In the United States, 50-70 million adults have a sleep disorder, with obstructive sleep apnea being the most common of such disorders. The CPAP machine is the standard treatment for sleep apnea. Philips is the largest producer of CPAPs in the world. In June 2021, the Food and Drug Administration (FDA) issued the most serious recall of certain Philips CPAP and BiPAP devices after discovering that users may inhale or swallow dangerous particles emitted from these machines. This can result in long-term or life-threatening injuries. Despite these serious conditions, many patients and medical suppliers were unaware of the recall or were not given adequate information about the dangers of Philips CPAP and BiPAP machines.
What are Philips CPAP Machines?
Philips continuous positive airway pressure machine (CPAP) treats obstructive sleep apnea by pressurizing air from the room and pushing it through a tube to a mask strapped to the face. The airflow prevents the uvula, soft palate, and tongue from obstructing the airway, thereby enhancing breathing, reducing snoring, and enabling the individual to sleep better. Similarly, a BiPAP machine provides continuous air pressure, but delivers two levels of pressure.
Why have Philips CPAP Machines been Recalled?
Philips Respironics recalled certain ventilators, BiPAP, and CPAP machines due to their potential health risks. The polyester-based polyurethane foam in certain devices can disintegrate and the wearer may inhale or swallow these fragments, as well as breathe in chemicals from off-gassing. The foam disintegration may be worse in humid environments or when using unapproved cleaning products. Injuries that can result from inhaling or swallowing polyurethane foam include:
- Irritation to the skin, eyes and respiratory tract
- Damage to the kidney and liver
- Chest pressure
- Lung and pulmonary cancers.
FDA Orders Philips to Notify Patients of Recall
In March 2022, the FDA issued an order to Philips Respironics requiring the company to alert patients of the company’s June 2021 recall of Philips Respironics ventilators, CPAP and BiPAP machines. The order came in response to complaints by consumers and healthcare professionals that they were unaware of the recall by Philips. In addition to compelling Philips to inform the public about the dangers of the foam used in its CPAP machines, the FDA communication instructed the company to notify the public about possible alternatives to treat sleep apnea. The FDA is requiring this notification because Philips devices pose an “unreasonable risk of substantial harm to the public health” and such notification is necessary to “eliminate the unreasonable risk of such harm and no more practical means are available…to eliminate such risk.”
Is There a Lawsuit?
Lawsuits against Philips were consolidated into a multi-district litigation (MDL) in federal court in the Western District of Pennsylvania in October 2021. As of December 2021, the MDL had 127 cases with tens of thousands more plaintiffs expected to join. Plaintiffs have brought claims against Philips for products liability and negligence. While the MDL is still in its early stages, several cases will likely go to trial.