Philips Timeline
Royal Philips N.V. and its US subsidiary Philips Respironics knew about degradation and off gassing issues with the polyester-based polyurethane (PE-PUR) foam the company used in many of its CPAP, Bi-PAP, and mechanical ventilator devices for years prior to the June 2021 global recall. Millions of sleep apnea patients who rely on Philips CPAP machines have been forced to choose between using dangerous recalled devices or risking serious injury or even death if they stop using it.
2008
The earliest complaints discovered in a query by Food and Drug Administration (FDA) related to keywords: contaminants, particles, foam, debris, airway, particulate, airpath, and black. In total, the FDA found at least 222,000 complaints that could potentially be related to foam degradation that the company received from 2008 to 2017.
2009
Royal Philips took a lead role in launching and marketing several of the recalled devices with media promotion, and participation in medical device conferences.
June 2, 2009
Philips Respironics issued a press release stating, “Royal Philips Electronics (NYSE:PHG, AEX: PHI) today introduced the Trilogy100 portable at-home life-support ventilator.”
October 13, 2009
Philips Respironics issued a press release stating, “Royal Philips Electronics (NYSE: PHG, AEX: PHI) today introduced the next generation Philips Respironics Sleep Therapy System at Medtrade 2009, the leading conference and expo for the home medical equipment industry.” The Sleep Therapy System referred to in the press release was the System One 60, one of the Recalled Devices
2011
An adverse event report from the FDA Manufacturer and User Facility Device Experience (MAUDE) database shows that Philips investigated a patient report of “black dust” on her nose after using a Philips CPAP device.
2014-2017
Philips received 110 complaints related to foam degradation but took no action to address the complaints.
2015
Philips received data from a variety of sources regarding degradation of the PE-PUR foam contained within the recalled devices, including complaints, test reports, information from suppliers, and information from another entity owned by Philips’s parent company. According to the FDA, Philips “failed to adequately evaluate this data and incorporate it into its CAPA (Corrective and Preventative Actions) system for further investigation and potential mitigation, as required by current good manufacturing practice requirements.”
November 2015
Philips asked foam supplier Polymer Technologies Inc. (Polytech) about the potential for PE-PUR foam degradation when exposed to “40C and high humidity.”
2016
Philips conducted testing that revealed the PE-PUR foam used in many of its CPAP, BiPAP, and ventilator devices was susceptible to degradation, resulting in the conclusion that “polyester urethanes show bad resistance against high humidity in combination with high temperature.”
August 2016
Polytech technical director Bob Marsh asked original foam manufacturer William T. Burnett technical director Lee Lawler about Philips’s request. Lawler responded, “I would not be surprised if ester foam, continuously exposed to 40C (104F) at high humidity, would exhibit signs of hydrolysis in as short a time as a year.” He said hot and humid conditions are “not a good environment for polyester foam. Polyether foam could last years in that environment.”
September 1, 2016
Royal Philips issued a press release regarding its promotion of the DreamStation CPAP, one of the Recalled Devices, at an international trade show. It directed media and others interested in obtaining further information to Netherlands-based Elena Calamo Specchia, who at the time, was working in Royal Philips’s Amsterdam office as the Royal Philips Spokesperson and Director of the Royal Philips Group Press Office.
April 12, 2018
Philips opened an informal Corrective and Preventive Action (CAPA) investigation into potential foam degradation on Trilogy ventilators in Australia..
April 20, 2018
Philips Project Mechanical Engineer Vince Testa sent an email to PolyTech about the breakdown of PE-PUR foam that “is pulled into the ventilator air path.”
April 23, 2018
Marsh (Polytech) sent an email to Lawler (Burnett), confirming that Philips is “finding degradation of the ester foam and the urethane film in their device, such that particles are breaking off and flowing in the airstream.”
May 2, 2018
In another email to Lawler, Marsh said Philips “tested [poly]ether vs [poly]ester in high heat and humidity and found ether to be the better performer.”
May 4, 2018
Lawler wrote to Marsh, “We would not recommend using polyester foam in such an environment and have no direct data to use to calculate the rate of hydrolysis. Polyether foam lifetime would not be expected to reduce significantly at the stated conditions. Use with pure oxygen could shorten the lifetime some by promoting more rapid oxidation. I do not know the extent of the reduction, but do not expect it to be overly significant.”
June 20, 2018
Philips closed the informal CAPA investigation without reference to other CPAP and BiPAP devices that utilized the same type of foam. According to the FDA, the company implemented a “preventative maintenance procedure for Trilogy devices” but they “did not verify the effectiveness of this measure.”
August 24, 2018
Internal company emails show Philips personnel discussing testing showing that PE-PUR foam would break down in high heat and humidity environments, concurring with the Trilogy ventilator complaints.
September 12, 2018
A report on additional testing conducted for Philips found that the PE-PUR foam showed “clear disintegration after 2 weeks.” Philips initiated “no further design change, corrective action, or field correction” of the recalled devices for at least three years. Philips continued to manufacture and sell the recalled devices.
2019
The FDA concluded that Philips’s leadership had discussed foam degradation issues concerning CPAPs, BiPAPs, and Triology ventilators at management review meetings since at least 2019.
April 2019
Philips received two complaints that “sound abatement foam ‘is degrading and entering the air path.’”
May 22, 2019
Philips’s internal testing reported the presence of formaldehyde in analyses of its DreamStation 1 devices, finding “tolerable limits of the Formaldehyde compound were exceeded during initial operation, as well as at the [redacted].” There is extensive research, including dozens of human epidemiological studies, showing an association between formaldehyde exposure and numerous forms of cancer.
June 2019
In response, Philips finally initiated a formal CAPA, but according to the FDA this assessment “failed to evaluate all relevant data.” Nonetheless, the company’s investigation ultimately concluded that the cause of degradation was “long-term exposure to environmental conditions of high temperature combined with high humidity.”
January 31, 2020
According to the FDA, Philips management, including executives, “were aware of potential foam degradation issues concerning CPAPs, BiPAPs, and Trilogy ventilators” since at least this date, or earlier, but implemented “no further corrective actions until April 2021.” Additionally, the FDA found that the firm became aware of the issue and related field complaints in at least 2015 or earlier.
March 6, 2020
In response to customer’s request for written guidance on SoClean Ozone product, Philips wrote a letter stating that using SoClean product will not automatically void warranties though they hold the right to void warranties, declining to dissuade patients from using SoClean Ozone products.
July 2, 2020
An internal biological risk assessment conducted by Philips found that the “biological and toxicological risks from exposure to degraded PE-PUR foam are of concern.”
December 10, 2020
Another Philips internal assessment indicated that there were risks posed to patients, determining “degraded PE-PUR foam is not considered biocompatible and presents significant biological risk to those patient populations who are exposed.”
January 11, 2021
Philips also conducted an internal biocompatibility risk assessment, which concluded that degraded foam presents a “significant biological risk to patients.”
February 15, 2021
Judge Conti appointed 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 to serve as plaintiffs co-lead counsel overseeing In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation.
April 13, 2021
Two months prior to the recall, Philips launched the DreamStation 2, which does not contain PE-PUR sound abatement foam.
April 26, 2021
Philips warned investors in its first quarter earnings report of “possible risks to users” of breathing assistance machines but did not disclose the full extent of its knowledge about the risks posed by the PE-PUR foam and attempted to deflect the blame on factors. At no point prior to this date did Philips even hint that there was a dangerous condition in its recalled devices.
May 17, 2021
Ken Cole from RJ Lee, an industrial forensics analytical laboratory and scientific consulting firm, produced a presentation analyzing the foam in Philips’s Trilogy EVO devices, “prompted by staff observation of color variance across both current production and previous builds.”
June 14, 2021
Philips announced a world-wide recall of millions of its CPAP, BiPAP, and mechanical ventilator machines because of the potential health risks of defective PE-PUR foam in the devices. Royal Philips has directly overseen and managed the recall.
June 14, 2021
In a separate communication, the company advised physicians that the recalled devices “could result in a wide range of potential patient impact, from transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment.”
July 8, 2021
Philips released an update to a global supplemental clinical information document that contained results based on its own testing of the affected devices, stating that: “According to analysis performed by Philips, the majority of particulates are of a size (>8 μm) . . . Smaller particulates (<1-3 μm) are capable of diffusing into deep lung tissue.”
July 22, 2021
The FDA upgraded Philips’s recall to its most serious classification, Class I, which indicates that use of the recalled devices may cause serious injury or death.
September 1, 2021
Philips received authorization from the FDA to begin repair and/or replacements for DreamStation devices. The company gave affected patients no clarity on how or when they would receive replacements. This authorization also did not encompass other devices manufactured with the same PE-PUR foam.
October 8, 2021
The Judicial Panel on Multidistrict Litigation centralized class action and personal injury lawsuits against Philips before Senior United States District Court Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated or consolidated pretrial proceedings.
November 9, 2021
The FDA released a Form 483 inspection report based on twenty-one site inspections of Philips’s Murrysville, Pennsylvania manufacturing facility between August 26, 2021 and November 9, 2021. The report concluded that Philips knew about the foam degradation issues since 2015, but never completed a health hazard evaluation, risk analysis, or design review prior to the recall.
November 9, 2021
FDA investigators issued a 29-page 483 Report to Rodney Mell, Head of Quality at Philips Respironics, which is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
December 2021
Philips initiated an additional recall of certain Trilogy EVO Ventilators. The Class I recall targeted ventilators that were using the same PE-PUR foam as other devices covered by the global recall.
March 10, 2022
The FDA issued a 518(a) notification order to Philips because of the company’s “failure to timely provide effective notice to health professionals who prescribe or use the Recalled Products and other persons (including consignees, distributors, retailers, and device users) who should be notified, of the recall and the health risks presented by the Recalled Products.” Philips was ordered to notify people of the “unreasonable risk of substantial harm to the public health” posed by the foam degradation within the next 45 days. This was the first 518(a) notification order issued by the FDA in the 21st century. Prior to the Philips recall, the agency had not issued a 518(a) notification order since 1995.
April 25, 2022
Royal Philips NV was subpoenaed by the Department of Justice (DoJ), indicating the company is under investigation for its conduct related to the recall.
May 2, 2022
The FDA took the historically unprecedented step of issuing a 518(b) notice, proposing a requirement for Philip to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices. In the notice, the FDA said there is sufficient evidence to determine “that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue.” The agency also stated, “Evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”
May 19, 2022
The FDA updated its safety communication related to the recall with new information on medical device reports (MDR). From April 2021 through April 30, 2022, the FDA received over 21,000 MDRs, including 124 reports of death, associated with the PE-PUR foam breakdown from the recalled devices.
June 17, 2022
Lawyers representing plaintiffs filed a Consolidated Amended Class Action Complaint for Economic Losses. The complaint outlines Philips’s pattern of misconduct leading to the recall of millions of its CPAP and BiPAP machines and ventilators. Plaintiffs are seeking to recover economic losses and punitive damages from Philips.
July 21, 2022
During the monthly status conference before Judge Conti, lawyers mentioned that there are more than 60,000 claims against Philips subject to a tolling agreement.
August 15, 2022
The FDA updated its safety communication related to the recall with new information on MDRs. From May 1, 2022 through July 31, 2022 the FDA received more than 48,000 MDRs, more than twice as many as the last period, including 44 reports of deaths associated with PE-PUR foam breakdown or suspected foam breakdown. The FDA is continuing an in-depth review and analysis, including examining the possible reasons for the increased number of reports during this time.
August 22, 2022
Lawyers representing plaintiffs filed a Consolidated Amended Class Action Complaint for Medical Monitoring and a Master Personal Injury Complaint. Plaintiffs are seeking to have Philips cover the cost of medical monitoring for patients who used the recalled devices. In addition, those with injuries allegedly caused by Philips’s recalled devices now have a set of common facts and claims for suing the company. .