Philips Respironics must hire an independent safety monitor, undergo regular facility inspections for five years and pay part of its revenue to the federal government under the terms of an agreement with prosecutors filed in federal court in Pennsylvania, capping one of the most catastrophic medical device recalls in decades.
The company will also face a review of its testing on the millions of replacement machines that it sent to customers after the old ones were recalled in 2021.
The consent decree with the Justice Department, filed in federal court last week, comes nearly three years after Philips acknowledged that an industrial foam fitted inside its widely used sleep apnea machines and ventilators to reduce noise could degrade and release toxic particles and fumes into the masks worn by patients.
A ProPublica and Pittsburgh Post-Gazette investigation last year found the medical device giant had withheld thousands of complaints about the foam for more than a decade before warning its customers — including medically vulnerable patients such as infants and the elderly — about the dangers.
The news organizations also revealed that a new, silicone-based foam that the company used in the replacement machines was also found to emit dangerous chemicals, including formaldehyde, a known carcinogen.
Though Philips maintained that the new foam was safe, scientists involved in the testing raised alarms, and the Food and Drug Administration said more tests were needed before determining if the devices pose risks to patients.
The consent decree requires Philips to carry out additional tests on the silicone foam if the independent safety monitor brought on by the company determines that prior testing was inadequate.
The agreement also prohibits Philips from selling all sleep apnea devices and other respiratory machines in the United States. In January, Philips disclosed that it would no longer distribute the machines in the country as part of the negotiations with the Justice Department — a major shift for a company that long dominated the industry.
Philips, which manufactures the devices at two plants outside Pittsburgh, is still able to export devices to other countries under the terms of the agreement. The company can also sell a select group of machines deemed “medically necessary” by the FDA inside the United States, including some ventilators, but must turn over up to 25% of the revenue to the government.
The payments “are an equitable remedy and not punitive,” according to the agreement.
In the consent decree, the Justice Department argued that the company had violated federal law by selling “adulterated” machines that did not comply with manufacturing requirements. The agreement was signed by Roy Jakobs, chief executive officer of Philips’ parent company, Royal Philips, headquartered in Amsterdam. The company did not admit fault.
If Philips fails to abide by the agreement, the company could be forced to pay up to $20 million a year.
Philips did not respond to questions about the consent decree, which still has to be approved by a judge.
The company has previously said that tests on the original foam caused no “appreciable harm” to patients. And in an online video about the settlement, Chief Patient Safety and Quality Officer Steve C de Baca said the silicone-based foam in the replacement machines was also safe.
Philips has “not identified any safety issues” with the replacement machines, he said, and “their use is not impacted” by the consent decree.
On an informational page for customers, Philips said the settlement with U.S. authorities will help it “restore the business.” The company also said it has launched multiple safety reforms.
The FDA said it would not comment until the settlement has been approved by the court. A Justice Department spokesperson declined to comment.
Patient safety advocates say it will take years to assess the impact of the devices on patient health. At the time of the recall, both Philips and the FDA described potential health risks including respiratory tract illnesses, headaches, nausea, and toxic and carcinogenic effects.
The FDA has said it received 561 reports of deaths reportedly associated with the degrading foam since 2021. The Post-Gazette and ProPublica previously identified reports that described nearly 2,000 cases of cancer, 600 liver and kidney illnesses, and 17,000 respiratory ailments.
Though the company says the foam in the recalled devices does not lead to long-term harm, the material has repeatedly tested positive for genotoxicity, the ability of a chemical to cause cells to mutate, a process that can lead to cancer.
Michael Twery, former director of sleep disorders research at the National Institutes of Health, said it could be difficult for Philips to earn back the trust of its customers.
“If a manufacturer misleads [the] FDA, how do they reestablish integrity?” he said.
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