'Inadequate' effort criticized by Food and Drug Administration
The Food and Drug Administration recently ordered the maker of a popular brand of CPAP and BiPAP breathing machines to notify customers of the company's voluntary recall over potential health risks.
In March, the FDA commanded Philips Respironics to step up efforts to share information about the recall with people who bought, sold, manufactured, transported, or are otherwise involved with the devices. So far, they say, Philips' efforts have been "inadequate."
The defective CPAP and BiPAP (continuous or bilevel positive airway pressure) devices were supposed to help alleviate restricted or obstructed breathing due to sleep apnea, chronic obstructive pulmonary disease (COPD), and emphysema, among other breathing problems. The machines work by providing a constant stream of air directly to the person by way of a mask and tube.
However, for some people, the Philips machines may have been doing more harm than good.
It turns out the polyester-based polyurethane foam (PE-PUR) used to reduce the machine's volume can deteriorate over time. It can break down into small, possibly-cancer-causing particles that are then inhaled by the user.
Illnesses that studies have linked to PE-PUR foam in CPAPs include bladder cancer, brain cancer, breast cancer, kidney cancer, leukemia, hematopoietic cancer, nasal cancer, multiple myeloma, lung cancer, rectal cancer, stomach cancer, thyroid cancer, and testicular cancer, among other diseases. Kidney disease requiring dialysis has also been linked with the material.
FDA order
The FDA's notice to Philips comes nine months after the company began its voluntary recall of specific CPAP and BiPAP products.
"This order is necessary to eliminate the unreasonable risk of harm posed by the recalled products," the FDA says, "because the company's notification efforts to date have been inadequate."
Under the Federal Food, Drug, and Cosmetic Act, because the FDA has determined the devices pose an unreasonable risk to human health, Philips is required to recall the equipment. They then must alert people who purchased, manufactured, distributed, sold, recommended, or were otherwise involved with the product.
The FDA has been critical of Philips' attempts to notify the public about the recall. An administration investigation allegedly found instances of Philips claiming to have notified entities it had, apparently, not contacted about the recall.
Now Philips has 45 days from the date of notice to alert professionals and customers about the recall.
Philips CPAP and BiPAP recall
The devices that have been recalled include:
- A-Series BiPAP V30 Auto Ventilator
- C Series S/T, AVAPS
- DreamStation ASV
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP, Auto CPAP
- DreamStation ST, AVAPS
- E30
- OmniLab Advanced Plus
- System One 50 series
- System One 60 series
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
Visit the FDA's recall page online to see a full list of recalled Philips' CPAP and BiPAP products.
Filing a Philips CPAP recall lawsuit
The cancers and types of kidney disease that require dialysis linked to defective CPAP and BiPAP PE-PUR machines are expensive to treat. The FDA alleges that Philips knew about the possible health risks in 2016 but did not issue a recall until 2021.
Victims of these defective products deserve compensation for their losses, including medical bills, lost income, pain and suffering, and other damages.
At Coby L. Wooten, Attorney at Law, P.C., we are actively reviewing CPAP recall cases involving a cancer diagnosis or a kidney diseases diagnosis that requires dialysis. If you or a loved one purchased or used a Philips CPAP or BiPAP device that has been recalled, see a doctor, then contact our law firm to learn more about your legal options during a free and confidential case evaluation.
There is a deadline to take action, so don't delay. Contact us now.