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Philips Respironics has recalled numerous CPAP, BiPAP, and ventilator devices, including the Philips SystemOne ASV4 Continuous Ventilator, due to potential health risks.
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Breathing Machines and Ventilators Recall

Philips recalled their breathing machines and ventilator devices in June 2021 because of potential health risks. The health risks come from sound abatement foam used to keep the machines quiet and reduce vibration.

The sound abatement foam may degrade and release particles and toxic gases into the machine’s airways that users may inhale or swallow. Lab tests showed degraded pe pur foam and gases contain several toxic and cancer-causing chemicals. Affected devices that are more than three years old or exposed to high heat or humid environments are more likely to have degraded sound abatement foam.

The recalled machines maker said people who inhale or ingest per pur foam particles or gases may suffer from toxic, carcinogenic, and respiratory effects.

Related Article: Philips CPA Machine Recall Suit

Which Philips SystemOne ASV4 Ventilators Were Recalled?

This recall affects the following Philips Continuous Ventilator, Non-life Supporting devices: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T, and AVAPS, OmniLab Advanced+.

Philips SystemOne ASV4 Ventilator Side Effects

The potential health risks of particulate exposure from a defective Philips Sleep Apnea Machine and other similar medical devices include:

  • Headache
  • Irritation
  • Inflammation
  • Chest pressure
  • Respiratory issues
  • Toxic effects
  • Cancer (carcinogenic effects)
  • Other health issues

Potential risks of chemical exposure due to Philips breathing machines off-gassing include:

  • Headache
  • Irritation
  • Hypersensitivity
  • Nausea/vomiting
  • Sinus infection
  • High blood pressure
  • Toxic effects
  • Carcinogenic effects

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Have you or a loved one suffered severe pain or injury from a defective medical device?

What to do if You're Using Recalled Machines

Dr. Mindy Pelz, a Doctor of Chiropractic (DC), holistic expert, and founder of Family Life Wellness, a biohacking center in the Bay Area, recommends avoiding certain inflammatory foods, such as canola and corn oil. She also recommends steering clear of foods with artificial ingredients like red dye and flavorings.

Research has shown a strong link between sleep apnea and type 2 diabetes. If you’re diabetic, Dr. Pelz notes that it’ll be important to monitor your blood sugar levels while waiting for your replacement device. According to the Cleveland Clinic, pauses in breathing throughout the night can increase your levels of carbon dioxide, which can increase insulin resistance and aggravate any diabetes symptoms you may already experience.

Lowering blood sugar will be important for those folks. One way to do that, according to Dr. Pelz, is to start “switching from refined flours, like cakes, breads and pastas,” to nature’s carbs, like fruits and vegetables. Pelz says that this, “will absolutely help you balance your blood sugar and lessen the symptoms of sleep apnea.”

Can I Use an Ozone-Based Device While I Wait for My Replacement from Philips?

In 2020, the FDA reported that devices or accessories using ozone gas or ultraviolet (UV) light have not been authorized for use in the United States.

William H. Maisel, M.D., M.P.H, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health stated that “Exposure to high levels of ozone gas may worsen a patient’s existing chronic respiratory diseases or increase the chance of a respiratory infection.

UV light-based products could cause burns, eye damage or increase the risk of skin cancer due to overexposure. The FDA has contacted manufacturers of products making these claims and asked them to submit data demonstrating their safety and effectiveness.”

What Additional Tips Does Philips Offer?

  • Don’t cease device use without consulting your doctor
  • Check your email regularly for updates and announcements
  • Don’t attempt foam removal on your own
  • Register your device whether you’ve used ozone cleaning methods or not
  • Be aware of fraudulent activity – Philips will never ask for credit card information or your social security number

Philips Ventilator Lawsuit Status

Lawsuits have been consolidated into a multidistrict litigation (MDL) in federal court. Like class action lawsuits, MDLs streamline the litigation and settlement process; however, unlike class actions, MDLs allow each plaintiff’s case to remain separate.

People injured by Philips sleep apnea machines are suing the company on the following grounds:

  • Defective design
  • Manufacturing defect
  • Failure to warn / lack of disclaimers
  • Consumer fraud / deceptive trade practices
  • Fraudulent concealment

The MDL was just formed in October of 2021 and is still in the early stages. But eventually, several of the cases will go to a jury trial. How these bellwether trials turn out will set the stage for settlement talks with the remaining tens of thousands of plaintiffs expected to join the MDL. The bigger the jury verdict, the bigger the settlement amounts.

The Philips CPAP MDL is out of the U.S. District Court, Western District of Pennsylvania. Judge Joy Flowers Conti is presiding. The case name is In Re: Philips Recalled CPAP Machine, BI-LEVEL PAP, and Mechanical Ventilator Products Liability Litigation (MDL # 3014).

April 2022 Lawsuit Update

There are currently at least 262 lawsuits pending in the Philips Recall CPAP MDL. There has been a spate of administrative activity from the court of late to launch this litigation into one of the biggest mass torts in history.

Judge Conti set a schedule for monthly status conferences for the remainder of the year and finalized appointments to the Plaintiffs’ Steering Committee (“PSC”). Conti has also established a common benefit fund for reimbursing PSC members for their time and expenses.

January 2022 Lawsuit Update #1

Judge Conti has issued an order announcing the process by which she will be appointing members of the Plaintiffs’ Steering Committee, a panel of attorneys from the plaintiffs’ side of the litigation who are authorized to make collective decisions on behalf of all plaintiffs.

This is one of the most important decisions Conti will make in this recall litigation.  While most victims bringing lawsuits have lawyers outside of the steering committee, many of the biggest decisions in the litigation on the issues common to all plaintiffs are made by the MDL Steering Committee.

Applications for appointment must be submitted by January 4, 2022. Judge Conti will conduct interviews and make selections on January 27.

January 2022 Lawsuit Update #2

This month the Judicial Panel on Multidistrict Litigation will decide whether to consolidate all SoClean CPAP cleaning device lawsuits into a new MDL. This would be separate and apart from the class action lawsuit.

SoClean cleaning devices use ozone technology to disinfect sleeping machines (including the recalled devices). The SoClean class action lawsuit alleges that the SoClean device releases unsafe levels of ozone, which causes severe respiratory problems.

There are currently at least 11 SoClean CPAP machine lawsuits pending. However, the Panel will have to choose these competing class actions. But each is a class-action is filed by a different lawyer, each seeking to represent thousands of prospective class members.

December 2021 Lawsuit Update

The lawsuits are starting to look better for victims bringing a claim. The FDA reports that an investigation has begun into the recall. Federal inspectors are reviewing internal documents, email communications, and testing reports from Philips to determine what led to the recall and whether the company complied with federal regulations.

The FDA inspection found that Philips was aware of the foam degradation problem for years but made a deliberate decision not to take any action. Officials identified “at least 14 tests or assessments” going back to 2016 showing that staff at Philips were well aware of “concerns related to potential foam degradation.” The inspectors also cited 2015 emails from Philips employees to the foam supplier indicating that Philips was aware of “polyurethane foam degradation issues.”

November 2021 Lawsuit Update

In response to the growing volume of lawsuits being filed in courts across the U.S., a new MDL (multidistrict litigation) was formally created last month.

The JPML panel established the new MDL in the U.S. District Court for the Western District of Pennsylvania (Pittsburgh) under Judge Joy Flowers Conti. Judge Conti is a very experienced jurist, but this appears to be her first venture into the world of consolidated mass tort administration.

The selection of Pennsylvania’s Western District was a small victory for the defendants, even though it was the defense lawyers their first choice. Lawyers for the plaintiffs would have much preferred the Eastern District of Pennsylvania in Philadelphia, which is generally viewed as a more favorable venue for tort claimants.

The MDL for the lawsuits will make a global settlement much easier to achieve.

How Much is the Lawsuit Worth?

It is too early to know for sure how much a lawsuit may be worth in terms of settlement value. However, based on prior mass torts claims in the highest settlement tier could be worth $100,000 to $150,000.

What Damages Could I Recover?

Like other types of personal injury and product liability cases, plaintiffs will be able to file for a variety of both economic and non-economic damages.

Economic damages, also known as special damages, are those that involve a specific dollar amount and are more objective in nature. For instance, some economic damages may include medical bills, ongoing treatment costs, lost wages due to time taken off from work to recover, lost earning capacity due to disability, physical therapy, and others.

Meanwhile, non-economic or general damages are more subjective and vary from person to person based on personal experience. They’re harder to quantify because they don’t have a specific amount of money attached to them. Some of these damages could include the pain and suffering that patients experience due to their illnesses, loss of enjoyment of life, or loss of consortium, which is the loss of a relationship to a certain extent due to injury or wrongful death.

In rare cases, punitive damages may apply. These damages aim to prevent individuals or entities from committing particularly egregious acts in the future by setting an example. They’re specifically intended to punish the defendant as opposed to rewarding the plaintiff. If the court determines that Philips exhibited gross negligence in the way it handled its device recall, repairs, and replacements, plaintiffs may be able to recover these damages.

The specific damages involved will determine in each case. An attorney can help determine what product liability damages are available to victims based on their personal experiences.

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If you or a loved one was diagnosed with cancer after using a recalled Philips sleep apnea device or ventilator machine, you should contact our law firm immediately.

You may be entitled to financial compensation for medical expenses by filing a SystemOne ASV4 Lawsuit and our lawyers can help you receive fair compensation.

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