After a significant recall of Philips’ CPAP, BiPAP, and mechanical ventilator products last year, newly released documents show that Philips had prior knowledge of safety concerns about the machines. The company could have known about the products’ flaws for several years before warning consumers of their risks, according to the U.S. Food & Drug Administration (FDA).
Philips Respironics, a subsidiary of Philips, makes a line of medical devices that help people with sleep apnea. Philips issued the initial recall in June 2021, per the FDA. Litigation against the manufacturer is now pending.
New Information About Philips’ Failure to Warn Consumers
The FDA released information showing that Philips likely knew about these risks to consumers long before issuing a recall. Among many other findings, the FDA notes:
Philips received more than 200,000 complaints and took no action. Between 2008 and 2017, the company received hundreds of thousands of complaints but did not investigate or perform risk analysis studies to understand the problem.
Philips’ most recent safety analysis is limited. The data Philips’ used to issue the 2021 recall did not consider all the available data the company had about the products. The FDA also notes that this analysis was not adequately performed to encompass all product lines.
There are problems with proposed design changes. The FDA states that Philips’ proposed changes to the devices were not sufficiently reviewed or validated.
The FDA report could provide important new evidence in the case against Philips.
Background on the Philips CPAP/BiPAP Recall
On June 6, 2021, the FDA issued a notice about the following risks related to the use of Philips’ CPAP, BiPAP, and other mechanical ventilators:
- Foam degradation. Risk is related to the polyester-based polyurethane (PE-PUR) foam found in these devices. This foam was intended to reduce noise and vibrations from the machines but was known to degrade over time, posing risks of toxic particle inhalation.
- Chemical release in the device’s airway. Degraded PE-PUR foam may release other chemicals through off-gassing. These chemicals may include volatile organic compounds (VOCs).
- Health risks. As a result of the above defects, consumers could face health complications, such as respiratory issues, skin conditions, and cancer, among other conditions.
Philips and the FDA warned CPAP and BiPAP users to consult a doctor before discontinuing use.
Additionally, users should know that the recall did not affect all Philips Respironics product line devices. Consult information from Philips to learn which devices are of concern.
If You Use a Philips CPAP or BiPap Machine, Here’s What You Should Know
At this time, more than 100 lawsuits have been filed across the U.S., and thousands more are expected to join the current MDL No. 3014. Here’s what consumers should know about these lawsuits:
A multidistrict litigation (MDL) in Pennsylvania was formed in October 2021, consolidating legal actions from five U.S. districts.
The plaintiffs in these cases assert that Philips violated consumer protection laws, among other claims. Others are personal injury cases.
If a Philips CPAP, BiPAP, or another mechanical ventilator caused you harm, you could be eligible to file a lawsuit.
Again, the FDA and Philips advise all users of these devices to consult a doctor before discontinuing use. Doctors may recommend alternative devices or therapies to treat sleep apnea.