Philips Respironics must stop producing sleep apnea devices in the U.S. until the manufacturer changes its safety measures per an agreement with the Department of Justice earlier this month. The government alleges that Philips violated the Federal Food, Drug, and Cosmetic Act (FDCA) during its manufacturing process. Philips first recalled millions of ventilators, CPAP machines, and BiPAP machines in June 2021. A polyurethane foam used to reduce noise in the devices was found to be prone to breaking down and potentially entering the device’s airway, making it possible for the device user to inhale debris and chemicals unknowingly. The foam contains dangerous chemicals that have been linked to asthma, cancer, and respiratory failure. 

Sleep Apnea Treatment Options

Obstructive sleep apnea is a condition that affects approximately 39 million adults in the U.S. People with the disorder will stop breathing during sleep, often multiple times a night. Sufferers feel tired throughout the day and struggle to get a good night’s sleep. The long-term implications of sleep apnea are significant — the condition has been linked to an increased risk of type 2 diabetes, heart attacks, and a shortened lifespan. While some patients can manage sleep apnea through lifestyle changes like weight loss and quitting smoking, the most common treatment is a sleep apnea machine.

CPAP stands for continuous positive airway pressure, and it’s a machine that delivers air through a mask fitted over the nose or mouth to the user’s airway. This prevents the stopped breathing that sleep apnea causes, and the machines are known for their effectiveness. BiPAP (bilevel positive airway pressure) machines are also used for sleep apnea and other conditions. Instead of providing continuous air, BiPAP devices have two pressure settings. These machines can significantly improve the quality of life for patients with sleep apnea. However, the foam degradation in Philips devices increases the risk of severe health conditions.

Department of Justice Settlement 

Under the agreement, Philips must hire independent experts to inspect its facilities and ensure they conform to safety standards. The company must also submit to facility inspections for five years and continue offering refunds or replacements to customers with faulty devices. There’s ample evidence that Philips knew the foam may cause health problems long before the recall. A 2023 investigation from ProPublica and the Pittsburgh Post-Gazette found that Philips had received complaints about the defective foam dating back over a decade. The FDA has received more than 116,000 complaints about foam degradation since 2021, and the agency has linked the Philips devices to 561 deaths.

In January, Philips agreed to stop selling its sleep apnea machines in the U.S. in a settlement with the U.S. Food and Drug Administration (FDA). Patients using Philips machines were advised to continue using them until the FDA provided further guidance. Philips has long been a leading provider of sleep apnea machines nationwide, and the agreement to stop distributing their devices is expected to impact the company’s market standing. How will the Department of Justice agreement affect Philips in the long run? It’s difficult to say with certainty, but the company no longer selling its sleep apnea devices in the U.S. is a significant blow. 

“Today’s action reflects our commitment to vigorously enforce federal law and prevent manufacturers from marketing adulterated and misbranded devices to vulnerable patients who need them,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division, in a press release. 

CPAP and BiPAP Lawsuits

Hundreds of people have filed CPAP lawsuits against Philips Respironics since the company announced the CPAP, BiPAP, and ventilator recall three years ago. The recall applied to 3.5 million machines, and many users suffered health problems after using the defective sleep apnea devices. However, for some patients, deciding to discontinue use was a difficult decision. CPAPs can be life-saving devices, and Philips was slow to replace the faulty machines. Nearly two years after the recall, hundreds of thousands of patients were still waiting on replacements. While they waited, they had to make the difficult decision of whether to forgo sleep apnea treatment or risk inhaling the toxic chemicals released when polyurethane foam degrades.

In 2022, the lawsuits against Philips were consolidated into multidistrict litigation (MDL) in Pennsylvania to streamline trial proceedings. The manufacturer agreed to a $479 million CPAP settlement last fall, but the settlement only covers economic losses and doesn’t account for personal injury damages. That means the lawyers representing plaintiffs who suffered illnesses after using the affected machines still plan to seek additional compensation from Philips. There’s still time to file a lawsuit against Philips if you’ve been diagnosed with a medical condition after using a device on the recall list. Finding an attorney experienced with CPAP lawsuits is important to ensure your case has the best chance of success.