The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their healthcare providers that recalled certain such defective medical devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these machines, may break down, potentially enter the device’s air pathway, and may be inhaled or swallowed by the person using the device. PE-PUR can also release toxic and even carcinogenic chemicals, including volatile organic compounds (VOCs) such as Diethylene glycol, Toluene Diisocyanate, Toluene Diamine, and Phenol Dimethyl Diazine.
The resulting medical issues from this toxic exposure can result in serious physical injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent a wrongful death. Philips’ urgent recall notice can be viewed here. The voluntary recall announcement issued in June 2021 is a follow-up to a previous notification from April 2021.
The affected defective medical devices include the following:
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use (E30)
- Continuous Ventilator, Non-life Supporting (DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, and OmniLab Advanced+)
- Noncontinuous Ventilator (SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto)
- Continuous Ventilator (Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent)
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use (A-Series BiPAP Hybrid A30 (not marketed in US) and A-Series BiPAP V30 Auto)
- Continuous Ventilator, Non-life Supporting (A-Series BiPAP A40 and A-Series BiPAP A30)
Philips estimates that three to four million devices may be affected, the majority of which are first-generation DreamStation products sold before April 2021. According to the recall notice, if you currently use the recalled CPAP and Bi-level PAP machines, you should stop immediately and speak to your doctor about alternatives. If you use one of the recalled ventilators, consult with your physician before making any changes.
Philips has known about problems with the recalled machines for years; however, the company left patients and consumers in danger while allegedly concealing this information. The reason? The company sought to delay announcing its recall until a new version of the machines could introduced, allowing the company to maintain its market share and profits.
What Injuries Can Defective Philips Ventilators, BiPAP, and CPAP Machines Cause?
Law firms across the country, including the experienced defective medical device attorneys of Dax F. Garza, P.C., are looking at all serious respiratory issues (asthma, fibrosis, lung cancer, any other restrictive lung disease), non-lung cancers, and the items identified in the recall safety information, which include:
- The presence of black debris/particles within the device’s air pathway
- Irritation in the eyes, nose, respiratory tract, and skin
- Toxic and carcinogenic effects to lung, liver, kidneys (cancer as well as lung, liver or kidney disease)
- Myocardial infarction
- Respiratory arrest
- Inflammatory response
- Kidney damage
- Liver damage
- Cancer diagnosis
Patients who have suffered any of these symptoms, including lung injury or cancer, after using a Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), or mechanical ventilator device may be eligible for financial compensation and should seek legal assistance immediately as time limitations apply to all products liability claims. The first lawsuit has already been filed.
Victims of Philips’ recalled sleep apnea devices may be able to recover the following damages:
- Medical expenses, including for hospital stays, doctor’s appointments, medications, and new devices to replace the defective ones
- Lost wages from having to miss work due to your injuries
- Loss of future earnings if the recalled device caused you to be too sick to work in the future
- Pain and suffering
- In cases that go to trial, the court or jury may also award punitive damages if it is found that Philips acted with reckless disregard for the effects of its actions
Nationwide Mass Tort Lawyers
Defective medical device lawsuits are covered under a law known as products liability that protects consumers from devices with design defects, manufacturing defects, or a failure by the manufacturer to properly warn about the dangers of their devices. Defective devices in the medical field cause at least 22,000 deaths each year according to the U.S. Consumer Product Safety Commission. When the law identifies a device as defective, a statute of limitations is often issued as well, meaning patients who were injured or killed only have a certain amount of time in which to file a claim.
Dax F. Garza has handled thousands of mass tort claims for those injured or killed by defective medical devices like these and by dangerous drugs. While headquartered in Texas, the firm has successfully resolved cases for victims across the country, garnering millions of dollars for those in need and bringing justice by holding negligent manufacturers responsible for their actions. Mr. Garza has represented victims across the state of Texas and the country as lead trial counsel in wrongful death, personal injury, defective product, and pharmaceutical litigation. If you or someone you care about was injured or killed by a defective sleep apnea machine, ventilator, or other such device, contact us today for a free, no obligation consultation with our experienced team.