The U.S. Department of Justice has subpoenaed Royal Philips NV over the recall of defective CPAP sleep apnea machines and respirators, which are alleged of causing severe problems to the users.
Philips Respironics and its U.S. subsidiaries were handed over the subpoena on April 8. The sleep machines used by millions of Americans are alleged of releasing toxic sound abatement foam particles and debris, which go directly into the pathways and lungs of individuals.
In June 2021, the company recalled millions of Philips DreamStation, CPAP and BiPAP machines as the manufacturer admitted that sound abatement foam made from polyester (PE-PUR) might break down and degrade, eventually releasing black particles or debris directly into the sleep apnea machine’s air pathway. It would expose the users to some toxic gases and chemicals.
The company now faces several product liability lawsuits and class action claims against its Philips CPAP machines. The lawsuits are brought forward by hundreds of former users reporting cases of cancer, lung damage and other respiratory problems.
The FDA declared in the last month that Philips CPAP recall notifications failed to meet federal requirements. As per the agency's report, the company lapsed in informing the CPAP machine users about the health risks. The investigators of FDA even suggested that Philips was aware of the sound abatement foam problem for years, yet it did not issue warnings to the users and failed to follow up the complaints.
