What consumers should know as Philips agrees to $1.1 billion CPAP settlement

Medical device maker Philips has agreed to a $1.1 billion settlement to settle claims brought by thousands of people with sleep apnea who say they were injured by the company’s CPAP machines.

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Medical device maker Philips has agreed to a $1.1 billion settlement to settle claims brought by thousands of people with sleep apnea who say they were injured by the company’s CPAP machines.

Smith Collection/Gado/Getty Images

Millions of CPAP sleep apnea machines made by medical device maker Philips and its subsidiary were found to have a dangerous problem, prompting consumer lawsuits and a massive recall in 2021. Now Philips has reached a $1.1 billion settlement to settle claims from people , who say they were injured. Part of the funds will also go towards medical supervision.

About 15 million Philips CPAPs and ventilators worldwide are affected by the Class I recall, a designation reflecting “a reasonable likelihood that use of or exposure to the products will cause serious adverse health consequences or death,” according to the Food and Drug Administration.

According to Philips’ recall notice, the devices were sold between 2008 and 2021 in the US under the Philips Respironics brand.

“As of April 2021, the FDA has received more than 116,000 MDRs [Medical Device Reports]including 561 reports of deaths” that were either reported or believed to be related to problems with the insulation foam in Philips devices, the FDA said earlier this year.

“Philips and Philips Respironics admit no fault or responsibility, or that Respironics devices caused any injuries,” the company said in announcing the new settlement agreement.

Here’s an overview of downloads and consumer status:

The settlement money is likely to flow next year

The $1.1 billion settlement — which includes $25 million in medical monitoring — was brokered by retired Judge Diane M. Welsh, but is not yet final because the settlement must be filed in federal court in Pennsylvania — the main state where the machines are were made.

Philips announced the new settlement on Monday along with its first-quarter financial results. The Netherlands-based company then posted what is likely to be a record one-day gain on its price vault, as investors welcomed news that the recall appeared to have been resolved at a lower cost than analysts had predicted.

“The repair of the patient sleep therapy device is almost complete,” Roy Jakobs, CEO of parent company Royal Philips, said in a statement. He added: “We regret the concern that patients may have experienced.”

“We are pleased to have reached a resolution” of the personal injury claims, the plaintiffs’ co-lead attorneys, Sandra L. Duggan; Kelly K. Iverson; Christopher A. Seeger; and Steven A. Schwartz, said in a joint statement to NPR.

The money will go to “users of now-recalled CPAP and other respiratory devices who suffer serious physical injuries” and to fund research into treatments for their injuries, the lawyers said. Philips says around 58,000 people have filed claims or registered to settle.

As for when consumers will see the money from the deal, Philips said it expects to make the payments in 2025.

This is not the only settlement

News of the personal injury settlement comes a week after Philips settled a class-action lawsuit over economic damages from the recall.

The settlement is worth at least $613.3 million, including $94.4 million in attorneys’ fees. It offers users and “payers” – such as insurance companies – reimbursement for recalled machines they have bought or leased.

The deal was approved last Thursday by Senior U.S. District Judge Joy Flowers Conti in federal court in West Philadelphia. The judge previously appointed Welsh to serve as mediator in the injury-related class action.

Philips says it expects to pay out that money this year.

What can consumers do?

As part of financial compensation, users are eligible for a $100 reward if they return their recalled device by August 9, 2024, the claim deadline.

People who suspect they own or use one of the affected devices should act soon to verify that if they haven’t already done so, the FDA says. The agency notes that the Philips download page offers ways to check serial numbers and register the product.

A dedicated website accepts applications for compensation for financial losses and states that participation in this agreement No affect or void any claims for personal injury or assistance in medical monitoring.”

As part of the financial loss settlement, users are also entitled to payment for each recalled device they purchased, leased or rented — and if they paid out of pocket to replace the recalled machine, they could be eligible for a replacement device reward. , according to the website.

The arrangement includes a prepaid shipping label, though administrators also warn users to check with their doctor before returning devices they’re still using.

A similar claims process is likely to emerge for an injury-related settlement once its terms are finalized.

Faulty machines can send particulates, VOCs into the respiratory tract

The recall was prompted by thousands of health complaints from CPAP users. The investigation found that the polyester-based polyurethane foam built into the sound and vibration damping equipment was also at risk of breaking down – especially when used in hot and humid conditions.

“If the foam breaks down, the person using the device may inhale or swallow black pieces of foam or certain chemicals that are not visible,” the FDA said.

The agency said in a 2022 letter to Philips that the foam also “may degrade and/or release harmful chemicals, which may result in toxic and carcinogenic effects and other significant harm to device users,” citing formaldehyde and other volatile organic compounds, or VOCs . .

“Philips has recognized that, in the worst-case scenario, exposure to VOCs as a class may cause possible toxic and carcinogenic effects, as well as respiratory, eye, nose, and skin irritation, nausea or vomiting, hypersensitivity reactions, dizziness, and headaches,” the FDA said.

The resulting problems “can potentially lead to serious injury and may require medical intervention to prevent permanent injury,” the agency said.

The plan to repair machines with this problem calls for replacing the polyester-based foam with a silicone-based foam.

What is the current status of Philips CPAP machines?

Sales of the popular Philips DreamStation and other respiratory units in the US are currently suspended; the company says it plans to resume sales of the device once it meets the terms of a consent decree with the US government.

Philips also says it will continue to service units still in use, including providing replacement parts.

Lawsuits against the company allege that Philips designed its CPAP machine poorly and brought it to market without proper warnings.

The FDA accuses Philips of failing to take appropriate precautions regarding the dangers of degrading foam in its CPAP and ventilator devices, despite having learned of the risk as early as 2015. That year, the FDA said in a letter to the company that the Philips subsidiary had initiated a preventive procedure due to complaints of disintegration foam. The agency says it became aware of the matter when the FDA inspected a manufacturing facility in Murrysville, Pennsylvania, in 2021.

When asked about the 2015 disclosure, a company representative said the only documentation of the problem was a single email, with other communications handled by phone, the FDA said in its letter.

What is sleep apnea and how much do CPAP machines cost?

Sleep apnea is a disorder that prevents people from getting enough oxygen while they sleep – often characterized by long pauses in breathing and loud snoring. People diagnosed with the disorder rely on continuous positive airway pressure, or CPAP, machines to keep their airways open and help them stay asleep.

Last June, the White House said President Biden uses a CPAP machine to help with sleep apnea.

Many units range in price from around $500 to over $1,300.

“The average price of a CPAP machine is about $800 among those we examined,” the National Council on Aging reported last year.

The recall also affects some models of Philips’ more complex BiPAP ventilators, which make it easier to inhale and exhale and normally cost hundreds of dollars more.

Many apnea and ventilator users also face additional costs, from spare parts and maintenance to buying another machine for travel.