Company that made millions of faulty sleep apnea devices ordered to overhaul its manufacturing

WASHINGTON (AP) — The company responsible for a global recall of sleep apnea devices will be barred from resuming production at its U.S. facilities until it meets a number of regulatory requirements. security, under a long-awaited settlement announced Tuesday by federal officials.

Philips will have to review its manufacturing and quality control systems and hire independent experts to review the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or refund all U.S. customers who received the defective devices, the department said.

This action is a major step toward resolving one of the largest medical device recalls in history, which has lasted nearly three years.

Most of the recalled devices are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep the mouth and nasal passages open during sleep. Untreated, sleep apnea can lead to dangerous drowsiness and an increased risk of heart attack.

Philips has recalled more than 5 million machines since 2021 because their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep. Efforts to repair or replace the machines have been hampered by delays that have frustrated regulators and patients in the United States and other countries.

Lawyers for the federal government alleged that the company failed to follow good manufacturing practices necessary to ensure the safety of the devices. The company has not admitted to the allegations, according to the court filing.

“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,” U.S. Attorney Eric Olshan said in a statement.

Under the legal agreement, Philips must hire independent auditors to create a plan to fix its manufacturing issues and monitor problems with the sleep devices. The plan must then be approved by the Food and Drug Administration. Experts must also certify that the new foam selected by the company meets FDA safety standards.

Jeffrey Reed, of Marysville, Ohio, suffered from persistent sinus infections and two bouts of pneumonia during the seven years he used a Philips device.

“I worry about my long-term health,” Reed said. “I’ve used this machine for years and no matter how much money I could get out of it, what’s going to happen?

Reed received a newer Philips device after returning his old device, but he doesn’t like using it, preferring a competitor’s device.

“I don’t trust the company,” Reed said. “I don’t want to use it.”

Reed is among more than 750 people who have filed personal injury lawsuits against the company over the devices. These cases were consolidated in federal court in Pennsylvania.

Similar lawsuits are pending in Canada, Australia, Israel and Chile, according to the company.

The Dutch manufacturer announced in January that it had reached an agreement in principle with the FDA and the Ministry of Justice. But U.S. regulators did not confirm the deal at the time because it had not yet been reviewed by a federal judge.

A company spokesperson said Tuesday that the agreement provides “a roadmap of defined actions, milestones and deliverables to meet relevant regulatory requirements,” in an emailed statement. He noted that Philips will still be able to export some machines for sale outside the United States.

The FDA website warns patients that risks from ingesting sound deadening foam could include headaches, asthma, allergic reactions, and more serious problems.

An FDA inspection of Philips’ Pennsylvania offices in fall 2021 revealed a series of red flags, including emails suggesting the company had been warned of the problem with its foam six years before the recall.

Between 2016 and early 2021, the FDA discovered 14 cases in which Philips was aware of the problem or was investigating the problem. “No further design changes, corrective actions, or field corrections have been made,” FDA inspectors noted repeatedly.

In 2022, the FDA took the rare step of ordering Philips to increase its customer outreach regarding the recall, including “clearer information about the health risks of its products.” At the time, the agency estimated that only about half of people in the United States with affected machines knew they had been recalled.

Customers trying to get refunds or new or refurbished devices from the company have reported long delays.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Education Media Group. The AP is solely responsible for all content.