WHO AND WHAT IS PHILIPS N.V AND MDL 3014?
Philips and it’s Philips USA entity, were formerly one of the largest electronics companies in the world, currently focused on the area of health technology, with non-healthcare divisions being divested. The sudden transition into becoming a healthcare conglomerate via corporate acquisitions may point to a reluctance to engaging in a long drawn-out MDL docket fight? There are approximately 300 pending claims filed into CPAP MDL 3014 as of April 14, 2022.
The JPML Initial Transfer and Consolidation Order for MDL 3014 (USDC WD PA, Honorable Joy Flowers Conti) Oct 8, 2021
https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3014-Transfer%20Order-09-21.pdf
Claims recognized and cited by JPML in transfer order: These actions share factual questions arising from Philips’ recall of certain Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP), and mechanical ventilator devices on June 14, 2021.4 The recalled devices allegedly contain polyester-based polyurethane (PE-PUR) sound abatement foam that may degrade into particles or off-gas volatile organic compounds that may then be ingested or inhaled by the user, causing injury. Plaintiffs allege that defendants concealed the problems with the PEPUR foam before the recall was announced and made misrepresentations regarding the recalled devices in connection with their marketing and sales.
FDA Recall Notice and the basis for MDL 3014
Official FDA Recall Advisory on Philips CPAP Equipment, November 2021:
Philips Urgent Recall Notice:
General Recall Notice by Philips USA:
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
MDL 3014 In Re: Phillips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation
The Honorable Joy Flowers Conti, Presiding
2:21-mc-01230
Official court link: https://www.pawd.uscourts.gov/mdl-3014-re-philips-recalled-cpap-bi-level-pap-and-mechanical-ventilator-products-litigation
CPAP MDL 3014 PTO No. 8 Appointing Leadership:
CPAP PHILIPS MDL 3014 PTO No. 8 Leadership Appointed Feb 15, 2022
Philips Corporate and Financials 2020
| Founded | 15 May 1891; 130 years ago Eindhoven, Netherlands |
| Founders | Gerard and Anton Philips |
| Headquarters | Amsterdam, Netherlands |
| Products | Medical equipmentHome appliancesIntellectual property |
| Revenue | €19.535 billion (2020)[1] |
| Operating income | €1.542 billion (2020)[1] |
| Net income | €1.195 billion (2020)[1] |
| Total assets | €27.713 billion (2020)[1] |
| Total equity | €11.901 billion (2020)[1] |
| Number of employees | 81,592 (2020)[1] |
| Website | www.philips.com |
Official FDA Recall Advisory on Philips CPAP Equipment, June 30, 2021:
Recalled Philips device brands include:
- Aeris
- BiPAP A30/A40 Series Device Models
- BiPAP V30
- C-Series ASV
- Dorma 400 and 500
- DreamStation
- E30
- Garbin Plus
- LifeVent
- REMstar SE Auto
- SystemOne (Q-Series)
- Trilogy 100
- Trilogy 200
- Trilogy Evo
An example of Philips running interference and attempting to mitigate the damages of the FDA initiated advisory and recall on risks of the various Philip’s medical devices.
What your law firm clients should not do:
“From the Philips USA CPAP Recall Advisory Page”
“Medical Device Recall Notification”
Re: Philips Respironics Sleep and Respiratory Care devices
Device registration and recall contact information
Patients, Users, or Caregivers
If your unit is affected, click the link below to begin the registration process. After registration, we will notify you with additional information as it becomes available.
If you have already registered, no further action is needed from you at this time.
877-907-7508
How to register your device video
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Other Legal Problems for Philips:
April 2020, the United States Department of Health & Human Services (HHS) entered into a contract with Philips Respironics for 43,000 bundled Trilogy Evo Universal ventilator (EV300) hospital ventilators.[94] This included the production and delivery of ventilators to the Strategic National Stockpile—about 156,000 by the end of August 2020 and 187,000 more by the end of 2020.[95] During the COVID-19 pandemic, beginning in March 2020, in response to an international demand, Philips increased production of the ventilators fourfold within five months. Production lines were added in the United States with employees working around the clock in factories producing ventilators, in Western Pennsylvania and California, for example.[95]
In March 2020, ProPublica published a series of articles on the Philips ventilator contract as negotiated by trade adviser Peter Navarro. In response to the ProPublica series, in August, the United States House of Representatives undertook a “congressional investigation” into the acquisition of the Philips ventilators. The lawmakers investigation found “evidence of fraud, waste and abuse.”[96]—the deal negotiated by Navarro had resulted in an over-payment to Philips by the US government of “hundreds of millions.”
Philips Brain Trust, HQ’d in Europe:
https://www.philips.com/a-w/about/supervisory-board.html
FDA Recall List CPAP-BiPAP Devices (Excerpt from Official FDA Notice)
| Device Type | Model Name and Number (All Serial Numbers) |
|---|---|
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | E30 (Emergency Use Authorization) |
| Continuous Ventilator, Non-life Supporting | DreamStation ASVDreamStation ST, AVAPSSystemOne ASV4C-Series ASVC-Series S/T and AVAPSOmniLab Advanced+ |
| Noncontinuous Ventilator | SystemOne (Q-Series)DreamStationDreamStation GoDorma 400Dorma 500REMstar SE Auto |
Ventilators
| Device Type | |
|---|---|
| Continuous Ventilator | Trilogy 100Trilogy 200Garbin Plus, Aeris, LifeVent |
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | A-Series BiPAP Hybrid A30 (not marketed in US)A-Series BiPAP V30 Auto |
| Continuous Ventilator, Non-life Supporting | A-Series BiPAP A40A-Series BiPAP A30 |
What is Philips in 2022?
In February 2015, Philips acquired Volcano Corporation to strengthen its position in non-invasive surgery and imaging.[56] In June 2016, Philips spun off its lighting division to focus on the healthcare division.[57] In June 2017, Philips announced it would acquire US-based Spectranetics Corp, a manufacturer of devices to treat heart disease, for €1.9 billion (£1.68 billion) expanding its current image-guided therapy business.
In May 2016, Philips’ lighting division Philips Lighting went through a spin-off process, and became an independent public company named Philips Lighting N.V.[58]
In 2017, Philips launched Philips Ventures, with a health technology venture fund as its main focus. Philips Ventures invested in companies including Mytonomy (2017) and DEARhealth (2019).[59][60]
Koninklijke Philips N.V. (in Dutch literally ‘Royal Philips’, commonly shortened to Philips) is a Dutch multinational conglomerate corporation that was founded in Eindhoven in 1891. Since 1997, it has been mostly headquartered in Amsterdam, though the Benelux headquarters is still in Eindhoven. Philips was formerly one of the largest electronics companies in the world, currently focused on the area of health technology, with other divisions being divested.
The company was founded in 1891 by Gerard Philips and his father Frederik, with their first products being light bulbs. It currently employs around 80,000 people across 100 countries.[2] The company gained its royal honorary title in 1998 and dropped the “Electronics” in its name in 2013,[3] due to its refocusing from consumer electronics to healthcare technology.
Philips is organized into three main divisions: Personal Health (formerly Philips Consumer Electronics and Philips Domestic Appliances and Personal Care), Connected Care, and Diagnosis & Treatment (formerly Philips Medical Systems).[4] The lighting division was spun off as a separate company, Signify N.V. The company started making electric shavers in 1939 under the Philishave brand, and post-war they developed the Compact Cassette format and co-developed the Compact Disc format with Sony, as well as numerous other technologies. As of 2012, Philips was the largest manufacturer of lighting in the world as measured by applicable revenues.
Philips has a primary listing on the Euronext Amsterdam stock exchange and is a component of the Euro Stoxx 50 stock market index.[5] It has a secondary listing on the New York Stock Exchange. Acquisitions include that of Signetics and Magnavox. They also have had a sports club since 1913 called PSV Eindhoven.
Philips Acquisitions
Companies acquired by Philips through the years include ADAC Laboratories, Agilent Healthcare Solutions Group, Amperex, ATL Ultrasound, EKCO, Lifeline Systems, Magnavox, Marconi Medical Systems, Philips Medical purchased Intermagnetics based out of Latham, New York for 1.3 billion in 2006, Optiva, Preethi, Pye, Respironics, Inc., Sectra Mamea AB, Signetics, VISICU, Volcano, VLSI, Ximis, portions of Westinghouse and the consumer electronics operations of Philco and Sylvania. Philips abandoned the Sylvania trademark which is now owned by Havells Sylvania except in Australia, Canada, Mexico, New Zealand, Puerto Rico and the US where it is owned by Osram. Formed in November 1999 as an equal joint venture between Philips and Agilent Technologies, the light-emitting diode manufacturer Lumileds became a subsidiary of Phillips Lighting in August 2005 and a fully owned subsidiary in December 2006.[64][65] An 80.1 percent stake in Lumileds was sold to Apollo Global Management in 2017.[66]
On 19 September 2018, Philips reported that it had acquired US-based Blue Willow Systems, a developer of a cloud-based senior living community resident safety platform.
On 7 March 2019, Philips announced that was acquiring the Healthcare Information Systems business of Carestream Health Inc., a US-based provider of medical imaging and healthcare IT solutions for hospitals, imaging centers, and specialty medical clinics.[67]
On 18 July 2019, Philips announced that it has expanded its patient management solutions in the US with the acquisition of Boston-based start-up company Medumo.[68]
On 27 August 2020, Philips announced the acquisition of Intact Vascular, Inc., a U.S.-based developer of medical devices for minimally invasive peripheral vascular procedures.[69]
On 18 December 2020, Philips and BioTelemetry, Inc., a leading U.S.-based provider of remote cardiac diagnostics and monitoring, announced that they had entered into a definitive merger agreement.[70]
On 19 January 2021, Philips announced the acquisition of Capsule Technologies, Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.[71]
On 9 November 2021, Philips announced the acquisition of Cardiologs, an AI-powered cardiac diagnostic technology developer, to expand its cardiac diagnostics and monitoring portfolio.[72]
Pre-FDA Recall: “A fairly mundane list of potential adverse effects”
CPAP Side Effects and Solutions
1. Nasal Congestion
One of the most common side effects associated with CPAP therapy is congestion or irritation of the nasal passages. This can include the feelings of stuffy nose, runny nose, a burning sensation, or nosebleeds.
Nasal congestion is caused by the flow of dry, pressurized air through the sinuses, and can be particularly common for those with frequent sinus infections.
How to Avoid It
- For short term relief, try a nasal saline spray to moisturize your nasal passages.
- For long term care you should consider using a CPAP humidifier. Humidification adds moisture to your airflow to relieve dryness and soothe irritation. For added relief, a heated humidifier gently warms the air as it moisturizes, for a more natural feel.
2. Dry Mouth
Waking up with dry mouth or a dry throat typically happens to mouth breathers and, like nasal congestion, it’s caused by breathing dry, pressurized air.
Though it’s more common in those who use a full face mask, it can also happen to people who use a nasal pillow mask or nasal mask, due to “mouth leak.” Mouth leak occurs when you sleep with your mouth open and your air pressure escapes out of your open mouth while exhaling.
How to Avoid It
- If you use a nasal pillow mask or nasal mask, consider also using a chinstrap. CPAP chinstraps gently keep your mouth closed while sleeping, and are designed to be used along with your CPAP device.
- No matter what type of mask you prefer, a CPAP humidifier will add moisture to soften your airflow.
3. Dry Eyes
If you wake up to dry eyes it’s a sure sign of a mask leak. The escaping air blows across your face, drying your eyes while you sleep. You may not even notice, as the amount of leakage can change with your sleeping position throughout the night.
How to Avoid It
- Before anything else, make sure your mask fits properly. Readjust the fit while lying in your preferred sleeping position, since your face shape changes when you lay down.
- Make sure your headgear isn’t too loose or too tight. It’s obvious how loose straps can allow air to escape, but an overly tight fit can also cause leaks by preventing your cushion from sealing properly.
- If your type of mask requires your cushion to inflate, hold it slightly above your face to give it time to build up CPAP pressure.
- f your mask still leaks after refitting, it may be time to replace it. To keep your sleep therapy effective you should replace your cushions every 2-4 weeks, your mask frame every 3 months, and your headgear every 6 months.
4. Bloating, Burping, and Gas
With higher pressure settings comes the chance of swallowing air– a condition referred to as ‘aerophagia’. When the flow of continuous positive airway pressure becomes difficult to breathe against, it can end up redirecting into your esophagus. Symptoms of aerophagia are bloating, burping, stomach pain, and passing gas.
How to Avoid It
- Talk to your doctor or sleep specialist about adjusting your pressure settings. You should never attempt to adjust your pressure settings without the supervision of a doctor or sleep specialist.
5. Difficulty Exhaling
While most CPAP users adjust well to their therapy, some people may find it difficult to exhale against the continuous flow of air. This can lead to the sensation of shortness of breath even though enough air is allowed.
How to Avoid It
- First, try your CPAP machine’s exhalation relief settings. This is usually called EPR, A-Flex, C-Flex, or SmartFlex. No matter what it’s called, it reduces the pressure of your airflow during exhalation.
- Talk to your doctor or sleep specialist about adjusting your pressure settings. You should never attempt to adjust your pressure settings without the supervision of a doctor or sleep specialist.
- Ask your doctor about switching to an APAP machine. APAPs, or AutoCPAP machines, use advanced algorithms to monitor your breathing pattern and adjust your pressure according to your needs.
- In some cases, your doctor may recommend using a BiPAP machine. BiPAPs, or Bi-Level CPAPs, provide two different pressure settings. A higher pressure during inhalation gives you the support you need to prevent apnea, while a lower pressure during exhalation allows a more natural breathing pattern.
6. Skin Irritation and Acne
Your CPAP mask can collect skin oils, dead skin cells, and sweat while you sleep, which can lead to the build up of germs and bacteria. This build up can cause skin irritation, rash, acne, and sores.
How to Avoid It
- It’s important to regularly wash your CPAP mask with soap and water, and replace your cushions every 2-4 weeks. Even with regular cleaning, micro-tears in the silicone or foam can collect germs over time.
- Mask liners and mask gel can help prevent the build up of sweat and skin oil, while also helping to promote a proper mask seal.
7. Claustrophobia
New CPAP users may find it difficult to adjust to the feeling of wearing a CPAP mask and tubing. This is especially true for those who require a full face mask. While the feeling usually goes away with time and practice, it can make it difficult to get into the habit of regularly using your CPAP machine.
How to Avoid It
- Introduce yourself to CPAP therapy gradually by using it while awake for short periods of time. Then try putting your CPAP mask on (with your CPAP device turned on) when reading or watching TV in bed.
- Consider switching to a nasal pillow mask or nasal mask, which have a smaller profile and a wider field of vision.
- If you require a full face mask consider a minimal-contact design, like the ResMed AirFit F30 or the DreamWear Full Face mask.
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