Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More | JD Supra (2024)

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.

Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More | JD Supra (2024)

FAQs

How many people have died from Philips sleep apnea machines? ›

The Food and Drug Administration says 561 deaths have been reported in connection to recalled Philips devices to treat obstructive sleep apnea and other breathing disorders.

How much will I get from a CPAP lawsuit? ›

The settlement is for economic loss, not the CPAP wrongful death and injury cases our firm is dealing with. These are small-time settlements. Most victims will get $100 for each recalled device and may be entitled to a device payment award ranging from $55.63 to $1,552.25, depending on the specific recalled device.

What's the status of the Philips CPAP lawsuit? ›

Millions of CPAP sleep apnea machines made by the medical device maker Philips and a subsidiary were found to have a dangerous problem, triggering consumer lawsuits and a massive recall in 2021. Now, Philips has reached a $1.1 billion deal to settle claims from people who say they were injured.

What is Philips doing about the recall on CPAP machines? ›

Requiring implementation of a Recall Remediation Plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall by way of receiving a new or reworked/remediated device, or for certain devices, providing the option for a partial refund.

What is the death rate of sleep apnea? ›

The American Sleep Apnea Association estimates that 38,000 people in the United States die each year from heart disease with sleep apnea as a complicating factor. People with sleep apnea have difficulty breathing or stop breathing for short periods while sleeping.

How many people have actually died from sleep apnea? ›

According to the National Commission on Sleep Disorders Research, approximately 38,000 deaths occur on an annual basis that relate to cardiovascular problems that in one way, or another are connected to sleep apnea.

How much will I get from the Philips CPAP settlement? ›

Lawyers estimate that potential CPAP lawsuit settlement amounts for cancer injuries may be between $100,000 and $500,000. Depending on the severity of the plaintiff's injuries, the amount could vary in individual cases. Philips announced a tentative agreement with the FDA in January 2024.

How long will it take to settle the CPAP lawsuit? ›

The Philips CPAP recall lawyers at Miller & Zois are reviewing sleep apnea machine cases from users of the Philips CPAP or BiPAP sleep apnea machines in all 50 states. As we discuss below, there is a settlement deal in the works in April 2024.

Did the CPAP maker agree to pay? ›

Philips reached an agreement to settle lawsuits from users of some of the company's sleep therapy machines. Medical device maker Philips announced a nearly $1.1 billion personal injury settlement over some of its CPAP, ventilators and BiPAP machines that were at the heart of a massive recall in 2021.

How many people are in the Philips CPAP lawsuit? ›

About 58,000 people filed claims or entered the census registry after the medical device company recalled more than 3 million CPAP, bi-level positive airway pressure and ventilator machines.

Has the Philips CPAP lawsuit been settled? ›

Philips agrees to pay $1.1 billion settlement after wide-ranging CPAP machine recall. Medical device company Philips reached a settlement Monday to shell out $1.1 billion to cover hundreds of personal injury lawsuits linked to its respiration and sleep apnea machines.

Why are people suing CPAP? ›

Millions of the company's sleep apnea devices were recalled in 2021 amid concerns they carried a potential cancer risk. Dutch conglomerate Philips has reached a $1.1 billion deal to resolve claims in the United States tied to more than 1 million recalled breathing machines.

Is the Philips CPAP recall serious? ›

Health Risks of Using Recalled Machines

A range of potential health problems could arise in people who use recalled Philips devices. There are two main reasons why it is believed that a breakdown of the PE-PUR foam in these devices could create health risks.

How serious is being put on BiPAP? ›

BiPap is usually very safe. It has a lower risk of complications, such as infection, compared with ventilator support like a tracheostomy. Most problems from BiPap involve the facemask.

Can I sue Philips for CPAP recall? ›

If you have cancer, lung problems, leukemia, myeloma or other injuries from using a recalled Phillips CPAP machine, you might be able to join a lawsuit to sue Phillips for injures sustained from their CPAP, BiPAP and ventilator machines potentially caused by carcinogens and toxic chemical exposure.

How many people have died from Philips Respironics? ›

30, 2023, there have been 561 reported deaths reportedly connected to recalled Philips Respironics devices, according to an update from the FDA. Between 2011 and April 2021, the FDA received 30 medical device reports (MDRs) related to these Philips Respironics devices.

How many people have died from Philips ventilators? ›

The FDA has received more than 500 reports of death tied to Philips' recalled sleep apnea devices since 2021, according to a Jan.

Are Philips CPAP machines safe? ›

If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. In June 2021, the FDA alerted people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks.

Is it safe to use Philips CPAP machine? ›

Many of Philips CPAPs, BiPAPs, and ventilators weren't safe for consumers to use because the devices' polyester-based polyurethane (PE-PUR) sound abatement foam deteriorates into carcinogenic particles. If inhaled or ingested, you may develop inflammation, asthma, and cancer, among other complications.

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