People who have sleep apnea—a condition that makes breathing difficult during sleep—or suffer from other breathing problems use these devices.
The Dutch company estimated there were three to four million devices impacted globally at the time of the initial recall. The U.S. Food and Drug Agency (FDA) classified the Philips recall as the most serious type of recall. The FDA identified the recall as a Class I recall where device use could cause serious injury or death.
FDA and Philips Updates and Actions After Initial Recall
Since the initial recall, the FDA has issued updates concerning the products. Additionally, the FDA has taken more actions that have ratcheted up concerns about the recalled products. In turn, Philips has taken additional actions.
What Causes the Foam to Break Down?
The FDA updated its guidelines to recommend that users of the recalled CPAP and BiPAP devices and their caregivers consult their healthcare provider to determine the best treatment plan and any changes to be made based on the recall. Previously, it was suggested that CPAP and BiPAP patients simply stop using the devices. The agency suggests that such a physician-assisted plan might include continued use of the device if they determine the benefits outweigh the risks. Or patients might seek other sleep apnea treatments.
Replacement Foam Needs Testing
The FDA had approved Philip’s repair and replace program. The program followed the recall, which included the use of a silicone-based foam instead of the PE-PUR foam. Later, the FDA discovered a device manufactured for a non-U.S. market that used the silicone-based foam had failed a singular safety test for the release of volatile organic compounds (VOCs). In November, the FDA requested that Philips get independent testing. The testing would determine any safety risks the replacement foam may pose to patients. In the meantime, if any user of the repaired/replaced CPAP or BiPAP devices has concerns they should consult their physician.
Specific Trilogy Evo Ventilators Added to Recall
A recent FDA inspection determined that a Philips supplier had incorrectly used the problem PE-PUR foam in the manufacture of certain Trilogy Evo ventilators with specific serial numbers. The FDA had not recalled these ventilators in the June 2021 recall.
In December 2021, Philips initiated a recall of Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021. The recall consisted of Trilogy Evo ventilators with specific serial numbers.
On January 26, 2022, the FDA provided an update related to the recall of these Trilogy ventilators. The medical device watchdog has also classified the Trilogy Recall as a Class 1 recall, the most severe type of recall.
Impact of Expanded Recall
The impact of the additional recalled Trilogy mechanical ventilators remains to be seen. Although it seems that there potentially are 215 Trilogy Evo ventilators users and 51 repair kits purchasers in the United States that may face serious health risks from foam degradation in their devices. With Philips’s increase in ventilator production during the COVID crisis and high demand for ventilators in general during the pandemic, it’s possible some COVID patients fighting for their life used the mechanical ventilators recalled in June or December. With the respiratory tract infection potential and other health concerns associated with the harmful black debris and gases from the foam breakdown, Philips may face more plaintiffs that include COVID patients/deceased that used the ventilators.
Injuries from the Products
When the sound abatement foam in the CPAP, BiPAP, and mechanical ventilators breaks down, device users can swallow or inhale black debris and gases. The FDA says such exposure could cause serious health problems for patients including skin, eye, respiratory tract irritation, and inflammation. Other health problems also include headaches, asthma, vomiting, adverse impacts on kidneys and livers, and toxic carcinogenic effects. As of June 2021, complaint reports on the recalled products exceeded 1200, and injury reports were 100+.
CPAP Litigation Update
By October 2021, plaintiffs had filed dozens of Philips CPAP device personal injury and class action lawsuits. Allegations in the litigations included claims that exposure to the deteriorating sound abatement foam in the machines exposed plaintiffs to cancer and severe respiratory risks as well as other health problems.
At least 107 of the lawsuits have been consolidated into a multidistrict litigation (MDL) in the United States District Court for the Western District of Pennsylvania. In Pre-Trial Order #8 the judge recently appointed co-lead counsel, Plaintiffs’ Steering Committee (“PSC”), or liaison counsel. Sample complaints show strict liability, negligence, warranty breaches, misrepresentation, fraud, and conspiracy causes of action against Philips. Users of various CPAP machines say it caused kidney disease, chest tightness during use, respiratory problems, and anxiety. There are also class action claims for actual damages for the cost of purchasing the devices.
The CPAP, BiPAP, and ventilator lawsuits promise to be voluminous and complex.