Philips Respironics (Philips) is a major manufacturer of the CPAP and BiPAP machines that help people with central sleep apnea and obstructive sleep apnea. Philips also makes ventilators that have no doubt saved lives in hospitals and other healthcare settings. These machines use a special type of foam to reduce the sound and vibration coming from these devices. Unfortunately, the foam Philips chose years ago can degrade and injure users, which eventually led to a 2021 CPAP recall. Let’s take a look at a recent development concerning Philips and its ventilator, CPAP and BiPAP products.

A Brief Overview of How We Got Here

In June 2021, the U.S. Food and Drug Administration (FDA) issued a Safety Communication notifying the public that Philips had recalled certain BiPAP, CPAP and ventilator machines. There were concerns that the polyester-based polyurethane (PE-PUR) foam used in these devices could break down, allowing small bits of foam to enter a person’s body. The FDA also mentioned that the foam could off-gas and release harmful gasses into the machine’s airflow causing additional harm.

In response to the CPAP recall, the FDA asked Philips to do several things, including:

• Let the FDA inspect the Philips manufacturing facilities.
• Take additional steps to notify health professionals who use or prescribe the affected products.
• Have an independent laboratory conduct additional testing concerning the health risks presented by the PE-PUR foam.

Philips agreed to these requests and recently reported its findings from its independent laboratory testing to the FDA.

Philips Testing and the FDA’s Response

Throughout 2021, 2022 and 2023, Philips provided regular updates concerning the testing being done by its independent laboratories. This testing examined two types of PE-PUR foam used in the recalled devices and assessed the risk they presented when they broke down and off-gassed VOCs (volatile organic compounds) or introduced particulates (tiny bits of foam material) into the airflow.

Philips used five independent laboratories across the United States and Europe and the testing examined both new and used devices, as well as devices cleaned with ozone, which the FDA suspects might make the PE-PUR foam problem worse.

Also tested were “lab-aged” machines. These are machines that were exposed to temperatures (90 degrees Celsius) and relative humidity (95%) that are far higher than what’s typically found in people’s bedrooms. If you’re not familiar with the metric system, 90 degrees Celsius is more than 190 degrees Fahrenheit.

When testing Type A foam, the laboratories concluded that any particulate or VOC exposure was “unlikely to result in an appreciable harm to health in patients.” When testing Type B foam (which accounted for 5% of the recalled machines), the laboratories concluded that “no overall risk conclusion [were] available at this time.”

As you might expect, the FDA was not satisfied with these results and asked that Philips complete more testing. Philips has agreed to this and while the FDA awaits additional test data, the FDA stands by its original patient recommendations concerning the use of the recalled machines.

If you’re curious about the nitty-gritty details of this testing, you can review the results in Philips’ July 2023 report. Just be warned that the content is a bit dense, although reading this report would work as a great sleep aid if you’re having trouble falling asleep.

I’ll provide more updates as they arrive, including major news concerning the CPAP recall or the ongoing litigation. If you have any questions on what your legal options might be if you’ve used a recalled machine, don’t hesitate to reach out by calling me. My direct line in the office is (919) 830-5602.

What’s Wrong With the Foam?

These machines use polyester-based polyurethane (PE-PUR) foam that can break down into little bits and enter a user’s airway. The foam can also break down by off-gassing harmful chemicals that the user inhales. These can potentially cause health problems for users, such as:

• Cancer
• Dizziness/headaches
• Asthma
• Nausea
• Vomiting
• Cough
• Sinus infections
• Organ damage
• Irritation to the respiratory tract, skin and/or eyes

As you might expect, a lot of people who use these CPAP machines have filed lawsuits. There are so many cases that the courts have set up multi-district litigation, or MDL to handle many of them.

What’s Multi-District Litigation?

An MDL is a consolidation of many related lawsuits so the court can more efficiently handle the cases and encourage the parties to settle. MDL usually takes place in federal court, although a state may have its own version of MDL litigation where cases from various counties are consolidated.

MDLs are not the same as class-action lawsuits, though. Class-action litigation involves multiple plaintiffs in a single case. In contrast, an MDL consists of many individual cases that get their pre-trial matters (like discovery) handled by a single court.

MDLs are also sometimes more likely than class action lawsuits to settle, especially after several bellwether cases go to trial.

There are a variety of logistical and legal reasons why cases might end up in a class action lawsuit instead of an MDL or vice versa. The important thing to know concerning the Philips CPAP, ventilator and BiPAP recall litigation is that many (if not most) of the cases have been consolidated into an MDL.

The Philips CPAP, BiPAP and Ventilator MDL

The bulk of the CPAP, BiPAP and ventilator litigation against Philips is part of “MDL 3014 In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation” (MDL 3014). The Honorable Joy Flowers Conti from the U.S. District Court for the Western District of Pennsylvania is the presiding judge in this case.

The MDL is still in the very early stages, with plaintiffs still joining MDL 3014 and filing their complaints. The cases will progress with parties exchanging information through discovery and the court making decisions about discovery disputes.

Eventually, the court will schedule a few bellwether cases for trial. After the bellwether trials, the parties will see if a global settlement is possible. Depending on how these bellwether cases go, it could give the plaintiffs or defendants a major advantage during settlement talks.

If a global settlement isn’t possible, many of the cases could get sent back to their respective federal district courts where they were originally brought. The litigants can proceed with their lawsuits and settle or go to trial.

How Can I Find Out If Something Important Happens in MDL 3014?

There are three ways to learn about recent developments. First, you can use an online search engine such as Google to look for any news stories, blog posts or articles about the case.

This is the easiest and quickest approach, but the problem is that unless there’s a big development in the MDL, such as a global settlement, you’re not likely to find much.

Second, you can go to the MDL 3014 court website, which is free and readily available to anyone with an Internet connection. Here, you’ll find court orders from the case. A court order usually reflects something “official” the court does, such as transferring a case, deciding a motion or scheduling a bellwether trial.

The drawback of going to the MDL 3014 website is that it only contains a small fraction of what’s going on in the case. This means it’s sometimes hard to understand the meaning or importance of a particular order.

For example, let’s say you see an order that indicates a judge has granted a plaintiff’s motion for sanctions against the defendant for not providing the requested discovery. But you don’t see each side’s legal briefs or memos arguing their legal positions. You also won’t see any other related motions that the court has yet to rule on.

In a way, seeing a court order all by itself is like being told the current score of a football game, but you aren’t told what quarter it is.

The third option for keeping up with MDL 3014 (or any other federal case) is to review the federal dockets. Dockets consist of a list of pretty much everything that happens in a case, organized by date. The docket will reflect pleadings, motions, an attorney’s entrance of appearance or a jury’s verdict after the trial.

If you want to know all the relevant updates to a particular case or MDL, looking at the dockets is the best approach. That being said, it’s not always the easiest way to learn about recent developments. This is because it can be difficult to understand the various bits of legal and court-specific jargon and codes that appear.

Another problem is that they’re not easily accessible by the public. Yes, anyone with access to the Internet can access federal court dockets, but they need to make a free PACER (Public Access to Court Electronic Records) account.

What’s not always free is using PACER. Information you get from PACER can cost 10 cents per page, although there’s a cap of $3.00 when reviewing a particular document. This is handy when you want to look at a particular court document that’s 500 pages and only have to pay $3.00 instead of $50.00.

If your PACER fees are less than $30.00 for a calendar quarter (three months), the fees are waived. This $30.00 threshold gets reset every quarter, so as long as you’re only using PACER sparingly, you can use it all year and not have to pay anything. But the worst part about PACER is that it’s not the most user-friendly website.

If you want more information about the CPAP litigation, or are thinking about joining MDL 3014, feel free to reach out to me at (919) 830-5602.