FDA Updates Death Toll From Defective Philips Respironics CPAP Machines

FDA Updates Death Toll From Defective Philips Respironics CPAP Machines

Philips Respironics, a major manufacturer of CPAP and BiPAP machines, is receiving additional scrutiny for the rising number of wrongful deaths associated with their defective products. A new announcement from the FDA revealed that it received thousands of new complaints about Philip’s defective CPAP machines in the first three months of 2023, and dozens of new deaths associated with the products. This report comes amid a slew of product liability lawsuits against the manufacturer brought by CPAP users who claim that the PE-PUR foam on the machines disintegrated, entered their airways, and caused serious health issues such as cancer.

The plaintiffs in the CPAP machines lawsuits are seeking compensation for damages including medical bills, reduced earning capacity, and pain and suffering. Even though multiple recalls by the manufacturer will likely support plaintiffs’ cases for liability, it is still beneficial to hire a product liability attorney to ensure that your compensation is maximized. Having a product liability lawyer on your side demonstrates that you are serious about pursuing compensation. It also allows you to benefit from their knowledge, resources, and negotiation skills.

Growing Number of FDA Reports About Defective CPAP Machines Draws Pushback from Manufacturer

CPAP machines help people with sleep apnea manage their condition by providing a consistent flow of oxygen through a mask as they sleep. Among other duties, the FDA is responsible for overseeing the quality and safety of medical devices like CPAP machines. Since just before Philips Respironics issued a recall of their CPAP devices, the FDA has been compiling medical device reports from various sources that detail injuries and deaths related to the defective device.

While Philips Respironics is obligated to file medical device reports, consumers, healthcare providers, and others can submit a report. According to the FDA, 6,000 medical device reports were filed in the first three months of 2023. Based on these reports, an additional 40 deaths have been connected to the defective CPAP machines. This brings the total number of fatalities related to the deteriorating foam to 385 out of 105,000 medical device reports submitted to the FDA.

Philips Respironics has argued that these reports need to be given the proper context. They claim that of the 6,000 medical device reports submitted to the FDA, only 1,200 were submitted in March, indicating that the rate of reports is slowing down significantly. Additionally, representatives for Philips Respironics have emphasized that the medical device reports have yet to be verified and therefore should not be taken as irrefutable evidence that any injury or fatality is a direct result of using a Philips CPAP machine. 

Product Liability Lawsuits Filed Over Deteriorating Foam in CPAP Machines 

CPAP machines are equipped with polyester-based polyurethane sound abatement foam that has the tendency to flake off or break down into small particles. These particles are then absorbed through the air tube and inhaled by the user. Philips Respironics issued a recall in June 2021 following reports of serious illness and death related to the disintegrating foam. Some of the injuries connected to the defective CPAP machines include: 

In order to address the foam defect, Philips Respironics first issued the 2021 recall. Then, they initiated a repair and replace program, but additional claims have been filed as a result of Philips Respironics’ mishandling of this process. The CPAP devices with the defective foam were supposed to be returned to Philips where they would be updated and sent back to the user. Instead, the serial numbers of the CPAP machines that had been sent in for repair were mislabeled, so when they were redistributed some CPAP users received machines with the incorrect settings. This led to a second recall.

In the midst of this situation, it has been uncovered that Philips Respironics had been alerted to the defect 6 years before they issued the first recall. CPAP users have accused Philips Respironics of manufacturing a defective product that they should have known was potentially carcinogenic, and have subsequently filed personal injury lawsuits. While Philips Respironics has already set aside 630 million dollars to compensate plaintiffs who have yet to experience injuries, this still leaves many CPAP users responsible for the costs of their medical bills lost wages, and other non-economic damages. The CPAP lawsuits are being overseen by Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania in a multidistrict litigation.

Recovering Compensation for Damages in a CPAP Lawsuit

CPAP users who have developed cancer or respirtory issues often find themselves with compromised lung capacity, organ damage, and other issues as a result of the illness and the related treatments. This can have significant consequences on a person’s lifestyle and financials, in addition to their physical health. For example, consider a construction worker suffering from lung cancer caused by a defective CPAP machine. The cancer and chemotherapy have left them weakened and fatigued, meaning they can no longer perform their job, maintain their home, or entertain their grandchildren. 

Plaintiffs in the CPAP machine lawsuits may be able to recover compensation for compensatory damages like these, provided that they can connect their damages to their injuries and offer proof of their value. Economic damages can typically be demonstrated with bills, pay stubs, or receipts, as they have a set monetary value. Non-economic damages require a subjective evaluation, as they compensate plaintiffs for emotional losses related to their injuries.

Examples of Damages in a Philips CPAP Lawsuit:

  • Medical bills
  • Job-related losses
    • Lost wages
    • Reduced earning capacity
    • Missed promotions
  • Pain and suffering
  • Loss of quality of life
  • Wrongful death

Contact a Product Liability Lawyer About Your Potential CPAP Lawsuit

The deadline to file a CPAP claim may be imminent, as Philips Respironics is pushing for the two-year statute of limitations on product liability claims to be enforced in June 2023, as it is two years from the date when users were notified of the defect through a recall.

CPAP users who are considering filing a product liability claim should not delay in seeking assistance from a personal injury lawyer. A personal injury lawyer can offer you clarity about the claims process, insight into how to document your damages, and a valuable skill set in negotiations to maximize your compensation.


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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