Millions of people in the United States use continuous positive airway pressure (CPAP) machines every night. CPAP machines are a common treatment for obstructive sleep apnea. CPAP machines use a hose that is connected to a mask or nosepiece to deliver air pressure to help people with obstructive sleep apnea breathe while they are asleep.
Philips Respironics (Philips) is a manufacturer of CPAP machines, but the company has come under harsh scrutiny since the June 2021 recall of millions of devices including ventilators, BiPAP, and CPAP machines.
FDA Criticizes Philips Respironics Over Poor Handling of June the 2021 CPAP Recall
In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure machines (Bi-Level PAP, BiPAP, or BPAP), and continuous positive airway pressure machines (CPAP) due to potential health risks stemming from the degradation of the polyester-based polyurethane (PE-PUR) foam used to make the devices operate more quietly. The FDA classified the recall as a Class 1 recall. Class 1 recalls are the most serious type of recall due to the reasonable probability that the use of, or exposure to, the product could cause serious health consequences or even death.
However, despite the Class 1 recall, between April 2021 and April 2022, the FDA received more than 21,000 medical device reports regarding Philips Respironics’ devices. Manufacturers such as Philips Respironics are required to submit the reports when their devices may have caused or contributed to a death or serious injury, or if a malfunction occurred that could cause serious harm or death. The medical device reports indicated injuries from Philips Respironics’ devices include cancer, pneumonia, asthma, respiratory problems, infections, headaches, cough, dyspnea, dizziness, nodules, and chest pain.
In addition to the medical device reports, the FDA received numerous complaints from patients who were unaware of the recall and did not know what they should do because they never received an official recall notice from Philips Respironics.
On March 10, 2022, the FDA issued an order to Philips Respironics that required the company to notify all device users, retailers, distributors, health care providers, and durable medical equipment suppliers about the recall and the health risks linked to the devices. Concerned by the reports that many patients and medical providers did not receive information on the device recall and defective foam, the FDA chastised Philips Respironics for the ineffective recall. The letter served as an official acknowledgment from the FDA that Philips Respironics failed to adequately inform the public about the recall.
The director of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D., explained the need for the order: “The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process. Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.”
The DOJ Subpoenas Royal Philips
In April 2022, Royal Philips (the parent company of Philips Respironics) announced the U.S. Department of Justice (DOJ) subpoenaed the company about the June 2021 recall. According to Royal Philips, the subpoena requested “information related to events leading to the Respironics recall.” Royal Philips said they would comply with the subpoena. Royal Philips’ CEO, Frans van Houten, thinks that the DOJ subpoena means an investigation is coming: “[T]hey are preparing an investigation and we just have to accept that.”
The FDA’s Second Proposed Order
After the DOJ’s subpoena, the FDA proposed another order to Philips Respironics admonishing the company for how it handled the device recall. In May 2022, the FDA proposed a second order under section 518(b) of the Federal Food, Drug, and Cosmetic Act. The order would require Philips Respironics to “submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015.”
How GoldenbergLaw Can Help You
If you or a loved one was injured by a Philips Respironics CPAP device, contact the Medical Device Lawyers at GoldenbergLaw. For more than 35 years, our team has provided clients with the Gold Standard of advocacy they deserve to get justice. Contact our team today and learn about how we can help you!