FDA Still Collecting Injury Reports From Recalled CPAP Devices Two Years Later
Two years ago, while Americans were hoping the U.S. government would announce the end of the pandemic and their lives could return to normal, thousands of doctors and their patients were hit with an announcement of a different sort – devastating news from the Dutch healthcare company Royal Philips, known in the U.S. as Philips Respironics.
On June 14, 2021, Philips Respironics announced a major recall of some of its Philips Respironics ventilator, BiPAP and CPAP machines. The makers had discovered the foam used to reduce the noise of the motor in the devices could disintegrate and release debris and chemicals into the air hoses, causing a toxic situation for users.
Since the CPAP recall, countless patients have struggled to make sure the machines they were using were either not affected or, in many cases, relied on Philips, who was responsible for fixing millions of devices through a repair and replacement program.
Early on in the CPAP recall, officials at Philips promised they would take swift action, assuring users would be able to continue to depend on their equipment. However, in the last 24 months, Philips has struggled to keep up with the demand for replacing the machines. Although in June of 2023, Philips reported that it is nearing completion of its replacement program, the FDA released updated figures on the number of complaints the agency has received concerning Philips’ machines.
The FDA has been collecting medical device reports (MDRs) regarding Philips recalled devices since April 2021, and the number of serious injuries continues to rise. Manufacturers like Philips must submit MDRs to the FDA for adverse events and product problems with medical devices. Healthcare professionals, patients, caregivers and consumers can also submit voluntary MDRs about serious adverse events associated with a medical device.
In the June 2 FDA announcement, the agency reported that in the first three months of 2023, more than 6,000 complaints were sent by users to the agency, with 40 reports of death. The new figures bring the total number of MDRs to 105,000, with 385 reports of death. This includes mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.
However, recently officials at Philips have expressed disagreement with the FDA’s reporting of the MDRs. The company contends that the majority of the MDRs are not current. And in this current cycle, according to Philips, the majority of MDRs go back months – to January and February. Philips attributed 4,800 MDRs to reports filed in January and February, with only 1,200 in March.
After the FDA reported the last round of MDRs, Philips stressed that while the MDRs are used for an official government log, they are unvetted complaints. There is no definite link between the devices and the deaths reported. The company instead described the MDRs as including “alleged malfunctions that do not involve reported serious injury or death.”
Deadlines For Filing CPAP Lawsuits
Despite the disagreement between Philips and the FDA, the increasing number of MDRs shows that thousands of victims of the recalled breathing machines are just now taking action, and many may deserve compensation from the manufacturer for their injuries.
Those injured by recalled Philips devices must understand that time may be running out if they have not yet filed a CPAP lawsuit.
There is a statute of limitations for product liability lawsuits, such as the CPAP lawsuits. In some states, the statute of limitations is two years when filing a product liability claim. In other states, people have more time. The two-year deadline for some CPAP lawsuits could be June 14, 2023. This means those who have yet to file a claim and still plan to, time is imminent.
Individuals who have sustained injuries caused by one of the recalled Philips machines should consider hiring a CPAP attorney with expertise in product liability claims to move forward quickly. A CPAP attorney will help you determine the statute of limitations for filing a CPAP lawsuit, ensure all pertinent information is collected, and follow through on documentation of the diagnosis of the illness or injury.
It is important to remember those responsible for the damage caused by faulty products should be held accountable to provide victims the compensation they deserve and protect future users of Philips machines.
