In 2021, Philips issued a massive recall for these devices manufactured and sold between 2009 and 2021 because they were defective. Former users of the recalled Philips DreamStation, BiPAP (Bi-Level Positive Airway Pressure), CPAP (Continuous Positive Airway Pressure), and mechanical ventilator machines, who developed health problems from using the devices are pursuing lawsuits against the manufacturer. These sleep apnea machines were found to contain a defective PE-PUR sound abatement which could degrade releasing chemical particles directly into the machine’s airway paths into the lungs of the user. Plaintiffs in Philips CPAP lawsuits are seeking financial compensation for the injuries they suffered from using the defective equipment.

You might be entitled to financial compensation if you or your loved one used the Philips sleep apnea machine for at least six months and developed related health complications such as respiratory problems, cancer, and lung damage. Reach out to the Philips CPAP attorneys at Stephens & Stephens and we will review your case and help you file a claim.

CPAP Machine and sleep apnea

Sleep apnea is a sleep disorder whereby breathing begins and stops repeatedly. There are different types of sleep apnea and they include:

  • Obstructive sleep apnea (OSA) – occurs when the throat muscles relax blocking air from flowing through to the lungs
  • Central sleep apnea (CSA) –occurs when the brain fails to send signals to the breathing-controlling muscles
  • Treatment-emergent central sleep apnea (complex sleep apnea) – which results from treatment when OSA converts to CSA.

CPAP is a medical device designed to address the problem of sleep apnea. Studies have shown that a good CPAP machine provides better therapy than any other form of treatment. The machine delivers a continuous stream of filtered and pressurized air into the patient’s airway holding it open and preventing collapsing during sleep. Bilevel Positive Airway Pressure (BiPAP) machine models use two pressures to keep the airway open. 

When sleeping, the devices provide just enough air pressure through a mask that seals the nose and mouth, allowing the user to breathe comfortably. The most common cause of sleep apnea is obesity or being overweight which affects the soft tissue of the mouth and throat causing it to block the airway when the person is sleeping.  

Philips recalls 

In June 2021, Philips recalled all its CPAP and BiPAP machines manufactured before 2021, which used the PE-PUR sound abatement foam. H recalled machines include:

  • DreamStation ASV
  • DreamStation ST
  • SystemOne ASV4
  • C Series ASV
  • OmniLab Advanced Plus
  • SystemOne (Q Series)
  • DreamStation CPAP
  • DreamStation Auto CPAP
  • DreamStation BiPAP
  • DreamStation Go
  • Dorma 400
  • Dorma 500 CPAP
  • REMStar SE Auto CPAP
  • Trilogy 100 and 200
  • Garbin Plus
  • Aeris
  • LifeVent
  • A-Series BiPAP

Within days of the Philips sleep apnea machine recall, affected victims were already filing consumer fraud class action lawsuits for economic compensation. These lawsuits alleged that the users wasted their money on harmful machines which later became useless. 

In March 2021, Philips released new models of sleep apnea machines which did not use the harmful PE-PUR sound abatement. The new Philips 100/200 Trilogy ventilators replaced the toxic PE-PUR foam with non-toxic silicone foam. However, the FDA warned that these new machines posed new health problems as the silicone inserts could detach and block the user’s airways. 

In September 2022, Philips issued another recall on some of its CPAP devices which contained magnets after discovering that they could have adverse effects on the functioning of pacemakers and nearby medical devices. The FDA had already received 14 severe injury complaints related to these face masks. As a result, the agency classified the magnet-related face mask recall as Class I, indicating that it could result in serious injury or death. The agency also announced that some of the refurbished devices the company had recalled were not delivering accurate or sufficient therapy. 

In March 2022, a year after recalling CPAP and BiPAP devices, Philips issued another recall for thousands of hospital V60 and V60 Plus ventilators because they contained a defective electrical power system that could make them suddenly shut down without warning. These defective machines are alleged to have caused several injuries and one death.

The US Department of Justice began an investigation into the recalls and issued a subpoena seeking more information on the matter. Some science shows that the machines could potentially cause skin cancer on the parts the user wears the mask.

Following the recall, the FDA directed Philips to offer refunds equivalent to the machines’ value to buyers. By April 2023, Philips had repaired and replaced about 2.2 million respiratory devices that were being used by patients in the US.  The repair and replacement program for the recalled machines is expected to end in 2023. Also, the company hopes to reach a settlement with the FDA before June 2023. 

Consolidation of the Philips CPAP Lawsuits

In July 2021, plaintiffs’ attorneys in one of the consumer class action lawsuits filed a motion asking the JPML to consolidate the CPAP recall consumer cases into an MDL. In October 2021, the motion was approved and all the Philips CPAP lawsuits in federal courts consolidated into a multidistrict litigation (MDL) in the Western District of Pennsylvania for discovery and pretrial under senior US District Judge Joy Flowers Conti. In January 2023, the court created a webpage for the MDL featuring an extensive index of the documents with all the court orders related to the litigation and a schedule for a monthly status conference. In October 2022, the federal MDL Judge issued an order allowing plaintiffs to file cases using the court-approved short-form complaint to ease the bulk filings. 

CPAP Tolling Agreement

At the beginning of 2022, the parties in the litigation reached a tolling agreement allowing CAP machine users to preserve their rights and prevent the statute of limitations from barring their claims.  The agreement was approved by Judge Flowers Conti. Consequently, potential plaintiffs who sign and register the tolling agreement preserve their right to file a claim even after the claim expiry as per the applicable statute limitations. In October 2022, a new Philips CPAP class action lawsuit claim registry was established to replace the old tolling agreement system. The new registry permits the potential claimants to formally register their product liability claim without filing a lawsuit. This system allows the plaintiffs to toll the statute of limitations. The court can also predict the size and scope of potential cases.

FDA increasing CPAP complaints

The agency also released a report indicating that it had received over 98,000 Philips CPAP machine complaints between April 2021 and February 2023. They involved health problems occurring from the use of the devices, such as cancer, respiratory problems, and pneumonia. The data also stated that about 350 fatalities had occurred from the use of the recalled machines. These statistics keep changing as new complaints are reported every month. In December 2021, the FDA investigation into the CPAP recall unveiled that Philips knew about the problems with their products for years but remained silent.

Philips defense

In its defense, Philips says that the PE-PUR foam degeneration was a result of using ozone cleaners. In October 2022, SoClean Inc, filed an amended complaint against Philips alleging the defendant made false statements blaming SoClean ozone machines used to disinfect the CPAP devices for the harmful degeneration. The plaintiff in this complaint provided new factual information including discoveries from the CPAP recall MDL and internal documents indicating that Philips was aware of its product defects for seven years before announcing the recall.

Also, Philips denies its devices could lead to cancer based on a new study published in the European Respiratory Journal. This study concludes that CPAP machines do not lead to a greater risk of cancer. Philips also suggested that their preliminary tests indicated that the CPAP device users were not exposed to toxic levels of VOC chemicals. However, the plaintiffs’ attorneys find this information misleading stating that the testing was performed on the new Philips machines but not the recalled ones under question. They also say that the VOC emissions in the original machines were not tested.

More CPAP MDL developments

In May 2022, Judge Conti issued a Pretrial Order No.16, formally appointing retired Magistrate Judge Diane M. Welsh as the mediator to negotiate a settlement in the Philips CPAP Recall MDL. The order is per Rule 16.1 of the Western District of Pennsylvania, which offers an option to parties in complex litigation disputes to take part in a court-sponsored alternative dispute resolution.

In July 2022, the court authorized a common fact discovery process in the pending Philips CPAP lawsuits on issues that apply to all claims. According to the new case management order, lawyers on both sides could begin the pretrial discovery to get the litigation moving. The science day was scheduled for September 1 2022 when the lawyers would have an opportunity to make presentations and educate the court about the underlying complex scientific issues in the litigation. 

In September 2022, the Department of Justice issued a press release announcing that Philips had agreed to pay a $24M settlement to the US government in the resolution of the illegal kickback claims scheme. A whistleblower complaint alleged that the company had been paying illegal kickbacks to medical equipment suppliers to submit insurance claims for the recalled Philips equipment. These illegal schemes were defrauding federal Medicare and Medicaid programs. 

In 2022, the Department of Justice also initiated a negotiation with Philips on the terms of a consent decree requiring the company to take responsibility for failure to handle the problem with the recalled CPAP machines. The decree would require the company to outline strategies it would apply to avoid similar problems in the future. It would also reflect the serious concerns arising from FDA investigations, which revealed that the company knew the problems with the sound abatement foam but ignored them for years.

In December 2022, Philips filed a motion to dismiss a consumer class action case involving 110 companies seeking economic damages on behalf of those who purchased CPAP machines. The defendant argues that it offered to repair and replace the recalled machines for free. For this reason, they could not prove they suffered any economic damage. In their response, the plaintiffs claim that they wouldn’t have bought the devices if they were informed of the dangers. 

Also, in December 2022, new lawsuits were filed alleging the CPAC foam released toxic particles that caused mouth and tongue cancer. In the case of Braverman v. Koninklike Philips N.V. (22-cv-7927), the plaintiff had been using two models of the recalled Philps machines every night for years for his sleep apnea. The Long Island resident started experiencing “continuous bouts of mouth cancer”. Braverman was also later diagnosed with tongue cancer, which he says occurred from the toxic foam particles from Philips CAP machines.

In March 2023, Royal Philips, the parent company to Philips Respironics set aside $1.63B funds to cover settlements for recalled machines. These funds will settle economic damage lawsuits filed against the company for the cost of the machines and medical monitoring for future injuries. However, they do not include damages related to physical injuries.

Evidence in internal emails

In June 2022, internal documents revealed during the CPAP class action discovery indicated that Philips was aware of the potential health problems related to their products for at least three years before they made the recall. In April 2018, a Philips mechanical engineer wrote an email to a supplier saying that the sound abatement foam in the machines was shedding and could cause the user to inhale the toxic foam particles. In the email, the engineer acknowledges that the situation wasn’t good for the product users. This email serves as evidence of the claims of negligence.

Health problems related to the CPAP machines as mentioned in the lawsuits include:

Philips’ recall highlighted the potential risks of exposure to the CPAP sound abatement foam are headache, chest congestion, sinus infection, irritation, airway inflammation, respiratory problem, and cancer.

FDA-reported injuries include cancer, pneumonia, asthma, respiratory problems, infections, headache, cough, difficulty breathing, dizziness, nodules, and chest pain.

  • Plaintiffs allege the following symptoms arising from the use of CPAP:
  • Chronic asthma, bronchitis, or pneumonia
  • Leukemia, lymphoma, and other cancer diagnosis
  • Pulmonary fibrosis, sarcoidosis, and lung diseases
  • Liver injury, kidney injury, heart attack, stroke, or heart failure
  • Symptoms such as headaches, vomiting, breathing problems, irritation, and nausea 

Is Philips likely to go bankrupt?

The frequent product recalls have been draining Philip’s financial resources. In October 2022, Royal Philips NV announced a cut of 4,000 jobs. Philips is worth less than $12 billion, and these lawsuits might amount to more than that in settlements. The plaintiffs in these lawsuits might end up with less payout than they deserve in bankruptcy court. 

Why Are Plaintiffs Filing CPAP Lawsuits?

The toxic foam used in the CPAP machines has been in use since 2009. The litigation is based on design defects, and failure to warn users and the public. The lawsuits allege that the company knew or should have known about the potentially life-threatening risks associated with degrading PE-PUR foam used in CPAP devices, and warned doctors and patients. The defendants should also have known that the foam could release harmful chemicals that could be potentially inhaled leading to health complications. The FDA began receiving complaints of black dust coming from the CPAP machines in 2011. Over the years, similar complaints have also been raised by users on different internet platforms. The CPAP lawyers at Stephens & Stephens can help you pursue compensation for such complaints.

Philips Admits CPAP Lawsuit Allegations

Philips admits that the sound abatement foam they used in their machines could degrade under certain conditions releasing harmful chemicals such as toluene diamine, toluene diisocyanate, and diethylene glycol. The company also admits that lab tests and evaluations have indicated that these compounds released from the foam are toxic and could potentially cause health risks, including life-threatening conditions that require medical intervention. 

Who qualifies for a CPAP Lawsuit?

  • Those potentially eligible for claims in the CPAP lawsuit include: 
  • People who have used one of the recalled Philips sleep apnea machines every night for at least 6 months 
  • Those who experienced certain health conditions after using the device for six months or more. These conditions include injuries related to the respiratory system such as pulmonary thrombosis and lung problems, damage to the kidneys or liver, and cancer.

The deadlines for filing CPAP lawsuits vary depending on the state’s statute of limitation (SOL), and it can range between one to six years. For this reason, it is best to consult with your attorney on the matter. This period starts from June 14 2021 when the recall was announced. There are, however, scores of exceptions that may come to play. 

What are the expected settlement amounts in the Philips CPAP lawsuits?

It is still too early in the litigation and no settlements have been made. The injuries in the lawsuit are also diverse, including severe injuries such as cancer and death. If liability is established, the payouts will depend on the severity of the injury among other factors, and on average the settlements may range between $100,000 and $500,000.

Call the Philips CPAP Mass Tort Lawyers From Stephens & Stephens, LLC

A CPAP lawyer from Stephens & Stephens, LLC can help. Our Philips CPAP lawsuit attorneys can be reached when you call 1-800-548-4494 or fill out the contact form on our website.