Goldwater Institute v. Hhs

FILED
NOT FOR PUBLICATION
MAR 24 2020
UNITED STATES COURT OF APPEALS MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS

FOR THE NINTH CIRCUIT

GOLDWATER INSTITUTE, No. 19-15615

Plaintiff-Appellant, DC No. 2:15 cv-1055 SRB

v.
MEMORANDUM*
U.S. DEPARTMENT OF HEALTH &
HUMAN SERVICES,

Defendant-Appellee.

Appeal from the United States District Court
for the District of Arizona
Susan R. Bolton, District Judge, Presiding

Argued and Submitted February 7, 2020
Arizona State University, Phoenix, Arizona

Before: TASHIMA, HURWITZ, and MILLER, Circuit Judges.

Goldwater Institute submitted a Freedom of Information Act (FOIA) request

to the Food and Drug Administration (FDA), seeking records related to the

approval of ZMapp, an investigational drug intended for use in treating persons

infected with the Ebola virus. The district court relied on FDA regulations to

*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
conclude that the entire contents of the FDA’s Investigational New Drug (IND) file

on ZMapp were exempt from disclosure under FOIA Exemption 4, 5 U.S.C. §

552(b)(4), and granted summary judgment in favor of the Department of Health

and Human Services (HHS). Goldwater timely appeals.

We have jurisdiction pursuant to 28 U.S.C. § 1291, and we review the grant

of summary judgment de novo. Animal Legal Def. Fund v. FDA, 836 F.3d 987,

990 (9th Cir. 2016) (en banc) (per curiam). We vacate the order granting summary

judgment and remand for further proceedings.

1. The district court erred in allowing the FDA to rely on its regulations

governing the confidentiality of IND files to withhold the entire ZMapp file,1 rather

than requiring the agency to meet its burden of showing that a paticular FOIA

exemption applies to the records it withheld. See Hamdan v. U.S. Dep’t of Justice,

797 F.3d 759, 772 (9th Cir. 2015); Civil Beat Law Ctr. for the Pub. Interest, Inc. v.

Ctrs. for Disease Control & Prevention, 929 F.3d 1079, 1089 (9th Cir. 2019)

(“[O]ur general FOIA requirement [is] that, ‘[t]o justify withholding, the

government must provide tailored reasons in response to a FOIA request. It may

1
See, e.g., 21 C.F.R. §§ 601.50 (providing, in part, that the existence of
an IND notice will not be disclosed unless previously publicly disclosed), 601.51
(similarly providing, in part, that information in a biological product file is not
available for public disclosure unless previously disclosed).
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not respond with boilerplate or conclusory statements.’” (quoting Shannahan v.

IRS, 672 F.3d 1142, 1148 (9th Cir. 2012))).

By concluding that FDA regulations governing IND applications barred

disclosure of the IND file in toto, the court essentially concluded that the FDA

regulations are coterminous with Exemption 4. This approach, however, is

inconsistent with FOIA’s “pro-disclosure purpose” and the requirement that we

interpret its exemptions narrowly. Animal Legal Def. Fund v. USDA, 933 F.3d

1088, 1096 (9th Cir. 2019).

In order to claim Exemption 4, the FDA must establish that the information

is (1) commercial or financial, (2) obtained from a person, and (3) privileged or

confidential. 5 U.S.C. § 552(b)(4); Food Mktg. Inst. v. Argus Leader Media, 139

S. Ct. 2356, 2362 (2019). The FDA’s Vaughn index and affidavits did not address

the requirements of Exemption 4, but cited only FDA regulations governing IND

applications. On appeal, the FDA again relies on broad, general arguments about

the confidentiality of IND files, rather than addressing the specific documents at

issue here and showing how they fall under Exemption 4 of FOIA. “No effort is

made to tailor the explanation to the specific document withheld.” Wiener v. FBI,

943 F.2d 972, 978–79 (9th Cir. 1991).

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 When examined under the requirements of Exemption 4, the FDA’s blanket

refusal to produce any records from the IND file does not warrant summary

judgment in its favor. For example, although the FDA argues that all records at

issue were obtained from a person as required by Exemption 4, so far as we are

able to determine from the record, that is incorrect. Of the 58 records Goldwater

seeks, it appears from the Vaughn indices that 41 are internal FDA emails, and 3

are FDA emails to others.2 Only 11 of the records sought are correspondence from

the commercial and expanded access IND sponsors (lines 38, 60, 72, 80, 81, 83,

85, 89, 101, 105, and 109). Two of the records are from the foreign treatment

provider (lines 82 and 86), and one is the expanded access IND sponsor’s

submission of updated forms (line 107). The FDA’s broad assertion is insufficient

to establish that all of the information in the documents is obtained “from a

person” for purposes of Exemption 4.

2
The following lines in the Vaughn index are internal FDA emails: 2,
3, 7, 8, 13, 16, 19, 22, 23, 27-34, 41, 43, 44, 47-50, 56-58, 76, 79, 91-98, 100, 104,
111, and 113. Line 18 is an “FDA email to commercial and expanded access IND
sponsors responding to email dated 08/01/14 at 7:30 PM and addressing timing of
expanded access IND submission.” Line 103 is an “FDA email to expanded access
IND sponsor and third party treatment provider holding the ZMapp to be imported
for use under the expanded access IND number and discussing submission of
paperwork.” Line 110 is an “FDA email to expanded access and commercial IND
sponsors responding to the email dated 09/14/14 at 7:04 PM regarding importation
of ZMapp for use under expanded access IND.”
4
 Nor do the affidavits submitted establish that the withheld documents

contain confidential commercial or financial information covered by Exemption 4.

The agency’s argument boils down to the assertion that the documents must

contain such information because they are in the IND file.3 But this is insufficient

under FOIA. See Wiener, 943 F.2d at 983 (rejecting the CIA’s reliance on an

affidavit that stated, without justification, that “‘disclosure of [the withheld]

portions reasonably could be expected to lead to identification of the source of the

information’”).

The FDA may, of course, rely on affidavits to establish that certain

documents are exempt from disclosure, but it must sufficiently explain why the

documents qualify under Exemption 4. See, e.g., Hamdan, 797 F.3d at 774 (FBI

affidavits gave specific explanations for withholding of particular groups of

documents); Berman v. CIA, 501 F.3d 1136, 1139–44 (9th Cir. 2007) (CIA

declaration explained information in documents and possible consequences of

disclosure); Lion Raisins Inc. v. U.S. Dep’t of Agric., 354 F.3d 1072, 1080 (9th

3
The reason given in the Vaughn index for withholding lines 3,7, 16,
18, 23, 38, 60, 72,79, 91, 92, 93, 94, 95, 101, 103, 105, 107, 109, 110, and 111 was
that “the document is protected from disclosure by FDA regulations because it
pertains to ZMapp, an investigational new drug, and an expanded access IND for
emergency treatment use of ZMapp.” Cf. Hamdan, 797 F.3d at 775 (“the same
explanation was not repeated unthinkingly for each document”).
5
Cir. 2004) (USDA declarations included “detailed and specific descriptions” of

documents withheld and the competitive harm that could result from their

disclosure), overruled in part on other grounds by Animal Legal Def. Fund, 836

F.3d at 990.

We do not discount the FDA’s expressed policy concerns regarding the need

to protect confidential information in IND applications. Nonetheless, on the

present record, the agency has failed to meet its burden of establishing that the

documents it withheld are exempt from disclosure under Exemption 4. We

therefore vacate and remand so that the district court can determine whether, under

established FOIA criteria, the documents at issue are exempt from disclosure under

Exemption 4. As part of its review on remand, the district court may also consider

whether information in the documents is exempt from disclosure under Exemption

5 or Exemption 6.4

2. On remand, the district court also must make a finding of

segregability as to any documents which the court concludes the agency may

4
Goldwater challenges only the district court’s determination as to
Exemption 4, raising no challenge about records withheld under Exemptions 5 and
6. However, the district court did not specify in its January 2018 order which
records were exempt under Exemptions 5 and 6. Although Goldwater originally
sought 58 records, the parties seemed to agree at oral argument that as few as 29
documents might be at issue on appeal under Exemption 4.
6
withhold. See Hamdan, 797 F.3d at 778–79 (“We have held that ‘[i]t is reversible

error for the district court “to simply approve the withholding of an entire

document without entering a finding on segregability, or the lack thereof,” with

respect to that document.’” (quoting Wiener, 943 F.2d at 988)); Yonemoto v. Dep’t

of Veterans Affairs, 686 F.3d 681, 688 (9th Cir. 2012) (“An agency may withhold

only that information to which the exemption applies, and so must provide all

‘reasonably segregable’ portions of that record to the requester.” (quoting 5 U.S.C.

§ 552(b))), overruled in part on other grounds by Animal Legal Def. Fund, 836

F.3d at 990.

VACATED and REMANDED. Goldwater shall recover its costs on

appeal.

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