Law Firm Client Intake Facts for the Philips Breathing Machine Recall 

 

This article is intended to provide supplemental training material when conducting law firm client intake to qualify prospective claimants affected by the Philips Respironics Class I recall announced in 2021

The recall affected millions of its CPAP, Bi-PAP, and mechanical ventilator devices due to health risks from defective polyester-based polyurethane (PE-PUR) sound-reducing foam liner. The foam was found to degrade, especially in hot and humid environments, and release black particles and toxic chemicals into device air pathways that can cause negative health effects, including cancer and serious respiratory problems.

Philips initiated the recall on June 14, 2021, and the recall is part of MDL 3014 In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation.

The massive recall that eventually hit about 5.5 million machines has dragged on for about two years at time of publication. It may help personal injury intake centers to convey to claimants that Philips makes over 40% of the world’s sleep apnea breathing machines.

At this time, Philips claims to have completed repairing 90% of machines that require refurbishing. Sadly, many users went months and years without a replacement. In fact, at the time of publication, many victims still not only are without a replacement, but are unaware there is recall. Hence, they have not even registered their devices for a replacement.

The company recalled the machines because of potential carcinogenic and toxic chemical exposure. While Philips waited until 2021 to initiate the recall, they allegedly knew about foam degradation issues with the recalled devices as far back as 2015. As part of the recall, Philips wrote the foam particles could result in “serious injury which can be life threatening.”

Knowledge reportedly is based upon awareness of documented foam degradation issues in October 2015 through emails between Philips and its raw foam supplier. The company investigated the problem of foam degradation internally and concluded that the foam represented a “significant biological risk to patients.” Yet, despite having knowledge of the foam degradation issues, Philips made the conscious decision not to notify relevant regulatory authorities, such as the FDA. In a later update, Philips noted that visible evidence of foam breaking down was found in approximately 2% of the returned/used first-generation devices.

Notably, the foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments. Hence, it is common practice for personal injury intake specialists to inquire about claimants’ use of specialized cleaning products. SoClean is one such product that was used to clean these devices and another multidistrict litigation is ongoing for this matter.

It may be beneficial for law firm intake professionals to explain that the SoClean MDL is a class action lawsuit filed against the makers of SoClean CPAP cleaning devices. The lawsuit claims that the manufacturers misled consumers by not telling them about the health risks associated with the devices. The SoClean MDL was consolidated under Judge Conti, who is also presiding over the Philips CPAP recall MDL. As of May 15, 2023, there were 41 pending cases in the SoClean MDL, which is about the same number of cases pending at the start of the year. The SoClean is not designed to extend the life of CPAP equipment or accessories. SoClean works with most CPAP equipment, but there are some brands and models that will need an adapter for SoClean to work. The SoClean MDL is an important issue for law firm client intake and their specialists to be aware of, as it may impact their clients and potential legal cases.

People who suffered cancer, lung problems, or other injuries after using a recalled Philips machine may file a Philips CPAP lawsuit for potential compensation. Individual injury lawsuits seek compensation for injuries and claim Philips manufactured defective devices but didn’t warn the public of the risk or serious injuries. A handful of class-action lawsuits demand that Philips pay for the cost of replacing CPAP devices.

Philips claims that it continues to monitor reports of potential safety issues and is providing the relevant regulatory agencies, such as the FDA, with required information related to the recall.

 

The Scathing FDA Investigative Report: Highlights for Your Law Firm Client Intake

In November 2022, the FDA published an Investigative Report that outlined several concerning findings related to Philips Respironics’ DreamStation and other breathing machines.

Below are highlights from the FDA Investigative Report:

• First, field reports and emails received by Philips indicated that the foam in these machines was degrading, leading to chemicals entering the breathing tube.

• Additionally, emissions tests performed by Philips confirmed the presence of harmful chemicals, including formaldehyde. The report stated that upon observing the foam degradation, “no further design change, corrective action, or field correction was conducted.”

• The report also reveals that Philips failed to conduct sufficient investigations, risk analyses, or design failure mode effect analyses, which raises concerns about the safety of other devices containing the same foam that has not been recalled. In a document from Philips titled Rationale for Concluding which Devices are Impacted by the Recall it fails to document the performance or results of an investigation, risk analysis, or design failure mode effect analysis, therefore you have not sufficiently demonstrated that other.

• Additionally, when preventative maintenance procedures were implemented due to field reports and complaints about foam degradation, no investigation or risk analysis was conducted by Philips. These findings suggest that the company was aware of potential health hazards related to their products but failed to take appropriate action in a timely manner, potentially causing harm to patients using these machines.

• Further, Philips generated a report that stated, “Polyester urethanes show bad resistance against high humidity in combination with high temperature”. This test report was conducted as a result of field reports/ complaints regarding foam degradation in Trilogy 200 ventilator devices in 2015” As a result, a risk analysis was not performed and no further design change, corrective action, or field correction was conducted when appropriate or within an appropriate timeframe.”  Here we see additional conduct that reflects poorly upon Philips non-actions and potentially negligent behavior.

• Finally, at the end of the report, the FDA concluded that, “firm management, including management with executive responsibility, were aware of potential foam degradation issues concerning CPAPs, BiPAPs, and Trilogy ventilators since at least 01/31/2020, or earlier, and implemented no further corrective actions until April 2021.”

 

But we can tell what the company did do, which is make billions of dollars in profits every year for the next five years, including from 2020 – 2021 when they raked in a reported record $6 billion during the pandemic, put the new, upgraded machines in the warehouse shelves of medical equipment providers to ensure profits kept rolling in, then they announced the recall. 

 

Danger Zone: In Between a Rock and a Hard Place

 

As mentioned earlier, many patients have been waiting months and years for replacement devices.

In this section, we will discuss the challenging decision patients must make when faced with the dilemma of using a recalled breathing device or going without it. This predicament, often described as being “between two rocks and a hard place,” forces patients to weigh the risks of continuing to use a recalled Philips CPAP device against the hazards associated with not using it at all, such as nighttime breathing difficulties.

Generally, legal intake specialists are not attorneys and cannot dispense legal advice. Hence, a law firm intake call center may consider allowing their agents to relay what can be found online from the FDA.

For patients who have a recalled Philips Respironics CPAP machine and have been waiting for a replacement, the FDA has been consistent by offering the following advice:

• According to the latest update from Philips, as of Jan. 25, 2023, it had completed 90% of its product replacements and repair kits globally. It has shipped 2,460,000 devices in the U.S.
• If you continue to use your old CPAP machine, you may expose yourself to chemicals with the potential risk of toxic effects, respiratory issues, and cancer. However, Philips has assured customers that the risk is low.
• Your doctor may tell you to try CPAP alternatives, such as lifestyle changes, nasal decongestants, losing weight, or sleep apnea surgery.
• If you can’t wait for Philips to replace your CPAP machine, your doctor may recommend that you continue to use your recalled device if the benefits outweigh the risks.
• The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement.
• Patients who have been waiting for a replacement should continue to monitor updates from Philips and the FDA.

It is important for users of recalled Philips Respironics devices to follow the advice provided by their doctors and to stay informed about the latest updates regarding the recall.

 

First Law Firm Client Intake Question: Which  Philips Respironics Breathing Machines were Recalled?

Philips recalled the following devices made between 2009 and April 26, 2021:

• A-Series BiPAP A30
• A-Series BiPAP A40 (ventilator) 
• A-Series BiPAP Hybrid A30 
• A-Series BiPAP V30 Auto (ventilator) 
• C-Series ASV (ventilator) 
• C-Series S/T and AVAPS 
• DreamStation 
• DreamStation ASV 
• DreamStation Go 
• DreamStation ST, AVAPS 
• Dorma 400 
• Dorma 500 
• E30 
• Garbin Plus, Aeris, LifeVent (ventilator) 
• OmniLab Advanced+ 
• REMstar SE Auto 
• SystemOne ASV4 
• SystemOne (Q-Series) 
• Trilogy 100 (ventilator) 
• Trilogy 200 (ventilator)

Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021, to May 24, 2021, with specific serial numbers.

 

Alternatives to CPAP Machines Law Firm Client Intake Professionals May Suggest Patients Discuss with Doctors

There are several alternatives to using a recalled Philips Respironics CPAP machine while waiting for a replacement. Although these may be viable options, the attorney call center must make claimants aware that they cannot provide any professional legal or medical advice. Here are some options patients may consider asking their doctors, especially when experiencing difficulties receiving a replacement:

• Lifestyle changes: Doctors may recommend lifestyle changes to help manage sleep apnea, such as losing weight, quitting smoking, avoiding alcohol and sedatives, and sleeping on your side.

• Nasal decongestants: Nasal decongestants can help relieve nasal congestion and improve airflow.

• Sleep apnea surgery: Surgery may be an option for some people with sleep apnea, such as nasal, palate, tongue, and jaw surgeries; tonsil or adenoid removal; skeletal surgery; palate implants; nerve stimulation, etc.

 

 

• CPAP alternatives: There are several CPAP alternatives available, such as ResMed AirSense 10 CPAP, Z2 Auto Travel CPAP Machine, DeVilbiss IntelliPAP 2 AutoAdjust CPAP, and F&P SleepStyle Auto CPAP.

Users are advised to use their recalled device if the benefits outweigh the risks. If a patient can’t wait for Philips to replace your CPAP machine, his or her doctor may recommend discontinuing use of the recalled device if the benefits outweigh the risks.

Patients who have been waiting for a replacement should continue to monitor updates from Philips and the FDA. It is important for users to discuss these alternatives with their doctor to determine which option is best.

 

Questions Personal Injury Intake Specialists May Ask Prospective CPAP Claimants

Personal injury intake forms will have many initial qualifying questions to ask prospective claimants to ensure the strongest likelihood a claim could be filed. Many are standard questions associated with other claim types, such as contact information, details on treating doctors and corresponding medical facilities, dates of device usage, symptoms of qualifying ailments, diagnosis and treatment dates of qualifying ailments, details on medications used to treat qualifying ailments, and more.

Below are additional questions that may be relevant and allow continued fettering of the facts.

• Have you received your new device yet?
• What health complications have you developed?
• How did you hear about the recall?
• Did your doctor tell you about the recall, or did you get a letter?
• Have you heard about the FDA Report that was released . . . and what they said about Philips Respironics and how they handled this recall so badly and did nothing to fix the problems they knew since 2015?
• Have you gotten on the prioritization list?
• When did you get the machine, about how many years ago?
• You probably had to go to a sleep study where they connected you to a bunch of wires to monitor your sleeping patterns before a doctor diagnosed you with sleep apnea, correct?
• A lot of patients developed COPD and other breathing complications . . . did you?
• Well, if you developed COPD, did you also develop dry mouth lost teeth?
• Did you know they recalled about 20,000 of the replacement devices?

 

Conclusion

The Philips Respironics Class I recall announced in 2021 affected millions of its CPAP, Bi-PAP, and mechanical ventilator devices due to health risks from defective polyester-based polyurethane (PE-PUR) sound-reducing foam liner. People who suffered cancer, lung problems, or other injuries after using a recalled Philips machine may file a Philips CPAP lawsuit for potential compensation.

Importantly, the FDA inspection found that a risk analysis was not performed, and no further design change, corrective action, or field correction was conducted in a timely manner. It is important for personal injury law firm intake centers and their specialists to be aware of how Philips handled the foam degradation issue internally as it may impact prospective claimants’ outlook, willingness to pursue a claim, and possibly the outcome of potential legal cases.

Strangely and against the weight of the evidence, Philips mentioned at one point that “no conclusive data linking these devices and the deaths reported” after additional testing was conducted. This appears to be highly inconsistent with legal filings and FDA findings.

A law firm call center should be aware of these findings and use them to help qualify prospective claimants who have been injured as a result of using Philips Respironics’ DreamStation and other recalled breathing machines.