CPAP Machine Recall News and Updates

The latest lawsuit news and updates regarding CPAP machines.

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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