HI Michael.
Just a quick second hypothetical situation that I could potentially see FDA going after a consultant (and the company together):
Company and consultant enter into contract where the consultant is to provide advice to the company in a specific area of the regulations (whatever the area might be) for which compliance is considered mandatory and for which prior case law provides for a specific criminal act prosecution.
Consultant has held himself or herself out as an expert and the company has chosen to leverage that expertise in this area specifically because they have no member of their staff knowledgeable in the specifics. Some areas I can think of would be validation, sterilization, etc. where a very specific knowledge base is required in order to understand the design of the testing as well as the results that come from the testing.
Consultant provides not just poor advice but wrong information or wrong interpretations base upon which the company makes a decision that ultimately violates the law and leads to a potentially criminal act and prosecution. The company opines that the decision they made was based specifically on the expertise of the consultant and they can then show that they proceeded exactly as the consultant had advised and that they were not specifically knowledgeable of the area and they had brought in the consultant for the purposes of providing the necessary advice. The consultant had put themselves out as experts and the company had done their due diligence on the consultant's background (and even some reference checks).
In this specific fact pattern I could see the agency also going after the consultant legally since the advice provided to the company was wrong and the company can show a good-faith effort to ensure that they had complied and the basis of the ultimate non-compliance was the actions or advice of the consultant.
Again, I am in the same camp as most others - I have never seen this happen in 25 years but I can imaging that such a fact scenario could potentially exist at some point.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 02-Apr-2013 17:39
From: Michael Swit
Subject: FDA Taking Enforcement Action Against a Consultant
This message has been cross posted to the following Discussions: OCRA and Regulatory Open Forum .
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Folks:
I was just asked this question and could not think, off the top of my head, of an instance that fit this scenario, so I am sharing it with you.
Question:
Has anyone come across any verbage (FDA Manuals, warning letter or a court decision) where FDA has discussed -- or alleged -- that a theoretically independent consultant can be held personally liable -- either via injunction or criminal prosecution or otherwise (e.g., civil money penalties) -- for FDA violations at the company for which they were consulting at the time the violation occurred?
Note: specifically interested in FDA liability and not products liability as was alleged in the Buckman case.
Thanks,
Michael
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
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Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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