FDA Criticizes Effectiveness of Philips’ CPAP Recall Communications

The U.S. Food and Drug Administration (FDA) is calling into question the effectiveness of Philips Respironics’ recall notification efforts regarding the serious risks associated with the company’s recalled CPAP, BiPAP, and ventilator machines. The agency stated in a notification order sent to Philips on March 10, 2022, that the company’s communication to healthcare providers, patients, and consumers about the CPAP recall and the serious health risks presented by the defective foam used in the recalled products has failed to meet federal requirements. Only when consumers using essential medical devices like CPAP machines are properly notified about device recalls and the risk of harm posed by these devices, can they make informed decisions about their healthcare. When medical device makers like Philips fail to properly communicate with device users and the healthcare providers who prescribe medical devices about recalls and potential health risks, consumers are robbed of this basic right. To find out whether you may be eligible to join the growing Philips CPAP litigation, contact Consumer Safety Watch today.

Philips Recalls Defective CPAP, BiPAP, and Ventilator Machines

In June 2021, Philips initiated a Class I recall of millions of Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP) devices, and Mechanical Ventilators that use a polyester-based polyurethane (PE-PUR) sound abatement foam, amid concerns that the foam could degrade over time and expose users to toxic foam particles or off-gassed chemicals. While the PE-PUR foam is intended to reduce sound and vibration during use, reports indicate that the foam may break down and allow black debris or chemicals to be released into the device’s air pathway, where they may be inhaled or swallowed by the user. According to the FDA, the Philips CPAP recall was initiated “because the risks identified with respect to the PE-PUR sound abatement foam can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” Among the potential side effects linked to the recalled CPAP machines are bladder cancer, breast cancer, leukemia, non-Hodgkin’s lymphoma, prostate cancer, and lung cancer.

FDA Requires Philips to Properly Notify Patients of CPAP Health Risks

On March 10, 2022, nine months after the initial CPAP recall, the FDA issued a notification order to Philips Respironics, demanding that the company notify patients and others of the June 2021 recall and the “unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products.” According to the FDA, the order “is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.” The FDA has reportedly received calls and complaints from consumers who contacted the agency to report problems or concerns regarding Philips CPAP, BiPAP, or ventilator machines affected by the recall and had no knowledge of the CPAP recall or the health risks presented by the recalled devices.

The FDA has also criticized Philips’ failure to provide patients and consumers with adequate updates about the CPAP recall and the process for obtaining a replacement device. “Since the initiation of the recall in June 2021, FDA has received, and continues to receive, complaints from patients and consumers expressing confusion regarding the recall and replacement process,” the FDA states in the letter to Philips. “Many patients and consumers that were informed of the recall and registered their device with Philips have reported to FDA that they have received no followup information or communications from Philips.” Sadly, due to their sleep apnea and other health conditions, many patients who were prescribed a recalled CPAP or BiPAP machine do not have the option of discontinuing use of their devices and have expressed fears about potential delays in receiving replacement products, considering the serious health risks associated with the recalled machines.

Contact Consumer Safety Watch Today to Discuss a Potential Claim

The Philips CPAP recall impacts millions of Americans with sleep apnea and other health conditions who rely on CPAP, BiPAP, and ventilator machines for breathing assistance. If you or someone you love has been diagnosed with cancer or another serious health condition allegedly caused by exposure to toxic foam particles or chemicals in Philips’ recalled sleep apnea machines, do not hesitate to speak to an experienced product liability lawyer about your legal options. You may have grounds to file a CPAP recall lawsuit against Philips, in order to pursue the financial compensation you deserve for your medical bills and other expenses, and a knowledgeable attorney can help you navigate the process of filing a legal claim. Contact Consumer Safety Watch today to learn more about the Philips CPAP recall and how to determine whether you may be eligible for compensation for your alleged CPAP device injuries.