A company that sells CPAP machines received complaints more than a decade before it issued a massive recall of the devices, a recent investigative report suggests.
In June 2021, Royal Philips issued a voluntary recall of select ventilators, CPAP and Bi-Level PAP machines over concerns that the foam used to dampen the sound created by the units could degrade and become toxic or possibly cancerous.
In a news release at the time of the recall, the company said the foam “may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.”
The U.S. Food and Drug Administration classified it as a Class I recall, the most serious type, which entails “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
According to federal law, device makers are required to report to the FDA within 30 days all reports of patient injuries, deaths and malfunctions that have the potential to cause harm – as well as to take action to investigate those reports.
However, a recent investigative report published by the Pittsburgh Post-Gazette and ProPublica said that Philips withheld more than 3,700 complaints regarding the faulty machines over an 11-year span prior to initiating the recall.
On top of the delayed reaction to user complaints, the report said Royal Philips failed to conduct a formal investigation of the issue until 2019.
According to the report, that investigation came nine years after the initial wave of patient complaints of “black shavings in the chamber” and three years after the company conducted tests that discovered the foam degradation issue.
Additionally, records obtained by the news outlets showed that Philips failed to warn the public for two months that it had discovered the risks to users to be “unacceptable” and that foam breaking down in the machines was emitting chemicals that could cause “life-threatening” injuries or “permanent impairment.”
Recent testimony in federal court contended that Roy Jakobs, the new CEO of Royal Philips, instructed employees to have distributors continue selling the remaining CPAP machines in their inventory, despite the findings of its own scientists two months before that showed the units were a critical risk to patients.
Since the recall, multiple lawsuits have been filed against the company claiming deaths, injuries and medical costs related to the use of the equipment.
On Sept. 7, Phillips announced a minimum settlement of $479 million to “consumers and third-party payors who paid or reimbursed for the purchase of the recalled devices.” The company did not admit liability, wrongdoing or fault in the settlement.
U.S. District Court Judge Joy Flowers Conti granted preliminary approval to the settlement on Oct. 11. The settlement – which resolves all economic loss claims in U.S. multidistrict litigation related to the recall – is likely just the tip of the iceberg for Philips, as it still faces multiple lawsuits.
Many truck drivers were affected by the CPAP recall. In 2021, FMCSA’s Medical Review Board suggested a 90-day waiver for drivers who were required to use CPAP machines to treat obstructive sleep apnea.
A CPAP machine uses mild air pressure to keep breathing passageways open during sleep.
In 2022, the board submitted its recommendations to FMCSA. Included in the recommendations was one that medical examiners be allowed to grant a 90-day extension to drivers who are neither symptomatic nor high-risk. LL
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