Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More

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What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021.

After all, these patients relied on these machines to treat their sleep apnea and help prevent the serious medical complications the condition can cause. It’s no surprise that these patients were alarmed when they found out that the machines they used every night to help them breathe safely while sleeping were actually putting them at risk of developing cancer or other serious injuries.

Here are the latest developments in the Philips CPAP machine recalls and lawsuits.

Why Are Philips CPAP Machines Being Recalled?

As a quick refresher, the voluntary recall of Philips CPAP machines resulted from problems involving the polyester polyurethane foam used in the machine. This polyester-based polyurethane (PE-PUR) foam helps the machine run more quietly and reduces the vibrations produced by the machine.

Unfortunately, this foam can degrade over time—posing a potentially dangerous situation. As this foam degrades, it can produce small particles that the user may ingest. This danger can exist even if there isn’t visible damage to the foam, and ingesting it may increase the risk of developing cancer or other health problems, particularly those pertaining to lung issues and injuries.

This sound abatement foam may also pose another risk: volatile organic compound emission. Volatile organic compounds are chemicals that may be emitted from this foam through off-gassing. In particular, Philips CPAP foam off-gassing has been found to emit two compounds of concern in amounts that exceed safety thresholds, according to Philips:

  • Dimethyl Diazine
  • Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1methylpropyl)

Attorneys, however, have also raised concerns about the off-gassing of other chemicals, like the following, from the foam used in the recalled CPAP machines:

  • Benzene
  • Formaldehyde
  • Methylene chloride (dichloromethane)
  • Perfluorooctanesulfonate (PFOS)
  • Flame retardants
  • Solvents

Between these two potential dangers of particle ingestion and chemical off-gassing, the foam that is used in the recalled Philips CPAP machines has the potential to pose serious health risks.

Philips CPAP Lawsuit Attorneys Are Now Accepting New Cases Involving Additional Types of Injuries

When lawyers first began pursuing lawsuits against Philips CPAP manufacturer Philips Respironics, many attorneys were originally considering only cases that involved a cancer diagnosis. This is because the first reports of the health risks associated with the problem of polyester-based polyurethane foam degradation in recalled CPAP machines focused on cancer.

As more information has emerged in the Philips CPAP machine recall and the resulting lawsuits, some evidence has pointed to other health risks besides an increased likelihood of developing cancer. Today, attorneys are moving forward with Philips CPAP lawsuits on behalf of medical device users who have suffered health issues like the following:

  • Asthma
  • Pulmonary edema
  • Pulmonary fibrosis
  • Other lung diseases or conditions
  • Kidney disease or damage
  • Liver disease or damage
  • Heart damage
  • Hyper- or hypothyroid disease
  • Immune disorders

This change is important for the sleep apnea sufferers who have used the recalled Philips CPAP machines because it expands the scope of who can seek compensation—not to mention accountability on the part of the device manufacturer—for the very real harms they have suffered. Dealing with these serious and, in some instances, life-threatening health conditions is a huge burden that can take a physical, emotional, and financial toll on the patient and their family. Now, more of the people harmed by foam degradation in recalled CPAP machines can receive the compensation they deserve for their damages.

FDA Investigation Suggests That Philips Knew of the Health Risks for Years Before the Recall Was Finally Issued

In response to the sudden and massive Philips CPAP recall 2021—which now includes as many as 15 million devices worldwide, according to NBC News—the Food and Drug Administration launched its own inspections and investigations.

Upon exploring the digital records maintained by a Philips Respironics manufacturing facility, some of which date back to 2015, the FDA concluded that the company “knew of problems for years, but didn’t act,” NBC News reported. Specifically, the write-up of the FDA investigation reported that “there were at least fourteen instances, assessments, and/or test reports, dated from 04/01/2016 to 01/22/2021, where your firm was aware of issues and concerns” related to those that eventually prompted a recall in June 2021. However, as the FDA noted, “a risk analysis is inadequate and no further design change, corrective action, or field correction was conducted when appropriate or within an appropriate timeframe.”

In other words, the reviewed emails and other correspondence that took place between Philips employees and foam suppliers, technicians, and other parties have documented that at least some level of knowledge of these health risks existed years before the company issued the recall. Yet, the FDA reported, Philips neglected to take the action during this time to mitigate the harms that could result from foam degradation.

If it is determined that the company did knowingly allow the issue of foam degradation to persist for years in products that users were exposed to on a nightly basis, it’s possible that many more consumers suffered harm and an increased risk of serious health issues as a result of this inaction.

Failing to promptly warn users of the potential dangers and to initiate a recall when the health risks first came to light could be determined to constitute negligence. That’s one of the arguments being made in the 100+ Philips CPAP recall lawsuits currently pending in which plaintiffs allege, as evidenced by the FDA investigation report, that Philips Respironics was aware of the health risks long before the company recalled the products that posed these dangers.

If you believe that using one of the now-recalled Philips CPAP machines has caused you to develop any type of serious health issue, you should speak to an attorney right away—at no cost—to learn about your legal rights and options.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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