FDA Calls Testing By Manufacturer Inadequate in Philips CPAP Recall Update

Additional testing of Philips CPAP sound abatement foam is being required, after the FDA questioned the company’s claims that the foam does not represent a health risk to consumers.

Federal regulators have issued an update on a Philips CPAP recall issued in 2021, saying that they are “unsatisfied” with both the status of the recall and the manufacturer’s testing of the sound abatement foam that was found to breakdown and release particles directly into the sleep apnea machines’ air pathways.

The U.S. Food and Drug Administration (FDA) published the Philips CPAP recall update on October 5, indicating that the agency continues to monitor the status of the recall more than two years after it was announced.

The recall impacted millions of CPAP, BiPAP and mechanical ventilators sold since 2009, which contained a defective polyester-based polyurethane (PE-PUR) foam, which was intended to cut down on noise as the machines were used. However, consumers were reporting small black particles and debris in the tubes, face masks and other parts of the machine.

As a result of the risk of serious health issues from the Philips CPAP foam, consumers were told to immediately stop using their machines unless needed for life supporting treatment, and thousands of lawsuits are now being pursued by former users who have developed cancer, lung damage and other respiratory injuries after using the recalled devices.

“While this matter is ongoing, the agency continues to monitor the company’s recall progress and share new information with device users, patient care facilities, and other stakeholders,” the FDA update states. “The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.”

Following the recall, the FDA required Philips to begin “extensive” testing on the sound abatement foam, in order to determine the potential health risks from particles and volatile organic compounds (VOCs) emitted as the foam degrades.

However, the agency says it is not satisfied with the testing done by the company so far, and has called upon Philips to do additional testing to better quantify the risks to CPAP users.

“The FDA has reviewed the available information and data provided to FDA by Philips. We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” FDA officials stated. “Although Philips concluded that the exposure to foam particles and VOCs from these devices is ‘unlikely to result in an appreciable harm to health in patients,’ the FDA believes additional testing is necessary.”

Philips CPAP Recall Device Replacement Problems

The scientific testing is not the only problem the FDA has with how Philips has conducted the recall, however.

The FDA has been extremely critical of Philips’ handling of the recall, at first warning that the company’s Philips CPAP recall notifications had been inadequate, and that the company’s CPAP repair program has been slow to get much-needed breathing assistance machines back to the consumers who need them.

In April, the FDA indicated the company claims it has shipped 2,460,000 new replacement devices and repair kits. However, the FDA warns that number is deceptive to consumers still waiting on their replacement devices.

In a safety communication posted on June 2, 2023, the FDA outlined additional information about medical device reports involving the recalled Philips CPAP machines that were received between January 1, 2023 and March 31, 2023, indicating that the agency was aware of more than 105,000 medical device reports involving problems caused by exposure to toxic sound abatement foam inside the sleep apnea machines, including 385 deaths.

In addition, a recent ProPublica CPAP recall investigative report found that Philips knew about problems with the PE-PUR foam up to a decade before it pulled the devices from the market.

The company would not launch a formal investigation into the problem until 2019, nearly a decade after the first reports, ProPublica investigators determined after reviewing numerous company documents, as well as interviews with former Philips employees.

The foam was even used in a ventilator which went on sale at the start of the COVID-19 pandemic, despite the company’s own tests having shown it was breaking down three years earlier, the report states.

October 2023 Philips CPAP Recall Lawsuit Update

Thousands of Philips CPAP lawsuits have already been filed against the company by individuals diagnosed with cancer, lunch damage or other respiratory injuries, as well as a number of Philips class action lawsuits that seek damages for all owners of the recalled machines, including economic damages and medical monitoring.

In September, Philips announced it would pay a minimum of $445 million in a CPAP recall settlement to individuals who bought, rented or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines. However, the settlement does not address any of the liability the company faces for injuries and deaths linked to the CPAP machines.

Even after agreeing to settle the class action complaints, Philips continues to face personal injury lawsuits brought over side effects of CPAP foam exposure, and the number of claims is expected to continue growing, both involving injuries diagnosed before the recall, as well as new injuries that continue to be diagnosed months after users breathed the toxic particles released as the sound abatement foam degraded inside their machines.

As part of the coordinated management of litigation the company is facing, a Philips CPAP lawsuit bellwether process is expected to be established, where small groups of representative claims will be prepared for early trial dates if Philips CPAP settlements can not be reached to resolve large numbers of claims.

While the outcome of these early verdicts will not have any binding impact on other plaintiffs, the average Philips CPAP lawsuit payout amounts awarded by juries are likely to have a big influence on how much the manufacturer will pay to settle claims, to avoid each claim being remanded to different U.S. District Courts nationwide for separate trial dates in the future. However, a settlement agreement reached before then may make such trials unnecessary.