Philips CPAP, BiPAP Recall, Emerging Major Litigation

This article is continuing our coverage of the Philips Respironics Ventilator, CPAP and BiPAP recall. If you did not read our first article, you may want to get up to speed before reading our first article at this link.

Our first article address why the Philips Respironics recalls may not have caught the attention of many law firms and why failing to understand the significance of these recalls would be a mistake for any plaintiffs’ law firm.

The “optics” for any defendant in a mass litigation are as important as any matter of law. This article will explain why the “optics” for Philips in the instant matter are, arguably, horrid.

The Problem and the Optics

The problem: Degradation of the polyester-based polyurethane (PE-PUR) sound dampening foam used by Philips Respironics in the design and manufacture, of a series of recalled Ventilator, CPAP and BiPAP devices.

Based on statements made by Philips, the degradation of the PE-PUR foam can lead to the release of several gaseous Volatile Organic Compounds (VOCs), including diethylene glycol, Toluene Diisocyanate, Toluene Diamine, Phenol Dimethyl Diazine as well as potential inhalation of degraded particles of the sound dampening foam.

The Optics: Exposure to diethylene glycol, resulting in 115 deaths in a two-month period in 1937, was the catalyst for the enactment of the Food, Drug and Cosmetic Act of 1938 and the creation of the modern-day FDA. Eighty-three years later, diethylene glycol is included in the list of toxic chemicals users of Philips Respironics Ventilator, CPAP and BiPAP recalled devices may have inhaled in significant doses (See more below on the history of Diethylene glycol and the creation of the FDA after “The Massengill Incident of 1937”).

These VOCs, when released, are likely to be delivered in high doses to the users of the recalled Ventilator, CPAP and BiPAP devices via direct inhalation.
This article will focus on the VOC, diethylene glycol as it was this toxic substance that led to the broad federalization of Food and Drug Law in the United States.

Given the history of diethylene glycol exposure in the United States, the recent exposure of humans to diethylene glycol presents horrible optics for Philips.

It is worth noting that this is not the first time Mass Tort Nexus has covered issues related to Diethylene glycol exposure to humans from FDA-regulated products. See this link.

MTN is currently compiling intake criteria and supporting clinical research, for the injuries known to be caused by the list of Volatile Organic Compounds (VOCs) associated with these devices. MTN members can obtain more detailed information by contacting Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com.

MTN is also working with MTN member case generation companies, record review companies and other service providers to assist those who assist your firm, in your marketing and case work-up for this major emerging litigation.

It is worth noting that qualifying clients, obtaining the required records and record review for this emerging litigation, will be complex and involve contact with medical providers your firm has likely never had reason to interact with.

The Massengill Incident of 1937

In 1937, a pharmaceutical manufacturer, S. E. Massengill Company, developed liquid oral preparation of sulfanilamide using diethylene glycol (DEG) as the solvent and excipient. The company branded the new drug as “Elixir Sulfanilamide”, Elixir Sulfanilamide, which was a liquid version (for oral ingestion) of the common antibiotic Sulfanilamide, commonly referred to as Sulfa. The diethylene glycol in Elixir Sulfanilamide was blamed for the deaths of approximately 100 individuals over the course of several months after its introduction.

Dr. Samuel Evans Massengill, when pressed to admit some measure of culpability, infamously answered, “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”

Harold Watkins, the company’s chief pharmacist and chemist primarily responsible for the development of Elixir Sulfanilamide, committed suicide while awaiting trial on charges arising from the 105 deaths in 15 states during the months of September and October of 1937.

There have been numerous other international incidents of mass casualties attributed to the ingestion and inhalation of diethylene glycol since the Massengill Incident.

The Food Drug and Cosmetic Act of 1938

The Massengill Incident of 1937 caused a public outcry and pressure on the federal government to revisit the Pure Food and Drug Act of 1906, which did not require drug makers to test products for safety prior to exposing humans to their products.

Congress responded quickly to public pressure, and enacted the Food Drug and Cosmetic Act of 1938, which was signed into law by President Franklin Roosevelt on June 25th 1938.

Eighty-Three Years Later

Jun 14, 2021: Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices.

Diethylene glycol is listed by Philips as one of the toxic substances emitted by the breakdown of the sound dampening foam used in their recalled BiPAP, CPAP and Ventilator devices.

Eighty-three years (to the month) after the Massengill/ Elixir Sulfanilamide incident led to the passage of the Food Drug and Cosmetic Act of 1938, and the ultimate creation of the modern FDA, we again appear to face an incident of a (now) FDA-regulated group of medical devices exposing humans to diethylene glycol, once again.

From an “optics” perspective, exposing individuals to diethylene glycol presents “optics” for Philips that they should never want to be put before a jury.

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MAJOR EMERGING HOME VENTILATOR LITIGATION

As a foreword, this litigation is one your firm should probably be signing clients for, now.

Caveat: The qualifying criteria (injury types) is still developing and will continue to do so.

This article expresses our opinions on possible criteria your firm may wish to consider at this stage of the litigation.

PREEMEPTION

Although we have not completed our review of all FDA approvals of the recalled devices, the fact that these devices are Class II makes it unlikely that any individual approval was sought or granted via the PMA process. Stay tuned.

These devices should not be confused with implantable Upper Airway Stimulation devices, which generally are subject to PMA approval.

THE RECALL

Philips Respironics has thus far issued recalls on a large number of their CPAP and BiPAP devices. See current recalled products at this link. Mass Tort Nexus expects more devices to be recalled.

While these devices are referred to as ventilators, they are not the type of device that you may normally think of when the you hear the word “ventilators.”
The term ventilator is often associated with the types of life-sustaining devices used in hospitals or surgery (when a person can not breath on their own). The use of these devices involves intubation with a tube past the bronchial bifurcation (Carina) to ensure that the air passed from the device to the patient enters the lungs vs the stomach.

WHAT IS CPAP AND BiPAP?

Conversely, CPAP and BiPAP devices, while technically, “ventilators,” are used by patients (generally at home), to mitigate the symptoms and effects of specific diseases, which we will discuss more in-depth herein.

The use of a CPAP and BiPAP does not involve intubation, the user simply places a mask over their nose and/or nose and mouth.

WHO USES THESE DEVICES?

Long term (chronic) users of BiPAP and CPAP devices generally suffer from one of two primary chronic diseases: Obstructive sleep apnea (OSA) and/or Chronic Obstructive Pulmonary Disease (COPD). COPD is more commonly referred to as Emphysema. These devices may also be used for shorter periods of time by individuals suffering from various acute disease states.

How Many Chronic Users Exist?

Based on statistical reports from reliable authorities, MTN estimates that between 8-10 million Americans user either a CPAP or BiPAP on a long term (chronic) basis.

Philips Respironics currently has 62.8% of the market. ResMed is the next biggest player, with a 32.2% share of the market.

For those readers that have taken the MTN Four Days to Mass Tort Success Course, as a matter of first impression, the Potential Plaintiff Numerosity for this emerging litigation appears to be in the hundreds of thousands, and possibly in excess of one million potential plaintiffs.

WHY WERE THESE PRODUCTS RECALLED?

According to reports, these devices used Polyester-based polyurethane (PE-PUR) as sound abatement foam. According to Philips, the recall was due to potential harmful effects (including cancer) caused by the degradation of the foam, allowing particles to enter the body of the user through inhalation. Additionally, Philips reported the outgassing of two toxic gases. Due to the fact that the product users are inhaling these gases directly, it is probable (at minimum) that these device users received far higher doses of these gases than is known to be safe.

ABOUT THE FOAM

Polyester-based polyurethane (PE-PUR) sound abatement foam is used in a wide variety of products as well as for numerous other purposes, such as “sound proofing” rooms. Polyester-based polyurethane is also used in the auto manufacturing industry to decrease the impact of “road noise” on drivers and passengers.

While Polyester-based polyurethane (PE-PUR) products are known to outgas (give off fumes) certain toxic chemicals, when used for the purposes described in the first paragraph, the level of exposure to humans should not exceed safe limits.

Philips Respironics used PE-PUR as a sound dampening material in BiPAP and CPAP devices. BiPAP and CPAP devices are primarily used by sufferers of Obstructive sleep apnea (OSA) and to a lesser extent, those who suffer from Chronic Obstructive Pulmonary Disease (COPD). COPD is more commonly referred to as Emphysema.

Users of BiPAP and CPAP devices affix a device over their nose while they sleep. The BiPAP and CPAP device provides positive pressure to the airways, preventing the airways from closing off during sleep, resulting in hypopnea. A hypopnea is a temporary cessation in breathing, that often causes a sufferer of OSA or COPD to partially awake numerous times during a sleep cycle. These disruptions of REM sleep result in sufferers essentially getting very little “beneficial” sleep. OSA or COPD sufferers often fall asleep while driving, resulting in an increased number of car accidents among those who suffer from these diseases.

Because the air of a BiPAP and CPAP machine is circulated through the device before entering the patients’ airways, any contamination of the air caused by the given BiPAP or CPAP device is breathed directly into the users’ airways (nose, throat, lungs).

The problems reported with the Philips Respironics BiPAP and CPAP devices are twofold:

1. The foam degrades over time. Particles of the foam break away and can directly enter the patients’ airways, ultimately lodging in the lungs.

2. The foam out gases two caustic, toxic chemicals (gasses), which are inhaled by users.

FOAM DEGRADATION

While the negative impact of absorption though inhalation of the gases emitted from Polyester-based polyurethane foam is well documented in the literature, we find no significant prior reports of wide scale inhalation of actual particles of the foam. This is likely due to the fact that Polyester-based polyurethane foam has never been widely used (with the immediate exception) in products that would likely increase human exposure though inhalation beyond safe limits.

HOW DO THE HUMAN LUNGS REACT TO THESE PARTICLES?

Again, for the same reasons stated above, the medical literature is bereft of information on this topic. It is reasonable to assume that when these Polyester-based polyurethane particles lodge in the lungs, the human body will react in one of two ways:

1. The body will attempt to encapsulate the particle (think asbestos/mesothelioma), which would increase the probability of cancer at the site of the particle (lungs).

2. The body is unable to encapsulate the particle, and therefore the particle continues to degrade and is absorbed in the blood stream, and the toxins within are then passed to every organ and anatomical structure of the human body.
We will continue to research the literature on the above topic, as we believe the subject will have been addressed by researchers to some degree, most likely evolving from mass industrial exposures (workers).

OUT GASING

The reported toxic “gases” which users of the recalled devices were exposed via inhalation included:

1. Dimethyl Diazine: Other names include: Azomethane; (CH3N)2; 1,2-Dimethyldiazene; Dimethyldiazene

2. Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) (also called carbolic acid)

Exposure to low doses of Dimethyl Diazine is known to cause a variety of health maladies. As indicated by the weight of the literature, the potential injuries or health maladies most associated with Dimethyl Diazine exposure frequently occur in the kidneys or liver (including organ failure and cancers in these organs); In that the kidneys and liver are the primary elimination pathways of Dimethyl Diazine.

MTN will continue to search the literature for support for other injury types; however, firms that are currently considering signing Plaintiffs for this emerging litigation would be well advised to sign kidney and liver injury (including total organ failure), as well as kidney and liver cancer patients.
Interestingly, Phenol may have therapeutic benefits in treating certain types of cancer, while causing different cancers. MTN has not completed our evaluation of Phenol re: cancer. Stay tuned.

One definite known regarding Phenol is that the substance is highly caustic. Phenol will cause chemical burns on human skin (epithelia cells) if not quickly treated. Epithelia cells are also significantly present the human respiratory system.

Epithelial cells of the lung are located at the interface between the environment and the organism and serve many important functions including barrier protection, fluid balance, clearance of particulate, initiation of immune responses, mucus and surfactant production, and repair following injury.
For these reasons, it may be advisable for firms to investigate cases in which any of the following occurred:

1. Significant respiratory distress leading to secondary injury, primarily heart attack. Screening (by medical professionals) should include ruling out other possible causes of the significant respiratory distress (including prior occurrences pre device use), more likely to be the cause of the current event vs the recalled device(s).

2. Sudden onset total respiratory failure, applying the same medical screening cited above.

LUNG CANCER

Starting with the caveat that MTN has yet to find significant support for low exposure to the subject chemicals (in gas form) causing lung cancer, Pathophysiological and epidemiological testimony offered by experts may suffice to meet the burden of proof (causation) related to these particles and gases, when inhaled or introduced into the body in the dosages and manners present with the subject devices.

The bottom line: If your criteria is too narrow, you are likely to reject cases that might result in a positive outcome for your client. If your criteria turn out to be overly broad, you may sign clients for whom you are unable to achieve a positive outcome. This is nothing new.

CLIENT DEMOGRAPHICS

Diabetics are 83% more likely to suffer from a chronic condition that would lead to the need for the use of these devices, as compared to the general population. If your firm has ever been involved in a litigation involving a diabetes drug, you may want to reach out to these past clients.

While defendants (in kidney failure cases) may argue that that your Plaintiff was predisposed to this injury, that same defendant did not warn that diabetics were at a higher risk of any injury type, than non-diabetics.

Your client population will skew towards males and older individuals. 10% of men and 3% of women aged 30–49 suffer from sleep apnea, while 17% of men and 9% of women aged 50–70 have this disorder.

Individuals who are significantly overweight suffer from sleep apnea at far higher rates than those who are within the normal weight range for their height and body type.

African Americans suffer from sleep apnea at higher rates than Caucasians.

Note: Users of these devices generally purchase the device from Durable Medical Equipment Companies (DME). Additionally, the disposable supplies required to use these devices are marketed by the same DME companies, as well as by online providers.

After consideration of your state’s specific bar rules and HIPAA, you may be able to use the forgoing information to tailor a very targeted client awareness campaign. You will not be filing suit against the DME companies or disposable suppliers.

EXPECTED DEFENSES

Phillips has floated the possibility that certain common solutions (made for the specific purpose) used to clean the parts of BiPAP and CPAP devices may have contributed to the problems with the foam.

The problem such a defense would face raises obvious questions:

Did Phillips warn/instruct users to only use certain cleaning solutions?

Does the problem occur in the absence of the use of these cleaning solutions?

Lastly, having sold these devices for nearly two decades (ending in 1999), I, John Ray, can attest to the fact that cleaning solutions used by end users generally are only used on the disposable components and exterior parts of the device that can be accessed without disassembly, not on the interior of the device where the foam was installed.

Defendants are most likely hoping to gain ground from a 2020 FDA advisory related to approved products for cleaning these devices; however, the advisory lends no support to any argument that the manner in which these devices were cleaned by end users impacted foam on the inside of the device.

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