Case Number: No. 2:21-mc-01230-JFC

Practice Area: Defective Drugs & Medical Devices Consumer Protection

Case Status: Pending

Court: United States District Court for the Western District of Pennsylvania

About the Recalled Philips CPAP, BiPAP, and Mechanical Ventilator Lawsuit:

On June 14, 2021, Philips announced a recall of many of its Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) machines, which are used to treat sleep apnea, and ventilators, which treat respiratory failure. The recalled products contain polyester-based polyurethane (PE-PUR) foam for sound abatement. It has now been revealed that the PE-PUR foam may break down and be inhaled or ingested and may emit volatile organic compounds (VOCs) resulting in adverse effects to organs, and even cancer. In an announcement to doctors, Philips explained that these hazards could result in “serious injury which can be life-threatening or cause permanent impairment.”

Since the recall, hundreds of lawsuits have been filed against Philips and over 50,000 individual claims have been asserted against Philips. Berger Montague has been involved since the beginning of the litigation and filed the largest class action suit in the country, Conley, et al. v. Koninklijke Philips N.V., et al., No. 1:21-cv-11328, that was transferred to the Western District of Pennsylvania (the federal court in Pittsburgh), and consolidated with other similar cases in the Multi-District Litigation (“MDL”) that is pending, In Re: Phillips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation, MDL Docket No. 3014, No. 2:21-mc-01230 (W.D. Pa.). Shanon J. Carson of Berger Montague has been appointed to the Plaintiffs’ Steering Committee in the MDL, and our firm continues to be a leader in the litigation.

The lawsuit alleges that Philips knew about the substantial and material risks from its CPAP, BiPAP, and mechanical ventilators long before the recall. The plaintiffs also allege that Philips self-servingly timed its recall to coincide with its launch of its next generation of products that do not suffer from the same issues. Thus, the only safe option that Philips offers to its customers — many of whom rely on the recalled breathing machines — is to purchase Philips’ newer model, profiting Philips further. The recall leaves patients without safe, free options, and patients are going to be forced to buy Philips’ next-generation product or a competitor’s product — at full price.

To speak with Berger Montague on a confidential basis about your personal injuries suffered as a result of using a Philips ventilator, BiPAP, CPAP machine, or to learn how you can join the lawsuit, please contact us by filling out the form on this page. Your consultation with Berger Montague is free of charge.

The Philips Recalled Products at issue include the following:

  • E30
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C Series ASV, ST, AVAPS
  • OmniLab Advanced Plus
  • SystemOne (Q Series)
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation Go CPAP, APAP
  • Dorma 400, 500 CPAP
  • REMStar SE Auto CPAP
  • Trilogy 100 and 200
  • Garbin Plus, Aeris, LifeVent
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 Auto
  • A-Series BiPAP A40
  • A-Series BiPAP A30

Philips FAQs

Why should I choose Berger Montague? I see many other law firms involved.

Berger Montague is a national law firm that litigates complex civil cases and class actions in both federal and state courts throughout the country. Berger Montague attorneys have held leadership positions in major cases for over half a century. In this case, Shanon J. Carson, an Executive Shareholder of Berger Montague PC, was appointed to the Plaintiffs’ Steering Committee of the consolidated CPAP litigation by the Court and has been named a Co-Chair of the Law & Briefing Committee for the case. Senior Counsel Dena Young has also been named to the Bellwether/Trial Committee. These positions make us part of the litigation’s key leadership. Berger Montague was one of the first firms in the country to file a case regarding the recall and has been actively involved in every step of the litigation as the case has progressed.

Are there costs for retaining Berger Montague?

Berger Montague is handling this case on a fully contingent basis. This means that our law firm only receives compensation if your case is successful. If we are not successful in your case, you will pay no fees to Berger Montague.

What is a retainer agreement?

A retainer agreement is a contract between you and a law firm specifying the work the law firm will perform and how the law firm will be compensated. As explained above, Berger Montague works on a contingency fee. The terms of this arrangement are set forth in the retainer agreement.

How do I register my recalled device with Philips?

To register, go to this website and follow the prompts. You will need the serial numbers on your recalled device to register.

Should I return my recalled machine to Philips or my DME supplier?

We do not recommend returning your machine to your DME supplier. For DreamStation 1 users, Philips has agreed a preservation protocol wherein Philips will preserve certain evidence from the machine for machines returned to Philips for people on the preservation registry. A copy of the order can be found here. For people that have a DreamStation 1, and have not been diagnosed by a doctor with a serious injury caused by the machine, we recommend returning the machine to Philips when requested by Philips. If you have been diagnosed with a serious injury, we do not recommend returning the DreamStation 1 to Philips, please contact us to discuss preservation, [email protected]. If you have a machine other than a DreamStation 1 or Trilogy ventilator, Philips is not remediating those machines. We are aware that Philips may be offering some money ($25/$50) for the return of those machines. We do not recommend that you take the money and we do not recommend returning the device to Philips. If you have been diagnosed with a serious injury, we do not recommend any machines to Philips, and please contact us to discuss preservation, [email protected].

What kinds of physical injuries are being reported as a result of the recalled machines?

Many clients have contacted us and alleged serious physical injuries resulting from long-term use of the recalled machines, including but not limited to COPD, adult-onset asthma, other serious respiratory issues, pulmonary fibrosis, injuries to the lungs, and many types of cancer, among other personal injuries.

Is it safe for me to continue using my CPAP/BiPAP?

Berger Montague is a law office and cannot give medical advice. Any decisions as to whether or not it is safe for you to discontinue using your machine must be discussed with your doctor.

If I take my recalled machine apart to inspect the foam, is this an issue?

Yes, this is an issue. Please do not take apart your machine without a repair kit and without first speaking to your attorney. You are required to preserve evidence that may be relevant to your case including the foam.

What is the strategy Philips is using to repair or replace recalled machines?

Philips has announced that it will either be replacing the current sound abatement foam with a new material or replacing machines with a new or refurbished unit. Some of our clients have already received a replacement. We learned that as of March 16, 2022, Philips is sending updates to those who have registered for the recall allowing them to check on the status of their replacement device. Philips is now stating that if you provide your health information on their new website, they can prioritize remediation to those patients at higher risk. We strongly discourage our clients from providing their health information to Philips at this time, especially if you believe that the device has caused you serious injuries, because this information should be transmitted to Philips through your attorneys in order to best protect your rights. If you do provide information on Philips’ website regarding your health information, please keep in mind that all information you provide should be truthful.

How do I get a replacement device from Philips?

Once you have registered on the recall site above (see question 3), you will be added to Philips’ queue for receiving a replacement machine and/or repair kit. Our clients have reported that individual phone calls to Philips do not move them to the top of the list. You can check the status of your replacement machine here.

What if I don’t currently have a physical injury but develop one in the future?

If you do not currently have a diagnosed physical injury at this time, that is good news. If you later become diagnosed with an injury caused by your recalled machine, most states hold that you will preserve all of your rights at that time. If you develop a physical injury that you believe is related to your use of a recalled Philips CPAP, BiPAP, or ventilator, please contact us immediately.

How long would a case like this take to resolve? 

Complex litigation such as this can take years to resolve. At this early stage, it is too soon to give any sort of timeframe. Other cases that have involved similar consolidations of injury cases have taken anywhere from three (3) to five (5) years to resolve, and sometimes longer. The Judge in the federal court overseeing this case has said that she intends for this case to move on a fast schedule.

Philips offered me a refund for a machine I purchased on my own to replace the affected DreamStation-1 machine. They agreed to refund me on the condition I send the affected machine back to them first. Should I do it?

If you accept a refund at this time, you may be waiving and/or releasing any claims you may have against Philips. Please contact Berger Montague before accepting a refund from Philips. You can email us at: [email protected]

Is there a qualified lab that I can send my recalled machine to in order to have it forensically analyzed?

Please do not send your machine to a lab. Leadership is working with experts on testing and if any testing is required, we will provide further instructions.

Will I be able to opt out of a class action settlement later?

If this action is certified as a class action by the Court at a later date, all class members will have the opportunity to receive a notice and decide whether to remain in the class or to opt out and pursue their own individual claim.

What might I receive in a class action?

The class action claims in the consolidated Philips litigation will be seeking compensation for class members’ economic losses, such as out-of-pocket expenses in purchasing a replacement machine or the costs of your original recalled machine. The class action claims are also expected to seek medical monitoring to cover the cost of potential future diagnostic and health-care costs which are other forms of economic injuries. Please note that if you have a diagnosed physical injury now as a result of using a recalled machine, then we would advise you to consult with Berger Montague about filing your own individual case related to your injury. Personal physical injuries and related pain and suffering are not likely to be covered by the class action claims in the case and should be brought on an individual basis.

How do I prove that my recalled machine caused my physical injury?

Plaintiffs’ counsel are working with various experts in the relevant fields of science, including epidemiology, toxicology, industrial hygiene, and pulmonology, among others, to prove causation, meaning that the breathing in of VOCs and other chemicals in the foam in the machines can cause various illnesses and cancer.

What is Berger Montague’s contact information for the team working on the Philips case?

The entire Berger Montague team working on the Philips CPAP case can be reached by emailing us at: [email protected]

Does modifying the Dreamstation unit with the foam replacement part void any future case?

Please do not take apart your recalled machine or discard any of its parts without first speaking to us. You can email us at: [email protected]

Does not returning the recalled unit to Philips once you have received a replacement void any future case?

No. People have the option of self-preserving their recalled DreamStation 1 machine (including through their attorneys) or sending the recalled machine back to Philips for preservation. Please see the answer above regarding returning machines for more information.

What type of cancers have been determined to date to be caused by CPAP?

Certain cancers may be linked to exposures to the volatile organic compounds (VOCs) released by the degradation of polyester-based polyurethane foam (PE-PUR) foam. These cancers include potentially brain, lung, thyroid, lymphatic, nasal, bladder, kidney, liver, stomach, lymphoma, leukemia, multiple myeloma, oral, among others. We are continuing to investigate the causal relationship with our experts.

Does using a SoClean Machine void my claim against Philips?

Philips is trying to avoid responsibility by pointing the finger at SoClean, but we believe that Philips is responsible for our client’s injuries in this litigation. Individuals that used SoClean to clean their recalled machines should contact us at: [email protected] to discuss this further.

Are there any costs involved in my contacting Berger Montague PC for advice?

Berger Montague is handling this case on a fully contingent basis. This means that our law firm only receives compensation if the case is successful. If we are not successful in this case, Berger Montague does not get paid. If your case qualifies as a personal injury case, it will be handled accordingly and on a contingency fee. Please contact us at: [email protected] to discuss any questions that you have, or any specific issues pertaining to your potential case.

The Court also permitted the plaintiffs to move forward with their claims of manufacturing defects, finding them not preempted. For example, the plaintiffs allege the debris, including silicone particles, on the implants’ surface is not an intended part of the design for the BIOCELL implants and further allege violations of Good Manufacturing Practices and other statutory standards by Allergan, all of which will now be subject to the discovery process.

About Berger Montague

Berger Montague is a national law firm focusing on complex civil litigation in federal and state courts throughout the United States. For over half a century, Berger Montague has played lead roles in consequential, precedent-setting cases and has recovered over $50 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago, Minneapolis, San Diego, San Francisco, Toronto, and Washington, D.C.

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