take pictures of it and hold onto them.  Since sleep apnea can present life threatening deprivations of oxygen while you are sleeping, you should not stop using the product until you have consulted with a physician.

Your doctor may advise you to stop using the product or recommend an alternative ventilator option for your condition. You should, however, preserve the device, record all serial numbers through pictures, and store the device safely in your home, even if you are advised not to continue using it by your medical care provider.  If you wish to pursue a claim against the manufacturers, hold off on filling out any forms/registering your device online or at the Philips.com website, until you have consulted an attorney. 

Sleep Apnea Is a Common Condition 

Obstructive sleep apnea is the most common sleep related breathing disorder.  It causes you to repeatedly stop and start breathing while sleeping. Obstructive sleep apnea occurs when the muscles in the back of your throat relax too much to allow normal breathing.  When the muscles relax, your airway narrows or closes, obstructing breathing for seconds or longer.  This can lower the level of oxygen in your blood and deprive your brain of oxygen.  Your brain senses that it is not getting enough oxygen and will briefly rouse you from sleep so that you can reopen your airway.

These periods of interrupted sleep can occur five to 30 times or more each hour, all night long.  Most patients with sleep apnea report fatigue during the day, memory problems, mood swings and depression. Since sudden drops in blood oxygen levels increase blood pressure and strain the cardiovascular system, some of the more serious effects of obstructive sleep apnea include high blood pressure, coronary artery disease, heart attacks, heart failure, strokes and arrhythmias leading to sudden death. 

Millions of people utilize PAP therapy devices while they sleep to push positive pressure through the blocked airway and keep the passage open. Continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) devices are two of the most commonly marketed devices to treat chronic sleep apnea.  Your doctor will likely have prescribed you the device after a diagnosis with obstructive sleep apnea. 

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Philips CPAP and BiPAP Devices for the Treatment of Obstructive Sleep Apnea

Philips is recalling between 3 to 4 million ventilators and sleep apnea devices. Eighty-percent of the recalled devices are CPAP machines. Philips is considered one of the leading manufacturers of sleep and respiratory care devices.  Philips reportedly controls approximately 65%.  The company’s 2020 sleep and respiratory device sales are believed to total over $10 billion. Since Philips’ sleep devices make up such a large share of the market, many users report being left feeling stranded because they cannot get a replacement device that is safe for use.  

The recall follows a dubious sequence of events:  

• On April 13, 2021, Philips launched its DreamStation 2 line of sleep assistance devices that were meant to replace the now recalled DreamStation 1 line of products.
• On April 26, 2021, Philips released its quarterly report in which it made a vague reference to “possible risks” associated with the previous DreamStation 1 line of products. However, no official recall was made at that time.
• On June 14, 2021, Philips announced a voluntary recall of their first generation DreamStation line of sleep assistance devices. 
• On June 30, 2021, the FDA issued a safety communication regarding the recall.
• On July 22, 2021, the FDA classified the Philips CPAP, BiPAP and ventilator recall as a Class I recall. 

Questions abound as to when Philips initially became aware of the dangerous defect in its sleep assistance devices and why they did not warn the public of these safety issues and/or correct them prior to April 26, 2021. 

The recall affects all serial numbers of the following CPAP AND BIPAP devices manufactured between 2009 and April 26, 2021: 

• 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 
• E30 (EMERGENCY USE AUTHORIZATION)
  

It also includes all of the following VENTILATOR devices manufactured between 2009 and April 26, 2021: 

• TRIOLOGY 100
• TRILOGY 200
• GARBIN PLUS, AERIS, LIFEVENT
• A-SERIES BIPAP HYBRID A30
• A-SERIES BIPAP V30 AUTO
• A-SERIES BIPAP A40
• A-SERIES BIPAP A30

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Link Between Philips CPAP Device Use and Cancer

The PE-PUR foam used in the devices can break down and release particles and chemical gases.  PE-PUR foams are formulated using isocynates.  These chemicals are often used in the production of polyurethanes, which are found in many consumer products like varnishes and coatings, adhesives, electrical potting compounds, and insulation foams (i.e. refrigerator and building insulation). Bulk polyurethane is also known to crumble when exposed to high humidity via hydrolysis over the course of several years. Unsurprisingly, isocyanate breakdown and exposure can have adverse health effects.

Philips’ own lab analysis found that degraded foam released a variety of potentially harmful chemicals including: 

• Tolene diamine (TDA): Compound used in polyurethane, hydraulic fluid and sensitizers for explosives.  TDA has been shown to be carcinogenic in rats and mice per the CDC, with oral exposure to TDA leading to skin, liver, and lung tumor formation. Potential health hazards of exposure include: genetic defects, skin reactions, toxicity, cancer, damaged fertility and organ damage.
  

• Toluene diisocyanate (TDI): Liquid used in foams and coatings. Per the World Health Organization, TDI should be treated as a potential human carcinogen. Potential health hazards of exposure include: cancer, eye damage, skin irritation, respiratory irritation and may be fatal if inhaled.
  

• Diethylene glycol: Solvent used in manufacturing other chemicals and found in antifreeze, brake fluid and lubricants. Potential health hazards of exposure include:  Irritation of skin, eyes, and mucous membranes; toxic if ingested.
  

• Methylenedianiline (“MDA”): Also considered a potential human carcinogen by the International Agency for Research on Cancer (“IARC”) and the National Institute for Occupational Safety and Health (“NIOSH”)

Smaller particulates are able to infiltrate deep lung tissue and deposit more easily into the alveoli, potentially causing cancers and other chronic respiratory conditions.

There is growing concern about the carcinogenicity and health risks associated with use of polyester-polyurethane. For example, studies have shown an increased incidence of non-small cell lung cancer (“NSCLC”) in women who worked with polyurethane materials at a foam manufacturing plant. (Mikoczy 2004). Most recently, older generation breast implants that are polyurethane based with textured shells and silicone interiors have been linked to a higher rate of anaplastic B-cell lymphoma. In addition, per the 1986 IARC monographs on human carcinogens, individuals working with TDI on a regular basis have experienced chronic bronchitis, chronic restrictive pulmonary disease, and hypersensitivity pneumonitis.

Consequently, degradation of the foam in the Philips CPAP device may result in the following types of cancer and related health conditions: 

• Blood cancers, leukemia, lymphoma 
• Nasal and Paranasal Sinus 
• Tongue and Oral 
• Nasopharyngeal (throat) 
• Esophageal  
• Cancers of the respiratory tract 
• Lung 
• Bladder
• Brain
• Breast 
• Colorectal
• Intestinal
• Liver
• Kidney
• Ovarian
• Pancreatic
• Prostate 
• Thyroid
• Uterine 
• Chronic Headache
• Inflammatory Response
• Chronic Upper Airway Irritation, 
• Chronic Cough and Chest Pressure 
• Recurring Sinus Infections 

Should I File a Philips Lawsuit?

In order to start a lawsuit, you must meet the following criteria:

1. Proof of use of a recalled machine 
   You must show that you used an affected Philips sleep device.  Prescriptions, medical records and receipts are all acceptable forms of documentation to prove this element. If you are filing a wrongful death suit after losing a loved one, your testimony as a caretaker along with your relative’s medical records may be enough evidence to satisfy this element of proof.
   

2. Proof of Cancer Diagnosis or Chronic Medical Condition
   Your medical records showing both your diagnosis with sleep apnea and cancer or an associated medical condition are important to proving this element. You should preserve any medical records you have and request additional medical records from your treating physicians if they show proof of your health condition. 
   

You must show that your cancer or medical condition developed after starting to use your Philips sleep device. If you started using the device after a cancer diagnosis, you likely cannot prove a link.  In addition, cases where the claimant can show a long history of use (at least one year or more) will likely be stronger than those where the claimant used the device for only a few weeks before their diagnosis. Your claim may also be complicated if you are a long-term smoker or have a family history of cancer.  

If you meet this criteria and wish to investigate what rights you have, you should contact a lawyer as soon as possible.  Each state has a statute of limitations, meaning the time you have to file your lawsuit.  Some states, like New York, begin evaluating your time to file your claim from the time that you learned you were injured and others begin running the clock from the time that you discovered your injury is related to the defective product.  Since some states may consider the June 14, 2021 as triggering the clock for statute of limitations purposes, you should not sit on your rights!  

Philips Lawsuit

If you meet the criteria necessary to assert a viable claim, you will file a lawsuit against Philips and potentially other manufacturers, distributors and retailers who put the machines on the market.  Your complaint would allege that these parties failed to warn against the risks posed by the device and that failure put you or your loved one in danger of developing cancer and other chronic health conditions. It is a personal injury claim based on negligence; its basis is that companies knowingly or negligently released a dangerous product to consumers, and you suffered harm due to that decision. 

If successful, you may collect damages against these parties based on their negligence. These damages are personal to you and your loved one; they may include medical expenses, lost wages, pain and suffering, and emotional distress. In severe cancer cases, courts may also consider long term pain and suffering, future medical bills, and financial and emotional distress sustained by dependents and partners. Damages may also include funeral and burial expenses if your loved one has passed away due to cancer or an associated medical condition.

Initially, your lawsuit against Philips will be pursued as an individual action against the company in a state or federal court of competent jurisdiction. When substantial personal injuries, such as a diagnosis of cancer, are incurred, it is preferable to initially file suit as an individual action so that the extent and nature of your physical injuries can be taken into consideration. 

However, many plaintiffs’ law firms already anticipate that there will be thousands of lawsuits filed against the company for similar injuries. There is already a motion pending before the Judicial Panel on Multidistrict Litigation (“JPML”), which if granted, would consolidate all pre-trial proceedings into one jurisdiction. This kind of consolidated litigation is called a Multidistrict Litigation (“MDL”) and is typically established to improve efficiency and streamline the civil process when there are a large number of lawsuits with similar fact patterns (i.e. related to a particular drug or device) and injuries being filed around the country. It also greatly reduces the cost for individual litigants because some of the fees and expenses associated with the lawsuit are shared amongst all the plaintiffs. However, it does not limit damages for litigants and unlike a class action; each plaintiff files their own individual lawsuit and claims, if successful, are compensated on an individual basis. 

Types of Compensation Awarded from Philips Sleep Apnea Lawsuits

You may receive compensation for medical bills, lost wages, pain and suffering, or other impacts on your lifestyle. Your awarded damages depend on many factors, starting with the type and severity of cancer or other injury.

Specifically, courts may consider:

• Effects on immediate and long-term health
• Impacts on quality of life due to cancer
• Emotional distress and other injuries to people close to you
• Financial impacts
• Effects on life overall, including future quality of life, financial situation, and health

If cancer or bodily injury arising from your use of the Philips device resulted in death, you would file a wrongful death claim. Damages are similar to those listed above but focus primarily on how losing your loved one affected your quality of life, financial solvency, and mental status. If you were financially dependent, incurred large medical bills, or very close to the deceased (spouse, sibling, etc.), you will likely receive a higher settlement amount than someone who was less dependent on their loved one.

These are not simple cases. Linking the device with the bodily injury that caused your harm involves meticulous interviews with medical providers and experts. The only way to ensure these lawsuits proceed correctly and successfully is to hire an experienced personal injury attorney.

The Jacob Fuchsberg Law Firm offers compassionate and thorough legal representation for those personally injured in all five boroughs of New York City and throughout the tri-state area of New York, New Jersey, and Connecticut.

‍Contact us online or call (212) 869-3500 today to schedule a free case evaluation.