Van Wey, Metzler & Williams

Philips CPAP Recall Lawsuit: Everything You Need to Know

Have you used a Philips sleep apnea machine and experienced injuries or illnesses as a result? Then, you may want to consider a Philips CPAP recall lawsuit. Due to potential health risks, including cancer, Philips Respironics has recalled certain mechanical ventilators, BiPAP, and CPAP machines.

What Happened with Philips Sleep Apnea Machines?

Philips Respironics issued a voluntary recall of 4 million CPAP (continuous positive airway pressure), BiPAP (bi-level positive airway pressure), and mechanical ventilators on June 14, 2021. This recall was due to the discovery that Philips found the sound-reducing polyester-based polyurethane (PE-PUR) foam used in the devices to have adverse effects.

  • The PE-PUR foam can degrade and break down into black particles, getting into the device’s air pathway and becoming swallowed by the user.
  • This event exposes the user to inhaling dangerous and potentially carcinogenic chemicals.

Injuries and Health Risks in Philips CPAP Recall Machines

There may be life-threatening risks associated with the recalled Philips sleep apnea devices.

  • Acute inhalation injury
  • Autoimmune disorders
  • Cancer (any type)
  • Chronic asthma
  • Chronic bronchitis
  • COPD
  • Emphysema
  • Headaches
  • Heart failure
  • Hypersensitivity
  • Inflammation and fluid build-up in the lungs
  • Interstitial lung disease
  • Kidney disease
  • Leukemia
  • Liver disease
  • Lung cancer
  • Lymphoma
  • Pneumonia
  • Pneumoconiosis
  • Pulmonary fibrosis
  • Respiratory failure
  • Sarcoidosis or
  • Stroke

Suppose you’ve experienced any of the above health issues and have used Philips Respironics sleep devices, whether it’s a Philips CPAP or other Philips sleep apnea device. In that case, you may be able to pursue a Philips CPAP lawsuit to get the compensation you deserve.

Which Philips Respironics Products Are Affected?

Several of Philips’ sleep and respiratory care devices, including CPAP machines and other sleep apnea devices, are affected by the product recall.

  • Continuous Positive Airway Pressure (CPAP)
  • Bi-level Positive Airway Pressure (BiPAP)
  • Mechanical Ventilators

Roughly 80% of the estimated 3-4 million recalled sleep apnea devices by Philips are CPAP machines–primarily the first generation of DreamStation machines.

Philips Ventilator, BiPAP, and CPAP Recall List

Philips Respironics mechanical ventilators, BiPAP, and CPAP machines affected by the recall include:

  • 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
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • E30
  • Garbin Plus, Aeris, LifeVent
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q-Series)
  • Trilogy 100
  • Trilogy 200
  • Trilogy Evo ventilator model numbers DS2110X11B and KR2110X15B
  • Repair kits for Trilogy Evo muffler assembly; Part number 113525 and Lot Numbers between 210414 and 210524
  • Both lists are in the recall database by the FDA.

Which Philips Sleep Apnea Devices Are Still Safe?

The following Philips products are still considered safe and have no recalls.

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • M-Series
  • DreamStation 2
  • Omnilab (based on Harmony 2)
  • Dorma 100
  • Dorma 200
  • REMStar SE
  • Oxygen concentrators
  • Respiratory drug delivery products
  • Airway clearance products

Philips CPAP Lawsuit: What We Know

On June 14, 2021, Philips announced a voluntary recall for various polyester-based sound abatement foam components. This component can disintegrate or outgas and cause the user to inhale toxic substances. Those substances include chemicals like benzene hexachloride (BHC), which could be carcinogenic. The recalled products include those in the first generation DreamStation product family.

The first-quarter company report from Philips revealed that the deterioration of PE-PUR foam, a sound-abatement foam and common material in CPAP and Bi-Level PAP devices, could cause adverse effects for users. The particles created by this process are small enough to enter the CPAP machine or other device’s air pathway or be inhaled directly into your lungs. Some chemicals found in these foams have also been identified as health hazards when off-gassing.

Following the initial recall by Philips of CPAP, BPAP, and ventilator breathing machines, they have since recalled specific Trilogy Evo ventilators with certain serial numbers. These specific models were distributed by Philips between April 15, 2021 and May 24, 2021, as this voluntary recall covers approximately 215 Trilogy Evo ventilators and, in addition, 51 Trilogy Evo repair kits in the U.S. The expansion was deemed necessary after it was discovered that the dangerous PE-PUR foam used in devices that were originally recalled were also found in some on the Trilogy Evo ventilators produced at that time. It should be emphasized that this expanded recall covers only the Trilogy Evo model numbers DS2110X11B and KR2110X15B, and muffler repair part number 113525 and Lot Numbers between 210414 and 210524. That is, certain Trilogy Evo models such as the Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal have been deemed safe for use by the FDA. Therefore, again, only the Trilogy Evo ventilators with the certain serial number should be cause for concern in light of this recent expansion.

What Does Philips Say?

Philips explains that unapproved cleaning methods, including ozone, can exacerbate foam degradation. They also say these environmental conditions involve the climate and temperatures of where our devices are being used or stored, not just caused by a patient’s use of them.

Philips elaborates more about their products as they explain how items like high humidity or temperature levels in certain areas could cause issues with your product. However, it is unlikely because those factors typically only exist in specific locations (not applicable for someone using the device).

The Philips CPAP user manual for the first-generation DreamStation product family, which includes the most affected medical devices, failed to warn of these potential health risks.

Philips CPAP Recall Lawsuit Settlements and Verdicts

As a Philips CPAP machine lawsuit plaintiff, you may be eligible for damages in one of the following forms:

  • Philips CPAP Lawsuit Settlement: By reaching an agreement with the defendant and avoiding going to court, you can start receiving compensation sooner.
  • Philips Jury Verdict: If you do not settle, your case will continue to court, where judges or jurors will hear it and reach verdicts on the award(s). There’s also no guarantee that these cases result in any type of financial compensation either way.

NOTE: For respiratory conditions, a plaintiff will have a better standing for their CPAP machine case if they are not also smokers or former smokers. A current and former smoker may worsen their chances in court.

What Damages Could I Get from a Philips CPAP Lawsuit

The victims of Philips’ recalled sleep apnea devices might be able to recover the following compensatory damages:

  • Medical expenses
  • Past lost wages from having to miss work due to illness
  • Future lost wages from having to miss work due to illness
  • Pain and suffering

Where Do Philips CPAP Lawsuits Stand Today?

There are many possible plaintiffs throughout the United States. Hundreds of thousands, potentially. However, litigation is only just beginning. There will likely be an MDL (multi-district litigation), which expedites the court process by temporarily consolidating all personal injury cases during pretrial proceedings. Unlike with class actions, each plaintiff’s case remains separate instead of being consolidated into one lawsuit.

Common causes of action against Philips:

  • Defective design (strict product liability and negligence)
  • Failure to warn
  • Consumer fraud / Deceptive trade practices
  • Negligence per se
  • Gross negligence
  • Fraudulent concealment
  • Fraudulent misrepresentation
  • Negligent misrepresentation
  • Breach of implied and express warranties

Who Makes the Recalled CPAPs?

Philips is a Dutch company that manufactures the recalled CPAP, Bi-Level PAP, and mechanical ventilator devices. In 2008, Philips acquired Respironics to create more DreamStation products going into 2020; they made $20 billion in revenue last year alone. They have a 65% market share in the CPAP industry.

How Liability Law Applies to the CPAP Cases

Depending on the state, a patient injured using a defective medical device can file a lawsuit based on three legal theories.

  • Design Defect
  • Manufacturing Defect
  • Failure to Warn

A statute of limitations will apply in all states, limiting your ability to file a claim based on time.

What If the Recalled CPAPs Injured Me?

Are you using one of the recalled Philips sleep apnea devices? Consider the following steps.

  • Consult with a healthcare provider
  • Preserve any evidence (such as debris in the CPAP’s air pathways)
  • Contact an attorney

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