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Philips and Department of Justice Settlement Agreement in the Works

This year has seen many developments relating to the tremendous June 2021 recall of Philips sleep apnea and ventilator machines. A new report in The New York Times reveals Philips and the Department of Justice (DOJ) may be one step closer to a settlement agreement. Philips recalled millions of its CPAP, BiPAP, and Dreamstation devices after it revealed that foam degradation releases toxic particles. The DOJ has investigated the company for an allegedly botched and inadequate recall response. According to The New York Times, the DOJ is negotiating a consent decree with Philips over a year after the initial recall. 

Philips Recalled Millions of Sleep Apnea Devices  

Philips recalled nearly 4 million Philips Respironics Sleep and Respiratory Care. This recall affected CPAP, BiPAP, and other ventilator machines that assist individuals afflicted with sleep apnea. The company claims it initiated the recall upon discovering the degradation of the polyester-based polyurethane (PE-PUR) foam. However, some evidence suggests Philips may have known about the problems with the sound abatement foam before 2021. 

Philips incorporated the sound abatement foam in its devices to cancel out the noise made by the machines. The problem is this foam could disintegrate over time, causing users to inhale toxic particles. Inhalation of these particles may result in cancer, organ damage, respiratory failure, and other life-altering health effects.

Criticisms of Philips Recall 

Federal agencies, departments, and lawsuits have pointed out the grave shortcomings of the Philips recall. The original recall encompassed almost 4 million devices, but now the recall involves more than 5 million breathing devices. Philips has faced disapproval for failing to implement a proper replacement or repair program. The vague instructions that accompanied the Philips recall left countless patients unsure of how to proceed with their machines. Many continued using the ventilators despite the hazardous breakdown of the sound abatement foam.  

Furthermore, more patients were unaware that there even was a recall in the first place. An FDA letter to Philips reprimanded the company for insufficiently informing the public. The letter sent in March 2022 stated that Philips’ inadequate communication with healthcare providers, patients, and distributors continues jeopardizing patient health. Philips posted that it has shipped 2 million replacement devices to the United States as of October 25, 2022. However, this still leaves millions without replacement devices over a year into the recall. 

DOJ and Philips Could Reach Settlement Agreement

The DOJ subpoenaed Philips in April 2022 for information on the company’s CPAP recall. On November 15, 2022, The New York Times reported that the DOJ and Philips are discussing terms for a consent decree. A consent decree is a settlement that resolves a dispute between two parties without admission of guilt or liability. The publication speculates that a consent decree would require Philips to outline the steps it would take to prevent a similar failure in the future. 

Philips’ recall has caused its stock to plummet and led the company to announce the layoff of over 4,000 employees. Additionally, hundreds of individuals have filed lawsuits against the company for life-threatening injuries linked to the foam degradation.