Quote:Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared

Philips knew about a dangerous breakdown inside its widely used ventilators and sleep apnea machines but waited years before recalling the devices.

Tainted 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 best selling 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 an 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 Food and Drug Administration, 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 United States 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, 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. And 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 United States 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.

“Unconscionable,” said Dr. Radhika Breaden, who scrambled at her Oregon sleep clinic to help thousands of patients who were using the devices. “We were all completely blindsided. You can’t have people inhaling black dust … without warning us.”

Read more of this lengthy article at https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared

Quote:Senator Calls for DOJ Action Against Philips for Keeping CPAP Machine Complaints Secret

The FDA also said it is “unsatisfied” with the company’s response to the crisis. Share prices dropped in early trading.

A powerful U.S. senator is calling on federal prosecutors to take immediate action against Philips Respironics after revelations the global company withheld thousands of warnings about popular breathing machines capable of spewing hazardous particles and fumes into the masks of patients.
“Philips brazenly turned a blind eye to its dangerous defective machines all in the name of profit,” Sen. Richard Blumenthal, D-Conn., said in a statement about the device maker, which has long dominated the market for ventilators and sleep apnea machines.

The call for enforcement from the Department of Justice comes just days after an investigation by ProPublica and the Pittsburgh Post-Gazette revealed the company kept secret more than 3,700 complaints about the faulty devices over the course of 11 years before launching a massive recall in 2021.
At the time, Philips acknowledged that an industrial foam placed inside the devices to reduce noise could break down in heat and humidity and release material into the air paths of the machines. By then, the company’s two factories in Pittsburgh had turned out millions of the tainted devices, which were delivered to infants, the elderly, COVID-19 patients and at least 700,000 veterans.

As the complaints mounted, stock prices for the device maker’s parent company, Royal Philips, soared to the highest levels in at least 40 years. In a statement, Philips said it regrets any “distress and concern” caused by the recall and it is cooperating with prosecutors and regulators.
“Philips’ priority is patient safety and quality,” the company said.

Safety tests on the foam by Philips in the wake of the recall were called into question by the FDA on Thursday, which said in a statement that the tests were not adequate and did not “fully evaluate the risks posed to users.” Philips agreed to conduct additional tests, the agency said.

Stock prices for Royal Philips, which fell in the wake of the ProPublica and Post-Gazette investigation, dropped by more than 9% on Friday morning after the FDA announcement.
The Justice Department, which has been examining the company’s testing practices and safety claims, can impose a range of penalties against medical device companies in violation of federal safety laws, including civil sanctions and criminal charges.

“Philips knew about the serious risks of its breathing machines for years, but inexcusably, withheld critical information,” said Blumenthal, a member of the Senate Judiciary Committee and chair of an investigations subcommittee that probes violations of laws and regulations impacting national health and safety. “The DOJ must take immediate, aggressive action against Philips for its years-long wrongdoing.”

Senate Majority Whip Dick Durbin, D-Ill., also lambasted Philips for “allowing consumers to breathe in harmful particles from their CPAP machines.”
“It’s deeply disturbing that Phillips would sit on this information as Americans became sicker and sicker,” Durbin said in response to the news organizations’ investigation.
To keep the public safe, federal law requires device makers to submit reports of device malfunctions, patient injuries and deaths within 30 days. In the years before the recall, ProPublica and the Post-Gazette found, Philips withheld the vast majority of complaints about the foam from the Food and Drug Administration, which oversees the medical device industry.

News of the recall stunned patients and their doctors, who scrambled to find information about the potential health risks. The FDA has since classified the recall as the most serious, for device defects that can cause severe injury or death.

“All I could do is tell them the truth, what their options were and be sympathetic,” said Dr. Byron Cooper, a Philips CPAP user and newly retired pulmonologist who treated sleep apnea patients in Washington, D.C. “It would have helped to have more transparency.”

Durbin and Rep. Jan Schakowsky, D-Ill., recently proposed legislation to streamline the recall process so that patients quickly learn about potential health risks.
“When these recalls, like the one Phillips finally issued after more than a decade, come to light, consumers have a right to be informed,” Durbin said.
Philips has said that complaints about the foam were limited before the recall and evaluated on a case-by-case basis, and that when it became aware of the potential significance of the problem in early 2021, the company launched the recall shortly after that.

Philips acknowledged the foam could release chemicals or break into particles capable of causing life-threatening injuries.
Since the recall, the company has changed course, saying recent testing on the DreamStation continuous positive airway pressure, or CPAP, machine and similar devices shows that chemical emissions fall within safety thresholds.

ProPublica and the Post-Gazette obtained copies of the results of four tests carried out in 2021 that were solicited by Philips. Three experts who reviewed the results for the news organizations disputed the company’s claim that emissions fall within safety thresholds. The experts also pointed out that the foam tested positive for genotoxicity, the ability of a chemical to cause cells to mutate, which can lead to cancer.

As doctors struggle to assess the long-term health risks, Connecticut Attorney General William Tong said third-party experts should conduct safety tests on the devices.
“There are still people with defective devices who are rightfully scared and frustrated and they deserve better from both Philips and FDA,” said Tong, who last year joined Blumenthal in a letter to federal regulators urging them to take action against the company.

Kushal Kadakia, a public health researcher at Harvard Medical School who has written about the recall, said the FDA should launch an advisory panel to determine whether the devices are safe and should also require Philips to carry out a study tracking the long-term health consequences.

The FDA, which said it does not comment on compliance matters, said that it is “unsatisfied” with the status of the recall and that the agency would continue to ensure that patients receive accurate information.

Last month, Philips reached a settlement in one of several lawsuits against the company, agreeing to pay at least $479 million to reimburse customers and others for the costs of the defective machines.

After ProPublica and the Post-Gazette published their investigation, which drew on previously undisclosed company records, interviews with Philips insiders and leaked test reports, Philips released a statement saying the stories “do not present new facts and we do not agree with the characterizations made in these articles.”

Sen. Blumenthal Calls for DOJ Action Against Philips for Keeping CPAP Machine Complaints Secret — ProPublica

Quote: Sep 27, 2023

 
Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice

 Philips had previously responded to ProPublica and the Pittsburgh Post-Gazette in the US, and NRC in the Netherlands. The articles do not present new facts and we do not agree with the characterizations made in these articles.  

Philips’ priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them. Philips regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this. Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale. We continue to dedicate all available resources to ensure that patients receive remediated devices.

The remediation of the sleep therapy devices is nearing completion, while the remediation of the affected ventilators is ongoing. Everyone at Philips is committed to achieving and maintaining the highest standards, building on a culture of integrity and compliance.

If you are a patient, business customer or clinician, you can find more information here.

 About Royal Philips

Click here to read more

Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice - News | Philips

Quote:People Who Used Recalled Philips Breathing Machines Face Painful Choices

The devices at their bedsides were lifelines, until they learned the foam inside could break down and make them sick. Now, they’re plagued by illness, lost sleep and worry.

They thought they were getting clean air from the lifelines at their bedsides, coveted nights of healthy sleep that for too long did not come easy.

Near Portland, Oregon, Kim Binford’s sleep apnea machine helped him manage chronic pain. Outside Indianapolis, Connie Thompson was able to stay awake in class during her senior year of high school. In the suburbs of Atlanta, Debra Miller could put her grandchildren in the car and drive without fear.

But in June 2021, Binford, Thompson, Miller and millions of others learned that a defect in the breathing machines they relied on for years had the potential to inflict serious harm, including cancer, kidney and lung problems, and severe respiratory infections.

In announcing a massive recall of ventilators and sleep apnea machines, Philips Respironics acknowledged that an industrial foam placed inside the devices to reduce noise could break apart and send tiny particles and fumes into the noses, mouths and lungs of patients.

As many as 15 million devices from two Pittsburgh-area plants were made with the crumbling material, including the company’s popular DreamStation continuous positive airway pressure, or CPAP, machine used by those with sleep apnea. The disorder causes breathing to stop and start through the night.

Since the recall, thousands of consumers have described unexplained illnesses while the reported death count linked to the recalled machines rose to more than 370. Some stopped using their devices altogether. Others bought secondhand machines, waited on a replacement from Philips or simply gambled, continuing to use their defective devices long after the recall.

Losses mounted quickly: lost sleep, lost money, lost nights spent worrying about a health threat that the U.S. government determined could cause severe illness or death.

Though it’s impossible to know what caused individual illnesses, or whether the machines were capable of advancing cancers that may have developed prior to use by patients, some medical experts say they fear long-term harm. The Food and Drug Administration has said the degrading foam, when inhaled or ingested, can lead to headaches, asthma, inflammatory conditions, respiratory tract problems and “toxic or cancer-causing effects to organs,” among other health complications.

Lawsuits against the company are ongoing in federal court in Pittsburgh, waged by families who say Philips should be held accountable for failing to warn customers about the risks years earlier.

In a statement, Philips said that patient health and well-being is a top priority and that the company increased production amid supply chain challenges to send replacement devices to customers. The company added that some received entirely new machines while others received a CPAP motor that would work with existing components.

Since the recall, Philips has walked back its initial assessment that the machines were potentially unsafe, saying new testing on the DreamStation and similar devices has shown that chemicals released by the foam are not at levels that can cause “appreciable harm.”

Medical experts and engineers familiar with the testing dispute that claim. Last month, the FDA announced that the company’s testing was inadequate and said that Philips had agreed to conduct additional assessments.

In the United States and beyond, families are still struggling.

“I worked my whole life to be pretty healthy,” said Miller, a retired elementary school teacher. “I didn’t want any debris in my lungs.”

For the rest of the long story by users, click on this link.