Sam Brusco, Associate Editor09.27.23
According to a ProPublica and Pittsburgh Gazette investigation, Philips received the initial complaints concerning the degraded PE-PUR sound abatement foam in its respiratory devices as early as 2010, but 11 years went by before it became a major recall.
ProPublica claims that Philips received reports early on warning of “black particles” or “dirt and dust” inside the devices’ airway chambers, yet withheld most of the warnings from the U.S. Food and Drug Administration (FDA).
Philips announced the major recall of its bi-level PAP, CPAP, and mechanical ventilator devices over the health risks—which ProPublica claims included “vomiting, dizziness and headaches, and newly diagnosed cancers of the lungs, throat, sinuses, and esophagus”—related to the devices' polyester-based polyurethane (PE-PUR) sound abatement foam breaking down on June 14, 2021. The around 20 respiratory devices affected by this issue amounted to millions.
Along the way, Philips issued several updates on remediation efforts in December 2021, June 2022, December 2022, May 2023, and July 2023. Philips claimed that it acted as soon as possible after it had learned about the problem’s “potential significance.”
ProPublica believes otherwise: “…the 11 years between the first complaints and the recall reveals a different story—one of a company that sought to protect its marquee products as stock prices soared to the highest levels in decades,” its article alleges. “Again and again, previously undisclosed records and interviews with company insiders show, Philips suppressed mounting evidence that its profitable breathing machines threatened the health of the people relying on them, in some cases to stay alive."
The publication backed its claims with an analysis of tens of thousands of reports demonstrating that Philips kept more than 3,700 complaints over 11 years from the FDA.
Philips responded to the ProPublica article in a press release the same day it was published, claiming, “The articles do not present new facts and we do not agree with the characterizations made in these articles.”
“Philips’ priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them. Philips regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this. Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale. We continue to dedicate all available resources to ensure that patients receive remediated devices.”
Philips is still in consent decree talks with the U.S. Department of Justice about how it handled the recall. The company said remediation of the sleep therapy devices is nearing completion and remediation of affected ventilators is continuing.
ProPublica claims that Philips received reports early on warning of “black particles” or “dirt and dust” inside the devices’ airway chambers, yet withheld most of the warnings from the U.S. Food and Drug Administration (FDA).
Philips announced the major recall of its bi-level PAP, CPAP, and mechanical ventilator devices over the health risks—which ProPublica claims included “vomiting, dizziness and headaches, and newly diagnosed cancers of the lungs, throat, sinuses, and esophagus”—related to the devices' polyester-based polyurethane (PE-PUR) sound abatement foam breaking down on June 14, 2021. The around 20 respiratory devices affected by this issue amounted to millions.
Along the way, Philips issued several updates on remediation efforts in December 2021, June 2022, December 2022, May 2023, and July 2023. Philips claimed that it acted as soon as possible after it had learned about the problem’s “potential significance.”
ProPublica believes otherwise: “…the 11 years between the first complaints and the recall reveals a different story—one of a company that sought to protect its marquee products as stock prices soared to the highest levels in decades,” its article alleges. “Again and again, previously undisclosed records and interviews with company insiders show, Philips suppressed mounting evidence that its profitable breathing machines threatened the health of the people relying on them, in some cases to stay alive."
The publication backed its claims with an analysis of tens of thousands of reports demonstrating that Philips kept more than 3,700 complaints over 11 years from the FDA.
Philips responded to the ProPublica article in a press release the same day it was published, claiming, “The articles do not present new facts and we do not agree with the characterizations made in these articles.”
“Philips’ priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them. Philips regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this. Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale. We continue to dedicate all available resources to ensure that patients receive remediated devices.”
Philips is still in consent decree talks with the U.S. Department of Justice about how it handled the recall. The company said remediation of the sleep therapy devices is nearing completion and remediation of affected ventilators is continuing.
