43 F.4th 231
2d Cir.2022Background
- In Dec. 2016 Charles Seife (journalist) sought under FOIA/HHS/FDA records Sarepta submitted in the FDA approval of Exondys 51 (accelerated approval granted Sept. 19, 2016).
- FDA produced ~45,000 pages but redacted portions under FOIA Exemption 4 ("trade secrets and commercial or financial information...privileged or confidential").
- The FOIA Improvement Act (FIA, effective June 30, 2016) requires an agency to withhold only if it reasonably foresees disclosure would harm an interest protected by an exemption or is prohibited by law.
- District court granted summary judgment to FDA/HHS/Sarepta, concluding redactions fell under Exemption 4 and met the FIA foreseeable-harm requirement.
- On appeal the Second Circuit held Exemption 4 protects a submitter's commercial or financial interests in information that is of a type held in confidence and not publicly disclosed by the submitter, and found defendants’ declarations sufficiently specific to show foreseeable harm to Sarepta.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Scope of the interest protected by Exemption 4 | Harm must be shown as a measurable diminution in the economic value of the information (i.e., an economic-loss metric). | Exemption 4 protects the confidentiality of the record itself; disclosure necessarily harms that confidentiality. | Exemption 4 protects the submitter's commercial or financial interests in information that is held in confidence and not publicly disclosed by the submitter. |
| Whether the FIA "foreseeable harm" prong is met here | Publicly available or substantially similar information negates foreseeable competitive harm; Seife's declarations challenge likelihood/degree of harm. | Declarations (Sarepta and FDA) gave reasonably specific examples how competitors could exploit the unpublished clinical details, creating foreseeable commercial/financial harm. | Defendants met the FIA foreseeable-harm requirement on summary judgment; Seife failed to raise a genuine factual dispute. |
Key Cases Cited
- Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356 (2019) (interpreting the ordinary meaning of "confidential" in Exemption 4)
- Wilner v. Nat'l Sec. Agency, 592 F.3d 60 (2d Cir. 2009) (agency affidavits must describe nondisclosure justifications with reasonably specific detail)
- Larson v. Dep't of State, 565 F.3d 857 (D.C. Cir. 2009) (standards for FOIA summary judgment and agency affidavits)
- Am. Civ. Liberties Union v. Nat'l Sec. Agency, 925 F.3d 576 (2d Cir. 2019) (review standard and timing for FOIA disclosure analysis)
- U.S. Dep't of State v. Ray, 502 U.S. 164 (1991) (agency bears burden to justify withholdings)
- Grand Cent. P'ship, Inc. v. Cuomo, 166 F.3d 473 (2d Cir. 1999) (FOIA summary judgment practice)