FDA Reports 260 Deaths Linked To Recalled CPAP Machines

FDA Reports 260 Deaths Linked To Recalled CPAP Machines

Introduction

According to federal regulators, at least 260 deaths have been linked to recalled Philips CPAP sleep apnea machines, BiPAP machines, and mechanical ventilators, which were taken off the market last year amid concerns that toxic particles from the sound abatement foam could enter the airways and users' lungs.

In July 2021, Philips issued a massive sleep apnea machine recall, affecting all DreamStation, CPAP, BiPAP, and ventilators that used a polyester-based polyurethane (PE-PUR) foam to reduce noise and vibrations while the machine was in use. The manufacturer acknowledged at the time that the foam is prone to break down over time, releasing harmful chemicals and gases.

On November 22, the US Food and Drug Administration (FDA) issued an update with new data on the number of medical device reports (MDRs) submitted by users over the previous year and a half.

Since the recall, Philips, doctors, and patients have submitted over 90,000 reports, including 260 reports of death linked to the breakdown of PE-PUR foam. Other problems reported by users include cancer, pneumonia, asthma, infections, headaches, coughs, dyspnea, dizziness, nodules, chest pain, and other respiratory problems.

Due to the serious side effects of the Philips CPAP foam, the FDA advised all owners to stop using the machines immediately following the recall unless the devices were required for life-sustaining therapy. However, CPAP replacement machines were scarce, and repairs were slow.

Philips announced a CPAP machine repair and replacement programme in September 2021, but there have been some concerns raised about the safety of the alternative foam material used by the manufacturer, which may also release harmful chemicals directly into the machine's air pathways.

The FDA has criticized Philips' handling of the recall, claiming that the company did not do enough to warn consumers about the health risks of using recalled CPAP machines.

According to a docket report (PDF) released on November 15, 2022 by the United States Judicial Panel on Multidistrict Litigation (JPML), there are currently at least 346 Philips recall lawsuits filed in the federal court system. Thousands of additional claims involving cancer and lung damage among former users of the breathing machines, on the other hand, have been registered on a tolling agreement.

Given the common factual and legal issues raised in the Philips Respironics CPAP lawsuits filed throughout the federal court system, the federal claims have been consolidated before the United States District Judge for the Western District of Pennsylvania, who is presiding over coordinated discovery and pretrial proceedings.

Throughout 2022 and 2023, the parties are expected to establish a "bellwether" process in which a small group of representative claims involving various types of breathing machines will be prepared for early trial dates to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation. The judge, however, has already appointed a Philips CPAP recall settlement master to work with the parties and determine whether an early agreement to resolve claims can be reached.