A federal judicial panel has granted motions to consolidate pretrial proceedings against Philips, which recently recalled millions of its CPAP and BiPAP devices. 

According to Reuters, the Judicial Panel on Multidistrict Litigation has since appointed Senior U.S. District Judge Joy Flowers Conti to oversee consumer class action complaints against the company. 

Many lawsuits have been filed for injuries caused by recalled Philips Respironics CPAP devices, BiPAP machines, and ventilators.

Earlier this summer, the United States Food and Drug Administration announced a mass recall of Philips Respironics CPAP devices, BiPAP machines, and ventilators.1

While investigation into these Phillips respiratory devices continues, the FDA says that small foam parts in the machine – known as sound abatements – can degrade and break down into microscopic particles.2 These foam parts can be drawn into the devices’ air hoses, or break down in heat, humidity and through improper cleaning methods.

The foam particles can then end up inhaled or swallowed by patients using the Phillips CPAP and BiPAP devices or ventilators. 

These sound abatements are made of polyurethane, a known carcinogen. 

When they break down, the foam parts can also release black debris or other harmful chemicals. The FDA has stated that inhaling the polyester-based polyurethane can lead to a range of health problems, and in response has ordered a recall of many of the devices.

A full list of affected Phillips BiPAP devices, CPAP machines, and ventilators is maintained on the F.D.A.’s medical device recall page.

Many Patients Who Suffer From Sleep Apnea Used the Recalled Phillips Devices

Most of the litigants in the consolidated lawsuits were prescribed CPAP or BiPAP devices to control sleep apnea, a disorder which prevents the body from maintaining regularly breathing patterns while asleep. 

Medical researchers have estimated that tens of millions of Americans suffer from sleep apnea, often undiagnosed. Although not always life-threatening, sleep apnea sufferers are at higher risk for developing potentially debilitating conditions, including diabetes, heart failure, and stroke. 

At Least 120 Lawsuits Against Philips for its Recalled Respiratory Devices 

In the wake of the FDA’s announcement of the danger, Phillips may be facing up to 120 separate legal actions. Of these, at least 90 are proposed class actions, while the remainder are personal-injury claims. 

All of the complaints allege that the sound-abatement foam found in the affected Philips CPAP and BiPAP machines was potentially dangerous. While the foam was used only to control noise and vibration, it was manufactured using polyurethane—a chemical which, while not inherently dangerous, can degrade and release toxic gases. 

Since sleep apnea affects most victims whenever they sleep, people who have been prescribed CPAP or BiPAP machines tend to use them nightly. 

Before the recall was announced, some Philips CPAP and BiPAP users reported physical illnesses and symptoms associated with polyurethane exposure, including chronic headaches, dizziness, and hypersensitivity. 

Although Philips’ products have not led to any known deaths, the FDA has clearly stated that the polyurethane degradation can yield cancer-causing carcinogens. 

Anyone who has owned a recalled Philips CPAP or BiPAP machine may be eligible for compensation—including the cost of a replacement unit, and any damages they may have suffered after inhaling toxic polyurethane gases.

What’s In The Judges’ Ruling on Phillips CPAP and BiPAP Device Lawsuits?

In October, the Judicial Panel on Multidistrict Litigation (J.P.M.L.) agreed to consolidate all Philips-CPAP-and-BiPAP-related litigation in United States District Court for the Western District of Pennsylvania. 

The J.P.M.L. is headquartered in Pittsburgh, where Philips manufactured most of the affected devices. The transfer decision was approved after involved counsel agreed on the revised choice of venue.

Collectively, the J.P.M.L. found that all of the claims against Philips “raise similar factual warnings regarding the recalled devices and the conduct of the recall.”

In consolidating the cases, the Panel agreed that the multidistrict litigation should encompass the proposed class actions and personal injury complaints. 

Phillips Allegedly Sold CPAP and BiPAP Devices That It Knew Were Dangerous

Reporting from Reuters and The Insurance Journal suggests that Philips likely knew that its devices posed substantive health risks long before it initiated a recall. All of the affected CPAP and BiPAP machines were part of Philips’ “first-generation” line of sleep apnea and respiratory aids.

However, Philips did not warn the public of “possible risks related to the sound abatement foam” in its products until April—two weeks after it had already introduced its reportedly safer “second-generation” devices. 

Only in June did Philips initiate a voluntary recall of its products. 

The Food and Drug Administration Announces the Recall of Phillips Devices

In September, 2021, the federal Food and Drug Administration announced what it calls a “Class I” recall of more than a dozen first-generation Philips sleep-apnea and respiratory control devices.

When the FDA’s Class I recall was issued, Philips said it had collaborated with the agency in the creation of a pro-consumer plan. As part of its proposal, which was eventually approved by the Food and Drug Administration, Philips pledged to repair affected CPAP and BiPAP machines. Anyone owning a recalled device would be given the option to send it to Philips, which would, ostensibly, replace the polyurethane-based sound-abatement foam with a more stable alternative. 

Philips has already manufactured and sold up to four million CPAP and BiPAP machines, half in the United States.

The recall affects all serial numbers of named devices manufactured between 2009 and 2021. And, because most such machines have a five-year shelf-life, some Philips consumers may have been exposed to toxic polyurethane emissions for over a decade. 

Philips has been unable to keep pace with incoming claims and has forced the recall deadline to September 2022. 

In the meantime, CPAP and BiPAP users have been afforded little practical relief. 

For example, Philips has been unwilling to provide replacement kits or “loaner devices” to persons with potentially unsafe products. Medicare, and most private insurance companies, have also refused to purchase new units unless the affected machine is at least five years old. 

Brand-new CPAP and BiPAP machines retail for between $500 and $1,000.

Possible Negligence by Phillips In Connection with Injuries Caused By Its Recalled Respiratory Devices

Most of the class action and personal-injury complaints against Philips have alleged that the company was negligent in the manufacture of its units; they also assert that Philips engaged in unfair business practices and fraud. 

Possible Negligence by Phillips In Connection with Injuries Caused By Its Recalled Respiratory Devices

Winning a mass tort lawsuit for injuries caused by dangerous medical devices usually involves proving that the Phillips and related manufacturers or merchants did not properly warn people taking it of the potential risks. 

That can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.

But battling bullies is what Justinian & Associates does.

Justinian & Associates has established a dedicated Philips CPAP and BiPAP practice.

We are currently accepting additional clients who have been injured by a recalled Phillips’ respiratory device.

If you believe you may have been hurt by a product that was supposed to improve your life, you’re entitled to compensation to help you with medical bills, lost work, and any pain or health challenges you endure. Don’t face it alone. 

We Are Warriors For The Injured

Our Texas and San Antonio mass tort lawyers have successfully represented dozens of victims injured by dangerous pharmaceuticals and other hazardous substances. That’s exactly why we were founded.

We have extensive knowledge of laws involving defective medical devices, and our attorneys are leaders in this field, chairing committees and organizations to help steer large lawsuits on behalf of other attorneys. 

Justinian & Associates has the experience, the resources, experience and trained investigators to take on adversaries of any size.

All we do is fight for injured victims.

Our only goal is justice for our clients, whatever that means for them. 

And we do not accept defeat. Unless we get you money for your injuries, you don’t pay us a dime.

The Time to Act is Now

Your rights can be lost if you wait.

There are laws that limit how much time you have to file a lawsuit after being injured. They are known as statutes of limitation. They may apply to your lawsuit to recover for your Phillips injuries. The countdown may already have begun. 

The legal team at Justinian and Associates has years of experience dealing with cases like Philips CPAP and BiPAP breathing devices. 

The statute of limitations (how long you have to file a case) may already be counting down. Don’t let it expire!

Call, text or email us for a free consultation, with no obligation. Speak to a Texas personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.

[1] Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, U.S. Food and Drug Administration (FDA), (Date Issued: June 30, 2021).

[2] Medical Device Recall Notification – Philips Respironics Sleep and Respiratory Care devices, Phillips.com (Issued June 14, 2021).

[3] US Food and Drug Administration Investigations Operations Manual 2021, Chapter 7 – Recall Activities.