FDA Policy/General

Court Tosses Attorney’s Privacy Suit Against FDA

The DC federal court has dismissed a complaint filed by an attorney identified as J. Doe seeking to keep the attorney’s identity secret in connection with a form FDA-483 that was scheduled to be published. The court granted an FDA motion to dismiss the complaint under the Federal Rules of Civil Procedure because it failed to state a claim for relief.

In 5/2023, the court temporarily granted the attorney’s motion to keep the identity secret, saying the attorney had met the burden of showing that privacy interests outweighed the public’s presumptive and substantial interest in learning the identity. But the court also said the decision to grant the motion would be “subject to any further consideration by the United States district judge to whom the case is randomly assigned.”

The attorney works at an FDA-regulated company that was inspected in the spring of 2022 and was issued a form FDA-483. The suit said the attorney did not interact with FDA during the inspection, but the form FDA-483 included “two factually inaccurate observations in which the FDA investigator made statements judging the actions, knowledge, and veracity of statements ascribed to the plaintiff, even though such observations were not fully investigated.” The form did not include the attorney’s name but identified the person’s role at the company, which the complaint said would readily identify the person at issue as J. Doe.

The decision says that although the attorney characterized the complaint as a “reverse-Freedom of Information Act (FOIA)” case, such cases are brought under the Administrative Procedure Act (APA) because there is no FOIA provision to stop an agency from releasing information.

Under the APA, the decision says, a claim must identify the law the challenged action contravenes. “This means that in a reverse-FOIA suit under the APA, the ‘plaintiff must show that the release of the information at issue was somehow unlawful,’ the decision says.… “Since plaintiff cannot point to any legal provision that would require withholding the information, binding Circuit authority compels this court to find that the complaint does not allege unlawful agency action.”

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