Philips Banned from Selling New CPAP Machines in U.S. Under Consent Decree

Following a massive Philips CPAP recall issued more than two years ago, the manufacturer must prove that it is following accepted good manufacturing standards and meet the goals of a remediation plan to replace devices.

A federal judge has approved a consent decree that prohibits Philips Respironics from manufacturing and distributing CPAP and BiPAP machines from its U.S. facilities, until the company meets certain requirements set by federal regulators in response to the handling of a massive Philips CPAP recall first issued in 2021.

The manufacturer has faced sharp criticism for selling millions of devices that contained a toxic sound abatement foam, which was found to degrade and release small black particles and chemicals directly into the machine’s air pathways.

Over the past two years, thousands of Philip CPAP lawsuits have been filed by former users left with severe lung damage, respiratory injuries and other injuries, and the FDA has identified serious deficiencies in the company’s recall and repair program, which has further increased the risks faced by owners fo the machines.

Due to the serious health issues from breathing the Philips CPAP foam, federal health officials told consumers to immediately stop using their machines unless needed for life supporting treatment. More than two years later, concerns about the way Philips handled the recall, leading the manufacturer to agree to suspend sales of all its CPAP and breathing machine devices in the U.S. late last year.

Philips CPAP Consent Decree

On April 9, U.S. District Judge Robert Colville, in the Western District of Pennsylvania, approved a consent decree between Philips and the U.S. Food and Drug Administration (FDA), which restricts the company from manufacturing or distributing CPAP and BiPAP devices from manufacturing facilities in Pennsylvania and California, until the company can prove to the agency that those facilities meet accepted manufacturing standards and comply with a remediation plan to repair or replace its recalled devices with safe alternatives.

The decree is in response to a complaint filed on April 4 by the FDA and U.S. Department of Justice prosecutors, according to a Justice Department press release issued on Tuesday. The complaint alleges that Philips violated the Food, Drug, and Cosmetic Act (FDCA) by manufacturing medical devices under conditions that failed to comply with the FDCA and current Good Manufacturing Practices.

In addition, the FDA and Justice Department also claim Philips Respironics failed to provide regulators with written reports of device corrections and removals, failed to properly get remediation plans approved by the FDA, and indicates the concerns mirror violations that have led to previous warning letters from the FDA since the recall was first announced.

“Today’s consent decree requires Philips Respironics to meet a series of stringent thresholds before restarting production and establishes safeguards against future violations of the Food, Drug and Cosmetic Act,” U.S. Attorney Eric G. Olshan, for the Western District of Pennsylvania, said in the press release. “This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk.”

In addition to restrictions on sales and distribution, the consent decree also requires Philips to hire outside experts to inspect other facilities manufacturing sleep and respiratory care devices, to correct any deficiencies, and to conduct an independent evaluation of testing taking place on potential replacement sound abatement materials.

The consent decree can be expanded to other Philips manufacturing facilities if the FDA finds they are out of compliance with FDCA rules.

CPAP Remediation Plan Concerns

A significant portion of the decree focuses on Philips efforts to replace or repair millions of devices recalled in 2021, which the FDA has called deficient.

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.

A year ago, in April 2023, the FDA issued an updated safety communication that warned consumers they may be in for a long wait for a replacement CPAP device, and that Philips was being deceptive in its announcements on how fast recalled breathing machines were being remediated.

Philips can only get out from under the consent decree restrictions and export its devices again if it can show all consumers who need a replacement CPAP device have received one within the timeframe steps set forth in the CPAP recall remediation plan, and that the defendants have enough devices in stock to address future potential remediation needs for the next year.

“Overall, this provision is intended to help ensure remediation of U.S. patients is prioritized over export for commercial distribution and patients receive the recall remediation devices that they are seeking from Philips Respironics in a timely manner,” a press release by the FDA states. “The FDA has a dedicated response team that will continue to meet regularly with the company to ensure the effective and efficient implementation of the Recall Remediation Plan and other related recall activities, as outlined in the consent decree. The agency also continues to assess the supply chain for this product area and believes there is adequate supply and that alternative manufacturers are able to handle patient demand for CPAP and BiPAP machines.”

April 2024 Philips CPAP Lawsuits Update

In addition to regulatory problems, Philips Respironics also faces massive liability in product liability and class action lawsuits being pursued by individuals who owned one of the recalled CPAP or BiPAP machines.

Given common questions of fact and law raised in the claims, all Philips CPAP recall lawsuits have been consolidated as part of a federal MDL, which is assigned to U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania, for coordinated discovery and pretrial proceedings.

The manufacturer has already indicated that it hopes to reach a global settlement for Philips CPAP lawsuits some time this year. However, negotiations to settle the personal injury claims will be complex, given the wide variety of different types of cancer and lung damage individual plaintiffs have alleged may be caused side effects of the Philips CPAP machines, including:

• Leukemia, Lymphoma or other Cancers
• Pulmonary Fibrosis, Sarcoidosis or other Lung Diseases
• Chronic Asthma, Bronchitis or Pneumonia
• Liver Injury, Kidney Injury, Heart Attack, Stroke or Heart Failure

Following pretrial motions, Judge Conti has already established a series of deadlines in Philips CPAP lawsuits designed to prepare cases for potential early trial dates. In addition, a court-appointed mediator is currently working with the parties to negotiate CPAP recall settlements.

However, unless Philips is able to successful convince the court to dismiss the litigation or negotiate a resolution for the claims following mediation efforts and any early bellwether trials, Judge Conti may begin remanding hundreds of individual claims back to U.S. District Courts nationwide for individual trial dates in the future.