Philips
(NYSE: PHG)
received the first complaints of degraded sound abatement foam in its respiratory devices in 2010, but 11 years passed before it turned into a major recall, according to a ProPublica and Pittsburgh Post-Gazette investigation published today.
According to ProPublica, Philips withheld the vast majority of the warnings about black particles, dirt, dust and other contaminants in devices’ airway chambers from the FDA even as the reports became more alarming each year.
It wasn’t until 2021 that Philips initiated a recall that now covers 5.5 million CPAPs and other devices. Since April 2021, the FDA received 105,000 reports of problems, including 385 reports of deaths associated with the foam degradation issue. (Here is MassDevice‘s full timeline of the recall.) After he took over in 2022, Philips CEO Roy Jakobs apologized for the recall on behalf of the Dutch medtech giant is deeply sorry about the recall.
In a series of statements to ProPublica, Philips said it acted as soon as it learned of the potential significance of the problem, which involved polyester-based polyurethane foam that the company chose to quiet the machines.
But ProPublica’s report went on to say: that “an investigation by ProPublica and the Pittsburgh Post-Gazette of 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. 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.”
Philips said today in response to the report: “The articles do not present new facts, and we do not agree with the characterizations made in these articles.”
An FDA Form 483, produced in 2021 after inspections of Philips Respironics’ Murrysville, Pennsylvania facility, also says Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway.
Philips continues to engage in consent decree talks with the U.S. Department of Justice over its handling of the recall. Philips says its remediation of the sleep therapy devices is nearing completion, while the remediation of the affected ventilators is ongoing.
