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PHILIPS CPAP RECALL

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The U.S. Food and Drug Administration (FDA) has issued a recall alert for up to 4 million Philips Respironics ventilators, BiPAP, and Philips CPAP machines due to potential serious health risks. The Philips devices have polyester-based polyurethane (PE-PUR) sound abatement foam (used to reduce sound and vibration) which may allegedly break down and enter the device’s air pathway, leading to potential foam and chemicals inhaled or swallowed by people using the device.

The affected Philips devices were distributed from July 2009 to April 2021, many of them sold in the United States. A majority of the recalled products are the Philips DreamStation machines, as well as the following machines:

  • A-Series BiPAP A30 (mechanical ventilator – continuous – non-life supporting)
  • A-Series BiPAP A40 (mechanical ventilator – continuous – non-life supporting)
  • A-Series BiPAP Hybrid A30 (mechanical ventilator – continuous – minimum ventilatory support – facility use)
  • A-Series BiPAP V30 AutoVentilator (mechanical ventilator – continuous – minimum ventilatory support – facility use)
  • C Series ASV, S/T, AVAPS (continuous ventilator, non-life supporting)
  • Dorma 400, 500 CPAP (non-continuous ventilator)
  • DreamStation ASV (continuous ventilator, non-life supporting)
  • DreamStation CPAP, Auto CPAP, BiPAP (non-continuous ventilator)
  • DreamStation Go CPAP, APAP (non-continuous ventilator)
  • DreamStation ST, AVAPS (continuous ventilator, non-life supporting)
  • E30 (under emergency use authorization – continuous ventilator, minimum ventilatory support, facility use)
  • Garbin Plus, Aeris, LifeVent Ventilator (mechanical ventilator – continuous)
  • OmniLab Advanced Plus In-Lab Titration Device (continuous ventilator, non-life supporting)
  • REMStar SE AutoCPAP (non-continuous ventilator)
  • SystemOne ASV4 (continuous ventilator, non-life supporting)
  • SystemOne Q series (non-continuous ventilator)
  • Trilogy 100Ventilator (mechanical ventilator – continuous)
  • Trilogy 200Ventilator (mechanical ventilator – continuous)

The Lyon Firm has years of experience in filing medical device recall lawsuits and works on behalf of injured plaintiffs nationwide to reach quick settlements and rightful compensation.

Philips CPAP lawsuit 

Complaints have already been filed against Philips on behalf of injured plaintiffs nationwide. In June 2021, Philips issued a recall notification for certain ventilators. In the Philips CPAP recall notification, the company advised of potential personal health risks related to exposure to degraded sound abatement foam particles and exposure to chemical emissions from the foam material.

Philips notified patients of health risks that may include headache, irritation, inflammation, respiratory issues, and possible toxic reactions and carcinogenic effects. The Lyon Firm is reviewing cases where patients used a recalled Philips CPAP device or ventilator and was later diagnosed with any of the following conditions:

  • Acute inhalation injury
  • Autoimmune disorders
  • Cancer
  • Chronic asthma
  • Chronic bronchitis
  • COPD
  • Emphysema
  • Heart failure
  • Interstitial lung disease
  • Kidney disease
  • Leukemia
  • Liver disease
  • Lung cancer
  • Lymphoma
  • Pneumonia
  • Pneumoconiosis
  • Pulmonary fibrosis
  • Sarcoidosis
  • Stroke

Philips CPAP Recall

The Philips CPAP recall notification advises patients discontinue the use of affected units and consult with physicians to determine potential risks and alternative therapy. Patients using life-sustaining mechanical ventilator devices should not discontinue the use of a machine without consulting physicians first.

Contact The Lyon Firm to review your unique case. We offer free, confidential case reviews, and take pride in representing plaintiffs who are injured by defective or unsafe medical devices on the market.

 Can I file a CPAP injury claim?

If you or a loved one have used a Philips CPAP, APAP, BiPAP or ventilator and suffered from a qualifying condition listed above, contact The Lyon Firm to review your case. Affected individuals may qualify for damages that can include:

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

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ABOUT THE LYON FIRM

Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

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Why are these cases important?

Many medical device recall cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove faulty devices and change designs and warnings as a result of litigation.

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Questions about the Philips CPAP Recall Litigation

What Philips sleep apnea devices have been recalled?

On June 14, 2021, Philips recalled four million of the following CPAP, BiLevel PAP, and mechanical ventilator devices:

  • A-Series BiPAP A30
  • A-Series BiPAP A40
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 AutoVentilator
  • C Series ASV, S/T, AVAPS
  • Dorma 400, 500 CPAP
  • DreamStation ASV
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation Go CPAP, APAP
  • DreamStation ST, AVAPS
  • E30
  • Garbin Plus, Aeris, LifeVent Ventilator
  • OmniLab Advanced Plus In-Lab Titration Device
  • REMStar SE AutoCPAP
  • SystemOne ASV4
  • SystemOne Q series
  • Trilogy 100Ventilator
  • Trilogy 200Ventilator
Why were the devices recalled?

The Philips CPAP, Bi-PAP, and mechanical ventilator devices contain sound abatement foam liners that can degrade into dangerous particles and chemicals that may be inhaled or ingested. The Philips devices contain no filter to prevent these sorts of issues. Lawyers have warned that the recalled Philips devices are allegedly unreasonably defective products that are dangerous and pose a risk of injury and cancer.

What injuries can a recalled Philips CPAP device cause?

The recalled Philips CPAP device, Bi-Level PAP, and ventilator devices can potentially result in lung injury, toxic exposure, pulmonary fibrosis, liver or kidney injury, and possibly cancer.

Who is liable for medical device injuries?

Medical device lawsuits often contain causes of action for strict liability, negligence, and breach of warranty. Strict liability applies to different factors than negligence-based claims.

In negligence cases, the actions of the defendant are the focus. In strict liability claims, the focus is on the condition of a product at the time it left the manufacturer. If a product is determined to be defective, the company is liable for any foreseeable injuries that are in-part caused by the defective condition of the product.

How is a Medical Device Defined as Defective?
Ohio Definition of Defective

A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:

(1)  Manufacturing/ Construction Defect:

These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).

As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.

(2) Defective design and/or formulation:

Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.

Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)

(3) Failure to warn or inadequate warning or instruction associated with the product:

All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.

Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.

(4) Misrepresentation:

The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.

The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.

Consumer Safety Lawsuits
Watch our Video About the Legal Process

Defective medical devices on the market present safety and health hazards for adults and children. Cheap and defective products may pose severe health risks. The manufacturers of medical devices have a duty to foresee potential injury and properly design and test products before they are released.

Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in illness and injury can lead to lawsuits filed by plaintiffs and a product liability lawyer.

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