CPAP Machine Recall News and Updates
The latest lawsuit news and updates regarding CPAP machines.
CPAP Machine Recall Update: Philips CPAP MDL Judge Gives Defendants Until Jan 6 to Reply to Amended Complaints
December 27, 2022
Author: Daniel Gala
The judge in multidistrict litigation (MDL) over recalled Philips CPAP machines has granted an extension to the defendants, giving them until January 6, 2023 to respond to a pair of amended complaints filed by the plaintiffs, court documents show.
In a December 14 order, Senior United States District Judge Joy Flowers Conti approved the two-week delay, giving the defendants additional time to craft their answers to both the Consolidated Seconded Amended Class Action for Medical Monitoring and the Amended Master Long Form Complaint for Personal Injuries.
The first complaint has been filed on behalf of a class of plaintiffs seeking reimbursement for the costs they will incur over their lifetimes due to the need for additional medical monitoring necessitated by the defective Philips devices. The other complaint involves allegations that the plaintiffs actually have suffered personal injuries, including cancer, as a result of the recalled CPAP machines.
The Philips CPAP MDL arose from the June 2021 recall of millions of Philips CPAP, Bi-PAP, and other mechanical ventilators. The recalls were announced following revelations that toxic fumes and toxic particles from the machines’ insulation foam had been found to enter the device’s airways, where they could be inhaled by users.
As of December 15, the MDL included a total of 352 cases, according to the Judicial Panel on Multidistrict Litigation (JPML). In addition to personal injury and medical monitoring plaintiffs, others have sought reimbursement for economic losses caused by the massive recalls.
If you have been diagnosed with cancer after years of regularly using a recalled Philips respiratory device, contact TheLawFirm.com for a free legal consultation!
Sources:
United States District Court Western District of Pennyslvania. (14 December 2022). Order Granting Joint Motion for Extension of Deadlines to Respond to Complaints and Other Associate Deadlines. Case 2:21-mc-01230. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation. MDL No. 3014.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 December 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
CPAP Machine Recall Update: Philips Asks Court to Dismiss Dozens of Cases from CPAP MDL
December 7, 2022
Author: Daniel Gala
Arguing a lack of standing and personal jurisdiction, consumer-electronics giant Philips and its affiliated entities are seeking to have dozens of lawsuits against them over defective CPAP devices dismissed, according to court filings dated December 6.
The filings were made in United States District Court for the Western District of Pennsylvania, where hundreds of cases against Philips have been centralized as part of multidistrict litigation (MDL) over the recalled devices, which include CPAP, Bi-PAP, and other mechanical ventilator machines.
The centralized cases were brought by plaintiffs alleging they have suffered harm as a result of the defective products, which were pulled off the market by the millions after it was revealed that the insulation foam used in the devices—previously known to be toxic and to off-gas toxic fumes—posed a direct health risk to users. Toxic fumes from the foam and small, toxic particles of the foam itself had been discovered in the devices’ airways, where they could be inhaled by patients who breathe through the devices for hours every day.
As of November 15, the latest data available, the CPAP MDL included 346 active cases. In their motion to dismiss for lack of personal jurisdiction, the Philips defendants are seeking to have 122 cases against Philips’ parent company dismissed, which amounts to more than one-third of the MDL’s total cases.
In the motion, Philips argues that the wide-ranging and far-reaching conglomerate’s Dutch parent company should be dismissed as a defendant in the MDL because the company—Koninklijke Philips N.V. (KPNV)—does not have a significant enough connection to the actions of its North American subsidiary—Philips RS North American LLC—for it to be held responsible in the courts of the United States for harms that its subsidiary caused in the US.
KPNV “has made clear that its exceedingly few contacts with either the United States or the development, marketing and sale of the relevant devices by its indirect subsidiary, Philips RS North America LLC (‘Respironics’), prevent the exercise of personal jurisdiction over it,” the defendants argue.
Even if the court were to grant Philips’ motion to dismiss with regards to KPNV, the claims against the other Philips defendants—including Philips’ North American subsidiary—would still proceed.
In addition to their motion to dismiss for lack of personal jurisdiction, the Philips defendants also filed a motion to dismiss a class action complaint that is part of the MDL for lack of standing.
The class action was filed on behalf of those who allegedly have suffered economic losses due to the Philips CPAP recalls, but the Philips defendants argue that the suit should be dismissed “with prejudice for lack of Article III standing, because all of the Plaintiffs fail to allege an injury in fact and Plaintiffs do not allege that the Respironics repair and replacement program failed to address any hypothetical economic injury.”
With the motions to dismiss having just been filed on December 6, the affected plaintiffs have not yet had the opportunity to offer their responses.
Many of the plaintiffs in the Philips CPAP MDL allege that they developed cancer following long-term, regular exposure to the toxic PE-PUR foam and the toxic fumes it its known to off-gas.
The types of cancer associated with such exposure include:
• Bladder cancer
• Brain cancer
• Breast cancer
• Hematopoietic cancer
• Kidney cancer
• Leukemia
• Liver cancer
• Lung cancer
• Lymphatic cancer
• Multiple Myeloma
• Nasal cancer
• Non-Hodgkin lymphoma
• Papillary carcinoma
• Prostate cancer
• Rectal cancer
• Stomach cancer
• Testicular cancer
• Thyroid cancer
If you or a loved one has been diagnosed with cancer after using a recalled Philips CPAP machine, contact TheLawFIrm.com for a free legal consultation!
Sources:
United States District Court Western District of Pennsylvania. (6 December 2022). Philips RS North America LLC’s and the Philips Defendants’ Motion to Dismiss Under Rule 12(b)(1) for Lack of Standing. Case No. 21-mc-1230. MDL No. 3014. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 November 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending.
CPAP Machine Recall Update: Philips CPAP MDL Court Approves Plaintiff / Defendant Fact Sheets
October 3, 2022
Author: Daniel Gala
Multidistrict litigation (MDL) over recalled Philips CPAP, BiPAP, and other respiratory devices took a significant step forward September 22 with the court’s approving final plaintiff and defendant fact sheets and establishing rules and guidelines governing their implementation.
The Philips CPAP MDL has centralized hundreds of lawsuits filed in the aftermath of the global recall of millions of Philips respiratory devices. The massive recalls were initiated after it was discovered that foam insulation used in the machines can off-gas toxic fumes and shed small, toxic particles that end up in the device’s airways. Now, users of Philips respiratory devices from around the world are suing, claiming that Philips knew or should have known that the toxic foam posed a health risk and alleging that the devices caused them serious harm, such as spurring the development of certain cancers and other ailments.
Plaintiff Fact Sheet
While the MDL remains in its relatively early stages, the release of the plaintiff fact sheet marks a key milestone, as it will streamline the gathering of data across the large number of cases. A plaintiff fact sheet allows every case within the MDL to file key information with the court in a uniform way. The plaintiff fact sheet for the Philips CPAP MDL consists of a total of 16 pages plus exhibits, and it asks for information ranging from basic personal information like name, age, and address to device usage and medical history.
Additionally, the plaintiff fact sheet contains a number of required authorizations, whereby the plaintiff approves the release of certain private information to the court and the defendants. These authorizations include an authorization for the release of insurance records, a Medicare authorization form, a release of psychotherapy notes (for claims of emotional distress), a release of employment records, a release of workers’ compensation records, and a social security release. For claims of lost wages or reduction in earning capacity, a plaintiff must also submit IRS Form 4506, which authorizes a third party to receive the plaintiff’s federal tax return.
Finally, plaintiffs must submit copies of “all medical records and/or documents relating to the use of the Device from any hospital or health care provider who treated you in the past ten (10) years and who treated you for any disease, condition, or symptom referred to in any of your responses to the questions above.”
As for the implementation of the plaintiff fact sheet, or PFS, the court orders that “[e]ach Plaintiff must submit a completed PFS, executed Authorizations, and documents responsive to the requests in the PFS.” The plaintiff fact sheets are to be filed electronically through MDL Centrality, the online platform for the company BrownGreer, a third-party vendor. In order to access MDL Centrality, the parties must “enter into a contract with the company specifying the services to be to be provided, the costs of such services, and the Parties’ payment obligations.”
Once the parties responses and documents are uploaded to MDL Centrality, the court order states that this will be considered effective service upon the opposing parties.
For cases that already were a part of the MDL as of the date of the September 22 order, the deadline for filing a plaintiff fact sheet is 60 days from the date of the order. For all other cases, the deadline is 45 days after the filing of the plaintiff’s short-form complaint with the MDL.
Defendant Fact Sheet
As would be expected, the defendant fact sheet requests much different information than the plaintiff fact sheet, focusing instead on data such as the defendants’ contacts with healthcare sales providers, including a specific section for identifying “all communications regarding the health hazards, potential health hazards, or safety of Plaintiff’s device.” Further, defendants are asked to name every piece of marketing literature that they provided to the plaintiff’s healthcare service providers and to disclose “compensation or remuneration in any form to any of Plaintiff’s identified Healthcare Professionals.”
The defendants must file a separate defendant fact sheet for each case against them. After a plaintiff files a fact sheet on MDL Centrality, defendants have 60 days to submit a defendant fact sheet along with all responsive documents.
Conclusion
With millions of devices recalled, the Philips CPAP MDL is expected to continue to grow, potentially into the thousands of cases. (As of September 15, it included a total of 323 active cases, according to the Judicial Panel on Multidistrict Litigation.) The release of the plaintiff and defendant fact sheets will only help expedite the addition of new cases to the litigation.
Philips continues to face other significant legal fallout from the recall of its respiratory devices, both in the US and abroad. On September 8, Reuters reported that prosecutors in France were investigating the circumstances surrounding the recall, with the Paris public prosecutor’s office telling the news agency via text message that it has “taken up, as of June 20, 2022, complaints filed on the grounds of aggravated deception, involuntary attacks on physical integrity, endangerment of life of others and administration of harmful substances.”
As of August, Philips announced that it had replaced only about half of the estimated 5.5 million respiratory devices covered by the recalls, which the company claims already has cost it roughly $900 million.
Sources:
United States District Court Western District of Pennsylvania. (22 September 2022). Pretrial Order No. 26 Fact Sheet Implementation Order. Case No. 2:21-mc-01230. MDL No. 3014. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Litigation.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 September 2022). MDL Statistics Report – MDL Distribution by District.
Van Campenhout, Charlotte. (9 September 2022). French prosecutors probe Philips respirator recall. Reuters.
CPAP Machine Recall Update: Philips CPAP MDL Prepares for Sept 1 Science Day
September 7, 2022
Author: Daniel Gala
The court’s so-called Science Day was held September 1 in multidistrict litigation (MDL) over millions of recalled respiratory devices made by consumer-electronics giant Philips. Additionally, on August 29, defendant Philips filed multiple motions to dismiss a class action lawsuit contained within the MDL.
‘Science Day’
As described by Judge Joy Flowers Conti in an August 31 order, Science Day is “an educational session that is an informal, non-adversarial tutorial program for the court” during which the parties explain the scientific underpinnings of the litigation.
The Philips CPAP MDL has centralized more than 300 active lawsuits filed in the aftermath of Philips’ shocking worldwide recall of millions of CPAP, BiPAP, and other respiratory devices in June 2021.
The reason for the recall was the PE-PUR foam used in the devices for noise and vibration reduction. Philips designed the devices to use PE-PUR foam even though it has long been known not only that PE-PUR foam is toxic but also that it off-gasses toxic fumes. It later was discovered that these toxic fumes and small particles of the toxic foam itself were able to enter the devices’ airways, where they could be inhaled by users.
For years, Philips ruthlessly sought to achieve and then maintain market dominance in the respiratory device industry, which meant that when millions of Philips CPAP and other devices were recalled for being unsafe, many patients were left without a feasible alternative. They faced a brutal choice: either discontinue their doctor-prescribed CPAP treatment regimen or continue to use a device that they now knew could cause them serious harm.
Philips’ Motions to Dismiss
On August 29, defendant Philips filed two motions to dismiss, one for an alleged lack of standing, and one for failure to state a claim. The twin motions are seeking to have a class action lawsuit that has been included in the MDL tossed out of court.
A day after they were filed, the court rejected the documents because they had been filed incorrectly, but the court has allowed the defendants an opportunity to rectify their mistake and refile the motions.
The class action lawsuit at issue is an economic losses case that alleges, in the words of the defendants “that when [Philips] Respironics initiated a voluntary recall on June 14, 2021…Respironics became immediately liable for economic damages to every person or entity that ever ‘acquired’ or ‘paid for’ a recalled device.” Unsurprisingly, Philips rejects this view, which is why it is trying to have the economic losses class action booted out of court.
The Health Risks of Inhaling PE-PUR Foam
According to the United States Food and Drug Administration (FDA), the potential health risks of inhaling particles of PE-PUR foam include:
• Irritation to the skin, eyes, nose, and respiratory tract
• Inflammatory response
• Headache
• Asthma
• Toxic or cancer-causing effects to organs, such as kidneys and liver
Meanwhile, risks associated with inhaling the toxic fumes that PE-PUR foam off-gas include:
• Headache
• Dizziness
• Irritation in the eyes, nose, respiratory tract, and skin
• Hypersensitivity reaction, such as an allergic reaction or other immune system reaction
• Nausea or vomiting
• Toxic and cancer-causing effects.
If you or a loved one has suffered serious harm after using a recalled CPAP, BiPAP, or other respiratory device made by Philips, contact TheLawFirm.com for a free consultation!
Sources:
United States District Court Western District of Pennsylvania. (31 August 2022). Order. Philips Recalled CPAP, Bi-level PAP, and Mechanical Ventilator Products Liability Litigation. Case No. 2:21-mc-01230.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 August 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
United States Food and Drug Administration (FDA). (Last updated 19 May 2022). Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Safety Communications.
United States District Court Western District of Pennsylvania. (29 August 2022). PHILIPS RS NORTH AMERICA LLC, KONINKLIJKE PHILIPS N.V., PHILIPS NORTH AMERICA LLC, PHILIPS HOLDING USA, INC., AND PHILIPS RS NORTH AMERICA HOLDING CORPORATION’S MOTION TO DISMISS THE CONSOLIDATED SECOND AMENDED CLASS ACTION COMPLAINT UNDER RULE 12(b)(1) FOR LACK OF STANDING. Philips Recalled CPAP, Bi-level PAP, and Mechanical Ventilator Products Liability Litigation. Case No. 2:21-mc-01230.
United States District Court Western District of Pennsylvania. (29 August 2022). Philips RS North America LLC’s Motion to Dismiss the Consolidated Second Amended Class Action Complaint for Economic Losses for Failure to State a Claim. Philips Recalled CPAP, Bi-level PAP, and Mechanical Ventilator Products Liability Litigation. Case No. 2:21-mc-01230.
United States District Court Western District of Pennsylvania. (29 August 2022). Memorandum of Law in Support of Philips RS North America LLC’s Motion to Dismiss the Consolidated Second Amended Class Action Complaint for Economic Losses for Failure to State a Claim. Philips Recalled CPAP, Bi-level PAP, and Mechanical Ventilator Products Liability Litigation. Case No. 2:21-mc-01230.
CPAP Machine Recall Update: Philips CPAP MDL Prepares for Sept 1 Science Day
August 2, 2022
Author: Daniel Gala
Multidistrict litigation (MDL) over recalled CPAP, BiPAP, and other mechanical ventilator products made by consumer-electronics giant Philips continues to make its way through pretrial proceedings, with the MDL’s science day scheduled to take place on September 1.
So-called “science days” are commonplace in litigation that involves highly technical or scientific matters. They are designed to be non-adversarial proceedings during which the parties educate the court on the science behind the case or cases.
Pursuant to an order issued July 21, science day will be held from 10 am until 4 pm on September 1, with a one-hour lunch break. The parties must submit a “joint, detailed schedule for science day” by August 18.
The Philips CPAP MDL arose from the June 2021 recall of millions of Philips respiratory devices after they were determined to be unsafe for patient use due to a problem with the products’ foam insulation. PE-PUR foam, which had been used in the recalled devices for noise insulation and vibration reduction, has long been known to off-gas toxic fumes and to be toxic itself. It subsequently was discovered that these toxic fumes were entering the device’s airways, where they were being inhaled by users. Further, small particles of the foam itself also were discovered in the airways.
As by far the dominant player in the CPAP and BiPAP industry, the Philips recall impacted millions of people. Many individuals who were unable to obtain or afford a replacement device were forced into an impossible choice: go without essential, doctor-prescribed treatment for their sleep apnea or other serious condition, or continue to use a recalled device that could be making them ill over the long term by causing them to inhale toxic fumes and particles.
In June 2022, Philips released the results of what it said was research conducted by five independent laboratories that had been hired to investigate the seriousness of the health risks posed by the recalled Philips devices. Philips claims the results show that, of the devices it received back as part of the recall, very few show visible signs of foam degradation and that the presence of volatile organic compounds (VOCs) off-gassing from the foam was at far too low of levels to pose a serious health risk. Also, according to Philips, users who cleaned their devices with ozone—something the device instructions advise against—experienced significantly more foam degradation than those that did not: “Devices with self-reported ozone use were 14x more likely to have significant visible foam degradation than those with self-reported no ozone use.”
However, critics were quick to push back on Philips purported research, pointing out that having “no visible signs of foam degradation” does not necessarily disprove the notion that tiny particles of the foam were entering the devices’ airways. Further, the company SoClean, Inc., maker of an ozone-based CPAP-device cleaning product, has sued Philips, alleging that Philips has tried to shift the blame for its own colossal failures.
“This is a case about a multination corporation [Philips] deflecting attention away from inexcusable design flaws, misleading the public, creating confusion, and causing hundreds of millions of dollars of damage in the process,” SoClean’s lawsuit says, adding later, “Without any explanation, Philips suggested to consumers and users of its sleep and respiratory care devices that ozone cleaners were somehow responsible for the product recall.”
As of July 15, the Philips CPAP MDL contained a total of 316 active cases.
Sources:
United States District Court Western District of Pennsylvania. (21 July 2022). Pretrial Order #20 Order Setting Schedule for Science Show and Tell on September 1, 2022. Case 2:21-mc-01230. MDL No. 3014. In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation.
United States Food and Drug Administration (FDA). (Last updated 19 May 2022). Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Safety Communications.
Philips. (28 June 2022). Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program. Company Release.
United States District Court District of Massachusetts. (12 October 2021). Complaint. Case No. 1:21-cv-11662. SoClean, Inc., v. Koninklijke Philips N.V., Philips North America LLC, and Philips RS North America LLC.
United States Judicial Panel on Multidistrict Litigation (JPML). (15 July 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
CPAP Machine Recall Update: Philips CPAP MDL Court Issues Discovery Plan
June 29, 2022
Author: Daniel Gala
The court in multidistrict litigation (MDL) over recalled Philips CPAP devices issued on June 17 a detailed initial discovery plan, outlining key deadlines related to fact discovery, depositions, and privilege logs in the highly complex litigation, which not only includes over 300 individual cases but also two class action lawsuits, as well.
Per the court-issued discovery plan, the parties must submit by June 29 three proposed orders, including a proposed amended protective order concerning confidential information, a proposed order regarding the discovery of documents and electronically stored information, and a proposed order governing privilege log protocol. Also by June 29, the MDL’s defendants are to have identified the sources reasonably believed to possess potentially relevant information. Fact discovery is to begin July 1.
The Philips CPAP MDL has centralized hundreds of federal lawsuits filed against Philips in the aftermath of the global recall of millions of its market-dominating CPAP, BiPAP, and other respiratory devices. The devices were pulled from the market after it was revealed that the PE-PUR foam used for vibration reduction and sound abatement was off-gassing toxic fumes and shedding toxic particles, both of which were entering the devices’ airways, where they were inhaled by users.
Plaintiffs allege that Philips new or should have known about the risk posed by its devices sooner, but that the company cynically waited for its next generation devices—which do not use PE-PUR foam—to become available before notifying the public and regulators about the serious health risks posed by its devices.
In addition to plaintiffs suing Philips alleging that the defective devices caused them to develop cancer, the MDL also contains two class actions: one brought on behalf of plaintiffs who allege they suffered economic losses due to the Philips recalls and another seeking compensation for the increased costs of medical monitoring that users of the defective devices will have to undergo for the remainder of their lives due to their increased risk of cancer caused by their exposure to the Philips machines.
The Philips CPAP MDL included a total of 303 active cases as of June 15.
As the US Food and Drug Administration (FDA) explains, “Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when information reasonably suggests that their device or a similar device they manufacture would be likely to cause or contribute to death or serious injury if the malfunction were to recur.” In addition to these mandatory reports from the manufacturer, MDRs also can be submitted voluntarily by medical professionals, consumers, and patients.
From 2011 until the device recalls in April 2021, Philips submitted to the FDA only 30 MDRs related to the breakdown of the PE-PUR foam in their devices, none of which resulted in injury or death. However, in the year from April 2021 through April 30, 2022, complaints skyrocketed, with the FDA receiving “more than 21,000 MDRs, including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown.”
Media reports tell of long-time Philips CPAP users who have been unable to obtain or afford replacement devices and had to choose between foregoing potentially life-saving treatment for their sleep apnea or putting themselves at serious risk for long-term health effects. For example, Christopher Taylor used his Philips CPAP device on a nightly basis for seven years before it was recalled in April 2021.
“I had to go six months, maybe seven, without CPAP machine, waking up not breathing all the time, just scared to sleep you know,” Taylor told Fox43.
Now that Taylor finally has a replacement CPAP machine, he still must live with the constant worry that the recalled Philips device will end up killing him one day.
“I have this overwhelming feat of ‘Is today the day I’m going to find out that machine killed me?’” he said regarding the increased cancer risk that he will have to deal with for the remainder of his life.
“We trusted in that company to give us a product from dying in our sleep that could kill us in 30 different ways or more,” Taylor lamented. “I’m taking this all the way to the courts because my voice needs to be heard.”
Taylor reportedly has joined a class action lawsuit against Philips.
If you or a loved one has been diagnosed with cancer following routine, long-term use of a recalled Philips respiratory device, contact TheLawFirm.com for a free legal consultation!
Sources:
United States District Court Western District of Pennsylvania. (17 June 2022). Case Management Order Initial Discovery Plan. In Re: Philips Recalled CPAP, Bi-level PAP, and Mechanical Ventilator Products Litigation. Case 2:21-mc-01230. MDL No. 3014
United States Judicial Panel on Multidistrict Litigation (JPML). (15 June 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Judicial Panel on Multidistrict Litigation (JPML). (15 June 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Food and Drug Administration (FDA). (Content current as of 19 May 2022). Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
De Tore, Jackie. (16 June 2022). One year after a CPAP recall, some people are still left without a fix. Fox43
CPAP Machine Recall Update: Philips CPAP MDL Court Sets Deadlines for Master Complaints, Answers, Motions to Dismiss
June 1, 2022
Author: Daniel Gala
On May 20, the court in multidistrict litigation (MDL) over Philips respiratory devices announced a number of key deadlines, including the dates by which master complaints and answers must be filed. The pretrial order establishing the deadlines also set dates by which the defendants must file any motions to dismiss.
The MDL has centralized federal lawsuits filed in the aftermath of Philips recalling millions of its CPAP, BiPAP, and other respiratory devices after revealing that the foam used for noise insulation and vibration reduction was emitting carcinogenic gasses and shedding toxic particles into the devices’ airways, where they were inhaled by users. Given the millions of devices on the market, it is expected that ultimately thousands of lawsuits will be filed against Philips.
Unlike class action lawsuits, in which many plaintiffs join a “class” in a single case, multidistrict litigation centralizes the pretrial proceedings for multiple cases, sometimes several thousand. Sometimes, the numerous cases that constitute an MDL can contain class action lawsuits among them.
Such is the case with the Philips CPAP MDL, which includes two separate class action lawsuits as well as hundreds of individual personal injury lawsuits. The first class action involves the class of plaintiffs alleged to have suffered economic losses as a result of the device recalls. The second class action is a medical monitoring complaint, which includes plaintiffs who now will be forced to undergo additional medical testing and monitoring for the remainder of their lives because of the increased risk of cancer they now have because of their exposure to Philips CPAP devices. These additional medical services can be quite costly, and even cost prohibitive for some individuals, particularly those without insurance.
These three different prongs of the CPAP MDL each have their own deadlines. For the economic loss class action, the complaint is due June 20; answers or motions to dismiss are due August 22; oppositions to motions to dismiss are due October 21; and replies in support of motions to dismiss are due December 5.
For the medical monitoring class action, the complaint is due August 22; answers or motions to dismiss are due October 24; oppositions to motions to dismiss are due December 23; and replies in support of motions to dismiss are due February 6, 2023.
For personal injury plaintiffs, the master complaint is due August 22; answers or motions to dismiss are due October 24; oppositions to motions to dismiss are due December 23; and replies in support of motions to dismiss due February 6.
The master complaint is a single filing that covers the facts and allegations common to all of the MDL’s personal injury plaintiffs. In addition, each case has its own complaint detailing the facts and allegations specific to that individual case.
As of May 15, the Philips CPAP MDL included a total of 293 active cases, according to the Judicial Panel on Multidistrict Litigation (JPML).
Sources:
United States District Court Western District of Pennsylvania. (20 May 2022). Pretrial Order #14 Scheduling the filing of consolidated amended class and master complaints, answers, motions to dismiss, and related briefing. Case No. 2:21-cv-01447. In Re: Philips Recalled CPAP Bi-Level PAP, and Mechanical Ventilator Products Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 May 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
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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About TheLawFirm.com (TLF)
TheLawFirm.com is a group of award winning attorneys, paralegals and associates from the legal profession who’s main goal is to educate and represent their clients with the utmost expertise, respect and trust.
We also work closely with a large group of experts from the medical profession so we can draw upon their expertise, in order to present as much accurate information relating to various mass tort and personal injury lawsuits as we can.
