In the wake of a disastrous recall involving defective sound-dampening foam in several of its breathing machines, Philips Respironics announced Monday that it was suspending sales of its continuous positive airway pressure — or CPAP — machines in the United States.
The decision comes as part of a consent decree with the U.S. Food and Drug Administration.
Philips Respironics North America is the seventh-largest employer in Westmoreland County, according to the state Department of Labor & Industry. It has facilities in Murrysville, East Huntingdon and Upper Burrell and employs 2,400 people in Pennsylvania, according to the company’s website.
An older Philips facility off of Golden Mile Highway in Plum is permanently closed.
The company has committed more than $392 million to address issues raised in the consent decree, according to Philips’ fourth-quarter earnings report released Monday.
In June 2021, the Dutch company Philips — which bought the Murrysville-based Respironics company in 2007 — was forced to recall millions of its sleep therapy and respirator machines after it was disclosed that the polyester-based polyurethane foam used in the machines to reduce sound and vibration could break down and potentially be breathed in or swallowed, according to the FDA.
“Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” Royal Philips CEO Roy Jakobs said in a news release accompanying the earnings report, which shows Philips
Last September, Philips agreed to a partial $479 million settlement to resolve a lawsuit filed by people who developed lung problems and cancer after using machines containing the foam.
The consent decree is being finalized and will be submitted to the relevant U.S. court for approval. The decree will provide Philips Respironics with a road map to comply with regulatory requirements, Philips officials wrote in the quarterly earnings statement.
Philips officials said CPAP and other breathing machine sales will continue outside the United States. Company officials could not be reached for comment on the effect on local jobs or whether sales would resume in the United States at some point.
Philips reported a positive operating income of $603 million in 2021, according to company earning reports. At the end of 2022, however, it reported an operating loss of nearly $1.67 billion, the bulk of which was linked to issues and recalls in the Respironics division.
The operating loss in 2023 was more than $124 million, according to the report.
Gerald McGinnis of Plum, founder of Respironics, died late last week.
Patrick Varine is a TribLive reporter covering Delmont, Export and Murrysville. He is a Western Pennsylvania native and joined the Trib in 2010 after working as a reporter and editor with the former Dover Post Co. in Delaware. He can be reached at pvarine@triblive.com.