`20- 4072- cv
`Seife v. FDA, et al.
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`UNITED STATES COURT OF APPEALS
`FOR THE SECOND CIRCUIT
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`August Term 2021
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`(Argued: March 7, 2022
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`Decided: August 5, 2022)
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`Docket No. 20-4072-cv
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`CHARLES SEIFE,
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`Plaintiff-Appellant,
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`v.
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`UNITED STATES FOOD AND DRUG ADMINISTRATION,
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES,
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`Defendants-Appellees,
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`-and-
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`SAREPTA THERAPEUTICS, INC.,
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`Intervenor-Defendant-Appellee.
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`ON APPEAL FROM THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
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`Before:
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`CHIN, LOHIER, AND ROBINSON, Circuit Judges.
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`Appeal from a judgment of the United States District Court for the
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`Southern District of New York (Furman, J.), entered October 6, 2020, in favor of
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`two government agencies and a pharmaceutical company in this Freedom of
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`Information Act ("FOIA") case. Plaintiff-appellant, a science writer and
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`journalism professor, sought records from the government agencies relating to
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`the pharmaceutical company's successful application for accelerated approval of
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`a drug for the treatment of a neuromuscular disease. The agencies produced
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`over 45,000 pages of documents, some of which were redacted under Exemption
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`4 of FOIA. The district court granted summary judgment for the agencies and
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`the pharmaceutical company on the basis that the redacted information fell
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`within Exemption 4 and publication would either cause foreseeable harm to the
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`interests protected by Exemption 4 or was prohibited by law. Plaintiff-appellant
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`appeals.
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`AFFIRMED.
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`JARED CARTER (Cortelyou C. Kenney, Tyler Valeska, on
`the brief), First Amendment Clinic, Cornell Law
`School, Ithaca, NY, and Thomas S. Leatherbury,
`Vinson & Elkins LLP, Dallas, TX, and David A.
`Schulz, Media Freedom & Information Access
`Clinic, Yale Law School, New Haven, CT, for
`Plaintiff-Appellant.
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`DOMINIKA TARCYNSKA, Assistant United States
`Attorney (Benjamin H. Torrance, Assistant
`United States Attorney, on the brief), for Audrey
`Strauss, United States Attorney for the Southern
`District of New York, New York, NY, for
`Defendants-Appellees.
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`KRISTEN E. ITTIG (Daniel R. Bernstein, Stuart W. Turner,
`Amanda J. Sherwood, and Aime Joo, on the brief),
`Arnold & Porter Kaye Scholer LLP, Washington,
`DC, and New York, NY, for Intervenor-Defendant-
`Appellee.
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`CHIN, Circuit Judge:
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`In this case, intervenor-defendant-appellee Sarepta Therapeutics,
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`Inc. ("Sarepta") obtained accelerated approval from defendant-appellee the Food
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`and Drug Administration (the "FDA") for a drug Sarepta created to treat a
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`neuromuscular disease. During the approval process, which spanned some nine
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`years, Sarepta submitted tens of thousands of pages of documents to the FDA, an
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`agency within defendant-appellee Department of Health and Human Services
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`("HHS," and, together with Sarepta and the FDA, "Defendants").
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`Plaintiff-appellant Charles Seife, a science writer and journalism
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`professor who has written about FDA practices, made a request to the FDA and
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`HHS under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, for
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`documents submitted by Sarepta as part of the approval process. After the FDA
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`constructively denied his request, Seife brought this action below.
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`During the course of the lawsuit, the FDA produced over 45,000
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`pages of records but redacted some pages pursuant to Exemption 4 of FOIA,
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`which shields from disclosure "trade secrets and commercial or financial
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`information obtained from a person and privileged or confidential."
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`5 U.S.C. § 552(b)(4). The district court held that the redactions were proper
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`because the information fell within Exemption 4 and met the additional
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`requirement set by the FOIA Improvement Act of 2016 (the "FIA"). Under the
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`FIA, an agency shall withhold information under FOIA only if "the agency
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`reasonably foresees that disclosure would harm an interest protected by an
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`exemption" or if disclosure is "prohibited by law." 5 U.S.C. § 552(a)(8)(A). The
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`principal issue presented on appeal is whether the district court correctly
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`concluded that Defendants satisfied the foreseeable harm requirement. To
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`answer that question, we must first discern the interests protected by Exemption
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`4.
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`We hold that the interests protected by Exemption 4 are the
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`submitter's commercial or financial interests in information that is of a type held
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`in confidence and not disclosed to any member of the public by the person to
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`whom it belongs. Because Defendants have shown as a matter of law that the
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`contested information falls within Exemption 4 and that disclosure would
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`foreseeably harm Sarepta's commercial or financial interests, we AFFIRM the
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`district court's grant of summary judgment for Defendants and denial of
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`summary judgment for Seife.
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`A.
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`Statutory Framework
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`BACKGROUND
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`Since 1967, FOIA has provided the public the right to request access
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`to federal agency records or information. The statute reflects "a general
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`philosophy of full agency disclosure unless information is exempted under
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`clearly delineated statutory language." Dep't of the Air Force v. Rose, 425 U.S. 352,
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`360-61 (1976). Such statutory exemptions include, inter alia, Exemption 4, which
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`provides that an agency need not disclose "trade secrets and commercial or
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`financial information obtained from a person and privileged or confidential."
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`5 U.S.C. § 552(b)(4). The agency has the burden of "justify[ing] the withholding
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` 5
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`of any requested documents." U.S. Dep't of State v. Ray, 502 U.S. 164, 173 (1991).
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`"All doubts are resolved in favor of disclosure." Bloomberg, L.P. v. Bd. of Governors
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`of the Fed. Reserve Sys., 601 F.3d 143, 147 (2d Cir. 2010) (quoting Local 3, Int'l Bd. of
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`Elec. Workers v. Nat'l Labor Rels. Bd., 845 F.2d 1177, 1180 (2d Cir. 1988)) (cleaned
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`up).
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`In 2016, Congress enacted the FIA out of concern that "some
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`agencies [were] overusing FOIA exemptions." S. Rep. No. 114-4 (2015), as
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`reprinted in 2016 U.S.C.C.A.N. 321, 322. The FIA thus further limited agency
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`withholding of requested documents. This reform codified executive branch
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`policies adopting "a presumption in favor of disclosure [under FOIA]."
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`Memorandum on the Freedom of Information Act, 74 Fed. Reg. 4683, 4683 (Jan.
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`21, 2009).1
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`When enacting the FIA, Congress explicitly referenced executive actions. A
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`Senate Report explains that the FIA "codifies the policy established in January 2009 by
`President [Barack] Obama for releasing Government information under FOIA." S. Rep.
`No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321, 324. In January 2009, President
`Obama told all agencies to "adopt a presumption in favor of disclosure [under FOIA]."
`Memorandum on the Freedom of Information Act, 74 Fed. Reg. 4683, 4683 (Jan. 21,
`2009). Subsequently, on March 19, 2009, the Department of Justice ("DOJ") issued a
`memorandum that referred to President Obama's memorandum and stated that DOJ
`would "defend a denial of a FOIA request only if (1) the agency reasonably foresees that
`disclosure would harm an interest protected by one of the statutory exemptions, or (2)
`disclosure is prohibited by law." Memorandum from Eric Holder, Attorney Gen., U.S.
`Dep't of Justice, to Heads of Exec. Dep'ts & Agencies at 2 (Mar. 19, 2009) (the "2009 DOJ
`Memorandum"). The language of the FIA mirrors that of the 2009 DOJ Memorandum.
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`In relevant part, the FIA amended FOIA to provide that, for FOIA
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`requests submitted after June 30, 2016, an agency could withhold information
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`only if it showed that the information both fell within an exemption of FOIA and
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`at least one of two additional requirements was met. The requirements are that:
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`(I)
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`the agency reasonably foresees that disclosure would harm an
`interest protected by an exemption described in subsection
`(b); or
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`(II) disclosure is prohibited by law.
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`5 U.S.C. § 552(a)(8)(A)(i)(I)-(II). Hence, the agency must show that disclosure of
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`the requested information would foreseeably harm a protected interest or that
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`disclosure is prohibited by law; otherwise, it must disclose the information, even
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`if the information falls within one of the FOIA exemptions. Applicability of a
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`FOIA exemption is still necessary -- but no longer sufficient -- for an agency to
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`withhold the requested information. In essence, the FIA imposes an additional,
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`independent burden on the agency.
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`Neither the Supreme Court nor this Court nor any of our sister
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`circuits has had occasion to consider the burden imposed by the FIA in an
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`Exemption 4 case.2
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`B.
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`The Facts
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`The relevant facts are drawn from the parties' affidavits and are
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`undisputed.
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`On September 19, 2016, the FDA granted accelerated approval to
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`Exondys 51, a drug developed by Sarepta to treat Duchenne muscular dystrophy
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`("DMD"). DMD is a fatal neuromuscular disease that affects young and
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`adolescent males. In the United States, there are approximately 9,000 to 12,000
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`DMD patients.
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`Dystrophin is a protein, encoded by the dystrophin gene, that
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`strengthens muscle fibers. DMD is caused by mutations in the dystrophin gene;
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`the mutations result in a lack of dystrophin, which in turn results in loss of
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`The only FOIA exemption to receive appellate scrutiny post-FIA is Exemption 5.
`2
`See Machado Amadis v. United States Dep't of State, 971 F.3d 364, 371 (D.C. Cir. 2020)
`(holding that the "chilling of candid advice [from attorneys within an agency] is exactly
`what [Exemption 5] seeks to prevent."); cf. Nat. Res. Def. Council v. United States Env't
`Prot. Agency, 19 F.4th 177, 194 n.18 (2d Cir. 2021) (referencing the district court's
`determination that "the EPA 'reasonably foresees that disclosure' of these records
`'would harm an interest protected by' Exemption Five." (quoting 5 U.S.C.
`§ 552(a)(8)(A)(i)(I)).
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`muscle tissue and function. Genes are composed of sequences known as exons.
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`The most common type of DMD mutation deletes exons of the dystrophin gene --
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`that is, parts of the dystrophin gene -- thus misaligning the remaining parts of
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`the gene and causing reduced dystrophin production.3
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`Exondys 51 was developed to target the dystrophin gene through a
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`mechanism known as "exon-skipping." "Exon-skipping" causes the cellular
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`machinery to skip the mutated part or parts of the dystrophin gene. With the
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`mutated parts skipped, the remaining exons in the gene are read in the correct
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`alignment, resulting in a shorter but functional form of the dystrophin gene.
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`Sarepta began researching possible treatments for DMD beginning in the early
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`2000s and, after years of research, designed Exondys 51 -- also known as
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`eteplirsen -- to skip exon 51 of the dystrophin gene. Around 13% of DMD
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`mutations are amenable to exon 51 skipping, and an exon 51 mutation is the
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`most common type of mutation amongst DMD patients.
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`In scientific terminology, the misalignment is caused by a "frame shift." J. App'x
`3
`at 142. The exons -- the sequences in a gene -- are in a specific order and are read by
`ribonucleic acid ("RNA") to create proteins like dystrophin. When there is a "frame
`shift," exons are moved out of order and the RNA can no longer read the exons in the
`dystrophin gene to create dystrophin.
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`In 2007, Sarepta submitted the Exondys 51 Investigational New
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`Drug application to the FDA. Sarepta then conducted Phase 1 proof-of-concept
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`studies on the drug. As early as 2011, Sarepta moved to Phase 2 and conducted
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`two Phase 2 studies, Study 201 and Study 202. Sarepta spent over three years
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`developing the clinical study procedure for the studies, in part because of
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`experimentation on dosing approaches and quantifying dystrophin. Both studies
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`involved the same twelve DMD patients with mutations amenable to exon 51
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`skipping. Study 201 was placebo-controlled, double-blinded,4 and conducted
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`over twenty-eight weeks. Study 202, a long-term Phase 2b study, followed
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`approximately six months after Study 201. In Study 202, all patients received
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`Exondys 51.
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`The results of both studies were documented in clinical study
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`reports. Each clinical study report was approximately 100 pages long and
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`accompanied by thousands of pages of attachments with supporting data and
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`background information. These clinical study reports and the study results were
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`disseminated to only certain individuals within Sarepta; furthermore, Sarepta's
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`In a double-blind clinical study, neither the patient nor the test-giver knows
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`whether the patient is receiving the drug or the placebo. See, e.g., Nat'l Inst. of Health,
`Dictionary of Cancer Terms: Double-Blind Study, https://www.cancer.gov/publications/
`dictionaries/cancer-terms/def/double-blind-study (last visited August 5, 2022).
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`10
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`agreements with the clinical trial site included terms of confidentiality. In June
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`2015, Sarepta submitted the clinical study reports to the FDA as part of Sarepta's
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`New Drug Application. The FDA received thousands of emails and calls from
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`the public urging approval of Exondys 51.
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`On September 19, 2016, the FDA granted Exondys 51 accelerated
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`approval, a special pathway for drugs treating serious conditions and providing
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`a meaningful advantage over existing therapy. There was, however, intense
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`internal conflict within the FDA over the approval of Exondys 51. Reviewers in
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`the Division of Neurology Products, the Office of Biometrics, the Office of
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`Clinical Pharmacology, the Office of Drug Evaluation-I, and the Office of New
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`Drugs all assessed the documents Sarepta submitted in its application. These
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`reviewers unanimously recommended that Exondys 51 not be approved due to
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`deficiencies in Sarepta's clinical studies. The head of the Center for Drug
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`Evaluation and Research, Dr. Janet Woodcock, nevertheless overrode the
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`recommendation. One reviewer, the Director of the FDA's Office of Drug
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`Evaluation-I, appealed Woodcock's decision to the FDA Commissioner, Dr.
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`Robert Califf. Califf upheld Woodcock's decision on September 16, 2016.
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`11
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`In December 2016, Seife submitted his FOIA request to the FDA and
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`HHS. At the same time, he requested expedited processing. On December 21,
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`2016, the FDA denied Seife's request for expedited processing. Seife appealed
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`that denial administratively and, on April 25, 2017, the FDA denied his appeal.
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`C.
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`The Proceedings Below
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`On May 25, 2017, Seife commenced this lawsuit challenging the
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`denial of expedited processing and what was tantamount to a constructive denial
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`of his FOIA request. Soon after, Seife moved for partial summary judgment on
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`expedited processing; following meet and confers, the FDA granted Seife's
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`request for expedited processing. The parties also agreed to a schedule for
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`producing documents responsive to a narrowed FOIA request. Two of the
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`records Seife requested related to the clinical study reports: first, "[a]ll non-
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`exempt portions of the narrative portion of the Clinical Study Report ("CSR")
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`related to Study 201 and Study 202"; and, second, certain Study 201 and Study
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`202 tables, figures, and graphs as well as "protocols and protocol amendments;
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`statistical analysis plans and plan amendments." Joint App'x at 2251-52.
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`On July 28, 2017, the FDA sent records, including the clinical study
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`reports, to Sarepta for review. Throughout August 2017, Sarepta and the FDA
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`12
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`conducted rounds of adding or removing certain redactions. On September 15,
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`2017, Sarepta moved to intervene as a defendant, and the district court granted
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`Sarepta's request. Between July 24, 2017, and December 8, 2017, the FDA
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`produced approximately 45,000 pages to Seife, but redacted some pages
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`pursuant to FOIA exemptions.
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`Seife challenged certain Exemption 4 redactions, including in parts
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`of the clinical study reports and their appendices. The parties submitted cross-
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`motions for summary judgment regarding those redactions, and Seife filed an
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`additional motion to strike a declaration, that of Ian Estepan, submitted by
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`Sarepta in connection with its motion for summary judgment. On March 27,
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`2019, the district court denied Seife's motion to strike and reserved judgment on
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`the cross-motions for summary judgment pending the decision in Food Marketing
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`Institute v. Argus Leader Media, a case involving Exemption 4 of FOIA which the
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`Supreme Court had agreed to review, see 139 S. Ct. 915 (2019). At that time, the
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`district court also ordered Sarepta to re-review its redactions to make sure all
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`publicly available information had been given to Seife. Defendants ultimately
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`produced unredacted versions of some previously redacted records. The
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`Supreme Court decided Argus Leader on June 24, 2019.
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`13
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`On October 6, 2020, the district court issued its opinion granting
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`Defendants' motion for summary judgment and denying Seife's motion for
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`summary judgment. The district court concluded that Defendants' declarations
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`demonstrated that the redacted information fell within Exemption 4 and that
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`disclosure either was prohibited by law or would cause foreseeable harm to the
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`interests protected by Exemption 4. It did so, however, without specifying what
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`those protected interests were. Judgment was entered on October 6, 2020.
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`This appeal followed.
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`DISCUSSION
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`FOIA cases are often resolved by summary judgment. See, e.g.,
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`Grand Cent. P'ship, Inc. v. Cuomo, 166 F.3d 473, 478 (2d Cir. 1999). Accordingly,
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`the evidence in FOIA cases is typically limited to affidavits "in lieu of other
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`documentary or testimonial evidence." Long v. Off. of Pers. Mgmt., 692 F.3d 185,
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`190 (2d Cir. 2012). Summary judgment for the agency in a FOIA case is
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`appropriate "when the affidavits describe the justifications for nondisclosure
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`with reasonably specific detail, demonstrate that the information withheld
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`logically falls within the claimed exemption, and are not controverted by either
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`contrary evidence in the record nor by evidence of agency bad faith." Wilner v.
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`14
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`Nat'l Sec. Agency, 592 F.3d 60, 73 (2d Cir. 2009) (quoting Larson v. Dep't of State,
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`565 F.3d 857, 862 (D.C. Cir. 2009)).5
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`"We review a district court's grant of summary judgment in FOIA
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`litigation de novo." See Am. Civ. Liberties Union v. Nat'l Sec. Agency, 925 F.3d 576,
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`588 (2d Cir. 2019). Additionally, we review a district court's evidentiary rulings
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`for abuse of discretion. See Lore v. City of Syracuse, 670 F.3d 127, 155 (2d Cir.
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`2012).
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`As a threshold matter, Seife does not dispute on appeal that the
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`redacted information falls within Exemption 4. See Pl.-Appellant's Reply Br. at
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`14 (stating that "this appeal is not about whether Exemption 4 applies.").6 The
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`Seife neither suggests there was, nor offers evidence of, agency bad faith relating
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`to his FOIA request.
`6
`In any event, the information falls squarely within Exemption 4. Exemption 4
`provides that an agency need not disclose "trade secrets and commercial or financial
`information obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4).
`First, Sarepta is a person for purposes of Exemption 4. See 5 U.S.C. § 551(2) (defining a
`person as "an individual, partnership, corporation, association, or public or private
`organization other than an agency" (emphasis added)). Second, the information is
`commercial or financial in nature as relates to development of a new drug. Third, the
`information is "confidential." "At least where commercial or financial information is
`both customarily and actually treated as private by its owner and provided to the
`government under an assurance of privacy, the information is 'confidential' within the
`meaning of Exemption 4." Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366
`(2019). The record indicates that the information was available only to select
`individuals within Sarepta while outside parties signed a nondisclosure agreement, and
`that it was provided to the government under an assurance of privacy due to FDA
`regulations.
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`15
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`parties disagree, however, as to whether the information meets the additional
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`burden imposed by the FIA. In relevant part, the FIA amended FOIA to add that
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`"an agency shall withhold information under [FOIA] only if" either of the FIA's
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`two prongs were met. 5 U.S.C. § 552(a)(8)(A). The two prongs are that: (1) the
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`agency reasonably foresees that disclosure would result in harm to an interest
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`protected by a FOIA exemption, 5 U.S.C. § 552(a)(8)(A)(i)(I), or (2) disclosure is
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`prohibited by law, 5 U.S.C. § 552(a)(8)(A)(i)(II). Summary judgment for
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`Defendants was thus proper if their affidavits described the justifications for the
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`redactions with reasonably specific detail, disclosure would result in foreseeable
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`harm to an interest protected by Exemption 4 or was prohibited by law, and Seife
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`failed to present evidence to the contrary. See Wilner, 592 F.3d at 73.
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`We begin with the foreseeable harm requirement. Two questions
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`are presented: first, what are the interests protected by Exemption 4; and,
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`second, did the district court err in granting summary judgment on the basis that
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`disclosure would result in foreseeable harm to such an interest?
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`A.
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`The Interests Protected by Exemption 4
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`In statutory interpretation, "a court's proper starting point lies in a
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`careful examination of the ordinary meaning and structure of the law itself."
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`16
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`
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`Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2364 (2019). That includes
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`"reference to the language itself, the specific context in which that language is
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`used, and the broader context of the statute as a whole." Robinson v. Shell Oil Co.,
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`519 U.S. 337, 341 (1997). Our reading of a statute should "give effect, if possible,
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`to every clause and word," Duncan v. Walker, 533 U.S. 167, 174 (2001) (internal
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`quotation marks omitted), with no provision "rendered superfluous," United
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`States v. Anderson, 15 F.3d 278, 283 (2d Cir. 1994).
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`1.
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`Existing Interpretations
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`Although this is a matter of first impression for the appellate courts,
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`there are two primary competing district court interpretations of the interests
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`protected by Exemption 4.
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`First, the district court for the District of Columbia has held that the
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`interests protected by Exemption 4 are "the submitter's economic or business
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`interests." Ctr. for Investigative Reporting v. Customs and Border Prot., 436 F. Supp.
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`3d 90, 113 (D.D.C. 2019) (cleaned up). To reach that conclusion, the court
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`considered all the terms in Exemption 4, including the words "confidential,"
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`"commercial," and "financial." The district court also held that for an agency to
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`show foreseeable harm to the submitter's economic or business interests, it has to
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`17
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`demonstrate that disclosure would cause "genuine harm to the submitter's
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`economic or business interests and thereby dissuad[e] others from submitting
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`similar information to the government." Id. (cleaned up).
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`Second, the district court for the Northern District of California has
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`taken a broader approach, holding that the interest protected by Exemption 4 is
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`"the information's confidentiality--that is, its private nature." Am. Small Bus.
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`League v. Dep't of Def., 411 F. Supp. 3d 824, 836 (N.D. Cal. 2019) (emphasis
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`omitted). In doing so, the court limited its analysis to the word "confidential,"
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`concluding that "under [Argus Leader], the plain and ordinary meaning of
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`Exemption 4 indicates that" confidentiality is the protected interest. Id.
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`Not surprisingly, the parties in this case disagree as to which
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`approach we should adopt. Taking his cue from the first approach, Seife argues
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`that an agency must show harm through "diminution in the economic value of a
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`submitter's intangible property" calculated in the same way as monetary
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`damages. Pl.-Appellant's Br. at 18-19. Defendants, however, urge us to adopt
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`the American Small Business League analysis, as they argue that "the interest
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`protected by Exemption 4 is the confidentiality of the information itself." Defs.-
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`Appellees' Br. at 26; see Intervenor-Def.-Appellee's Br. at 26 (arguing that
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`18
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`
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`confidentiality is "an interest protected under the exemption"). As the district
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`court recognized in American Small Business League, confidentiality is a broad
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`interest; thus, "[d]isclosure would necessarily destroy the private nature of the
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`information, no matter the circumstance." 411 F. Supp. 3d at 836.
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`2.
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`Analysis
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`We hold that the interests protected by Exemption 4 of FOIA are the
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`commercial or financial interests of the submitter in information that is of a type
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`held in confidence and not disclosed to any member of the public by the person
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`to whom it belongs. We examine the ordinary meaning and structure of
`
`Exemption 4, looking at the words themselves, the specific context in which the
`
`words appear, "and the broader context of the statute as a whole." Robinson v.
`
`Shell Oil Co., 519 U.S. at 341; see also Abuelhawa v. United States, 556 U.S. 816, 819
`
`(2009) (explaining that "statutes are not read as a collection of isolated phrases").
`
`Exemption 4 covers "trade secrets and commercial or financial
`
`information obtained from a person and privileged or confidential."
`
`5 U.S.C. § 552(b)(4). For purposes of this case, Exemption 4 protects information
`
`that is "commercial or financial," "obtained from a person," and "confidential."
`
`All these clauses limit the scope of Exemption 4 and thus define its protected
`
`
`19
`
`
`
`interests, as we must "give effect, if possible, to every clause and word." Walker,
`
`533 U.S. at 174.
`
`The plain text of Exemption 4 indisputably protects confidential
`
`information. But it protects only certain confidential information, namely,
`
`confidential information that is commercial or financial in nature. The statute
`
`therefore contemplates harm specifically to commercial or financial interests.
`
`Furthermore, the confidential commercial or financial information must be
`
`obtained from a person. That requirement indicates the contemplated harm is to
`
`the person from whom the agency receives the confidential information -- that is,
`
`the submitter. Thus, the protected interests are the submitter's commercial or
`
`financial interests, and the FIA's foreseeable harm requirement refers to harm to
`
`the submitter's commercial or financial interests.7
`
`
`We reject Seife's proposition that harm must be "measured by the diminution in
`7
`the economic value of the information to the submitter," Pl.-Appellant's Br. at 27,
`because we find no support for that reading in the statutory text. Furthermore, a court
`is well-equipped, when looking at the evidence in the record, to foresee whether a
`specific identifiable harm to a submitter's commercial or financial interests will occur
`without being restricted to finding a measurable diminution in economic value. See S.
`Rep. No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321, 328 ("The standard
`mandates that an agency may withhold information only if it reasonably foresees a
`specific identifiable harm to an interest protected by an exemption.").
`
`20
`
`
`
`
`
`
`
`The "specific context in which that language is used" and the
`
`"broader context of the statute as a whole" reinforce our conclusion. Robinson,
`
`519 U.S. at 341. The FIA amended FOIA to add an independent statutory
`
`requirement that an agency must meet to withhold information. The specific
`
`context of the language used makes clear that, at least in Exemption 4 cases, the
`
`FIA requirement poses an additional burden on the withholding agency.
`
`Congress explicitly wrote that the FIA does not apply to information withheld
`
`under Exemption 3. 5 U.S.C. § 552(a)(8)(B) ("Nothing in this paragraph requires
`
`disclosure of information that is . . . otherwise exempted from disclosure under
`
`[Exemption 3]."). But the statute says nothing about excluding Exemption 4.
`
`Defendants argue that we should look only at the word
`
`"confidential" and hold that the interest protected by Exemption 4 is simply
`
`"confidentiality." If we were to accept that interpretation, any and all
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`confidential information would be exempt from disclosure, for disclosure "would
`
`necessarily destroy the private nature of the information" and confidentiality --
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`the interest purportedly protected by Exemption 4 -- would necessarily be
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`harmed. Am. Small Bus. League, 411 F. Supp. 3d at 836.
`
`
`21
`
`
`
`Defendants' position is belied by both the structure of the statute
`
`and common sense. Congress expressly enacted the FIA to address situations
`
`where information would fall within an exemption and yet no harm would result
`
`from disclosure, emphasizing that in those circumstances the information must
`
`be disclosed. See S. Rep. No. 114-4 (2015), as reprinted in 2016 U.S.C.C.A.N. 321,
`
`322-24 (stating that agencies were "relying on these discretionary exemptions
`
`. . . even though no harm would result from disclosure"). The foreseeable harm
`
`requirement must be met independently from the elements of the exemption;
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`otherwise, the FIA adds nothing.
`
`
`
`
`
`In arguing that the interest protected by Exemption 4 is the
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`"confidentiality of the record maintained by the person who submitted that
`
`record to the government," Defs.-Appellees' Br. at 29, Defendants rely on Argus
`
`Leader. The crux of their argument is that the Supreme Court squarely held in
`
`Argus Leader that the interest protected by Exemption 4 is confidentiality. See id.
`
`at 29 ("[Argus Leader] thus makes clear that the 'interest protected by' Exemption
`
`4 is . . . the confidentiality of the record."). We are not persuaded.
`
`
`
`
`
`Defendants' reliance on Argus Leader is unfounded. In Argus Leader,
`
`the Supreme Court answered the question whether the term "confidential" in
`
`
`22
`
`
`
`Exemption 4 should be given its ordinary meaning. Argus Leader Media, 139 S.
`
`Ct. at 2363. The Supreme Court did not once mention the FIA or what interests
`
`Exemption 4 protects, and for good reason -- the underlying FOIA request in that
`
`case was filed prior to the FIA's effective date.
`
`
`
`
`
`Here, we answer an entirely different question -- rather than
`
`consider the meaning of an isolated term, we consider which interests are
`
`protected by Exemption 4 as a whole. That is a question the Supreme Court
`
`neither answered nor had cause to answer in Argus Leader. At bottom, Argus
`
`Leader interpreted one word. While the focus on confidentiality was appropriate
`
`in that context -- where the only question was the definition of "confidential" -- it
`
`is not appropriate here, where we must read the statute in its entirety. In fact, as
`
`Defendants ignore, Argus Leader itself acknowledged commercial or financial
`
`limitations to confidentiality in the terms of Exemption 4. Compare id. at 2364
`
`("Exemption 4 protects information 'which would customarily not be released to
`
`the public by the person from whom it was obtained' such as 'business sales
`
`statistics' and 'customer lists'" (quoting S. Rep. No. 813, 89th Cong., 1st Sess., 9
`
`(1965)) (emphasis added)) with Defs.-Appellees' Br. at 29 (omitting the
`
`emphasized portion).
`
`
`23
`
`
`
`
`
`
`
`In conclusion, we hold that the interests protected by Exemption 4
`
`are the submitter's commercial or financial interests in information that is of a
`
`type held in confidence and not disclosed to any member of the public by the
`
`person to whom it belongs. An agency in a FOIA case can therefore meet the
`
`foreseeable harm requirement of the FIA by showing foreseeable commercial or
`
`financial harm to the submitter upon release of the contested information.
`
`B.
`
`Summary Judgment
`
`
`
`
`
`Thus, to be entitled to summary judgment, Defendants' submissions
`
`had to "describe the justifications for nondisclosure," that is, why the release of
`
`the information would harm Sarepta's commercial or financial interests, in
`
`"reasonably specific detail." Wilner, 592 F.3d at 73 (quoting Larson, 565 F.3d at
`
`862). Moreover, the showing of harm to Sarepta's commercial or financial
`
`interests could not be controverted by contrary evidence in the record. See id.
`
`
`
`
`
`
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`
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`a.
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`Affidavits in the Record
`
`In support of their motions for summa
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