Summary: The U.S. District Court for the Western District of Pennsylvania issued a consent decree against Philips Respironics due to safety issues with their sleep therapy devices, stemming from a 2021 recall of 15 million devices. This recall was due to the degradation of sound-dampening foam, posing health risks. The decree mandates a Recall Remediation Plan for affected patients, following allegations of violations of the Federal Food, Drug, and Cosmetic Act.

Key Takeaways:

  • The consent decree halts production and sale of CPAP and BiPAP machines until safety standards are met.
  • The action follows a significant recall caused by potentially harmful degradation of device foam.
  • A mandated Recall Remediation Plan offers replacements or refunds for affected devices.

A consent decree of permanent injunction was issued by the U.S. District Court for the Western District of Pennsylvania against Philips Respironics and its affiliates, including Royal Philips CEO Roy Jakobs, halting production over safety concerns related to their sleep therapy devices.

This decree significantly limits the production and sale of new CPAP and BiPAP machines—widely used in treating obstructive sleep apnea—across several of the company’s U.S. facilities until they meet specific safety and manufacturing standards.

This legal action stems from a June 2021 recall affecting 15 million devices globally, where the polyester-based polyurethane (PE-PUR) foam used in these devices for sound and vibration dampening was found to potentially degrade. The FDA quickly issued an alert following Philips’ recall, warning users of the potential dangers.

This degradation could lead to users inhaling or ingesting harmful black foam particles or chemicals, posing serious health risks that could require medical intervention to prevent permanent injury.

Recall Remediation Plan Mandated

The consent decree mandates a Recall Remediation Plan, developed in agreement with the FDA, to provide affected patients with replacements or partial refunds for certain faulty devices.

“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 Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Today’s action is a culmination of those efforts. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”

Allegations and Inspections

This decree follows allegations by the Department of Justice, on behalf of the FDA, that Philips Respironics violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) by distributing adulterated and misbranded devices.

These violations were identified during the FDA’s 2021 inspection of Philips Respironics’ Murrysville, Pennsylvania, facility and subsequent inspections in Mt. Pleasant, Pennsylvania, and a subsidiary in Carlsbad, California, which has since stopped manufacturing operations.