June 2021 Phillips Safety RecallPhilips issued a voluntary recall notification for more than a dozen models of CPAP and BiPAP breathing machines on June 14, 2021, after receiving several complaints about the presence of the black particles within a device's air pathway. The company warned that the particles come from foam used in the construction of the CPAP, BiPAP, and ventilator devices included in the recall. Specifically, Philips uses polyester-based polyurethane (PE-PUR) foam to reduce sounds and vibration during CPAP use. Users risk inhaling or swallowing PE-PUR if it breaks down into particles. The foam also releases chemicals into the device's air pathway, which users might inhale. Additionally, high heat and humidity and unapproved cleaning methods can speed up foam degradation, putting users at greater risk for illness. The results of ingesting or inhaling PE-PUR can lead to life-threatening injuries, some of which could cause permanent damage.
Machines Included in the Philips CPAP RecallPhilips recalled various continuous and non-continuous CPAP and BiPAP devices. If you used any of the following devices, you might qualify to join the Philips CPAP lawsuit:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Medical Complications and Diagnoses from Philips CPAP UseBefore their voluntary safety recall, Philips received reports of headaches, upper airway irritation, persistent coughing, chest pressure, and sinus infections. The U.S. Food and Drug Administration (FDA) warns of potential risks associated with particulate and chemical exposure from PE-PUR foam. They include:
- Irritation to skin, eyes, nose, and respiratory tract
- Inflammatory response
- Carcinogenic effects
- Acute Respiratory Distress Syndrome
- Chronic bronchitis
- Organ damage or disease in the lungs, liver, or kidneys
- Chronic migraines
Costs of Adverse Health ConsequencesThe diagnosis of a severe condition, illness, or disease comes with various economic and non-economic costs that devastate victims and their families. Medical expenses and lost wages are typically the most common costs involved with medical devices, but other costs also impact people. For example, Philips CPAP users diagnosed with chronic conditions such as asthma or COPD have lifelong medical expenses, including doctor visits, inhalers, oxygen, etc. Some conditions prevent people from engaging in the same activities they did before Philips made them ill. They might need domestic help with cooking, cleaning, yard work, snow removal, and other things to maintain a household. Their condition can also impact their ability to do certain activities with their family and friends, effectively reducing the quality of their life. Illness and disease also affect mental health and relationships inside and outside the bedroom. An attorney can review your case and help you seek compensation for the costs you've incurred because of using a Philips CPAP device.
Basis of Philips CPAP LawsuitsThe Philips CPAP recall prompted CPAP lawyers across the country to file lawsuits on behalf of people who used the company's devices and suffered adverse health effects. In October 2021, all lawsuits against Philips were consolidated into one court, referred to as multi-district litigation (MDL). As of May 2022, the MDL includes 274 cases in the U.S. District Court, Western District of Pennsylvania, but the number of lawsuits may grow. Although Philips wanted the cases consolidated in Massachusetts, the home of their headquarters, Pennsylvania, was the ultimate choice. The CPAP machines in this recall were manufactured in Pennsylvania, and Philips RS North America LLC also makes its home in Pennsylvania. Evidence shows that Philips was fully aware of the defects in their machines related to the PE-PUR foam and did not warn customers about the risks. Additionally, the company acknowledged that the PE-PUR foam releases toxic chemicals, including:
- Toluene Diamine
- Toluene Diisocyanate
- Diethylene Glycol
How Long Do I Have to File a Phillips CPAP Recall Lawsuit?In most product liability cases, victims have two or more years to file a personal injury lawsuit to seek compensation, depending on the state where they file the lawsuit. The Philips MDL falls under Pennsylvania law, so the state's two-year statute of limitations likely applies. However, if you do not live in Pennsylvania, your state's statute of limitations could impact the deadline. The statute of limitations time clock likely began on June 14, 2021, when Philips announced their voluntary CPAP recall. Your deadline for filing a lawsuit could be June 14, 2023, if you live in a state with a two-year personal injury statute of limitations. It's best to contact an experienced product liability lawyer as soon as possible to discuss your case regardless of the time. The law allows for some exceptions in rare circumstances. An attorney can evaluate your situation to see if it warrants an exception, so do not assume you will not qualify to join the lawsuit based on time concerns.
FDA Inspection Report FindingsAfter Philips announced their CPAP and BiPAP recall, the FDA investigated the recall. They concluded their Philips Respironics facility investigation in Murrysville, Pennsylvania, and issued a report in late 2021. Their investigation revealed:
Inadequate Risk AnalysisThe FDA report revealed that Philips did not investigate or perform any analysis to determine which devices to recall. Additionally, Philips did not perform risk analysis when they became aware of the polyester-based polyurethane (PE-PUR) foam degradation or toxic emissions. The FDA found evidence of testing in January 2019 that showed Philips' popular DreamStation 1 device failed emissions testing and had toxic levels of a formaldehyde compound during initial operation.
Failure to Implement Corrective ActionsFDA investigators found that Philips did not initiate, perform, or document any corrective or preventive actions concerning their defective CPAP and BiPAP machines. The company received more than 222,000 complaints between 2008 and 2017 and did nothing.
Failure to Ensure the Devices Conformed to User Needs and Intended UseUser manuals for defective ventilators recommend using a bacterial filter when multiple patients use the device, typically in a hospital or nursing home setting. The filter catches debris released into the device's airpath, but Phillips did force users to conform to this procedure in their design.
Failure to Establish Adequate Design ChangesAccording to the FDA, Philips failed to verify, review, or validate a preventative maintenance procedure, the replacement component, or the time frame to replace the component. More simply, they made and implemented design changes to defective devices without double-checking them.
Failure to Report Correction or Removal of Devices to FDAPhilips received several complaints about devices and failures caused by PE-PUR foam degradation and found the foam was toxic and carcinogenic. Yet, they did not file a written report with the FDA.
Failure of Executive Management to Take ActionPhilips executive management has known about potential foam degradation issues with their CPAP, BiPAP, and Trilogy ventilators since at least January 2020. They did not take any corrective action until April 2021. Philips management needed to make the company's quality policy understood, implemented, and maintained at all organizational levels.
Failure to Adequately Establish Procedures to Ensure Products Conformed to Specified RequirementsFDA investigators found that Philips had no data, documents, or written agreements that clearly described or referenced quality requirements. This failure is related to material sourcing. The FDA report expects that Philips should have procedures that protect them from using poor-quality materials in their devices.
Failure to Adequately Evaluate SuppliersFDA findings showed that Philips hired consultants and suppliers without fully evaluating them. They also did not base their selection on the supplier's ability to meet specified requirements or provide safe materials for their devices.
How Much Compensation Could I Receive for a Philips CPAP Lawsuit?It's far too early to determine settlement amounts for Philips CPAP recall lawsuits. Additionally, many factors contribute to the amount an individual might receive. As a general rule of thumb, those suffering the worst health outcomes typically receive the most compensation in these cases. For example, someone diagnosed with terminal cancer because they used a Philips CPAP machine will likely receive far more compensation than someone who now suffers from something treatable, like asthma. Types of damages you could receive include compensation for:
- Medical expenses
- Estimated future medical treatment costs
- Lost wages
- Estimated lost future wages
- Pain and suffering
- Other economic and non-economic losses
What Do I Do to Join the Philips CPAP Recall Lawsuit?You must prove that you used one of the recalled Philips CPAP or BiPAP devices and submit medical documentation to prove the adverse health consequences you suffered and their relation to the defective device. Your first step to holding Philips accountable and joining the lawsuit is to contact an experienced medical device lawyer. An attorney can ensure you submit all the correct documents and meet deadlines so you do not miss out on the chance to recover compensation.
Will I Have to Testify in Court for a Philips CPAP Lawsuit?It's highly unlikely you will have to go to court or testify to recover compensation from Philips if you have a viable claim against them for using one of their CPAP devices. As mentioned above, an MDL consolidated lawsuits against Philips. This means that most plaintiffs will not need to appear in court to receive compensation. You might have to testify if you have a high-value claim or a case that vastly differs from other plaintiffs. Your experienced medical device lawyer can review your case and advise you if you might have to go to court.
Can I Afford a Lawyer to Represent Me in a Philips CPAP Lawsuit?Yes, you can afford a lawyer if you suffered adverse health consequences from using a Philips CPAP device. You do not need to pay an upfront retainer fee like you would for a criminal attorney or tax lawyer. Instead, your attorney will diligently pursue the best outcome possible for your situation. If they recover settlement money for you, they deduct attorney fees and other legal costs from the settlement. Contact Dolman Law Group for a free consultation today.