Claims FDA Report "[D]id not necessarily relate specifically to the issue that led to the recall"
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In our last blog post, "Philips CPAP and BiPAP Replacement Foam May Continue to Cause Issues", we reported on the November 12, 2021, Food and Drug Administration (FDA) update regarding the June 2021 recall of some Philips Respironics ventilators, CPAP, and BiPAP machines. Since then, the Philips Respironics CEO has pushed back on recent claims that the company failed to properly investigate complaints about its ventilators, CPAP, and BiPAP machines.
As background, based on some observations made during the FDA's inspection of a Philips manufacturing plant, the FDA expressed concerns regarding the new foam replacement part for the defective sound abatement component which patients would receive when they participated in the Philips repair-and-replace program. At the time of our last blog post, "Philips CPAP and BiPAP Replacement Foam May Continue to Cause Issues", the findings of the manufacturing facility inspection led the FDA to request additional independent testing.
Next, as reported in our Drug Injury Watch blog post "Philips Breathing Devices Recall Update: FDA Releases Explosive New Findings in November 2021", this same FDA inspection of the Philips manufacturing facility led to the discovery that Philips supposedly did not open any formal investigations concerning complaints about the defective sound abatement component made by users of the recalled ventilators, CPAP, and BiPAP machines.
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In this December 2021 article, "‘A Very Broad Search’: Philips Pushes Back On FDA Claim Of 222,000 Uninvestigated Complaints", the Philips Respironics CEO, Frans van Houten, commented on the second aspect of those FDA inspection findings. Essentially, the company thinks that the number of complaints made by users was widely overcounted:
“The complaints that were referenced by the FDA are the result of a very broad search. Therefore, the complaints did not necessarily relate specifically to the issue that led to the recall,” van Houten said. “Not all entries in the database actually are a safety issue or a defect. Together with the FDA we have to go through the details and demonstrate what is related to the particulates and what were innocent queries.”
The FDA-483 also charges that management at Philips was “aware of potential foam degradation issues concerning CPAPs, BiPAPs and Trilogy ventilators” since January 2020 – and perhaps even earlier. All of this means Philips could be staring down the barrel of a forthcoming warning letter from the agency, an industry veteran told Medtech Insight on 17 November at the WCG-FDAnews 16th Annual FDA Inspections Summit.
The company’s problems “could lead to a warning letter,” Ballard Graham said. “It could lead to something more stringent as well because if they have a management culture that apparently ignores issues that come up – kind of push them to the back burner – then [FDA] is going to look at other things in [their quality] system to see, ‘What else are you ignoring? What else are you not paying attention to?’” Graham was a compliance VP at Abbott for 13 years following a 31-year stint at the FDA, where he was an investigator, branch director and district director.
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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