Last summer, Philips Respironics made a startling announcement. Some of the company’s medical devices had flaws that could expose patients to carcinogenic chemicals. The FDA recalled several Philips CPAP machines, ventilators, and BiPAP machines. After a recall, a manufacturer typically offers a repair, refund, or replacement. Philips said it would repair or replace all devices within a year of the recall. A year and a half later, thousands are still waiting for the promised resolution, and Philips now says repairs won’t be complete until 2023. Concerningly, some of the devices reworked after the 2021 recall might have some of the same issues.
BiPAP and CPAP machines are vital for people with sleep apnea, a condition that affects more than 20 million Americans. Someone with sleep apnea will stop breathing for a few seconds. This can happen up to 400 times a night, and when left untreated, the disorder can cause diabetes, high blood pressure, and heart failure. CPAP stands for continuous positive airway pressure, and the machine provides a constant air supply to keep airways open during sleep. Sleep apnea symptoms can improve with lifestyle changes, but a CPAP or BiPAP device is the most common treatment. For many, these machines are a lifesaver — sleep apnea patients who don’t receive treatment are more likely to die prematurely.
The Philips devices were recalled after the manufacturer received 30 medical device reports complaining about the machine’s sound abatement foam over ten years. CPAP machines are loud, and the foam helps reduce noise. Consumers told the company that the foam was degrading inside the devices and, in some cases, being inhaled or swallowed. Polyester-based polyurethane (PE-PUR) foam exposure can cause asthma, skin or respiratory tract irritation, and headaches. PE-PUR foam contains carcinogenic chemicals linked to lung cancer, kidney failure, and non-Hodgkin’s lymphoma.
Philips Replacement Device Concerns
Internal emails show that Philips knew about the issues with the machines as early as 2015 but didn’t initiate a recall and instead treated it as an isolated problem. Since last year, the FDA has received more than 90,000 complaints about Philips devices, and there have been 260 reported deaths. As a result, thousands of people have filed CPAP lawsuits against Philips for failing to warn consumers about the danger of defective devices. Many of these plaintiffs were diagnosed with health conditions after using the machines.
The company initially promised to repair or replace all affected machines by the end of this year, but that deadline has since been extended into 2023. Worryingly, some of the devices redesigned because of the recall still have issues. Philips replaced the PE-PUR foam in the company’s Respironics Trilogy ventilators with a silicone sound abatement foam, but the new foam can separate from its plastic backing and lower the amount of air a patient receives. Philips also informed the FDA that “particulate matter” was found in the air pathway of the ventilators. Laboratory testing showed PE-PUR foam particles and environmental debris, which can be dangerous if inhaled. And in September, the FDA issued a Class I Recall for certain Philips CPAP and BiPAP masks because the magnets in the masks can interfere with implanted medical devices like pacemakers, cochlear implants, and insulin pumps.
For consumers wary of Philips after the 2021 recall, the news about replacement machines being unsafe is concerning. These machines are lifesaving and keep people breathing, and living without them is often not possible. Doctors have told patients to keep using the recalled devices because untreated sleep apnea can cause lifelong problems. Some sleep apnea patients have even taken matters into their own hands and removed the sound abatement foam.
The U.S. Department of Justice Steps In
In April, Philips informed its investors that the company was being investigated by the U.S. Department of Justice (DOJ). According to The New York Times, the government is negotiating a consent decree with Philips. A consent decree is a settlement agreement that doesn’t include an admission of guilt or liability but would likely require Philips to share more information about what went wrong and steps they’ll take to stop it from happening again. In the meantime, patients must decide whether they can trust Philips’s assessment of device safety.
The company maintains that its malfunctioning devices don’t increase cancer risk and says the chemical exposure can cause moderate, but not serious, injuries. The FDA has publicly disagreed with this assessment, as do the thousands of patients suing the company because they have breathing problems and cancer diagnoses after using Philips machines. Many of the lawsuits filed against Philips have been consolidated into multidistrict litigation (MDL) to streamline the process. There’s still time to file a CPAP lawsuit if a recalled Philips device has caused injuries, but the statute of limitations varies by state. In states with two-year deadlines, the last day to file a claim might be June 14, 2023 — two years after Philips and the FDA announced the recall.