Since a few months before the June 2021 recall, the FDA has been collecting Medical Device Reports (MDRs) linking Philips recalled devices-- DreamStation, CPAP, BiPAP and mechanical ventilators-- to serious injuries, from coughs to cancers. Submitting MDRs to the FDA is mandatory for medical device manufacturers – to document and detail adverse events and product problems. Voluntary MDRs regarding serious adverse events associated with a medical device can also be submitted by healthcare professionals, patients, caregivers and consumers.
CPAP Injury Reports
During the first 18 months post-recall, more than 90,000 MDRs were submitted to Philips or federal health officials. Then complaints began to decrease until a spike this month, likely spurred by the statute of limitations. As well this month, the FDA updated its June 2021 safety communication, adding over 6,000 complaints from the first three months of 2023, including 40 patient deaths. The FDA and Philips, however, pointed out that MDRs are unvetted complaints, and the injuries they report may not have been directly caused by a recalled machine.
In this latest announcement, the FDA stated that the 6,000 new figures bring the total number of MDRs to 105,000, with 385 reports of death. This number includes mandatory reports from Philips and voluntary reports, reporting a swath of injuries including pneumonia, asthma, dyspnea (difficulty breathing), cancer, lymphoma, lung damage and other injuries linked to the toxic chemicals and gasses released as the sound abatement foam.
CPAP Deadline
Those injured by recalled Philips devices should be aware – and notified by Philips--that a deadline is looming for filing a CPAP lawsuit. The Statute Of Limitations (SOL) applies for most product liability lawsuits, including CPAP lawsuits.
The SOL varies by state but is generally from two to six years. Product liability claims typically begin as soon as an injury was caused by the product. Many states, however, have a discovery rule, which adds more time to file a claim based on when the plaintiff knew or should have known a cause of action exists.
For instance, under California product liability law, the product liability statute of limitations is two years from the time the injured party knew or should have known of their injuries, so that deadline could be June 14, 2023. In Florida, a complaint must be filed within four years from the time when the injury is or should have been discovered. And the Sunshine State has enacted a 12-year statute of repose, which bars actions that are not brought within a specified period of time after some event has occurred, such as the initial sale of a product.
Another factor affecting the SOL is the tolling agreement. In early 2021, just before the first year’s anniversary of the recall, the parties agreed to a private tolling agreement that could be utilized by a plaintiff or plaintiff’s counsel while deciding whether to pursue a lawsuit for personal injuries, wrongful death or economic damages.
Before filing a complaint, it is imperative that you know these dates:
- When you last used the recalled Philips CPAP machine
- When you became aware the Philips CPAP machine may have caused your injury
- When you were diagnosed with an injury
- The statute of limitations laws in the state where the Philips CPAP machine was purchased and/or used
READ MORE CPAP LUNG CANCER LEGAL NEWS
Lawyers are still reviewing CPAP complaints by individuals who have experienced adverse health issues they believe are associated with the toxic foam found in Philips’ sleep machines.