Henson v. Department of Health and Human Services et al

Filing 112

ORDER DISMISSING CASE: The Court GRANTS 89 MOTION for Summary Judgment filed by Food & Drug Administration, Department of Health and Human Services. This case is DISMISSED with prejudice. The Clerk of the Court is directed to enter judgment accordingly. Signed by Judge David R. Herndon on 3/23/17. (lmp)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF ILLINOIS
J. DONALD HENSON, SR.,
Plaintiff,
v.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES and FOOD & DRUG
ADMINISTRATION,

No. 14-cv-908-DRH-DGW

Defendant.
MEMORANDUM & ORDER
HERNDON, District Judge:
I.

Introduction

Before the Court is a motion for summary judgment brought by defendants
Department of Health and Human Services and Food & Drug Administration
(Doc. 89). Defendants seek summary judgment in their favor as to plaintiff J.
Donald Henson, Sr.’s (Henson) complaint alleging a cause of action under the
Freedom of Information Act (“FOIA”). Henson opposes defendants’ motion (Doc.
91). For the following reasons, defendants’ motion is GRANTED.
II.

Background

On August 19, 2014, plaintiff Henson, a former employee of the Food &
Drug Administration (“FDA), filed this pro se action against the Department of
Health and Human Services (HHS), the Food & Drug Administration (FDA), and

Page 1 of 16

two individual FDA officials, Frederick J. Sadler and Sarah Kotler, claiming that
they violated the Freedom of Information Act (“FOIA”), 5 U.S.C. 552 (Doc. 39) 1.
Henson later filed two amended complaints, the second of which was filed on
December 5, 2014 (Doc. 39). Henson alleges that the FDA denied the majority of
his 46 individual FOIA requests by failing to properly acknowledge receipt or
assign each with a “tractable FOI-ID-#” (Doc. 39, ¶ 5).

2

However, as recorded in

the Agency Information Management Systems (AIMS), between November 2011
and August 2014, Henson submitted 18 FOIA requests to the FDA (Doc. 89). FDA
aggregated several of those requests, pursuant to its regulations, because of their
overlapping nature (Docs. 89-1, ¶ 17 & 89-5, ¶ 16). See also 21 C.F.R. § 20.42.
The majority of the records sought by Plaintiff Henson were related to FDA’s
premarket approval of a particular device, PMA P980022, and its supplements.
PMA P980022 is an application by Medtronic Minimed Inc. for a continuous
glucose monitoring system, which is a Class III device which was approved by the
FDA on June 15, 1999 (Doc. 89-5). All of these premarket approval records are
located in FDA’s Center for Devices and Radiological Health (“CDRH”).
After the FDA received plaintiff’s FOIA request, it was logged by FDA’s
Division of Freedom of Information (“DFOI”). Thereafter, the request was

1

On April 11, 2015, the Court dismissed Frederick J. Sadler and Sarah Kotler for lack
of subject matter jurisdiction (Doc. 63).
2

As explained by the defendants in the pending motion, many of plaintiff’s
communications were not requests that fall under FOIA. Instead, he sent letters and
emails that did not seek agency records, but sought responses to questions and other
information outside the scope of the FOIA. Also, plaintiff’s written correspondence was
often repetitive and voluminous, thus requiring consolidation.
Page 2 of 16

forwarded to the FDA office most likely to possess responsive records. DFOI
assigned fifteen of plaintiff’s FOIA requests to CDRH because those requests
sought records related to a medical device regulated by CDRH.
As mentioned above, plaintiff submitted 18 FOIA requests to the FDA
between November 2011 to August 2014. During that same four-year period
plaintiff also submitted numerous supplemental communications to the FDA, in
addition to his FOIA requests. He sent letters and emails seeking responses to
questions and additional information, which FDA alleges were outside the scope
of FOIA (Docs. 89-1 & 89-5). 3
During this time, plaintiff repeatedly filed motions in this Court, many of
which were repetitive in nature. See Doc. 111, pgs. 3-4. The Court later stayed
this matter pending FDA’s re-processing of plaintiff’s FOIA requests to ensure that
the agency fulfilled its obligations under FOIA (Doc. 66). The FDA proposed that
CDRH conduct a new search and provide the plaintiff with all responsive records,
a Vaughn index, and documents previously produced to plaintiff with the addition
of a Bates-stamp. This was done in an effort to resolve the matter at issue and
address plaintiff’s claims.
3

DFOI and CDRH allege that they reviewed plaintiff’s letters marked R-1 though R-10 to ensure
that all of the documents described in his letters were included in at least one of the 18 FOIA
requests. Based on that review, the agency determined that there was an overlap between the
documents referenced in R-1 through R-10 and portions of one or more of plaintiff’s FOIA
requests (Docs. 89-3 & 89-8). FDA also identified documents described in plaintiff’s letters R-2, R3, R-5, and R-9 that may not have been covered by FDA’s responses to plaintiff’s FOIA requests.
FDA notes that it then produced the relevant documents, which were reviewed, redacted, and
Bates-stamped, to plaintiff on June 3, 2016, along with a Vaughn index (Docs. 89-1; 89-5).
Furthermore, R-1, R-3, R-6, and R-8 all referenced documents posted on FDA’s public website.
Thus, CDRH sent Plaintiff a letter dated June 3, 2016 with a list of the FDA websites where he
could find the available documents (Doc. 89-1).
Page 3 of 16

The rolling production of documents was completed on November 20,
2015, with defendants having produced approximately 7964 bates-numbered
pages of documents along with corresponding Vaughn indices (Doc. 89-7). 4
Thereafter, the Court lifted the stay (Doc. 87). On June 3, 2016, DFOI and CDRH
reproduced documents responsive to FOIA Request 2012-7286, which had been
provided to plaintiff prior to this lawsuit, but were absent from the re-production
disclosures (Docs. 89-1 & 89-3).
Subsequent to the reproduction, defendants filed the pending motion for
summary judgment (Doc. 89). Defendants move for summary judgment under
FEDERAL RULE

OF

CIVIL PROCEDURE 56. Attached to the motion for summary

judgment are declarations of William H. Holzerland, Director of the Division of
Information Disclosure (CDRH) (Doc. 89-5), and Sarah Kotler, Director of the
Division of Freedom of lnformation (DFOI) (Doc. 89-1) in which each director
declared their compliance with FOIA. Henson filed his response to the motion for
summary judgment shortly thereafter (Doc. 91). Subsequent to the filing of
plaintiff’s response, the Court issued an order providing plaintiff with notice of the
Rule 56 requirements regarding the pending motion for summary judgment (Doc.
109). In said order, the Court directed plaintiff to Fed. R. Civ. P. 56, particularly
Rule 56(e). The Court also included a copy of Rule 56 attached to the order (Doc.
109-1). Following the Court’s order, plaintiff filed a response (Doc. 111).

4

CDRH later produced an additional 1,247 pages in a subsequent disclosure in response to
plaintiff’s letters. Thus, since the filing of this case, FDA has produced 8,439 pages of Batesstamped documents and 457 pages of Vaughn indices in response to Plaintiff’s FOIA requests
(Docs 89-1, ¶¶ 18-19 & 89-5, ¶¶ 18-19).
Page 4 of 16

III.

Summary Judgment Standard

“FOIA cases typically and appropriately are decided on motions for summary
judgment.” Citizens for Responsibility & Ethics in Washington v. U.S. Dep't of

Veterans Affairs, 828 F.Supp.2d 325, 329–330 (D.D.C. 2011). Summary
judgment is proper when the pleadings, discovery, and disclosures establish that
there is no genuine issue of material fact and the movant is entitled to judgment
as a matter of law. Winsley v. Cook Cnty., 563 F.3d 598, 602–03 (7th Cir. 2009);
Fed. R. Civ. P. 56; see Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). In
deciding whether a genuine dispute exists as to any material fact, a court must
view all the evidence and draw all reasonable inferences in favor of the nonmoving party. See Weber v. Univ. Research Assoc., Inc., 621 F.3d 589, 592 (7th
Cir.2010). The existence of an alleged factual dispute, by itself, will not defeat a
summary judgment motion; “instead, the nonmovant must present definite,
competent evidence in rebuttal,” Parent v. Home Depot U.S.A., Inc., 694 F.3d 919,
922 (7th Cir.2012), and “must affirmatively demonstrate, by specific factual
allegations, that there is a genuine issue of material fact that requires trial.”

Hemsworth v. Quotesmith.com, Inc., 476 F.3d 487, 490 (7th Cir.2007).
In FOIA cases, the Court may resolve summary judgment solely on the basis
of affidavits or declarations from agency employees if they are “relatively detailed
and non-conclusory.” SafeCard Servs., Inc. v. SEC, 926 F.2d 1197, 1200 (D.C.
Cir. 1991). Also, an agency has the right to file a motion for summary judgment to
demonstrate that it has reasonably conducted a search based upon a plaintiff’s
Page 5 of 16

request and has either produced all relevant documents or has legitimate reason
for withholding such documents. Liverman v. Office of Inspector General, 139
Fed. Appx. 942, 945 (10th Cir. 2005). Ultimately, if the agency’s submissions or
reasons for withholding seem adequate and made in good faith from the face of
the briefings, a district court may elect to award summary judgment in favor of
the agency without need for discovery. Liverman, 139 Fed. Appx. at 945.
IV.

Analysis

FOIA serves the “basic purpose of ensuring an informed citizenry, vital to
the functioning of a democratic society.” Bensman v. United States Forest Serv.,
408 F.3d 945, 958 (7th Cir. 2005). FOIA requires federal agencies to make
information available to the public when requested, unless the information falls
within one of the specified exemptions. See Enviro Tech Int'l, Inc. v. EPA, 371
F.3d 370, 374 (7th Cir.2004). Furthermore, it gives federal courts authority “to
enjoin the agency from withholding agency records and to order the production of
any agency records improperly withheld.” GTE Sylvania, Inc. v. Consumers Union

of U.S., Inc., 445 U.S. 375, (1980) (citing 5 U.S.C. § 552(a)(4)(B)).
As long as the government agency is able to demonstrate that it conducted a
reasonable search pursuant to a plaintiff’s FOIA request, and withheld documents
that properly fall within the claimed FOIA exemptions, a district court can elect to
award summary judgment in favor of the government agency without need for
discovery. Becker v. I.R.S., 34 F.3d 398, 406 (holding that district court judge did
not abuse discretion in denying discovery prior to granting agency’s motion for
Page 6 of 16

summary judgment when judge concluded agency affidavit and index was
sufficient).
Here defendants move for summary judgment asserting that they are
entitled to judgment as a matter of law because FDA has conducted reasonable,
good-faith searches for responsive records, and thus complied with its FOIA
obligations. The facts support defendants’ position.
Plaintiff alleges that the “primary purpose for his FOIA litigation, was to
obtain the necessary, original, review file documentation of FDA’s device
application review for PMA P980022 et al.” and “this objective has been
consistently thwarted by the defendants” (Doc. 111). Specifically, plaintiff alleges
that of his 46 FOIA requests, only one was fully answered. However, upon review
of the pleadings and the exhibits and affidavits provided by the defendants, the
Court disagrees.
a. FDA Properly Searched and Produced Documents Responsive to
Plaintiff’s FOIA Requests
In order to obtain summary judgment, the defendants must show that they
made a good faith effort to conduct a search for the requested records. Patterson

v. IRS, 56 F.3d 832, 841 (7th Cir. 1995); Oglesby v. United States Dept. of the
Army, 287 U.S.App. D.C. 126, 920 F.2d 57, 68 (D.C.Cir. 1990). Courts evaluate
the adequacy of the search for reasonableness “in light of the specific request.”

Patterson, 56 F.3d at 841. The defendants may establish the reasonableness of
their search through affidavits that provide a reasonably detailed description of its
search method and procedures. Id. Here, defendants have satisfied their burden,
Page 7 of 16

as established by both Sara Kotler and William Holzerland’s declarations (Docs.
89-1 & 89-5) and attachments describing the scope of FDA’s search (Docs. 89-3 &
89-7).
As to the dispute regarding the number of plaintiff’s FOIA requests, FOIA
requires that a records request must “reasonably describe[]” the records sought. 5
U.S.C. § 552(a)(3)(A); see also 21 C.F.R. § 20.40. To fulfill this requirement, the
request must have enough specificity that “an agency employee [can] locate the
records ‘with a reasonable amount of effort.’” Moore v. FBI, 283 Fed. Appx. 397,
398 (7th Cir. 2008).
Here, the FDA ensures that it properly accounted for the records requested
by plaintiff, despite the fact that many of the requests were not “reasonably
described”. 5 U.S.C. § 552(a)(3)(A). 5 Notwithstanding Henson’s failure to comply,
FDA employees spent a significant amount of time corresponding with him “in an
attempt to clarify Plaintiff’s document requests” (Doc. 89-1, ¶¶ 16–17 & Doc. 89-5,
¶¶ 14–17). CDRH and DFOI contacted FDA employees who had received plaintiff’s
letters or attended plaintiff’s July 3, 2012 meeting with the FDA, and asked those
employees to search their files for documents related to the specified letters or
meeting (Doc. 89-1). Also, both Kotler and Holzerland communicated with
Henson in order to further clarify exactly what Henson requested so a reasonable
search could be conducted (Id.). During said communications, Holzerland
5

FDA aggregated several of plaintiff’s FOIA requests because of their overlapping nature. (Doc. 891, ¶17 & Doc. 89-5, ¶16). See also 21 C.F.R. § 20.42. FDA’s aggregation did not modify the scope
of Plaintiff’s FOIA requests, but instead sought to reduce duplicate productions. (Doc. 89-1, ¶17&
Doc. 89-5, ¶16).
Page 8 of 16

explained to Henson that the questions Henson submitted did not qualify as FOIA
requests, and that a proper FOIA request must reasonably describe the agency
records sought (Doc. 89-5, ¶ 15). 6
Looking to the adequacy of FDA’s search for the documents relevant to
plaintiff’s 18 FOIA requests (the number of requests that were recorded by AIMS)
(Doc. 89-2), FDA presented affidavits and documentation of the searches
conducted in response to the 18 requests. Both Kotler and Holzerland’s sworn
declarations describe the extensive searches conducted by the FDA, and how the
requests were processed by both DFOI (Doc. 89-3) and CDRH (Doc. 89-7). The
declarations also describe the manner of search conducted, the indices and
search parameters. FDA employees also “conducted a careful page-by-page, lineby-line review of all CDRH records produced to Plaintiff throughout the course of
this litigation” to ensure that any information that could reasonably be segregated
within the records was disclosed (Doc.89, ¶ 27).
The Court believes, and Plaintiff Henson presents no evidence to refute, that
the search undertaken by the FDA was reasonably calculated to uncover all
relevant documents. In re Wade, 969 F.2d 241, 249 n.11 (7th Cir. 1992)( “[T]he
issue is not whether other documents may exist, but rather whether the search for

6

FDA is not required to respond to a FOIA request for copies of documents that it has provided
access to in an alternative form. See Tax Analysts v. Dep't of Justice, 845 F.2d 1060, 1065 (D.C.
Cir. 1988). Thus, FDA does not have a FOIA obligation to send Henson documents that were
already posted on FDA’s website. However, FDA reviewed plaintiff’s R-1 though R-10 letters to
confirm that all of the documents described in those letters were included in at least one of
plaintiff’s 18 FOIA requests in order to provide Henson with the information requested (Doc. 89-1,
¶ 36 & Doc. 89-5, ¶ 24).
Page 9 of 16

undisclosed documents was adequate.”). The declarations and charts show how
plaintiff’s FOIA requests were processed by CDRH (Doc. 89-7) and DFOI (Doc. 893), and the final result of the disclosures (Docs. 89-8 & 89-4), all of which offers
further support for the Court’s conclusion. Accordingly, this Court finds that the
FDA’s search was adequate and met its obligations under FOIA to make a goodfaith effort to locate records responsive to the request.
b. FDA’s Redactions were Proper.
Information and documents subject to a FOIA are only allowed to be
withheld by a government agency if found to fit within any of the nine exemptions
defined within 5 U.S.C. § 552(b)(1)-(9). The burden of proof rests upon the
government agency to demonstrate that it was justified in determining that any
such requested information and/or documents fall within a particular FOIA
exemption. Becker v. I.R.S., 34 F.3d 398, 402 (7th Cir. 1994). Additionally, all
claimed FOIA exemptions must be narrowly construed, with a policy generally
favoring disclosure. Id. (citations omitted).
The nature of a FOIA case at the summary judgment stage requires the
government agency to submit an affidavit or declaration that sufficiently describes
the documents withheld, the exemptions that support withholding those
documents, and the reasons that demonstrate why those documents fall under the
claimed exemptions. As long as the declaration and any Vaughn Index submitted
by the agency are not controverted by other evidence on the record or by a
showing of agency bad faith, it will then be sufficient to justify a granting of
Page 10 of 16

summary judgment without the Court conducting an in camera review of the
withheld documents. Kimberlin v. Dep’t of Treasury, 772 F.2d 204, 210 (7th Cir.
1985). In this case, the Court finds the declarations submitted by the FDA
directors to be sufficient for describing the applicable exemptions under 5 U.S.C.
§ 552(b).
i.

Exemption 4

FOIA Exemption 4 states that FOIA does not apply to 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). FDA’s guideline for
implementing Exemption 4 provides that “[d]ata or information submitted or
divulged to the [FDA] which fall within the definitions of a trade secret or of
confidential commercial or financial information are not available for public
disclosure.” 21 C.F.R. § 20.61. Holzerland’s sworn declaration states that:
“The records redacted pursuant to FOIA Exemption 4 contain
information that constitutes trade secrets or commercial
information obtained from a person that is privileged or
confidential. Specifically, CDRH-DID generally relied on FOIA
Exemption 4 to withhold information related to Medtronic’s trade
secrets or confidential commercial information used to support its
application PMA P980022 and supplements to PMA P980022. For
example, CDRH-DID asserted FOIA Exemption 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.
CDRH-DID also relied on FOIA Exemption 4 to redact Medtronic’s
confidential commercial information in documents related to
CDRH’s processing of Trade Complaint CPT1100031. Since Trade
Complaint CPT1100031 was submitted by Plaintiff and alleged
serious injury by the device that was approved in PMA P980022,
Page 11 of 16

the redacted confidential commercial information in the Trade
Complaint documents is similar to the information that is redacted
under FOIA Exemption 4 in PMA P980022 and its supplements.”
(Doc. 89-5, ¶¶ 30-31). Based on Holzerland’s explanation regarding Exemption 4,
and no evidence to the contrary, the Court finds the redaction under Exemption 4
to be appropriate. In further support of this conclusion, Holzerland and Kotler,
both division directors with the FDA, declare that all redactions were accounted
for in Vaughn indices sent to the plaintiff and the indices include a particularized
explanation of each redacted page (Doc. 89-1, ¶ 28 & 89-5 ¶ 39),
ii.

Exemption 5

Exemption 5 of FOIA prevents agencies from having to disclose “interagency or intra-agency memorandums or letters which 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). Pursuant to FOIA Exemption 5, the FDA redacted agency information
that is both pre-decisional and deliberative. (Doc. 89-1, ¶ 33 & 89-5 ¶ 42). Both
CDRH-DID and DFOI productions also contained redactions to information
subject to the attorney-client privilege that is incorporated in Exemption 5. (Doc.
89-1, ¶ 33 & 89-5 ¶ 43). Specifically, Holzerland’s sworn declaration states that:
“CDRH-DID redacted certain records containing information
exempt from disclosure under FOIA Exemption 5. FOIA
Exemption 5 protects from public disclosure of “inter-agency or
intra-agency memorandums or letters which 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).
Of the records that CDRH-DID redacted pursuant to FOIA
Exemption 5, the majority include agency information that is both
pre-decisional and deliberative. For example, much of the redacted
Page 12 of 16

information in the CDRH Ombudsman records is CDRH’s internal
pre-decisional deliberations regarding how to manage Plaintiff’s
voluminous correspondence with FDA. CDRH-DID also redacted
information that is subject to the attorney-client privilege that is
incorporated in Exemption 5.”
(Doc. 89-5, ¶¶ 32-33). Also, Kotler’s sworn declaration discusses the
redaction of certain records pursuant to Exemption 5. Her declaration states that:
DFOI redacted some information within records responsive to
FOIA Request 2012-8504 that is not responsive to the request. For
example, DFOI redacted information in internal agency emails that
discussed FOIA requests submitted by requestors other than
Plaintiff. FOIA Exemption 5 also applies to these redactions, as
they regard internal, pre-decisional deliberations. See 5 U.S.C. §
552(b)(5).
The remainder of information redacted by DFOI in its production
documents was also exempt from disclosure under FOIA
Exemption 5, 5 U.S.C. § 552(b)(5). Exemption 5 protects from
public disclosure of "inter-agency or intra-agency memorandums
or letters which 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).
Of the records that DFOI redacted pursuant to FOIA Exemption 5,
5 U.S.C. § 552(b)(5), the majority include agency information that
is both pre-decisional and deliberative. For example, DFOJ
asserted Exemption 5 to withhold information in the document
responsive to FOIA Request 2014-4 769 because it is deliberative
information in an internal memorandum regarding Plaintiffs
appeal of an FDA FOIA request. Specifically, the information was
authored by an FDA employee and contains pre-decisional
information and opinions for an HHS FOIA Officer to consider
while reviewing the Plaintiffs appeal. As another example, DFOI
asserted Exemption 5 to withhold information in General Counsel
records that contained internal, deliberative, and pre-decisional
discussion with an agency attorney regarding how the agency
should proceed after Plaintiffs July 3, 2012 meeting with FDA.
DFOI's production to Plaintiff also contained redactions to some
information that is attorney-client privilege information, pursuant
to 5 U.S.C. § 552(b)(5).

Page 13 of 16

The information that DFOI redacted in the limited number of
documents described in Plaintiffs R-2, R-3, R-5, and R-9 that may
not have been covered by FDA's responses to Plaintiffs FOIA
requests, was withheld because it was either not responsive, predecisional and deliberative pursuant to 5 U.S.C. § 552(b)(5)…”
(Doc. 89-1, ¶¶ 40-44). Based on Kotler’s and Holzerland’s explanations regarding
Exemption 5 with no evidence to the contrary, and the fact that both declared that
all redactions were accounted for in Vaughn indices with appropriate explanations
(Doc. 89-1, ¶ 28 & 89-5 ¶ 39), the Court finds the redaction under Exemption 5 is
appropriate.
iii.

Exemption 6

Exemption 6 of FOIA exempts from disclosure “personnel and medical files
and similar files the disclosure of which would constitute a clearly unwarranted
invasion of personal privacy.” 5 U.S.C. § 552(b)(6); see also 21 C.F.R. § 20.63.
Kotler and Holzerland assert that the majority of information that FDA withheld
pursuant to FOIA Exemption 6 identifies specific Medtronic patients (Doc. 89-5 ¶
34). Additionally, a limited amount of private personal information related to
Medtronic and to FDA personnel was redacted. This included private email
addresses of Medtronic employees, and an FDA employee’s cell phone number.
(Id.). Specifically, Holzerland’s sworn declaration states that:
“DFOI redacted some information within records responsive to
FOIA Request 2012-8504 that is not responsive to the request.
Kotler Decl. ¶ 40. For example, DFOI redacted information in
internal agency emails that discussed FOIA requests submitted by
requestors other than Plaintiff. Id. 35. The information that FDA
redacted in the limited number of documents described in
Plaintiff’s R-2, R-3, R-5, and R-9 that that may not have been
Page 14 of 16

covered by FDA’s responses to Plaintiff’s FOIA requests, is either
not responsive to Plaintiff’s FOIA requests, or is redacted in
accordance with FOIA Exemptions 5 and/or 6. See Holzerland
Decl. ¶ 35; Kotler Decl. ¶ 45.
The majority of information withheld from Plaintiff pursuant to
FOIA Exemption 6 consists of information that identifies patients
in reports submitted by Medtronic. For example, the personally
identifying information withheld includes the serial numbers of
devices belonging to patients who reported feedback information
to Medtronic, dates related to the patients’ medical histories, and
the patients’ telephone numbers. Additionally, a limited amount of
private personal information related to Medtronic and FDA
personnel was redacted, such as the personal email addresses of a
Medtronic employee, an FDA employee’s cellphone number, and
the name of an FDA employee who was on extended leave.
The information that CDRH-DID redacted in the limited number of
documents described in Plaintiff’s R-2, R-3, R-5, and R-9 that may
not have been covered by FDA’s responses to Plaintiff’s FOIA
requests is redacted in accordance with FOIA Exemptions 5 and/or
6.”
(Doc. 89-5, ¶¶ 34-36). Based on Holzerland’s explanation regarding Exemption 6,
and Kotler’s sworn declaration, in addition to the fact that Holzerland and Kotler
declare that all redactions were accounted for in Vaughn indices and include a
particularized explanation of each redacted page (Doc. 89-1, ¶ 28 & 89-5 ¶ 39),
the Court finds the redactions of personal privacy information under Exemption 6
to be appropriate.
Therefore, the Court finds that FDA produced responsive records that are
properly redacted under the FOIA exemptions 4, 5, and 6. As mentioned above,
FDA conducted a careful page-by-page review of the FDA records provided to
plaintiff throughout the course of this litigation (Doc. 89-1, ¶ 27 & 89-5 ¶ 37).
Also, for those records containing information exempt from disclosure, FDA
Page 15 of 16

ensured that any information that could reasonably be segregated within said
records was disclosed to plaintiff (Id.).
Finally, it is important to note that no documents were fully withheld from
Plaintiff Henson; all redactions were accounted for in the Vaughn indices and
included an explanation for said redactions (Doc. 89-1, ¶ 28 & 89-5 ¶ 39). Thus,
the Court finds that the FDA reasonably conducted a search based upon Henson’s
FOIA requests and the agency produced all relevant documents. As to the
necessary redactions, the Court finds that FDA had a legitimate reason for
withholding certain information based on the FOIA exemptions.
V.

Conclusion

For the foregoing reasons, the Court GRANTS defendants’ motion for
summary judgment (Doc. 89). This FOIA cause is DISMISSED with prejudice.
The Clerk of the Court is directed to enter judgment accordingly.
Furthermore, plaintiff’s pending motions are RENDERED MOOT (Docs.
93, 97, 103, 105 & 106).
IT IS SO ORDERED.
Signed this 23rd day of March, 2017.

Digitally signed by
Judge David R. Herndon
Date: 2017.03.23
15:11:55 -05'00'
United States District Judge

Page 16 of 16