If you’ve experienced negative side effects as a result of the Phillips sleep apnea machine, the Tennessee CPAP lawyers at Fob James Law Firm want to help you.
Our biggest concern is making sure you get the justice and the compensation that you deserve. Please don’t hesitate to reach out to us.
Contact Fob James Law Firm today for a free case evaluation.
The Problem With Phillips CPAP And Sleep Apnea Machines
Philips recalled millions of CPAP and other sleep apnea machines because many users were breathing toxic foam caused by a serious issue with their machines.
Breathing in this toxic foam can cause cancer and other major health problems. The foam was going directly into the tube that users were using to breathe correctly while they slept.
Aside from causing cancer, which is obviously severe and completely unacceptable, many users also reported headaches, upper airway irritations, coughing, chest pressure, sinus infections, asthma, damage to their liver and kidneys, nausea, vomiting, and increased breathing problems.
Class Action Lawsuit
In June 2021, a class-action lawsuit was filed against Philips in Massachusetts. The lawsuit claims that Phillips knew about the toxic foam and the severe health issues it was causing people for years.
There are claims that users had been complaining about the issues for many years, but Philips didn’t issue a public warning until April 2021.
It was another two months, June 14th, 2021, before Philips officially recalled the devices.
Interestingly, Philips didn’t announce the recall of their machines until right around the time that they were coming out with a newer device.
Many patients who desperately need these devices had no choice but to purchase the newer machine, meaning Philips continued to profit even after they made the recall of their current machine public.
Philips Lawsuits Are Based On 2 Violations
1. Design Defect
One of the reasons people were filing lawsuits against Philips is for the simple fact that the devices they sold to patients were defective and dangerous. The foam they used in the device is so dangerous that when it degrades it causes cancer. This alone might be enough of a problem for a lawsuit.
2. Failure To Warn
Not only did Philips use the material in their medical devices that were incredibly dangerous, but they didn’t warn the public as soon as they became aware of the risks.
There are allegations that users had been complaining of health issues as a result of the foam for years.
At the very least, Philips became aware of the issue in April 2021 and didn’t issue a recall until the middle of June 2021. This means that people continued to buy and use the machines for at least two months, despite the fact that Philips was well aware of the risks.
Tennessee CPAP Lawsuit FAQs
What Is Sleep Apnea?
Sleep apnea is a serious sleep disorder where a person’s breathing repeatedly stops and starts throughout the time that they are sleeping. There are three main types of sleep apnea:
- Obstructive Sleep Apnea. This is the most common form of sleep apnea and occurs when the throat muscles relax. When this happens, you can’t get enough air, which lowers the oxygen level in your blood.
- Central Sleep Apnea. This type of sleep apnea occurs when the brain fails to send proper signals to the muscles that control breathing. You may wake up with shortness of breath or have difficulty getting to sleep or staying asleep.
- Complex Sleep Apnea Syndrome. This is also referred to as treatment-emergent central sleep apnea. It occurs when you have both obstructive sleep apnea and central sleep apnea.
What Is A CPAP Machine?
A continuous positive airway pressure (CPAP) machine is the most commonly prescribed method for treating sleep apnea. This medical device sends a steady flow of oxygen into your mouth and nose while you sleep, which keeps your airways open and allows you to breathe more normally.
CPAP machines have motors that generate a constant stream of pressurized air which travels through an air filter and into a flexible tube. The tube delivers purified air into a mask that you seal around your nose or mouth while you sleep.
Which CPAP Machines Were Recalled?
Philips ended up recalling millions of breathing machines because of the issue with the foam. In addition to recalling sleep apnea machines, other life-saving mechanical ventilators were recalled as well, including the following types:
- DreamStation Machines.
- Continuous Positive Airway Presure (CPAP) Machines
- Bi-Level Positive Airway Pressure (Bi-Level PAP)
- Mechanical Ventilators
The specific recalled models were manufactured before April 26, 2021 and are listed below:
- A-Series BiPAP A30® and Hybrid A30®
- A-Series BiPAP A40®
- A-Series BiPAP V30 Auto®
- C-Series ASV®
- C-Series S/T and AVAPS®
- Dorma 400®
- Dorma 500®
- DreamStation ASV®
- DreamStation Go®
- DreamStation ST, AVAPS®
- Garbin Plus®, Aeris®, LifeVent®
- OmniLab Advanced+®
- REMstar SE Auto®
- SystemOne ASV4®
- SystemOne (Q-Series)®
- Trilogy 100®
- Trilogy 200®
To see if your machine is affected by the recall, type in the serial number, excluding spaces, in the following link.
What Is The Toxic Foam?
The toxic foam that was causing people severe health issues is polyester-based polyurethane. While people were using the machine, the foam began to degrade into very small particles that the users were breathing in or ingesting. The foam also produced toxic gases, which caused cancer, lung irritation, and organ damage.
How Long Have The CPAP Machines Been On The Market?
These damaging machines have been sold to patients since 2009, meaning some users have been exposed to the foam and gases for more than ten years.
Can I File A Lawsuit Against Phillips?
If you used any of Philips’ sleep apnea machines that they recently recalled, you may be eligible to file a lawsuit. It’s important to keep track of when you used the machine and how long you used the device. Also, take note of which device you used. Additionally, have you been diagnosed with cancer or any other type of health condition that you and your doctor believe is related to the device? If yes, you may have a valid legal claim against Phillips. Your best bet is to contact the Nashville, TN CPAP lawyers at Fob James Law Firm right away for a free consultation. We can help determine if you have a viable claim or not. We can also help you obtain your medical records and figure out what you should do next.
Do I Have A Case?
We encourage you to contact the Fob James Law Firm at 833-684-0503 to speak to one of our attorneys. Every case is different and your case should be investigated on an individualized basis. Consultations with the Fob James Law Firm are always free and there is no obligation when you call us. Generally speaking, if your situation tracks the scenarios listed below, you may have a case:
- Use of one of the following Philips (Respironics) Recalled Devices for one (1) year or more used for the treatment of Obstructive Sleep Apnea:
- Dreamstation (1st Generation Product Family)
- OmniLab Advanced Plus
- Dorma 400
- Dorma 500
- REMStar SE Auto
- Use of one of the following Philips (Respironics) Recalled Ventilators for one (1) year or more used for the treatment of one or more respiratory conditions:
- Trilogy 200
- Garbin Plus
- Developed one or more of the following medical conditions after using the noted recalled Philips (Respironics) products:
- Lung cancer
- Chronic respiratory illness
- Kidney disease
- Kidney cancer; OR
- Saw your condition worsen after using the noted recalled Philips (Respironics) products for one year or more.
Essentially, to qualify, you need to show the following three things.
First, you must show that you used one of the covered products for a year or more.
Second, you must show that you used the product to treat one of the noted conditions.
And third, you must show that you developed one of the noted medical conditions or that your preexisting condition worsened after using the product for the specified period.
If you fulfill these requirements, you should qualify as a class member in one of the Philips CPAP class-action lawsuits.
Am I Entitled To Compensation?
It is certainly possible. If we determine that you have a viable lawsuit, this means we believe you are entitled to compensation. If you file a lawsuit and we are successful in negotiating your case or we win at trial, you might be entitled to the following types of compensation:
- Medical Bills. If we win your case, you should be entitled to payment for past medical bills. Additionally, you’ll likely be able to collect monetary damages to help you pay for any future medical treatment or procedures you might need that are related to your use of a defective Philips sleep apnea machine.
- Lost Income. If you lost income as a result of being in the hospital because of a defective sleep apnea machine, you will be able to recover lost income. This includes income you might lose in the future if you’re no longer able to work.
- Pain and Suffering. When you use a medical device, you assume that it’s safe and that the manufacturers aren’t knowingly deceiving you about its safety. When you find out that you’ve been severely injured as a result of their negligence, it’s often emotionally painful and traumatizing. You might be entitled to monetary damages for this.
- Punitive Damages. Punitive damages are awarded as a way to punish companies and to deter them from engaging in this type of behavior in the future. Philips knew that their devices were defective, yet they continued to sell them anyway and didn’t warn the public. This is unconscionable. In an egregious case like this, it’s likely that a court would award punitive damages if you’re successful in your case.
CPAP Lawsuit Updates
Now we can discuss the most recent update to the case. Essentially, the class action panel that determines who qualifies came out with guidelines on who can sue in this particular class-action claim.
In other words, the panel has specified who qualifies as a member of the protected class. And their findings are exactly what was outlined in the “Do I Have A Case?” section above.
Thus, if you meet these criteria, you can join the ongoing class action. If you are unsure about if you meet the criteria for a claim, please give Fob James Law Firm a call to see what your options are.
Sept. 30, 2021: The United States Judicial Panel on Multidistrict Litigation (JPML) heard arguments for centralizing 32 Philips CPAP lawsuits in multidistrict litigation (MDL) in the United States District Court for the Eastern District of Pennsylvania, or in the alternative, the Western District of Pennsylvania.
October 8, 2021: The JPML entered a transfer order that transferred all CPAP lawsuits to the Western District of Pennsylvanian. This means that the MDL proceedings will be heard by the Federal District Court for the Western District of Pennsylvania.
December 8, 2021: The first pretrial status conference took place. Per Hon. Joy Flowers Conti, there will be in person status conferences held on a monthly basis.
January 11, 2022: Judge Conti issued an interim preservation order outlining certain steps that must be taken when Philips repairs recalled devices or when Plaintiffs return recalled machines to Philips for evidence preservation.
March 9, 2022: Medical equipment suppliers of CPAP machines filed a class action lawsuit against Philips seeking refunds for stock they are unable to sell because of the recall.
April 11, 2022: There are roughly 275 pending cases in the MDL: however, we expect this number to dramatically increase. Lawyers for the Plaintiffs have requested a streamlined process for filing cases. If this request is approved the number of filed lawsuits will increase exponentially as firms “bulk file” cases. Judge Conti has entered an order appointing lawyers to the Plaintiffs’ Steering Committee and other important Committees. She has also issued an order establishing a common benefit fund and setting procedures for plaintiffs lawyers to submit time and expense requests to the fund. The next status conference is scheduled for April 20, 2022.
May 9 , 2022: Royal Phillips announced that it received a subpoena from the Department of Justice (DOJ). This indicates that the DOJ is potentially investigating the recall of Phillips’ sleep apnea machines and/or Philips response to the recall.
June 5, 2022: Judge Conti has appointed retired Magistrate Judge Diane M. Welsh as Settlement Mediator. Judge Welsh is a very experienced mass tort mediator, and she was agreed to by the parties. As Settlement Mediator, Judge Welsh’s role is to oversee and facilitate mediation and settlement negotiations between the plaintiffs and defendants.
July 9, 2022: Judge Conti recently issued a Case Management Order that allows both the plaintiffs and defendants to conduct discovery. This gives the plaintiffs’ lawyers the opportunity to obtain documents from Philips reflecting what and when Philips knew about the toxic phone in its CPAP machines.
August 15, 2022: Judge Conti approved the the Plaintiffs’ and Defendants’ joint motion for a “science day”, which will allow both sides to educate the Court as to scientific complexities and disputes in the case. The science day is set for September 1, 2022.
October 4, 2022: Philips received more bad news as French prosecutors announced they have launched an investigation into Philips’ recall of its respiratory devices. Roughly 370,000 devices were recalled in France. A Philips spokesperson stated that the company would not immediately comment.
March 1, 2023: Plaintiffs’ counsel are pushing for bellwether trials in mid 2024. The bellwether is a test trial that allows the parties to evaluate the strength of the case and possible settlement values. To no surprise, counsel for Phillips is pushing for bellwether trials to start in 2025 or 2026. It appears Phillips would rather delay the bellwether trials as long as possible.
March 20, 2023: So far more than 300 lawsuits have been filed against Philips in the federal court system. Claimants also have the option to file their claims with the registry established by the court to toll the statute of limitations. This preserves the claim so that it can filed a later time.
CPAP Medical Updates
FDA Discovers Issues After Inspecting Phillips’ Manufacturing Facility
The FDA discovered new issues with the CPAP machines during its recent inspection of Philips’ manufacturing facility.
Most notably, the FDA uncovered that the silicone-based foam used in similar devices sold outside of the United States had failed safety tests for the release of potentially dangerous chemicals called volatile organic compounds (“VOCs”).
The FDA has ordered Philips to hire an independent lab to conduct additional testing to determine potential safety risks connected with the foam.
On November 9, 2021, the FDA issued a report listing observations from an inspection of Philips’ facility in Murrysville, Pennsylvania. The FDA inspector issued an inspection closeout report (Form 483) which found in part:
- Philips’ risk analysis and corrective and preventative actions were inadequate. According to the report, “No formal investigation, risk analysis, or CAPA [Corrective and Preventative Action] were initiated, performed, or documented, in response to the at least 222,000 complaints that could potentially be related to foam degradation and received from 2008 to 2017[.]”
- Philips’ DreamStation 1 device failed emissions testing for VOCs and Aldehydes. The FDA’s report noted that the “tolerable limits of the Formaldehyde compound [a Group 1 carcinogen] were exceeded during initial operation.”
- Philips’ management and executives knew of potential foam degradation issues but failed to do anything about it for over 14 months, possibly longer. The report said, “[Philips] management, including management with executive responsibility, were aware of potential foam degradation issues concerning CPAPs, BiPAPs, and Trilogy ventilators since at least 01/31/2020, or earlier, and implemented no further corrective actions until April 2021.”
The FDA investigator’s November 2021 report also points out that, dating back to at least 2015, Philips knew about a preventative maintenance servicing procedure implemented by another Philips entity related to foam degradation issues and complaints in the field.
And yet, despite having this information, Philips did not perform or document any further investigation, health hazard evaluation, risk analysis, or design review on the issue.
The FDA investigator also noted that there were at least 14 instances from April 1, 2016 to Jan. 22, 2021, where Philips Respironics was aware of potential foam degradation problems with various sleep and respiratory care devices, but failed to perform an adequate risk analysis within an appropriate time frame.
The FDA issues an update of its June 2021 recall notice
November 12, 2021: the FDA issued an update of its June 2021 recall notice. Among other things, the FDA’s updated notice listed several of the potential risks caused by inhaling or swallowing pieces of foam and inhaling chemicals released by the foam including:
- Irritation to the skin, eyes, nose, and respiratory tract
- Inflammatory response
- Hypersensitivity reaction
- Toxic and cancer-causing effects
FDA Orders Philips To Improve Communications To Patients About The Recall
March 10, 2022: the Food and Drug Administration issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products.
The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.
You can read more about the FDA’s notification order on the FDA’s website.
FDA Releases Data Reflecting Serious Health Incidents and Death
March 2, 2023: The FDA released updated data from Medical Device Reports (“MDRs”) concerning the Philips CPAP and BiPAP devices recalled in June 2021. According to the MDRs, as of December 31, 2022, there have been 98,000 serious adverse health incidents and 350 tragic deaths allegedly linked to the recalled devices.
Contact a Tennessee CPAP Lawyer For Help
At Fob James Law Firm, our job is to help you to the best of our ability and fight for you. If you’ve suffered any health consequences as a result of using these Phillips CPAP machines, you should contact us immediately.
We can determine if you are eligible to file a lawsuit or not. It won’t cost you anything to speak with us. Additionally, you’ll never pay us anything until we successfully settle or win your case in court.
Our Tennessee CPAP attorneys are experienced, dedicated, and they truly care about you. We treat all of our clients exactly how we would want our own family members to be treated. Contact us right now at 833-684-0503 or set up a free case evaluation so we can help you.