Phillips CPAP Recall Lawsuit Lawyers | Sleep Apnea Machine Attorneys
CPAP machines are used to treat those who have obstructive sleep apnea disorder. The machine takes pressurized air from the room and delivers it to the patient through a mask that they wear over their face. The CPAP machine depends on clear air because this goes directly to the patient’s lungs. It is the most common way of treating sleep apnea. Philips is a major manufacturer of CPAP machines. It has recently recalled several models of machines because of defects that make the air that patients breathe dangerous. Specifically, patients have been inhaling chemicals that can cause cancer while they sleep. The device itself has a foam in it that breaks down over time. The particles find their way into the air that users breathe and end up in their lungs. Victims who inhale toxic, broken-down PE-PUR foam particles may be injured as a result. These injuries can include respiratory complications such as: asthma, sinus infections, irritation of the upper airway, coughing as well as chest pressure. Hundreds of victims are filing Philips CPAP lawsuits and Phillips BiPAP lawsuits alleging that it is defectively designed causing the foam to breakdown leading to injuries.
The Philips Machines that Have Been Recalled
This particular problem affects the following types of Philips machines:
- CPAP machines
- BiPAP machines
Not all models of Philips machines were recalled. Particularly, this recall affects four million machines, spread over 18 products. You should check the recall list to see if your particular product is on the list.
Update- 9-8-2023- “One of the nation’s largest makers of machines for sleep apnea sufferers has agreed to pay at least $479 million to compensate customers who bought the devices. Philips Respironics and Koninklijke Philips N.V., its Netherlands-based parent company, will also set aside $15 million for customers seeking to replace their continuous positive airway pressure (CPAP) machines, court documents posted Thursday show. The settlement comes more than two years after Philips recalled millions of its CPAP devices due to reports from users saying foam unexpectedly spewed from the devices and into their mouths. ” CBS News
5/3/2022- “The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user. Amsterdam-based Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the Class I recall, which knocked it out of the sleep therapy market for at least a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators have been inadequate to date.” Mass device
4/25/2022- “Philips on Monday said it has set aside still more money to resolve its Respironics quality problems, while disclosing a U.S. Department of Justice subpoena the company and its subsidiaries received on April 8 seeking information about the recall. In Monday’s first-quarter results, Philips said it took a 65 million euros (about $70 million) provision related to the repair and replacement of sleep apnea devices and ventilators and an approximately $107 million provision tied to possible higher costs of executing its program. The extra costs caused Philips’ earnings to miss the consensus estimate. The latest provisions are on top of the aside 725 million euros set aside last year, which was equal to about $825 million at the time of the announcement.” Med tech drive
3-11-2022- “Nine months into Philips’ wide-ranging Class I recall of many of its CPAP and BiPAP machines and other respiratory devices, the FDA isn’t entirely pleased with how the company has handled the recall. In a notification sent to Philips on Thursday, the agency ordered the Dutch devicemaker to immediately alert all users of the affected machines—as well as the medical equipment suppliers, distributors and retailers who sell them and the healthcare providers who prescribe them—about the recall. Philips is also required to give users instructions for registering their devices on the company’s website and to include information on the main recall webpage about the potential dangers of using ozone cleaners on the affected devices. The FDA said the order was necessary—even after Philips spent the bulk of the past year scrambling to rectify its safety issues—because “the company’s notification efforts to date have been inadequate.” Fierce Biotech
9-15-21- In the beginning of September, Phillips drafted an important press release stating that they have FDA approval to fix Dreamstation, which was previously recalled. They also have clearance from the FDA to repair other CPAC machines that they manufacture.
June, 2021- In June of 2021, Philips Respironics announced a massive recall for its CPAP, BiPAP, and manual ventilator machines. “In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Additionally, the foam damage may get worse in hot and humid settings and by using ozone or ultraviolet (UV) light cleaners or other cleaning methods not recommended by the manufacturer. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators with specific serial numbers, also related to the potential health risks posed by the polyester-based polyurethane foam. In response to the June 2021 recall, in August 2021 the FDA initiated an inspection of a Philips Respironics’ manufacturing facility to determine what may have caused or contributed to the foam issues and assess adherence to the agency’s quality system regulations. FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality.” FDA
How CPAP Machines Treat Sleep Apnea
Sleep apnea is a potentially dangerous condition in which the throat muscles relax while the person is sleeping. Breathing will repeatedly stop and start during sleep. The danger is that the person may not start breathing again. Even still, sleep apnea causes poor sleep, and it can have various other health effects. Patients will first visit a sleep lab, and a doctor who specializes in sleep may recommend a number of treatment options. They can range from oral appliances to machines like a CPAP.
The CPAP machine consists of a mask and hose that is connected to a unit. Patients will also connect a humidifier to keep them from inhaling dry air that could cause runny nose or other reactions. The machine will come with a preset pressure based on what the doctor has recommended. The patient will connect the mask to the hose (which is connected to the unit). They will then place the mask over their face. Air will come through the mask directly to the patient’s nose.
Why Philips CPAP and BiPAP Machines Have Been Recalled
The problem with the Philips CPAP machine is that the air that users breathe is not always pure. Although the problem does not affect every single machine, a number of the Philips units have had issues that put users in potential danger.
Here, the issue specifically relates to foam that was used in the unit itself. Philips designed the machine with foam to cut down on sound and vibration while the machine was in use. Specifically, this is called polyester-based polyurethane (PE-PUR) sound abatement foam.
The problem is that the foam can break down over time. The issue is even more pronounced when there is any humidity in the room. The foam degrades into small particles, and users end up breathing them in as part of the air that comes through the CPAP. People who use CPAP machines breathe this air for hours every single night. Over time, foam made out of chemicals can build up in the lungs. This can sicken CPAP machine users. There are risks that patients can develop lung cancer because of the toxins contained in these chemicals. There are also reports of other lung problems associated with the use of Philips CPAP machines.
“As the PE-PUR foam breaks down, it leads to the production of volatile organic compounds or VOCs. You cannot see these chemicals that infiltrate the products’ airflow and transfer to users. Additionally, patients and health care professionals might not always see or be aware of the tiny black particles or pieces of the sound abatement foam, signaling an issue with the sleep apnea devices.” Your case works
Other Problems Associated with Philips Machines
In addition, users of Philips machines have reported the following problems:
- Respiratory tract problems
- Kidney and liver cancer
The FDA issued a Safety Communication about the problem in June 2021. This detailed the voluntary recall of the products that Philips initiated. The Safety Communication described the issue that machine users could breathe in or swallow particles of foam, causing lung problems. Patients were advised to consult with their healthcare providers about whether they should continue to use the machines pending the recall.
Philips will begin the recall work in October 2021. It may take the company up to a year to finish repairing the defective machines. In the meantime, patients will need to figure out another option to treat their sleep apnea.
Contact a Philips CPAP Lawsuit Attorney Now
If you or a loved one have been using an affected version of the Philips CPAP or BiPAP machine, you should seek out an attorney immediately. In addition, you should also visit a doctor to have your lungs examined. If you are diagnosed with any type of cancer or other lung ailment, you have the legal right to file a lawsuit.
At this stage, product liability attorneys are still investigating the defects in this product. They are exploring the possibility of filing lawsuits against Philips for the defective machines. Already, consumers have filed a class action lawsuit against Phillips, but this seeks compensation for the amount of money that they spent to purchase the CPAP machine as opposed to for personal injury that they suffered.
Seek a medical examination
However, we expect this to grow to be a large lawsuit. Hundreds of thousands of people have used the affected CPAP machines over the years, and the universe of possible plaintiffs is large. It may take some time for patients to realize that they have been sickened by these machines. They should seek a medical examination now, so that they do not have any issues with a statute of limitations.
Right now, Phillips’ role in the product defects (besides allegedly designing and selling a dangerous product is still to be learned. If these cases proceed to discovery, attorneys may learn what Philips knew about these possible defects and whether the company continued selling the product after it knew of the dangers.
Damages in Philips CPAP Lawsuits
If plaintiffs are successful in these lawsuits, they may receive the following damages:
- The cost of all of their medical bills
- Lost wages for time missed from work
- Pain and suffering
- Loss of enjoyment of life
- Wrongful death damages if a family member died from cancer
- Possible punitive damages, depending on what Philips did
You should contact an attorney today to discuss your case. They will advise you what you need to do to prepare your possible lawsuit against Phillips. You have a limited amount of time after you learned that you have been sickened to file a lawsuit.