J. Donald Henson, Sr. v. HHS

In the
United States Court of Appeals
For the Seventh Circuit
____________________
No. 17-1750
J. DONALD HENSON, SR.,
Plaintiff-Appellant,
v.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.,
Defendants-Appellees.
____________________
Appeal from the United States District Court for the
Southern District of Illinois.
No. 14-CV-908 — David R. Herndon, Judge.
____________________
SUBMITTED MARCH 9, 2018 * — DECIDED JUNE 15, 2018
____________________
Before WOOD, Chief Judge, and BAUER and HAMILTON, Cir-
cuit Judges.
HAMILTON, Circuit Judge. Plaintiff J. Donald Henson, Sr.,
appeals from the district court’s grant of summary judgment
* We have agreed to decide this case without oral argument because
the briefs and record adequately present the facts and legal arguments,
and oral argument would not significantly aid the court. See Fed. R. App.
P. 34 (a)(2)(C).
2 No. 17-1750
for defendants on his claims under the Freedom of Infor-
mation Act, 5 U.S.C. § 552. We affirm.
Under the Food, Drug, and Cosmetics Act, “Class III”
medical devices are those that support or sustain human life,
that are of substantial importance in preventing impairment
of human health, or that present a potential, unreasonable risk
of illness or injury. See Riegel v. Medtronic, Inc., 552 U.S. 312,
317 (2008); 21 U.S.C. § 360c(a)(1)(A). Class III devices must un-
dergo scientific and regulatory review before they are mar-
keted. See 21 U.S.C. § 360e; 21 C.F.R. §§ 814.1 et seq.
Plaintiff Henson sent the Food and Drug Administration
requests under the Freedom of Information Act seeking doc-
uments related to the premarket approval process for a glu-
cose monitoring system. The agency produced documents re-
sponsive to Henson’s requests. He was not satisfied with the
response, so he sued, alleging that the agency failed to satisfy
its obligations under the Freedom of Information Act. The
agency then reprocessed Henson’s requests and provided
him with responsive documents totaling 8,000 pages.
In his amended complaint, Henson alleges that he is dia-
betic, that he had observed 14 deficiencies with his own glu-
cose monitor, and that he contacted the agency to relay his
concerns. Henson says that, after speaking with the Ombuds-
man for the Center for Devices and Radiological Health
(“CDRH”), the branch of the FDA responsible for overseeing
the premarket approval process, he sent the agency 46 re-
quests for documents related to the premarket approval pro-
cess for the glucose monitor. Henson also sent ten letters, la-
belled sequentially from “R-1” to “R-10,” that he contends
were new requests, but none of those letters was answered.
The FDA eventually provided Henson with more than 7,000
No. 17-1750 3
pages in response to his requests. Henson then called and
wrote to two FDA employees, insisting that the agency was
withholding documents to which he was entitled. But Hen-
son’s calls and letters went unanswered. In his complaint, he
named the agency and the two agency employees as defend-
ants. He also attached two summaries detailing the requests
that he made to the agency. Henson asked the court to order
the production of the withheld documents.
On the defendants’ motion, the district judge dismissed
the two agency employees from the case, concluding that the
Act “does not create a cause of action for a suit against an in-
dividual employee of a federal agency.” A magistrate judge
then granted the agency’s request for a stay of discovery be-
cause cases under the Act generally proceed to discovery only
after a plaintiff’s case survives a motion for summary judg-
ment. Rather than move for summary judgment, however, the
agency asked the court to stay the case so it could reprocess
Henson’s requests by conducting a new search for responsive
documents. The agency said it would give Henson documents
responsive to his requests on a rolling basis and a so-called
Vaughn index—a list of each redacted or withheld document
cross-referenced with the exemption that the agency asserts is
applicable. See Solar Sources, Inc. v. United States, 142 F.3d
1033, 1036 n.3 (7th Cir. 1998); Vaughn v. Rosen, 484 F.2d 820,
826–28 (D.C. Cir. 1973). The court granted the stay.
After the agency had reprocessed Henson’s requests, the
court lifted the stay and the agency moved for summary judg-
ment. The agency argued that it had conducted a reasonable
search for all documents responsive to Henson’s requests and
that it had properly withheld and redacted documents pursu-
ant to the exemptions to disclosure listed in 5 U.S.C.
4 No. 17-1750
§ 552(b)(4)–(6). In support of its motion, the agency provided
the affidavits of two employees: Sarah Kotler, the agency’s Di-
rector of the Division of Freedom of Information, and William
Holzerland, the Director of the Division of Information Dis-
closure for the CDRH. Their affidavits detailed the following
information: The two directors sent documents in response to
18 of Henson’s requests and to some of his letters. They did
not respond to the remainder, including Henson’s letters, be-
cause the requested materials were either outside of the Act’s
scope, duplicative of Henson’s other requests, or available on
the agency’s website. The agency also appended to its motion
tables describing the 18 requests and Henson’s “R” letters, the
scope of the search undertaken by the agency, and the pro-
duction following the stay. The affidavits also described why
the agency had redacted records pursuant to certain of the
Act’s exemptions to disclosure. The defendants did not file
with their motion for summary judgment the Vaughn indices
themselves. The agency later said it withheld them so as not
to burden the district court.
Judge Herndon granted summary judgment for the de-
fendants. He first determined that the affidavits established
that the agency performed an adequate search for the docu-
ments requested by Henson. The judge also concluded that
the agency had applied the Act’s exemptions correctly to
withhold or redact documents: exemption 4 for trade secrets
relating to the raw materials used to manufacture the glucose
monitor, the raw materials used in the testing process, and the
pump’s battery film; exemption 5 for “pre-decisional and de-
liberative” agency documents; and exemption 6 for docu-
ments that identified patients who had reported feedback to
the agency or the manufacturer of the glucose monitor and
No. 17-1750 5
those patients’ medical histories, as well as agency employ-
ees’ cell-phone numbers and the personal email addresses of
the manufacturer’s employees. See § 552(b)(4)–(6).
On appeal, Henson raises three challenges. First, he argues
that the district court should not have dismissed one of the
agency employees as a defendant. He contends the discipli-
nary provisions of § 552(a)(4)(F) cannot be enforced unless in-
dividual agency employees are proper defendants under the
Act. Second, he argues that the magistrate judge erred by
staying the case pending the agency’s motion for summary
judgment. Third, Henson argues generally that the district
court erred in granting summary judgment on the merits. We
address these arguments in turn.
First, we agree with the district court that the Act does not
authorize suits against the individuals named in Henson’s
complaint. Under 5 U.S.C. § 552(a)(4)(B), “on complaint, the
district court . . . has jurisdiction to enjoin the agency from
withholding agency records and to order the production of
any agency records improperly withheld from the complain-
ant.” (Emphasis added.) The statute defines “agency” as
“each authority of the Government of the United States,
whether or not it is within or subject to review by another
agency, but does not include—(A) the Congress; (B) the courts
of the United States; (C) the governments of the territories or
possessions of the United States; (D) the government of the
District of Columbia.” 5 U.S.C. § 551(1). An individual em-
ployee is not an “agency” as defined by the Act. The district
court properly dismissed the claims against the two agency
employees.
Henson resists this conclusion by arguing that
§ 552(a)(4)(F) allows suits against individuals. That provision
6 No. 17-1750
allows the court, when ordering the production of records, to
question whether agency personnel have acted arbitrarily or
capriciously and whether discipline is warranted. But under
the statute, the issue of any discipline is left to the agency, not
a court. See id. We agree with our colleagues in other circuits
that a plaintiff may not sue an individual agency employee
for violating the Freedom of Information Act. See Drake v.
Obama, 664 F.3d 774, 785–86 (9th Cir. 2011); Batton v. Evers, 598
F.3d 169, 173 n.1 (5th Cir. 2010); Martinez v. Bureau of Prisons,
444 F.3d 620, 624 (D.C. Cir. 2006) (noting that Privacy Act and
Freedom of Information Act “concern the obligations of agen-
cies as distinct from individual employees of those agencies”);
see also Bavido v. Apfel, 215 F.3d 743, 747 (7th Cir. 2000) (stat-
ing that Privacy Act authorizes suits against only agencies,
not individuals).
Second, the magistrate judge did not err by staying dis-
covery and setting a briefing schedule for summary judg-
ment. Henson argues that the judge’s decision constituted an
improper order “directing” the agency to file a motion for
summary judgment. He also contends that the judge lacked
authority to set a briefing schedule because no written referral
from the district judge exists in the record.
We do not understand the magistrate judge’s order as
Henson does. The magistrate judge reasoned that, in cases un-
der the Freedom of Information Act, it is prudent to entertain
summary-judgment motions before discovery. The magis-
trate judge’s decision to grant the stay and set a briefing
schedule was within his considerable discretion to manage
the court’s docket to ensure the “just, speedy, and inexpen-
sive” resolution of this case. See Fed. R. Civ. P. 1, 6(b); Dietz
No. 17-1750 7
v. Bouldin, 136 S. Ct. 1885, 1891–92 (2016); Keeton v. Morn-
ingstar, Inc., 667 F.3d 877, 884 (7th Cir. 2012). Also, the lack of
a more specific written referral to the magistrate judge does
not matter here. The district court’s local rules establish that
most non-dispositive pretrial civil motions, including mo-
tions to stay discovery, are to be handled by a magistrate
judge. See S.D. Ill. Civ. L.R. 72.1(a)(1); see also 28 U.S.C.
§ 636(b)(1)(A).
Third, we turn to the merits of the district court’s grant of
summary judgment. Henson disputes both the adequacy of
the agency’s search and the applicability of the Act’s exemp-
tions 4, 5, and 6 in this case.
We begin with whether the agency’s search was adequate,
a question that we review de novo. See Rubman v. U.S. Citizen-
ship & Immigration Servs., 800 F.3d 381, 388 (7th Cir. 2015). To
prevail on summary judgment on a claim under the Act, the
agency must demonstrate that there is no genuine issue of
material fact about the adequacy of its search. See id. at 387.
An agency “must show that it made a good faith effort to con-
duct a search for the requested records, using methods which
can be reasonably expected to produce the information re-
quested.” Id., quoting Oglesby v. U.S. Dep’t of Army, 920 F.2d
57, 68 (D.C. Cir. 1990). Good faith is presumed, and it can be
reinforced by evidence of the agency’s attempts to satisfy the
request. See id. To support an agency’s assertion that it con-
ducted a reasonable search, the agency may offer non-conclu-
sory affidavits. See Matter of Wade, 969 F.2d 241, 249 n.11 (7th
Cir. 1992). The affidavits must be reasonably detailed, set
forth the search terms used in electronic searches and the kind
of search performed by the agency, and aver that all files
8 No. 17-1750
likely to contain responsive documents were searched. See
Rubman, 800 F.3d at 387, quoting Oglesby, 920 F.2d at 68.
The undisputed facts show here that the agency’s search
for responsive documents was reasonable. Holzerland’s affi-
davit establishes that the agency searched its database by the
premarket-approval number assigned to the glucose monitor
Henson inquired about. The agency also had the recipients of
Henson’s letters and those representatives with whom Hen-
son had met search their files for responsive documents. Kot-
ler attested that, in response to Henson’s request for docu-
ments about a meeting he had with the agency’s general coun-
sel, the general counsel searched his files. Other documents
responsive to Henson’s requests of the ombudsman were
identified, Kotler described, through a search of files. Kotler
also detailed how Henson’s other requests were handled in a
similar manner. The agency also provided Henson with re-
sponsive documents after reviewing the documents and cre-
ating a Vaughn index. Henson has no basis for suggesting that
these were not reasonable efforts to locate responsive docu-
ments to his many (and often repetitive) requests. We agree
with the district court that the agency undertook a search rea-
sonably calculated to uncover all relevant documents.
We next turn to whether the agency properly withheld or
redacted documents pursuant to the Act’s exemptions. We ex-
amine de novo whether the district court had an adequate fac-
tual basis for its decision. See Patterson v. I.R.S., 56 F.3d 832,
836 (7th Cir. 1995). That inquiry depends on factors such as
the specificity of the agency’s affidavits, whether the judge re-
viewed the documents in camera, and whether the judge re-
viewed the Vaughn indices. See id.; Rubman, 800 F.3d at 388;
Solar Sources, 142 F.3d at 1038–39; Becker v. I.R.S., 34 F.3d 398,
No. 17-1750 9
402 (7th Cir. 1994). If a sufficient factual basis for the decision
exists, then we review the conclusion for clear error. See Ap-
pleton Papers, Inc. v. Environmental Protection Agency, 702 F.3d
1018, 1022 (7th Cir. 2012). Therefore, while we examine closely
whether the district judge had an adequate factual basis for
his conclusion that an exemption applies, we do not conduct
a de novo review of each finding. See Rubman, 800 F.3d at 388.
Henson challenges both the adequacy of the factual basis and
the applicability of exemptions 4, 5, and 6.
Henson’s challenge to the adequacy of the judge’s factual
basis fails. Henson had the agency’s Vaughn indices yet did
not point to specific claims of exemption with which he disa-
greed. Neither Henson nor the agency filed the indices with
the district court. And although Henson argued in the district
court that the agency did not narrowly construe the exemp-
tions to the Act’s disclosure mandate, as it is required to do,
see Patterson, 56 F.3d at 835–36, he never provided the judge
with the indices or pointed to specific entries that purportedly
showed that the agency improperly redacted documents.
Having failed to provide the Vaughn indices to the court,
plaintiff cannot complain here for the first time that the judge
did not have an adequate factual basis to decide the agency’s
claims of exemption. See Allen v. City of Chicago, 865 F.3d 936,
944–45 (7th Cir. 2017).
The district court would have had a stronger factual basis
for its decision if the judge had reviewed the Vaughn indices
or conducted an in camera review of at least a reasonable sam-
ple of the documents. See, e.g., Solar Sources, 142 F.3d at 1038(noting that “we might give some weight to the appellants’
argument” that a factual basis was not established by the gov-
10 No. 17-1750
ernment’s affidavit had judge not conducted in camera re-
view); Becker, 34 F.3d at 402 (concluding that judge’s decision
rested on adequate factual basis when judge reviewed docu-
ments in camera and reviewed Vaughn indices).
Still, this is an adversary process. Henson was in the better
position to focus the judge on the contested issues. He had the
ability to identify which redactions he believed were unsup-
ported, rather than objecting generally, as though every entry
in the Vaughn indices gave insufficient grounds for redaction.
Rather than ask a busy district judge to examine documents
(in this case Henson asked the judge to examine over 67,000
documents) or to parse the Vaughn indices as an original mat-
ter, it is better to put the burden on the plaintiff to identify
with particularity the claims of exemption he was challeng-
ing, at least where the Vaughn indices appear facially ade-
quate, as they do here.
We recognize that the burden remains on the government
to justify decisions not to disclose information, see 5 U.S.C.
§ 552(a)(4)(B). Insofar as we are concerned with the district
judge’s basis for his decision, the agency met its burden be-
cause it provided detailed affidavits in support of its decision
to redact information. See Rubman, 800 F.3d at 388. Moreover,
the agency produced Vaughn indices and furnished them to
Henson.
In this appeal, as a precautionary step, we opted to order
the agency to file the indices in this appeal. That is not how
future cases should proceed as a matter of course. Rather, if
Vaughn indices are created (they are not required in every
case, see, e.g., Solar Sources, 142 F.3d at 1039–40), the plaintiff
or the government should file the indices with the district
court and, if warranted, with a request to seal them. If the
No. 17-1750 11
plaintiff wishes to claim that the government has claimed in-
applicable exemptions to disclosure, the plaintiff should iden-
tify specifically which ones are disputed. In some cases, per-
haps, indices might be so opaque that it would be impossible
for the plaintiff to identify which entries in the indices are con-
tested. In other cases, the plaintiff might argue that none of
the withheld information is exempt from disclosure. In those
cases, if the plaintiff has been given a copy of the indices, they
should be filed with the court and the plaintiff should explain
why he or she cannot narrow the scope of the dispute. We de-
viated from the ordinary procedure here to ensure that the in-
dices provided Henson with a basis for objecting in a specific
manner to the agency’s claims of exemption. They did, so we
conclude that Henson needed to specify in the district court
which redactions he thought improper.
Because Henson’s challenge to the judge’s factual basis
fails, we next examine whether the judge clearly erred in up-
holding the agency’s claims of exemption. We find no clear
error.
The judge found that the agency properly invoked exemp-
tion 4 to withhold “information relating to the raw material
used in the manufacturing process, raw material used in the
testing process, and the pump’s battery film.” Exemption 4
protects from disclosure “matters that are … trade secrets and
commercial or financial information obtained from a person
and privileged or confidential.” 5 U.S.C. § 552(b)(4). We have
suggested that this exemption applies when disclosing the
contested information would cause “substantial competitive
harm to the firm that owns the information.” General Elec. Co.
v. NRC, 750 F.2d 1394, 1402–03 (7th Cir. 1984), citing National
Parks & Conservation Ass’n v. Kleppe, 547 F.2d 673, 681–84 (D.C.
12 No. 17-1750
Cir. 1976). The Act does not define “trade secret,” and there is
some disagreement about the scope of this exemption. See
New Hampshire Right to Life v. Dep’t of Health and Human Servs.,
136 S. Ct. 383 (2015) (Thomas, J., dissenting from denial of cer-
tiorari); Anderson v. Dep’t of Health & Human Servs., 907 F.2d
936, 944 (10th Cir. 1990) (adopting definition of “trade secret”
narrower than agency’s definition); see also 18 U.S.C.
§ 1839(3) (defining “trade secret” for purposes of criminal
law). We do not decide which approach is best here because
Henson’s challenge fails under every approach.
We see no clear error in the judge’s determination that the
materials used to manufacture the glucose monitor and its
battery film were exempt from disclosure as trade secrets or
were otherwise confidential. Henson provided no evidence to
the district judge contradicting Holzerland’s declaration that
the agency redacted information relating to the materials
used to make the monitor and its battery film. The Vaughn in-
dices confirm that the agency limited its redactions pursuant
to exemption 4 to these kinds of information. There is no evi-
dence that the manufacturer of the glucose monitor disclosed
the information that the agency redacted, nor is there evi-
dence that the raw materials do not have economic value by
virtue of remaining confidential. Because there is no evidence
that the materials used to make the monitor and the battery
film have been made public, there is no reason to doubt that
substantial competitive harm could befall the manufacturer if
that information were released to the public.
The district judge also did not clearly error in finding that
exemption 5 applied to the agency’s pre-decisional and delib-
erative documents and communications protected by the at-
No. 17-1750 13
torney-client privilege. Exemption 5 allows an agency to with-
hold “inter-agency or intra-agency memorandums or letters
that would not be available by law to a party other than an
agency in litigation with the agency.” 5 U.S.C. § 552(b)(5).
This exemption incorporates the attorney-client privilege and
the work-product privilege. See Appleton Papers, 702 F.3d at
1022; Becker, 34 F.3d at 403 n.15. The affidavits provided by
the agency set forth the categories of information that were
redacted, and the Vaughn indices detail on an individual basis
the topics discussed by the agency’s employees and the pur-
poses for the communications. Henson did not contradict any
of the agency’s representations, so we see no clear error.
Finally, there was no clear error in the judge’s determina-
tion that the agency properly applied exemption 6, which ex-
cuses the disclosure of “personnel and medical files and sim-
ilar files the disclosure of which would constitute a clearly un-
warranted invasion of personal privacy.” 5 U.S.C. § 552(b)(6).
Under exemption 6, the court must balance an individual’s
right to privacy against the Act’s policy of opening agency ac-
tion to the light of public scrutiny. See U.S. Dep’t of State v.
Ray, 502 U.S. 164, 175 (1991).
Based on the affidavits provided to the district court and
the Vaughn indices, the agency redacted medical information
about the manufacturer’s patients and the contact infor-
mation for employees of the manufacturer and the agency. We
agree with the district court that this information was pro-
tected by exemption 6 because the revelation of personal iden-
tifying information tips the scales in favor of non-disclosure.
See id. at 175–76; U.S. Dep’t of Navy v. Fed. Labor Relations Auth.,
975 F.2d 348, 350 (7th Cir. 1992) (names and home addresses
protected from disclosure by exemption 6). Moreover, the Act
14 No. 17-1750
requires transparency from the government—not the manu-
facturer’s patients and employees. See U.S. Dep’t of Justice v.
Reporters Comm. For Freedom of the Press, 489 U.S. 749, 774–75
(1989).
The judgment of the district court is AFFIRMED.