Based on evidence discovered during the official investigation, it appears that Philips could be liable for failure to warn in a CPAP lawsuit.
Earlier this year, Philips Respironics issued a voluntary recall of its sleep apnea CPAP devices over serious health concerns. The company immediately informed users of the CPAP device to speak with their physicians about continued use and suggested purchasing antibacterial filters for the machine.
What Proving Philips’ Liability Will Require from Your Lawyer
Philips informed the public of potentially life-threatening hazards caused by inhaling debris from the PE-PUR sound insulation foam. However, they might still be liable for failure to warn in a CPAP lawsuit. Plaintiffs’ lawyers will need to prove two things in a court of law:
- Philips manufactured defective machines
- The plaintiffs used the defective machines in question
The extent to which Philips will be liable depends on when the company knew about what health hazards. In other words, how long did Philips know that a problem with the machine was causing severe and life-threatening side effects before they issued a recall? We want plaintiffs to prove that the company had plenty of time to warn people but neglected to do so.
What Is Failure to Warn?
Failure to warn is a legal term used in product liability cases. A company has a responsibility to tell its consumers how to use a product properly. This includes instructions and associated hazards if someone misuses the product.
Common warnings include choking hazards, dishwasher and microwave warnings, and extreme temperature risks. If a company fails to inform consumers, the company might come under the scrutiny of legal liability should consumers be negatively impacted.
What did Philips Fail to Warn Consumers About?
The sound dampening foam used in Philips CPAP machines, PE-PUR, was found to be degrading and releasing particles into the machine’s tubing. Consumers inhaled PE-PUR particulate and potentially carcinogenic and toxic gases as a result. This could occur if the users cleaned their CPAP machines with ozone.
Particle inhalation could be detected in the mask, tubing, and device outlet by looking for black specks. Gas inhalation could only be detected by medical conclusions derived from side effects and what we know about the released gasses.
Philips attempted to quickly release a newer sound insulation foam made from silicone, post-recall. After the U.S. Food and Drug Administration (FDA) found potential safety hazards, Philips did not receive approval for this version of the product.
How Long did Philips Know About the Hazards?
Based on newer information gathered during the investigation, we know that Philips was aware of these safety issues in 2015. Furthermore, they neither acted upon these issues nor issued consumer safety warnings until 2021.
NBC reports that the company recalled a reported 15 million machines, half of which were in the United States. They recalled so many machines that there “weren’t enough resources to offer consumers replacements or repairs” until 2022. This has potentially left millions without the safe life-supporting ventilation and sleep apnea therapy they need.
Following the recall, the FDA undertook a series of inspections of the Philips CPAP manufacturing facility in August and November 2021. During this time, officials reviewed digital files, operations, and product testing. The FDA’s findings are incriminating.
Consumer Issues Should Have Pointed to a Defect
Consumers have been filing complaints for years. Not only that, but the staff has also been aware of the foam’s tendency to degrade since 2016, with at least one employee bringing up the issue with Philips’ foam supplier citing issues with the product.
There’s even evidence to support that the company was aware of an issue with the machine much earlier. Between 2008-2021, the company had received over 220,000 consumer complaints about debris, airways, foam, and particles.
At this point, we can confidently say that Philips might not have been aware of medical repercussions in 2015, but they were aware of PE-PUR’s structural issues.
How Long did Philips Know About the Health Issues?
It wasn’t until recently that Philips say they became aware of the health issues caused by PE-PUR foam. But this “recently” is subjective. Between 2016 and 2021, an FDA inspector found at least 14 instances of potential Volatile Organic Compound (VOC) emissions from the devices in question.
These compounds are linked to various cancers and other serious health issues in Philips CPAP therapy patients.
When did Philips Start Notifying Consumers?
According to Philips, in the years leading up to the recall, they worked with consumers on a case-by-case basis. But, despite overwhelming evidence that there was a bigger issue with the foam well before 2021, they didn’t alert consumers to the issue until they could avoid financial losses.
In the weeks leading up to the CPAP recall, Philips sent a statement out to investors in its quarterly earnings report in which they address “a quality issue in a component that is used in certain sleep and respiratory care products.” This was released on April 26, 2021. Houten then assured investors that they were working on a preventive provision to address the issue.
How Will These Facts Play into the Lawsuit?
Between the investigation and what we know about Philips’ recall timing, we would say Philips could be liable for the defective devices. The company knew about ongoing issues through consumer complaints and internal testing. Our lawyers will fight to show that Philips failed to warn CPAP users of dangers to their health.
Call Chalik & Chalik Injury Lawyers to Get Started on Your CPAP Defect Lawsuit
You could recover compensation for your illness or negative symptoms caused by using Philips CPAP or ventilator machines. Our team will gather evidence that demonstrates your losses and Philips’ liability.
Call our team at (855) 529-0269 to speak to Chalik & Chalik Injury Lawyers staff. We offer free consultations so you can discuss your defective product situation with our team. We have won millions for our past clients, and we want to fight for you, too.
