The Food and Drug Administration (FDA) has announced it has received more than 100 reports of deaths linked to popular sleep aid devices. According to an NBC news report this latest revelation after the company behind these recalled products – Philips Respironics – a subsidiary of Royal Philips – recently told its shareholders that it was served subpoenas by the U.S. Department of Justice as part of an ongoing investigation into the Respironics recall.
Serious Product Defects
The global recall of CPAP, BiPAP, and ventilator devices by Philips was first announced in June 2021 after the company said there was a noise-abatement carcinogenic foam inside the device, which could break down and be unknowingly inhaled by users. The FDA quickly labeled the recall as Class I, a designation reserved for the most serious type of recall that could cause serious injuries and/or fatalities. FDA investigators said the recall affected more than 15 million devices worldwide. A number of sleep apnea patients relied on the recalled devices that Philips said did not have enough parts to repair or replace the defective devices immediately. So, many patients did not have other options. Since April 2021, the FDA has received more than 21,000 medical device reports of MDRs associated with the Philips devices including 124 reports of deaths. Philips is also facing 185 personal injury lawsuits and more than 100 class-action lawsuits tied to this device recall. In December, an FDA inspection found that nearly 10 years ago, the company got more than 100 complaints related to the sleep aid device product defects
, but did not act right away. An FDA investigation alleges that for years, Philips knew about the health risks associated with its sleep aid devices but didn’t do anything about it.
Defective Medical Devices
Defective medical devices have the potential to cause serious health complications. While sleep apnea machines are for external use, there are a number of medical devices that are implanted. When such devices fail, individuals are forced to undergo additional, unnecessary surgeries and bear related expenses. Manufacturers of medical devices have the responsibility and legal obligation to make devices that are safe for consumers many of whom already have health vulnerabilities. If you or a loved one has developed cancer as the result of one of these sleep apnea machines or has suffered adverse health effects as a result of other defective medical devices, you may be able to seek compensation for your injuries, damages, and losses. An experienced product defect lawyer can help you pursue maximum compensation for the losses you have endured. Source: https://www.nbcchicago.com/consumer/fda-124-suspected-deaths-tied-to-recalled-sleep-aid-devices/2839977/