Defective Devices Archives - Blizzard Greenberg PLLC

Phillips Cannot Seem to Get its Sleep Apnea Recall Right

April 14, 2022/in Defective Devices /by e.blizzard

A company that has issued a product recall already has enough legal risk from the fact that they may have sold a defective product that injured scores of people. When they issue recall instructions, they should certainly be correct. They are only compounding their legal issues if they cannot properly execute their own recall. That is exactly what has happened to Phillips Respironics, as it has been criticized by the Food and Drug Administration for bungling its own product recall.

Phillips CPAP and BiPAP Users Were Injured by Defective Devices

Phillips was forced to recall hundreds of thousands of devices used to treat obstructive sleep apnea. The problem was that Phillips used a piece of foam to insulate against noise when the device was placed on a flat surface, such as a nightstand. For many users, this foam degraded over time, and the particles made their way into the lungs of patients using the machine. The polyurethane foam contains numerous toxins that patients should not be inhaling. Some patients suffered from the following side effects:

Headaches
Airway irritation
Permanent lung damages
More serious life-threatening injuries that come from breathing in particles of toxic foam
Cancer-causing effects from inhaling chemicals

The Repair Kit Provided Was No Safer than the Existing Defective Device

Phillips’ recall solution provided to customers seemed to be a quick fix designed to move as much of the problem as it could out of its own hands and into the consumer’s. The company provided a silicone foam repair kit to patients for them to remove the damaged foam from their CPAP machine and replace it themselves. Theoretically, this may have worked if the silicone substance itself were safe. However, this recall was an instance in which Phillips was replacing one defective solution with another.

The FDA was clearly alarmed by the fact that Phillips apparently knew of the degradation problem with its sound abatement foam for years but kept selling the product. The FDA decided to take a more active and hands-on approach to the recall, conducting its own investigation through site visits. The agency wanted to learn more about what happened.

The FDA Is Learning the True Scope of the Problem

One visit that the FDA made was to the manufacturing plant where the silicone insert was being made. During this visit, the FDA learned that the silicone-based foam might be no safer than the polyurethane foam that sickened and injured scores of patients.

The specific problem was that the silicone insert failed one key safety test of its own. This test revealed that the silicone insert could release its own “chemicals of concern” that patients could inhale in their sleep. These are volatile organic compounds that can sicken patients.

Phillips had conducted its own testing of the silicone inserts, and its results did not have similar findings. As a result, the FDA has ordered Phillips to conduct independent third-party testing on the safety of the silicone inserts. In the meantime, the FDA is not recommending that patients discontinue their use of the machine, given the critical (and potentially life-saving role) that these CPAP machines perform.

Patients are not left with any alternatives that have been tested and confirmed to be safe. It would be extremely dangerous for a patient with obstructive sleep apnea to stop using a sleep apnea machine altogether. Yet Phillips’ mishandling of the recall and providing a solution that is still potentially dangerous prolongs the problem for patients and makes it worse.

The FDA Has Been Very Critical Of Phillips

The FDA has specifically noted that Phillips’ efforts to notify its customers of the recall to date have been “inadequate.” In March 2022, the FDA took two actions that showed its frustration with Phillips:

On March 10, 2022, the FDA issued a notification order to Philips Respironics that directed the company to notify its customers of the June 2021 recall. To date, the FDA found that the company’s efforts to notify patients of the recall were “inadequate.”
On March 14, 2022, the FDA added information to its FAQs on its website that expressed concern with how Phillips is prioritizing the distribution of replacements to its customers. The first-come first-serve may not adequately address the dangers that some patients face. Some patients may be forced to continue using a dangerous product while they wait for a replacement part to be delivered.

At this point, the FDA is still trying to determine whether Phillips violated the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. The FDA has already conducted an inspection, and it is reviewing the results of the inspection.

None of this bodes well for Phillips in its attempts to defend against the growing number of lawsuits filed by people who were injured by its sleep apnea CPAP and BiPAP machines. There is mounting evidence that the company knew about these defects for years and did nothing to recall the product from the market until the company had a new line of products ready to go.

Call a Phillips Sleep Apnea Lawsuit Attorney

If you or a loved one have been using a Phillips Respironics sleep apnea machine and have sustained the injuries described above, you may be entitled to financial compensation. Hundreds of people have been filing product liability lawsuits against Phillips, and evidence is emerging that Phillips knew about this issue for years. Call the attorneys at Blizzard Greenberg at (866) 560‑1867 or contact us online to schedule your free initial consultation.

American Academy of Sleep Medicine Issues Guidance on CPAP Recalls

February 14, 2022/in Defective Devices /by e.blizzard

It has been difficult for users of Phillips CPAP and BiPAP machines to get the facts underlying the recall involving the devices they use. They certainly cannot trust the company itself. First, Phillips hid the defects for years until it could bring a new line of products to the market. Second, the company tried to replace the defective part with one made of a different material that could be equally dangerous. The American Academy of Sleep Medicine (AASM) has given guidance to patients about whether to continue using Phillips devices in the wake of the news of the defect.

Phillips CPAP and BiPAP machines contain a layer of polyurethane foam that is used as sound abatement. The problem is that the foam breaks down over time. The machine has tiny bits of chemical particles in it that users breathe in continuously at night. The breakdown of the foam also released harmful chemicals. Patients who have used the machine for an extended period of time could develop cancer or suffer from organ damage.

Phillips Knew About this Problem for Years

Phillips’ proposed recall solution was really not much of a solution. The FDA initially approved Phillips’ recall plan, which was to send consumers a kit to replace the polyurethane foam with a silicone-based foam. However, the FDA learned that the silicone foam failed at least one safety test. After Phillips had sent out 250,000 kits, the FDA reversed course on the recall. Now, consumers must make a decision about whether to keep using their machines, knowing that they are defective and dangerous.

Patients Should Work with their Healthcare Provider

The AASM’s guidance was to tell patients to make their own decision in concert with their doctor. The ideal thing would be for patients to be able to use a machine that is not subject to the recall. However, the AASM recognized that this is not always possible. The average CPAP machine can cost between $400-600. Machines with more advanced features can cost more. Many patients cannot afford the cost of a new CPAP machine, especially during these tough economic times. Health Insurance companies may refuse to cover the cost of a new device if they already paid for one.

On the other hand, there is a danger for the patient to stop using the machine, especially considering what it treats. Sleep apnea could cause a patient to stop breathing during their sleep. It may not be safe for someone to suddenly stop using the machine and go without a CPAP machine entirely.

Factors to Consider in Your Decision About Using Your CPAP Device

According to the AASM, the patient needs to consult with their doctor and consider their own unique situation before they make a decision about using the machine. Specifically, the patient and their doctor should bear the following in mind:

Comorbidities
Severity of symptoms
Risks associated with PAP discontinuation
Safety-sensitive roles

Regardless of what decision you come to with your provider, this is a conversation that you should have as soon as possible – if you have not done so already. Some patients may have such severe issues that doctors will advise them to keep using the current machine until the problem can be fixed. Others may suggest that you stop using the devices temporarily.

The American Thoracic Society has issued similar guidance, namely that patients should not stop using the machines on their own. Some may need to continue using it in spite of the risks until they can get a replacement for the defective machine or its parts.

Product Liability Lawsuits Against Phillips

Even if users are forced to continue using the older CPAP machines while waiting for a suitable replacement, they can still file a lawsuit against Phillips for the defect. There are several theories that could entitle plaintiffs to financial compensation:

The use of polyurethane foam that could degrade over time and sicken users makes the product unreasonably dangerous and is a design defect.
The fact that Phillips knew of the design defect for so long (some estimates say six years) and did not warn of the danger is a marketing defect.

In addition, lawsuits will likely allege that Phillips committed fraud by intentionally withholding information about the product defects until there was a new line of products available to be sold.

In their latest earnings guidance, Phillips explained that quarterly earnings had taken a hit from the effects of the recalls. Now, the company estimates that there were 5.2 million devices affected by the recall globally. This will likely lead to a surge of lawsuits in the United States. The number of cases has topped 200, but we expect it to grow into the thousands.

If you have used a Phillips CPAP machine and have been diagnosed with mouth, nose, throat, or lung cancer or other significant lung problems, you may be entitled to financial compensation.

Hire a Houston Product Liability Lawyer Today

Blizzard Greenberg, PLLC helps injured consumers go after large companies like Phillips when their products have hurt people who trusted them. We are not afraid of large corporations or their lawyers, and we will take the fight to them. Call us today at (866) 560-1867 or fill out a contact form online to schedule your free initial consultation.

Philips CPAP Recall: Foam Can Cause Cancer

January 25, 2022/in Defective Devices /by e.blizzard

Sleep apnea is a condition that causes people to stop breathing for a short period of time in their sleep. Physicians often prescribe sufferers a machine to use when they sleep. In April 2021, Phillips alerted the public to safety issues with its popular CPAP and BiPAP machines, namely that patients were ingesting and inhaling dangerous chemical particles from the machine itself. These are devices meant to help people with obstructive sleep apnea sleep safely at night and continue breathing steadily. A CPAP device consists of a mask that is connected to a hose that delivers steady air pressure. The hose is connected to a compressor that pressurizes the air and forces it through the tube.

Phillips itself is the one that noticed the issue and voluntarily recalled the machines. The FDA gives recalls their own rating based on the potential dangers. This recall was a Class I, which is the most serious type of recall reserved for those that “will cause serious adverse health consequences or death.”

Phillips Knew About This Issue for Years But Did Nothing

The timing of the recall notice seems somewhat suspect. Phillips had snuck the announcement in one of its quarterly filings with the SEC. At the time that Phillips discovered the defect in its DreamStation CPAP, the company had just released the next generation of its product. It is difficult to believe that Phillips just learned about the problem right when it issued the recall. In fact, Phillips is being sued by one of its suppliers who alleges that Phillips blamed its product for the dangers when Phillips knew about the problem with the foam for years. In fact, an FDA investigation found that Phillips received hundreds of thousands of complaints about this exact issue before issuing a recall.

Phillips did not recall the machines for almost two months after its regulatory filing detailed the problem. This recall affected roughly 750,000 devices. These CPAP machines were manufactured over a 12-year period. Those who are using older machines likely have a higher risk of injury because they have been breathing in harmful particles for a longer period of time.

Phillips did not replace the device entirely. Instead, it provided users with a kit to repair and replace the device. The company has sent out over 250,000 repair kits, but there are also issues with the proposed remedy. In the meantime, users were not told to stop using their devices. Instead, they were only told that they should consult with their doctor about the next steps.

The Foam in the Sleep Apnea Machine Releases Harmful Particles and Chemicals

Sleep apnea devices are not quiet. There are vibrations in the machine itself. When it is placed on a flat surface (as it is supposed to be), the sound can reverberate off the nightstand. So, the same device that is meant to help you sleep could actually keep you awake. With that in mind, the manufacturers of this CPAP device decided to design the machine with a layer of foam insulation that was intended to absorb the sound.

The specific type of foam in the Phillips CPAP machine is polyester-based polyurethane. These are commodity plastics that are made with a blowing agent such as carbon dioxide or pentane. Polyurethanes are made as the result of a chemical process, and they include numerous catalysts, chemicals, and materials that could be dangerous to human health.

The problem is that the sound abatement foam does not stay intact over time. When it is placed inside an active working machine, the foam can degrade and break down. There are several possible outcomes for the disintegrating foam:

Since air comes through the machine and is breathed in by the patient, they may ingest particles of foam into their airways and lungs.
The degraded foam may release certain chemicals into the airway that the patient breathes in when they sleep.

Potential Injuries from Phillips Sleep Apnea Machines

Either way, the patient may ingest harmful substances. Beyond the risk of irritation to the eyes and respiratory tract, there are even more serious side effects. Some of the major risks of inhaling or ingesting these dangerous substances include:

Damage to internal organs
Cancer
Inflammatory responses

In the wake of the recall, the FDA sought to learn more information about the product defect and how it happened. The FDA is also looking into the safety of the repair kit that CPAP machine users received, which replaced the polyurethane foam with silicone. Silicone has its own safety problems according to some scientific studies. Phillips may have traded one problem for another, as a silicone-based product failed one safety test overseas.

It is too early to tell how many people have been injured by this defective CPAP device. At the time of the initial recall, the FDA cited over 100 reports of injury. It is likely that the real number is far higher.Injured Consumers Are Filing Lawsuits Against Phillips

By the end of 2021, there had already been over 100 lawsuits filed by people claiming personal injury from a defective CPAP machine. Given the dangers of sustained ingestion of these dangerous chemicals, we expect the number of lawsuits to grow substantially. There is already multidistrict litigation in federal court that is moving forward.

One of the first lawsuits was filed by a patient who was diagnosed with lung cancer in June 2021. He had used a Phillips sleep apnea device for six years. There are likely many more people like this plaintiff who will come forward.

Contact a Phillips Sleep Apnea Defective Products Lawyer

If you or a loved one have used a Phillips CPAP or BiPAP device and have suffered one of the injuries above, you may be entitled to significant compensation. The attorneys at Blizzard Greenberg PLLC can help… Call us today at (866) 560-1867 or contact us online to schedule your free no-risk consultation.

What You Need to Know About Your CPAP and Cancer

October 29, 2021/in Defective Devices /by e.blizzard

Users of recalled Philips devices used to treat sleep apnea may have been exposed to toxic chemicals and carcinogens. As a result, the company has issued a recall for several products. The recall includes bilevel positive airway pressure (BiPAP), adaptive-servo ventilation (ASV), and continuous positive airway pressure (CPAP) sleep apnea devices. Disintegrating polyurethane foam (PE-PUR), used to soften both sound and vibrations given off by these products, was discovered inside the air pathway of the device and is potentially linked to an increased risk of developing certain cancers.

The company has advised those who depend on the recalled devices to discontinue use immediately and find an alternative option. They are currently in the process of either repairing or replacing the affected devices. Users of Philips CPAP, BiPAP, or ASV machines that utilize them as life-saving devices might continue using their devices if their healthcare provider determines that the benefits outweigh any potential risks. If you or a loved one has suffered from lung problems or other injuries or has been diagnosed with cancer after using a recalled Philips device, you could be entitled to compensation.

Sleep Apnea Basics

While many cases of sleep apnea go undiagnosed, approximately 22 million Americans knowingly suffer from the disorder. According to the American Sleep Apnea Association, there are three primary types of sleep apnea. Obstructive sleep apnea is the most common and occurs when your throat muscles are relaxed. Central sleep apnea happens when your brain fails to send the appropriate signals to the muscles that control your breathing. When someone suffers from central and obstructive sleep apnea, it is known as treatment-emergent or complex sleep apnea.

Here are some of the most common symptoms to look out for if you think you may be suffering from sleep apnea:

Daytime fatigue
Low energy throughout the day
Waking up with a sore throat
Experiencing dry mouth in the morning
Irritability
Insomnia

Because lifestyle modifications like losing weight or quitting smoking do not always work for everyone, considering therapies like CPAP devices may be a patient’s only option. In severe cases, nasal or sinus surgeries may solve the problem. Sleep apnea restricts a person’s body from receiving an ample amount of oxygen at night which can lead to life-threatening diseases like diabetes, heart disease, or cancer. If you are suffering from sleep apnea, you should seek the advice of a medical professional as soon as possible.

Why is Exposure to Polyurethane Foam Dangerous?

The development of malignant diseases, including cancer, may arise from inhaling the urethane in polyurethane foam because it is a possible carcinogen. While intact, PE-PUR foam is harmless; when broken down by high heat, humidity, or unapproved cleaning practices, it emits hazardous chemicals.

Here are some harmful chemicals emitted by recalled Philips devices when the foam decomposes:

Formaldehyde — can cause nasal cancer if inhaled regularly.

PFOS — fluorinated chemicals belonging to the PFAs category can lead to several different types of cancer, including liver, kidney, bladder, and pancreatic

Dichloromethane — also known as methylene chloride, can cause non-Hodgkin lymphoma, multiple myeloma, liver cancer, and lung cancer.

Benzene — a chemical that damages a cell’s DNA, can cause several types of cancer, including breast and lymphatic cancer.

Solvents — may lead to stomach, bladder, lung, or hematopoietic cancer.

Volatile organic compounds (VOCs — have been linked to various types of nasal cancer).

Flame retardant — has been linked to learning disabilities, thyroid and liver cancer.

If you were exposed to PE-PUR from a Philips recalled device, you may experience irritation of the nose or throat, inflammation in your respiratory tract, nausea, dizziness, or passing out. Heavy exposure may damage the kidneys, liver or affect your bone marrow over time.

Some potential diseases PE-PUR foam may have exposed users of Philips recalled machines to include:

Breast cancer
Brain cancer
Non-Hodgkin lymphoma
Nasal cancer
Leukemia
Stomach cancer
Liver cancer
Bladder cancer

We encourage you to contact our team of exceptional defective medical device attorneys to determine if you are eligible to file a claim for a defective Philips device. If you used your device for at least six months, have developed a disease directly linked to PE-PUR foam, and file your claim within the statute of limitations, you may be eligible to seek compensation for your injuries. Our initial consultation is always free, and we are ready to carefully assess your situation and determine whether you qualify to seek compensation for a concerning diagnosis.

What Should I Do If My Device Was Recalled?

Visit Philips’s website to determine if you are using a recalled device; you can do so by looking up your device’s serial number. Upon determining that your device is affected, you may begin a claim on the company’s website. You should stop using any recalled Bilevel PAP, CPAP, or ASV right away. Schedule a visit with your primary healthcare provider to determine if you have suffered any adverse effects after using a recalled Philips device.

If you cannot wait for a new device, you should still talk to your doctor to determine if continuing use of the device benefits you more than puts you at risk. Your doctor will provide you with alternative treatment options and advice on the next steps you should take to safeguard your health. Our CPAP cancer lawyers have the right experience to assist you in filing a defective medical device claim. The time you have to file is limited, which is why you should not hesitate to reach out to one of our knowledgeable attorneys.

Why File a CPAP Lawsuit?

If you or a loved one was injured after using a Philips recalled device, you have the right to file a claim and receive potential compensation. Our CPAP cancer attorneys will investigate your claim on your behalf to see if your case is eligible. Because potential health risks associated with using Philips recalled devices range from minor to potentially life-threatening, you should speak with your doctor as soon as possible to address any symptoms of complications you may be experiencing. Seeking compensation for your damages can not only help pay for your immediate injuries but also any future medical bills you may incur. While Philips CPAP lawsuits remain in their initial stages and no settlements have been reached, you should not accept financial responsibility for your pain and suffering. Call us at (866) 560-1867 or contact us online to schedule your no-obligation consultation today.

How a CPAP Cancer Attorney Can Help You

October 29, 2021/in Defective Devices /by e.blizzard

When you have trouble getting sleep at night or have a medical condition that makes it challenging to get the good night’s rest your body needs, not only is it frustrating but detrimental to your health. People who suffer from sleep apnea turn to breathing devices and ventilators as a solution. CPAP machines or continuous positive airway pressure therapy devices are used to treat obstructive sleep apnea. Patients struggling with sleep apnea often use these kinds of devices on a nightly basis to maintain a normal breathing rhythm as they sleep. Specific devices made by Philips Respironics, including their Bi-Level Positive Airway Pressure machine (Bi-Level PAP) and CPAP machines, may have put users at risk by exposing them to potentially cancer-causing compounds.

The company has recalled millions of these devices and has advised owners of C-PAP and Bi-Level PAP machines to discontinue use immediately. Patients using their mechanical ventilator as a life-sustaining device should continue using their machine and contact their doctor to discuss alternative options. At Blizzard Greenberg, our defective medical devices lawyers are prepared to advocate on your behalf. If you or a loved one has suffered serious side effects or been diagnosed with cancer after using a Philips breathing device, you may be entitled to compensation. Read on to discover how one of our CPAP cancer attorneys can help you get the justice you deserve.

What is Sleep Apnea?

According to the American Sleep Apnea Association, approximately 22 million Americans suffer from sleep apnea. There are multiple different types of sleep apnea, and about eight million Americans use CPAP Machines to treat this disorder.

The three primary types of sleep apnea are:

Obstructive sleep apnea -— is the most common type of sleep disorder. This form of sleep apnea happens when a person’s throat muscles relax, and their breathing repeatedly stops and starts.

Central sleep apnea -— this form of sleep apnea happens when a person’s brain fails to send the right signals to the muscles responsible for controlling your breathing.

Complex sleep apnea -— when a person has central and obstructive sleep apnea, it’s known as complex sleep apnea or treatment-emergent central sleep apnea.

While anyone can suffer from sleep apnea, including children, there is some risk factors that could put you at an increased risk. These risk factors include having narrow airways, being overweight, smoking, having a history of sleep apnea, having diseases like high blood pressure or type 2 diabetes, being older, or being male. If you suffer from sleep apnea, it is recommended that you seek out the advice of a medical professional.

Some common signs or symptoms of sleep apnea include:

Dry mouth
Irritability
Loud snoring
Episodes of stopped or shallow breathing
Daytime sleepiness

If sleep apnea is left untreated, it can cause you to have significant health issues such as developing high blood pressure, Type 2 diabetes, or suffering from a sudden heart attack. CPAP machines mitigate the effects of sleep apnea, so addressing recent issues with these devices is essential.

Why Were Philips CPAP Devices Recalled?

CPAP Machines are used by fitting a face mask over the user’s mouth and nose during sleep. These devices provide the user with a steady flow of oxygen that increases the air pressure in their throat and keeps their airways open. BiPAP machines are often used by individuals who cannot tolerate a CPAP machine. Users of both CPAP and BiPAP devices use them regularly every night.

Philips announced a recall of their CPAP and BiPAP devices and ventilators because of a defect with the polyester based polyurethane foam (PE-PUR) used in the machine to absorb noise and vibration. When this foam is broken down, it releases compounds and toxic chemicals that could potentially cause cancer or other health hazards. Some users have reported seeing black debris in the air pathway. While the reason for the degrading foam remains unclear, the company cites that exposing the device to high heat, humidity, or unapproved cleaning methods could intensify the breakdown rate of the foam.

How Would I Know If My CPAP Machine is Causing Me Harm?

Seeing your doctor is the best and most accurate way to determine if using one of the recalled Philips CPAP devices has been hazardous to your health. You may be unaware of a serious issue that your primary healthcare provider should address as soon as possible.

Some potential side effects you may experience from the emitted particles include:

Headache
Skin or eye irritation
Irritation of the respiratory tract
Coughing
Dizziness
Sinus infection
Nausea
Chest Pressure

If you are experiencing any of the listed side effects, do not hesitate to speak with a medical professional as soon as you can. You may be entitled to financial compensation if you believe that your Philips CPAP or BiPAP machine is responsible for your illness.

What If I Suspect My CPAP Machine Caused My Cancer?

The company has not currently revealed the number of patients affected by a recalled Philips CPAP machine. However, if you have suffered side effects or adverse health issues after using a Philips recalled device, you may be able to file a defective product lawsuit. Speak to your doctor immediately if you suspect that your illness is related to toxic chemicals the device may have exposed you to.

Call Us Today to Schedule a Free Case Evaluation with a CPAP Cancer Lawyer

When a physician prescribes a device for a medical condition you are struggling with, the last thing you expect is for your illness to get worse. At Blizzard law, our compassionate and dedicated team of defective medical device lawyers understand that the consumer should not be responsible for damages caused by defective products. If a company knowingly produced and sold a dangerous device that directly contributed to your injuries, they will have an obligation to right their wrong.

Contact our office at (866) 560-1867 or send us an email to schedule a meeting with one of our product liability lawyers today! Our initial consultation is always free, and one of our expert attorneys can help you determine if you are eligible to pursue compensation.

Did Your CPAP Cause Cancer?

September 21, 2021/in Defective Devices, News /by e.blizzard

Philips announced a voluntary recall on June 14, 2021, for its Philips Continuous Positive Airway Pressure (CPAP), Adaptive-Servo Ventilation (ASV), Bi-Level Positive Airway Pressure (Bi-PAP) devices, and mechanical ventilator machines. CPAP is a small machine used to deliver pressurized humidified air via a hose and mask put over the user’s nose or mouth. The purpose of CPAP is to keep the user’s airways open as they sleep. The company claims that CPAP can also decrease episodes of shallow breathing, breathing pauses while sleeping, lessen daytime fatigue and lower the user’s chances of heart disease, vascular disease, and stroke.

If you or a loved one has suffered lung problems, cancer, or other injuries after using one of the recalled Philips machines, you may be entitled to compensation. At Blizzard Greenberg, our exceptional personal injury attorneys can help you determine if filing a CPAP lawsuit is in your best interest.

Why are CPAP Machines Being Recalled?

Philips recalled an estimated 2 to 3 million devices due to a product defect that potentially exposed its users to carcinogens and toxic chemicals. When polyester-based polyurethane (PE-PUR) sound abatement foam is broken down in these devices, it releases hazardous particles and gases that can potentially harm a person’s health if inhaled or swallowed. There is no way to avoid the risk of decomposing polyurethane foam if you have used one of these machines.

Here are some chemicals you could be breathing from your CPAP machine:

Benzene – has been linked to certain cancers, including leukemia. May damage a cell’s DNA when inhaled.

Solvents – have been linked to stomach, lung, bladder, and hematopoietic cancer.

Perfluorooctanesulfonate (PFOs) – has been associated with higher risks for breast, bladder, kidney, pancreatic, prostate, and testicular cancer. These compounds fall under the category of PFAS.

Methylene Chloride or Dichloromethane – has been linked to lung and liver tumors, NHL, brain cancer, and multiple myeloma.

Formaldehyde – has been linked to forms of nasal cancer.

Flame Retardant – has been associated with damage to cellular DNA, learning disabilities, thyroid, and liver cancer.

Volatile organic compounds (VOCs) – have been linked to nasopharyngeal or nasal cancer. Approximately two-thirds of these machines were sold in the U.S.The FDA identifies the CPAP recall as Class 1, the most severe type of recall. According to a statement released by the company, the use of ozone cleaning machines, an unapproved cleaning method, and high heat and humidity can exacerbate the problem.

While the analysis of potential health risks remains ongoing, you should not hesitate to see your primary care physician as soon as possible if you’ve used a Philips breathing device to treat sleep apnea or other respiratory issues. Your doctor will discuss alternative treatments and advise you to immediately stop using the Philips CPAP or other recalled ventilation devices.

CPAP Foam Exposure Symptoms

Over time, the patented sound abatement foam contained in Philips sleep and respiration devices breaks down. When this happens, the foam, made from polyester-based polyurethane, deteriorates and emits toxic gases. When carcinogen-tainted air is funneled into the body, it can lead to several different serious illnesses.

Some immediate symptoms users of these devices may experience include:

Feeling nauseous
Vomiting
Dizziness
Inflammation
Headache
Hypersensitivity
Respiratory issues
Irritation to skin, eyes, or respiratory tract
Cognitive difficulties

Respiratory issues suffered after using one of these devices may be worse in patients with lung disease.

Some additional injuries caused by absorbing these foam particles include:

Heart problems
Liver failure
Kidney failure
Respiratory failure

Although the company has received limited reports of health issues and further investigation is warranted, you may be at an increased risk of developing cancer or suffering other injuries if you have used a recalled Philips CPAP machine.

Here are some types of cancers commonly associated with PE-PUR foam particles:

Leukemia
Hematopoietic cancer
Non-Hodgkin’s lymphoma
Bladder cancer
Nasal cancer
Stomach cancer
Lymphatic cancer
Prostate cancer
Lung cancer
Liver cancer
Testicular cancer
Multiple myeloma

As of June 14, 2021, there have been no reports of health issues or deaths related to gas emissions from a Philips CPAP machine. However, some users have noticed black particles in the air path circuit. Because the defective CPAP devices may potentially cause cancer, you should speak to your primary care physician as soon as possible.

Can You File a Lawsuit?

If you use any recalled BiLevel PAP or CPAP device, discontinue use altogether and talk to your doctor about the risks of using one of these devices. Your physician can help you make the right care decisions based on your unique circumstances and advise you on what steps should be taken next. Your doctor might also be able to recommend safer alternatives. If you have used a Philips recalled device and suffered health issues, you may consider filing a lawsuit. Injuries such as a cancer diagnosis after using a Philips sleep device, developing respiratory problems, or organ damage may also be included in a potential lawsuit.

Contact Blizzard Greenberg for a free consultation

Filing a lawsuit not only holds Philips accountable for your health or the health of your loved one at risk, but it may also be able to help you pay for any past and future medical expenses. Our lawyers can assist you in evaluating your eligibility for a CPAP lawsuit free of charge. Let our Houston medical device attorneys investigate your claim and help you recover the compensation you desire for your suffering. The deadline to file a claim is limited; talk to one of our exceptional medical device attorneys at Blizzard law as soon as possible. Contact us at 866-560-1867 today for a free consultation and case evaluation.

The Intertwined History of Pelvic Mesh and Hernia Mesh

October 23, 2017/in Defective Devices /by e.blizzard

For women suffering from pelvic organ prolapse, pelvic mesh seemed like a miracle cure. Unfortunately, the lack of clinical testing of pelvic mesh products led to massive recalls and lawsuits after women began experience debilitating and permanent injuries. Transvaginal mesh injuries are the same types of injuries suffered by hernia mesh patients, which should come as no surprise considering both products are made out of the same material. This has left many hernia mesh victims wondering why manufacturers didn’t take the hint.

For women who have given birth or patients who have undergone surgery, the pelvic muscles can stretch and weaken causing organs like the bladder to sink lower in the body than normal. This is called pelvic organ prolapse and in the late 1990s, the first pelvic mesh was developed to treat the condition. Pelvic mesh is made out of polypropylene plastic, a material that is cheap to produce and abundantly available. Polypropylene plastic is also preferred because it is not biodegradable and it will not absorb into human tissues.

Three years after hitting the market, pelvic mesh products were subject to recalls. However, the original approval allowed other pelvic mesh devices to be approved through the controversial 501(k) approval process. The U.S. Food and Drug Administration (FDA), allows medical devices and prescription drugs to go through a much less stringent approval process if the device or drug is similar to one currently approved by the FDA.

Even though the first pelvic mesh product was eventually recalled, its approval allowed for the eventual approval of nearly sixty more pelvic mesh products. None of these devices were ever subject to clinical studies to prove their safety and efficacy. As a result, patients were unaware of the dangers associated with pelvic mesh, including bleeding, erosion of the device, the abnormal connection of two organs or tissues, nerve damage around the mesh, and migration of the mesh. Now thousands of woman are suffering from mesh erosion, vaginal scarring, urinary incontinence, painful intercourse, injury to the bladder, and other debilitating injuries.

Pelvic organ prolapse and hernias were once thought to be very similar conditions, so manufacturers designed hernia mesh based on pelvic mesh devices. Hernia mesh products produced a similar history when the FDA began recalling hernia mesh devices for causing complications. However, through the 501(k) approval process, dozens of hernia mesh manufacturers flooded the market. Because it is made out of the same material as pelvic mesh, hernia mesh has produced similar complications, including producing scarring, inflammation, bleeding, nerve damage, migration, and the connection of two organs.

All patients deserve to know the risks associated with medical devices and procedures. Both pelvic mesh and hernia mesh patients were not warned of the dangers, even after polypropylene plastic mesh products proved to be dangerous. The dangers of this type of mesh have been well known by manufacturers for over ten years, but to preserve profits, manufactures did not warn patients.

What’s Wrong With Zimmer Biomet Shoulder Implants?

October 9, 2017/in Defective Devices /by e.blizzard

For over seven years, shoulders implants with high rates of fractures have been used in thousands of patients. The Zimmer Biomet Shoulder Implant has caused many patients to suffer permanent and debilitating injuries, including lack of function, lack of mobility, and chronic pain.

What Is The Zimmer Biomet Shoulder Implant?

The Comprehensive Reverse Shoulder device manufactured by Zimmer Biomet is used in reverse shoulder replacements. Reverse shoulder replacements are much less common than ordinary shoulder replacements and are usually performed on large rotator cuff tears that have caused arthritis in the joint. Many patients undergoing a reverse shoulder replacement have already undergone unsuccessful shoulder replacement surgeries.

During a normal shoulder replacement surgery, an artificial implant is used that is designed to replicate the normal anatomy of a shoulder. However, in a reverse shoulder replacement surgery, the artificial joint is designed to be the opposite of arm’s natural anatomy. By working in reverse, the joint and shoulder utilize different muscles in the arm for movement.

A reverse shoulder implant can be beneficial for patients who have suffered a rotator cuff injury because the shoulder will rely on the deltoid muscle, rather than the previously injured rotator cuff, to operate the arm.

A History of Recalls

Several models of Zimmer Biomet’s reverse shoulder implant have been recalled throughout the years. The device was approved in 2008, and by 2010 the company recalled certain implants after receiving reports of device fracture. However, in December 2016, Zimmer Biomet initiated another recall of some of its reverse shoulder implants after more reports of device fracture. Several months later, the U.S. Food and Drug Administration (FDA) issued warning letters to patients and surgeons cautioning that the fracture risk associated with Zimmer Biomet’s reverse shoulder implants is much higher than what the company advertised on the label.

When a Zimmer Biomet shoulder implant fails, it can cause a variety of dangerous conditions for patients. Fractures in the implant can require additional surgeries, cause permanent damage, permanently limit mobility, and cause chronic pain.

Pelvic Mesh Manufacturer Settles For $750 Million

August 22, 2017/in Defective Devices /by e.blizzard

For women suffering from pelvic mesh complications, holding the manufacturers responsible for their defective devices is incredibly important. Luckily, for some victims, a resolution to their claims has finally arrived. One popular pelvic mesh manufacturer, Endo International PLC, has agreed to pay $750 million to settle 22,000 pelvic mesh lawsuits.

Women have been complaining of severe complications from vaginal mesh products for many years, and in 2016, Endo decided to shut down one of its units that was producing the devices. The decision came after the company was faced with thousands of pelvic mesh lawsuits.

This latest settlement is not the first the company has made. Endo has agreed to several large settlements over the past few years totaling $2.6 billion. Endo might now be able to wash its hands of the defective devices, but other manufacturers are still drowning in tens of thousands of transvaginal mesh lawsuits.

Healthcare giant Johnson & Johnson (J&J) is facing over 54,000 pelvic mesh lawsuits. Unlike Endo, J&J has gone to great lengths to fight its defective mesh lawsuits in court, but the company hasn’t been very successful. This past January, the first pelvic mesh case to go to trial against J&J was finally concluded when the Supreme Court of New Jersey declined to hear an appeal from the manufacturers. The original verdict awarding the plaintiff $11 million in damages was upheld. J&J has lost four consecutive pelvic mesh trials, including the most recent verdict in June that awarded the plaintiff $2.16 million in damages.

Endo’s settlement and J&J’s courtroom losses are having a profound effect on pelvic mesh litigations against other manufacturers. Other manufacturers like Boston Scientific, C.R. Bard, and Cook Medical, among others, might decide to follow Endo’s example and settle their losses now, rather than suffer J&J’s multiple multimillion-dollar losses in court.

Court Rulings Will Stick

The first transvaginal mesh case to go to trial finally came to a conclusion in January 2017. The plaintiff was a South Dakota woman named Linda Gross who experienced severe complications from the transvaginal mesh product she had implanted. Although Ms. Gross’s trial concluded in 2013, device manufacturer defendants Johnson & Johnson and Ethicon fought the verdict for over three years. However, the Supreme Court of New Jersey declined to hear an appeal from the manufacturers, allowing the original jury verdict to stand. This sends a clear message to vaginal mesh manufacturers that jury verdicts and awards will stand up to appeals.

Stockert 3T Device More Dangerous Than Anticipated

July 17, 2017/in Defective Devices /by e.blizzard

When the U.S. Food and Drug Administration (FDA) sent out a warning letter to patients and physicians in 2015 regarding infections from the Stockert 3T heater-cooler device, it was thought the full scope of the risk was understood. However, nearly two years later a new study has found the infection risk was more widespread than previously believed.

The Initial Problem

The Stockert 3T is manufactured in Germany by LivaNova. In early 2015, the company began to receive complaints from European patients about infections connected to the device. The heater-cooler device has been linked to rare bacteria called mycobacterium chimaera, or M. chimaera.

Studying The Infection Risk

Researchers from Pittsburgh looked into the infection risk presented by the Stockert 3T by collecting samples from across the country. Researchers tested 89 samples from 23 difference states, the District of Columbia, and Canada and found 33 units were contaminated with M. chimaera. The Stockert 3T is used in approximately 60% of hospitals for regulating patient body temperatures during cardiac/thoracic surgery, so the threat to patients is very real.

M. chimaera is a particularly dangerous bacteria because it presents very generic symptoms, making it difficult to diagnose. Last year, the FDA reported 79 instances of patient infections from the device, including at least 12 deaths. However, the agency believes many cases go unreported.

Infection Risk In Children

Recently, children who underwent cardiothoracic surgery in which the Stockert 3T was used have developed life-threatening infections because of the device.

Nearly one dozen children were infected with mycobacterium abscessus, or M. abscessus, a fast growing bacteria resistant to many types of antibiotics after undergoing surgery at the Children’s Hospital in New Orleans. M. abscessus can cause skin to become red, tender to the touch, swollen, or even painful. Infected skin can also develop boils. M. abscessus can also cause fever, chills, and muscle aches, among other symptoms.

Unfortunately, the Children’s Hospital in New Orleans is concerned there could be even more patients infected. Bacteria spread into open surgical wounds can lay dormant for months or even years before manifesting symptoms.

M. abscessus is most commonly spread in a hospital setting by contaminated medical equipment. Invasive procedures using contaminated medical equipment can expose a patient’s open surgical wound to the bacteria.

Informing Patients

After the latest findings from researchers, some hospitals are reaching out to patients to inform them they may have been exposed to the risk. Because it can take months or even years for infection symptoms to manifest, it is incredibly important for cardiac surgery patients to watch out for signs of an infection. If you underwent cardiac or thoracic surgery within the last five years, talk to your doctor about your infection risk.