FDA Links 124 Potential Deaths to Recalled Philips Sleep Aid Devices

According to NBCChicago.com, a representative for Philips Respironics stated that the company is examining all claims of fatalities or injuries related to their products. Philips Respironics is involved in a massive global sleep aid device recall, leaving many sleep apnea sufferers without a replacement, and is now being scrutinized by federal authorities in several ways.

The Food and Drug Administration (FDA) stated that it had received more than 100 reports of deaths connected to popular sleep aid devices used by many worldwide. As many as 5,000,000 units were recalled in the initial recall. Hundreds of thousands of those units that were repaired were recalled again for a similar toxic substance issue.

This recent disclosure follows the revelation that Philips Respironics, a Royal Philips subsidiary responsible for the recalled product, notified investors of subpoenas from the U.S. Department of Justice concerning the Respironics recall investigation. Philips initiated a global voluntary recall of CPAP, BiPAP, and ventilator devices in June 2021 due to a cancer-causing noise-reduction foam within the devices that could degrade and be unintentionally inhaled by users.

A class-action lawsuit was filed against Philips by users in relation to the recall, and the FDA quickly categorized the recall as Class One – the most severe type of recall.

FDA investigators later found that the recall affected over 15 million devices globally.

Such a large number of sleep apnea patients worldwide depended on the recalled devices that Philips was unable to immediately repair or replace, leaving some individuals without many alternatives.

One such patient is Edward Coleman, a 73-year-old Vietnam veteran from Michigan City, Indiana, who was prescribed a Philips DreamStation by his VA doctors for his sleep apnea, which helped regulate his breathing while he slept. Edward described his sleep as being disrupted two to three times each night, making it difficult to get a proper night’s rest. Awaiting a replacement device, Coleman has chosen to sleep without any sleep aid device after evaluating the risks, but he is concerned for other veterans who may be unaware of the issue. Coleman’s primary concern is to inform other veterans so they can have their machines repaired or replaced.

Many Americans, like Coleman, are not appeased by the latest regulatory disclosures. Since April 2021, the FDA has received “more than 21,000 medical device reports (MDRs)” linked to the degradation of noise-reduction foam in Philips Respironics ventilator, BiPAP, and CPAP devices.

According to the FDA, among these MDRs are 124 death reports connected to the recalled Philips devices. MDRs are a post-market surveillance mechanism the FDA uses to monitor medical devices, including reports of device-related malfunctions, injuries, or deaths.

An FDA spokesperson said that these MDRs submitted to the FDA include mandatory reports from Philips as well as voluntary reports from healthcare professionals, consumers, and patients.

The FDA is investigating each report while sharing preliminary findings with the public.

A spokesperson for the FDA stated that based solely on the submitted reports, there is no direct causal link between the deaths and foam degradation, and the 124 deaths have not been verified beyond the medical device reports submitted to the FDA.

In response to the FDA’s findings, Philips stated that although the company investigates all allegations of device malfunction, death, or severe injury, the cause of an event usually cannot be determined solely from the FDA’s MDR reporting system. A Philips spokesperson told NBC 5 Responds that after announcing the recall in June 2021, the company experienced a sharp rise in complaints allegedly related to possible foam degradation.

Philips expressed regret for any inconvenience caused by this issue and reaffirmed their commitment to supporting patients who depend on their sleep and respiratory care solutions.

The company also cited a study published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM) in December that found no increased cancer risk for patients using their devices.

As the recall proceeds, Philips is facing mounting pressure.

During a call with shareholders last month, Royal Philips’ CEO Frans van Houten revealed that the U.S. Department of Justice served the company and its subsidiaries subpoenas on April 8 in relation to the ongoing investigation into the recall.

Van Houten stated that the relevant subsidiaries are cooperating with the agency, and the subpoenas were a general request for information regarding the recall without specific allegations.

In addition to the legal pressure from the Department of Justice, the company is also dealing with numerous lawsuits in courts across the country.

In the same call, Philips acknowledged being involved in 185 personal injury lawsuits and over 100 class-action lawsuits related to the device recall. The company expects these class-action lawsuits to be consolidated into two cases this summer.

An FDA inspection reported by NBC 5 Responds in December revealed that, nearly a decade ago, Philips received more than a hundred complaints concerning product defects in the sleep aid devices but did not act immediately.

In an earlier statement, the company downplayed these FDA findings, claiming that each of the “limited complaints” received had been “evaluated and addressed” on a case-by-case basis.

Since the announcement of the recall, Philips has committed to repairing or replacing every affected device but acknowledges it will take time.

So far, the company has shipped 1.1 million replacement devices and repair kits to patients in the United States out of over 15 million affected devices worldwide.

During the company’s April earnings call, CEO van Houten expressed hope that 90% of the replacement machines would be sent to customers by the end of 2022. It is now March 30, 2023, and the company has failed to meet its goals leaving customers without a remedy for their medical conditions.

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