What Should I Expect from a CPAP Lawsuit Against Philips?
Legally Reviewed and Edited by: Terry Cochran
Many Americans suffer from sleep apnea, which causes shallow or interrupted breathing during sleep. Chronic disruption of oxygen flow during sleep can contribute to medical problems, such as headaches, strokes, and heart attacks.
Sleep apnea is a widespread health problem, and many sufferers use CPAP (Continuous Positive Airway Pressure) devices to manage the condition. Philips recalled millions of CPAP, BiPAP, and ventilators in June 2021 for possible health hazards, including cancer.
You may be eligible to file a lawsuit if you used one of the recalled Philips medical devices and are experiencing side effects or severe illness. Working with one of the Philips CPAP machine recall attorneys at Cochran, Kroll & Associates, P.C. can help you seek damages for your personal injuries resulting from the use of a recalled Philips device.
What Caused Philips to Recall its CPAP Machines?
CPAP therapy is the most common treatment for sleep apnea and involves wearing a mask over the nose and mouth while sleeping. CPAP machines help keep the airway fully open during sleep to prevent airway compression or collapse caused by sleep apnea.
Philips has developed and sold CPAP and Bilevel Positive Airway Pressure (BiPAP) machines under their Respironics brand to treat sleep apnea and other conditions. A major range of sleep apnea devices was DreamStation, including DreamStation and DreamStation Go.
To make Philips sleep apnea machines as quiet as possible while sleeping, the company developed a special polyurethane foam called PE-PUR for sound reduction.
According to the company, PE-PUR sound abatement foam can break down into microscopic particles. High temperatures and humidity where the devices are stored can exacerbate foam degradation.
The Philips CPAP recall has been classified as Class 1 by the Food and Drug Administration (FDA) because the devices likely cause serious injuries or death.
Philips recalled the following CPAP machines and ventilators manufactured between 2009 and April 26, 2021:
CPAP and BiPAP Devices
- C-Series ASV
- C-Series S/T and AVAPS
- Dorma 400
- Dorma 500
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- A-Series BiPAP A40
- A-Series BiPAP A30
- A-Series BiPAP V30 Auto
- A-Series BiPAP Hybrid A30 (not marketed in the US)
- Garbin Plus, Aeris, LifeVent
- Trilogy 100
- Trilogy 200
FDA Inspection Report: How Serious is the CPAP Recall?
Philips reports that the health complaint rate was below 0.03% in 2020. The company has also tried to deflect the blame for the sound abatement foam deteriorating over time to patients’ misuse of ozone-based compounds.
SoClean Inc., a manufacturer of ozone-based cleaning solutions, filed a lawsuit against Philips in October 2021 for $200 million. They claim that Philips pointed out the ozone cleaners at SoClean to distract attention from its own poor choice of materials and design problems.
The FDA inspected Philips’ production facility in November 2021. A team of FDA inspectors analyzed internal documents, emails, and product testing reports to determine why Philips recalled the CPAP devices and ventilators.
They also needed to determine whether the company complied with federal regulations. The FDA found numerous flaws in the manufacturing process and previous failures to detect foam degradation before Philips’ recall notice in June 2021.
Inadequate risk analysis
The FDA found Philips did not perform a suitable or timely risk analysis of various CPAP, BiPAP, and ventilator devices upon becoming aware of potential degradation and emission concerns.
The DreamStation 1 produced large quantities of formaldehyde, one of the most deadly carcinogens. The substance can cause lung damage, myeloid leukemia, and malignant diseases of the paranasal sinuses, nasal cavity, and nasopharynx.
Correction and prevention procedures were insufficient
Although there were at least 222,000 complaints about foam degradation between 2008 and 2017, Philips did not conduct an official investigation, perform a risk analysis, or take any corrective or preventative actions.
There are no effective procedures for design changes
Philips failed to ensure the Trilogy 100 and 200 devices met user expectations and performed as expected. For the Trilogy 100 and 200 machines, there was a lack of a bacterial filter to filter out particles that could cause injury to the user’s lungs.
Before market introduction, breathing machines and ventilators did not undergo sufficient review.
Lack of reports to the FDA
The degradation of polyurethane foam has led to numerous complaints and at least one Trilogy unit failure. The foam was later found to be mutagenic, cytotoxic, carcinogenic, and non-biocompatible. However, none of these complaints were reported to the FDA.
The executive management did not guarantee quality at all levels
CPAPs, BiPAPs, and Trilogy ventilators were experiencing foam degradation before January 31, 2020, but no action was taken until April 20, 2021. The FDA also observed a lack of quality assurance procedures in place. Action should’ve been taken to ensure compliance with specified requirements and QA of the foam suppliers dating back to 2016.
According to the FDA report, Philips failed to tell the FDA about the potential dangers of using their devices, which they believe Phillips was aware of before the recall. Additionally, they did not disclose the risks to the public and did not admit their products had design flaws.
Since the recall didn’t occur until 2021, there is plenty of evidence the company failed to act on knowledge of potential hazards for years. Philips’ failure to warn, along with defects in the machines and its actions or inactions constituting fraud, is a major cause of CPAP lawsuits.
What Chemicals are in the Sound Abatement Foam in CPAP Machines?
Philips reports their CPAP machines, BiPAP machines, and mechanical ventilators can cause severe injuries, impairment requiring medical intervention, or death. Their recalled sleep apnea devices may cause these symptoms of particle and chemical exposure:
- Acute upper respiratory irritation
- Skin, eye, throat, and respiratory tract irritation
- Inflammation of the lungs or asthma such as pulmonary fibrosis
- Sinus infection
- Toxic effects on internal organs, including the kidneys and liver
- Vomiting and nausea
Philips disclosed a laboratory report on the deteriorating foam used in CPAP devices. According to the analysis, the foam showed several hazardous compounds.
- Diamine toluene was present in the deteriorating sound abatement foam. This chemical’s potential side effects include skin reactions, cancer, and infertility.
- Philips’ lab team found diethylene glycol during the analysis. If taken orally, it is harmful to the skin, mucous membranes, and eyes.
- The analysis also revealed the foam contained toluene diisocyanate. Toluene diisocyanate can cause skin irritation, eye damage, lung damage, and different types of cancer.
The analysis also uncovered two gases: Dimethyl diazene and phenol 2,6-bis, commonly known as carbolic acid. Although Philips claims these gases are hardly detectable, patients could’ve been exposed to levels of hazardous gases beyond what is considered safe.
According to Phillips, they received complaints about black debris and particles in the outlet of the humidifier, tubing, and mask. To date, no patient deaths have been documented. However, a number of health studies and CPAP/BiPAP lawsuits have linked the recalled Philips Respironics devices to several types of cancer, including brain cancer, lung cancer, and non-Hodgkin’s lymphoma.
What to Do if Your CPAP Machine is Making You Sick
If you have any symptoms and your device is on the recall list, visit your doctor. When filing a claim against Philips, you need medical documentation proving your condition and illness are related to the defective ventilators.
This includes proof of CPAP or BiPAP use and other documents. You should replace BiPAP and CPAP devices after five years of use.
Your doctor can tell you to stop device usage and pursue other long-term treatments, such as positional therapy or weight loss, to help manage your sleep apnea. Your doctor may also advise you to continue using a recalled Philips medical device for a short period. This is only the case if the benefits outweigh any defective sound abatement foam risks.
The company’s Medical Device Recall Notification website has more information on the recall and instructions for customers.
Should I Use Inline Bacterial Filters?
Some patients whose doctors advise them to keep using their CPAP machine might need an inline bacterial filter. The filter prevents sound abatement foam particles from entering their lungs. The FDA provides more information about using inline bacterial filters.
The FDA warns of a few drawbacks to inline bacterial filters. If the toxic sound abatement foam deteriorates, these filters might not remove every dangerous chemical released. You may have trouble breathing if you have filters on your ventilator because they can block airflow.
To prevent inhalation and ingestion of other particles, you and your doctor should monitor your devices.
What Should I Expect from a CPAP Lawsuit Against Philips?
Many people have filed product liability lawsuits against Phillips because the company failed to inform patients about the potential dangers of using its devices. 137 CPAP lawsuits are pending in the MDL as of December 15, 2021.
A multidistrict litigation (MDL) in federal court has been initiated against Philips arising from multiple claims. The United States District Court for the Western District of Pennsylvania is handling the Philips CPAP MDL. The lawsuit is titled In Re: Philips Recalled CPAP, BI-LEVEL PAP, and Mechanical Ventilator Products Liability Litigation.
However, unlike class-action lawsuits, MDLs keep each plaintiff’s case independent to make the settlement process more efficient. This is an ongoing MDL, so you should consult a product liability attorney at our firm as soon as possible to see if you have a claim after using a recalled device and showing symptoms.
Could I File a Philips CPAP Lawsuit?
A product liability claim can be used in personal injury law to hold manufacturers of consumer products and medical devices liable. These parties are responsible for injuries caused by an unreasonable danger in the product or failing to warn consumers of the danger.
If you want to start a product liability case against Philips for using one of their devices, you need to prove the following:
Usage of one of the recalled devices for at least six months
Take a look at the make and model of your device and compare it to the FDA list of recalled Philips devices. Your doctor should also have the same information for your device.
Medical records indicating you have been injured or became seriously ill as a result of the foam used in the recalled device
The potential health risks from the FDA indicate the side effects and serious health conditions that can result from these devices. If you believe your symptoms resulted from one of the chemicals in the device, your doctor can evaluate your symptoms.
The attorneys at Cochran, Kroll & Associates P.C. can help you obtain the documentation to prove your case if you have become injured or ill after using a device for more than six months. We can start your product liability claim in Michigan, which has a three-year statute of limitations.
Philips CPAP Lawsuit Settlement Information
You may be entitled to a Philips CPAP machine settlement if you have been exposed to toxic sound abatement foam particles. The settlement can include any costs or damages related to losing your Philips product or replacing it with a new CPAP or Bi-PAP.
What kind of money can I get from the settlement?
You may suffer economic and non-economic losses due to an injury or illness caused by the recalled device. The economic damages include:
- Expenses from past medical care you had to obtain for an injury or illness caused by the PE-PUR foam
- The reasonably expected cost of future medical treatment for your illness
- Loss of income due to inability to work
- Financial losses you may incur if you are unable to work and earn the same income as before your injury or illness
A CPAP lawsuit typically includes the following non-economic damages:
- Pain and suffering as a result of your illness
- Loss of convenience
- Loss of society and companionship
- Loss of enjoyment of life due to your inability to engage in hobbies or activities
Unless the product defect caused the person’s death or permanent loss of an essential bodily function, the amount of non-economic loss damages in a product liability suit cannot exceed $280,000.
How long can these types of cases last?
Complex MDLs usually entail multiple stages because they take place in federal court. The MDL judge goes over pretrial motions, discovery, and settlement conferences. The court lets each side recommend a few plaintiffs to be tried as bellwether trials.
A bellwether trial reviews what an injured party might expect to receive in their lawsuit. Bellwether trials act as a test case by providing a sampling of the individuals involved in the MDL.
These trials can influence how both sides see the outcomes of the cases in the MDL, with one or both sides negotiating for a settlement. The success or failure of the bellwether trials can influence the settlement amount for all the injured parties.
How Can a Lawyer Help With My CPAP Lawsuit?
The right attorney is essential if you are experiencing health problems after using a Philips medical device on the recall list. To file a successful CPAP lawsuit, you must demonstrate that your diagnosed condition was caused by one of the recalled devices.
You must also prove the resulting economic and non-economic losses are directly caused by using the device.
As a former registered nurse, Eileen Kroll, one of our law firm’s senior partners, takes a comprehensive approach to assessing medical device product liability cases. Her clinical expertise is valuable in cases that involve defective devices as the basis for a mass tort lawsuit.
The combination of Eileen’s legal experience and medical knowledge improves your chances of receiving fair compensation. Her experience working as an ICU nurse allows her to interpret your medical records to build your claim.
Eileen is the lead attorney handling our firm’s medical malpractice and mass tort cases. She understands the nuances of class-action litigation and fights tirelessly for victims’ rights.
Get Legal Help With Your CPAP Lawsuit
If you develop symptoms due to using a recalled Philips BiPAP or CPAP device, contact the attorneys at Cochran, Kroll, & Associates, P.C. We can help you build a case using your medical records, documenting your symptoms, and tracking the use of recalled Philips devices.
Contact us today for a free consultation of your case and begin the process of filing a lawsuit against Philipps for your CPAP injuries or illness.
Our contingency fee basis means we only get paid if we win your case, so there is no financial risk to you to get started. Call our law firm today at 1-866-MICH-LAW and schedule your no-obligation, free case evaluation.
Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.