Many patients with breathing issues use CPAP and BiPAP ventilators to treat their illnesses. But on June 30th, 2021, the U.S. FDA issued an alert to the public that the Philips Respironics BiPAP and CPAP ventilators have been recalled due to potential health risks. Since the recall, many are claiming injuries from the devices and are filing multiple lawsuits. Will these lawsuits result in a mass tort? Read on to find out more:

What are CPAP and BiPAP?

CPAP and BiPAP are ventilators that many patients use to treat various types of breathing-related illnesses. Patients with sleep apnea use CPAP machines. Sleep apnea is a breathing disorder where a person can randomly stop breathing on and off while sleeping, causing the person to snore very loudly.  CPAP stands for continuous positive airway pressure that has an adjustable pressure setting. BiPAP is another form of positive airway pressure therapy that is bi-level and has two pressure settings (IPAP and EPAP). Both machines are portable and generate pressured air to open and support the airway during sleep via a hose, mask, and other accessories.

Why Were They Recalled?

The recall is due to a special material that manufacturers use to make these machines called a PE-PUR (polyester-based polyurethane). This material can break down into particles that the user may ingest or inhale and cause serious harm. There is no filter on the machines to prevent this. PE-PUR can also give off toxic and carcinogenic chemicals from use which the user ultimately breathes indirectly. The following are the side effects and injuries that can develop:

  • Increase the risk of cancer
  • Increase the risk of pulmonary fibrosis
  • Organ damage
  • Headaches
  • Irritation
  • Inflammation
  • Vomiting/Nausea
  • hypersensitivity
  • Respiratory issues
  • Exposure to toxic materials

Is There a Lawsuit?

Following a recall, there are usually many that will file lawsuits due to claims of injuries. Since the recall, many are filing lawsuits against multiple manufacturers for various injuries. The following manufacturers involved include:

  • Koninklijke Philips N.V.
  • Philips North America LLC
  • Philips RS North America LLC

These lawsuits are looking for compensation due to injuries including:

  • Medical expenses
  • Lost wages
  • Loss of future earnings
  • Pain and suffering
  • Punitive Damages

On June 29, 2021, a class-action lawsuit was filed in federal court in Massachusetts: Shelton v. Koninklijke Philips N.V., et al., No. 1:21-cv-11076 (D. Mass.). As of now, there is no multi-district litigation (MDL) for the CPAP and BiPAP lawsuits because it is in the early stages. Additionally, we can potentially expect the cases to be consolidated into a federal MDL within the next year as there is already a request for the lawsuits to be combined into an MDL. There are many claims against the manufacturers such as:

  • Defective design
  • Failure to warn
  • Manufacturing defect
  • Negligence