On May 2, 2022, following the FDA’s Section 518(a) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) action against Philips, which required Philips to provide notification to customers of the recall and the health risks presented by the recalled devices, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a letter proposing that Phillips be issued a new order, but this time under Section 518(b) of the FDCA.

Section 518 of the FDCA is designed to protect public health. Under Section 518(a), the FDA may require manufacturers or other appropriate individuals to notify all health professionals who prescribe or use the device and any other person (including importers, distributors, retailers, and device users) of the health risks resulting from the use of the defective device, so that these risks may be reduced or eliminated. In turn, Section 518(b) authorizes the FDA, after offering an opportunity for an informal hearing, to order manufacturers, importers, or distributors to repair, replace, or refund the purchase price of devices that present unreasonable health risks.

Despite explicit authority granted under Section 518 of the FDCA to regulate medical devices, the FDA seldomly employs it. Before Philips, the latest use of Section 518 was the issuance of a Section 518(a) notification in 1995 to a firm called Telectronics. Telectronics manufactured pacemakers; however, their pacemaker’s wire, responsible for delivering electric pulses to the heart, began to break and puncture the individual’s heart to whom the device was surgically implanted. This faulty wire affected nearly 22,000 Americans and is to blame for two patients’ deaths, at least a dozen injuries, and over 1,000 surgeries to remove the defective wire resulting in an additional four deaths during the operations. When issuing the 518(a) notification, the FDA accused Telectronics of not warning patients about the malfunctions until January 1995, even though it received the first reports in 1994.

The issuance of the 518(b) notice is significant—we have found no past examples of the FDA exercising its repair/replace/refund authority under Section 518(b). However, per the FDA’s May 2, 2022 letter, Phillips may make recent history and receive a 518(b) order. The FDA asserts four reasons which justify the issuance of a 518(b) order.

First, as outlined in the 483 report, the CDRH states that the recalled devices contain polyurethane (“PE-PUR”) foam that may degrade into particles and be inhaled by device users. This foam contains harmful chemicals, including toluene diisocyanate isomers (“TDI”), toluene diamine isomers (“TDA”), and diethylene glycol (“DEG”). Inhalation or ingestion of these particles may cause toxic and potentially carcinogenic effects and irritation of the respiratory tract, eyes, nose, and skin, asthma, inflammatory responses, and headache.

The CDRH further states that testing of the recalled devices showed that these devices emitted volatile organic compounds (“VOC”). These compounds include dimethyl diazine, phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl), and formaldehyde. Due to the risk associated with the potential degradation of and the VOC emissions from the PE-PUR foam contained in the recalled devices, the CDRH believes there is sufficient evidence for the FDA to determine that the recalled devices present an unreasonable risk of substantial harm to the public health.

Second, the CDRH states that there are reasonable grounds that Phillips did not adequately evaluate the devices subject to the recall despite receiving various test reports, complaints, information from supplies, and information from another entity owned by Philips’s parent company that the devices’ foam was potentially degrading as early as 2015. By continuing to manufacture the products that contained the potentially degrading foam, the CDRH held that Philips failed to evaluate the devices adequately and, in turn, implement corrective and preventive actions that could have potentially mitigated the harm of the degraded foam as required by current good manufacturing requirements. As a result, the CDRH believes that under these circumstances, there is enough evidence for the FDA to determine that there are reasonable grounds to believe that Philips’s manufacturing of the recalled devices was not adequately conducted consistent with the state of the art as it existed at the time when Phillips manufactured the devices.

Third, the CDRH held that while the use of ozone to clean the recalled devices may exacerbate the degradation of the PE-PUR foam, the unreasonable risk associated with the devices was not caused by the ozone cleaning agents but instead was caused by the foam’s susceptibility to degradation under even relatively mild environmental conditions. Therefore, CDRH believes that there is sufficient evidence for the FDA to determine that there are reasonable grounds to believe that the unreasonable risk associated with the recalled devices was not caused by using ozone cleaning products and instead caused by the manufacturer, importer, distributor, or retailer of the devices failure to exercise due care in device installation, maintenance, repair, or use.

Lastly, the CDRH stressed that patients and providers could not readily mitigate that risk even when aware of the unreasonable risk associated with the recalled devices. The FDA has cautioned against using an additional filter in these recalled devices, and the removal of PE-PUR foam from BiPAP or CPAP machines may present a severe risk. Further, no solution is offered as a viable way to prevent the potential chemical emissions from being inhaled. Therefore, repairing, replacing, and/or issuing a refund for the affected devices is necessary.

The next step in this saga is whether the FDA will issue the Section 518(b) order.

According to the FDA, between “April 2021 through April 30, 2022, the FDA received more than 21,000 medical device reports (“MDRs”), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.”

If you have been injured as a result of the use of a recalled Philips CPAP, Bi-Level Pap, or Ventilator, you may contact us to discuss your legal rights.

Blog Post by Kelly K. Iverson and Bailey Corbin.

Kelly K. Iverson is a partner at Lynch Carpenter, LLP, and was appointed by Judge Joy Flowers Conti as Plaintiffs’ Co-Lead Counsel in In re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Liability Litigation, MDL No. 3014 (W.D. Pa.).