Dive Brief:

• The FDA has ordered Philips to notify customers, including patients and suppliers, of its recall of millions of sleep apnea and ventilator machines, writing in a Thursday news release that "this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company's notification efforts to date have been inadequate."
• The order comes nine months after Philips initiated its recall of certain sleep apnea and ventilator machines, which the FDA eventually labeled a Class I event. In a letter to the company, the FDA said that despite its efforts to have Philips "voluntarily expand" communication efforts, the agency is continuing to hear from patients and consumers who are unaware of the recall. In addition to issues about the notification of the recall, the FDA wrote it has "concerns that Philips has not, and is not" providing patients and other consumers with sufficient information regarding the progress of the recall and the process for getting replacement devices.
• "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," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in the statement. "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."

Dive Insight:

It has been almost one year since Philips publicly acknowledged product safety issues with certain sleep apnea and ventilator machines.

The company in June officially initiated a recall due to foam used to dampen sound in machines breaking down, creating the risk of particles being inhaled or ingested by users and possibly exposing them to toxic chemicals. The recall ultimately affected more than 5 million devices.

The FDA wrote in Thursday's statement that once broken down, the foam can result in serious injury, including injuries that can be life-threatening, can cause permanent impairment and/or require medical intervention to prevent permanent injury.

The agency ordered Philips to notify all device users, durable medical equipment suppliers, distributors, retailers and healthcare providers that prescribe the products about the health risks posed by the foam in recalled products.

The FDA also ordered Philips to maintain "prominently displayed information" on their main webpage for the recall regarding the risk of using ozone cleaners on the recalled devices, which the company has attributed as one cause of the foam breakdown.

Other orders from the FDA include providing a link to testing done on devices using the foam.

"The information currently available on Philips' website is vague, and does not provide healthcare providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients," the agency stated in its letter.

The company has 45 days from the time of the order to comply.

"We are doing and will continue to do everything possible to support our customers, clinicians and their patients, and to accelerate the replacement actions," a Phillips spokesperson said in an emailed statement. "We have been in dialogue and cooperating with the FDA from the start of the recall. There is nothing in the Order that we have not already been doing and are about to do."

Philips said in a Thursday press release that the company has reached "the vast majority" of the installed base in the U.S., resulting in the registration of 2.6 million devices. More than 650,000 replacement devices have been shipped to customers in the U.S. and the repair and replacement program is expected to be completed in the fourth quarter of 2022, according to the statement.

The number of total impacted devices in the U.S. and how many remaining customers need to be reached was not provided in the statement.

The recall could cost Philips hundreds of millions of dollars and it has opened up the market for rival ResMed, possibly permanently altering the competitive landscape. As of January, the company has set aside 725 million euros to address the recall, which was equal to about $825 million at the time of the announcement.

The financial impact of the recall may grow as Philips faces lawsuits in and outside of the U.S.

In its annual report released in February, Philips said that the company faced about 100 class-action lawsuits in the U.S. as of Dec. 31, 2021, that allege "economic loss and/or medical monitoring claims." In addition, the company also is facing approximately 120 personal injury lawsuits in the U.S. that were consolidated into multi-district litigation in the U.S. District Court for the Western District of Pennsylvania in October.

The company and/or subsidiaries also are facing consumer class-action lawsuits in Australia, Canada and Israel.

"While the company believes it is probable that these lawsuits will in the aggregate lead to an outflow of economic resources for Philips Respironics or other Philips entities, given the significant uncertainty regarding the nature of the relevant events and potential obligations, the company is not currently able to reliably estimate the amount of the obligation associated with these various lawsuits," Philips said in its annual report.