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FDA Proposes Order Requiring Philips Respironics to Refund, Repair, or Replace Defective Devices

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The FDA’s Center for Devices and Radiological Health (CDRH) announced this week that they are proposing an order requiring Philips Respironics to submit a plan to replace, repair or refund recalled sleep apnea machines. This order is in response to the manufacturers blatant failure to adequately address the myriad of life-threatening problems associated with millions of CPAP, BiPAP and ventilator machines sold since 2015. This comes as nor surprise to the users who have suffered from lung/pulmonary/airway disease, blood cancers, nasal/sinus/oral/throat and other cancers.

The Philips Dreamstation, CPAP, BiPAP and mechanical ventilators were recalled in June of 2021. Philips Respironics acknowledged that the devices contained defective polyester-based polyurethane (PE-PUR) sound abatement foam. This foam is subject to degradation and breakdown, causing toxic chemicals and debris to be directly released into the machine’s air pathways.

This problem has been linked to reports of long term side effects for Philips CPAP users, including respiratory injuries, lung damage, and cancer. Thousands of former patients are actively pursuing lawsuits against the company, including in the multidistrict litigation before Judge Joy Flowers Conti in Pittsburgh, PA.

The FDA has accused Philips of botching both the recall and the investigation of the associated problems. The agency initially approved Philips CPAP repair and replacement plan in September 2021, but has since criticized the company’s plan and lack of transparency throughout the entire process.

After a thorough inspection, the FDA discovered that the silicone foam the company chose to replace the toxic sound abatement foam might also not be safe for consumer’s use. A similar silicone foam used in another device failed various safety tests due to chemicals of concern which could potentially cause similar respiratory side-effects. Because of this, the FDA ordered Philips to bring in a third party to investigate the safety of their proposed new foam.

This March, the FDA sent a letter to Philips Respironics, notifying the company that the recall efforts for sleep apnea machines sold since 2019 were inadequate. These recalls left many patients and medical equipment suppliers unaware of the recall, leading to continued use of the defective devices. 

The letter stated: “CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015,” the FDA’s latest update on the recall states. “Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more).”

It is currently unclear when the above mentioned formal hearing would take place.

In addition, Philips Respironics has received a subpoena from the U.S. Department of Justice. This is believed to be indicative of the fact that a federal investigation into the handling of the CPAP machine recall is being considered. 

In November of 2021, FDA investigators found evidence which led them to believe that the company knew about the toxic effects of the sound abatement foam for years before issuing any sort of product recall.

According to multiple allegations filed this past year, Philips Respironics continuously places their desire for profits before consumer safety, ultimately leading them to delay warnings surrounding the serious health risks associated with their defective devices.

If you or a loved one has been impacted by one of Philips Respironics medical devices, please contact the New York attorneys at Rheingold Giuffra Ruffo Plotkin & Hellman for a free consultation today. Our experienced team has over 50 years of experience with product liability and medical malpractice cases. 

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