Update, Oct. 6, 2023: This story was updated to note a fall in Royal Philips’ stock prices.
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.”
“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.”