Philips Recall of CPAP Machines Has Resulted in DOJ Investigation

Subpoena issued by federal law enforcement officials suggests a review is underway for problematic recall of Philips CPAP machines

Philips Respironics and its U.S. subsidiaries have received a subpoena from the U.S. Department of Justice, which appears to be investigating the company’s recall of CPAP machines used by millions of Americans, which have been found to release toxic sound abatement foam particles and debris directly into the air pathways and lungs of individuals who used the device for treatment of sleep apnea.

During an earnings call this week to review the company’s latest financial results, officials disclosed that a subpoena was received on April 8, seeking information about the Philips recall of CPAP machines last year, which the company is interpreting as signs that the DOJ is launching an investigation.

Millions of Philips DreamStation, CPAP and BiPAP machines were recalled in June 2021, after the manufacturer acknowledged that a polyester-based (PE-PUR) sound abatement foam inside the devices may breakdown and degrade, releasing black particles or debris directly into the sleep apnea machine’s air pathways, exposing users to a number of toxic chemicals and gases.

Hundreds of former users have already come forward to report cases of cancer, lung damage and other respiratory problems caused by exposure to the Philips CPAP foam particles, and the company now faces a mounting number of product liability lawsuits and class action claims.

The rollout of the recall was contentious and left many users confused about what they should be doing. First, there was no initial Philips CPAP replacement plan, and many users were unaware that the recall had even been issued. In addition, many individuals continued to use the machines, due to unclear directions and information about whether the devices posed an immediate danger.

Last month, the FDA declared that Philips CPAP recall notifications had failed to meet federal requirements. The agency indicated it had to intervene and called on the company to address its lapses in notifying customers about the health risks following the recall of CPAP machines that were being used on a nightly basis by several million individuals.

But that was not the only problem with the CPAP machine recall. In January, for example, the FDA expanded the recall after inspectors discovered several hundred devices which used the same sound abatement foam were not originally included in the initial announcement.

Additionally, an inspection of the Philips manufacturing facility led to the discovery that the silicone foam Philips chose to replace the toxic sound abatement foam might not itself be safe. A similar silicone foam used in another device marketed outside of the U.S. had failed safety tests due to “chemicals of concern” which could also potentially cause respiratory problems. The FDA ordered Philips to have a third party investigate the safety of the new foam and warned consumers some devices that had already been replaced may be unsafe.

On top of all of that, FDA investigators in November suggested Philips knew about the sound abatement foam problem for years before issuing a recall, indicating the company had not followed up on complaints and warnings.

It is unclear which aspect of the recall the Justice Department is investigating currently.

As the scope of investigations and lawsuits continues to expand, Philips is expected to face massive liability for problems stemming from the recall of CPAP machines that threatened the health and safety of Americans.