On April 26, 2021 Philips announced to investors in its Quarterly Report “proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.” Philips has detailed under Regulatory Update the following:
…from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips' sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone, and certain environmental conditions involving high humidity and temperature. The majority of the affected devices are in the first-generation DreamStation product family. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected. Philips is in the process of engaging with the relevant regulatory agencies regarding this matter and initiating appropriate actions to mitigate these possible risks. Given the estimated scope of the intended precautionary actions on the installed base, Philips has taken a provision of EUR 250 million.
Philips recalled an estimated 3.5 million devices on June 14, due to the Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices and Mechanical Ventilators were distributed with defective and dangerous abatement foam that could degrade and deliver toxic chemicals into the user’s air pathway.
The FDA, however, didn’t issue a safety communication until June 30th. The agency urged consumers who did not have to rely on the sleep apnea machines for life life-sustaining therapy to immediately stop using the devices and contact their doctors to decide on alternative treatments for the condition.
In its recall notice Philips also advised consumers using life-sustaining mechanical ventilator devices not to stop or alter their prescribed therapy. The company states that “alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.”
But Philips had told investors a few weeks before the Quarterly Report in April that its new “next-generation CPAP platform”, known as DreamStation 2, had been introduced and was not affected by the issue. This begs the question: why didn’t it offer to consumers requiring life-sustaining therapy to replace this new device with the defective sleep machine ?
Perhaps the sleep machine lawsuits will answer that question.
READ MORE DEFECTIVE PRODUCT LEGAL NEWS
“Unfortunately, [your] website does not describe the claim process or, most importantly, the time frame necessary for repair or replacement of the Defective Devices. Patients have also reported to my Office that the dedicated phone number does not afford them the ability to speak directly with a person knowledgeable about the recall and that requests for return phone calls are not fulfilled.”
Attorney General Tong wants Philips to explain whether all defective devices will be replaced at no charge, when those devices will be replaced, and whether the company has notified medical equipment suppliers about the need to stop distributing the defective devices. The letter requests a response within 10 days – time’s up!