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In June 2022, Philips Respironics issued an FDA Class I Recall for its DreamStation ASV Continuous Ventilators amid reports that foam from the devices may break down and be inhaled or ingested, and may emit volatile organic compounds (VOCs) resulting in adverse effects to organs, and even cancer.
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If you or a loved one was injured by a Philips Respironics C Series ASV Ventilator, and you are in need of legal assistance, don’t hesitate to contact our CPAP Recall Lawyers immediately.

You may be entitled to compensation by filing a CPAP lawsuit, and our lawyers can help. Please click the button below for a Free Confidential CPAP Lawsuit Evaluation or call us toll-free 24 hrs/day by dialing (866) 588-0600.

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Philips Respironics Ventilator Recall

The FDA classified the Philips Respironics Ventilator / Philips CPAP machine recall as Class 1 – the most serious – because using the affected devices may cause serious injuries or death. Devices meant to improve people’s breathing are instead contaminating their airways.

The recalled Philips Respironics Bi-PAP machines, Philips CPAP machines, and mechanical ventilator devices have sound abatement foam liners made from PE-PUR (polyester-based polyurethane). PE-PUR can disintegrate into particles that users then inhale or ingest, and there is no filter to prevent this. These particles can be small, even less than 5 microns, which can permeate through the lungs’ alveoli and enter the bloodstream.

PE-PUR foam can also emit (off-gas) vapors of toxic chemicals beyond the safe exposure threshold. Some of these dangerous volatile organic compounds (VOCs) include:

  • Toluene Diamine
  • Toluene Diisocyanate
  • Diethylene Glycol

PE-PUR foam is more likely to degrade the older the device is and the more people use it. Climate and environmental conditions such as high heat and humidity in the locations where the devices are stored can also exacerbate foam degradation. Any body heat or moistness that the user generates should not negatively affect the foam.

Some victims reported black debris in their breathing tubes and airpath circuits, which likely represents foam degradation. Philips Respironics claims unapproved cleaning processes – such as ozone or ultraviolet light – can worsen foam degradation.

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Philips C Series ASV Ventilator Injuries

In the recall letter, Philips Respironics explained that the problems with Philips Ventilators could result in “serious injury which can be life-threatening or cause permanent impairment,” which may include:

  • Cancer (carcinogenic effects)
  • Headache
  • Irritation
  • Inflammation
  • Chest pressure
  • Respiratory issues
  • Toxic effects
  • Other health issues

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Philips Recall Lawsuit Allegations

Auto CPAP Lawsuits allege that Philips Respironics knew about these substantial and material risks from its DreamStation ventilators and Philips CPAP machine / BiPAP machines long before the recall. The complaints further allege that patients who used the affected devices have complained to Philips about black particles in their machines for many years, but Philips did not warn the public about the hazards until late April 2022 and did not recall its machines until June 14, 2022.

The Auto CPAP lawsuits further contend that Philips timed its recall to coincide with the launch of its next generation of ventilators and Philips CPAP products that do not suffer from the same issues. Thus, the only safe option that Philips offers to its customers—many of whom need and rely on the recalled breathing machines—is to purchase Philips’s newer model of obstructive sleep apnea machine, profiting Philips further.

Finally, the complaints allege that Philips has no concrete timeline for replacing the recalled ventilators, Philips CPAP machines, and other devices and may not provide replacements for a year or more, even though patients need to use their devices every day.

As a result, the sleep apnea recall leaves patients without safe, free options, and patients are going to be forced to buy Philips’ next-generation product or a competitor’s sleep apnea machine — at full price.

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Philips CPAP Machine Lawsuit Updates

August 4, 2022: A “science day” has been scheduled for September 1 in the Philips CPAP Recall MDL. This is a sign that Judge Conti is ready to start digging into the science and most sleep apnea lawyers are hopeful that the scientific evidence links a large number of injuries to the Auto CPAP recall.

In class action MDLs, a science day is intended to give attorneys for both sides the opportunity to make presentations to the judge in order to educate the Court about complex scientific issues.

The CPAP / Sleep Apnea MDL Judge ordered the science day in response to a joint motion by the parties and gave them until August 18, 2022 to submit proposals for how the science day should be handled. Science days are common in MDLs involving product liability claims.

July 7, 2022:  Judge Conti has submitted an order that gets the sleep apnea class action lawsuit moving. Attorneys have been ordered to begin pretrial discovery. This is all work that needs to be done to get the CPAP recall lawsuit in a settlement posture for both sides.

June 27, 2022: Judge Conti recently issued a discovery management order imposing certain deadlines for the parties to submit joint proposals on pretrial discovery matters related to Philips sleep apnea machines. Proposed plaintiff fact sheets and implementation rules are due by July 8, a protocol for depositions of fact and expert witness are due by August 15, and a proposal for written discovery including deadlines and limitations is due by September 9.

June 14, 2022: Discovery in some of the sleep apnea recall lawsuits has yielded internal documents showing Philips knew about the issues with the sound abatement foam in their CPAP devices for 3 years before announcing a recall.

In April 2018, a product engineer from Philips contacted the foam supplier about customer reports of the foam shedding and getting into the airways of the CPAP devices. Philips knew of the problem and did nothing, according to the plaintiffs’ lawyers.

The email and the customer reports provide compelling evidence that Philips knew about the health hazards of their CPAP machines for years before doing anything. This will help the plaintiffs build the case against Philips in the CPAP lawsuit and hopefully speed up the settlement.

June 6, 2022:  Judge Conti recently issued Pretrial Order #16, which appoints retired Magistrate Judge Diane M. Welsh to serve as settlement mediator in the litigation.

The appointment of Judge Welsh as settlement mediator was apparently done to comply with this requirement. However, Welsh could take a large role in a CPAP lawsuit down the road.

May 25, 2022: It has been a year since Philips first initiated the recall of over 15 million CPAP and BiPAP machines used for sleep apnea. During that time, regulators at the FDA have been deeply involved in the CPAP lawsuit investigation process and have kept the public well informed about the problems with Philips sleep apnea machines.

FDA has published data on adverse health event reports it received between April 2022 and April 2020 in connection with recalled Philips CPAP devices and sleep apnea machines. According to these reports, the agency received over 21,000 reports of adverse health events connected to the CPAP machines.

Problems reported have included cancer, pneumonia, and respiratory problems. Unfortunately, there have also been 124 deaths linked to CPAP problems.

May 10, 2022: It is likely the CPAP defects will cause many deaths. Victims are just beginning to link the deaths of their loved ones with CPAP.  One recently filed wrongful death CPAP lawsuit is a case in point.

Plaintiff Doug Shiffler of Oregon lost his wife to cancer and filed a CPAP lawsuit against both Philips and a Maryland company that manufactured the toxic sound abatement foam in the recalled CPAP machines (Wm. T. Burnett & Co).

The CPAP lawsuit filed asserts that Shiffler’s wife used one of the recalled Philips DreamStation CPAP machines every night for about 20 months. She was subsequently diagnosed with advanced lung cancer. Joleen eventually died from lung cancer and Doug filed a wrongful death lawsuit claiming that her cancer and death were caused by toxic particles in the foam of her DreamStation device.

May 6, 2022: The FDA is contemplating requiring Phillips to offer a full refund for people who want their money back for their defective CPAP.

May 3, 2022: The Wall Street Journal reports that Philips recently received a subpoena from the Department of Justice seeking information and documents related to the CPAP recall. The subpoena suggests that the DOJ has launched a formal investigation which could lead to penalties and actions beyond the growing number of civil lawsuits.

April 16, 2022: There are now at least 274 active CPAP lawsuits in the Philips CPAP MDL class action. Thousands of additional lawsuits will be registered with the MDL Court with a mechanism that allows victims to hold back filing a lawsuit but tolls the statute of limitations to preserve their claims.

March 23, 2022: Philips has announced that it is recalling hundreds of ventilator machines used in hospitals across the U.S. because defective adhesives can cause the machines to suddenly stop working.

March 19, 2022:  The FDA has now formally intervened in the Philips CPAP recall process. Earlier this month, the agency sent Philips a letter advising the company that its efforts to notify consumers about the health risks posed by its recalled CPAP and BiPAP machines have been deficient.

The FDA is now requiring Philips to “improve its communication about the recall and the serious risk posed by the foam used in the recalled products.”  The new notification efforts by Philips will take place under the close supervision of the FDA.

March 16, 2022: There are now at least 262 Philips CPAP recall lawsuits in the MDL class action.

March 10, 2022:  The next status conference on March 22, 2022, will be a different dynamic with the new CPAP lawyers Steering Committee in place.  There were a lot of skeptics of the CPAP lawsuits’ viability in the early stages. However, it has become increasingly clear that many of these lawsuits will be viable.

January 29, 2022: Judge Conti recently issued an order laying out options for evidence preservation of recalled CPAP and BiPAP devices. Plaintiffs can return their recalled devices to Philips to have them repaired for free, in which case the company will be required to take pictures and document the condition of the device as evidence. Plaintiffs can also elect to send their device to Philips and have it held in evidence preservation and not repaired.

January 22, 2022: After issuing a recall of around 15 million CPAP and BiPAP machines last year, Philips got the FDA’s preliminary blessing on a repair program that would have replaced the toxic PE-PUR foam in the recalled devices with an alternative silicone-based foam. Soon after this new repair program was announced, however, concerns arose as to whether the new silicone foam presented potential health risks. Earlier this week, the FDA ordered Philips to submit independent testing of the new silicone replacement foam.

January 19, 2022: There are now at least 221 CPAP lawsuits in the MDL class action lawsuit.

What Should I Do if I’m Using a Recalled Philips CPAP Machine?

If you or a loved one are using one of the recalled Philips CPAP machines, Philips says you should speak with your physician to figure out the best options for continued treatment.

“Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where disruption is unacceptable,” the recall notice states. “In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.”

The company has begun replacing the PE-PUR foam in the recalled CPAP machines with new material.

Tell your doctor about any symptoms you have that may be related to the use of a recalled Philips CPAP machine.

Should I File an Individual Lawsuit or a Class Action?

There are some pros and cons to look over when deciding whether to file an individual claim or a class action lawsuit against Philips Respironics:

The pros:

Class actions do provide significant advantages because you have more power in a group. A class action is in itself a support group where people can compare evidence and discuss injuries which may help bolster the case.

Since class actions involve many plaintiffs, the cost for legal counsel is almost negligible since it’s spread out among the members of the class. The amount that lawyers receive is decided by the judge presiding over the case and therefore always kept in check.

Class actions also help the judicial system by consolidating many individual cases into one, which can expedite the entire process.

Guaranteed settlements are another advantage, even though they may not be as much as an individual lawsuit. Class actions ensure that every member of the class gets some compensation, even those with minor injuries.

However, many class actions have tiers for compensation. Those having the most severe injuries will receive more than those that do not. Furthermore, when filing an individual case, you run the risk that the defendant will run out of money before your case even makes it to court.

The cons:

A class action does not afford class members the same level of say on the amount of the settlement. It does not allow class members to testify or even be in the courtroom. The exception is if you are the lead plaintiff filing the class action. The class is represented by a single representative who makes decisions that will benefit the class as a whole.

An individual lawsuit can be resolved quicker than a class action, which can drag on for years due to the immensity of the lawsuit. With so many plaintiffs, complications can arise. If you need immediate relief to pay medical bills or are fearful you will not survive your injuries, a class action may not be your best choice.

There is no recourse in a class action should the judge side with the defendant. There are strict policies governing class actions that dictate that members cannot appeal individually or as a class if the judgment is against the class.

Get a Free C Series ASV Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at our law firm is an experienced team of Philips C Series ASV Lawyers that focus on the representation of plaintiffs in C Series ASV Lawsuits. Our Personal Injury Lawyers are handling individual litigation nationwide and currently accepting new Philips sleep apnea machine cases in all 50 states.

If you or a loved one was diagnosed with cancer after using a recalled Philips C Series ASV ventilator, CPAP, Philips sleep apnea machine, or other similar devices, you should contact our law firm immediately. You may be entitled to financial compensation for medical expenses by filing a C Series ASV Lawsuit and our lawyers can help you receive fair compensation.

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