A recent Food and Drug Administration (FDA) investigation of prominent sleep apnea device manufacturer, Philips Respironics, revealed that the manufacturer had knowledge of its devices’ dangerous defect for almost six years before it issued a nationwide recall.
Philips Respironics manufactures ventilators, CPAP, and BiPAP machines to treat sleep apnea and prevent the medical complications that the condition can cause. On June 14th, 2021, Philips issued a voluntary recall of more than 15 million ventilators, CPAP, and BiPAP machines due to a defect with the devices’ polyester-based polyurethane (PE-PUR) noise-canceling foam. The PE-PUR foam was found to degrade into particles that can enter the device’s air pathway and may also emit gas chemicals, like dimethyl diazine and Phenol 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl). Inhalation of the particles or chemicals can lead to serious respiratory and cardiovascular problems. It is also believed that certain cancers could be caused by inhaling a large amount of the particles across many months or years.
In July 2021, the FDA classified the Philips recall as Class I – the most serious class of recall. Since then, Philips has implemented a repair and replace program, which the FDA has been monitoring, to ensure that sleep apnea patients are having their condition safely treated by devices without the defective foam.
FDA Investigation of the Philips CPAP Machines
In August 2021, the FDA launched its own investigation of the Philips recall. After examining internal documents and communications between Philips employees, the investigation concluded that Philips likely knew of the degradation problems with the PE-PUR foam as soon as 2016. The FDA uncovered more than 220,000 customer complaints, with at least 110 directly pertaining to foam degradation, and several internal tests that confirmed the degradation issues with the PE-PUR foam. However, despite awareness of the issues and harms associated with the foam’s degradation, Philips ultimately decided not to alter the design of the foam.
Specifically, the FDA noted that Philips failed to conduct an adequate risk analysis or take proper corrective action once it learned of the risks of degradation. The delay between the discovery of the issue and the company’s recall notice is significant enough that it is likely that Philips could be found negligent by legal definition. Therefore, the company could be liable for the damages suffered by potentially thousands of consumers who have been harmed due to the foam defect.
How Goldenberg Lauricella Can Help You
Medical device manufacturers have a duty to reasonably warn consumers of known risks associated with their products. If you or a loved one was harmed by a defective Philips sleep apnea machine, contact the defective CPAP machine attorneys at Goldenberg Lauricella today. We have more than 35 years of experience, knowledge, and compassion to provide you with the Gold standard of advocacy.