Philips consent decree outlined 

PITTSBURGH – The provisions of a consent decree between Philips Respironics and the U.S. Department of Justice were outlined in an April 4 filing in federal court, including selecting and retaining an independent expert to conduct inspections at certain facilities for several years. 

The expert will conduct audit inspections every six months for a period of two years and then once every year thereafter for a total of five years at four facilities in Pennsylvania and one facility in California. 

Other provisions in the 73-page filing, which must be approved by a judge, include: 

• Permit the U.S. Food and Drug Administration to, without prior notice and when it deems necessary, inspect the facilities and take any other measures necessary to monitor and to ensure continuing compliance with the terms of the decree. 

• Pay the U.S. Treasury a percentage of net revenue from the sale of any medically necessary devices, including some ventilators, at the following rate: 10% of net revenue between entry of the decree and Dec. 31, 2024; 12% of net revenue between Jan. 1, 2025, and Dec. 31, 2025; and thereafter, 25% of net revenue. The payments, which will end when the injunction is lifted, are “equitable remedy and not punitive.” 

• Select and retain an independent expert to review and evaluate testing data and analyses, and review and evaluate the company’s plan for assuring the safety of the new foam they are using to manufacture replacement devices and rework devices. 

Until the provisions of the decree are met, in the U.S., Philips Respironics is permanently restrained and enjoined from directly or indirectly manufacturing, holding and/or distributing any device at or from covered facilities, according to the filing. The company may continue to sell a select group of devices deemed "medical necessary" by the FDA in the U.S. and it may continue to export devices to other countries.

Philips recently added a section to its website about “Understanding the consent decree.” 

The company announced earlier this year that it had agreed to the terms of a consent decree related to its recall of certain sleep and respiratory care devices. 

Philips also announced earlier this year that it would stop selling 19 sleep and respiratory products in the United States.