FDA defeats lawsuit by lawyer vying to shield identity in inspection report
By Mike Scarcella
Nov 25 (Reuters) -A judge has dismissed a lawsuit against the U.S. Food and Drug Administration by a lawyer who objected to being identified in an FDA inspection report.
U.S. District Judge Amy Berman Jackson in Washington on Friday said the unidentified lawyer failed to show that the agency was legally required to maintain the person's anonymity.
“Binding circuit authority compels this court to find that the complaint does not allege unlawful agency action,” Jackson wrote.
An attorney for the anonymous lawyer did not immediately respond to requests for comment. The FDA had no immediate comment on the order.
The attorney’s lawsuit and FDA response did not name the company that was the focus of the inspection.
The lawsuit cited fears by the lawyer that being identified in the report could lead to reputational harm or disciplinary action from attorney licensing authorities. The FDA report wrongly linked the attorney to an allegation of non-compliance in 2022 with federal rules, according to the lawsuit
The FDA report at issue — Form 483 — is sent to a company's management after an investigator finds "any conditions that in their judgment" could be a violation of federal food-and-drug laws.
The FDA argued in seeking dismissal of the lawsuit that the observations of an FDA inspector "hardly constitutes evidence of untruthfulness" that might lead to an attorney misconduct hearing or harm future job chances.
The lawsuit was styled as a "reverse" federal Freedom of Information Act lawsuit, where a plaintiff tries to stop the release of information that is otherwise included in a U.S. public record.
But Jackson said there was no pending records request at the time the FDA was prepared to release its report, and so the attorney could not seek an exemption under the federal records law.
The case is J. Doe v. U.S. Food and Drug Administration et al, U.S. District Court for the District of Columbia, No. 1:23-cv-01389.
For plaintiff: David Mills of Cooley
For defendants: James McGlinchy of the U.S. Justice Department
Read more:
Lawyer can't shield identity in FDA inspection report, US says
Lawyer sues FDA to keep identity secret in public inspection report
Reporting by Mike Scarcella
Related Assets
Latest News
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.
