CPAP Machine Recall News and Updates

The latest lawsuit news and updates regarding CPAP machines.

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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