Keith Meyers
6 years ago
The U.S. Food and Drug Administration (FDA) is intensifying its caution regarding Philips Respironics devices used for treating obstructive sleep apnea, stating that the products “might result in severe injuries or fatalities.” In June 2021, Philips recalled over 5 million continuous positive airway pressure (CPAP) machines because noise-reducing foam within the units was disintegrating […]
Philips CPAP Lawsuits
The U.S. Food and Drug Administration (FDA) is intensifying its caution regarding Philips Respironics devices used for treating obstructive sleep apnea, stating that the products “might result in severe injuries or fatalities.”
In June 2021, Philips recalled over 5 million continuous positive airway pressure (CPAP) machines because noise-reducing foam within the units was disintegrating and entering users’ mouths. Breathing in the foam could lead to “severe injury that could be life-threatening,” according to Philips’ recall announcement at the time.
Philips attempted to repair some devices, but the fixed machines have also been recalled, as reported by the FDA.
The FDA classified this as a Class I recall, the most severe kind, when it issued a new alert about the devices on Friday. When Philips reprogrammed the repaired CPAP machines, they were assigned incorrect or duplicate serial numbers, the FDA explained.
The mistake may cause the devices to provide incorrect prescriptions to sleep apnea patients or fail to offer any therapeutic benefits, according to the FDA. This could result in respiratory or heart failure, officials warned. Philips has received 43 complaints about the repaired devices, but no injuries or deaths have been reported.
“Wrong therapy or therapy failure could lead to multiple health issues, such as respiratory failure, heart failure, severe injury, and death,” the FDA stated.
On Friday, Philips confirmed that some of the repaired CPAP devices were not functioning correctly, disclosing that “a limited number (1,200) of fixed first-generation DreamStation CPAP devices was allegedly incorrectly programmed with either a wrong serial number or a duplicate serial number.”
Philips also mentioned that it had identified the machines potentially delivering faulty prescriptions and is alerting patients so the devices can be replaced.
“We have shipped over half of the replacement devices to patients,” the company stated.
The 2021 recall affected 20 different Philips devices, including the A-Series BiPAP ventilators and DreamStation CPAP machines. Last December, the company also recalled its Trilogy 100 and 200 style ventilators.
Around 30 million people in the U.S. have sleep apnea, a condition in which airways become obstructed during sleep, disrupting breathing, based on 2022 data from the American Medical Association.
Since April 2021, the FDA stated that the agency had received more than 98,000 customer complaints about the original Philips recall. Some complaints mentioned associations between the devices and cancer, respiratory issues, pneumonia, chest pain, dizziness, and infections. By the end of 2022, the FDA had received reports of 346 deaths linked to claims about the foam issues, according to the agency.
Numerous sleep apnea patients have filed lawsuits against Philips concerning the CPAP machines. Carrie Markham from Florida, one such patient, is suing because she has not received a replacement in two years. Ms. Markham informed CBS Orlando last month that she learned about the recall on Facebook instead of a company notification.
In a February statement, Philips said it tested its devices and found “no conclusive data connecting these medical devices and the deaths reported” by the U.S. FDA. The company conducted additional tests after the recall and discovered no link between its devices and cancer.
Amid its recall of over 5 million sleep apnea devices and ventilators, Philips has sent “significantly fewer” replacement or repaired devices to customers than the 2.46 million listed on its website, according to an FDA notice on Thursday.
The discrepancy is partly due to Philips’ number including internally shipped repair kits for its repair facilities, the agency explained.
“We are worried this might affect the estimated wait time for consumers still waiting for a replacement device,” the FDA said, urging patients to contact Philips for an update on their replacement device.
Philips began recalling the devices in 2021 because of the risk of soundproofing foam breaking down and being inhaled by patients. Since then, patients have experienced long waits for sleep apnea devices.
Philips spokesperson Steve Klink said in an email statement that the company is “investigating how to best address the FDA’s concern.”
Up to now, the company has reported the number of replacement devices and repair kits produced and shipped to their destination countries, which means not all of them are in patients’ hands yet, Klink explained. Approximately 2.2 million devices have been fixed and sent to patients in the U.S. In December, Philips announced that it was on track to complete production for 90% of replacement devices by the end of the year.
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