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Mr. Trotz has handled personal injury cases involving car accidents, trucking accidents, slip and fall, premises liability, and negligent security. Each and every day, Mr. Trotz represents those who have been injured through no fault of their own, and many of his clients have sustained traumatic, catastrophic and life-altering injuries.
On June 14, Philips Respironics issued a formal recall notification for specific Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and mechanical ventilator devices. The recall was due to “identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component of these devices.”
This guide delves deeper into Philips Respironics to help you understand the reason behind the recall and the potential health risks linked to the defective devices.
Sleep apnea is a chronic breathing disorder affecting millions of Americans. It causes patients to stop breathing for at least 10 seconds per apnea event, sometimes hundreds of times a night. The condition results from a partial or complete collapse/obstruction of the upper airway, or a weak signal by the brainstem to initiate breathing.
During apnea events, blood oxygen levels drop and the heart rate increases disrupting the patient’s sleep. That, in turn, affects their sleep quality, daytime focus, and overall health.
Sleep apnea is classified as one of three main types.
Obstructive apnea is the most common and occurs when throat muscles relax. In turn, the patient’s airway closes or narrows as they breathe. This results in lowered blood oxygen concentration.
In response, the brain briefly rouses the patient from sleep to help reopen the airway. This pattern repeats 5-30 times every hour of the night impairing the patient’s ability to experience restful sleep.
Central sleep apnea occurs when the brain sends depressed signals to initiate breathing. Here, the patient makes no effort to breathe for short periods.
This condition is also called mixed sleep apnea or treatment-emergent central sleep apnea. It occurs when one has both central and obstructive types of this disorder.
Treatment for sleep apnea is typically done using device-aided therapy, including CPAP, Bi-PAP, and mechanical ventilators.
A CPAP machine is specially designed for people with obstructive sleep apnea. The device increases air pressure in the airway, preventing it from relaxing and causing an obstruction when you breathe.
A CPAP machine provides continuous pressurized air via a mask that covers your nose and/or mouth. The device pushes air at pressures high enough to keep your airway open. A physician will determine the appropriate air pressure based on your specific needs. Factors that may determine your pressure include weight, anatomy, and the results of your sleep study.
BiPAP machines have similar supplies and attachments as CPAP machines. However, these machines are designed to treat complex sleep apnea, central sleep apnea, or chronic obstructive pulmonary disorder (COPD).
BiPAP machines pump pressurized air into your airways at two distinct pressure levels. That way, you can breathe in at high pressure and breathe out at a lower pressure.
The device helps:
A ventilator helps to mechanically assist or control the patient’s breathing by delivering predetermined amounts of oxygen in the breathing gas.
In apnea treatment, continuous ventilators are set to fluctuate between a predetermined minimum and maximum pressure to deliver the perfect pressure for each breath. The devices track and adjust their pressure to match the patient’s breathing pattern
Philips used polyester-based polyurethane sound abatement foam to dampen the sounds and vibrations in the recalled devices.
The said polyester-based polyurethane (PE-PUR) foam may:
According to Philips’ lab results, degraded polyurethane foam produced potentially harmful chemicals such as:
If you use Philips devices whose foam has degraded, you’re likely to inhale these potentially harmful chemicals. These chemicals may then enter your body, reach the bloodstream, and travel to any body tissue and organ.
Unfortunately, most of the harmful chemicals from the degraded foam are carcinogenic and can cause cancer in living tissues.
CDC warns that Toluene Diisocyanate is present in the foam and is a potential toxin and carcinogen. The United States Environmental Protection Agency (USEPA) cautions that exposure to isocyanates (present in the foam) has many potentially harmful effects. Isocyanates also contain compounds classified as known animal carcinogens and potential human carcinogens. Moreover, the International Agency for Research on Cancer states that the methylene diphenyl diisocyanate, present in polyurethane foam, is a probable carcinogen associated with bladder cancer.
Thus, once these harmful chemicals travel to your organ and body tissues, they can cause mutations and DNA damage that may eventually lead to cancer.
As noted above, polyurethane foam present in the recalled Philips devices contains compounds that are known or potential carcinogens.
Here’s an outline of some scientific evidence linking the exposure to polyurethane foam to different types of cancer.
These issues may be linked to degraded polyurethane foam.
Besides cancer, there are other potential risks linked to exposure to PE-PUR chemicals, such as:
Philips Respironics is a leading manufacturer and distributor of CPAP, BiPAP, and other machines to help treat people suffering from sleep apnea. The company is committed to delivering solutions that result in healthier practices, patients, and businesses.
To date, Philips has produced millions of CPAP, BiPAP, and ventilation devices using PE-PUR sound abatement foam. According to Frans van Houten, Philips’ CEO: 3-4 million devices have been targeted in the recall. 80% of these machines treat sleep apnea, and nearly two-thirds of the machines have been recalled in the U.S.
On June 14, 2021, Philips Respironics voluntarily recalled BiPAP machines, CPAP machines, and ventilation devices distributed between 2009 and April 2021.
This recall was due to the possibility of PE-PUR foam used in the devices:
Philips reported the foam degradation to be caused by:
According to Philips, the highlighted issues can be fatal. They can also cause permanent impairment or require immediate medical attention to prevent the same.
If exposed to degraded foam:
You may experience an inflammatory response, irritation (skin, eye, and/or respiratory tract), asthma, headaches, and adverse effects on body organs.
Philips noted that to date, they have received sizable complaints concerning the presence of black particles/debris within the device’s air path—extending to the device mask, tubing, humidifier, and outlet. They have also received complaints about some of the highlighted health risks above.
If exposed to chemical emissions:
You may experience nausea, headaches, skin irritation, hypersensitivity, carcinogenic exposure, and toxic effects.
According to Philips, they have yet to receive reports of serious harm or health impact due to the issue.
From the recall notification, the company is continuing with the analysis of potential health risks and keeps updating the public with new information. In the meantime, Philips is providing patients and clinicians with information and resources on the potential risks of using affected devices. They are also issuing instructions on the next steps.
The company is also committed to replacing the current PE-PUR foam with new material that’s safe from harmful degradation and off-gassing.
On July 29, 2021, the FDA posted answers to FAQs about the Philips recall. The organization then labeled the device recall as a Class I recall, the most serious scenario.
The FDA is ensuring Philips Respironics evaluates:
The organization is also analyzing MDRs (medical device reports) for the affected devices distributed between 2009 and 2021 to identify any documentation related to the issue. While the FDA does not have evidence that any other devices from Philips and other manufacturers are affected, it’s monitoring the supply and demand of these devices to assess potential shortages.
The organization is also committed to continually share any new information with the public.
Products listed in the Philips recall notification include:
Philips Respironics advises users as follows:
In cases of CPAP and BiPAP devices
Discontinue using the affected CPAP and BiPAP devices and consult your doctor to determine whether the benefits of continued device therapy outweigh the identified potential risks.
In cases of life-sustaining ventilator devices (LifeVent, Trilogy 100, Trilogy 200, etc.)
Do not alter or stop the prescribed therapy without consulting your therapist. The reason is, alternate options to life-sustaining therapy may be limited or inexistent. Disrupting the prescribed treatment may be unacceptable too.
In these cases, the benefit of continued use may outweigh the potential risks. Of course, the doctor must evaluate the situation and offer guidance on the appropriate course of action. If the patient must continue using the defective device, they should put an inline bacterial filter to reduce exposure to the degraded particles. It’s important to note that bacteria filters cannot reduce exposure to VOCs (volatile organic compounds).
Talk to your doctor to weigh the risks of continued use and decide on a suitable way to move forward. This may include:
In the case of at-home care:
Therefore, closely monitor any foam particles/debris on the filter. You should also monitor any airflow resistance through the device after placing the filter.
If you suspect you are having a problem with a BiPAP, CPAP, or mechanical ventilator, report the issue via the FDA’s MedWatch Voluntary Reporting Form.
In the case of health care providers and facilities:
If foam degradation is evident, discontinue the use of the device, if possible, then report the issue via the FDA’s MedWatch Voluntary Reporting Form.
Philips Respironics is offering needed information concerning the recall to relevant regulatory agencies. Philips will replace the current foam with new, safer material and the company has already started the work by obtaining regulatory clearance.
Philips will strive to address all defective devices in the scope of the recall and correction expeditiously.
In the meantime, the company is striving to ensure the supply of sleep apnea devices meets the demand by increasing the production of their DreamStation 2 CPAP machines. This category is not affected by the recall.
Many factors come into play when determining whether you may be eligible for compensation in the Philips device recall lawsuit.
Such factors include:
If you think you have a potential claim, discuss it with our licensed attorneys during a free consultation to determine eligibility. Note, the deadlines for filing claims still apply, so it’s best to contact us right away.
Defective product cases are often different and unique based on the available facts. Overall, faulty equipment/machine claims usually include compensation for:
Yes. Philips is a large organization with extensive resources. They can hire multiple lawyers to defend them from defective device claims. That makes having a skilled and knowledgeable attorney a necessity.
A defective products lawyer is also better poised to evaluate the facts surrounding your case and determine whether you’re eligible. If you’re eligible, they can help you gather all the necessary evidence, such as proof of BiPAP or CPAP use, medical documentation, and other evidence linking your health condition to the defective devices. Furthermore, lawyers have mastered their negotiation skills throughout the years, making them better positioned to get you a better deal/compensation.
If you or anyone you know is suffering serious health conditions like cancer, and you suspect the culprit to be the recalled Philips devices, you (or the affected person) may be eligible for compensation. Let a team of NST Law defective product attorneys review your claim to help determine the legal options that may be available to you.
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