Timeline Stories
August 22, 2022
Lawyers representing plaintiffs filed a Consolidated Amended Class Action Complaint for Medical Monitoring and a Master Personal Injury Complaint. Plaintiffs are seeking to have Philips cover the cost of medical monitoring for patients who used the recalled devices. In addition, those with injuries allegedly caused by Philips’s recalled devices now have a set of common facts and claims for suing the company. .
August 15, 2022
The FDA updated its safety communication related to the recall with new information on MDRs. From May 1, 2022 through July 31, 2022 the FDA received more than 48,000 MDRs, more than twice as many as the last period, including 44 reports of deaths associated with PE-PUR foam breakdown or suspected foam breakdown. The FDA is continuing an in-depth review and analysis, including examining the possible reasons for the increased number of reports during this time.
July 21, 2022
During the monthly status conference before Judge Conti, lawyers mentioned that there are more than 60,000 claims against Philips subject to a tolling agreement.
June 17, 2022
Lawyers representing plaintiffs filed a Consolidated Amended Class Action Complaint for Economic Losses. The complaint outlines Philips’s pattern of misconduct leading to the recall of millions of its CPAP and BiPAP machines and ventilators. Plaintiffs are seeking to recover economic losses and punitive damages from Philips.
May 19, 2022
The FDA updated its safety communication related to the recall with new information on medical device reports (MDR). From April 2021 through April 30, 2022, the FDA received over 21,000 MDRs, including 124 reports of death, associated with the PE-PUR foam breakdown from the recalled devices.
May 2, 2022
The FDA took the historically unprecedented step of issuing a 518(b) notice, proposing a requirement for Philip to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices. In the notice, the FDA said there is sufficient evidence to determine "that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue.” The agency also stated, “Evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”
April 25, 2022
Royal Philips NV was subpoenaed by the Department of Justice (DoJ), indicating the company is under investigation for its conduct related to the recall.
March 10, 2022
The FDA issued a 518(a) notification order to Philips because of the company’s "failure to timely provide effective notice to health professionals who prescribe or use the Recalled Products and other persons (including consignees, distributors, retailers, and device users) who should be notified, of the recall and the health risks presented by the Recalled Products.” Philips was ordered to notify people of the “unreasonable risk of substantial harm to the public health” posed by the foam degradation within the next 45 days. This was the first 518(a) notification order issued by the FDA in the 21st century. Prior to the Philips recall, the agency had not issued a 518(a) notification order since 1995.
February 15, 2021
Judge Conti appointed Sandra L. Duggan of Levin Sedran & Berman LLP, Kelly K. Iverson of Lynch Carpenter LLP, Christopher A. Seeger of Seeger Weiss LLP, and Steven A. Schwartz of Chimicles Schwartz Kriner & Donaldson-Smith LLP to serve as plaintiffs co-lead counsel overseeing In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation.
December 2021
Philips initiated an additional recall of certain Trilogy EVO Ventilators. The Class I recall targeted ventilators that were using the same PE-PUR foam as other devices covered by the global recall.