Respirators hazardous to health - Safety warning from Philips

Expired
In mid-June 2021, users of Philips ventilators received a safety warning. The foam used in the ventilators was said to dissolve into microparticles and could enter the lungs of those affected. A recall of the medical devices was ordered in the U.S. instead of a safety notice.
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Schweiz | Österreich | Liechtenstein

The Philips safety notice advises those affected to take the following measures:

 

For patients using life-sustaining mechanical ventilators:

  • Do not interrupt or change prescribed therapy until you have spoken with your physician. Philips recognizes that alternative ventilators may not be available, or may be very limited, for patients who require a ventilator for life-sustaining therapy or in cases where interruption of therapy is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefits of continued use of these ventilators may outweigh the risks.
  • If your clinician determines that you need to continue using this equipment, use an in-line bacterial filter. Refer to your user manual for instructions on installation.

For patients using BiLevel-PAP and CPAP-devices: 

  • Please consult your physician or prescriber before making any changes to your prescribed therapy. Although the risks identified in this letter have led Philips to recommend discontinuation, it is important that you consult with your physician to determine the most appropriate options for continued treatment. Determine with your physician whether the benefits of continued therapy with your device outweigh the identified risks.

The case

The ventilators in question are used to treat sleep apnea, among other conditions.

Philips communicated the following via its homepage (translated into german):

To date, Philips Respironics has received several complaints regarding the presence of black debris/particles in the air duct circuit (which extends from the device outlet, humidifier, tubing and mask). Philips was also notified of headaches, upper respiratory irritation, coughing, chest pressure, and sinus infections.

Potential risks of exposure from chemical emissions from the affected foam include: Headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.

In the official recall of the product in the U.S., Philips stated that these problems can lead to serious injuries that can be life-threatening or cause permanent impairments.

Problematic Decision for the affected
Those affected are in a dilemma: On the one hand, Philips communicates with regard to the affected products that the continuation of therapy with the faulty ventilator should not take place without medical consultation. On the other hand, Philips warns in certain terms that the ventilators are dangerous.

Either way, those affected are faced with a difficult decision. Immediately discontinuing the use of the ventilator can trigger severe medical reactions/risks such as daytime fatigue, breathing cessation, oxygen deprivation, cardiac arrhythmias and even infarction risks etc can occur.

On the other hand, according to Philips, the treating physicians - who have no knowledge about the dangerousness of the defective products due to the lack of studies and expert opinions - should decide about the further use.

This situation is very unsatisfactory for those affected and the consultation of a specialist is urgently recommended.

 

Replacement of a defect-free device - Unwinding the contract
According to Philips' safety warning, the defective medical devices do not have the warranted characteristics. A ventilator is supposed to serve a safe medical treatment and there must not be a risk that the ventilator will transfer harmful foam particles into the lungs of the persons concerned.

Subsequently, it will have to be examined to what extent the defective product suffers from a material defect entitling to the rescission of an underlying contract.

The law firm Amann Partners Attorneys at Law (RA Dr. Maximilian Maier and RA Dr. Alexander Amann) will support the affected parties in asserting warranty claims in Switzerland, Austria and Liechtenstein.

At this point, the attention of the concerned parties from Switzerland is drawn to the particularly short limitation period of Art 201 Abs 3 OR (so-called hidden defect). If the defect of a product becomes known at a later point in time - because the defect was not recognizable at the time of handover of the product - the notification of the defect to the contractual partner must be made immediately after the discovery, otherwise the item will be considered approved also with regard to these defects. For this reason, prompt action is recommended.

Rejecting attitude of legal protection insurances
Since in the past also legal protection insurances in Switzerland have shown a rejecting attitude towards affected consumers in this Causa, the consumers are also supported by the law firm Amann Partners in the notification of the insurance case and the claim settlement with their insurance company.

Future health risks
Whether and to what extent foam microparticles entered the lung tissue of those affected and what health consequences this may have for them is currently unclear due to the lack of substantial medical surveys. If one follows the manufacturer's assumption - that there is the possibility that foam particles decomposed over a longer period of time by the ventilator could have been introduced into the lung tissue of (possibly already ill) patients - the suspicion is very close that this process has left health consequences for the patients. In any case, possible future health consequences may not be excluded without further ado by the persons concerned.

The law firm Amann Partners will assist those affected in asserting their legal claims and will collect data and information in order to be able to substantiate any damages.

Dr. Maximilian Maier

 

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