Expert Commentary

How they did it: A reporting team led by Pittsburgh Post-Gazette and ProPublica exposes dangerous defect in popular breathing machine

The reporters share 11 tips for covering science and the medical device industry.

(Courtesy of ProPublica.)

In the summer of 2022, Michael Sallah, the deputy managing editor of investigations at the Pittsburgh Post-Gazette, received an email from a source who encouraged him to look at personal injury lawsuits filed in federal court in Pittsburgh. The lawsuits involved Phillips Respironics, one of the leading makers of breathing machines, including ventilators and sleep apnea machines.

The source also sent him a Food and Drug Administration inspection report of one of the Philips factories that made the breathing machines, located on the outskirts of Pittsburgh.

“As we started to dig in and look, it was pretty horrifying stuff that we were coming up with,” Sallah says.

Through a monthslong investigation, the reporting team, which also included ProPublica, Mediahuis NRC in Amsterdam and Northwestern University’s Medill Investigative Lab, discovered that patients who were using Philips breathing machines, including sleep apnea machines, also called CPAP machines, were dying and the scale of the crisis was far greater than the public knew.

The foam in the Philips breathing machines was breaking down in heat and humidity, sending toxic fumes and small particles into the lungs of vulnerable patients, including infants, older adults, pregnant women and veterans, the investigation revealed.

 “This is going right into your nose, your mouth, your sinuses down to your esophagus, into your respiratory system and lungs,” says ProPublica investigative reporter Debbie Cenziper

The reporting also revealed that Philips had known about the defective machines since 2010 and didn’t alert the public. Neither did the FDA, which had received warnings about contaminants in the machines.

And in 2021, when the company recalled its popular DreamStation breathing machines, it sent out replacement parts that continued to release cancer-causing chemicals, the investigation revealed.

The reporters also found:

  • Philips continued to aggressively market the machines while its own experts warned of the dangers the devices were posing to patients.
  • Philips failed to turn over more than 3,700 complaints about the eventually-recalled machines, sometimes waiting years before submitting them to the FDA. The FDA requires companies to disclose patient complaints to the agency within 30 days.
  • Other leading device makers also submitted late reports about patient complaints involving flawed pacemakers, prosthetics, dialysis machines and screws and plates for bones. In 2023, 1 in 8 reports from medical device companies, including more than 232,000 complaints, were submitted to the FDA past the 30-day deadline.

As a result of the investigation:

  • The Government Accountability Office is launching an investigation of the FDA’s oversight of medical devices. It’s the first in a decade. Sens. Richard Blumenthal (D-CT) and Dick Durbin (D-IL) asked the GAO to investigate how the FDA tracks warnings about dangerous devices, oversees recalls and takes actions against companies.
  • Rep. Jan Schakowsky (D-IL), the ranking member of the House Energy and Commerce subcommittee that oversees consumer product safety, also called for investigations.
  • Connecticut’s Attorney General William Tong called for third-party experts to conduct safety tests on recalled machines.
  • Philips Respironics announced in January that it was going to stop manufacturing and selling all CPAP machines in the United States.

The reporting team included Sallah, Michael Korsh and Evan Robinson-Johnson from Post-Gazette; Cenziper from ProPublica; and Monica Sager from Northwestern University.

In an interview, Sallah and Cenziper, both Pulitzer Prize winners, share these 11 reporting tips for journalists.

1. To strengthen a reporting project, collaborate with other newsrooms.

After Sallah began looking into the lawsuits in federal court, he reached out to long-time reporting colleague Cenziper to pitch a collaboration. The two had worked together at the Miami Herald and later at The Washington Post and had been wanting to find a collaborative project. This seemed to be the one.

Pittsburgh was ground zero for Philips because it’s where the company manufactured the breathing machines. Meanwhile, ProPublica journalists had a lot of experience writing about the FDA.

“We all bring different strengths, skills and resources to the table,” says Cenziper.

They also collaborated with Mediahuis NRC in Amsterdam, which helped provide sources there at the headquarters for Philips’ parent company, Royal Phillips. They also worked with Northwestern University’s Medill Investigative Lab, where student journalists helped comb through more than 100,000 patient complaints involving Philips breathing machines, filed in FDA’s tracking system since 2010.

2. Collaborate with student journalists.

Cenziper is also a professor at the Medill School of Journalism at Northwestern University and the director of the Medill Investigative Lab. Sallah is a media fellow at the lab.

Cenziper had been working with Medill student journalists for several years on different investigative projects at The Washington Post and ProPublica.

“And both organizations have embraced their work because young journalists bring fresh eyes, fresh perspective, passion and grit to the table,” Cenziper says.

In this case, students helped dig into the data and documents and sit down with families across the country, willing to share their experiences with the breathing machines.

The students were also savvy at mining social media, which helped in finding patients affected by the defective devices.

3. Share information to gain patients’ trust.

The reporters wanted to humanize the stories and they had to get the patients to trust them.

“We’re asking people to basically lead us to their bedrooms, where these breathing machines are set up,” Cenziper says.

So they shared with patients some of the information they had discovered in the FDA reports.

“These folks were living in a vacuum,” Sallah says.

There was very little information available to them to know and understand what the crisis involved. Some had been kept the dark by the company and the FDA for years.

“Debbie and I were able to approach them and offer them a bit more [information] and give them a little sense of guidance so they can navigate things, and in return, some of them were very grateful and seemed to open up more, the more we could share with them,” Sallah says.

“I also think it was in some ways therapeutic for some of the people to share their stories with us,” Cenziper adds. “We sat in so many living rooms — I don’t mean for a quick hour interview; I mean half a day or more — just talking to people and listening to people and looking at their family photos and reading their medical records.”

4. Take the time to gain the trust of internal sources.

It took the reporters many months to get the company scientists to talk. The scientists were hesitant because talking to the press could risk their jobs and reputations and potentially made them vulnerable to libel or defamation lawsuits.

But the reporting team kept calling until one day one scientist agreed to talk, explaining the complexity of the science behind the defective machines and how dangerous the chemicals were to humans.

“I’ve been doing this for 30 years and I still believe that people at the end of the day want to do the right thing,” says Cenziper. “And at the end of the day, our sources believed this company kept a very dangerous secret and that someone needed to provide answers. Someone needed to have to provide transparency.”

The reporters consulted with their editors and lawyers and agreed to protect the identities of their internal sources.

5. Understand the science. Really.

Mastering the data and understanding the science helps you write with authority, Sallah says.

It took the reporters months to understand the complicated science behind volatile organic compounds released from the defective sleep apnea machines.

“It’s really up to you to understand everything. Everything,” Sallah says. “And that meant science, it meant the mechanics as much as we could so that there were no gaps.”

They were meticulous in understanding the toxicology.

“We were primed and briefed over and over about these concepts until we finally absorbed them and understood them,” Sallah says.

When they were talking to experts, they’d ask the basic questions.

“We’d say, ‘Look, this is going to sound like a dumb question, but…’” Sallah says. “And they never took it that way. They were so appreciative of us taking the time to learn this that they made it as basic, as comprehensive, as accurate as they could be.”

6. Find several experts to guide you.

It took many phone calls to find the scientists who were willing to read the FDA reports, take the time to interpret them and weigh in on something that they hadn’t been a part of.

But getting experts was a necessary part of the reporting process.

“When you’re writing about science, always find a guru who can guide you through it,” Cenziper advises.

And rely on more than one expert.

“We didn’t want just one toxicologist. We had three to five,” she says.

When Philips tried to downplay the toxicity of various chemicals, the reporters kept talking with scientists to understand the science and how the machines worked. They eventually realized that there was one thing the company couldn’t reconcile: The chemical cocktail released by the breathing machines triggered what’s known as genotoxicity, which means it can mutate human cells and lead to cancer.

“We reached that point through a lot of our own inquiry into where this finally ends and that’s something [the company] couldn’t dispute,” Sallah says. “You don’t want a ‘he said, she said’ [story]. You want to be able to give the reader some finality and that was one of our quests.”

7. You’ve heard it before, but here it is again: Avoid acronyms and jargon.

Sleep apnea machines are also known as CPAP machines, which stands for continuous positive airway pressure machines. They use mild air pressure to keep breathing airways open while patients sleep.

The reporters didn’t introduce the word CPAP until several paragraphs into their first story. At the beginning and throughout they mostly used “breathing machines” and “sleep apnea machines.”

“We worked very hard at trying to make [the stories] as conversational as we could,” Sallah says. “You’re not writing some sort of a dissertation on the ways in which these machines work. You have to make it interesting. So the ways in which these machines operate have to kind of be woven into the story in a way where it’s still a narrative.”

“I always tell young journalists it doesn’t matter how great your findings are. It doesn’t matter if you’re going to bring down a president,” Cenziper adds. “None of that matters if people stop reading what you wrote.”

8. Don’t settle for long wait periods for your public records (FOIA) requests.

The reporters asked the FDA for documents related to the 2021 Philips breathing machines recall and the health hazards posed by the machines, including internal emails and Philips monthly status reports. When the FDA said it would need more than two years to provide the records, lawyers for ProPublica and Post-Gazette sued the FDA in federal court in New York. Their lawsuit was successful.

“Transparency in this case is a matter of significant and urgent public concern,” Sarah Matthews, ProPublica’s deputy general counsel, said in a statement shared by the news organizations in their Goldsmith application. “These records will shed light on the recall of Philips ventilators and other breathing devices that have put the health of millions of Americans in jeopardy.”

The FDA agreed to turn over the records in batches, which continues to date.

“Our very last story was based entirely on records that we received through FOIA,” Cenziper says.

9. Read the documents. Don’t settle for numbers.

The reporters had a massive data challenge because they were looking at thousands of complaints in an FDA database that was difficult to navigate and manipulate. They eventually paid for a subscription to a proprietary database of the reports, which was more manageable.

But, in addition to getting a sense of the scope of the problem, they began to read the complaints.

“Numbers are just numbers,” Cenziper says. “You need to understand what goes into the data.”

By reading the complaints, the reporters spotted patterns of failure by the FDA.

“If I had a recommendation for other journalists, it would be, look at what’s going into the data. Take the time to read documents,” Cenziper says. “Don’t just publish summary numbers.”

10. When covering medical devices, understand the role of regulators.

The FDA has made a lot of progress in overseeing pharmaceuticals, but its process is different for medical devices. The FDA mostly leaves it up to the medical device industry to regulate itself, the reporters explain.

“And that can be dangerous because the guinea pigs are the patients, the people, who are out there, who need these devices and it can take years of deaths and injuries before they finally figure out this device is hurting people,” Sallah says.

Take the time to understand the role of government regulators and the history of gaps and weaknesses in their oversight, he advises.

“It’s not just going to be the devices themselves that break down, but it’s also how long it takes for the government to respond and to take action despite all the enforcement tools it has at its disposal,” Sallah says.

11. Keep a timeline.

One of the reporters’ organizing tips is to create a timeline, especially for large investigative projects.

“We did a very big 40-some page timeline with hyperlinks,” Cenziper says. “That not only helped us get our thoughts together and our lede and nutgraf, but also helped us organize the stories.”

“That was the single most important document that we created,” Sallah says of the shared document.

They also published a timeline of the events, starting from when the breathing machines arrived in the market. 

Read the stories

With Every Breath: Millions of breathing machines, one dangerous defect

Portraits of Pain

A Failure to Protect: Millions of people used tainted breathing machines. The FDA failed to use its power to shield them.

Millions of People Used Tainted Breathing Machines. The FDA Failed to Use Its Power to Protect Them.

Senators call for probe into FDA’s oversight of medical devices, citing series on Philips CPAP recall

Philips Recalled Breathing Machines in 2021. Chemicals of “Concern” Found in Replacement Machines Raised New Alarm.

Video: “With Every Breath” Captures the Human Toll of Philips’ Failure to Disclose Dangerous Defects of Its CPAP Devices

Timeline: Inside Philips, an unfolding crisis

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