Court orders Philips to stop CPAP, BiPAP, ventilator production

A court has ordered the Dutch medical device company Philips and its subsidiary, Respironics, to stop making sleep apnea machines in the US until they resolve a slew of manufacturing issues. The case was brought against Philips by the Department of Justice (DOJ) on behalf of the Food and Drug Administration (FDA) after the company failed to fix potentially fatal flaws in its devices.

The US District Court for the Western District of Pennsylvania issued a consent decree of permanent injunction on 9 April against Philips, Respironics, and several defendants, including Royal Philips CEO Roy Jakobs, to stop the company from manufacturing new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and ventilators at Philips Respironics facilities in Pennsylvania and California. It also means the company must immediately implement a Recall Remediation Plan that it has agreed to with FDA. (RELATED: FDA inspection turns up more problems for Philips Respironics, Regulatory Focus 16 November 2021)

In June 2021, Philips initiated a class I recall for certain ventilators, CPAP, and BiPAP machines after it received adverse event reports that the sound-dampening polyester-based polyurethane (PE-PUR) foam could break apart and be breathed or swallowed by users, potentially causing permanent and life-threatening injuries. However, according to Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), the company's response was inadequate, leading the agency to take more drastic measures. (RELATED: Shuren: FDA needs new authorities to prevent device shortages beyond public health emergencies, Regulatory Focus 2 February 2024)

“Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall,” said Shuren, in an agency statement. “Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”

The recall remediation plan sets a timeframe that Philips must follow to provide users with new, updated, or equivalent devices with a renewed warranty or a refund. It also must make a good-faith effort to reach users who may be affected by the faulty devices in a timely manner. The consent decree also imposes certain restrictions prioritizing US patients, such as preventing the company from exporting remediated devices to other countries until US patients affected by the recall have been taken care of and ensuring it has enough remediation devices for US patients for the next year.

The plan also requires Philips to hire independent experts to review and evaluate their manufacturing testing data and inspect their manufacturing facilities.

Philips acknowledged agreeing to the consent decree in a press release and stated it will provide the company with a roadmap of actions, milestones, and deliverables to meet regulatory requirements it agreed to on 29 January.

“Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more,” said Jakobs. “With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world.”

FDA statement

Philips statement

Court orders Philips to stop CPAP, BiPAP, ventilator production

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