Following Philips CPAP Recall Failures, U.S. Senators Seek Probe into FDA Medical Device Oversight

Law makers question whether FDA knew the manufacturer was withholding information about Philips CPAP problems, and failed to take enforcement action to require an earlier recall.

Two U.S. Senators have called for an internal investigation into the U.S. Food and Drug Administration (FDA) handling of medical devices, fearing that a Philips CPAP recall issued in 2021, and the agency’s handling of it, may point to serious systemic problems.

Senators Dick Durbin and Richard Blumenthal sent a letter (PDF) to the Government Accountability Office (GAO) on December 13, requesting a probe into the FDA’s oversight of medical devices. The letter raises concerns about how thoroughly and quickly the FDA investigates problems with medical devices.

Their concerns were stoked by a recent ProPublica investigation, which revealed that the FDA failed to detect problems with CPAP sleep apnea machines for more than a decade before millions of the devices were recalled. The report revealed that Philips had known about the risk that the CPAP sound abatement foam may breakdown and fail as early as 2010, but withheld information from regulators, doctors and consumers.

Philips DreamStation CPAP Recall

The massive Philips CPAP DreamStation recall was publicly announced in July 2021, impacting millions of CPAP, BiPAP and mechanical ventilators sold since 2009, which contained a defective polyester-based polyurethane (PE-PUR) foam that was intended to cut down on noise as the machines were used. However, the manufacturer acknowledged at that time that the foam was known to degrade and breakdown, releasing small black particles, chemicals and toxic gasses directly into the machine’s air pathways.

Due to the serious health issues from breathing the Philips CPAP foam, consumers were told to immediately stop using their machines unless needed for life supporting treatment.

More than two years after the recall, there are now thousands of Philips CPAP lawsuits being pursued by former users, each involving allegations that regular users of the machines developed various forms of cancer, respiratory illnesses, lung diseases and other complications after exposure to the foam particles.

The ProPublica investigation revealed that Philips began to receive reports of sound abatement foam used in its devices breaking down as early as 2010, but failed to take immediate actions to recall the machines or warn users.

In addition to waiting more than a decade before publicly disclosing the issue, the report also found that Philips hid more than 3,700 reports of problems with the CPAP machines from the U.S. Food and Drug Administration (FDA), and that the company’s own scientists had confirmed there was a health risk for users several years before the recall was finally issued.

“Rather than reporting the adverse event report to FDA or initiating a recall, it waited and withheld thousands of additional adverse event reports for more than a decade. Even when Philips Respironics conducted an internal health hazard evaluation, which confirmed that inhaling the chemicals from the sound abatement foam could cause ‘permanent impairment,’ it did nothing, while patients suffered,” the senators wrote. “That is unacceptable.”

The senators say it is clear the FDA missed opportunities to protect consumers from injuries and deaths caused by the recalled breathing devices. They indicate the agency received at least 30 adverse event reports prior to the recall, and knew that the manufacturer had a history of withholding adverse event reports from the agency.

The letter notes the FDA did not take enforcement action even when it knew Philips Respironics was breaking the law.

GAO Investigation Requested

Durbin and Blumenthal call for a GAO investigation into the FDA’s oversight of medical devices, noting that there were 898 medical device recalls in 2022; a 125% increase in the number of recalls announced 10 years before in 2012, when the agency recorded just 399 of such recalls. In addition 2022 saw 70 class I recalls, which was the highest in 15 years.

Class I recalls are declared when the FDA believes problems with a product could result in serious injuries or deaths.

The Senators want the GAO to determine the extent and nature of medical device recalls and whether the FDA is using that data to improve its performance, a review of actions the agency has taken to make sure medical device recalls are announced in an appropriate and timely fashion, and what processes the FDA uses to determine when a recall should be announced, among numerous other questions into the agency’s performance.

December 2023 Philips CPAP Lawsuit Update

In September, Philips announced it would pay at least $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.

The settlement agreement seeks to resolve all economic claims against the manufacturer, and automatically include about 1.3 million users who have returned devices to Philips through its recall program without the need to submit a claim.

However, that still leaves thousands of individual claims unresolved.

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.