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The following is a statement from Plaintiffs’ Co-Lead Counsel in the Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation (Sandra L. Duggan of Levin Sedran & Berman LLP, Kelly K. Iverson of Lynch Carpenter LLP, Christopher A. Seeger of Seeger Weiss LLP, and Steven A. Schwartz of Chimicles Schwartz Kriner & Donaldson-Smith LLP) regarding Philips’ newly released testing results.

“This PR spin masquerading as research lacks any credibility and is yet another shameless attempt by Philips to cast blame for the dangers found in its now-recalled breathing devices that pumped degraded foam and chemicals into patients. Despite their previous acknowledgements to the FDA of how detrimental the foam degradation is, Philips continues to desperately try to downplay the issue and the health risks consumers face as a result. The FDA has criticized prior studies completed by Philips as ‘not adequately performed to identify or detect quality problems’; this new data suffers from the same flaws and bias.

“In an official notice to Philips, the FDA rejected the claim that ozone cleaners are responsible for foam degradation issues, concluding that ‘the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents,’ and ’patients and providers cannot readily mitigate the unreasonable risk associated with the recalled devices.

“Philips knew as far back as 2015 that the foam it used in the recalled devices would degrade, creating an unreasonable health hazard to patients, but waited until June 2021 to issue a recall or notify health regulators. Today, thousands of patients who put their trust in Philips are suffering from cancer and respiratory illnesses, while millions more are forced to rely on the company’s dangerously defective devices while waiting for a replacement. We look forward to holding Philips fully accountable for its misconduct.”

Lawyer: Philips ‘knew of problems with sleep apnea machines since 2016’, Euro News Source, December 12, 2022

‘A constant information lag’: The troubled recall of Philips CPAP machines underscores flaws in device oversight, STAT, December 1, 2022

FDA says Philips filed 21,000 reports on bad foam Aug-Oct.

Reuters
November 23, 2022
Toby Sterling

AMSTERDAM, Nov 23 (Reuters) – The U.S. Food and Drug Administration (FDA) on Wednesday said Philips filed 21,000 medical device reports in connection with faulty foam in its ventilation and sleep apnoea devices in the Aug-Oct 2022 period.Philips has been recalling 5.5 million such devices since June 2021 after it became aware that a foam part can deteriorate and threaten users’ health.In a statement, Philips said that it believes the large number of reports are a result of publicity around the issue, which has wiped 30 billion euros off its market valuation.”The vast majority, 93%, of the approximately 90,000 medical device reports filed since April 2021 are alleged technical malfunctions that do not involve serious injury,” the company said.

Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

FDA.gov

UPDATE – November 22, 2022: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) received from August 1, 2022, to October 31, 2022, that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.

Philips Respironics provides update on filed MDRs in connection with the voluntary recall notification/field safety notice* for specific CPAP, BiPAP and mechanical ventilator devices

Philips website
November 22, 2022

Amsterdam, the Netherlands – In June 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices.At the time the recall notification/field safety notice* was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following Philips’ public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice in June 2021, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation.This led to a steep increase by more than 20,000 Medical Device Reports (MDRs) filed by Philips Respironics to the FDA between April 2021 and April 2022. In the following 6 months through October 2022, Philips Respironics filed an additional approximately 70,000 MDRs. The vast majority (93%) of the approximately 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. It is important to note that the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. Philips Respironics investigates all allegations of technical malfunction, serious injury or death.

Third-party epidemiological studies

In July 2022, Philips Respironics published a summary of a systematic literature review of Positive Airway Pressure (PAP) device use and cancer risk: Based on 13 epidemiological studies identified from a systematic literature review, no association has been established between use of PAP devices, including Philips Respironics PAP devices, and risk of cancer in patients with obstructive sleep apnea (OSA). Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.

* Voluntary recall notification in the US/field safety notice outside the US.

Philips respirator recall reaches 260 reported deaths, FDA says

MedTechDive
November 22, 2022

Elise ReuterMore reports of deaths and complaints related to Philips’ ongoing recall of its sleep apnea devices and ventilators have been received by the Food and Drug Administration, the regulator said.Since April 2021, the agency has received 260 reports of deaths amid more than 90,000 medical device reports “reportedly associated” with the breakdown of soundproofing foam in the recalled devices. The most recent update, from August to October 2022, includes 21,000 reports and 91 deaths.The FDA cautioned in a statement that these reports alone can’t determine the prevalence of an event and may be affected by under-reporting or lack of verification that the device caused the problem.Philips began the recall in June 2021 due to potential health risks with PE-PUR foam used to soundproof the devices breaking down and being inhaled by patients. Some of the injuries reported to the FDA include cancer, pneumonia, asthma and other respiratory problems.The company currently is repairing or replacing more than 5.5 million affected devices — a process that is expected to extend into 2023.

That could be compounded by recent problems with Philips’ Trilogy ventilators that had been reworked as part of the recall. In a Nov. 17 report, the FDA reported that the new silicone sound abatement foam installed in the ventilators can separate from the plastic backing and block the device’s air inlet. The company also detected trace amounts of particulate matter in some of the reworked devices, including PE-PUR foam particles.

Philips is in consent decree talks with the U.S. Department of Justice related to its handling of the recall, but neither party has revealed the terms of the agreement. In the meantime, patients continue to face long waits for CPAP machines.

In October, the company said 90% of the recall is expected to be completed by the end of the year.

Frustrations Grow Over Company’s response to Breathing Device Recalls, The New York Times, Nov. 15, 2022

As a CPAP recall drags on, sleep apnea sufferers are getting angry AP, October 25, 2022

Philips CEO Starts Tenure by Cutting 4,000 Jobs Amid Recall Woes Bloomberg October 24,2022

Philips recall sparks 48K complaints to FDA in 3 months, including 44 deaths Fierce Biotech, Aug 17, 2022

Philips parts ways with CEO in midst of massive recall Reuters, August 16, 2022

For sleep apnea patients with recalled CPAP machines, restless nights, The Washington Post, July 23, 2022

Philips Knew of CPAP Foam Decay Years Before Recall, Emails Show, Bloomberg, June 9, 2022

Philips updates latest ventilator recall following report of patient death, 4 injuries, Fierce Biotech, June 6, 2022

Philips Subpoenaed by DOJ Over Sleep-Apnea Device Recall, The Wall Street Journal, April 25, 2022

FDA Finds Maker of Recalled Sleep Aid Devices Knew Of Problems For Years, But Didn’t Act, NBC Chicago, December 2, 2021

CPAP Machine Recall Caused by Flawed Design, Not Cleaning Products, Suit Claims, Bloomberg, October 13, 2021