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Update: 124 Deaths, 21,000 Complaints Linked to Recalled CPAP Devices
May 23, 2022 - In the year since Philips issued a nationwide CPAP recall for many of its ventilators and CPAP machines and BiPAP machines, the issue has sparked more than 21,000 complaints, including more than 120 reported deaths. Medical device reports linked to foam deterioration detailed a wide range of injuries and adverse effects including cancer, pneumonia, asthma, infection, headache, nodules, chest pain, and death.
What is the Philips Garbin Plus Ventilator?
The Philips Garbin Plus Ventilator is a portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway).
Philips Garbin Plus Ventilator Injuries
The potential health risks of particulate exposure in defective Philips Garbin Plus ventilator machines and other similar medical devices include:
- Chest pressure
- Respiratory issues
- Toxic effects
- Cancer (carcinogenic effects)
- Other health issues
Philips Sleep Apnea Machine Recall
Philips recalled the above sleep apnea machines over concerns that the PE-PUR sound abatement foam could degrade and become toxic, potentially leading to cancer and other serious health problems in some users. When the foam deteriorates, tiny particles and gases may be inhaled or ingested.
Studies are being performed to determine whether the inhaled or ingested sound abatement foam particles could potentially cause lung injuries such as lung scarring, sarcoidosis, or pulmonary fibrosis. Research is also being conducted to determine whether the inhaled or ingested particles could lead to nasal, throat, or lung cancers, or blood cancers including multiple myeloma and leukemia.
Philips reports that the complaint rate for health issues for the recalled products was just 0.03% in 2020. However, a recent inspection report by the U.S. Food and Drug Administration (FDA) of Philips’ manufacturing facility reported many deficiencies. The company says it has not received any reports of patients who have been injured by chemical emissions but decided to initiate the recall to ensure patient safety.
“The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation,” Philips said.
Philips has since been subpoenaed by the U.S. Department of Justice (DOJ), which is looking into the events leading up to the recall.
What Does the FDA Say About the Philips CPAP Recall?
The FDA has identified this as a Class I recall which is the most serious type of recall. The FDA is continuing to work with the company to assure it has sufficient evidence to support the recall strategy, including its corrective actions.
As a medical device manufacturer, Philips is responsible for ensuring the manufacture of safe and effective devices as well as establishing an appropriate mitigation strategy to reduce public harm in the event of device failure or defect. Philips has indicated that it will replace the current insulation foam with new material.
A timeframe for device replacement has not yet been set. The FDA is currently reviewing the information Philips Respironics has provided regarding replacement devices while continuing to work with Philips Respironics on their corrective actions for existing devices. The FDA will then determine whether the proposed replacement devices pose any additional risk to people who use these devices.
Why is PE-PUR Foam Dangerous?
PE-PUR foam is generally not harmful if it remains intact. However, if the foam breaks down, it can release particles and chemical gases which can be harmful to someone using the device.
Break down of the foam may result in particles and chemicals being released into the device’s air pathway which the user may inhale or swallow. Even if there are no visible particles, the foam could be releasing harmful chemicals which are then inhaled.
Philips discovered emissions of two toxic gases, dimethyl diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)-, that exceeded the safe exposure threshold during laboratory testing. The potential risks of particulate and chemical exposure include irritation to eyes, skin and respiratory tract as well as inflammatory response, headache, asthma, adverse effects to other organs such as the kidney and liver as well as other toxic or carcinogenic effects.
To date, Philips has received complaints about the presence of black debris/particles within the device’s air pathway. Philips has also received reports of headache, upper airway irritation from continuous positive airway pressure, cough, chest pressure, and sinus infection. However, there have been no reports of death as a result of these issues.
Can I Sue Philips Over a CPAP Recall?
People who suffered cancer, lung problems, or other injuries after using a recalled Philips ventilator machine may file a lawsuit for potential compensation.
Individual injury lawsuits seek compensation for injuries and claim Philips manufactured defective devices but didn’t warn the public of the risk or serious injuries. A handful of class-action lawsuits demand that Philips pay for the cost of replacing ventilator devices.
The lawsuits allege that Philips Respironics knew about these substantial and material risks from its ventilators and sleep apnea machine long before the recall.
The complaints further allege that patients who used the affected devices have complained to Philips about black particles in their machines for many years, but Philips did not warn the public about the hazards until late April 2021 and did not recall its machines until June 14, 2021.
The lawsuits further contend that Philips timed its recall to coincide with the launch of its next generation of ventilators and sleep apnea devices that do not suffer from the same issues. Thus, the only safe option that Philips offers to its customers—many of whom need and rely on the recalled breathing machines—is to purchase a newer model of the Philips sleep apnea machine, profiting the company further.
Finally, the complaints allege that Philips has no concrete timeline for replacing the recalled ventilators, Philips sleep apnea devices, and other devices and may not provide replacements for a year or more, even though patients need to use their devices every day.
As a result, the sleep apnea recall leaves patients without safe, free options, and patients are going to be forced to buy Philips’ next-generation product or a competitor’s sleep apnea machine -- at full price.
The 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 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).
What Should I Do if I'm Using a Recalled Sleep Apnea Machine or Ventilator?
If you or a loved one are using one of the recalled sleep apnea devices or ventilators, the company recommends that you talk to your doctor to determine the best options for continued treatment.
“Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where disruption is unacceptable,” the recall notice states. “In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.”
Philips has begun replacing the PE-PUR foam in the recalled machines with new material.
Tell your doctor if you have any signs or symptoms that may be linked to the use of a recalled sleep apnea machine.
So far, dozens of lawsuits have been consolidated into a multidistrict litigation (MDL) and sent to a Pittsburgh federal court.
See all related medical device lawsuits we've covered.
Get a Free Garbin Plus Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of Philips Garbin Plus Ventilator Lawyers that focus on the representation of plaintiffs in lawsuits. Our Personal Injury Lawyers are handling individual litigation nationwide and currently accepting new Philips Garbin Plus cases in all 50 states.
If you or a loved one was diagnosed with cancer after using recalled sleep apnea devices, or ventilator machines, you should contact our law firm immediately for Garbin Plus Lawsuit information. You may be entitled to financial compensation for medical expenses by filing a Garbin Plus Lawsuit and our lawyers can help you receive fair compensation.