A 2021 recall of CPAP machines has led to a flood of lawsuits from users seeking compensation for injuries sustained from their use of the devices and the chemicals they ingested. The class action lawsuit alleges the manufacturer knew of problems long before it initiated the recall, which needlessly exposed people to injury.
What Is a CPAP Machine?
CPAP stands for Continuous Positive Airway Pressure. A CPAP is durable medical equipment designed to treat obstructive sleep apnea. CPAP machines deliver a continual stream of filtered and pressurized air into a patient’s airway to hold the airway open and prevent it from collapsing while they are sleeping.
Similar machines called Bilevel Positive Airway Pressure machines or BiPAP machines use two pressures to hold the airway open instead of one. Most people who use CPAP or BiPAP machines use them every time they sleep.
CPAP machines made by Philips NV are the subject of a recall and various lawsuits by people who allege they were harmed by them.
New CPAP Lawsuit Updates
The number of lawsuits filed over the CPAP devices is so large that they were consolidated into what’s known as multi-district litigation. MDLs coordinate sprawling and complex cases into one court before a single judge.
The CPAP MDL includes proposed class actions with claims for violations of state consumer protection statutes, breach of warranties and unjust enrichment, as well as personal injury cases. The MDL was assigned to Senior U.S. District Judge Joy Flowers Conti. It encompasses several hundred cases. Other lawsuits filed in other courts are likely to be transferred, too.
In September 2022, Phillips settled a claim made by the U.S. government that it was paying illegal kickbacks. The company agreed to pay $24 million to settle this.
In October 2022, a new registry for claims was set up that lets people harmed by the product register their complaint directly with Phillips without having to file their own lawsuit and requiring them to use only a short form complaint, which simplifies the process. This allows potential plaintiffs to toll or pause the statute of limitations on their claim.
In December 2022, a website was created for the MDL litigation with all documents in the case available. Phillips filed a motion to dismiss the MDL, claiming that plaintiffs could have had their machines be replaced or repaired by Phillips. That motion has not been decided yet.
In the same month, an additional lawsuit was filed by a plaintiff alleging mouth and and tongue cancer resulted from the toxic foam particles the machine emitted. It was reported in news media that the Justice Department was negotiating a consent decree with Phillips to settle the MDL.
As of January 2023, the MDL and other suits are ongoing with the court recently issuing an order about electronic discovery. The cases will continue to move forward towards resolution.
Which CPAP Machines Were Recalled?
The machines recalled are made by Philips NV, which is based in Amsterdam, Netherlands, and has a U.S. headquarters in Delaware. It researched, developed, designed, manufactured, sold, distributed and marketed CPAP machines, as well as other devices aimed at treating respiratory failure and breathing disorders such as BiPAP machines.
Philips announced on June 14, 2021, that it was recalling some BiPAP and CPAP machines as well as other ventilators because of health risks associated with polyester-based polyurethane foam that was used in the devices to reduce sound and vibration. The foam can break and enter the device’s air pathway, and debris or certain chemicals could be inhaled or swallowed with potentially carcinogenic or toxic effects.
The recall affected more than 15 million devices. The specific devices recalled include several device types with different model names and numbers. Additional devices and some masks were also later recalled. Lists by device type and model name and number are available here and here.
How Serious Is the CPAP Recall?
The U.S. Food and Drug Administration classified the recall as Class I, which is the most serious and indicates the recalled devices could cause serious injuries or death.
Manufacturers such as Phillips are required to complete medical device reports for the FDA when there is information that suggests a device may have caused or contributed to a death or serious injury. Between 2011 and April 2021, Philips submitted 30 reports. By November 2022, the FDA received 90,000 medical device reports and had counted 260 deaths, all associated with foam and plastic breakdown and the magnets in the mask can cause interference with pacemakers and medical devices (classified by the FDA as a Class 1 recall due to its severity). The reports came from Philips as well as health professionals, consumers and patients.
If your device is one of the devices subject to the recall, you should stop using it immediately. If your device is on the recall list but you have not registered it with Philips, you should register it on its recall website for updates on corrective measures. If you have another Philips device that has not been recalled, you should register it on its site in case there are updates on new devices affected.
What Can Happen to People Who Use the CPAP Machines?
Philips’ recall notice said potential risks of particulate exposure associated with the foam include headache, irritation, inflammation, respiratory issues and cancer.
Reported injuries submitted to the FDA include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.
Why Are People Filing CPAP Lawsuits?
Lawsuits filed against Philips since the recall was announced allege the company knew or should have known about the CPAP devices’ potentially life-threatening health risks but did nothing to warn physicians or patients. The foam deemed potentially toxic has been used by the company since 2009, according to the CPAP lawsuits.
The CPAP litigation is centered on design defect and failure to warn, alleging Philips has known about the potential health risks since it began using the foam, and it knew or should have known of the risk that degraded PE-PUR foam could produce harmful chemicals that are inhaled by people using the CPAP devices.
A report from the FDA Manufacturer and User Facility Device Experience said the company had a report as early as 2011 from a patient who discovered black dust on her nose after using the device. Other device users complained of black particles on Internet message boards for several years prior to the 2021 recall.
Where Are the Lawsuits Being Heard?
One plaintiff moved to centralize the CPAP lawsuits in either the Eastern or Western District of Pennsylvania. Plaintiffs in more than 50 other lawsuits supported centralization but differed on the preferred district.
Suggested venues include the two Pennsylvania districts as well as the Northern District of California, the Middle District of Georgia, the Northern District of Georgia, the District of Kansas, the Eastern District of Louisiana, the District of Massachusetts, the Western District of Missouri, the District of Oregon, the Eastern District of Virginia and the Southern District of West Virginia. Lawyers for Phillips suggested the District of Massachusetts or the Western District of Pennsylvania.
The Judicial Panel on Multidistrict Litigation chose the Western District of Pennsylvania. The order cited the fact that most of the recalled products were primarily manufactured by Philips in Murrysville, Pennsylvania, which is in the Western District.
Questions Lawyers May Ask About a Potential CPAP Lawsuit
Lawyers will want to know details about your experience with your CPAP machine. They’ll want to know how long you used them prior to the recall. They’ll also want to know specifics about your symptoms and possible associated health issues.
You should document your use of the machine as extensively as possible, as well as any contact with the manufacturer. You also should document any contact with health care providers or anyone else about medical issues associated with your use of the CPAP machine.
Can I Sue Over My CPAP Device?
Other attorneys across the country continue to file lawsuits, but the cases are being transferred to the MDL and subject to the same process led by the appointed plaintiffs’ leadership team.
That means some plaintiffs could be picked to lead so-called bellwether trials that are aimed at helping to determine the validity of the claims to aid in the settlement process. Attorneys not in the leadership class can still receive a portion of any fees that are awarded, and plaintiffs with particularly viable claims could be viable contenders for bellwether spots.
It’s important to talk to an experienced attorney to see where your case might fit, or if it would be more beneficial to seek compensation as a member of a class should one be certified.
Have You Developed Cancer Or Other Serious Injuries After Using a Philips Cpap Machine?
