CPAP Machine Recall News and Updates

The latest lawsuit news and updates regarding CPAP machines.

CPAP Machine Recall Update: Philips CPAP MDL Passes 250 Cases

May 2, 2022
Author: Daniel Gala

Federal multidistrict litigation (MDL) over recalled CPAP and BiPAP devices made by Philips Electronics continues to grow, passing 250 cases as of mid-April, court records show.   

The Philips CPAP MDL has centralized lawsuits from all over the United States accusing Philips of putting potentially deadly products on the market while failing to warn consumers of risks about which Philips either knew or should have known. The respiratory devices in question—including Philips’ popular DreamStation model—were subject to recall in June 2021 due to problems with the PE-PUR foam used for sound abatement.   

Despite it long being known that PE-PUR foam contains and off-gasses toxic, carcinogenic compounds, Philips decided to use the material in its respiratory devices. Perhaps unsurprisingly, it later was discovered that toxic fumes from the foam and small particles of the foam itself were capable of entering the devices’ airways, where they were inhaled by users. The June 2021 recall covered twenty different models of Philips CPAP, BiPAP, and ventilator devices manufactured between 2009 and April 26, 2021.   

With Philips being by far the market leader in respiratory devices and with millions of Americans suffering from ailments that require CPAP, BiPAP, or ventilator devices for treatment, it is likely that Philips CPAP litigation ultimately will include many thousands of cases.   

Plaintiffs in the Philips CPAP MDL allege that they have developed cancer as a direct result of their long-term, regular use of recalled Philips devices with PE-PUR foam. They claim that Philips new about the potential risks but continued to sell the devices anyway, cynically issuing a recall only when their next generation devices—which do not use PE-PUR foam—were ready for release.   

“Philips knew about the potential health risks from its PAP devices related to PE-PUR foam degradation well before notifying the public on June 14, 2021,” alleges one Philips CPAP lawsuit filed in November 2021. “Philips knew about the possibility of PE-PUR foam degradation since it began using this particular foam in its PAP devices.”    

The number of cases in the relatively new Philips CPAP MDL exactly doubled in the four months from December 15, 2021 to April 15, 2022, going from 137 cases in mid-December , to 274 cases in mid-Aprilaccording to the Judicial Panel on Multidistrict Litigation (JPML).   

Meanwhile, the MDL continues to make its way through the early stages of the pretrial process. The agenda for an April 20 status conference shows a large number of important topics to be covered, from pleading deadlines to the appointment of special masters for overseeing the discovery process to the selection of bellwether cases. The weighty agenda indicates both how early in the MDL process the Philips CPAP litigation remains but also that the parties and the court continue to make steady progress toward the first bellwether trial.   

If you or a loved one has been diagnosed with cancer after using a recalled Philips CPAP, BiPAP, or ventilator device on a regular basis for a long period of time, contact TheLawFirm.com today for a free legal consultation!     

  Sources:   

United States Food and Drug Administration (FDA). (30 June 2021). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.

United States District Court Western District of Pennsylvania. (15 November 2021). Complaint. First Amended Complaint and Jury Trial Demanded. Case No. 2:21-cv-01447. MDL 3014. In Re: Philips Recalled CPAP Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation.

United States Judicial Panel on Multidistrict Litigation (JPML). (15 December 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District.  

United States Judicial Panel on Multidistrict Litigation (JPML). (15 April 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.

CPAP Machine Recall Update:
Philips CPAP Class-Action Complaint Filed in Montana Federal Court

March 14, 2022
Author: Daniel Gala

A plaintiff has filed a federal class-action complaint over the millions of recalled CPAP devices made by global electronics giant Philips, joining a slew of lawsuits alleging that the defective products cause serious bodily harm, including cancer.   

The class-action complaint was filed February 22 in Montana District Court by plaintiff Robert “Bob” Pittman, who alleges that he used the Philips CPAP DreamStation on a nightly basis beginning in 2012, including while working in Montana for extended periods during 2015.   

The Philips CPAP Recall   

Philips’ popular DreamStation model was among numerous models of CPAP, BiPAP, and other respiratory devices recalled by the company in June 2021. The devices are used primarily to treat sleep apnea, a very common condition that affects roughly 25% of all men and 10% of woman, according to Cleveland Clinic. While people who are older than 50 and overweight are at the greatest risk of developing sleep apnea, the condition is seen in patients of all ages, including children and babies.   

Philips was by far the market leader in sleep-apnea devices at the time it issued its far-reaching recall, which, by the company’s own estimates, covered three-toi-four million of devices. The recalls were due to problems with the PE-PUR foam used in the devices for sound abatement. It has been known for decades that PE-PUR foam both contains toxic materials and off-gasses toxic fumes, which is why it typically is used in applications where humans will not be exposed to either the foam or its fumes. However, both the toxic gases and small particles of the foam itself were found to enter the airway of the recalled Philips devices.   

“The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway,” the United States Food and Drug Administration (FDA) said in a June 2021 Safety Communication. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.”   

Users of Recalled Philips Devices Left With No Good Options   

As Pittman’s recently filed class-action complaint points out, the recall of millions of Philips devices has left those suffering from sleep apnea with no good options.   

“[P]atients who purchased the Recalled Devices must either stop use to mitigate against further toxic exposure, or continue to use their Recalled Devices to prevent severe sleep apnea while Philips delays replacing the Recalled Device. Philips has placed the onus on patients and their doctors to balance the danger Philips created.”   

The putative class action also accuses Philips of delaying its public announcement of the dangers of its CPAP machines to coincide with the release of its next-generation devices, which do not use PE-PUR foam.   

“On April 13, 2021, Philips announced it was launching the DreamStation 2, the next generation machine in its DreamStation product family,” the complaint says. “Less than two weeks later, on April 26, 2021, Philips publicly disclosed for the first time that the PE-PUR foam in its breathing devices might degrade. Philips made this disclosure in its Quarterly Report for Q1 2021, under a section entitled, ‘Regulatory Update.’ In the same disclosure, Philips insinuated that patients could safely purchase devices from its DreamStation 2 product family.”   

One CPAP User’s Experience   

The plaintiff Pittman claims that, for roughly a decade beginning around 2012, he used Philips CPAP devices on a nightly basis for eight hours per night. In February 2021, Pittman was diagnosed with throat and lymph cancer, despite never having been a smoker, not being overweight, never contracting COVID-19, and having no family history of either form of cancer.   

“Bob [Pittman] received Philips’ recall notice in the summer of 2021, while he was undergoing radiation for his cancer,” the complaint says, adding later, “In February 2022, Bob entered hospice care, seeking palliative relief from his cancer symptoms.”   

Despite Pittman’s cancer diagnosis, which he alleges was caused by his Philips DreamStation CPAP machine, “Bob’s sleep apnea symptoms make it impossible for him to completely stop use, and Philips has not yet provided a replacement. Bob cannot afford to purchase a replacement from Philips’ competitors.”   

The Putative Class Action   

Pittman’s complaint seeks class-action certification for a class that includes “[a]ll persons residing in Montana who purchased a Recalled Device for personal use” and contains a total of ten counts, including strict product liability, negligent recall, breach of express warranty, breach of implied warranty of merchantability, fraudulent misrepresentation, and unjust enrichment, among others.   

“Philips knew that its representations and omissions about the Recalled Devices were false in that the Recalled Devices contained PE-PUR foam and thus were at risk of causing adverse health effects to users of the Recalled Devices,” the complaint alleges.   

With Philips itself estimating that three-to-four million devices were covered by its June 2021 recall, the number of lawsuits is expected to continue to grow, as well. In October 2021, the US Judicial Panel on Multidistrict Litigation (JPML) transferred federal Philips CPAP cases to the Western District of Pennsylvania for “coordinated and consolidated pretrial proceedings.”   

As of February 15, the relatively young Philips CPAP MDL contained a total of 233 active cases, a figure that is projected by some observers to grow into the several thousand.   

If you or a loved one has been diagnosed with cancer after regularly using a recalled Philips CPAP or other respiratory device, contact TheLawFirm.com for a free legal consultation!     

Sources:   

United States District Court District of Montana. (22 February 2022). Class Action Complaint and Jury Demand. Case 2:22-cv-00012. Pittman v. Koninklijke Philips N.V., et al   

Cleveland Clinic. (Accessed 13 March 2022). Sleep Apnea. Health Library   

United States Food and Drug Administration (FDA). (30 June 2021). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication   

United States Judicial Panel on Multidistrict Litigation (JPML). (15 February 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District

CPAP Machine Recall Update:
Philips CPAP MDL Court Sets Interview Schedule For Plaintiff Leadership Positions

January 25, 2022
Author: Daniel Gala

The court in multidistrict litigation (MDL) over recalled Philips CPAP and BiPAP devices has issued a final interview schedule for plaintiff leadership positions, with so many applicants vying for the influential spots that the interviews will be held over the course of four days in late January and early February.   

The candidates are competing for the positions of lead counsel, liaison counsel, as well as for spots on the Plaintiff Steering Committee (PSC). Attorneys named to these spots will have the authority to make certain decisions on behalf of all plaintiffs in the MDL, as well as the potential for billing “common benefit” hours for work that benefits all plaintiffs, not just the attorney’s own clients. Under certain conditions, an attorney can bill common benefit hours to other plaintiffs in the MDL.   

Interviews will be held on January 26 and 27 as well as February 1 and 2 from 10:30 am until 5:00 pm. The interviews will be conducted remotely via Zoom.   

Ultimately, it will be up to the court to select which candidates are assigned to each position.   

The Philips CPAP MDL arises from the July 2021 recall of millions of Philips CPAP and BiPAP machines due to dangerous defects relating to the foam insulation used to dampen the noise emanating from the devices. The PE-PUR foam used by Philips for sound insulation previously had been known not only to consist of toxic materials itself but also to “off-gas” toxic fumes, as well.   

Only after the Philips devices had been on the market for years and sold to millions of patients worldwide did the company acknowledge in mid-2021 that the toxic fumes emitted by the PE-PUR foam could enter the machines’ airways, from where they would be inhaled by the user. Similarly, it also was revealed that small particles of the PE-PUR foam itself also were capable of entering the airways, where they too could be inhaled into the lungs.   

In July 2021, Philips recalled millions of CPAP, BiPAP, and other mechanical ventilator devices that utilized the PE-PUR foam.   

However, plaintiffs allege that Philips knew of the dangers posed by the PE-PUR foam well before summer 2021 but did not warn regulators, physicians, or consumers.   

“Philips knew about the potential health risks from its PAP devices related to PE-PUR foam degradation well before notifying the public on June 14, 2021,” alleges one Philips CPAP lawsuit filed in November 2021. “Philips knew about the possibility of PE-PUR foam degradation since it began using this particular foam in its PAP devices.”   

That lawsuit—filed by a woman from Midway, West Virginia, who was diagnosed with lung cancer in July 2021—contains a total of eight different counts, including failure to warn, design defect, breach of implied warranty of merchantability, breach of express warranty, as well as alleged violations of Massachusetts fair-business laws. (Philips North America is headquartered in Cambridge, Massachusetts.)   

The plaintiff flatly accuses Philips of causing her lung cancer.     

“Plaintiff’s development and progression of her lung cancer, resulting treatment, and need for future medical care and treatment would not have occurred but for the defective nature of the subject devices and Philips’s wrongful conduct,” her lawsuit says.   

Given the number of recalled devices and their widespread use, it is perhaps unsurprising that the Philips CPAP MDL continues to grow at a rapid pace. As of January 19, the Philips CPAP MDL included a total of 221 cases, an increase of more than 60% in the month since mid-December, when the MDL contained 137 cases.   

  Sources:    

United States District Court Western District of Pennsylvania. (19 January 2022). Docket. Case No. 2:21-cv-01923. MDL No. 3014. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation    

United States Judicial Panel on Multidistrict Litigation (JPML). (19 January 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District

United States District Court Western District of Pennsylvania. (15 November 2021). Complaint. First Amended Complaint and Jury Trial Demanded. Case No. 2:21-cv-01447. MDL 3014. In Re: Philips Recalled CPAP Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation

CPAP Machine Recall Update
Philips CPAP MDL: Selection Process for Plaintiffs’ Steering Committee Underway

January 4, 2022
Author: Daniel Gala

As relatively new multidistrict litigation (MDL) over defective Philips CPAP devices begins to take shape in the Western District of Pennsylvania, the selection process for members of the Plaintiffs’ Steering Committee (PSC) is currently underway, an important preliminary step in getting the MDL up and running in earnest. 

In an order issued December 20, Senior United States District Court Judge Joy Flowers Conti established deadlines of January 4, 2022 for applications to the PSC; January 11 for objections; and January 18 for responses to those objections. Interviews for potential PSC members will take place on January 27 and 28.

Forming a leadership structure for an MDL’s numerous plaintiffs is in an important early step in multidistrict litigation. Members of the Plaintiffs’ Steering Committee have the authority to make certain decisions on behalf of all plaintiffs in an MDL, as well as to do “common benefit” work that, as the name suggests, is—in theory, at least—to the benefit of all plaintiffs (and, under certain circumstances, can be billed to them).

In a 2020 article in the Lewis & Clark Law Review, law professor David L. Noll notes the incredibly crucial role that not only court-appointed leadership but also the court orders establishing such leadership positions have in multidistrict litigation. However, despite this significance, Noll further describes a lack of uniformity when it comes to such important practices.

“Orders appointing MDL leaders serve as a constitution or charter for a particular MDL, reallocating functions that otherwise would be performed by individually retained plaintiff’s attorneys to court-appointed leaders,” Noll writes. “As such, they perform a crucial role in the ‘MDL model’ of aggregate litigation and settlement. Yet in spite of their importance, knowledge of these orders is mostly folk wisdom.”

Noll identifies the lack of a statutory framework for establishing court-appointed leadership in an MDL, which results in a great deal of variation among appointment orders. This can be something of a surprise given the prevalence of court-appointed leadership positions in multidistrict litigation. For his paper, Noll and his team examined 201 of the 202 MDLs then-pending in June 2019. Of those, 86.57% included an appointment order, with 78.11% specifically having an order appointing lead plaintiffs’ counsel. More than half of the MDLs (54.23%) featured an order that “specifies tasks to be performed by lead plaintiffs’ counsel.”

With so much authority and responsibility given to court-appointed lead attorneys, the potential for conflict is clear. Attorneys representing different clients are likely to have different interests at stake and may not see eye-to-eye on all matters relating to the litigation. This potential for conflict is represented in the data, with the appointment order being challenged in more than one-third (37.81%) of all MDLs examined by Noll and his team.  

Interestingly, court-appointed leadership structures are far less prevalent among MDL defendants than plaintiffs. Court orders established a lead defense counsel in only 13.93% of the MDLs, with a defense leadership structure being created in only 2.49%.

Despite the controversial and somewhat enigmatic process behind the establishment of plaintiff leadership structures and the selection of their members, for better or worse, they play an important role in MDLs as they presently function in the United States. The selection of the PSC and the form it ultimately takes will both figure crucially in the future course of the Philips CPAP MDL.       

As of December 15, the Philips CPAP MDL contained 137 cases.

Sources:   

United States District Court Western District of Pennsylvania. (20 December 2021). Pretrial Order #5. Case 2:21-mc-01230. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation. MDL No. 3014     

Noll, David. L. (2020). What do MDL leaders do?: Evidence from leadership appointment orders. Lewis & Clark Law Review, 24(2), 433-468     

United States Judicial Panel on Multidistrict Litigation (JPML). (15 December 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District

CPAP Machine Recall Update: Inside a Philips CPAP Lawsuit

December 2, 2021
Author: Daniel Gala

With the first status conference in multidistrict litigation (MDL) over recalled Philips CPAP and BiPAP respiratory devices set to take place in mid-December, the long pretrial process is about to begin in earnest. The litigation stems from Philips’ recall of millions of its market-leading devices due to the risk of inhaling dangerous fumes and foam particles.       

PE-PUR foam, used for noise insulation in many Philips CPAP and BiPAP machines, has been known for years to emit hazardous fumes, yet Philips chose to use it in its breathing devices anyway. Perhaps unsurprisingly, it later was discovered that these fumes were capable of entering the devices’ airways, where they could be inhaled by unsuspecting users who were simply following their doctor’s orders.    

Worse yet, in addition to emitting toxic fumes, it also was discovered that the PE-PUR foam sometimes deteriorated into tiny particles, which also were found to have entered the airways where they, too, could be inhaled by users. These foam particles contain hazardous substances and known carcinogens, in addition to the damage the particles themselves can do when inhaled into the lungs.    

With more than 100 cases having now been filed in the Phillips CPAP MDL and many more expected to follow, it sometimes can be easy to lose sight of the importance of each individual case. In order to better understand the substance of the litigation, and to help us remember that each case represents a life, it can be helpful to take a closer look at a single lawsuit.    

One such lawsuit was filed November 30 by a resident of Salt Lake City, Utah, who blames his esophageal and stomach cancer on the defective Philips respiratory device he was instructed to use by his doctor. Just like millions of other Americans, the plaintiff suffered from sleep apnea, for which he was prescribed the Philips DreamStation CPAP device in 2018.    

“As a result of using the subject device, Plaintiff was exposed to toxic and harmful substances and suffered severe personal injuries including esophageal and stomach cancer that would not have occurred but for the defective nature of the subject device and Philip’s failure to warn Plaintiff or his physicians of the serious health risks associated with use of the subject devices,” the the lawsuit alleges.    

The plaintiff’s complaint names a total of seven counts, including failure to warn, design defect, and breach of warranty. The lawsuit also seeks punitive damages.    

“Philips knew or should have known that the subject devices were inherently dangerous with respect to the risk of PE-PUR foam degradation causing exposure to toxic particulates, chemical emissions, or other compounds resulting in harmful and carcinogenic effects, including esophageal and stomach cancer,” the plaintiff says, arguing as to why defendant Philips’ conduct has been so egregious as to deserve additional punishment.    

Later, the plaintiff adds, “Philip’s intentional, reckless, fraudulent, and malicious failure to disclose information regarding the health and safety risks of the subject devices deprived Plaintiff, [his] physicians, and health care providers the necessary information to enable them to weigh the true risks of using the subject devices against their benefits.”    

The plaintiff has requested a jury trial.    

As of November 15, the Philips CPAP MDL contained a total of 127 cases, each of which represents an individual whose life—like the Salt Lake City plaintiff—has allegedly been irreparably altered due to Philips’ actions and omissions. Tragically, with Philips respiratory devices having dominated the market, there are many, many more similar stories yet to be told, and many lawsuits yet to be filed.      

  Sources:    

United States District Court Western District of Pennsylvania. (30 November 2021). Complaint and Jury Trial Demanded. Case No. 2:21-mc-01230-JFC. MDL 3014. In Re: Philips Recalled CPAP Bi-Level PAP, and Mechanical Ventilator Products Litigation    

United States Judicial Panel on Multidistrict Litigation (JPML). (15 November 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District

CPAP Machine Recall Update: Philips CPAP MDL Gets Underway in Pittsburgh

November 16, 2021
Author: Daniel Gala

Multidistrict litigation (MDL) over recalled Philips CPAP devices got underway in earnest on November 10 with the issuing of the court’s first pretrial order, establishing the MDL’s general framework while also finalizing such basic matters as the MDL’s official name and website.    

Established in early October, the MDL has centralized more than 100 federal lawsuits filed against consumer-electronics and medical-device giant Philips, which recalled millions of CPAP and similar machines in June over concerns about the toxicity of foam used in the devices as sound insulation.    

“The recalled devices allegedly contain polyester-based polyurethane (PE-PUR) sound abatement foam that may degrade into particles or off-gas volatile organic compounds that may be ingested or inhaled by the user, causing injury,” summarized the Judicial Panel on Multidistrict Litigation (JPML) in the Transfer Order creating the MDL.    

Though recognized for its sound-dampening qualities, the tendency for PE-PUR foam to off-gas, or emit, toxic fumes has been well-established for some time. Still, Philips chose to use the material in its breathing devices. The recalls were issued after it was established that both fumes and particles from the PE-PUR foam were entering the devices’ airways, where they can be inhaled by users.    

Inhaling the fumes and/or particles from PE-PUR can be highly dangerous, as the materials are believed to be highly carcinogenic in addition to posing other serious health risks.    

According to the US Food and Drug Administration (FDA), exposure to PE-PUR foam particles can cause “irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.” https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks    

Meanwhile, “potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache, upper airway irritation, cough, chest pressure, and sinus infection.”    

The degradation of the PE-PUR foam is believed to be exacerbated by exposure to high heat and/or humidity.      

While the Philips CPAP MDL included “at least 132 separate actions” as of November 10, that number is expected to grow into the many hundreds or even the thousands, given the widespread use of Philips respiratory devices affected by the recalls.    

Sources:    

United States District Court Western District of Pennsylvania. (10 November 2021). Pretrial Order #1. Case 2:21-mc-01230. MDL 3014. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilators Products Liability Litigation    

United States Judicial Panel on Multidistrict Litigation (JPML). (8 October 2021). Transfer Order. MDL No. 3014. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilators Products Liability Litigation    

United States Food and Drug Administration (FDA). (30 June 2021). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

CPAP Machine Recall Update: Hearing on Potential Philips CPAP MDL Set for September

August 31, 2021
Author: Daniel Gala

Oral arguments over the creation of multidistrict litigation (MDL) to handle what is expected to be an influx of federal Philips CPAP lawsuits will be held September 30, court documents show.

If approved, the MDL would centralize pretrial proceedings for the many thousands of Philips CPAP lawsuits observers anticipate will be filed in the aftermath of Philips’ June recall of millions of respiratory care devices.

In a Notice of Hearing Session issued August 13, the Judicial Panel on Multidistrict Litigation (JPML) confirmed that the motion to form a Philips CPAP MDL will be among those argued at the panel’s September 30 hearing. Oral arguments are scheduled to take place in person at St. Louis, Missouri, though the panel has reserved the right to switch to remote video hearings pending developments in the coronavirus pandemic.

A motion to have federal Philips CPAP cases transferred to an MDL was filed July 7 by plaintiff Thomas Starner. Starner’s motion cited a total of ten plaintiffs (including himself) in five different federal districts, all of whom were seeking establishment of an MDL.

With defendant Philips formally having stated its lack of opposition to an MDL, it is highly likely that the JPML will grant the plaintiffs’ motion following the September 30 hearing.

Philips made its position clear when, in a reply brief filed August 4, the company stated, “Signficantly, all interested parties, including Defendants, submitting a response to the Motion to Transfer…support transfer of these actions.”

Given the lack of opposition, the Philips reply brief asserts that “[t]he primary issue before the Panel is which of the prospective courts is the most appropriate transferee forum,” on which point Philips argues that either the Eastern District or Western District of Pennsylvania would be the most appropriate venue.

In addition to the Pennsylvania courts favored by Philips, a number of plaintiffs have asked that the MDL be conducted in the District of Massachusetts, where Philips’ North America division has its primary place of business.

Given that Philips as well as a large proportion of plaintiffs are amenable to the MDL being established in either the Eastern or Western District of Pennsylvania, it seems likely that the JPML will assign the litigation to one of those two courts.

The litigation arises from Philips’ June 14 recall of an estimated three to four million CPAP machines and other respiratory devices due to serious defects with those products’ insulation foam. Specifically, the so-called PE-PUR foam used for noise insulation has been found to deteriorate into tiny particles that then are able to enter the CPAP’s airway, where they can be inhaled by unsuspecting patients.

Toxic fumes “off-gassed” by the PE-PUR foam also have been found to be entering the airway, where they similarly are inhaled by patients, who often are instructed to breathe exclusively through the devices for the duration of their sleep each night.

The toxins contained in and/or emitted by PE-PUR foam are associated with short-term symptoms including headache and dizziness and, following long-term exposure, with a variety of cancers.

Philips, having consolidated control of roughly two-thirds of the CPAP market, is by far the dominant player in the respiratory device industry, leaving few alternatives for patients in urgent need of a replacement device.

With several million patients affected by the recall, the number of Philips CPAP lawsuits in the United States alone is expected to grow into the many thousands.

Bookmark TheLawFirm.com for the latest updates on Philips CPAP litigation!

Sources:

Judicial Panel on Multidistrict Litigation (JPML). (13 August 2021). Notice of Hearing Session

United Stated Judicial Panel on Multidistrict Litigation (JPML). (7 July 2021). Motion for Transfer and Coordination or Consolidation under 28 U.S.C. §1407. MDL No. 3014. In re: Philips Recalled CPAP, Bi-Level PAP, and Ventilator Litigation

United States Judicial Panel on Multidistrict Litigation (JPML). (4 August 2021). Reply Brief In Support Of Motion For Transfer And Coordination Or Consolidation Under 28 U.S.C. §1407. MDL No. 3014. In re: Philips Recalled CPAP, Bi-Level PAP, and Ventilator Litigation

CPAP Machine Recall Update: Philips CPAP Plaintiffs Seek Multidistrict Litigation, Philips Not Opposed

August 09, 2021
Author: Daniel Gala

Plaintiffs suing consumer-electronics and medical-device giant Philips following the recall of millions of CPAP and BiPAP devices are seeking the centralization of federal cases as multidistrict litigation (MDL), court documents show. In response, Philips has moved for several federal CPAP cases against it to be paused pending a decision by the Judicial Panel on Multidistrict Litigation (JPML), the judicial body responsible for overseeing MDLs.

On June 14, Philips announced the global recall of millions of CPAP and BiPAP respiratory devices due to problems with their PE-PUR foam, which is used as a sound-insulation material. Despite it previously having been known that PE-PUR foam “gasses off” toxic fumes, Philips still decided to use the substance in its market-dominating assisted-breathing machines.

In the June 14 recall announcement, Philips admitted not only that it had discovered that these toxic fumes were entering the devices’ airways but also that small particles of the foam itself had been found in the airways, too.

“The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals,” the Philips recall announcement disclosed.

When patients are connected to their CPAP or BiPAP devices, which they typically are prescribed to do for the duration of their sleep each night, 100% of the air that they inhale has passed through the devices’ airways. This means that millions of affected patients could have been inhaling toxic gases and particles for hours on end every night for a period of years.

As expected, a slew of legal actions against Philips have followed, with federal class action complaints having been filed in the Eastern District of Pennsylvania and Massachusetts, among many other suits. On July 7, the plaintiffs in the Pennsylvania case filed a motion with the JPML requesting that an MDL be established.

Multidistrict litigation (MDL) is intended to create greater efficiency and consistency by centralizing pretrial proceedings for multiple cases involving the same defendant(s) and highly similar facts. MDLs can include anywhere from just a few cases to many thousands of cases. In addition to a centralized discovery process, MDLs also conduct bellwether trials, which are intended to resolve not only the cases directly at issue but also to inform settlement negotiations for the MDL’s other cases by testing the strength of the various claims.

In their motion seeking the MDL, the Pennsylvania plaintiffs highlighted the large number of similarities between the Philips cases.

“The facts surrounding Philips’ manufacture, sale, testing, and recall of its CPAP, Bi-Level PAP, and mechanical ventilator devices are uniform among all purchasers and users of the devices,” their motion states.

For its part, Philips does not appear to be contesting the formation of multidistrict litigation, with court documents indicating there is no opposition to the plaintiffs’ MDL motion.

“The primary issue before the Panel is which of the prospective courts is the most appropriate transferee forum, given that transfer is warranted in this matter and there is no opposition to it,” stated a reply brief filed August 4.

At the time of the MDL motion’s filing on July 7, there were a total of ten similar federal actions pending against Philips across five different districts. By August 4, that number had grown to 35 class action and individual lawsuits in 10 federal courts, court documents show.

As the JPML considers the plaintiffs’ request, Philips has asked the courts in those various actions to stay the proceedings pending an outcome on the MDL motion.

For example, on July 21, Philips asked that the Massachusetts District Court “stay all proceedings in this action, including the filing of answers, motions to dismiss, and other responsive pleadings by all parties, until the Judicial Panel on Multidistrict Litigation issues a decision on the plaintiffs’ request for an MDL.

Sources:

Philips News Center. (14 June 2021). Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

United Stated Judicial Panel on Multidistrict Litigation (JPML). (7 July 2021). Motion for Transfer and Coordination or Consolidation under 28 U.S.C. §1407. MDL No. 3014. In re: Philips Recalled CPAP, Bi-Level PAP, and Ventilator Litigation

United States Judicial Panel on Multidistrict Litigation (JPML). (4 August 2021). Reply Brief In Support Of Motion For Transfer And Coordination Or Consolidation Under 28 U.S.C. §1407. MDL No. 3014. In re: Philips Recalled CPAP, Bi-Level PAP, and Ventilator Litigation

United States District Court District of Massachusetts. (21 July 2021). Defendants Philips North America LLC and Philips RS North America LLC’s Motion To Stay Proceedings Pending A Decision By The Judicial Panel On Multidistrict Litigation On A Motion To Transfer. Case No. 1:21-cv-11076-DJC

CPAP Machine Recall Update: One Month After CPAP Recall, Philips Already Facing Lawsuits

July 21, 2021
Author: Daniel Gala

Within a month of announcing on June 14 a massive global recall of millions of CPAP and BiPAP machines, Dutch consumer electronics and medical equipment conglomerate Philips already is facing numerous lawsuits over the devices, with many thousands more expected to follow.

The lawsuits include at least 10 already filed in Massachusetts federal court for which the plaintiffs’ lawyers have requested class action status, the Boston Globe reported. July 15. A hearing on the class action motion has been scheduled for September. Philips’ North America affiliate is headquartered in Cambridge, Massachusetts.

The voluntary recall of millions of CPAP and BiPAP machines was, according to Philips, a result of the PE-PUR foam used to provide noise insulation for the devices. Philips chose to use the PE-PUR foam in its assisted-breathing machines despite it being known that the foam emits, or “gasses off”, certain toxic fumes. Further, Philips claims that it became aware of the PE-PUR foam deteriorating into small particles, and of those particles entering the devices’ airways.

Either of these factors alone could prove highly detrimental to human health, particularly when considering that CPAP and BiPAP machines are intended to be used by patients continuously for several hours every single day. The toxins contained in PE-PUR foam are associated with short-term symptoms such as headache and dizziness as well as serious long-term ailments, including a variety of cancers.

The first lawsuits filed suggest that plaintiffs and their lawyers will focus on the timing of the Philips recall, raising the familiar question of what the company knew and when.

“The central allegation is that Philips had knowledge of the defect but failed to alert the public of the serious dangers it presented,” an attorney representing one of the Massachusetts plaintiffs told The Globe.

Similar claims are made in a lawsuit reported by WRBL in Georgia. The plaintiff in that case, Fredrick Heller, was diagnosed with lung cancer after using a now-recalled Philips device for years. He blames the PE-PUR foam for his cancer.

“In the Lawsuit, we allege that Mr. Heller’s lung cancer was caused by his prolonged use of one of Philips recalled devices that’s intended for the treatment of obstructive sleep apnea,” said an attorney for Heller, according to WRBL.

Heller’s attorneys also questioned the timing of Philips’ voluntary recall.

“Philips Respironics has not disclosed when it first received reports from users of its Sleep & Respiratory Care devices of the presence of black debris or particles within the airpath circuit. But given how long the devices have been on the market, it’s unlikely that the company only recently learned of these issues,” they said. “Meanwhile, Philips continued to rake in profits from its CPAP and BiPAP machines.”

One of the federal Massachusetts-based lawsuits goes a step further, accusing Philips of timing its recall in order to maximize profits, capitalizing on its massive dominance in the CPAP market, of which it controls approximately two-thirds.

“Philips timed its recall…to coincide with the launch of its next generation of products,” alleges the lawsuit, as quoted by The Globe. This next generation, coincidentally, utilizes a supposedly safer insulation foam. “Thus, the only safe option that Philips offers to its customers…is to purchase Philips’s new model, thus profiting Philips further.”

With millions of devices recalled, these initial lawsuits are certain to be only the beginning.

Stay tuned to TheLawFirm.com for the latest updates on Philips CPAP litigation!

Sources:

Murphy, Sean P. (15 July 2021). After recalling millions of sleep apnea machines, Philips sued by consumers. Boston Globe

Philips News Center. (14 June 2021). Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

Ealy, Maxsim. (8 July 2021). Medical device company Philips faces lawsuit over recently recalled devices. WRBL

Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article. 

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