The U.S. Food and Drug Administration (FDA) has called out Philips Respironics for its inadequate efforts in notifying patients, suppliers, and healthcare providers of a massive recall of some of the company’s breathing assistance devices. On March 10, 2022, the agency ordered the company to notify these users of the recall and the products’ risks.
It's a move that Levin Papantonio Rafferty attorney Troy Bouk called a “strong statement” from the federal agency. Bouk, an attorney with Levin Papantonio Rafferty, was appointed to the Science and Expert Committee for the Philips CPAP multidistrict litigation.
The FDA order appears to have had at least some effect.
By March 14, 2022, the FDA had updated its Philips Respironics breathing CPAP, BiPAP, and Ventilator Recalls FAQ page to include details about how the manufacturer will prioritize replacement devices.
Replacement Strategy for Recalled Breathing Devices
People who use CPAPs, BiPAPs, and mechanical ventilator devices do so because their health requires it. When Philips recalled these devices, it left many of these patients in a desperate quandary—having to choose between the health risks posed by foam degradation and those from ceasing use of the devices without any sort of legitimate alternative.
The FDA pointed out to Philips that defaulting to a first-come-first-served replacement strategy would not properly account for this balance of risks as it applies across a broad spectrum of patient needs.
The Philips Respironics online patient portal has since debuted with new functionality that lets users of recalled devices enter their information to be factored into prioritized replacement decisions. Portal users can also tap into the tool to check on the status of their replacement devices.
When Enough Was Enough the FDA Got Busy
The FDA’s notification order expressed concern that a significant number of individuals who use the recalled Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines devices do not know about the health risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. This foam can break down causing serious, possibly life-threatening injuries.
“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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in an FDA press release.
“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,” Shuren continued.
Specific Demands in the FDA’s Order
Under the terms of the order, Philips Respironics must take specific steps to improve its communication with the public.
Philips must provide the following entities with recall- and risk-related information:
Durable medical equipment (DME) suppliers
Health care providers who prescribe the products
The medical device company must also update its website with language that explains to users the risks of using ozone cleaners on recalled devices, as well as instructions on how to register their devices on Philips’ website.
Users who know about the recall have waited a long time—the recall was issued in June 2021—for clear directions on getting replacements for their devices. The FDA wants Philips to send monthly replacement updates to those who have registered their recalled devices. The agency further recommends that users, DME suppliers, distributors, retailers, and healthcare providers receive details on Philips’ replacement process.
Preventing Unreasonable Risk of Substantial Harm
The FDA is well within its rights to issue the notification order. Section 518(a) of the Federal Food, Drug, and Cosmetic Act gives the agency the authority to order a manufacturer to notify users/consumers and others upon determining that a device presents an “unreasonable risk of substantial harm to the public health” and such notification is necessary to “eliminate the unreasonable risk of such harm and no more practical means are available [under the Federal Food, Drug, and Cosmetic Act] to eliminate such risk.”