Philips Settles Respirator Case for $1.1 Billion

Santa Clara, CAPhilips Respironics has agreed to settle over 700 lawsuits for $1.1 billion. Since the massive 2021 recall of its faulty breathing machines and ventilators that released toxic and carcinogenic fumes into customers’ mouths, throats and lungs, more than 50,000 people have been involved in the litigation.

And it’s not over yet: medical experts say the machines could be associated with “certain” diseases. Philips went so far to say when launching the recall that the degrading foam inside the machines could cause serious harm and carried cancer-causing materials. Since the recall, the FDA has received at least 561 reports of death associated with the CPAP machines.

The non-profit newsroom ProPublica, along with the Pittsburgh Post Gazette, reported last September 2023 how Philips suppressed evidence of its tainted machines since 2010 and that company insiders knew the devices posed an ‘unacceptable’ risk. Philips had insulated the devices with industrial foam to silence a rattle that customers complained kept them awake. But then they complained of “black particles” or “dirt and dust” inside machines and an “oily-like” substance. Other consumers just warned of “contamination.” A 2011 report said “Black shavings in the chamber” and another in 2014 said “contaminated with unknown sticky substance”. Despite over 25 complaints that the foam was defective, Philips in 2015 brought to market its DreamStation. Six years later it issued the recall, saying the foam contained “toxic and carcinogenic” materials.

Medical device manufactures are lawfully bound to report to the FDA within 30 days when they learn that any of their devices may have caused or contributed to a death or serious injury. As well, manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. But Philips chose profit over people and withheld more than 3,700 complaints over 11 years, according to ProPublica and the Gazette. Their investigation further revealed that scientists working for the company grew increasingly alarmed (in 2018 a mechanical engineer at Philips emailed that the foam is “disintegrating” and writes, “This is not a good situation for our users” and Philips had “an unchecked pattern of corporate secrecy”.

FDA Letdown

As for the FDA, it “conducted an inspection of a Philips Respironics’ manufacturing facility to determine what may have caused or contributed to the foam issues and assess adherence to the agency’s requirements for quality manufacturing”. It found that the new foam failed a safety test and emitted “volatile organic compounds” and requested Philips to do more testing at an independent laboratory. And that’s as far as the FDA went, saying “At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk…”. But the agency did warn in late 2023 of DreamStation and CPAP machines overheating.

Philips said the silicone foam was tested against safety limits in keeping with the FDA and chemicals were not emitted at unsafe levels. Formaldehyde, however, is a risk at high exposure. The company submitted to the FDA additional test results, but as of December 2023, the agency said more tests are needed on the foam before determining if the devices pose “risks to patients.”

The FDA in April 2024 announced the consent decree against Philips. According to the agency, it “provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall… Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.” 

Having said that, why would the FDA allow consumers to breathe into machines that emit formaldehyde at levels exceeding safety thresholds established by multiple organizations (according to ProPublica) but acceptable to the FDA? (Here is more about the FDA stalling to alert the public that it rejected Philips test results.)

The $1.1 Billion Settlement

Back to the settlement. According to CBS News, plaintiffs’ attorneys said, "This settlement ensures the millions of Americans who purchased defective Philips devices receive significant financial compensation," and they urged users of the machines to file a claim at the settlement website. The deadline for claim submissions is Aug. 9, 2024.

Claims for financial losses related to the purchase, lease or rent of the recalled devices can now be submitted, with eligible users entitled to:

• a Device Payment Award for each recalled device purchased, leased or rented;
• a Device Return Award of $100 for each recalled device returned by Aug. 9, 2024; and/or
• a Device Replacement Award for money spent to buy a comparable machine on or after June 14, 2021 and before Sept. 7, 2023 to replace a recalled device.