FILED NOT FOR PUBLICATION MAR 24 2020 UNITED STATES COURT OF APPEALS MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS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). 2 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).
3 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.,
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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). 2 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).
3 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
VACATED and REMANDED. Goldwater shall recover its costs on
appeal.