Lawyer sues FDA to keep identity secret in public inspection report

  • Law firm Cooley filed a complaint in DC federal court
  • FDA claims general policy is to not redact names of high-up officials

(Reuters) – A lawyer at a company inspected last year by the US Food and Drug Administration has sued the agency to block it from disclosing the attorney’s identity in a public report that raises questions about the business’ regulatory compliance.

The unidentified lawyer filed the lawsuit anonymously on Tuesday in Washington, DC, federal court through lawyers at law firm Cooley.

The complaint alleged that disclosing the attorney’s identity on the inspection report will cause “reputational harm that could impede the plaintiff’s ability to continue practicing as an attorney.”

Cooley filed the lawsuit as a “reverse” Freedom of Information Act case, an action in which a party wants to bar a federal agency from releasing public information.

The lawsuit, which seeks an injunction against the FDA, did not identify the company, which the complaint said was regulated by the FDA.

The lawyer’s legal team at Cooley did not immediately respond to a request for comment. The FDA declined to comment.

The FDA told the lawyer’s company in November, according to the lawsuit, that the agency “does not generally redact the names or titles of high-ranking officials.”

The lawsuit said the FDA intends to release an inspection report that includes information about the attorney.

The agency issues such as reports to the management of regulated companies after an inspection show possible regulatory compliance drawbacks. The reports are not a final determination that any company has committed wrongdoing.

The unidentified attorney did not interact with the FDA at the time of the inspection, according to the lawsuit.

Disclosing the attorney’s identity in the report, Cooley attorneys said, will “incorrectly and prematurely connect preliminary, inaccurate factual allegations against the company to plaintiff’s conduct.”

The case is J.Doe v. US Food and Drug Administration et al, US District Court for the District of Columbia, No. 1:23-cv-01389.

For plaintiff: David Mills and Victoria Pasculli of Cooley

For defendants: No appearance yet

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Reporting by Mike Scarcella

Our Standards: The Thomson Reuters Trust Principles.

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