Though Philips has argued in court that its U.S. subsidiary should bear the sole responsibility of paying out damages related to its massive CPAP machine recall, instructions to continue selling potentially affected home ventilators came from the parent company’s top leadership, according to a new follow-up report from ProPublica and the Pittsburgh Post-Gazette.
The two newsrooms previously collaborated on a yearlong investigation that was published last month, which dove into more than 100,000 recall-related complaints submitted to Philips and the FDA over the course of a decade.
The latest findings were disclosed in federal court testimony this month, during a Pittsburgh hearing over whether Philips should be found liable for personal injury and wrongful death claims, in addition to class-action complaints that would have the company cover the cost of ongoing medical monitoring for users of the machines. The medtech giant previously reached a settlement that only addressed economic losses, such as the out-of-pocket cost of replacing a personal device.
Philips’ recall of its CPAP and BiPAP hardware for sleep apnea started in 2021, after it was discovered that the foam used to muffle the sounds of the ventilators’ motors could degrade and send small particles and fumes into the user’s airway. The repair-and-replace effort would balloon into an international project spanning as many as 5.5 million devices; the company has said that about 99% of the work has since been completed.
According to the latest from ProPublica and the Post-Gazette, during the two months after Philips raised the foam safety issue with the FDA in early 2021 and halted manufacturing—but before it instituted an official recall that summer—the company told distributors that it could keep selling the machines in their inventory and did not warn users of the potential dangers.
That directive came from Roy Jakobs—currently Philips’ CEO—who at that time was chief business leader of the company’s connected care division, the report said, citing evidence presented in court by the attorneys for the plaintiffs in the class-action suit. Jakobs, who subsequently led the first stages of the CPAP recall effort, was named chief in August 2022 after Frans van Houten stepped down as CEO.
In a statement to the Post-Gazette, Philips said Jakobs gave the green light to distributors because the company’s “understanding of the issue was still evolving” and that the June 2021 decision to launch a recall was reached after collecting additional data and “careful consideration of a reasonable worst-case scenario and in an abundance of caution.”
“At that time and pending the conclusion of the technical investigation, Philips Respironics’ ship hold decision would not extend to devices already in the possession and control of distributors and customers. In the absence of an authorized recall, Philips Respironics was not in a position to communicate to its distributors and customers to halt distributing devices,” the company said in a separate statement to Fierce Medtech.
But during the intervening two months, Philips had internal testing results that found the potential risks to patients was “unacceptable,” with chemicals that could cause “life-threatening” injuries or “permanent impairment,” according to ProPublica and the Post-Gazette.
Previous court documents have shown that Philips engineers were aware for years of the degradation issues associated with the ventilators’ polyester-based polyurethane foam, especially when exposed to high heat and humidity on a nightly basis.
“Recently we’ve received a few complaints from our customers that the foam is disintegrating … The material sheds and is pulled into the ventilator air path. As you can imagine, this is not a good situation for our users,” an engineer wrote in one April 2018 email exchange that was unsealed in Pittsburgh federal court last year.
Philips has since said that its additional safety tests have shown a low chance of long-term health impacts from the foam particles, including independent examinations of the company’s DreamStation, DreamStation Go and System One sleep therapy machines.
However, the FDA recently took issue with those findings. Earlier this month, the agency said it “remains unsatisfied with the status of this recall” and called on Philips to conduct additional safety testing.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” said the FDA’s device center director, Jeffrey Shuren, M.D., in an Oct. 5 statement.
The agency has continuously warned that inhaling the foam particles could potentially lead to irritation, headaches, asthma, nausea or “toxic or carcinogenic effects to organs, such as kidneys and liver.” It has given the recall a Class I rating, its most serious, and associated it with a heightened risk of injury or death.
The FDA has also tallied more than 105,000 medical device reports between April 2021 and the end of March of this year, including 385 reports of death—though both the FDA and Philips have noted these reports include unvetted submissions, and injuries may not be directly linked to the company’s devices.
According to the previous investigation from ProPublica and the Post-Gazette, Philips received thousands of complaints in the 11 years leading up to its 2021 recall and failed to turn more than 3,700 over to the FDA in a timely manner.