Public Citizen v. United States Department of Health & Human Services , 975 F. Supp. 2d 81 ( 2013 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
PUBLIC CITIZEN,
Plaintiff,
Civil Action No. 11-1681 (BAH)
v.
Judge Beryl A. Howell
UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES,
Defendant,
v.
PFIZER INC. and
PURDUE PHARMA L.P.
Intervenors-Defendants.
MEMORANDUM OPINION
The plaintiff, Public Citizen, has requested, under the Freedom of Information Act
(“FOIA”), 5 U.S.C. § 552, annual reports that were required to be submitted by two companies,
Pfizer, Inc. (“Pfizer”) and Purdue Pharma L.P. (“Purdue”), to the Office of Inspector General
(“OIG”) of the United States Department of Health and Human Services (“HHS”), as part of the
companies’ compliance with settlement agreements arising from the companies’ illegal off-label
promotion of drugs reimbursed by federal health care programs. 1 Between forty and one
hundred times each year over the last decade, HHS’ OIG has participated in such settlement
agreements by entering into Corporate Integrity Agreements (“CIAs”) with companies seeking to
1
Off-label marketing of drugs for non-FDA approved uses is “considered by the FDA to be a violation of the Food
Drug and Cosmetic Act,” and is “dangerous for the public health” due to the “lack of supporting data for the off-
label uses and exposure of patients “to risk of serious adverse effects without any clear evidence that the drug will
be effective for the intended purpose.” Declaration of Aaron Kesselheim, M.D., J.D., M.P.H., Asst. Professor of
Medicine, Harvard Medical School, (“Kesselheim Decl.”) ¶ 8, ECF No. 26-2.
1
resolve civil and administrative health care fraud cases and avoid costly exclusion from
participation in Federal health care programs. See Declaration of Gregory E. Demske, Asst.
Inspector General for Legal Affairs, OIG, HHS, (“Demske Decl.”) ¶¶1-2, ECF No. 22-1. In
return for these benefits, under the CIA, the companies must agree to enhanced compliance
measures, subject to auditing by an outside independent party and monitoring by the OIG. Id. ¶
2.
Public Citizen is a “nonprofit public interest organization,” which has, inter alia, “fought
for safe, effective, and affordable drugs and medical devices; responsible controls over the
delivery of health care; consumer access to health care information,” and issued publications on
these topics. Declaration of Sidney Wolfe, M.D., Public Citizen Health Research Group
Director, (“Wolfe Decl.”) ¶ 2, ECF No. 26-1. Noting that Pfizer has entered into three serial
CIAs with HHS’ OIG, due to the company engaging in allegedly illegal behavior at the same
time it was subject to a CIA, the plaintiff filed the FOIA requests at issue in the instant suit to
address “a serious question about the adequacy of OIG oversight of companies during the CIA
process.” Id. ¶¶ 11, 14; see also Declaration of Edward Nowicki, Pfizer Vice-President and
Asst. General Counsel, Deputy Compliance Officer – Global Programs, (“Nowicki Decl.”) ¶ 4,
ECF No. 22-1 (“The 2004 CIA expired in 2009. Since that time, Pfizer entered into a new CIA
with HHS in 2009.”). The plaintiff explains that “[t]o the extent that the annual reports [required
by the CIA] reveal instances of illegal activity by the companies, the public has a strong interest
in knowing that OIG had access to this information and in knowing whether OIG acted
forcefully in responding to it.” Wolfe Decl. ¶ 14.
HHS has withheld the bulk of the requested records on grounds that they contain
confidential, commercial information exempt from disclosure under FOIA Exemption 4 and
2
private, personal information exempt from disclosure under FOIA Exemption 6. 5 U.S.C. §
552(b)(4) and (6). The plaintiff challenges HHS’ withholdings for eight categories of records, as
well as the adequacy of HHS’ search for records pertaining to one of the companies. Pending
before the Court, are cross-motions for summary judgment by HHS and the defendant-
intervenors Pfizer and Purdue, and by the plaintiff. For the reasons stated below, these motions
are granted in part and denied in part.
I. BACKGROUND
A. Annual Reports Required To Be Submitted Under Corporate Integrity
Agreements With Pfizer And Purdue
In May 2004, Pfizer entered into a CIA with HHS’ OIG as part of a larger settlement
agreement with the United States and various States “related to Pfizer’s promotional practices of
a Pfizer product.” Nowicki Decl. ¶ 4; see also Def.’s Mot. Summ. J., Ex. 1 (“Pfizer Corporate
Integrity Agreement”) (“Pfizer CIA”) at 1, ECF No. 22-1. This CIA superseded a prior CIA that
Pfizer had entered with HHS’ OIG in October 2002. Id. “Among other things, the CIA required
Pfizer to implement, update and/or review its policies and procedures relating to compliance with
relevant federal regulations,” and to submit to the OIG annually over the five-year period while
the CIA was in force an Annual Report that addressed at least twenty enumerated items.
Nowicki Decl. ¶ 4; Pfizer CIA at 24–27. Pfizer claims these annual reports “contain highly
sensitive, confidential commercial information,” and, consequently, marked the documents
submitted as “Confidential and FOIA Exempt.” Nowicki Decl. ¶ 14. The 2004 Agreement
expired in 2009. 2 Id. ¶ 4.
In May 2007, Purdue entered into a CIA with HHS “contemporaneously with a
settlement agreement between Purdue and the United States which resolved an investigation by
2
Although Pfizer entered into a new CIA in 2009, the FOIA request at issue was limited to the 2004 CIA. Nowicki
Decl. ¶ 4. See also Compl. ¶ 5, ECF No. 1.
3
the U.S. Attorney . . . over Purdue’s marketing of OxyContin® Tablets.” Decl. of Bert
Weinstein, Purdue Vice President of Corporate Compliance, (“Weinstein Decl.”) ¶¶ 1, 4, ECF
No. 22-2. “Purdue has been required to . . . submit[] its Annual Reports to HHS each year since
2007” as part of its obligations under the CIA. Id. ¶ 1. Purdue also claims these reports contain
“highly confidential and proprietary information,” and, consequently, marked the Annual
Reports at issue as “Confidential and FOIA Exempt.” Id. ¶¶ 1, 9.
Both Pfizer and Purdue agreed to the terms set forth in their respective CIAs with the
OIG “as part of the resolution of civil and administrative health care fraud cases.” Demske Decl.
¶ 2. They both contain the standard provisions that “the OIG agrees not to seek an exclusion of
that entity from participation in Federal health care programs,” on condition that the company
subject to the CIA “adopts measures designed to promote compliance,” with Federal laws and
regulations, including “hiring [] a compliance officer, establish[ing] a code of conduct and
policies and procedures, employee training, confidential disclosure mechanisms, and reporting of
violations of law.” Id. Also, both CIAs require review of the company’s compliance with these
measures by an independent party, called an Independent Review Organization (“IRO”), which
submits annually to the company a report “addressing the requirements of the CIA and including
the results of the audits and reviews.” Id. ¶ 3. The IRO Report is later submitted to the HHS as
part of the company’s Annual Report, along with any responses to IRO Report’s findings from
the company. Id.; Purdue CIA at 28; Pfizer CIA at 25. The CIAs themselves are posted on the
HHS website. Demske Decl. ¶ 3.
As part of the CIAs, the companies are given the opportunity to “clearly identify any
portions of its submissions that it believes are trade secrets, or information that is commercial or
financial and privileged or confidential, and therefore potentially exempt from disclosure under
4
the Freedom of Information Act (FOIA), 5 U.S.C. § 552.” Def. Mot. Summ J., Ex. 6 (“Corporate
Integrity Agreement between the [OIG] of the [HHS] and Purdue Pharma L.P.”) (“Purdue CIA”)
at 30, ECF No. 22-2; see also Pfizer CIA at 28. At the same time, the CIAs direct that the
company “shall refrain from identifying any information as exempt from disclosure if that
information does not meet the criteria for exemption from disclosure under FOIA.” Id. HHS is
not obligated to accept the companies’ designation of any document as FOIA exempt. Indeed,
based on the materials released, HHS disagreed with the companies’ designations, at least in
part, with respect to certain documents, which have been partially released to the plaintiff. See,
e.g., Declaration of Julie A. Murray, Counsel for Public Citizen, (“Murray Decl.”) Ex 3 Attachs.
A, D, E, F, G, H, ECF No. 26-3 (released documents bearing legend “Confidential and FOIA
Exempt.”). 3
B. The Plaintiff’s FOIA Request
On November 12, 2009, the plaintiff submitted a FOIA request to HHS seeking “all
annual reports submitted to the [OIG] by Purdue Pharma L.P. pursuant to the May 2007
Corporate Integrity Agreement between OIG and Purdue Pharma L.P,” and “by Pfizer, Inc.
pursuant to the May 2004 Corporate Integrity Agreement between OIG and Pfizer.” Decl. of
Robin R. Brooks, HHS OIG FOIA Officer, (“Brooks Decl.”) Ex. A at 1, ECF No. 22-1. 4 In
response, HHS conducted a search of its CIA database and “the Compliance File room where
active compliance case files and Implementation and Annual Reports are maintained.” Brooks
3
In connection with Pfizer’s submission of documents pursuant to an earlier CIA executed on October 24, 2002,
HHS was prompted to caution the company that “[t]o date almost all of the documents submitted pursuant to the
CIA have been stamped ‘FOIA exempt.’ As a result we would like to advise you that in the event that Pfizer’s CIA
materials are requested under FOIA, such materials may not be fully exempt as you have noted . . . . Therefore, you
should not assume that all of Pfizer’s reports and other documents submitted pursuant to the CIA will be exempt
from a FOIA request.” Murray Decl., Ex. 3 Attach. G (HHS letter, dated November 19, 2003, to Pfizer) at 1–2, ECF
No. 26-3.
4
Public Citizen’s request for a fee waiver was granted, following an administrative appeal of HHS’s initial denial of
this request. See Brooks Decl. ¶¶ 4, 6, 8, 11.
5
Decl. ¶ 13. HHS’s FOIA liaison also “confirmed with the attorneys monitoring the CIA’s [sic]
that all responsive records had been accounted for.” Id.Under Executive Order 12,600, HHS was required to “notify submitters of records
containing confidential commercial information . . . when those records are requested under the
[FOIA].” 52 Fed. Reg. 23,781 § 1 (June. 23, 1987). HHS regulations also require such a
“predisclosure notification.” See 45 C.F.R. § 5.65(d); Brooks Decl. ¶ 24. Consequently, HHS
notified Pfizer and Purdue of the plaintiff’s request and consulted with them “regarding the
release of their information.” Brooks Decl. ¶ 24.
On June 22, 2010, HHS notified the plaintiff that it had “located 1177 pages of records
responsive” to the Purdue portion of the FOIA request. Brooks Decl. Ex. J. Of those pages,
1,093 were withheld in their entirety under FOIA Exemptions 4 and 6, see 5 U.S.C. §§ 552(b)(4),
(b)(6), while 84 pages were partially released with portions redacted under the same exemptions.
Id. With respect to the Pfizer portion of the FOIA request, HHS notified the plaintiff, on
September 21, 2010, that 9,432 pages of responsive records had been located, with 5,216 pages
withheld in their entirety as well as portions of 4,216 pages, under FOIA Exemptions 4 and 6.
Brooks Decl. Ex. L; see also Fed. Def.’s Combined Reply Supp. Def.’s Mot. Summ. J. and
Opp’n to Pl.’s Cross Motion for Summ J. (“Def.’s Reply”) at 2, ECF No. 29 (noting that search
“netted more than 9000 pages of records and more than 4,200 of those pages were released to the
plaintiff, with portions withheld under Exemptions 4 and 6”). The plaintiff appealed these
withholding determinations under Exemptions 4 and 6 to HHS. See Brooks Decl. Exs. K, M.
On April 12, 2011, HHS denied the plaintiff’s appeal of the Purdue withholdings and redactions.
Brooks Decl. Ex. N. “A decision was not made on the appeal regarding Pfizer’s documents prior
to the filing of this lawsuit.” Brooks Decl. ¶ 20.
6
C. Procedural History
The plaintiff filed the instant lawsuit on September 16, 2011, against HHS. See Compl. ¶
1. The unopposed motions of Pfizer and Purdue to intervene were granted on November 18 and
December 7, 2011, respectively. See Minute Orders dated November 18, 2011 and Dec. 7, 2011.
HHS thereafter filed two Vaughn indices, one pertaining to Pfizer and one pertaining to Purdue,
on March 7, 2012. See Vaughn Index of Withheld Pfizer Inc. Documents (“Pfizer Vaughn
Index”), ECF No. 18; Vaughn Index of Withheld Purdue Pharma L.P. Documents (“Purdue
Vaughn Index”), ECF No. 19.
The plaintiff now challenges the adequacy of HHS’s search for “Pfizer IRO responses
and corrective action plans,” which the plaintiff claims “were not clearly identified in the
Vaughn Index of withheld Pfizer documents.” Pl.’s Mem. Supp. Pl.’s Mot. Summ. J. and Opp’n
to Def.’s and Def.-Intervenor’s Mots. Summ. J. (“Pl.’s Mem.”) at 38, ECF No. 26. In addition,
the plaintiff challenges HHS’s withholdings under Exemptions 4 and 6 of the following eight
categories of records included in the Annual Reports: (1) “Reportable Events”; 5 (2) Disclosure
Log summaries; 6 (3) screening and removal of Ineligible Persons; 7 (4) summaries of government
investigations or legal proceedings; (5) communications with the Food and Drug Administration
5
The CIAs define “Reportable Events” as “anything that involves a matter . . . that a reasonable person would
consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program
and/or any FDA requirements relating to the labeling or promotion of products for which penalties or exclusion may
be authorized.” Purdue CIA at 19–20; see Pfizer CIA at 21.
6
Each company was required by its CIA to “maintain a disclosure log, which shall include a record and summary of
each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any
corrective action taken in response to the internal reviews.” Purdue CIA at 17; Pfizer CIA at 19. The referenced
disclosures were made in connection with “a disclosure program,” which “includes a mechanism . . . to enable
individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s
chain of command, any identified issues or questions associated with Pfizer’s policies, conduct, practices, or
procedures with respect to a Federal health care program requirements [sic] or FDA requirements believed by the
individual to be a potential violation of criminal, civil, or administrative law.” Pfizer CIA at 18; see also Purdue
CIA at 16 (same).
7
An “Ineligible Person” “is currently excluded, debarred, suspended, or otherwise ineligible to participate in Federal
health care programs or in Federal procurement or nonprocurement programs; or has been convicted of a criminal
offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or
otherwise declared ineligible.” Pfizer CIA at 19; Purdue CIA at 17
7
(“FDA”) about off-label promotion; (6) portions of Pfizer’s off-label findings and detailing
sessions; 8 (7) portions of IRO reports pertaining to, inter alia, the IRO’s findings and
recommendations, the companies’ compliance programs, “corrective action taken by the
company,” and the “IRO’s description of the company’s systems, policies, procedures, and
practices,” Pl.’s Mem. at 28–29; 9 and (8) Purdue’s supplement, dated June 18, 2009, to its first
Annual Report, which was submitted on September 25, 2008 (“2009 Purdue Supplement”). 10
See Pl.’s Mem. at 9–13 & n.3, ECF No. 27.
With the exception of the 2009 Purdue Supplement, the parties have not identified the
specific documents in the Vaughn indices that are covered by each of the broad challenged
categories and, thus, has left the Court to speculate as to which specific withheld documents are
actually at issue in this lawsuit and which documents the parties agree were appropriately
withheld. Certainly, the combined use Vaughn indices and detailed declarations is an acceptable
practice for an agency to justify its application of an exemption. See Judicial Watch, Inc. v.
FDA, 449 F.3d 141, 148 (D.C. Cir. 2006) ( agency’s “decision to tie each document to one or
more claimed exemptions in its index and then summarize the commonalities of the documents
in a supporting affidavit is a legitimate way of serving the same functions” of the Vaughn index
by “organiz[ing] the withheld documents in a way that facilitates litigant challenges and court
review of the agency’s withholdings”). Nevertheless, the declarations are most helpful when tied
8
“Detailing sessions” are mandated intensive reviews of commercially available records Pfizer was required to
obtain to determine the content of any discussions between Pfizer sales representatives and health care providers
regarding potential off-label uses for Pfizer medications during a one week period each quarter. See Pfizer CIA at
22–23. Pfizer was required to make findings based on this review and take any corrective action necessary. Id. at
23. The findings and corrective actions were required to be submitted to the OIG. Id. Purdue’s CIA did not contain
this requirement.
9
Pfizer and Purdue were required to retain “Independent Review Organizations” to “assess[] and evaluate[] [their]
systems, processes, policies, and practices” relating to certain programs. Pfizer CIA at 14; see also Purdue CIA at
14.
10
The plaintiff refers to this document as a “cover memorandum for a supplement to its first annual report,” Pl.’s
Mot. at 2, ECF No. 26, and attached the heavily redacted released copy of the document as an exhibit. Murray Decl.
Ex. 3, Attach. E at 30-37, ECF No. 26-3.
8
to the specific documents described in the indices. See id. at 150 (remanding case for further
explanation, noting that “[p]roving the merits of the exemption does no good if the court cannot
tie the affidavits to the documents”); Judicial Watch, Inc. v. U.S. Dep’t of Justice, 800 F. Supp.
2d 202, 214 (D.D.C. 2011) (finding “that the DOJ’s Vaughn indices and declarations are
adequate” where “declarations work in conjunction with the Vaughn indices by dividing the
withheld documents into specific categories based on the nature of the document (the category
numbers are cross-referenced accordingly in the Vaughn indices), linking each category (and in
turn each document) to a particular FOIA exemption, and articulating what the documents in
each group reflect and why they fall within the specified FOIA exemption”). The lack of
specificity in this case regarding both the identification of withheld documents in the Vaughn
indices that are at issue and the precise connection between the documents discussed in the
declarations and the documents listed in the Vaughn indices, has significantly complicated the
Court’s task of resolving the plaintiff’s challenge.
II. LEGAL STANDARD
Congress enacted the FOIA as a means “to open agency action to the light of public
scrutiny.” Am. Civil Liberties Union v. U.S. Dep’t of Justice, 655 F.3d 1, 5 (D.C. Cir. 2011)
(quoting Dep’t of Air Force v. Rose, 425 U.S. 352, 361 (1976)). As the Supreme Court has
“consistently recognized [] the basic objective of the Act is disclosure.” Chrysler Corp. v.
Brown, 441 U.S. 281, 290 (1979). At the same time, the statute represents a “balance [of] the
public’s interest in governmental transparency against legitimate governmental and private
interests that could be harmed by release of certain types of information.” United Techs. Corp. v.
U.S. Dep’t of Def., 601 F.3d 557, 559 (D.C. Cir. 2010) (“United Technologies”) (internal
citations omitted). Reflecting that balance, the FOIA contains nine exemptions set forth in 5
9
U.S.C. § 552(b), which “are explicitly made exclusive and must be narrowly construed.” Milner
v. U.S. Dep’t of Navy, 131 S. Ct. 1259, 1262 (2011) (internal quotations and citations omitted)
(citing FBI v. Abramson, 456 U.S. 615, 630 (1982)); see also Pub. Citizen v. Ofc. of Mgmt. and
Budget, 598 F.3d 865, 869 (D.C. Cir. 2010). “[T]hese limited exemptions do not obscure the
basic policy that disclosure, not secrecy, is the dominant objective of the Act.” Rose, 425 U.S. at
361.
The agency invoking an exemption to the FOIA has the burden “to establish that the
requested information is exempt.” Fed. Open Market Comm. of Fed. Reserve Sys. v. Merrill, 443
U.S. 340, 351-352 (1979); see also Assassination Archives & Research Ctr. v. CIA, 334 F.3d 55,
57 (D.C. Cir. 2003) (holding that the agency “bears the burden of establishing the applicability of
the claimed exemption”). In order to carry this burden, an agency must submit sufficiently
detailed affidavits or declarations, a Vaughn index of the withheld documents, or both, to
demonstrate that the government has analyzed carefully any material withheld, to enable the
court to fulfill its duty of ruling on the applicability of the exemption, and to enable the adversary
system to operate by giving the requester as much information as possible, on the basis of which
he can present his case to the trial court. Oglesby v. United States Dep't of the Army, 79 F.3d
1172, 1176 (D.C. Cir. 1996) (“The description and explanation the agency offers should reveal
as much detail as possible as to the nature of the document, without actually disclosing
information that deserves protection…[which] serves the purpose of providing the requestor with
a realistic opportunity to challenge the agency's decision.”); Tax Analysts v. IRS, 410 F.3d 715,
720 (D.C. Cir. 2005) (noting that, to avoid voluminous Vaughn index submissions, court
permissibly relied on a mix of deposition testimony, declarations, a Vaughn index, and in camera
review to evaluate agency’s withholding determinations).
10
A district court must review the Vaughn index and any supporting declarations “to verify
the validity of each claimed exemption.” Summers v. Dep’t of Justice, 140 F.3d 1077, 1080
(D.C. Cir. 1998). The FOIA provides federal courts with the power to “enjoin the agency from
withholding records and to order the production of any agency records improperly withheld from
the complainant.” 5 U.S.C. 552(a)(4)(B). Moreover, a district court has an “affirmative duty” to
consider whether the agency has produced all segregable, non-exempt information. Elliott v.
U.S. Dep’t of Agric., 596 F.3d 842, 851 (D.C. Cir. 2010) (referring to court’s “affirmative duty to
consider the segregability issue sua sponte”) (quoting Morley v. CIA, 508 F.3d 1108, 1123 (D.C.
Cir. 2007)); Stolt-Nielsen Transp. Group LTD. v. United States, 534 F.3d 728, 733-735 (D.C.
Cir. 2008) (“‘[b]efore approving the application of a FOIA exemption, the district court must
make specific findings of segregability regarding the documents to be withheld’”) (quoting
Sussman v. U.S. Marshals Service, 494 F.3d 1106, 1116 (D.C. Cir. 2007)); Trans-Pacific
Policing Agreement v. U.S. Customs Serv., 177 F.3d 1022, 1027-1028 (D.C. Cir. 1999) (“we
believe that the District Court had an affirmative duty to consider the segregability issue sua
sponte…even if the issue has not been specifically raised by the FOIA plaintiff”); see also 5
U.S.C. § 552(b) (“Any reasonably segregable portion of a record shall be provided to any person
requesting such record after deletion of the portions which are exempt under this subsection.”).
Summary judgment is appropriate when “there is no genuine dispute as to any material
fact.” FED. R. CIV. P. 56. “In FOIA cases, ‘[s]ummary judgment may be granted on the basis of
agency affidavits if they contain reasonable specificity of detail rather than merely conclusory
statements, and if they are not called into question by contradictory evidence in the record or by
evidence of agency bad faith.’” Judicial Watch, Inc. v. U.S. Secret Serv., 726 F.3d 208, at *14
(D.C. Cir. 2013) (quoting Consumer Fed’n of Am. v. U.S. Dep’t of Agric., 455 F.3d 283, 287
11
(D.C. Cir. 2006) and Gallant v. NLRB, 26 F.3d 168, 171 (D.C. Cir. 1994)). “Ultimately, an
agency’s justification for invoking a FOIA exemption is sufficient if it appears ‘logical’ or
‘plausible.’” Judicial Watch, Inc. v. U.S. Dep’t of Defense, 715 F.3d 937, 941 (D.C. Cir. 2013)
(quoting ACLU v. U.S. Dep’t of Defense, 628 F.3d 612, 619 (D.C. Cir. 2011)); Larson v. U.S.
Dep’t of State, 565 F.3d 857, 862 (D.C. Cir. 2009) (quoting Wolf v. CIA, 473 F.3d 370, 374-75
(D.C. Cir 2007)).
III. DISCUSSION
The plaintiff raises two issues regarding HHS’s response to its FOIA request: the
adequacy of the defendant’s search and the appropriateness of the Exemption 4 withholdings. 11
Each of these issues is addressed seriatim below.
A. The Adequacy of HHS’s Search
The plaintiff contends that the defendant’s search for records responsive to the request for
Pfizer Annual Reports was inadequate because certain documents referenced in released
documents were not identified in the Vaughn Index of withheld Pfizer documents or released to
the plaintiff. See Pl.’s Mem. at 38. Specifically, the plaintiff contends that Pfizer stated in each
of its Annual Reports that the company’s response to the IRO’s findings and recommendations,
and any other observations, would be provided to the OIG, as necessary, under separate cover, at
11
All of the documents withheld by the defendant under Exemption 6, which exempts from disclosure “personnel or
medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy,” 5
U.S.C. § 552(b)(6), are also withheld under Exemption 4. In construing Exemption 6, the D.C. Circuit has held that
“the disclosure of names and addresses is not inherently and always a significant threat to the privacy of those listed;
whether it is a significant or a de minimis threat depends upon the characteristic(s) revealed by virtue of being on the
particular list, and the consequences likely to ensue.” Nat’l Ass’n of Retired Fed. Employees v. Horner, 879 F.2d
873, 877 (D.C. Cir. 1989). “Exemption 6’s requirement that disclosure be ‘clearly unwarranted’ instructs us to ‘tilt
the balance (of disclosure interests against privacy interest) in favor of disclosure.’” Morley, 508 F.3d at 1127 (D.C.
Cir. 2007) (quoting Wash. Post Co. v. U.S. Dep’t of Health and Human Servs., 690 F.2d 252, 261 (D.C. Cir. 1982)).
Here, the defendant’s declarant states that the only information withheld under Exemption 6 consists of “employee
names and personal identifying information, such as telephone numbers and email addresses.” Brooks Decl. ¶ 27.
The plaintiff has clarified that it is not challenging the withholding of names, phone numbers, signatures, or email
addresses of any individuals. Pl.’s Mem. at 36. Thus, given that the plaintiff is not contesting the application of
Exemption 6 to the information withheld on this basis, no Exemption 6 challenge is before the Court.
12
a later date. Murray Decl., Ex. 3 Attach. H (containing Pfizer’s statements regarding later
submission of CIA Section III.D Responses in Annual Reports submitted for 2004-2009, at OIG-
000066; OIG-001862; OIG-003715; OIG-005864; OIG-007893). These responses were
specifically required by Section V.B.6 of Pfizer’s CIA (“Section V.B.6 documents”). Pfizer CIA
at 25. The plaintiff contends that the Section V.B.6 documents, which Pfizer was required to
submit, and presumably did submit to the OIG, are “missing” and the defendant “does not appear
to have acknowledged these missing documents or attempted a follow-up search to find them.”
Id. at 38. The defendant does not dispute that Pfizer submitted to the OIG its comments
responding to the IRO Reports, as required in Section V.B.6 of the CIA and referenced in each
Annual Report, or that such documents are responsive to the FOIA request. Rather, the
defendant disputes that Pfizer’s Section V.B.6 documents are missing and instead asserts that
they were identified in the search and withheld, as described in the Pfizer Vaughn index entries
174, 175 and 176. See Def.’s Reply at 5.
In support of its position that “the very information that Plaintiff claims establishes that
the search was inadequate is accounted for in the Vaughn index,” the defendant highlights the
information set forth in the Pfizer Vaughn index entries 174, 175 and 176. Id. These three
entries, 174, 175 and 176, describe three letters, which were released with virtually all text
redacted, from Pfizer’s counsel to the OIG, dated February 13, 2006, February 19, 2008 and
November 11, 2009, respectively, as follows: “This letter and the accompanying attachments
contain confidential information related to communication with the OIG regarding Pfizer’s
responses to the OIG’s review of Pfizer’s Annual Report. These documents contain confidential
information regarding IRO reviews and reports as well as Pfizer’s responses thereto and
excerpts from certain Pfizer policies and verbatim.” Id. (emphasis in original).
13
The defendant’s response that the plaintiff’s challenge to the adequacy of the search for
Pfizer documents “fails as a factual matter,” Def.’s Reply at 5, has two fundamental problems.
First, the documents described in the Pfizer Vaughn Index entries 174, 175 and 176 relate only to
the first, third, and possibly the final 2009 Annual Reports. See Supplemental Decl. of Julie
Murray, Counsel to Public Citizen, (“Murray Suppl. Decl.”) Ex. 1, Attachs. D, E, F, ECF No. 34-
1 (Feb. 13, 2006 letter states submission is “regarding Pfizer’s first Annual Report;” Feb. 19,
2008 letter states “Re: Follow-up to the Third Annual Report;” and the last letter is dated Dec.
11, 2009 letter, which is after submission of fifth Annual Report). Thus, the Section V.B.6
documents released in part and described in the Pfizer Vaughn index are only for three Annual
Reports (first, third and last), even though the company indicated in its Annual Reports for all
five years that it was filing Section V.B.6 documents. Nowicki Decl. ¶ 12. Thus, it appears that
Pfizer’s Section V.B.6 documents for at least two years were neither released to the plaintiff nor
referenced in the Vaughn index and, thus, are correctly deemed “missing” by the plaintiff. Pl.’s
Mem. at 38.
Second, the plaintiff challenges whether the documents described at Pfizer Vaughn Index
entries 174, 175 and 176, which the defendant points to as evidence of the adequacy of its search,
are actually the Section V.B.6 documents. See Pl’s Reply in Supp. Pl.’s Mot. Summ. J. (“Pl.’s
Reply”) at 20–21, ECF No. 34. The plaintiff’s declarant submitted copies of the heavily redacted
versions of the documents corresponding to Vaughn index numbers 174, 175 and 176. See
Murray Suppl. Decl., Ex. 1 Attachs. D, E, and F (Bates Nos. OIG-009386, OIG-009420, OIG-
009428). The opening paragraphs of each letter indicate that Pfizer is responding to specific
OIG requests for additional information, but nowhere indicate that this information is provided to
comply with the CIA’s Section V.B.6. The plaintiff claims that these documents “provide only
14
‘supplemental information that [OIG] requested’ in response to Pfizer’s annual reports,” Pl.’s
Reply at 20, rather than submitting Pfizer’s own independent “review [of] the Internal Review
Organizations findings and recommendations, and any other observations . . . pursuant to Section
III.D” of the CIA. See, e.g., Murray Decl. Ex. 3 Attach. H, Bates No. OIG-003715; Murray
Suppl. Decl. Ex. 1 Attach. F, Bates No. OIG-009428. Thus, as a factual matter, the plaintiff has
raised a significant question as to whether the letters listed in the Vaughn index entries 174, 175
and 176 actually correspond to the information referenced in the CIA’s Section V.B.6.
The defendant nowhere adequately explains these factual discrepancies. Rather, the
defendant’s fallback position is that the law does not require the agency to do any more
searching since the agency has demonstrated in affidavits that it “conducted a reasonable
search,” and no bad faith has been alleged. Def.’s Reply at 4. While “the adequacy of a FOIA
search is generally determined not by the fruits of the search, but by the appropriateness of the
methods used to carry out the search,” see Iturralde v. Comptroller of Currency, 315 F.3d 311,
315 (D.C. Cir. 2003), “if a review of the record raises substantial doubt, particularly in view of
‘well defined requests and positive indications of overlooked materials, summary judgment is
inappropriate,” Valencia-Lucena v. U.S. Coast Guard, 180 F.3d 321, 326 (D.C. Cir. 1999)
(quoting Founding Church of Scientology v. Nat’l Sec. Agency, 610 F.2d 824, 837 (D.C. Cir.
1979)).
In this case, the defendant concedes the existence of Pfizer Section V.B.6 documents
required to be submitted to the OIG on an annual basis under the CIA, by pointing to the three
heavily redacted letters described in the Pfizer Vaughn Index entries 174, 175 and 176.
Moreover, the existence of these documents is confirmed by the released portions of five annual
reports referencing the “later” submission of the Section V.B.6 documents. See Murray Decl. Ex.
15
3 Attach. H (Bates Nos. OIG-000066, OIG-001862, OIG-003715, OIG-005864 and OIG-
007893). Therefore, at a minimum, Pfizer’s Section V.B.6 documents for two annual reports,
which the defendant does not dispute should exist and should have been accounted for, are not
represented in the Vaughn index, nor has the defendant provided any explanation as to what steps
it undertook to track down these missing documents.
That the defendant was under an obligation to do so is made clear in Campbell v. United
States Department of Justice, 164 F.3d 20, 28 (D.C. Cir. 1998). In Campbell, the D.C. Circuit
held that an agency must “revise its assessment of what is [a] ‘reasonable’ [search] in a particular
case to account for leads that emerge during its inquiry.” Id. at 28. In other words, when leads
to other documents arise during the course of a search for responsive records, the agency must
expand the scope of its search. Id. This does not mean that “mere reference to other files” that
are relevant to a FOIA request triggers an obligation for the agency to expand a search since “[i]f
that were the case, an agency responding to FOIA requests might be forced to examine virtually
every document in its files, following an interminable trail of cross-referenced documents like a
chain letter winding its way through the mail.” Steinberg v. U.S. Dep’t of Justice, 23 F.3d 548,
552 (D.C. Cir. 1994); see also Morley, 508 F.3d at 1121. Yet, when, as here, the agency
concedes that responsive documents exist and, further, that its search should have recovered
those documents, by stating as a factual matter that they were, in fact, located, summary
judgment is inappropriate when the plaintiff raises substantial factual questions about those
assertions. Indeed, the D.C. Circuit has instructed that “a court may place significant weight on
the fact that a records search failed to turn up a particular document in analyzing the adequacy of
a records search.” Iturralde, 315 F.3d at 315 (citing Krikorian v. U.S. Dep’t of State, 984 F.2d
461, 468 (D.C. Cir. 1993)). As the D.C. Circuit explained in Valencia-Lucena, “what causes us
16
to conclude that the search was inadequate arises from the fact that the record itself reveals
positive indications of overlooked materials.” 180 F.3d at 326 (internal quotations omitted).
Here, there can be no doubt that, in the course of a search for responsive records, the
defendant was or became aware that Pfizer’s Section V.B.6 documents for five annual reports,
not just three such reports, should exist. Yet, the defendant offers no explanation, and cites to no
produced document, to account for the missing records for at least two annual reports. Although
the defendant is correct that “a search is not unreasonable simply because it fails to produce all
relevant material,” Meeropol v. Meese, 790 F.2d 942, 952-53 (D.C. Cir. 1986), the defendant
was affirmatively obligated to make an effort to find the two missing year’s responses when the
“leads” to those documents are obvious. See Campbell, 164 F.3d at 28.
Moreover, neither the redacted records produced nor the Pfizer Vaughn Index sufficiently
indicates that entries 174, 175 and 176 are actually the Section V.B.6 documents that Pfizer was
required to produce under Section III.D and Section V.B.6 of the CIA, as all three letters appear
to be responding to direct questions from the OIG, rather than Pfizer’s own findings and
recommendations in response to an IRO Report. Therefore, the defendant has not sustained its
burden of showing the adequacy of its search and may either supplement its declarations to
address the factual questions raised by the plaintiff about the Pfizer Section V.B.6 documents or
perform an additional search to locate the missing records. 12
12
The defendant also argues that because no challenge to the adequacy of the search was raised during the
administrative appeal, the plaintiff has failed to exhaust its administrative remedies. See Def.’s Reply at 5 n.1. As
the plaintiff rightfully points out, however, the inadequacy of the defendant’s search was not apparent until after the
agency filed its Vaughn indices, which show that Pfizer Section V.B.6 documents for at least two, if not all five,
annual reports are missing. The Court, therefore, rejects this defense to the plaintiff’s challenge to the adequacy of
the search.
17
B. Exemption 4 Withholdings
Under the FOIA, “trade secrets and commercial or financial information obtained from a
person” that is “privileged or confidential” may be withheld from disclosure. 5 U.S.C. §
552(b)(4). 13 If the documents are not trade secrets, to sustain the burden of showing that
Exemption 4 was properly applied, an agency must establish that the withheld records are “(1)
commercial or financial, (2) obtained from a person, and (3) privileged or confidential.” Pub.
Citizen Health Research Grp. v. FDA, 704 F.2d 1280, 1290 (D.C. Cir. 1983). No party to this
action disputes the second prong of this test, nor could they, as the statute makes clear that a
“person includes an individual, partnership, corporation, association, or public or private
organization other than an agency.” 5 U.S.C. § 551(2) (emphasis added). Nor do the defendant
and defendant-intervenors claim that the withheld documents are “financial.” See Def. Mem.
generally; Declaration of Peter J. Claude, Partner at PricewaterhouseCoopers, LLP (“Claude
Decl.”), ECF No. 22-2; Mem. Supp. Def.-Intervenor Pfizer’s Mot. Summ. J. (“Pfizer Mem.”),
ECF No. 23-1, generally.
The parties contest only whether, under the first and third prongs of the test, the eight
categories of challenged, withheld documents are “commercial” materials and, if so, whether
they are “privileged or confidential.” To resolve this dispute, the Court will first examine the
scope of the term “commercial” in the FOIA context and address the plaintiff’s contention that
any document referring to illegal or potentially illegal activity falls outside the meaning of this
13
Although neither of the companies whose documents are at issue have claimed trade secret protection, the
defendant HHS has asserted, with only limited evidentiary support and no further discussion, that “the materials
withheld under Exemption 4 also constitute trade secrets.” Def. Mem., 8 n.1, ECF No. 22; see also Declaration of
Peter J. Claude, Partner at PricewaterhouseCoopers LLP (“Claude Decl.”) ¶ 13, ECF No. 22-2 (“In addition to being
commercially valuable, some of these procedures should be considered to contain trade secrets, as I understand that
term is defined by the OIG. These procedures are the product of innovation and are developed through substantial
effort.”). These conclusory statements, without any effort to show that the documents satisfy the requisite elements
for trade secret protection, are wholly insufficient to support such a finding. Thus, as do the parties, the Court will
focus on whether the withheld records are “commercial” information.”
18
term. Next, the Court will review each category of documents at issue and assess whether the
defendant and defendant-intervenors have met their burden of showing that challenged, withheld
records contain commercial information. Finally, for any category of documents found to
contain commercial information, the Court will evaluate whether the information is confidential
or privileged.
1. Scope of “Commercial” Information.
The term “commercial” is not defined in the FOIA. 14 Absent a precise statutory
definition or clarity from the legislative history, the D.C. Circuit has “consistently held that [this]
term . . . in [Exemption 4] should be given [its] ordinary meaning[].” Pub. Citizen Health
Research Group, 704 F.2d at 1290; see also Nat’l Ass’n of Home Builders v. Norton, 309 F.3d
26, 38 (D.C. Cir. 2002); Bd. of Trade v. Commodity Futures Trading Co., 627 F.2d 392, 403-404
(D.C. Cir. 1980) abrogated on other grounds by U.S. Dep’t of State v. Wash. Post Co., 456 U.S.
595 (1982); accord Perrin v. United States, 444 U.S. 37, 42 (1979) (“A fundamental canon of
statutory construction is that, unless otherwise defined, words will be interpreted as taking their
ordinary, contemporary, common meaning.”). “[I]nformation is commercial under this
exemption if, in and of itself, it serves a commercial function or is of a commercial nature.”
Nat’l Ass’n of Home Builders, 309 F.3d at 38 (citing Am. Airlines, Inc. v. Nat’l Mediation Bd.,
588 F.2d 863, 870 (2d Cir. 1978)) (internal quotations omitted). Thus, “records that actually
reveal basic commercial operations, such as sales statistics, profits and losses, and inventories, or
relate to the income-producing aspects of a business,” fall within the scope of “commercial”
information. See Pub. Citizen Health Research Grp., 704 F.2d at 1290. For instance, documents
14
The D.C. Circuit has concluded that the legislative history about the meaning of the key terms used in Exemption
4 is “unhelpful,” since while “Congress clearly indicated that Exemption 4 as a whole could cover such materials as
‘business sales statistics, inventories, customer lists, [and] scientific or manufacturing processes or developments,’
H.R. REP. No. 1497, 89th Cong., 2d Sess. 10, reprinted in 1966 U.S. CODE CONG. & AD. NEWS 2418, 2427, it
offered no guidance concerning which prong of the exemption would protect each of these diverse types of
information.” Pub. Citizen Health Research Grp.,704 F.2d at 1286.
19
that contain “revenue, net worth, income, and EBITDA” information are plainly commercial.
Kahn v. Fed. Motor Carrier Safety Admin., 648 F. Supp. 2d 31, 36 (D.D.C. 2009); see also
Greenberg v. FDA, 803 F.2d 1213, 1216 (D.C. Cir. 1986) (holding that customer lists constitute
commercial information); Rural Hous. Alliance v. U.S. Dep’t of Agric., 498 F.2d 73, 75 (D.C.
Cir. 1974) (holding that loan application information in agency report was subject to Exemption
4); Racal-Milgo Gov’t Sys., Inc. v. Small Bus. Admin., 559 F. Supp. 4, 6 (D.D.C. 1981) (finding
that Exemption 4 shielded information “much more sensitive than mere prices,” such as “audits
of private concessions in national parks; technical proposals for development of a system to
analyze gases generated by petroleum refineries; general selling prices, inventory balances, profit
margins, purchase activity, freight charges, costs of goods sold, and customer names, obtained
from a utility in the course of a government investigation; appraised value for customs duty
assessment purposes of imported machinery parts; design recommendations, design concepts, a
customer list, and biographical data on key employees; and computer usage, manpower
allocation, travel costs, biographical data on employees, and detailed cost data from a contract
with the Government”) (internal citations omitted).
The scope of “commercial” information has also been applied more broadly to records
containing information in which the provider of the records has “a commercial interest.” Baker
& Hostetler LLP v. U.S. Dep’t of Commerce, 473 F.3d 312, 319 (D.C. Cir. 2006) (finding letters
describing favorable market conditions for domestic lumber companies “plainly contain
commercial information within the meaning of Exemption 4”). For example, in Public Citizen
Health Research Group, the court found that “documentation of the health and safety experience
of [the company’s] products” was commercial because such documentation was “instrumental in
gaining marketing approval for their products.” 704 F.2d at 1290. At issue in Public Citizen
20
Health Research Group were reports submitted to the FDA about the safety of certain medical
devices in order to show the products were sufficiently safe to enter the marketplace. Id.Although not “commercial” in the sense of reflecting sales or profit-and-loss figures, the court
found that the reports fit comfortably within the broader definition of “commercial” that
examines whether the provider has a commercial interest in the documents because they are
helpful or “instrumental” to its business interests. Id.; see also Critical Mass Energy Project v.
Nuclear Regulatory Comm’n, 830 F.2d 278, 281 (D.C. Cir. 1987) (holding that non-profit
organization’s reports describing the operations of members’ nuclear power plants contained
“commercial” information since disclosure of health and safety problems resulting from
operation of nuclear power facilities could materially affect “commercial fortunes” of members).
Pfizer urges an even broader construction of Exemption 4, stating that “a company has a
‘commercial interest’ in all records that relate to every aspect of the company’s trade or
business.” Pfizer’s Mem. in Opp’n to Pl.’s MSJ & Reply in Supp. of Def.’s MSJ (“Pfizer
Reply”) at 6, ECF No. 31. This is plainly incorrect. See, e. g., Getman v. NLRB, 450 F.2d 670,
673 (D.C. Cir. 1971) (“a bare list of names and addresses of employees which employers are
required by law to give the [agency] . . . cannot be fairly characterized as . . . ‘financial’ or
‘commercial’ information”); Nat’l Bus. Aviation Ass’n v. FAA, 686 F. Supp. 2d 80, 86–87
(D.D.C. 2010) (list of aircraft registration numbers was not sufficiently “commercial” to qualify
for Exemption 4 withholding even though certain commercial information could be deduced
from other publicly available sources in conjunction with the requested documents); Chicago
Tribune Co. v. FAA, No. 97 C 2363, 1998 WL 242611 at *3 (N.D. Ill. May 7, 1998) (finding that
Federal Aviation Administration records pertaining to in-flight medical emergencies did not have
a sufficiently “direct relationship with the operations of a commercial venture” to qualify for
21
withholding under Exemption 4). Indeed, the D.C. Circuit has explained that “the reach of the
exemption for ‘trade secrets or commercial or financial information’ is not necessarily
coextensive with the existence of competition in any form.” Wash. Research Project, Inc. v. U.S.
Dep’t of Health, Educ. and Welfare, 504 F.2d 238, 244 (D.C. Cir. 1974). Thus, the D.C. Circuit
has cautioned that, consistent with the narrow construction given to FOIA exemptions, “[n]ot
every bit of information submitted to the government by a commercial entity qualifies for
protection under Exemption 4.” Pub. Citizen Health Research Grp., 704 F.2d at 1290.
The plaintiff argues that many of the challenged withheld documents fail to qualify as
“commercial” information because “[i]nformation about a company’s violation of laws and
regulations is not commercial in nature.” Pl.’s Mem. at 17. In support, the plaintiff seizes upon
language in Critical Mass Energy Project v. Nuclear Regulatory Comm’n, 975 F.2d 871 (D.C.
Cir. 1992) (en banc) (“Critical Mass”), generally describing the exemptions in the FOIA as
designed to protect “legitimate governmental and private interests.” Id. at 872. Thus, according
to the plaintiff’s argument, the FOIA necessarily excludes from the coverage of Exemption 4
“information about suspected or confirmed illegal conduct by the companies or their employees
and the companies’ corrective action . . . to comply with applicable laws,” Pl.’s Mem. at 17,
because protecting against the disclosure of potential illegal conduct is a non-legitimate goal.
The defendant counters that commercial information does not lose the protection of
Exemption 4 “even when that information was directly related to the potential wrongdoing.”
Def.’s Reply at 8. The Court agrees with the defendant for three reasons. First, the language
from Critical Mass relied upon by the plaintiff is too thin a reed to support the weight of its
argument. The D.C. Circuit’s use of the qualifying word “legitimate,” referred to the interests
served by the entire FOIA, not just Exemption 4. See Critical Mass, 975 F.2d at 872. This
22
judicial qualifier does not apply as an over-arching limit on the scope of any particular term used
in the FOIA and, thus, cannot be read to limit the types of “commercial” activities subject to
Exemption 4.
Second, the plaintiff’s proposed construction of Exemption 4 would impose on this
statutory provision a limitation which is simply not supported by the plain text. On the contrary,
the term “commercial” is generally defined to mean “engaged in commerce” or “having
reference to, or bearing on commerce.” Commercial, NEW OXFORD AM. DICTIONARY at 341 (2d
Ed. 2005) (“concerned with or engaged in commerce; making or intending to make a profit”);
Commercial, MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY at 231 (10th Ed. 1999) (“occupied
with or engaged in commerce or work intended for commerce; viewed with regard to a profit”);
Commercial Activity, BLACK’S LAW DICTIONARY at 38, (9th Ed. 2009) (“An activity, such as
operating a business, conducted to make a profit); see also Carlson v. U.S. Postal Serv., 504 F.3d
1123, 1129 (9th Cir. 2007) (“[I]nformation is commercial if it relates to commerce, trade, or
profit”) (internal quotation marks and citation omitted). Thus, using its ordinary meaning, the
term “commercial” is not limited only to lawful activities but also extends more broadly to any
type of activity bearing on commerce.
Several of the cases cited by the defendant support this plain text meaning of the term
“commercial.” 15 In ISC Group, Inc. v. United States Department of Defense, Civ. A. No. 88-
0631, 1989 WL 168858, at *2-3 (D.D.C. May 22, 1989), the court found that “financial
summaries and forecasts, inventory and labor data, and other financial analyses” contained in a
15
Two of the cases relied upon by the defendant are unhelpful since the parties in those cases did not dispute
whether the requested documents were “commercial;” consequently, the courts did not confront, let alone consider,
the issue of whether documents containing information about illegal conduct could also qualify as “commercial”
under Exemption 4. See Am. Mgmt. Servs., LLC v. Dep’t of the Army, 842 F. Supp. 2d 859, 880 (D.D.C. 2012) (“It
is undisputed that the information in question is ‘commercial or financial.’”); Hersh & Hersh v. U.S. Dep’t of Health
and Human Servs., C 06-4234, 2008 WL 901539, at *7 (N.D. Cal. Mar. 31, 2008) (“[S]ince there is no other dispute
as to whether the information qualifies as commercial or financial . . . .”).
23
report investigating potential fraud in Department of Defense contracts were “commercial or
financial” information subject to Exemption 4. The fact that certain of this financial information
also reflected fraudulent activity was not a disqualifier for withholding. See also M/A-Com Info.
Sys., Inc. v. U.S. Dep’t of Health and Human Servs., 656 F. Supp. 691, 692 (D.D.C. 1986)
(holding that the agency properly withheld under Exemption 4 documents containing
“accounting and other internal procedures [the submitting company] was willing to undertake to
obtain by consent dismissal of the debarment action without admission of liability or resolution
of the facts in dispute.”).
Similarly, in Watkins v. United States Bureau of Customs and Border Protection, 643
F.3d 1189 (9th Cir. 2011), the Ninth Circuit rejected a FOIA requester’s contention that
“Notices of Seizures” for allegedly counterfeit goods were not “commercial” because they
pertained to “the unlawful importation of counterfeit goods, and not any sort of legitimate
commercial activity.” Id. at 1195. Noting that such Notices are not “final determinations that
goods seized are counterfeit,” but are more “akin to a finding of probable cause,” the court
explained that “we cannot conclude that information contained in a Notice of Seizure is non-
commercial just because it’s likely — perhaps even very likely — that the merchandise seized is
counterfeit.” Id. Since the Notices disclose “intimate aspects of an importers business such as
supply chains and fluctuations of demand for merchandise,” the court further found that they
“contain plainly commercial information.” Id.Finally, the third reason to reject the plaintiff’s argument to exclude from the scope of
“commercial” any “suspected or confirmed unlawful conduct,” Pl.’s Mem. at 1, is that it is based
on an error of reasoning by fallaciously imputing the properties of a “part” to the properties of
the “whole.” Specifically, the overall commercial nature of an undertaking is not altered when
24
some aspect of that activity is suspected to constitute, or actually results in, a violation of a rule,
regulation or statutory requirement. This is particularly true in the context of a heavily regulated
industry, such as pharmaceuticals. The Ninth Circuit in Watkins implicitly recognized the
fundamental unfairness that would result if the protection of Exemption 4 were unavailable to
withhold otherwise confidential commercial documents of a company simply because the
company was accused of wrongdoing, noting that, in some cases, “importers sometimes
acquiesce in the Agency’s seizure and forfeiture of legitimate goods,” even without proof of
legal violation. 643 F.3d at 1195 (emphasis in original).
Although the Court finds unpersuasive the plaintiff’s argument that any information
related to potential wrongdoing categorically falls outside Exemption 4, this does not mean that
all of the withheld information submitted pursuant to the CIAs is automatically commercial. The
defendant must provide sufficient justification about each category of challenged documents to
show that the withheld documents are, indeed, “commercial” within the meaning of Exemption
4. As discussed in more detail below, the Vaughn indices and declarations fall short in many
instances of the level of specificity the FOIA requires.
2. Sufficiency of Showing That Withheld Documents Are “Commercial”
Set against the broad scope of the term “commercial,” the Court next examines each
challenged category of withheld documents to determine whether they meet this prerequisite for
application of Exemption 4. In this regard, the Court is mindful that the defendants bear the
burden of establishing the applicability of this exemption and that “conclusory and generalized
allegations of exemptions are unacceptable.” Morley, 508 F.3d at 1115 (internal quotation marks
omitted). With respect to each category of withheld documents, the defendant makes only the
conclusory statement that “[t]he records contain Pfizer and Purdue’s commercial or financial
information.” Brooks Decl. ¶ 25. The Vaughn indices offer no additional details on this critical
25
question. See Pfizer Vaughn Index, Purdue Vaughn Index, generally. Consequently, as set forth
below, the Court relies primarily upon the declarations of the defendant-intervenors to tease out
any information regarding whether the withheld documents are “commercial” for the purposes of
Exemption 4.
a. Reportable Event Summaries
Under the terms of the CIAs, Reportable Events are those events where “a reasonable
person would consider a probable violation of criminal, civil, or administrative laws applicable
to any Federal health care program and/or any FDA requirements relating to the labeling or
promotion of products for which penalties or exclusion may be authorized.” Purdue CIA at 19–
20; see also Pfizer CIA at 21. Each company was required to notify the OIG within 30 days of
“determining that the Reportable Event exists.” Purdue CIA at 20; Pfizer CIA at 21. In those
reports, the companies were required to provide “a complete description of the Reportable Event,
including relevant facts, persons involved, and legal and Federal health care program authorities
implicated,” “a description of [the company’s] actions taken to correct the Reportable Event,”
and “any further steps [the company] plans to take to address the Reportable Event and prevent it
from recurring.” Pfizer CIA at 21–22; see also Purdue CIA at 20.
Similarly to HHS, Purdue’s declarant does not discuss whether the Reportable Event
summaries are commercial at all but merely skips over this critical factor to focus on the “highly
confidential and privileged” nature of this information. See Weinstein Decl. ¶ 25 (“Because a
Reportable Event is the subject of highly confidential and privileged internal investigations
undertaken at Purdue to determine the underlying facts and potential violations, public disclosure
of the event would cause Purdue commercial injury.”); Brooks Decl. generally. Pfizer’s
declarant states that “[t]he Reportable Event summary logs contain highly sensitive commercial
information about the Reportable Event itself as well as Pfizer’s internal investigation of the
26
Reportable Event and any corrective actions taken.” Nowicki Decl. ¶ 26. More specifically,
“[t]he Reportable Event summaries often contain sales and marketing tactics, analysis of
compliance with the CIA and any corrective actions taken.” Id. ¶ 27 (emphasis added). The
import of this statement is that Pfizer’s summaries do not always contain information regarding
“sales and marketing.”
The Court could speculate that Reportable Event summaries could reveal information
about the companies’ activities in a specific place, at a specific time, and involving specific
activity with respect to a particular product and customer, all of which could in context be
considered “commercial” information. Such speculation is not the Court’s job, however. See
Coastal States Gas Corp. v. U.S. Dep’t of Energy, 617 F.2d 854, 870 (D.C. Cir. 1980) (“The
courts will not speculate as to whether [the] Exemption [] might, under some possible
congruence of circumstances not proven or even asserted be properly applied to these
documents, nor will we assume that all the necessary conditions are met merely because the
agency invokes an exemption.”); Founding Church of Scientology, 603 F.2d at 949 (“The
reviewing court should not be required to speculate on the precise relationship between each
exemption claim and the contents of the specific document.”).
Without more information about the commercial nature of the information contained in
the Reportable Event summaries, the Court has insufficient information to evaluate whether the
summaries contain commercial information and are being properly withheld. Consequently, the
Court denies summary judgment to the plaintiff and the defendants regarding the challenged
category of withheld documents containing Reportable Event summaries.
b. Disclosure Log Summaries
The companies were required by their CIAs to “maintain a disclosure log, which shall
include a record and summary of each disclosure received” by the company’s compliance officer
27
regarding the potential violation of “criminal, civil, or administrative law.” See Purdue CIA at
16–17; Pfizer CIA at 18–19. As described by Pfizer’s declarant, “[t]he Disclosure Logs contain
information regarding reports (some of which are made anonymously) by individuals to Pfizer’s
Compliance Officer (or his designee) regarding potential violations of criminal, civil or
administrative laws as required by the CIA. The Disclosure Logs contain summaries of reports
made, status of the internal review of the issue(s) raised in the reports, and any corrective actions
taken in response.” Nowicki Decl. ¶ 32.
The declarants for the defendants focus on the highly confidential nature of the disclosure
log summaries, but do not address the key issue of whether this category of withheld documents
contains commercial information. Id. (“This information is highly confidential”); Weinstein
Decl. ¶ 22 (“The Disclosure Log is maintained in a proprietary and highly confidential
database.”). Again, the Court will not speculate. See Coastal States Gas Corp., 617 F.2d at 870;
Founding Church of Scientology, 603 F.2d at 949. Without more information about the
commercial nature of the information contained in the disclosure log summaries, the Court has
insufficient information to evaluate whether these documents are being properly withheld.
Consequently, the Court denies summary judgment to the plaintiff and the defendants regarding
the challenged category of withheld documents containing the disclosure log summaries.
c. Ineligible Persons Information
Each company is required by their CIA to “ensure that all current Covered Persons 16 are
not Ineligible Persons,” meaning that they are not “currently excluded, debarred, suspended, or
otherwise ineligible to participate in the Federal health care programs or in Federal procurement
or nonprocurement programs” or have “been convicted of a criminal offense that falls within the
16
A “Covered Person” is defined in Purdue’s CIA to “include[]: all owners, officers, directors and employees [of the
company]” and all contractors, not including part time employees or people not involved in the business operations
of the company. See Purdue CIA at 2–3. The definition in Pfizer’s CIA is similar. See Pfizer CIA at 2–3.
28
ambit of 42 U.S.C. § 1320a-7(a), but ha[ve] not yet been excluded, debarred, suspended, or
otherwise declared ineligible.” Pfizer CIA at 19–20; Purdue CIA at 17–18. The companies are
required to include in their Annual Reports two key items of information relating to enforcement
of the CIAs provisions regarding Ineligible persons: (1) “any changes to the process by which
[the company] fulfills” the Ineligible Persons requirement, and (2) “the name, title, and
responsibilities of any person who is determined to be an Ineligible Person.” Purdue CIA at 28;
Pfizer CIA at 25.
Purdue’s declarant does not address this category of withheld documents except to say
Purdue’s “proposed actions regarding ineligible persons[] all directly relate to Purdue’s
compliance with legal and regulatory requirements, and are proprietary in nature.” Weinstein
Decl. ¶ 15. Pfizer’s declarant offers a similarly general statement that “[t]his information reflects
Pfizer’s internal business processes and judgments made to develop and implement the Ineligible
Person Management process as well as confidential information related to Pfizer’s screening and
removal of Ineligible Persons.” Nowicki Decl. ¶ 29.
With respect to the first item of information, which requires the defendant-intervenors to
notify the OIG of “any changes to the process by which [the company] fulfills the requirements
of [the CIA] regarding Ineligible Persons,” Pfizer CIA at 25, Purdue CIA at 28, such
modifications to internal processes are sufficiently commercial to qualify for Exemption 4
because they involve the process by which the companies make decisions about managing and
conducting their business operations. Such information is “instrumental” to conducting business
because such individuals must be vetted and, when necessary, removed from the defendant-
intervenors’ employ to allow the company to continue a significant part of its business with
federal health care programs. Pfizer CIA at 20; Purdue CIA at 18–19. Consequently,
29
information concerning changes to processes regarding the screening or removal of Ineligible
Persons amounts to “commercial” information under Exemption 4. 17
By contrast, the second item of information relating to Ineligible Persons consists only of
the “name, title, and responsibilities of any person who is determined to be an Ineligible Person.”
Pfizer CIA at 25 (Section V.B.11), Purdue CIA at 28 (Section V.B.12). This information is static
and does not appear to have anything to do with the ongoing creation or selling of products, nor
does this information appear to be “instrumental” to conducting commerce. Indeed, no
defendant declarant has provided any information revealing how such information could be
“commercial.” Accord Getman, 450 F.2d at 673 (holding that list of names and addresses of
employees are not ‘commercial’ information”); Comptel v. F.C.C., 910 F. Supp. 2d 100, 116
(D.D.C. 2012) (“The FCC has not met its burden to show that names and contact information
should be exempt as confidential commercial or financial information. . . . While the Court
assumes corporations can have a commercial interest in the names of certain staff, it is not a
certainty that a corporation would have a commercial interest in the names of every one of its
employees.”). Consequently, the Court grants summary judgment to the plaintiff and orders the
release of any documents withheld under Exemption 4 because they contain the “title and
responsibilities of any person who is determined to be an Ineligible Person.” 18 See Pfizer CIA
(Section V.B.11); Purdue CIA (Section V.B.12).
d. Investigations Or Legal Proceedings
The CIAs require the companies to, “[w]ithin 30 days after discovery . . . notify OIG, in
writing, of any ongoing investigation or legal proceeding . . . conducted or brought by a
17
The Court must still determine, as discussed in Section III.B.3.b, infra, whether these withheld documents are
“privileged or confidential” for application of Exemption 4.
18
The plaintiff has made clear that it is not seeking “names, e-mail addresses, telephone numbers, or signatures of
individuals named in withheld documents.” Pl.’s Mem. at 2. Any such personally identifiable information may be
redacted from released documents.
30
governmental entity or its agents involving an allegation that [the company] has committed a
crime or has engaged in fraudulent activities.” Purdue CIA at 19 (Section III.G); see also Pfizer
CIA at 21 (Section III.G). The “notification shall include a description of the allegation, the
identity of the investigating or prosecuting agency, and the status of such investigation or legal
proceeding.” Purdue CIA at 19 (Section III.G); see also Pfizer CIA at 21 (Section III.G).
Additionally, the companies are to “provide written notice to OIG within 30 days after the
resolution of the matter, and shall provide OIG with a description of the findings and/or results
of the investigation or proceedings, if any.” Purdue CIA at 19; see also Pfizer CIA at 21.
The reporting requirement for investigatory or legal proceedings consists of three parts:
(1) the description of the allegation; (2) the identity of the agency conducting the investigation;
and (3) the status of the investigation or proceeding. The defendants’ declarants do not expressly
address the commercial nature of any part of this category of withheld documents. Instead,
Purdue’s declarant stresses that “[p]ublic disclosure of this information, which includes non-
public legal and/or regulatory actions, such as with a Reportable Event, would certainly have
negative commercial consequences for Purdue.” Weinstein Decl. ¶ 26. Similarly, Pfizer’s
declarant states that “release of such information would cause Pfizer competitive harm and could
be useful to Pfizer’s adversaries in current litigation.” Nowicki ¶ 28.
The legal proceedings described in this category of withheld document pertain to
allegations of the company’s criminal or fraudulent conduct. Although the defendants do not
expressly say so, common sense dictates that such allegations about the company itself relate to
the conduct of employees and/or policies and practices of management in the operation of the
companies’ business and thereby implicate the companies’ “commercial interests.” While the
support for this conclusion in the declarations from the defendant and defendant-intervenors is
31
thin, the definition of the reporting requirement in the CIAs provides sufficient context for the
Court to reach this conclusion. Therefore, the first part of the reporting requirement regarding a
description of the allegation is “commercial” under Exemption 4.
The other two parts of this reporting requirement, however—the identity of the agency
conducting the investigation and the status of the investigation—do not appear to be
“commercial,” and nothing in the declarations is provided to assist the Court is reaching any
other conclusion. The identify of an outside agency conducting an investigation and that
investigation’s status (e.g., closed, ongoing, active, stayed, dormant, etc.) would not, standing
alone, reveal any information about the business operations or other commercial activities of the
defendant-intervenors. While the defendant-intervenors’ declarants indicate that release of the
broad category of information would cause competitive harm or be of some use to “adversaries
in current litigation,” Nowicki Decl. ¶ 28, the basis for these assertions is unexplained. While
the Court appreciates that revealing the existence of an investigation, even if the status is closed,
may be embarrassing or harmful to the reputation of a company, the law is well-settled that this
potential consequence of a disclosure does not convert the information into “commercial” under
Exemption 4. The D.C. Circuit made this point clearly in United Technologies. There, defense
contractors sought to use Exemption 4 to shield the release of information on the ground that
they would suffer competitive harm because “their competitors will use the documents to
discredit them in the eyes of current and potential customers” and their “reputation will suffer as
a result.” United Technologies, 601 F.3d at 563. The court bluntly rejected this argument, stating
“Exemption 4 does not protect against this species of harm,” and further explaining that
“[c]alling customers’ attention to unfavorable agency evaluations or unfavorable press does not
amount to an ‘affirmative use of proprietary information by competitors.’” Id. at 563–64. In
32
short, “Exemption 4 does not guard against mere embarrassment in the marketplace or
reputational injury.” Id. at 564; see also Occidental Petroleum Corp. v. SEC, 873 F.2d 325, 341
(D.C. Cir. 1989) (holding that a submitter’s “right to an exemption, if any, depends upon the
competitive significance of whatever information may be contained in the documents, not upon
whether its motive is to avoid embarrassing publicity”); CNA Fin. Corp. v. Donovan, 830 F.2d
1132, 1154 (D.C. Cir. 1987) (noting that public embarrassment to a corporation does not warrant
withholding material under Exemption 4).
The identities of the agencies conducting the investigations and the status of those
investigations are not “commercial” for Exemption 4 purposes. Therefore, the Court grants
summary judgment to the plaintiff and orders the release of any documents withheld because
they contain the identity of the agency conducting the investigation and the status of the
investigation or proceeding.
e. Company Communications with FDA About Off-Label Promotions
The CIAs require each company to provide copies of communications from the FDA that
“substantively discuss . . . unlawful or improper promotion of [the company’s] products or the
misbranding of [the company’s] products.” Purdue CIA at 20; see Pfizer CIA at 22; Nowicki
Decl. ¶ 30 (clarifying that this provision of Pfizer’s CIA is limited to “unlawful or improper
promotion of [the company’s] products,” and does not include “misbranding”). Although the
defendants’ declarants say nothing about the commercial nature of these communications, again,
the Court may rely on the definition in the CIA to determine that the subject matter of the
communications expressly relates to promotion of the companies’ products. Since this category
of withheld documents pertains to the marketing and sale of the companies’ products, the Court
finds that these documents are “commercial” within the meaning of Exemption 4.
33
f. Pfizer’s Off-Label Findings And Detailing Sessions
Pfizer, and not Purdue, was required to “provide to OIG a list and explanation of all
actively promoted Pfizer products and, if available from third parties, information about the
estimated relative usage . . . of those products for off-label purposes.” Pfizer CIA at 22.
Furthermore, in each Annual Report, “Pfizer shall obtain commercially available non-Pfizer
records reflecting the purported content and subject matter of detailing interactions between sales
representatives and [health care providers] for the Covered Products.” Id. After obtaining these
third party records, “Pfizer shall review the records . . . and shall identify any instances in which
the records appear to indicate that Covered Person may have discussed and/or disseminated
information about off-label uses of the Covered Products.” Id. at 23. “Pfizer shall make findings
based on its review . . . and shall take any responsive action it deems necessary.” Id. Pfizer was
required to provide these underlying documents and findings as part of its Annual Report. Id.
Pfizer’s declarant explains that the details it provides to the OIG about its “Review of
Detailing Sessions . . . includes detailed information regarding Pfizer’s internal review and
monitoring of sales representative activities that are designed to ensure compliance with FDA
promotional and other legal requirements.” Nowicki Decl. ¶ 33. This declarant further states
that this information also describes “the manner in which Pfizer addresses potential violations of
Company policies and procedures.” Id. The description of the subject matter of this category of
challenged, withheld documents is sufficiently specific to demonstrate that these documents
pertain to sales representative activities, and reflect activities “instrumental” to Pfizer’s
commercial operations because compliance with FDA regulations is required for Pfizer to sell its
products. Therefore, the Court finds that the category of withheld documents regarding Pfizer’s
off-label findings and detailing sessions are “commercial” for purposes of Exemption Four.
34
g. Independent Review Organization Reports
The CIAs require each company to engage an IRO to review its transactions, systems,
and compliance activities. See Purdue CIA at 14; Pfizer CIA at 14. The IROs are required to
provide the companies with detailed reports regarding the IRO’s findings and, in turn, the
companies are required to provide summaries and assessments of changes made as a result of the
IRO findings. See Purdue CIA at 15; Pfizer CIA at 16–18. Pfizer’s declarant explains that the
IRO’s role “is to make an independent evaluation of Pfizer’s ‘Promotional and Product Related
Functions.’” Nowicki Decl. ¶ 21. In performing this task, the IRO reports contain detailed
information about Pfizer’s “managed care contracting process,” policies and procedures “relating
to responses to financial programs” and “policies and procedures relating to responses for
medical information requests.” Def.’s Mem. at 18. Pfizer’s declarant further describes the
contents of the IRO reports as containing information “related to Pfizer’s internal structure and
operations, how the company interacts with [health care providers] and the medical community,
and Pfizer’s policies governing the selling, detailing, marketing, advertising, promoting and
branding of . . . all Pfizer human pharmaceutical products.” Nowicki Decl. ¶ 22. Purdue’s
declarant states that the IRO report contains “an extensive, probing review of Purdue’s
confidential business systems and policies, as well as selected samples of individual
transactions.” Weinstein Decl. ¶ 20. These reports contain such information as the identity of
customers and the underlying business practices that gave rise to the need for corrective action.
Id.
This description of the information contained in the IRO reports is sufficiently detailed to
leave the Court no doubt that these documents include extensive information about the
defendant-intervenors’ marketing and sales programs and contracting processes, and,
consequently, are commercial under Exemption 4.
35
h. 2009 Purdue Supplement
The plaintiff challenges the withholding of the 2009 Purdue Supplement, which it
describes as the “transmittal memorandum and supplement to Purdue’s first annual compliance
report.” Pl.’s Mem. at 26. According to the plaintiff this “cover memorandum” to OIG was
produced only in heavily redacted form. Id. The Purdue Vaughn Index states that the “withheld
portions of the document [under Exemption 4] contain information regarding Purdue’s
promotional monitoring program and other confidential and proprietary policies and
procedures.” Purdue Vaughn Index No. 22. A promotional monitoring program falls within the
scope of commercial information under Exemption 4 because it pertains directly to the methods
by which Purdue sells its products.
Yet, the vague reference in the Purdue Vaughn Index to “other confidential and
proprietary policies” is insufficient to allow the Court to determine whether those portions of the
document are commercial under Exemption 4. Purdue Vaughn Index No. 22. Thus, to the extent
that the 2009 Purdue Supplement pertains to its promotional monitoring program, the Court finds
that it is “commercial” within the meaning of Exemption 4. Given the paucity of information
provided in the declarations and Purdue Vaughn Index about the other portions of the document,
however, it is impossible for the Court to determine whether the entire document contains
commercial information and whether any non-commercial information can be segregated from
the commercial information. Therefore, the Court denies summary judgment to all parties
pertaining to the “other confidential and proprietary policies” as to the segregable parts of the
2009 Purdue Supplement.
36
* * *
In sum, the following categories, or sub-parts of categories, of challenged, withheld
documents are not “commercial,” and the Court grants summary judgment to the plaintiff with
respect the portions of the Annual Reports that require the defendant-intervenors to report on: (1)
the “name, title, and responsibilities of any person determined to be an Ineligible Person,”
pursuant to the Purdue CIA §§ III.F and V.B.12, and the Pfizer CIA §§ III.F and V.B.11; and (2)
the identity of the agency conducting, and status of, an investigation or proceeding, pursuant to
the Purdue CIA §§ III.G and V.B.13, and the Pfizer CIA §§ III.G and V.B.15.
Due to the insufficiency of the declarations and Vaughn indices, the Court is unable to
assess for the following categories, or sub-parts of categories, of challenged, withheld documents
whether the subject matter is “commercial” for the purpose of Exemption 4: (1) Reportable
Event summaries, submitted pursuant to §§ III.H and V.B.9 of the Purdue CIA, and §§ III.H and
V.B.12 of the Pfizer CIA; (2) disclosure log summaries, submitted pursuant to the §§ III.E and
V.B.10 of the Purdue CIA, and §§ III.E and V.B.14 of the Pfizer CIA ; and (3) references to
“other confidential and proprietary policies” in the 2009 Purdue Supplement. The Court will
give the defendant and defendant-intervenors the opportunity to supplement their declarations
and/or Vaughn indices to sustain their burden of showing the commercial nature of these
documents or, alternatively, to release them. See Comptel v. FCC, No. 06-1718, 2013 WL
2171793, at *7 (D.D.C. May 20, 2013) (after denying summary judgment without prejudice to
give agency opportunity to file supplemental information, court reviewed amended declarations
and Vaughn index, stressing that agency “has the burden to show that the information redacted is
commercial or financial, in addition to demonstrating that it was obtained from a person and is
privileged or confidential”).
37
The Court has been able to conclude, based upon the context and the CIAs’ definitions, in
conjunction with the declarations and Vaughn indices, that the following categories, or sub-parts
of categories, of challenged, withheld documents are “commercial” for the purposes of
Exemption 4: (1) changes to the processes by which the companies fulfill the Ineligible Persons
requirement in Section III.F of the Purdue and Pfizer CIAs; (2) the description of the allegations
subject to investigations or legal proceedings required to be included in the Annual Reports,
pursuant to § III.G of the Purdue and Pfizer CIAs; (3) company communications with the FDA
regarding off-label promotions required to be included in the Annual Reports, pursuant to § III.I
of the Purdue and Pfizer CIAs; (4) Pfizer’s off-label findings and detailing sessions required to
be included in the Annual Reports, pursuant to §§ III.J and V.B.17 of the Pfizer CIA; (5) IRO
reports required to be included in the Annual Reports, pursuant to §§ III.D and V.B.5-8 of the
Purdue CIA, and §§ III.D and V.B.6-9 of the Pfizer CIA; and (6) the portions of the 2009 Purdue
Supplement addressing Purdue’s promotional monitoring program. The Court next examines the
sufficiency of the showing that these commercial documents are confidential to warrant
application of Exemption 4.
3. Sufficiency of Showing That Commercial Documents Are Confidential
A “commercial” document may only be withheld under Exemption 4 if it is
“privileged” 19 or “confidential.” 5 U.S.C. § 552(b)(4). A two prong test is used to determine
19
Pfizer argues that all of the challenged documents fall under the “self-evaluation and self-critical reports”
privilege for Exemption 4 purposes. Pfizer Mem. at 22. The Court is not persuaded by Pfizer’s tortured reading of
Circuit precedent. Pfizer cites only a single, unpublished district court case from this Circuit to support its
proposition that “courts have long recognized” a self-evaluative privilege. Id. (citing Washington Post Co. v. Dep’t
of Justice, Civil Action No. 84-3581, 1987 U.S. Dist. LEXIS 14936, at *21 (D.D.C. Sept. 25, 1987)). As Pfizer
points out, that case was reversed on other grounds. See Wash. Post Co. v. Dep’t of Justice, 863 F.2d 96, 99 (D.C.
Cir. 1988). Indeed, in remanding that case for consideration of the applicability of a FOIA exemption other than
Exemption 4, the D.C. Circuit court reserved judgment as to whether Exemption 4 encompasses a self-evaluative
privilege. Id. (“We will decide the exemption (4) question” if “the report [at issue] is not shielded under exemption
(7)(B)”). Notably, the D.C. Circuit has rejected the use of the “self-evaluative privilege in the context of private
litigation . . . where… the documents in question have been sought by a governmental agency,” FTC v. TRW, Inc.,
38
whether information involuntarily submitted to a Federal agency is “confidential” for FOIA
purposes. “Commercial or financial matter is ‘confidential’ for purposes of the exemption if
disclosure of the information is likely to have either of the following effects: (1) to impair the
Government’s ability to obtain necessary information in the future; or (2) to cause substantial
harm to the competitive position of the person from whom the information was obtained.” Nat’l
Parks and Conserv. Ass’n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974) (“National Parks”); see
also B.d of Trade v. Commodity Futures Trading Com., 627 F.2d 392, 404 (D.C. Cir. 1980). As
discussed below, the Court examines the sufficiency of the showing by the defendant and
defendant-intervenors that the release of the withheld commercial documents would either
“impair the Government’s ability to obtain necessary information in the future,” id., or “cause
substantial harm to the competitive position” of Pfizer or Purdue. 20
628 F.2d 207, 210 (D.C. Cir. 1980), and has cautioned that “federal courts should not create evidentiary privileges
lightly . . . and we would unlikely fashion a privilege lacking in historical or statutory basis,” First E. Corp. v.
Mainwaring, 21 F.3d 465, 467 n.1 (D.C. Cir. 1994) (internal quotation marks omitted). As this Court noted in
Mahnke v. Washington Metropolitan Area Transit Authority, the “self-evaluative” privilege is “rarely recognized”
and “[c]ourts are ‘reluctant to expand [the privilege] beyond cases involving public health or safety.’” 821 F. Supp.
2d 125, 150 n.16 (D.D.C. 2011) (citations omitted) [alterations in the original]. No case from any federal court has
been cited by the parties in which the “self-evaluative privilege” was successfully used to justify the withholding of
documents under Exemption 4. The Court declines to extend whatever self-evaluative privilege may exist in the
civil discovery context to shield from disclosure under Exemption 4 reports involuntarily provided to a government
agency and, thus, only considers whether the commercial documents withheld in this case are also confidential.
20
The bar is lower for withholding confidential information voluntarily provided to the Government: voluntarily
submitted information need only be “of a kind that would customarily not be released to the public by the person
from whom it was obtained” to be withheld as confidential. Critical Mass, 975 F.2d at 878. While HHS and
Purdue, which joined HHS’ arguments, concede that the companies’ submissions to OIG were involuntary, Pfizer
contends that because it entered into its CIA with HHS voluntarily, the information required by the CIA was also
produced voluntarily. See Pfizer Mem. at 16–17. Pfizer’s argument is contrary to the law of this Circuit. “For
purposes of Exemption 4, information provided to the government because it is required for participation in a
voluntary government program is treated as a mandatory, as opposed to a voluntary, submission of information.”
Judicial Watch, Inc. v. U.S. Dep’t of the Treasury, 796 F. Supp. 2d 13, 35 n.8 (D.D.C. 2011); see also Ctr. for Auto
Safety v. Nat’l Highway Traffic Safety Admin., 244 F.3d 144, 149 (D.C. Cir. 2001) (holding that when an agency has
“actual legal authority” to compel production of information, such production is not voluntary for the purposes of
the FOIA); Pub. Citizen Health Research Grp. v. F.D.A., 964 F. Supp. 413, 414 n.1 (D.D.C. 1997) (“Information is
submitted involuntarily, however, if it is supplied pursuant to statute, regulation or some less formal mandate.”).
Pfizer does not dispute that the documents at issue were “submitted to the OIG in accordance with the terms of the
2004 CIA.” Pfizer Mem. 16. As such, the information was submitted involuntarily because it was submitted
“pursuant to statute, regulation, or some less formal mandate.” Pub. Health Research Grp., 964 F. Supp. at 414 n.1.
Therefore, the Court will apply the more stringent confidentiality standard applicable to involuntarily submitted
documents recognized in National Parks and Critical Mass.
39
a. The Government’s Ability to Obtain Necessary Information
The defendant argues that the release of the withheld documents would harm the
government’s interest in two ways. “First, health care providers currently under CIAs would be
reluctant to provide complete information,” citing as an example that “providers may hesitate to
fully explain the circumstances or submit their full investigative reports if they are concerned
that the public may have access to that information [regarding instances of possible
noncompliance].” Def.’s Mem. at 26. “Second, the OIG’s inability to prevent the disclosure of
confidential proprietary information would severely impair [HHS’s] ability to negotiate
meaningful CIAs in the future.” Id. Neither argument is persuasive.
First, the Court is skeptical of the defendant’s contention that release of the withheld
commercial information could jeopardize the government’s ability to obtain full and complete
reporting as required under the CIAs. The court in Critical Mass was similarly skeptical about
impairment of the government’s ability to obtain information when the submission was required.
Critical Mass, 975 F.2d at 878 (“because the concessioners [were] required to provide this
financial information . . . there is presumably no danger that the public disclosure will impair the
ability of the Government to obtain this information in the future”) (alteration in original).
Instead, the D.C. Circuit explained that the focus is on the risk that disclosure may adversely
affect the “continued reliability” or “quality” of the information obtained by the government, not
its availability. Id.With respect to the “quality” of the submissions, the government is well-protected by the
penalty terms of the CIAs for breaches of the reporting requirements. The CIAs contain
extensive monetary and injunctive penalties for violations of the agreement, including exclusion
from federal health care programs, the so-called “death penalty.” See Purdue CIA at 32–38;
Pfizer CIA at 30–36. For instance, if Pfizer were to fail “to report a Reportable Event and take
40
corrective action, as required in Section III.H,” Pfizer could be considered in material breach of
the agreement. Pfizer CIA at 33 (Section X.D.1.a) “The parties agree that a material breach of
the CIA by Pfizer constitutes an independent basis for Pfizer’s exclusion from participation in
the federal health care programs.” Id. at 34 (Section X.D.2). Other failures to adhere fully to the
CIA can lead to substantial monetary penalties. See Pfizer CIA at 31–32 (Section X.A); Purdue
CIA at 32–33 (Section X.A). Thus, the defendant has a variety of methods by which to
guarantee the continued completeness and accuracy of the reports submitted by these and other
companies subject to CIAs.
The defendant’s second argument about future trouble negotiating CIAs is similarly
unavailing, and largely for the same reason: namely, that the alternative to full compliance with
the CIAs is a potentially draconian penalty. CIAs are entered into as part of “the resolution of
civil and administrative health care fraud cases.” Demske Decl. ¶ 2. The incentive to enter into
such an agreement is that “the OIG agrees not to seek an exclusion of that entity from
participation in Federal health care programs.” Id. Exclusion from Federal health care programs
is such a severe penalty that it is known in the healthcare industry as “a corporate death
sentence.” Kesselheim Decl. ¶ 9. It strains credulity to believe that the specter of potential
disclosure under the FOIA of certain information required to be submitted to the agency pursuant
to a CIA’s requirements would lead a pharmaceutical company to choose instead the risk of
exclusion from federal drug reimbursement programs. Indeed, “nearly every” Department of
Justice investigations into the types of behavior that led to Pfizer and Purdue’s original CIAs
“has resulted in a settlement with the defendant pharmaceutical manufacturer, with
41
manufacturers choosing not to risk a finding of guilt at trial and exclusion from engaging in
federal health programs.” Id. 21
Purdue’s declarant seeks to bolster the defendant’s impairment argument by stating that
“It was critical to Purdue during negotiation of the CIA with OIG that the materials Purdue
would submit to OIG would be kept confidential and not subject to disclosure under FOIA.”
Supplemental Declaration of Bert Weinstein, Vice-President of Corporate Compliance, Purdue
Pharma, (“Weinstein Suppl. Decl.”) ¶ 2, ECF No. 29-1. This is belied by other language
included in the CIA, however, which makes clear that submitted information may be subject to
disclosure under the FOIA. While the CIA permits Purdue to “clearly identify any portions of its
submissions that it believes are trade secrets, or information that is commercial or financial and
privileged or confidential, and therefore potentially exempt from disclosure under the Freedom
of Information Act,” Purdue CIA at 30, the final determination must be left up to the agency.
See 5 U.S.C. § 552(a). In any event, merely because it was important to Purdue “that the
materials Purdue would submit to OIG” be shielded from disclosure is not the same as saying
Purdue would not have signed the CIA without such assurances. Purdue, notably, never makes
such an argument, nor does the defendant agency.
21
The defendant briefly cites two cases for its position that the first prong of the National Parks test is met and
release of the documents would impair the government’s ability to secure CIAs with companies in the future, but
neither case is persuasive. The context in Judicial Watch, Inc. v. Export-Import Bank, 108 F. Supp. 2d 19 (D.D.C.
2000), differs materially from the instant case. In Judicial Watch, the Export-Import Bank established that if
disclosure of the withheld records at issue were required, the “Bank’s function of providing insurance would be
undermined” and its ability “to fulfill its statutory purpose” would be impaired. Id. at 29–30. The defendant here
nowhere claims that disclosure would have such dire results as impairing its ability to carry out its statutory purpose.
The other case cited by the defendant is likewise inapposite. In Hersh and Hersh v. United States Department of
Health and Human Services, No. C 06-4234, 2008 WL 901539 (N.D. Cal. Mar. 31, 2008), the court deferred to the
agency’s assertion about impairment of the government interest, as was appropriate since, unlike in the instant case,
that assertion was not substantively challenged. Id. at *7 (“Plaintiff, moreover, presents no adequate grounds to hold
otherwise,” noting that the plaintiff’s only argument was that certain information submitted under the CIA had been
temporarily, inadvertently disclosed and the erroneous belief that the CIA report at issue had been publicly filed
with the SEC).
42
The defendant’s concern about its ability to negotiate future CIAs is, at most, minor,
since the enticement for companies to enter into CIAs to avoid the “corporate death sentence”
will continuing to be compelling. “A minor impairment cannot overcome the disclosure mandate
of FOIA.” Wash. Post Co. v. U.S. Dep’t of Health and Human Servs., 690 F.2d 252, 269 (D.C.
Cir. 1982). Therefore, the Court finds that the defendant has not shown how the release of the
withheld documents will “impair the Government’s ability to obtain necessary information in the
future.” National Parks, 498 F.2d at 770.
b. Competitive Harm
The Court next examines the second prong of the National Parks test: whether the agency
has sufficiently shown that release of the withheld information is likely to “cause substantial
harm to the competitive position of the person from whom the information was obtained.” Id. at
770; see also Pub. Citizen Health Research Grp. v. FDA, 704 F.2d at 1290-91 (D.C. Cir. 1983);
McDonnell Douglas Corp. v. U.S. Dep’t of Air Force, 375 F.3d 1182, 1187 (D.C. Cir. 2004)
(party invoking Exemption 4 is not required “to prove disclosure certainly would cause it
substantial competitive harm, but only that disclosure would ‘likely’ do so”). Not all harm to the
information provider qualifies as “competitive harm.” As noted, the D.C. Circuit has made clear
that, “[i]n this inquiry, it is simply irrelevant that” confidential treatment of the documents would
avoid disclosure of information “that might be damaging to [the provider’s] reputation.”
Occidental Petroleum Corp., 873 F.2d at 341 (D.C. Cir. 1989). To qualify as “substantial
competitive harm,” the harm must be “limited to harm flowing from the affirmative use of
proprietary information by competitors.” Pub. Citizen Health Research Grp., 704 F.2d at 1291
& n.30 (emphasis in the original). 22
22
The defendant spills a great deal of ink on the argument that “when a company invests time and other resources
into developing policies and procedures, among other things, they will face competitive harm if those products are
43
Based upon the Court’s foregoing analysis, the following challenged records are
“commercial” and must meet this second prong of the National Parks test to be appropriately
withheld under Exemption 4: (1) changes to the processes by which the intervenor-defendants
fulfill the Ineligible Persons requirement; (2) the description of the allegations subject to
investigations or legal proceedings; (3) company communications with the FDA regarding off-
label promotions; (4) Pfizer’s off-label findings and detailing sessions; (5) IRO reports; and (6)
the portions of the 2009 Purdue Supplement addressing Purdue’s promotional monitoring
program. Each of these categories of commercial documents is examined below to evaluate the
sufficiency of the showing that disclosure would cause substantial competitive harm to the
defendant-intervenors.
In reviewing the sufficiency of the declarations and Vaughn indices, the Court is mindful
that merely conclusory statements about competitive harm, even if repeated numerous times, are
not sufficient. See Pub. Citizen Health Research Grp., 704 F.2d at 1290-1291 (“Conclusory and
generalized allegations of substantial competitive harm, of course, are unacceptable and cannot
support an agency's decision to withhold requested documents.”); Occidental, 873 F.2d at 342(requiring more than “conclusory statement” regarding substantial competitive harm); Wash.
Post Co., 690 F.2d at 269 (D.C. Cir. 1982) (“[T]he government produced no evidence except a
conclusory affidavit by the HHS director of personnel policy. Thus, the government has not yet
established its Exemption 4 claim.”); Mead Data Cent., Inc. v. U.S. Dep’t of Air Force, 566 F.2d
released to the public.” Def.’s Reply at 15 (alterations in original omitted). The level of resource expenditures may
be relevant to evaluating the proprietary nature of information, but it is not necessarily a measure of competitive
harm for purposes of Exemption 4. Rather, it is the prospect of the affirmative use of the disclosed information by
competitors that makes release of the information competitively harmful. See Pub. Citizen Health Research Grp.,
704 F.2d at 1291. The defendant’s argument is a virtual non-sequitur in this case, because the primary argument
raised by the plaintiff is not about the level of resource expenditures in the creation of the withheld records, but
rather that release of these records would not constitute competitive harm because they could not be used
affirmatively by the defendant-intervenors’ competitors. See Pl.’s Reply at 12. Furthermore, to the extent the
plaintiff “ignore[d]” the resource expenditure defense to disclosure, as the defendant contends, Def.’s Reply at 15,
this does not amount to “concession” since the level of expenditures is irrelevant.
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242, 258 (D.C. Cir. 1977) (“An agency cannot meet its statutory burden of justification by
conclusory allegations of possible harm.”); Comptel, 910 F. Supp. 2d at 117 (“[C]onclusory
assertions, without any additional description of the contents of the redacted information or
reasons for non-disclosure, are insufficient to show that Exemption 4 was appropriately
invoked.”); Biles v. U.S. Dep’t of Health and Human Servs., No. 11-1997, 2013 WL 1154207, at
*9 (“[C]onclusory claims of commercial harm . . . are therefore insufficient to establish HHS’
burden of proof”). Even with deference given to agency declarations, “deference does not mean
blind acceptance.” Mudge Rose Guthrie Alexander & Ferdon v. U.S. Int’l Trade Comm’n, 846
F.2d 1527, 1532 (D.C. Cir. 1988).
First, to support the contention that disclosure of the changes implemented by the
defendant-intervenors for screening and removing Ineligible Persons would cause substantial
competitive harm, Pfizer’s declarant explains that “[t]his information reflects Pfizer’s internal
business processes and judgments made to develop and implement the Ineligible Person
Management process . . . .” Nowicki Decl. ¶ 29. Purdue’s declarant mentions only that “the
determination, screening and training of relevant covered persons/vendors, as well as its
proposed actions regarding ineligible persons, all directly relate to Purdue’s compliance with
legal and regulatory requirements, and are proprietary in nature.” Weinstein Decl. ¶ 15. These
process changes reflect the companies’ views of effective ways in which to ferret out Ineligible
Persons, in the context of the companies’ particular organizational structure and operations.
Although the declarations provide only slim support, the Court finds that disclosure of these
process changes may risk competitive harm by revealing confidential information about the
companies’ broader structure and operations in which the changes to Ineligible Persons processes
are implemented. See United Technologies, 601 F.3d at 564 (finding proprietary manufacturing
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and quality control processes were subject to withholding under Exemption 4 since “[o]nce
disclosed, competitors could, it appears, use the information to improve their own manufacturing
and quality control systems, thus making ‘affirmative use of proprietary information’ against
which Exemption 4 is meant to guard.”). Consequently, the Court grants summary judgment to
the defendant and defendant-intervenors as to the withholding under Exemption 4 of documents
reflecting “changes in process” pertaining to Ineligible Persons.
Second, regarding the likely competitive harm posed by disclosure of documents
containing the description of the allegations subject to investigations or legal proceedings, the
defendant and defendant-intervenors have not provided a sufficient showing to sustain summary
judgment. Pfizer’s declarant states only that “the summary information that Pfizer submits to
OIG is highly sensitive, confidential information that Pfizer does not publicly release.” Nowicki
Decl. ¶ 28. This conclusory statement says nothing about how the revelation of these
descriptions of allegations, now dating back to at least several years ago, would be used by
competitors affirmatively to harm Pfizer. Purdue’s declarant does no better by stating “[p]ublic
disclosure of this information, which includes non-public legal and/or regulatory actions, such as
with a Reportable Event, would certainly have negative commercial consequences for Purdue.”
Weinstein Decl. ¶ 26. This is a conclusory statement that, again, does nothing to show why or
how competitors will be able to use this information affirmatively cause to harm to Purdue. As
noted, Exemption Four does not shield embarrassing information or information that may cause
reputational harm, but only information that can be affirmatively used by a competitor. See CNA
Fin. Corp. v. Donovan, 830 F.2d at 1154 & n.158; Pub. Citizen Health Research Grp., 704 F.2d
at 1291 n.30. Therefore, the Court denies summary judgment to all parties regarding the
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descriptions of allegations contained in the summaries of legal and investigatory inquiries
provided by the defendant-intervenors in their Annual Reports.
Third, the defendant-intervenors’ communications with the FDA regarding off-label
marketing are at least partially non-confidential. Pfizer’s declarant makes this clear when he
states that “Pfizer’s communications with the FDA are usually confidential commercial
information that Pfizer maintains under strict confidentiality.” Nowicki Decl. ¶ 30 (emphasis
supplied). This statement implicitly acknowledges that these communications are not always
strictly confidential, which is further confirmed by the declarant’s statement that some
communications, such as Warning Letters from the FDA, are publicly available. Id. Purdue’s
declarant says nothing to address this category of records. Neither the Vaughn indices nor the
declarations provide sufficient specificity for the Court to determine which documents may
contain confidential commercial information and which do not. Therefore, summary judgment
as to the company communications with the FDA will be denied to all parties.
Fourth, Pfizer’s off-label findings and detailing sessions are the murkiest of the withheld
records requested by the plaintiff. Pfizer’s declarant does little to shed light on what the
detailing sessions are, how they are conducted, and from where the records are derived. He
merely states that the information “is highly confidential and includes detailed information
regarding Pfizer’s internal review and monitoring of sales representative activities,” but neither
Pfizer nor the defendant has explained how Pfizer obtains the underlying documents on which
these analyses are based. See Nowicki Decl. ¶ 33. Nevertheless, since the off-label findings by
Pfizer reflect the company’s “findings” about its own sales force’ activities, the potential risk of
competitive harm from disclosure of what those activities are is plain. Therefore, as to Pfizer’s
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off-label findings, the Court grants summary judgment to the defendant and defendant-
intervenors.
The documents reflecting “detailing sessions” are more difficult, particularly given the
lack of information provided to the Court about the precise nature of these documents. The CIA
requires Pfizer to obtain “commercially available non-Pfizer records” to conduct its review.
Pfizer CIA at 22. If these detailing session documents are commercially available from third
parties, it is unclear what the basis is at all for Pfizer’s assertion of confidentiality. In any event,
the level of specificity provided as to the nature of the detailing session documents is too
minimal to demonstrate, as is the agency’s burden, that the release of this information would
cause competitive harm. Therefore, summary judgment is denied to all parties as to the
documents containing detailing sessions.
Fifth, the IRO Reports present “an extensive, probing review of Purdue’s confidential
business systems and policies, as well as selected samples of individual transactions,” Weinstein
¶ 20, and “Pfizer’s internal structure and operations, how the company interacts with HCPs and
the medical community, and Pfizer’s policies governing the selling, detailing, marketing,
advertising, promoting and branding of Government Reimbursed Projects, meaning all Pfizer
human pharmaceutical products promoted or sold by Pfizer in the United States that are
reimbursable by Federal health care programs,” Nowicki Decl. ¶ 22. These details make clear
that competitive harm would result from their disclosure. For instance, Purdue’s declarant states
that the reports contain “selected samples of individual transactions . . . which may contain
private patient information as well as . . . the identity of Healthcare Professionals who are
customers.” Weinstein ¶ 20. It is thus obvious that the release of such information would be
akin to releasing customer lists which could easily be used affirmatively by competitors to harm
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Purdue. Similarly, a competitor could certainly use internal details of the sale and marketing of
Pfizer’s products against it a number of ways, such as setting prices, competing for ad space, or
identifying areas of strength or weakness. Therefore, the Court finds that information pertaining
to the IRO Reports, responses, and corrective action taken in response to the IRO Reports were
properly withheld under Exemption 4, and summary judgment is granted to the defendant and
defendant-intervenors on this category of information.
Finally, Purdue’s declarant makes only a single conclusory statement about the potential
competitive harm that could be caused by the release of the 2009 Purdue Supplement, stating that
the promotional monitoring program “is considered proprietary and highly confidential. Thus, it
would be detrimental to Purdue if these documents were publicly disclosed.” Weinstein Decl. ¶
29. These nineteen words provide only slim support for a finding that competitive harm is likely
to result from revelation of this promotional monitoring program. Nevertheless, the subject
matter plainly relates to core aspects of the company’s marketing and sales efforts and, thus, how
Purdue conducts those activities in compliance with applicable regulations and laws. Similar to
the changes in business processes that the defendant-intervenors use to fulfill the Ineligible
Persons requirement, disclosure of how Purdue has continued to perfect its promotional
monitoring program could be put to affirmative use by its competitors, thus making it
confidential under the terms of Exemption 4. Therefore, summary judgment is granted to the
defendant and defendant-intervenors on the withholding of Purdue’s promotional monitoring
program information contained in the 2009 Purdue Supplement.
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* * *
In sum, of the six categories, or sub-parts of categories, found to contain commercial
matter, the Court concludes that there is sufficient support for finding that the following withheld
documents are also confidential: (1) changes to the processes by which the companies fulfill the
Ineligible Persons requirement in § III.F of the Purdue and Pfizer CIAs; (2) Pfizer’s off-label
findings required to be included in the Annual Reports, pursuant to §§ III.J and V.B.17 of the
Pfizer CIA; (3) IRO reports required to be included in the Annual Reports, pursuant to §§ III.D
and V.B.5-8 of the Purdue CIA and §§ III.D and V.B.6-9 of the Pfizer CIA; and (4) the portions
of the 2009 Purdue Supplement addressing Purdue’s promotional monitoring program.
Therefore, this information was properly withheld under Exemption 4, and summary judgment is
granted to the defendant and defendant-intervenors as to these documents. The declarations and
Vaughn indices submitted to support the withholding of the remaining commercial documents
are insufficient for the Court to assess whether the documents warrant confidential treatment and
qualify for withholding under Exemption 4. Thus, summary judgment is denied to all parties
with respect to the following documents containing commercial matter: (1) the description of the
allegations subject to investigations or legal proceedings required to be included in the Annual
Reports, pursuant to § III.G of the Purdue and Pfizer CIAs; (2) company communications with
the FDA regarding off-label promotions required to be included in the Annual Reports, pursuant
to § III.I of the Purdue and Pfizer CIAs; and (3) Pfizer’s detailing sessions required to be
included in the Annual Reports, pursuant to §§ III.J and V.B.17 of the Pfizer CIA. As to these
documents, the defendant and defendant-intervenors may submit supplemental declarations
and/or Vaughn indices demonstrating that disclosure of the withheld documents would likely
cause competitive harm or, alternatively, release the withheld documents.
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Finally, any supplemental support for continued withholding of any of the challenged
documents must also address whether any reasonably segregable portions of withheld documents
have been released, keeping in mind that an “‘agency cannot justify withholding an entire
document simply by showing that it contains some exempt material.’” Hodge v. FBI, 703 F.3d
575, 582 (D.C. Cir. 2013) (quoting Stolt-Nielsen Transp. Grp., 534 F.3d at 734).
IV. CONCLUSION
The fundamental problem in this case is the lack of detail provided in the defendants’
declarations and the Vaughn indices. Mere conclusory statements regarding the alleged
commercial nature and confidentiality of the records withheld is not sufficient to allow this Court
to determine whether the withheld information is properly exempt under FOIA’s Exemption 4.
For the reasons explained above, the Motion for Summary Judgment of the defendant and
defendant-intervenors is denied in part and granted in part. This motion is DENIED, without
prejudice, because the Court has insufficient information to determine if the disputed records are
“commercial” within the meaning of Exemption 4 with respect to (1) the Reportable Events
summaries required by § V.B.9 of the Purdue CIA and § V.B.12 of the Pfizer CIA; (2) the
Disclosure Log summaries required by § V.B.10 of the Purdue CIA and § V.B.14 of the Pfizer
CIA; (3) the title and responsibility information of Ineligible Persons required by § V.B.11 of the
Pfizer CIA and § V.B.12 of the Purdue CIA; (4) information pertaining to the agency conducting
an investigation and the status of that investigation required by § V.B.13 of the Purdue CIA and
§ V.B.15 of the Pfizer CIA; and (5) reasonably segregable information in the 2009 Purdue
Supplement that does not pertain to its promotional monitoring program. The defendant and
defendant-intervenors’ Motion is also DENIED, without prejudice, because the Court does not
have sufficient information to determine if the disputed records are confidential within the
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meaning of Exemption 4 with respect to (6) the summaries of legal and investigatory inquiries
required by § V.B.13 of the Purdue CIA and § V.B.15 of the Pfizer CIA; (7) company
communications with the FDA as required by § V.B.14 of the Purdue CIA and § V.B.16 of the
Pfizer CIA; and (8) the “underlying records reflecting the content of detailing sessions between
HCPs and Covered persons” as required in § V.B.17 of the Pfizer CIA.
The Motion for Summary Judgment of the defendant and defendant-intervenors is
GRANTED with respect to the following records, which the Court finds were properly withheld
under Exemption 4 as commercial and confidential: (1) the records reflecting “changes in
process” of the monitoring and removal of Ineligible Persons required by § V.B.11 of the Purdue
CIA and § V.B.10 of the Pfizer CIA; (2) the Off-Label Findings and summary of responsive
action taken by Pfizer required by § V.B.17 of the Pfizer CIA; (3) the IRO reports required by §§
V.B.5–8 of the Purdue CIA and §§ V.B.6–9 of the Pfizer CIA; and (4) the portions of the 2009
Purdue Supplement pertaining to its promotional monitoring program.
The plaintiff’s Cross-Motion for Summary Judgment is granted in part and denied in part.
The Cross-Motion is GRANTED as to the inadequacy of the defendant’s search for responsive
records regarding the Pfizer Section V.B.6 documents; and as to the following records, which the
Court finds were not properly withheld under Exemption 4 and must be released to the plaintiff:
(1) the titles and responsibilities of Ineligible Persons removed required by § V.B.12 of the
Purdue CIA and § V.B.11 of the Pfizer CIA; and (2) the identity of the investigatory agency and
status of any investigations required by § V.B.13 of the Purdue CIA and § V.B.15 of the Pfizer
CIA. In all other respects, the plaintiff’s Cross-Motion for Summary Judgment is DENIED,
without prejudice.
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For the remaining records at issue, the parties are directed to meet and confer and, by
November 8, 2013, provide the Court with (1) a status report that sets forth a list of the records
that remain in dispute, in light of this Memorandum Opinion, and that identifies each such
disputed record by a Bates number, or other unique identifier, and by citation to the particular
page(s) of the Vaughn index where the disputed record is described; and (2) a proposed briefing
schedule for any further proceedings in this matter, including deadlines for the submission of any
renewed dispositive motions, supplementary Vaughn indices, and/or supplementary declarations.
An appropriate Order accompanies this decision.
Digitally signed by Beryl A. Howell
DN: cn=Beryl A. Howell, o=District
Date: October 4, 2013 Court for the District of Columbia,
ou=District Court Judge,
email=howell_chambers@dcd.usco
urts.gov, c=US
__________________________
Date: 2013.10.04 14:38:01 -04'00'
BERYL A. HOWELL
United States District Judge
53