Philips Subpoenaed By DOJ Over Defective Sleep Apnea Machines, Respirators

Philips Respirator Sleep Apnea DOJ Subpoena Overview: 

• Who: Royal Philips NV has been subpoenaed by the U.S. Department of Justice (DOJ).
• Why: The DOJ has asked the company to provide information related to events leading up to its recall of defective sleep apnea machines and respirators. 
• Where: The defective products were sold throughout the United States.

Philips has been subpoenaed by the U.S. Department of Justice (DOJ), which wants more information on the events leading to a major recall of the company’s sleep apnea machines and respirators. 

In an Apr. 25 U.S. Securities and Exchange Commission filing, Royal Philips NV said Philips Respironics, which manufactured the faulty devices, and several of its U.S. subsidiaries had received the subpoena Apr. 8.

The subpoena called on the companies to “provide information related to events leading to the Respironics recall.” 

It said the relevant subsidiaries were “cooperating with the agency.” 

FDA Warned Philips Respironics About ‘Inadequate’ Recall Efforts

The U.S. Food & Drug Administration (FDA) issued a warning to Philips Respironics in March after discovering that the company’s “inadequate” efforts to notify the public about recalled respirators had put people in danger.

The FDA sent a legal notification order to Philips Respironics requiring the company to notify patients and others of its June 14, 2021, recall of certain ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. 

The recall came after the company found there was a “risk of substantial harm to the public health” posed by the degradation of the sound abatement foam used in the products. 

The breakdown can cause black debris from the foam to be inhaled or swallowed, causing irreversible harm to lung tissues. 

However, since June, Philips’ efforts to notify the public of the recall have been insufficient, and multiple patients and medical suppliers have claimed they were unaware of the recall nine months later, the FDA said.

Philips Faces Dozens of Class Action Lawsuits Over Recalls

Philips North America LLC has recalled millions of its CPAP and BiPAP machines that contain toxic foam, leading to dozens of class action lawsuits claiming that the company initially hid the problem from consumers, and is now forcing them to purchase new devices.

The plaintiffs say Philips knowingly exposed them and others to dangerous toxins present in sound muffling foam included in their CPAP and BiPAP machines.   

Between 3 and 4 million of the BiPAP, CPAP and mechanical ventilator devices were recalled by Philips and its associated manufacturers.

In February this year, the recall expanded to 215 of its Trilogy Evo ventilators and 51 repair kits due to the risk of death or serious injury.

If you used a recalled Philips CPAP machine and were diagnosed with cancer or a lung injury you may qualify to join a free CPAP recall class action lawsuit investigation. Click here for more information.

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