Philips Reaches $1.1B Settlement Over Defective CPAP Machines

Updated May 2, 2024

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Philips, the Dutch multinational corporation and parent company of CPAP manufacturer Philips Respironics, announced Monday it had reached a $1.1 billion settlement to address claims related to its defective sleep apnea machines.

The settlement, announced in conjunction with the company’s first-quarter earnings report, assigns a total payout for personal injury litigation resulting from the 2021 recall of certain Philips Respironics devices used to treat sleep apnea and other breathing conditions. The deal also earmarks funds for medical monitoring of people who used the defective devices.

The 2021 recall came amidst disturbing reports that the machines were emitting toxic chemicals stemming from the breakdown of noise abatement foam. As part of the settlement, Philips did not admit fault, nor did it acknowledge that any injuries or deaths were caused by the company’s devices.

The settlement comes three weeks after Philips Respironics was handed stiff penalties that limit its ability to do business in the United States. On April 9, a U.S. federal court issued a consent decree that bans the company from selling sleep apnea machines in the U.S. and halts production until a number of requirements have been met. Philips must also hire independent safety experts to oversee the process and submit to facility inspections for five years.

The move is a crucial step in ensuring that more consumers aren’t sold dangerous devices. Last year, an investigation by ProPublica and the Pittsburgh Post-Gazette found that Philips had been fielding complaints about its devices for more than a decade but had kept this information from the public.

Thousands of people who used the defective machines reported severe side effects, including respiratory ailments, cancer, and liver and kidney diseases. Since April 2021, the Food and Drug Administration has received more than 500 reports of deaths allegedly associated with the recalled devices. Trusted Source U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. View Source

Furthermore, the replacement machines that Philips issued were found to pose health risks as well, Trusted Source U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. View Source as they were made with a silicone-based foam that was found to emit toxic chemicals. Though Philips insists that the new machines are safe, the FDA said that more testing is needed. Under the new consent decree, an independent safety monitor will investigate the quality of the prior testing and may require Philips to do additional testing on the foam.

The decree also lays out remediation measures for affected Philips customers, including the option of a partial refund. In a press release, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, notes that it “marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.” Trusted Source U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. View Source

There are a few exceptions in the decree. Philips can continue to sell a select group of devices that the FDA deems “medically necessary,” but it must give a percentage of the revenue to the U.S. government. The company can also continue selling devices outside the U.S.

Philips Respironics, which is based outside Pittsburgh, has a long history in the sleep apnea industry. Formerly known as just Respironics, it produced the first commercially available CPAP machines in 1985. Philips acquired the company in 2008.

Several years later, the company redesigned its CPAP machines to add industrial foam made of polyester-based polyurethane. The intent was to muffle the sounds the machine made, but the foam crumbled when exposed to heat and humidity. Soon after, customers began reporting concerning symptoms.

It’s unclear when, if ever, Philips will resume producing sleep apnea devices for the U.S. market. If it does, it will face the challenging task of regaining consumer trust and reassuring the public that its products are safe.

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Written By

Annie Atherton, Contributing Writer

Annie is a Seattle-based, general interest freelance writer whose work has appeared in The Washington Post, the BBC, Insider, The Atlantic, and many other publications.

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