Mistakes in the Recall Process of Phillips CPAP Machines

December 6, 2022
Mistakes in the Recall Process of Phillips CPAP Machines

The breakdown of soundproof foam in Phillips CPAP and BPAP machines has led to recalls of millions of Phillips breathing devices. However, the recall process has been a mess from the start, with the recalls happening a decade after problems began to arise and the recall notice failing to reach patients. Many Phillips CPAP users have been waiting for a replacement device or refunds since the recall notice, while others have yet to be notified recalls were taking place.

Over a year after the recall, the Federal Drug Administration (FDA) has received over 90,000 reports of further problems with Phillips devices, including reports of 260 deaths. This lack of accountability and communication from Philips has resulted in the FDA issuing a rare regulatory order to force Philips to contact all consumers about the recall.

Why Were Phillips CPAP Machines Recalled?

Continuous positive airway pressure (CPAP) machines are used by those with sleep apnea to facilitate breathing while they sleep. Philips CPAP machines had to be recalled in June of 2021 due to an issue with the soundproof foam inside the machines. Humidity could break down the foam, leading to toxic chemicals releasing into the airways of users of Philips CPAP machines.

The following are some of the adverse health conditions caused by Philips CPAP machines:

In June of 2021, Phillips recalled over 15 million breathing devices affected by the soundproof foam breaking down and causing adverse health conditions. Despite the recall, many consumers have reported issues with receiving a replacement or refund of their CPAP machine. Others have noted a lack of communication from Philips that led to them not knowing of the recall or learning about it through the media. These mistakes have led to many seeking compensation for damages in Philips CPAP lawsuits.

Phillips Failed to Handle the Recall Process Correctly

The FDA cannot police recalls from every manufacturer of medical devices. The manufacturers themselves have to handle the recall process properly. That means notifying consumers of problems with their products and replacing the devices or issuing a refund in a timely manner.

The main issue with the Philips recall is their inability to communicate with consumers directly, as their products are sold through third-party vendors. It doesn’t track individual device buyers, meaning these consumers heard of the recall from the media rather than the manufacturer. The consumers were left in the dark, unsure of what to do now that a device they used for health reasons was recalled. 

In the recall notice authored by Philips, they stated that consumers could stop using the CPAP machines or contact their physician about how to proceed. This puts the onus on physicians to make serious decisions about weighing the health risks associated with Philips CPAP machines against the benefits CPAP machines provide. The lack of information provided to physicians and nurses left them not knowing what to do, without information on what to tell clients or how to proceed with a potentially dangerous CPAP machine.

FDA Investigations Into Phillips Show a Company Unwilling to Accept Responsibility

Due to how poorly the Philips recall of CPAP machines was going, the FDA conducted an investigation into Philips. In their initial findings, they discovered that Philips had received complaints back in 2015 of the problems with the soundproof foam in their CPAP machines. The degrading foam led to sinus problems, chest injuries, and several forms of cancer. During 2015, they also discovered that Philips learned from the foam supplier that humidity could break down the foam in as quickly as a year but did not act on the information until 2021.

After receiving more than 90,000 reports about problems with Philips CPAP machines, including 260 reports of death, the FDA contacted 182 suppliers of Philips machines to see what they knew of the recall. Of the 182 Philips device suppliers, 28 were unaware of any recall.

Statistics Regarding Philips’ Reporting of CPAP Issues

There were also troubling statistics regarding Philips’ handling of the CPAP recall process that pointed to how they failed to address the issue of defective CPAP machines adequately. Between 2011 and April 2022, Philips submitted just 30 reports of medical equipment with foam breakdown. Between April 2021 and July 2022, they had 69,000 reports of issues with Philips CPAP medical devices and 169 reports of deaths. In the three months between August and October of 2022, the FDA received 21,000 reports of issues and 92 additional death reports. The discrepancies in these statistics show that Philips was trying to hide the issues with their products rather than honestly reporting the adverse effects caused by their CPAP machines.

The FDA Was Forced to Issue a 518(a) Order

The ineffective approach from Philips during the recall process led to the FDA issuing a 518(a) order in March of 2022, which they have not done in over 25 years. This order required that Philips notify all CPAP device users, healthcare professionals, and vendors of the recall of CPAP machines within 45 days of the 518(a) order. 

In May of 2022, the FDA threatened to issue a 518(b) order, requiring Philips to replace, repair, or refund users of any recalled CPAP machine. This order has not been used yet, but the threat of such a drastic and unprecedented order speaks to the FDA’s lack of patience with Philips’ mistakes in handling the recall process. A representative of the FDA gave the following statement in response to the ongoing troubles with the Philips CPAP recall process: “The FDA has been reviewing the company’s response and interacting with the firm. We will continue to take steps until the company adequately mitigates the risk to patients.”

New Problems Arise Regarding Phillips CPAP Refurbishment Process

In November of 2022, the FDA reported that recalled machines that were refurbished had an issue with detaching from their backing and blocking the air inlet. This has caused even more health problems for those affected by defective Philips CPAP machines.

There have also been instances of Philips refusing to replace older models of their CPAP machines. Richard Benedict, an energy consultant from Rio Rancho, New Mexico, could not get a replacement for his CPAP machine because the model was over five years old. He was told his insurance could pay for the replacement, and his only recourse with Philips would be a $50 check. He had already gone through a five-month-long process of trying to get a new machine from a competitor, only for his replacement not to come. He also had to call Philips’ 800 number numerous times to check the status of his $50 check just to receive no information. 

Contact Dolman Law Group for Help With Your Philips CPAP Lawsuit

Dolman Law Group is a personal injury law firm that has helped many product liability victims recover compensation for damages caused by defective products. Philips continued failure to handle the CPAP recall process correctly has left many victims in the dark. Our product liability lawyers could help you recover compensation if you received damages, such as medical bills, lost wages, and pain and suffering, resulting from using a Philips CPAP machine.

Matthew Dolman

Clearwater Personal Injury and Insurance Attorney

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess or $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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