The Investigation and Report
The recent investigation conducted by ProPublica and the Pittsburgh Post-Gazette unearthed test results that found foam in the replacement CPAP machines and respirators emit formaldehyde and other dangerous chemicals, and users are developing new illnesses, including asthma and cancer. Journalists at the news outlets said the test results from independent laboratories found that the silicone foam used in replacement machines are different from the original devices, but with the same dangerous issues. They also found scientists working for Philips “grew increasingly alarmed” at the test results and that infighting broke out as the new threat reached the highest levels of the Pittsburgh operation.
The FDA, however, has decided that not using the devices could be more harmful to patient health, at least until it has more information regarding the foam issue. The agency hasn’t provided any new information on the latest test results, but in a completely different issue, on November 2023 it warned about the potential for overheating in the replacement DreamStation 2 devices, which could lead to burns, smoke and fire.
And in a repeat performance, Philips failed to disclose complaints to the FDA – complaints that described deaths and thousands of cancer cases. The Dutch medical equipment maker again says their machines are safe and testing shows they don’t emit ‘excessive’ amounts of dangerous chemicals. How and why are there different test results? And who determines “excessive”? A Philips spokesperson told PBS News that formaldehyde levels in its machines with silicone foam are far below those set by the World Health Organization and there are no safety issues.
Debbie Cenziper, one of the leaders of the ProPublica and Pittsburgh Post-Gazette investigation, told PBS that Philips solicited help of independent testing labs to determine whether the foam is emitting elevated levels of chemicals. Some of those reports show elevated levels and some don’t. ProPublica talked to toxicologists – they fear that of the millions of machines in use, some show elevated levels but “we don’t know what people are being exposed to. We can’t say the machines are unsafe at this point but they are emitting chemicals. We are giving people the facts so they can discuss with their doctor. People didn’t know anything about problems with original machines before the recall so this pattern is happening again.”
READ MORE CPAP HEALTH RISK LEGAL NEWS
Philips announced in September that its CPAP users can file for a piece of the proposed $479 million class action settlement. The settlement will compensate users of 20 different breathing devices and ventilators sold in the United States between 2008 and 2021. Attorneys for the plaintiffs urge them to file a claim at the settlement website, saying "This settlement ensures the millions of Americans who purchased defective Philips devices receive significant financial compensation," but they issued that statement before this current investigation was made public.