By Debbie Cenziper, ProPublica; Michael D. Sallah, Michael Korsh and Evan Robinson-Johnson, Pittsburgh Post-Gazette; and Monica Sager, Northwestern University

Tainted continuous positive airway pressure (CPAP) machines and ventilators went to children, the elderly and at least 700,000 veterans despite internal warnings. Company insiders said the devices posed an “unacceptable” risk.

The first complaints landed at the offices of Philips Respironics in 2010, soon after the company made a fateful decision to redesign its bestselling breathing machines used in homes and hospitals around the world.

To silence the irritating rattle that kept users awake at night, Philips packed the devices with industrial foam — the same kind used in sofas and mattresses. It quickly became clear that something had gone terribly wrong.

The reports coming into Philips described “black particles” or “dirt and dust” inside machines that pump air to those who struggle to breathe. One noted an “oily-like” substance. Others simply warned of “contamination.”

The complaints targeted some of the company’s most celebrated devices built in two factories near Pittsburgh, including ventilators for the sick and dying and the popular DreamStation for patients who suffer from sleep apnea, a chronic disorder that causes breathing to stop and start through the night.

Yet Philips withheld the vast majority of the warnings from the U.S. Food and Drug Administration (FDA), even as their numbers grew from dozens to hundreds to thousands and became more alarming each year.

“Black shavings in the chamber,” said one 2011 report that was kept from the government.

“Contaminated with unknown sticky substance,” noted another three years later.

By 2015, the year Philips launched the DreamStation, the company had amassed at least 25 complaints that pointed to a specific cause — the foam was falling apart.

In June 2021, more than a decade after the first reports, Philips announced a recall of millions of machines that had been delivered to nearly every corner of the U.S. and dozens of other countries.

The company acknowledged that the foam it had chosen could crumble in heat and humidity and send potentially “toxic and carcinogenic” material into the noses, mouths, throats and lungs of users.

In a series of statements, the industry giant said it acted as soon as it learned of the “potential significance” of the problem.

But 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, that Philips suppressed mounting evidence that its profitable breathing machines threatened the health of the people relying on them, in some cases to stay alive.

Federal law requires device makers to turn over to the government within 30 days all reports of patient injuries, deaths and malfunctions that have the potential to cause harm and to take action to investigate them.

A ProPublica and Post-Gazette analysis of tens of thousands of reports shows that Philips withheld more than 3,700 complaints over 11 years from the FDA, which oversees medical devices.

The company did not launch a formal investigation of the problem until 2019 — nine years after the first wave of complaints and three years after the first known tests for the company found that the foam was degrading.

Instead, as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the hazardous foam.

The sales pitch worked: The devices went to infants, the elderly and at least 700,000 veterans. The company also promoted machines meant for some of the sickest people in the country, rolling out a new ventilator filled with the foam in the early months of the COVID-19 pandemic.

Philips didn’t stop even after the company learned the foam was breaking down in its ventilators in Japan and had to be replaced — and after tests in the U.S. revealed that the material released chemicals at dangerous levels.

Among them: formaldehyde, a compound used in fertilizer, dyes and glues that has been tied to respiratory problems and certain cancers.

In 2018, the company called more than a dozen engineers and safety supervisors to a series of urgent meetings in Pittsburgh to investigate the problem in what eventually became known to insiders as Project Uno.

Still, the public was not warned.

All the while, people using Philips machines were suffering from illnesses that no one could explain: vomiting, dizziness and headaches, along with newly diagnosed cancers of the lungs, throat, sinuses and esophagus.

One man in Philadelphia coughed so hard that he broke his ribs, and a Florida woman with a hacking cough was hospitalized for days and placed on oxygen.

[…]

To examine what happened at Philips, reporters interviewed more than 200 former company supervisors, doctors, toxicologists, patients and the relatives of those who died and obtained company records that show officials knew about the dangers but continued to sell machines that the FDA had since said are capable of causing severe illness or death.

Reporters also reviewed thousands of complaints submitted to the company and government describing device malfunction and injuries, including more than 370 reports of deaths.

As part of the investigation, the news organizations collaborated with Mediahuis NRC, the publisher of one of the largest newspapers in the Netherlands, where Philips’ parent company is located.

In a statement to the news organizations, Philips said its top priority is patient safety and that it regretted “the distress and concern” caused by the recall.

“We deeply apologize for that and continue to work hard to resolve this,” the company said.

Philips said complaints about the foam were limited in the years before the recall and that the reports were evaluated on a case-by-case basis. The company added that it became aware of the potential significance of the problem in early 2021 and launched the recall shortly after that.

Former company engineers and safety supervisors, who spoke on the condition of anonymity because they still work in the industry, said top officials at Philips repeatedly dismissed a dangerous breakdown that ultimately set off a worldwide health crisis involving as many as 15 million devices.

“It was a catastrophic series of errors,” said a former compliance supervisor. “There were people who knew and knew for a long time.”

In the months since the recall, the company has walked back its initial acknowledgment of the health risks posed by the degrading foam, saying tests on the DreamStation and similar devices show the chemicals released by the material fall within safety thresholds.

“The whole product complies with safety norms,” Roy Jakobs, chief executive officer of parent company Royal Philips, said last year.

ProPublica and the Post-Gazette obtained copies of four tests carried out in 2021 that were solicited by Philips. Three experts who reviewed the results for the news organizations dispute the company’s claim and point to another finding that they say is even more alarming.

The foam tested positive multiple times for genotoxicity — the ability of a chemical to cause cells to mutate, a process that can lead to cancer.

“You’re basically changing cells,” said one engineer who was familiar with the testing. “I don’t even know if we really scratched the surface of how bad this really is.”

In New York, 58-year-old retired music teacher and father of three Mark Edwards said he’ll spend the rest of his life fearing that a sleep apnea machine caused years of respiratory infections and two benign tumors in his throat.

Edwards brought home a DreamStation in 2017 and set it up next to his bed, where he sleeps with his rescued German shepherd, Tyson. He continued using it even after he said he began to spot black particles in his mask.

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A competitive edge

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Throughout the 1980s, McGinnis invented a series of breathing masks and ultimately developed the nation’s first mass-produced continuous positive airway pressure, or CPAP machine, sold under the banner of his growing company, Respironics.

During a scientific renaissance that transformed Pittsburgh from a steel town into a hub for medical innovation, the company became a dominant player in a thriving industry that would change the lives of those struggling with sleep apnea.

[…]

Locked in a race to make its breathing machines quieter, the company inserted the foam to muffle the sound. The change was a triumph in the world of sleep apnea, a way to quiet the humming, vibrating machines that disturbed patients and their partners as they slept.

[…]

It was a risky move. Studies published in scholarly journals showed the foam broke apart in heat and moisture. The company used it anyway, even though the machines send air for hours at a time into the lungs of users.

“Anybody who has half a brain cell in chemistry knows that this was a stupid idea,” said the engineer who was familiar with the recent testing.

Soon, alarming reports began to surface.

In June 2010, Philips found that a machine sent back to the company by a customer was contaminated with “foam particles,” FDA records show.

Rather than alerting the government as federal law required, records reveal that the company kept the report about the problem in-house for the next decade.

[…]

By the end of 2014 — about six years after Philips started using the foam — more than 500 reports from healthcare workers, patients and others had flooded the company in a pattern that would not be revealed to the government or the public for years, the records show.

[…]

Philips received more than 3,700 reports about foam problems before recalling machines

For more than a decade, the company used polyester-based polyurethane foam in its ventilators and CPAP machines to reduce noise. In that time, it received thousands of complaints about “dust contamination,” “black particles” and “foam degradation.”

[…]

Mounting Injuries

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The company alerted the FDA but said nothing to its customers — news reports at the time were largely limited to the company’s positive earnings. Over the next six weeks, more complaints came in, one after another:

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Philips withheld thousands of complaints about foam problems from the FDA

After Philips issued a recall in 2021, the company turned complaints over to federal regulators, including more than 2,500 that it had withheld for more than two years.

[…]

The true extent of the crisis may not be known for years.

As news of the problem spread, customers and others stepped forward by the thousands, describing emergency room visits and sudden illnesses in reports submitted to Philips and the government.

The reports detailed nearly 2,000 cases of cancer, 600 liver and kidney illnesses and 17,000 respiratory ailments.

[…]

Via https://childrenshealthdefense.org/defender/philips-respironics-ventilators-children-elderly/