What Philips Knew and When, What Philips Did or Did Not Do, Much More, From the FDA Form 483 Inspection Report
We occasionally go "off-topic" on this Drug Injury Watch blog to report about significant safety issues involving medical products as did back in June 2021 with this post, "Products Recall: Philips Bi-Level PAP, CPAP, and Mechanical Ventilator Devices Using PE-PUR Sound Abatement Foam". That article was mostly about the potential health risks, including cancers and organ failures, for patients with polyester-based polyurethane (PE-PUR) exposures. This update about the Philips breathing devices recall focuses on the remarkable findings set forth in an FDA Form 483 issued to Philips Respironics on November 9, 2021.
The FDA conducted an inspection of the Murrayville, Pennsylvania Philips Respironics plant during the period August 26, 2021 - November 9, 2021, in connection with the June 2021 Philips breathing devices recall. The "inspectional observations" made by an FDA representative during this inspection resulted in the FDA Form 483 issued to Philips Respironics on November 9, 2021.
We start with Observation 1 from that FDA Form 483 document, captioned "Risk analysis is inadequate", which begins as follows:
Specifically, a) There is no documented investigation, risk analysis, or design failure mode effect analysis to support your firm’s rationale for which polyester polyurethane foam-containing products were affected, included, or not included in your firm’s ongoing recalls.
Now we go into more depth concerning the more remarkable findings set forth in the FDA Form 483, and the probable ramifications, by referring to a few news reports about this significant development as regards the Philips breathing devices recall.
First, from a November 16, 2021 article, "FDA inspection turns up more problems for Philips Respironics", published on the Regulatory Affairs Professionals Society (RAPS) site:
The investigation also found that Philips had ignored earlier red-flag signs that foam was breaking down and entering the breathing tube of their products, with executive-level managers having been aware of “potential foam degradation issues concerning CPAPs, BiPAPs and Trilogy ventilators since at least 1/31/2020,” wrote FDA investigator Katelyn Staub-Zamperini.
Field reports and complaints had prompted testing of the foam components as far back as 2016, with an April 2016 field sample showing “base polymer cleavage and embrittlement of the returned foam material” from the samples. The inspection found that although there were at least 14 tests or assessments, or reported incidents, from 2016 to the present when Philips was aware of problems with foam degradation or concerns about volatile organic compound (VOC) emissions, the firm made no design changes and took no field or corrective actions.
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Second, a November 15, 2021 article, "FDA Inspection of a Philips Facility Raises Red Flags", published on the Medical Device and Diagnostic Industry (MD+DI) site, covers the critical point that the FDA's findings suggest that Philips Respironics has known about the potential foam degradation issues for years. We get this excerpt from the "Philips knew about the foam degradation problem 6 years ago" part of that MD+DI article:
The investigator's report also points out that around Nov. 25, 2015, Philips was aware of a preventative maintenance servicing procedure implemented by another Philips entity on Trilogy ventilator products regarding foam degradation issues and complaints in the field. However, Philips Respironics either did not perform or did not document any further investigation, health hazard evaluation, risk analysis, or design review of the issue. The company did, however, provide the investigator with an email that the other Philips entity sent on Nov. 25, 2015, detailing the preventative maintenance procedure and timeline.
The investigator also noted on the report that there were at least 14 instances between April 1, 2016 and Jan. 22, 2021, where Philips Respironics was aware of potential foam degradation problems with various sleep and respiratory care devices, but the firm did not perform an adequate risk analysis within an appropriate time frame.
Third, from a November 15, 2021 article, "Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices", written by Shawn M. Schmitt for Medtech Insight:
Things have gone from bad to worse for Royal Philips, which has been reeling from an early summer recall of millions of breathing machines because of degraded sound abatement foam. Now the company has been slapped with multiple risk management and quality systems observations after a recent on-site facility inspection by an investigator with the US Food and Drug Administration.
In one of the more damning observations made by investigator Katelyn Staub-Zamperini during the 26 August-9 November inspection, Philips apparently opened no formal investigations after it received hundreds of thousands of complaints of particles and other contaminants when the devices were used....
The charges made by the FDA are particularly noteworthy given that Philips has been sued by users of the recalled devices because, they say, the company knew about problems with the foam for quite some time but did nothing to fix them.
Turning to the legal aspect of this matter, all of the Philips breathing devices user's lawsuits filed in federal courts around the country were consolidated last month as a Multidistrict Litigation (MDL) case, IN RE: PHILIPS RECALLED CPAP, BI-LEVEL PAP, AND MECHANICAL VENTILATOR PRODUCTS LIABILITY LITIGATION, MDL No. 3014, by means of a Transfer Order filed October 8, 2021. This Philips breathing device MDL has been assigned to federal court District Court Judge Joy Flowers Conti.
Our law firm is investigating lawsuits against Philips for patients who have been diagnosed with cancer, lung disease, and kidney or liver failure, as well as other medical conditions, following their use of these recalled Philips products:
- Philips Bi-Level Positive Airway Pressure (Bi-Level PAP) Devices
- Philips Continuous Positive Airway Pressure (CPAP) Machines
- Philips Mechanical Ventilators
For more information, see the "Philips Breathing Devices Recall: Legal Cases Overview" page on our website.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.
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