NOTICE: Philips Discontinues Numerous Devices and Halts Dreamstation Sales in the U.S.

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Pittsburgh Post-Gazette

After a tumultuous CPAP recall, Philips must launch new safeguards under the DOJ agreement

Philips Respironics must hire an independent safety monitor, undergo regular facility inspections, and pay part of its revenue to the federal government for at least five years under an agreement with prosecutors filed in federal court in Pittsburgh on Thursday that caps one of the most catastrophic medical device recalls in decades.

The company also will have to hire an independent expert and review its testing on the millions of replacement sleep apnea machines it sent to customers after the old ones were recalled in 2021.

After a tumultuous CPAP recall, Philips must launch new safeguards under DOJ agreement | Pittsburgh Post-Gazette

[MaNoise]

Good they will review testing! it should not take so long to be reviewing. People are actively using the machines.

There should be no foam inside the therapy airway / ‘treatment air’ and the air should be filtered at near hepa or N95 respirator standards.

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PROPUBLICA

After CPAP Recall, Philips Must Institute New Safeguards in Agreement With U.S. Justice Department

The consent decree with the Justice Department, filed in federal court last week, comes nearly three years after Philips acknowledged that an industrial foam fitted inside its widely used sleep apnea machines and ventilators to reduce noise could degrade and release toxic particles and fumes into the masks worn by patients.

A ProPublica and Pittsburgh Post-Gazette investigation last year found the medical device giant had withheld thousands of complaints about the foam for more than a decade before warning its customers — including medically vulnerable patients such as infants and the elderly — about the dangers.

The news organizations also revealed that a new, silicone-based foam that the company used in the replacement machines was also found to emit dangerous chemicals, including formaldehyde, a known carcinogen.

Note: This is the recap of this story re-bundled.

After Recall, Philips Must Launch New Safeguards in DOJ Agreement — ProPublica

[SarcasticDave94]

Here's a Reuters article regarding Philips Respironics machines and a federal court ruling.

April 9 (Reuters) - A U.S. federal court issued a decree to restrict the production and sale of Philips' (PHG.AS), opens new tab new sleep apnea machines at several facilities in the country, the Food and Drug Administration said on Tuesday.

The U.S. District Court for the Western District of Pennsylvania has entered into what is known as a consent decree against the company's subsidiary Philips Respironics to curb the sale and production until certain requirements are met.

In January, the Dutch health technology company had said that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the FDA.

The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.

The decree also requires implementation of a recall remediation plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall.

The plan outlines remediation options such as a new or reworked device for the patients with the option for partial refund of certain devices.

As part of this plan, Philips is also required to make several attempts to contact a patient or a medical equipment provider regarding actions they must take to help ensure patients receive remediation in a timely manner.

Almost the whole of the company's actionable registered sleep therapy devices have been remediated globally, Philips told Reuters, adding that it will retain experts to review aspects of the remediation.

The company said it will continue to provide new sleep and respiratory care devices outside the United States as the consent decree allows for exports.

Reporting by Christy Santhosh; Editing by Maju Samuel

Philips Respironics ruling

[TimaaaaaaaahRocks]

The company said it will continue to provide new sleep and respiratory care devices outside the United States as the consent decree allows for exports.

Philips Respironics ruling

The upside, they can export unsafe, illegal, garbage. “In a closed society where everybody's guilty, the only crime is getting caught. In a world of thieves, the only final sin is stupidity.", Hunter S. Thompson

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Eli Lilly's weight loss drug Zepbound could help treat sleep apnea — paving the way to Medicare coverage

Eli Lilly announced today that the drug behind Zepbound was found to help alleviate sleep apnea in patients with obesity in late-stage clinical trials. The medication, tirzepatide, is sold by the company in the United States as Mounjaro for diabetes and Zepbound for weight loss.

The pharma giant said on Wednesday that it’s planning to seek approval from the U.S Food and Administration (FDA) to expand the use of the drug to include treating sleep apnea. That could open up access to the medication, too: If regulators expand the approved use of Zepbound the medication could join Novo Nordisk’s Wegovy in being covered by Medicare.

Eli Lilly's weight loss drug Zepbound could help treat sleep apnea — paving a way to Medicare coverage (msn.com)

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FDA

2024
CDRH Safety Report

Introduction

Although medical devices provide great benefits to patients, they also present risks. CDRH’s public health 
responsibilities span the life cycle of medical devices and, at every stage, we must make well-supported 
regulatory decisions, taking into account the totality of available evidence, to determine whether the benefits 
outweigh the risks.
 
CDRH strives to permit the marketing of only devices with a favorable benefit-risk profile, but not all information 
regarding the benefits and risks of a device is available, nor can it be generally known, before a device 
reaches the market.
 
New information about the device’s safety, such as reports of unexpected adverse events, may become 
available once the device is more widely distributed and used under real-world conditions, including routine 
clinical practice and in the home setting, as well as in broader patient populations, and by a broader range of 
clinicians. 

CDRH Vision

Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.
Our vision does not signal a competition with other countries, but rather, provides a metric for timely patient access to devices that meet 
the FDA’s standards.

 https://www.fda.gov/media/177866/downloa...ovdelivery

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REUTERS

Philips shares surge on US recall settlement news

AMSTERDAM, April 29 (Reuters) - Philips (PHG.AS), shares surged 35% early on Monday as the medical devices maker announced a smaller-than-expected settlement to resolve claims over recalled breathing devices in the United States.
Philips said it had agreed to pay $1.1 billion to settle all personal injury claims filed in the U.S., ending uncertainty that had slashed its market value over the past three years.

"This settlement is significantly lower than expectations of $2-4 billion and worst case of $10 billion," 

Philips shares surge on US recall settlement news | Reuters

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Pittsburgh Post-Gazette


In wake of a massive recall, SEC launches investigation into Philips Respironics

Feds to focus on whether global company properly alerted investors to breathing machine dangers

As Philips Respironics settles costly legal battles over its defective breathing machines, the Securities and Exchange Commission has investigated the company's practices. Whether it withheld critical information about the dangers of the devices before pulling them from the shelves in one of the largest recalls of its kind, the Post-Gazette has learned.

The SEC is seeking information about the company's inner workings — including scientific tests of the flawed devices — and the steps it took to inform investors who stood to lose billions of dollars, according to multiple sources who spoke on the condition of anonymity.



SEC launches investigation into Philips Respironics | Pittsburgh Post-Gazette

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Pittsburgh Post-Gazette

Philips Respironics to leave Pittsburgh headquarters slash 300 manufacturing jobs

The company will all but end manufacturing of breathing machines at two major Western Pa. plants in 2025

Still reeling from one of the largest medical device recalls in U.S. history, Philips Respironics plans to cut 300 manufacturing jobs in Western Pennsylvania and relocate some 500 workers from its Pittsburgh headquarters to its two major plants in the nearby suburbs, the company announced.

Philips will leave its building in Bakery Square starting in the fourth quarter of 2024 and will move the workers over the next two years into its centers in Murrysville and New Kensington. The company will all but end manufacturing at the two plants in 2025 after once dominating the market for breathing machines and making what became signature products.

Philips Respironics leaving Pittsburgh headquarters, cutting 300 jobs | Pittsburgh Post-Gazette