CPAP Recall Lawyers

Personal injury attorneys can navigate legal action against defective device harms.

Philips Respironics Recall.

Individuals who are at risk of physical harm, through the use of one of several Philips Respironics ventilators, BiPAP, or CPAP machines should read the recent warning issued by the U.S. Food and Drug Administration (FDA), alerting people and their health care providers that Philips Respironics has recalled certain devices due to potential health risks of inhaling, or swallowing a polyester-based polyurethane (PE-PUR) substance which was used to reduce the sound in certain device models.  The sound-abatement foam may break down into tiny particles that can enter the air pathway and become inhaled, or ingested.  The foam also has the potential to “off-gas” chemicals which may be toxic.  Off-gas refers to a gas that is produced as a by-product of an industrial process, or given off by some manufactured material.  Off-gases may occur based on a user’s method of cleaning the Philips device.  High heat and high humidity environments also may contribute to foam degradation.

If you, or a loved one are using one of the affected devices listed on the report of recall, talk to your doctor, and make any recommended adjustments to your treatment.  Depending on the harms to your  health, it may also be prudent to consult with a defective device attorney who can explain when legal action is warranted.

Defective devices.

Medical device injuries can lead to a manufacturer vigorously defending any negative litigation to maintain company value. Part of that effort is to recall defective devices and repair, or replace the harmful component, or device.  It is important to speak with a lawyer who has experience with product liability laws addressing the three main types of device defects.  Products may result in harm due to design, manufacture, or marketing defects.

  • Design. A device could malfunction because it was designed incorrectly, or there were problems at the design stage that were not addressed before the product was manufactured and made available to consumers.
  • A device may have been designed with no defects, but during the manufacture process, or assembly of a device, a mistake that causes a malfunction during proper use may be identified, but not corrected.
  • Marketing defects usually involve a failure to warm of possible dangers, false claims related to a certain device, or inaccurate warning labels.

A product is considered defective if it poses unreasonable dangers to individuals who purchase and utilize it in accordance with the directions and warnings provided.  Lawsuits for medical device defects can be built individually, or as part of a class-action lawsuit, when many individuals have suffered harms by the use of a device.

Warning underway by company.

Once the Philips company discovered that the foam used in the specified machines can deteriorate and project tiny particles into a user’s airway, the company issued a recall.  Individuals should contact health care providers and enquire about their particular unit by providing the serial number.  They should also report any side effects that can stem from simple headaches, acute and chronic respiratory problems, and risks of cancer.

  • Consumers have found black debris in breathing tubes and have reported feeling sick with symptoms such as headache, inflammation, breathing problems, irritation, nausea, and other potential toxic effects. Inhalation of toxic chemicals may also increase the risk of cancer.

Consumer actions.

Once a consumer has established that their Philips device is listed on the recall notice, they should register their device(s) on the recall website at www.philips.com/src-update. Information is provided on the website regarding the recall status and how to receive corrective action.  Consumers will need to identify their device Serial Number to register.  In the event the user chooses not to use the website to register their unit, they can call 1-877-907-7508. Philips is implementing a permanent corrective action to address the issues described in the recall notice.

Drawbacks to legal action.

Defective device lawsuits can be drawn out, costly, time consuming and stressful for victims who have suffered personal injury harms related to a product defect, or defective medical device.  Many legal actions consider that consumers are owed a specific duty by manufacturers and strict liability laws allow harmed individuals to sue a manufacturer, or seller of a defective device.  Madalon Law has cultivated relationships with judges, regional attorneys, court administration and potential case experts supporting effective movement of defective device litigation and its harmful effects on consumers.  A competent lawyer can recover necessary damages in the best interests of their clients.

Negligence.

Negligence laws are established at the state level, and claims must be proven to warrant damage awards.  Personal injury lawsuits for defective and dangerous products are often more complex because manufacturers are liable under different legal principles.  People who have suffered 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 compensation and should seek legal assistance.  If a consumer unknowingly purchases a defective product and is harmed by the recommended use of the product, they may file a product liability lawsuit against any responsible party.  In the case of a medical device, dangers may include severe harmful, and life-threatening outcomes.

Stream of commerce.

The stream of commerce theory references the principle that individuals who participate in placing a defective product in the general marketplace should be held strictly liable for harm caused by the product.  Identifying responsible parties to a defective product case will require research to determine what step in the process led to the negative outcomes.  The list of possible negligent parties includes the manufacturer of a product; the manufacturer of an integral part, or ingredient used in the manufacture of the product; companies who assemble, or install a product; wholesalers; advertisers; and retailers of the product.  Since multiple parties may be responsible for the malfunction of a defective device, legal action can be initiated against any, or all parties, including medical personnel if they are involved in the directed use of a defective medical device.

Defective medical device litigation.

Defective medical device claims can be initiated regarding failed devices asserting product liability, breach of warranty, or strict negligence.  Medical device manufactures can be sued for:

  • Failure to warn. Lack of transparency regarding possible side effects that manufacture was, or should have been aware of.
  • Reasonable design and manufacture of a product upholding owed duty of care to consumer did not occur.
  • Breach of warranty. Product fails to live up to manufacturer, or seller statements regarding the value  of a medical device.

It is important to have the guidance of legal counsel and lawsuits for defective medical devices may require a plethora of witnesses and scientific evidence supporting defects in a device to prove negligence.  Madalon Law can assist injured parties with a potential defective device claim and comprehensive damage award/settlement.

Madalon Law 

Call (877) 486-2883 for a Free Consultation.

Sources:

Philips issues Dreamstation CPAP recall notification | AASM

 

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

 

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

 

https://www.fda.gov/medical-devices/medical-device-safety