Investigation raises new questions about Philips breathing devices after 2021 recall

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• John Yang:

  And now an update to a story we brought you last year. In 2021 a widely used breathing device was the subject of a safety recall. But as Ali Rogin reports, it turns out the replacement devices might also pose dangerous problems.

• Ali Rogin:

  For millions of Americans with breathing conditions like sleep apnea, CPAP machines have proven to be life saving devices. But when the same devices become potentially life threatening, the consequences can be deadly.

  Back in October, we brought you the story of a joint investigation published by the Pittsburgh Post-Gazette and ProPublica detailing serious issues with some models of Philips breathing machines, including CPAP, and respirators.

  The machines were recalled in 2021, but not before a number of users of the machines reported developing new illnesses, including cancer and asthma.

  Now, new reporting on the replacement machines that Philips sent out to those customers found that the new machines are emitting elevated levels of dangerous chemicals, including formaldehyde a known carcinogen.

  Joining us now is Debbie Cenziper, one of the leaders of the ProPublica Pittsburgh Post-Gazette investigation. Debbie, thank you so much for joining us.

  First of all, how did you find out about these problems the new Phillips machines we're having?

• Debbie Cenziper, ProPublica:

  Yeah. So ProPublica and the Pittsburgh Post-Gazette has been working more than a year on this investigation. And we've developed a number of sources who shared with us test results that had not been made public, as well as internal records that showed that scientists working for the company were growing increasingly alarmed about the results on these new machines that showed that the machines were releasing chemicals like formaldehyde.

• Ali Rogin:

  And were the new problems similar to the ones that the old machines were experiencing? Or was this just a new set of problems that developed independent of the first model?

• Debbie Cenziper:

  Yes, great question. So the recalled machines had an industrial foam fitted inside the machines that was found to break down and heat and humidity, and release particles as well as fumes into the lungs of patients who, you know, strapped these machines onto their noses and mouths.

  And so after the recall, Philips changed out that foam with a different kind of foam. This one made of silicone, the new foam is not found to break down. But the test results show that it is releasing chemicals. And that is what is causing a concerns not just by scientists in the company, but also at the FDA.

• Ali Rogin:

  How widespread has this problem been determined to be?

• Debbie Cenziper:

  Essentially every replacement machine and refurbished machines sent out by Philips, after the recall, has this new foam in it. So it's pretty widespread? I mean, millions of machines have been replaced not only in the United States, but around the world.

• Ali Rogin:

  And what does Philips say about these new machines?

• Debbie Cenziper:

  Philips says these machines are safe. And that the testing shows that these machines do not admit excessive levels of dangerous chemicals. The FDA is asking for more testing, and will not weigh in on whether or not these machines pose a risk until then. These machines, as you noted in your intro are life saving. They're important.

  And so I think what the FDA did is they weighed the benefits and the risks and they said, continue to use these machines until we get more test results. The issue is it's been more than two years, which leaves people kind of caught in the middle unsure what to do about this. And that is the crux of the problem.

• Ali Rogin:

  And why has there been such a variation in the chemical levels that were found in independent testing versus what Philips testing has shown?

• Debbie Cenziper:

  Right. So Philips solicited the help have independent testing labs to figure out if this foam was emitting high levels of chemicals like formaldehyde, and some of those reports, and we have copies show that there were elevated levels, and some show not elevated levels.

  And so when we speak to toxicologists, their fear is that if there are millions of machines out there with this foam, and some tests show high levels, and some tests don't, we don't know what people are being exposed to.

• Ali Rogin:

  What should people do if they suspect that their replacement machine is also faulty?

• Debbie Cenziper:

  We can't say the machines are unsafe, we can't. Nobody can at this point. What we can say is what we know, which is that these machines are emitting chemicals in some cases that are concerning levels to toxicologists. But people didn't know that. And so we felt as journalists, it was our job to give people the facts so that they could go to their doctors and ask what to do. We're not medical experts, right.

  But at least let people have all the facts because people didn't know, you know, originally about the problems with the original machines until that recall. And so that same pattern kind of happened again, and we wanted to put the word out there.

• Ali Rogin:

  We know that there was already litigation underway, that pertains to the original defective machines. What is the status of that? And is there litigation ongoing in any other places besides Pennsylvania, where much of that has taken place?

• Debbie Cenziper:

  All of the lawsuits have been consolidated into one big ongoing case out of federal court and Western PA. One of the cases was settled by Phillips in the plaintiffs, but there are several large ongoing cases that are still playing out, including a personal injury case. And there are hundreds of plaintiffs involved in that in that ongoing litigation.

• Ali Rogin:

  Debbie Cenziper with ProPublica, thank you so much for your time.

• Ali Rogin:

  Thank you for having me.

• John Yang:

  In a statement to PBS News Weekend, a Philips' spokesperson said independent lab test of the silicone foam and repaired and replacement sheet machines found no safety issues. Spokesperson also said the levels of formaldehyde found in all Philips machines with silicone foam were far below safety limits set by the world authorization and the FDA