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.,
Defendant-Intervenors.
MEMORANDUM OPINION
The plaintiff, Public Citizen, brought this suit under the Freedom of Information Act
(“FOIA”), 5 U.S.C. § 552, seeking certain records filed by the defendant-intervenors, Pfizer Inc.
(“Pfizer”) and Purdue Pharma L.P. (“Purdue”), in compliance with the companies’ “Corporate
Integrity Agreements” (“CIAs”) 1 with the Office of the Inspector General (“OIG”) of the United
States Department of Health and Human Services (“HHS”). See Public Citizen v. U.S. Dep’t of
Health & Human Servs. (Public Citizen I), 975 F. Supp. 2d 81, 88–89 (D.D.C. 2013). The
defendant and defendant-intervenors objected to the release of these records, claiming they were
exempt from disclosure under the FOIA’s Exemption 4, which applies to “trade secrets and
1
The CIAs are part of “settlement agreements . . . with companies seeking to resolve civil and administrative health
care fraud cases and avoid costly exclusion from participation in Federal health care programs.” See Public Citizen
v. U.S. Dep’t of Health & Human Servs. (Public Citizen I), 975 F. Supp. 2d 81, 88 (D.D.C. 2013). “In return for
these benefits, under the CIA[s], the companies must agree to enhanced compliance measures, subject to auditing by
an outside independent party and monitoring by the OIG.” Id.
1
commercial or financial information obtained from a person and privileged or confidential.” 5
U.S.C. § 552(b)(4). After this Court denied in part and granted in part the parties’ initial cross-
motions for summary judgment, the parties submitted revised Vaughn 2 indices and supplemental
declarations in support of renewed motions for summary judgment. Pending before the Court
are HHS’ Renewed Motion for Summary Judgment (“Def.’s 2d Mot.”), ECF No. 51; Pfizer’s
Renewed Motion for Summary Judgment (“Pfizer’s 2d Mot.”), ECF No. 47; Purdue’s Renewed
Motion for Summary Judgment (“Purdue’s 2d Mot.”), ECF No. 50; and the plaintiff’s Renewed
Motion for Summary Judgment (“Pl.’s 2d Mot.”), ECF No. 53. For the reasons set forth below,
the defendant and defendant-intervenors’ motions are granted and the plaintiff’s motion is
denied.
I. BACKGROUND
The facts underlying this action have been explained in the Court’s prior Memorandum
Opinion and need not be repeated in detail here. See Public Citizen I, 975 F. Supp. 2d at 89–93.
For the purposes of the instant motions, only a brief summary of the facts and the procedural
history is necessary to provide context for the documents still at issue in this litigation.
A. Public Citizen I and Subsequent Procedural History
In 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 Pharm L.P.,’ and ‘by Pfizer, Inc. pursuant to the May 2004
Corporate Integrity Agreement between OIG and Pfizer.’” Id. at 90–91. These reports were
submitted by the defendant-intervenors to the HHS OIG “as part of the companies’ compliance
with settlement agreements arising from the companies’ illegal off-label promotion of drugs
2
A Vaughn index is a document that correlates all withholdings with specific FOIA exemptions and the agency's
specific nondisclosure justifications. Vaughn v. Rosen, 484 F.2d 820, 827 (D.C. Cir. 1973).
2
reimbursed by federal health care programs.” Id. at 88. HHS “withheld the bulk of the requested
records on grounds that they contain confidential, commercial information exempt from
disclosure under FOIA Exemption 4.” Id. at 89.
In the parties’ initial summary judgment motions, eight categories of documents were in
dispute, and the plaintiff challenged the defendant’s search for responsive records as to a ninth
set of documents. See Public Citizen I, 975 F. Supp. 2d at 91–92. The Court granted summary
judgment to the plaintiff on two subsets of records in dispute, namely, documents pertaining to
“the titles and responsibilities of Ineligible Persons removed [as] required by § V.B.12 of the
Purdue CIA and § V.B.11 of the Pfizer CIA;” and “the identity of the investigatory agency and
status of any investigations required [to be disclosed] by § V.B.13 of the Purdue CIA and
§ V.B.15 of the Pfizer CIA.” Id. at 119. The Court also found that “the defendant’s search for
responsive records regarding the Pfizer [§] V.B.6 documents,” was inadequate, id. at 119, and
allowed the defendant to “either supplement its declarations to address the factual questions
raised by the plaintiff [in Public Citizen I] or perform an additional search to locate the missing
records,” id. at 98. 3
The Court granted summary judgment to the defendants as to four categories of disputed
records, namely:
(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; 4 (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
3
Pfizer was required by § V.B.6 of its CIA to provide responses to required Independent Review Organization
(“IRO”) reports and recommendations pertaining to certain Pfizer programs. See Public Citizen I, 975 F. Supp. 2d
at 92, 92 n.9, 119. The plaintiff challenged the adequacy of the defendant’s search for records responsive to this
portion of the plaintiff’s original FOIA request because the redacted documents released by the defendant indicated
that Pfizer had filed supplemental follow-up documents, as required by the CIA, that were not included in the
defendant’s release of records or reflected on Pfizer’s Vaughn Index. See id. at 95.
4
This category of records is unique to Pfizer, as Purdue’s CIA did not have a similar requirement. See Public
Citizen I, 975 F. Supp. 2d at 107–08. The content of these records is explained in greater detail in Part III.B, infra.
3
portions of the 2009 Purdue Supplement pertaining to its promotional monitoring
program.” Id. at 118–19.
Remaining at issue after Public Citizen I were six categories of records, specifically:
(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 summaries of
legal and investigatory inquiries required by § V.B.13 of the Purdue CIA and §
V.B.15 of the Pfizer CIA; (4) reasonably segregable portions of the 2009 Purdue
Supplement that do not pertain to Purdue’s promotional monitoring program; (5)
company communications with the FDA required by § V.B.14 of the Purdue CIA
and § V.B.16 of the Pfizer CIA; and (6) the “underlying records reflecting the
content of detailing sessions between HCPs and Covered persons” as required by
§ V.B.17 of the Pfizer CIA. Order at 2, ECF No. 35.
Following Public Citizen I, the plaintiff moved for reconsideration, arguing that the
declaration of Dr. Kevin Rodondi (the “Rodondi Declaration”) created issues of material fact
sufficient to deny summary judgment to the defendants as to three sets of records. See Pl.’s Mot.
Part. Reconsideration (“Pl.’s Mot. Rec.”) at 1, ECF No. 37. The plaintiff also complained that
the Court “overlooked [the plaintiff’s] argument that records revealing suspected or confirmed
illegal activity cannot, as a matter of law, be ‘confidential’ for the purpose” of the FOIA. Id.
Finally, the plaintiff sought clarification as to one record ruled upon in Public Citizen I, namely,
a June 18, 2009 supplement to Purdue’s First Annual Report required by its CIA. See Mem. &
Order at 10, ECF No. 44.
In denying the Motion for Reconsideration, the Court found the plaintiff’s arguments as
to the Rodondi Declaration utterly without merit. See id. at 5–8. First, the plaintiff was in error
as to whether the declaration was considered by the Court in ruling on the plaintiff’s Motion for
Summary Judgment. See id. at 5 (“The plaintiff’s underlying premise is incorrect, since the
Court read and evaluated the declaration in preparing its Memorandum Opinion . . .”). Second,
in reviewing the contents of the Rodondi Declaration, the Court noted that “the declaration
provides nothing but qualified statements that are insufficient to raise a genuine issue of material
4
fact.” Id. The Court further noted that although it saw no need to cite explicitly to the Rodondi
Declaration in Public Citizen I, “[r]eferences to the declaration were woven throughout the
plaintiff’s briefing, to which the Court responded in detail.” Id.
As for the plaintiff’s argument that the Court “overlooked” the plaintiff’s argument that
records revealing illegal activity could not, as a matter of law, be confidential within the meaning
of Exemption 4, the Court pointed out that the plaintiff had failed to make that argument in any
of its voluminous summary judgment briefs or accompanying declarations and exhibits. Id. at 8.
Instead, the plaintiff had argued vociferously and unpersuasively that records regarding
suspected or confirmed illegal activity could not, as a matter of law, be “commercial” within the
meaning of Exemption 4, and the Court addressed that argument extensively. See Public Citizen
I, 975 F. Supp. 2d at 101–03. Even if the plaintiff’s new argument had been raised, the Court
found the argument was implicitly rejected by the Court’s finding that “the overall commercial
nature of an undertaking is not altered when some aspect of that activity is suspected to
constitute, or actually results in, a violation of a rule, regulation or statutory requirement.” Id. at
10.
Finally, the Court addressed the plaintiff’s request for “clarification” as to which record
the Court was referring by the short title the “2009 Purdue Supplement.” The Court had fully
described the document in Public Citizen I as “Purdue’s supplement, dated June 18, 2009, to its
first Annual Report, which was submitted on September 25, 2008” and even cited the plaintiff’s
exhibit, which was a redacted copy of the same record at issue. See Public Citizen I, 975 F.
Supp. 2d at 92, 92 n.10. Nevertheless, the Court attached a copy of the document about which
the plaintiff was confused to its Order on the plaintiff’s motion for reconsideration. See Mem. &
Order Appendix, ECF No. 44-1.
5
B. The Remaining Documents In Dispute
In its Order in Public Citizen I, the Court required the parties jointly to file a status report
that, inter alia, “sets forth a list of the records remaining in dispute . . . and identifying 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.” Order at 3. This
requirement was a direct response to the vague, generalized, and inadequate statements made by
the parties in their first round of summary judgment briefing regarding what records were in
dispute. Indeed, in Public Citizen I, the Court admonished the parties that 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.” 975
F. Supp. 2d at 93. 5
Prior to filing the list of remaining disputed documents, the defendant released “some
documents for which this Court had denied all parties’ earlier motions for summary judgment,”
removing those documents from dispute. 6 Pl.’s Mem. Supp. Pl.’s 2d Mot. (“Pl.’s 2d Mem.”) at
2, ECF No. 53. The parties timely filed the list of the remaining disputed records, see generally
Status of Records Remaining in Dispute (“Rec. Status”), ECF No. 46, and renewed their cross-
motions for summary judgment. In the subsequent renewed round of summary judgment
5
One of the remaining categories of disputed records, namely, the actions taken regarding Ineligible Persons,
provides an example of this lack of clarity. None of the parties identified precisely the section or sections of the
defendant-intervenors’ CIAs that required submission of the disputed records and, instead, directed the Court to
pages of the CIAs, each of which listed multiple types of submissions the defendant-intervenors were required to
make as part of their Annual Reports. Due to the generalized page references made by the parties, the Court did not
address a subset of records required for submission under one clause of one section of the CIAs. The plaintiff did
not raise this omission in its Motion for Reconsideration, either. See generally Pl.’s Mot. Rec.
6
The defendant and defendant-intervenors maintain that their voluntary release of certain responsive documents
“should not be construed as a concession or waiver of any kind.” Status of Records Remaining in Dispute (“Rec.
Status”) at 3 n.5, ECF No. 46.
6
briefing, 7 the defendant “introduced new evidence to support the adequacy of its search for the
missing Pfizer responses to and corrective action plans based on IRO reports,” in other words,
the Pfizer § V.B.6 documents. See Pl.’s 2d Mem. at 2. The new information regarding the
“missing” Pfizer responses is contained in the Second Declaration of Robin R. Brooks, the FOIA
Officer for the HHS OIG (“2d Brooks Decl.”), ECF No. 51-1. The defendant’s declarant clearly
and succinctly explains the links between the records listed in the original Pfizer Vaughn Index,
ECF No. 18, the exemptions applied, and the presence or absence of any additional responsive
records pertaining to the “missing Pfizer responses.” See 2d Brooks Decl. ¶¶ 5–18. On the basis
of this new evidence, the plaintiff “is now satisfied that the missing Pfizer documents were either
included in records accounted for in the first Pfizer Vaughn index . . . or were never submitted to
HHS.” See Pl.’s 2d Mem. at 2. Thus, the plaintiff is no longer challenging the adequacy of the
defendant’s search for responsive documents. See id. Consequently, the defendant and
defendant-intervenors are granted summary judgment as moot regarding (1) the allegedly
missing Pfizer documents required to be submitted pursuant to § V.B.6 of the Pfizer CIA and (2)
those documents previously in dispute but now either no longer in dispute or released voluntarily
by the defendant. 8
In light of the confusion stemming from deficiencies in the initial round of summary
judgment briefing, the voluntary release of certain records by the defendant and defendant-
7
In lieu of filing a detailed opposition to the plaintiff’s Renewed Motion for Summary Judgment, the defendant has
adopted the “factual and legal arguments” made by the defendant-intervenors, since the adequacy of the defendant’s
search for the allegedly missing Pfizer § V.B.6 documents is no longer contested. See Def.’s Opp’n Pl.’s 2d Mot. &
Def.’s Reply Supp. Def.’s 2d Mot. (“Def.’s Opp’n”) at 1, ECF No. 60.
8
The documents previously listed as in dispute on the initial Joint Status Report but no longer in dispute are: Pfizer
Bates Nos. OIG 000123–000124; OIG 000126; OIG 000128; OIG 000129–000131; OIG 000137–000138; OIG
000139; OIG 000140; OIG 000141; OIG 001921–1923; OIG 001925; OIG 001946–001947; OIG 001949; OIG
001951; OIG 001953; OIG 003827–003829; OIG 003831; OIG 003846–003847; OIG 003849; OIG 003851; OIG
003853; OIG 005967–005969; OIG 005971; OIG 005985–005986; OIG 005988; OIG 005990; OIG 005992; OIG
007971–007975; OIG 007991–007992; OIG 007994; OIG 007996; OIG 007998; Purdue Bates Nos. OIG 000430–
000436; OIG 000473–000500; OIG 001082–001088. See Rec. Status at 3–4; Parties’ Update to Joint List of
Records Remaining in Dispute/2d Supplemental Purdue Vaughn Index (“Suppl. Rec. Status”) Appendix B at B-1,
ECF No. 64.
7
intervenors, and the plaintiff’s decision to cease pursuing other records, the Court ordered the
parties to file a Supplemental Joint Status Report identifying the specific records the plaintiff no
longer disputes were properly withheld and the records that remain in dispute. 9 See Minute
Order, August 12, 2014; Parties’ Update to Joint List of Records Remaining in Dispute/2d
Supplemental Purdue Vaughn Index (“Suppl. Rec. Status”), ECF No. 64.
The records that remain at issue thus fall into four categories:
(1) Reportable Event summaries required by § V.B.12 of the Pfizer [CIA] and §
V.B.9 of the Purdue CIA;
(2) Disclosure Log summaries required by § V.B.14 of the Pfizer CIA and §
V.B.10 of the Purdue CIA;
(3) information regarding actions taken in response to screening and removal
obligations for Ineligible Persons required by § V.B.11 of the Pfizer CIA and §
V.B.12 of the Purdue CIA; and
(4) Pfizer documents reflecting the content of detailing sessions that reveal off-
label promotion required by § V.B.17 of the Pfizer CIA. 10
Pl.’s 2d Mot. at 1. Of these four categories, categories one and two, referring to Reportable
Event summaries and Disclosure Log summaries, respectively, involve both defendant-
intervenors. See id. Purdue challenges whether the third category, regarding actions taken
toward Ineligible Persons, pertains to it at all. See Part III.C infra; see also Third Decl. of Julie
A. Murray, Counsel for Plaintiff (“3d Murray Decl.”) Attachs. A–B (reproducing redacted
documents already released by the defendant pertaining to Purdue’s Ineligible Persons
information). The fourth category regarding the “content of detailing sessions” applies to Pfizer
only.
9
Indeed, defendant-intervenor Purdue recognized the confusion and apparently “requested that HHS file a revised
Supplemental Vaughn Index incorporating the two additional documents Plaintiff has put at issue here,” Purdue’s
Reply Supp. Purdue’s 2d. Mot (“Purdue’s 2d Reply”) at 6 n.4, ECF No. 58, though no such supplemental Vaughn
index was filed.
10
Pfizer and Purdue’s CIAs were filed by the defendant along with its first Motion for Summary Judgment, ECF
No. 22. See Decl. of Edward Nowicki, Pfizer Vice President & Assistant General Counsel, Deputy Compliance
Officer – Global Programs (“1st Nowicki Decl.”) Ex. 3, ECF No. 22-1 (reproducing Pfizer CIA); Def.’s 1st Mot.
Summ. J. (“Def.’s 1st Mot.”) Ex. 6, ECF No. 22-2 (reproducing Purdue CIA).
8
Relevant to the instant motions, in Public Citizen I the Court found that (1) insufficient
information was provided by the parties to determine whether the Reportable Event summaries 11
and the Disclosure Log summaries 12 were commercial in nature, 975 F. Supp. 2d at 118; (2)
insufficient information was provided by the parties to determine whether the “detailing
sessions” documents referred to in § V.B.17 of the Pfizer CIA were “confidential” in nature, id.;
and (3) the Court did not rule on whether information regarding “the actions taken by [the
defendant-intervenors] in response to the screening and removal obligations set forth in” their
CIAs regarding Ineligible Persons 13 were properly withheld, id.
II. LEGAL STANDARD
A. Summary Judgment In FOIA Cases
“[T]he vast majority of FOIA cases can be resolved on summary judgment.” Brayton v.
Office of the U.S. Trade Rep., 641 F.3d 521, 527 (D.C. Cir. 2011). When an agency’s response
to a FOIA request is to withhold responsive records, either in whole or in part, the agency “bears
the burden of proving the applicability of claimed exemptions.” Am. Civil Liberties Union v.
U.S. Dep’t of Def., 628 F.3d 612, 619 (D.C. Cir. 2011). The government may sustain its burden
of establishing that requested records were appropriately withheld through the submission of
11
“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.’” Public Citizen I, 975 F. Supp. 2d at 92 n.5 (citation omitted).
12
“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.’ 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.’” Public Citizen I, 975 F. Supp. 2d at 92 n.6 (internal citations omitted).
13
“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.’” Public Citizen I, 975 F. Supp. 2d at 92 n. 7.
9
declarations detailing the reason that a FOIA exemption applies, along with an index, as
necessary, describing the materials withheld. See, e.g., id. at 619. “If an agency’s affidavit
describes the justifications for withholding the information with specific detail, demonstrates that
the information withheld logically falls within the claimed exemption, and is not contradicted by
contrary evidence in the record or by evidence of the agency’s bad faith, then summary judgment
is warranted on the basis of the affidavit alone.” Id.
B. FOIA’s Exemption 4
The dispute over whether the remaining documents at issue may be withheld as exempt
under the FOIA’s Exemption 4 rests on whether those documents are “commercial” and
“confidential.” See Jurewicz v. U.S. Dep’t of Agric., 741 F.3d 1326, 1331 (D.C. Cir. 2014). The
Court reviewed extensively the precedent surrounding these terms in Public Citizen I, 975 F.
Supp. 2d at 99–103, 110–15, but a brief review of the FOIA’s Exemption 4 and the key terms
“commercial” and “confidential” is helpful in resolving the instant motions. Records must be
both “commercial” and “confidential” in order for them to be exempt from disclosure under
Exemption 4. 14 Neither term is defined in the FOIA, but the D.C. Circuit has “consistently held
that [this] term . . . in [Exemption 4] should be given [its] ordinary meaning[].” Pub. Citizen
Health Research Grp. v. U.S. Food & Drug Admin., 704 F.2d 1280, 1290 (D.C. Cir. 1983).
“[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 26, 38 (D.C. Cir.
2002) (internal quotation marks and citation omitted), or are records in which the provider has “a
14
Exemption 4 also exempts documents that reveal “trade secrets” and “financial” information. See 5 U.S.C.
§ 552(b)(4). The defendant and the defendant-intervenors do not assert that the documents remaining in dispute fall
into either of those categories. See generally, Def.’s Mem. Supp. Def.’s 2d Mot. (“Def.’s 2d Mem.”), ECF No. 51;
Pfizer’s Mem. Supp. Pfizer’s 2d Mot. (“Pfizer’s 2d Mem.”), ECF No. 47-1; Purdue’s Mem. Supp. Purdue’s 2d Mot.
(“Purdue’s 2d Mem.”), ECF No. 50. There is no dispute that all of the documents came from a “person,” as required
under Exemption 4, leaving only the “commercial” and “confidential” prongs of the analysis in dispute. See Public
Citizen I, 975 F. Supp. 2d at 98.
10
commercial interest.” Baker & Hostetler LLP v. U.S. Dep’t of Commerce, 473 F.3d 312, 319
(D.C. Cir. 2006).
In addition to being “commercial,” for Exemption 4 to apply, the records must also be
“privileged 15 or confidential.” See 5 U.S.C. § 552(b)(4); Jurewicz, 741 F.3d at 1331. A two
prong test is used to determine whether information involuntarily submitted to a Federal agency
is “confidential” for FOIA purposes: whether release of the records would (1) impair the
Government’s ability to obtain necessary information in the future; or (2) 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”);
accord Jurewicz v. U.S. Dep’t of Agric., 741 F.3d 1326, 1331 (D.C. Cir. 2014). Releasing the
documents involuntarily submitted documents in dispute in this matter has already been found
not to “impair the Government’s ability to obtain necessary information in the future.” See
Public Citizen I, 975 F. Supp. 2d at 111–13. Thus, only the second prong of the National Parks
test remains at issue in the instant matter. Id. “Substantial competitive harm” is “limited to harm
flowing from the affirmative use of proprietary information by competitors.” Pub. Citizen
Health Research Grp., 704 F.2d at 1291, 1291 n.30 (emphasis in the original); see Jurewicz, 741
F.3d at 1331 (same).
III. DISCUSSION
As noted, the plaintiff continues to contest the withholding of only four categories of
responsive records. The parties’ arguments regarding the Reportable Event summaries and the
Disclosure Log summaries generally overlap and are addressed together in Part III.A infra. The
15
Although Pfizer pressed the argument that all of the documents submitted pursuant to the CIAs were subject to the
“self-evaluation and self-critical reports” privilege, this Court rejected that argument in Public Citizen I, 975 F.
Supp. 2d at 111 n.19, and Pfizer does not reassert it here. See generally Pfizer’s 2d Mem.
11
documents relating to the Pfizer “detailing sessions” 16 are addressed in Part III.B infra, and the
documents pertaining to the actions taken by the defendant-intervenors in response to screening
for Ineligible Persons are addressed in Part III.C infra.
A. Reportable Event Summaries And Disclosure Log Summaries
In the cross-motions for summary judgment that were resolved in Public Citizen I, the
parties failed to provide sufficient information to determine whether the summaries of the
defendant-intervenors’ Reportable Events and Disclosure Logs were “commercial” within the
meaning of Exemption 4, rendering any discussion of whether these documents were
“confidential” premature. See Public Citizen I, 975 F. Supp. 2d at 103–04. The parties have
remedied the deficiencies here, as explained below.
1. The Reportable Event Summaries And Disclosure Log Summaries Are
“Commercial”
The plaintiff offers no arguments as to why the Reportable Event summaries and
Disclosure Log summaries should not be considered “commercial” within the meaning of
Exemption 4. See generally Pl.’s 2d Mem. Consequently, the defendant-intervenors’ arguments
as to the commercial nature of the documents may be accepted as conceded. See Jones v. Horne,
634 F.3d 588, 603 (D.C. Cir. 2011) (upholding District Court’s granting of defendant’s motion to
dismiss when plaintiff failed to respond to motion); United States v. Kellogg Brown & Root
Servs., Inc., 856 F. Supp. 2d 176, 185 (D.D.C. 2012) (holding argument in dispositive motion
left unaddressed by opposing party as conceded); Buggs v. Powell, 293 F. Supp. 2d 135, 141
(D.D.C. 2003) (same). Nevertheless, the Court briefly summarizes the defendant-intervenors’
16
“‘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. Pfizer was required
to make findings based on this review and take any corrective action necessary. The findings and corrective actions
were required to be submitted to the OIG. Purdue’s CIA did not contain this requirement.’” Public Citizen I, 975 F.
Supp. 2d at 92 n.8 (internal citations omitted).
12
rationale as it also helps illuminate the basis for the defendant-intervenors’ arguments that the
disputed records are “confidential.”
Purdue’s declarant avers that “[b]y their very nature, these Reportable Event Summaries
and Disclosure Log Summaries describe and directly relate to Purdue’s business transactions and
therefore deal with commercial matters.” Suppl. Decl. of Bert Weinstein, Purdue Vice President,
Corporate Compliance (“1st Suppl. Weinstein Decl.”) ¶ 4, ECF No. 50-2. This is because the
“Reportable Event Summaries describe in detail basic business operations and techniques at
Purdue, in particular Purdue’s internal training exercises and the conduct of individuals engaged
in promotional activities involving Purdue products.” Id. ¶ 5. Likewise, Pfizer’s declarant states
that “[a]ll ‘Reportable Event’ letters and summaries relate to Pfizer’s sales and marketing
activities, such as its speaker programs, detailing sessions, and sampling plans.” 2d Decl. of
Edward Nowicki, Pfizer Vice President and Asst. General Counsel, Chief Compliance
Counsel—Global Programs, R&D/Medical & PGS (“2d Nowicki Decl.”) ¶ 15, ECF No. 47-2.
Such activities are “instrumental” to defendant-intervenors’ methods for selling their
products. A company has a clear commercial interest in its “basic business operations and
techniques,” 1st Suppl. Weinstein Decl. ¶ 5, and its “sales and marketing activities,” 2d Nowicki
Decl. ¶15. Thus, Purdue and Pfizer have shown adequately that the Reportable Event summaries
are “commercial” within the meaning of Exemption 4.
As for the Disclosure Log summaries, the defendant-intervenors’ declarants make
similarly adequate proffers as to what is contained in the summaries to illustrate why they are
appropriately considered “commercial.” For instance, Purdue’s declarant states that “[t]he
Disclosure Log Summaries . . . constitute ‘commercial’ information in that they identify and
describe interactions with prescribers, consumers, and other customers of Purdue’s various
13
healthcare products, all vital business functions for Purdue.” 1st Suppl. Weinstein Decl. ¶ 6.
Moreover, “the Disclosure Log Summaries include details of identification and techniques
related to Purdue’s product promotion, its Code of Business Ethics, and compliance with
industry guidelines in general.” Id. ¶ 7. Pfizer’s declarant similarly avers that its Disclosure Log
summaries contain information “about how Pfizer compensates and disciplines its employees,”
2d Nowicki Decl. ¶ 39, and “details about internal investigations of the matters reported, which
demonstrates how Pfizer conducts its compliance program,” id. ¶ 38, along with activities such
as “promotional statements, call planning activities, sample distribution, travel and expense, and
other interactions between sales representatives (or other Pfizer employees) and doctors, health
care providers, and customers,” id. ¶ 35.
Both declarants make clear that the information contained within the Disclosure Log
Summaries is sufficiently “instrumental” to the companies’ operations to qualify as
“commercial” within the meaning of Exemption 4. Both declarants state that the documents in
question contain information about interactions between the companies’ salespeople and
customers, how the companies promote their products, and the way the companies implement
their compliance programs. See 1st Suppl. Weinstein Decl. ¶¶ 6–7; 2d Nowicki Decl. ¶¶ 35–39.
Consequently, the Disclosure Log summaries are “commercial” information.
2. The Reportable Event Summaries And Disclosure Log Summaries Are
“Confidential”
The parties use the bulk of their briefing to address whether the Reportable Event and
Disclosure Log summaries are “confidential,” i.e., whether the release of such documents would
cause “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). Purdue and
14
Pfizer’s declarants make a strong case as to why the information contained in these documents
could be used to cause substantial commercial harm.
For instance, Pfizer’s declarant describes how a competitor could use the Reportable
Event summaries to “learn how Pfizer promotes its products through its marketing programs,”
and “its related compliance controls around these programs,” which would allow that competitor
to “copy Pfizer’s approach.” 2d Nowicki Decl. ¶ 26. Similarly, Purdue’s declarant explains that
“Purdue has made a significant investment of time and monies over the course of the CIA to
interpret the requirements of a CIA and to operationalize its requirements within its own
processes and practices.” 2d Suppl. Decl. of Bert Weinstein, Purdue Vice President, Corporate
Compliance (“2d Suppl. Weinstein Decl.”) ¶ 5, ECF No. 58-1. The declarant goes on to state
that “[t]he details . . . would have substantial commercial value to Purdue’s competitors, whether
or not they are under a CIA, as evidence of emerging practices within the industry and the types
of conduct where other companies have drawn the lines, without the competitor having to make
the same investment to determine what might or might not constitute illegal practices.” Id.
The plaintiff responds to these declarations, and the declarations pertaining to the other
two disputed categories of records, by rehashing an argument already rejected in Public Citizen I
and the denial of the plaintiff’s motion for reconsideration: that, because some of the information
contained in the records at issue may pertain to illegal activity, the records cannot be withheld
pursuant to Exemption 4. The plaintiff’s arguments on this score continue to reflect a
fundamental misunderstanding of the purpose behind the FOIA’s Exemption 4.
As noted in Public Citizen I, “the overall commercial nature of an undertaking is not
altered when some aspect of that activity is suspected to constitute, or actually results in, a
violation of a rule, regulation or statutory requirement.” 975 F. Supp. 2d at 102. Whether
15
records potentially exempt from disclosure under Exemption 4 may lead to possible legal
conclusions about the lawfulness of the activities described therein, has little bearing on whether
the activities described are “commercial” or “confidential.” Rather, the applicability of
Exemption 4 rests on what information can be gleaned from the disputed records about the
company’s commercial enterprises and whether that information can be used affirmatively by the
company’s competitors. See Jurewicz, 741 F.3d at 1331. Even if the activities described in such
records pertain to what may be deemed illegal conduct, the context of and facts about the activity
revealed in the records may retain their commercial character, in terms of revealing closely held
information about the company’s operations and structure that would be valuable to competitors.
Thus, the Court, again, rejects the plaintiff’s argument that when disputed records reflect facts
that may lead to the conclusion that an unlawful act occurred, those records are stripped of
eligibility for Exemption 4 withholding.
The plaintiff’s argument that there is no “competitive market for information about
suspected or confirmed unlawful policies and practices,” Pl.’s 2d Mem. at 4, is predicated on an
overly simplistic view of the concerns and practices of competitors in a highly regulated industry
such as pharmaceuticals. As an example, the plaintiff argues that “the operations described in
Reportable Event summaries are in part going to be those a reasonable person would consider a
probable violation of criminal, civil, or administrative laws.” Pl.’s 2d Mem. at 6. The plaintiff
conclusorily states that “[a]ll companies are aware of their legal obligations and the steps they
must take to comply.” Id. While the plaintiff’s argument may be true of industries that operate
with few regulatory constraints, the pharmaceutical industry operates under a unique set of
restraints, not the least of which being that the companies are prohibited by law from selling all
of their goods directly to consumers. See Christopher v. SmithKline Beecham Corp., 635 F.3d
16
383, 396 (9th Cir. 2011) (remarking that pharmaceutical industry is “heavily regulated” and that
“pharmaceutical manufacturers . . . have structured their 90,000-person sales force and their
marketing tactics to accommodate this unique environment.”).
In the context of this “unique environment,” id., Purdue’s declarant explains the precise
way in which Purdue’s competitors could use information pertaining to its compliance policies:
The analysis and application of the relevant law consumes significant legal and
compliance resources for a pharmaceutical company like Purdue. Purdue relies in
part on external legal, consulting, and other resources for benchmarking its own
activities against others in the industry and to assist it in making decisions in
circumstances where the line between lawfulness and unlawfulness is not clearly
drawn. 2d Suppl. Weinstein Decl. ¶ 4.
The information contained in the Reportable Event and Disclosure Log summaries,
according to the declarants, provides competitors with two valuable pieces of information: what
Pfizer and Purdue have determined is a legally and, presumably, profitable, compliant manner of
operating and what these companies have determined is illegal, particularly where “the line
between lawfulness and unlawfulness is not clearly drawn.” See id. As Pfizer’s declarant
explains, “Pfizer’s Disclosure Program is one aspect of [its] compliance program,” and its
release would cause Pfizer to “lose its competitive advantage if a competitor obtained details of
Pfizer’s program at little or no cost.” 2d Nowicki Decl. ¶ 43. In addition to the “substantial time
and money,” id., the defendant-intervenors invest in their compliance programs, the activities
described in the summaries and the reactions taken in response to them also represent a savings
in exposure to risk. See id. ¶ 4 (noting that “mitigating risk through [its] compliance program
gives [Pfizer] a competitive advantage”). 17 Contrary to the plaintiff’s assertions, the declarants
17
Pfizer’s declarant states that the release of the compensation and discipline information in these records could also
be used by a competitor to poach disgruntled employees away from Pfizer. See 2d Nowicki Decl. ¶¶ 39–40; Pfizer’s
2d Mem. at 14. This potential for competitive harm is unsupported and speculative, but it is unnecessary to
determine the ultimate accuracy of this contention, since the defendant-intervenors have provided ample evidence
otherwise to meet their burden in justifying withholding the disputed records under Exemption 4.
17
have successfully demonstrated the value to competitors contained in the Disclosure Logs and
Reportable Event Summaries: they are, in a sense, a free roadmap as to what works in
pharmaceutical marketing without violating the legal framework of regulatory enforcement and
laws that govern the industry, and what activities to avoid, and release of this roadmap would
allow competitors to avoid incurring the experiential or monitoring costs Pfizer and Purdue did
in gaining the information.
The defendant-intervenors’ internal treatment of these records bears out this conclusion.
Pfizer and Purdue’s declarants state that their companies maintain tight internal controls on these
records and only a few individuals have access to them. See 1st Suppl. Weinstein Decl. ¶ 9
(“Purdue diligently ensures that information such as that contained in the Reportable Event
Summaries and Disclosure Log Summaries is maintained securely and not disseminated beyond
those within the company who need access.”); 2d Nowicki Decl. ¶ 41 (“Pfizer . . . maintains the
confidentiality of the Disclosure Log even within the Company inasmuch as revealing the
content of the information could cause a chilling effect and would undermine its compliance
program”). These internal controls are not ultimately dispositive as to whether the disputed
records are “confidential” within the meaning of Exemption 4, but they do corroborate the
defendant-intervenors’ assertions that their release could result in competitive harm,
notwithstanding the plaintiff’s arguments that a loss of anonymity and internal confidentiality
controls would have no effect on—or could potentially increase reporting of—allegedly unlawful
activity. See, e.g., Pl.’s Reply Supp. Pl.’s 2d Mot. (“Pl.’s 2d Reply”) at 4–6, ECF No. 62.
The plaintiffs’ other contentions regarding the confidentiality of the summaries are on
more sound footing, but they are ultimately not enough to overcome the obvious competitive
harm that would result from the release of the summaries as described above. The plaintiff
18
correctly points out that merely because the defendant-intervenors “marked [the Reportable
Event summaries] as ‘FOIA confidential’ and ‘the government obligated itself in good faith not
to disclose documents or information received pursuant to the CIA,’” Pfizer’s Mem. Supp.
Pfizer’s 2d Mot. (“Pfizer’s 2d Mem.”) at 8, ECF No. 47-1 (quoting Hersh & Hersh v. U.S. Dep’t
of Health and Human Servs., No. 06-4234, 2008 WL 901539, at *7 (N.D. Cal. March 31, 2008)),
does not mean these documents were properly withheld under the FOIA. The Court has already
considered and rejected these bases for withholding. See Public Citizen I, 975 F. Supp. 2d at 90;
id. at 90 n.3; id. at 113.
Similarly, the plaintiff is correct that the alleged “chilling effect” that disclosure of these
documents might have on the defendant-intervenors’ employees’ willingness to come forward
with possible violations does not meet the definition of “competitive harm” for the purposes of
Exemption 4. See Pl.’s 2d Mem. at 7–8. Since the cognizable competitive harm under
Exemption 4 is limited to that which “flow[s] 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), it is highly unlikely that any internal chilling of potential whistleblowers employed by
Pfizer or Purdue could be used affirmatively by their competitors to wreak substantial harm.
* * *
While the plaintiff is correct to discount the merits of several of the defendant-
intervenors’ arguments regarding the competitive harm posed by the release of the Disclosure
Log summaries and the Reportable Event summaries, the plaintiff is unable to overcome the
substantial competitive advantage to be gained by the defendant-intervenors’ competitors to be
able to learn from Pfizer and Purdue’s mistakes at little or no cost in capital or exposure to risk.
Since the defendant-intervenors have shown there is no material fact in dispute regarding the
19
commercial and confidential nature of the Reportable Event summaries and Disclosure Log
summaries, the Court finds that these two sets of documents are exempt from disclosure under
the FOIA’s Exemption 4. 18
B. Detailing Sessions
The Court in Public Citizen I already determined that the “‘underlying records reflecting
the content of the detailing sessions between [Health Care Providers] and Covered persons’ as
required in § V.B.17 of the Pfizer CIA” were “commercial” within the meaning of Exemption 4.
Public Citizen I, 975 F. Supp. 2d at 118. 19 Thus, the parties’ dispute over this set of records
relates only to whether the information contained in the “detailing sessions” is “confidential.”
Pfizer’s declarants adequately explain why these records are confidential.
First, Pfizer’s declarant states that “‘[d]etailing sessions’ are sales presentations, either by
face-to-face meetings or through electronic, interactive media, by Pfizer’s employees (usually
sales representatives) to health care providers.” Decl. of Bill Nealon, Pfizer Lead, Business
Analytics & Insights CD/BD Pain/Neuroscience/Rare Diseases (“Nealon Decl.”) ¶ 3, ECF No.
47-4. They “are intended to educate health care providers about Pfizer’s products, including
giving details about their potential use, the conditions for which they can be prescribed, side-
effects, and to answer any questions.” Id. They are primarily “marketing” sessions, and “Pfizer .
. . regularly assess[es whether] detailing sessions are [effective] in educating health care
providers and promoting Pfizer’s products.” Id. ¶ 5.
To assess these sessions’ effectiveness, Pfizer “hire[s] a market research firm to survey
health care providers,” asking the provider “to answer questions that solicit ‘verbatim’ recall of
18
This ruling covers the documents with the following Bates Number ranges (all of which begin with the prefix
OIG-): Pfizer Documents 000088–000101; 001887–001893; 003752–003759; 005885–005891; 007911–007915;
000112–000120; 001906–001919; 003772–003825; 005904–005965; Purdue Documents 000019–000020; 000398–
000414; 000518–000520; 001060–001076. See Suppl. Rec. Status Appendix A at A-1 to A-4, ECF No. 64.
19
“Purdue’s CIA did not contain this requirement.” Public Citizen I, 975 F. Supp. 2d at 92 n.8.
20
the detailing session.” Id. ¶¶ 6–7. These surveys are costly 20 and “tend[] to capture a provider’s
major recollections—e.g. a disease or treatment option—that the provider retained in the mind
after the detailing session.” Id. ¶ 8. These “verbatims” were “intended as a business tool [and] it
was hoped that verbatims could be carefully reviewed for suggestions of possible improper
promotion.” 2d Nowicki Decl. ¶ 55. Moreover, despite the fact that this information is now
several years old, Pfizer notes that “[m]arketing strategies used a few years ago (even on
products Pfizer no longer owns) inform marketing strategies Pfizer uses today to market these
and other Pfizer products.” Decl. of Laura Chenoweth, Pfizer Senior Vice President and Assoc.
General Counsel, Chief Counsel for Global Established Pharma business (“Chenoweth Decl.”),
¶ 9, ECF No. 47-3.
Verbatims are not, despite their name, a record of “the actual conversation of a detailing
session—instead it captures a health care provider’s subsequent recollection and dominant
impressions.” 2d Nowicki Decl. ¶ 56. As a result, “one cannot ascertain from a verbatim
whether actual improper promotion occurred.” Id. Instead, verbatims “may only suggest a
possibility of improper promotion,” id. ¶ 57, which must then be “followed up and investigated
to determine whether there is any direct and substantial evidence of improper promotion,” id.
¶ 58.
Pfizer offers three reasons why this information is “confidential” within the meaning of
Exemption 4, or, in other words, how its competitors could use the information contained in the
verbatims against it: (1) “Pfizer pays a substantial fee for the verbatims;” (2) the content of the
verbatims reflects precisely targeted customers’ recall of the company’s marketing approach; and
(3) “Pfizer is contractually bound to keep the [information] confidential.” See Pfizer’s 2d Mem.
20
In 2013, Pfizer spent “a total of $200,000 [on] . . . verbatim surveys for compliance purposes.” Nealon Decl. ¶ 10.
21
at 18–19. 21 The first and second justifications are sufficient to show that the verbatims are
“confidential” within the meaning of Exemption 4. As Pfizer’s declarant explains:
If a competitor could get a verbatim at essentially no cost, Pfizer would be put at a
competitive disadvantage. Such a competitor could use the verbatim to
understand the strengths and weaknesses of Pfizer’s marketing strategies at little
cost to itself, information Pfizer paid to acquire. A competitor could then copy
marketing techniques that are working or exploit weaknesses in Pfizer’s
marketing efforts with its own marketing or promotion efforts. Nealon Decl. ¶
12.
As this detailed explanation indicates, a competitor could use the content of the verbatims
affirmatively to wreak competitive harm on Pfizer by acquiring records that, according to Pfizer
and undisputed by the plaintiff, show what is and is not working in companies’ marketing from
the perspective of its customers. See id. This kind of harm was contemplated by the D.C.
Circuit in Worthington Compressors, Inc. v. Costle, 662 F.2d 45, 48 (D.C. Cir. 1981). In that
case, one manufacturer of air compressors sought another manufacturer’s “production
verification and quality control reports” that were submitted to the Environmental Protection
Agency. Id. The manufacturer whose reports were being requested filed a reverse-FOIA action
to prevent their disclosure, claiming the reports were protected by Exemption 4. Id. at 49. In
applying the National Parks test, the D.C. Circuit noted that when commercial information “is
freely or cheaply available from other sources . . . it can hardly be called confidential and agency
21
Pfizer also rather disingenuously asserts that because the “records reflecting the content of the detailing sessions”
do not, in and of themselves, show improper promotion efforts, they do not “directly address, discuss, or identify
off-label promotion.” Pfizer’s 2d Mem. at 18. Therefore, according to Pfizer, since the plaintiff is only seeking
records that “relate to off-label promotion,” Pl.’s 2d Mem. at 14, and the content of the detailing sessions can only
trigger an investigation into the possibility of off-label promotion, these records fall outside the plaintiff’s request
and should not be released since they are non-responsive to the plaintiff’s request, see Pfizer’s 2d Mem. at 18. The
plaintiff’s initial FOIA request sought complete copies of “all annual reports submitted to [HHS] OIG by Pfizer, Inc.
pursuant to the May 2004 Corporate Integrity Agreement between OIG and Pfizer.” Decl. of Robin R. Brooks,
FOIA Officer, HHS OIG, Apr. 6, 2012 (“1st Brooks Decl.”) Ex. A (FOIA Request from Public Citizen, November
12, 2009) at 1, ECF No. 22-1. Thus, the records are clearly responsive to the initial request, since no party disputes
the records were “submitted to OIG by Pfizer” pursuant to its CIA. The plaintiff’s subsequent limitation of the
documents in dispute to “Pfizer documents reflecting the content of detailing sessions that reveal off-label
promotion required by § V.B.17 of the Pfizer CIA,” Pl.’s 2d Mot. at 1 (emphasis added), still encompasses all
detailing session content submitted as part of Pfizer’s obligation to the defendant, regardless of whether the content
itself actually “reveal[s] off-label promotion,” id.
22
disclosure is unlikely to cause competitive harm.” Id. at 51. Nevertheless, when “competitors
can acquire the information only at considerable cost, agency disclosure may well benefit the
competitors at the expense of the submitter.” Id.
The D.C. Circuit’s holding is directly applicable here. Pfizer obtains these verbatims at
considerable cost, see Nealon Decl. ¶ 10, and is then required to turn over portions of them to
comply with its CIA, see Pfizer CIA § V.B.17. The information itself is valuable to a
competitor, since it would reveal “marketing techniques that are working,” for Pfizer and allow
the competitor to “exploit weaknesses in Pfizer’s marketing efforts with its own marketing or
promotion efforts,” Nealon Decl. ¶12. This is a classic example of the competitive harm with
which the Worthington court was concerned, since “competition in business turns on the relative
costs and opportunities faced by members of the same industry” and “there is a potential windfall
for competitors to whom valuable information is released under FOIA.” Worthington
Compressors, Inc., 662 F.2d at 51.
The plaintiff’s arguments to the contrary are unavailing. While the plaintiff is correct
that the information in the verbatims is known by both the health care provider who was
surveyed and the market research firm, Pl.’s 2d Reply at 13, it is not “freely or cheaply available
from [those] sources,” Worthington Compressors, Inc., 662 F.2d at 51. A competitor wishing to
obtain this information would, absent its release through the FOIA, have to pay a market
research firm to conduct a similar survey, incurring the same expenses Pfizer incurred in the first
instance. A competitor’s ability to obtain the information at virtually no cost would cause
competitive harm to Pfizer, since it could be used affirmatively by those competitors to challenge
23
Pfizer’s place in the market and exploit any vulnerability revealed through the verbatims’
content. 22
Consequently, Pfizer has shown the “‘underlying records reflecting the content of the
detailing sessions between [Health Care Providers] and Covered persons’ as required in § V.B.17
of the Pfizer CIA” are confidential under Exemption 4 and that it is entitled to summary
judgment on this set of documents. 23
C. Ineligible Person Responses
The defendant-intervenors’ CIAs required them to institute a “screening program” to
identify and exclude “Ineligible Persons” from any involvement with Federal health care
programs. See Public Citizen I, 975 F. Supp. 2d at 104–05. The defendant-intervenors also were
required to notify the defendant of “‘any changes to the process by which [the company] fulfills’
the Ineligible Persons requirement,” and provide the “name, title, and responsibilities of any
person who is determined to be an Ineligible Person.” Id. at 105 (internal citations omitted;
alteration in original). The plaintiff has made clear in this round of summary judgment briefing
that a third category of information is also required to be reported regarding Ineligible Persons:
“[T]he actions taken by [the company] in response to the CIA’s Ineligible Person screening and
removal obligations.” Pfizer’s 2d Mem. at 2.
In Public Citizen I, the Court found that the information pertaining to “any changes to the
process” of Ineligible Person screening was both commercial and confidential, and awarded
summary judgment to the defendant and defendant-intervenors. See Public Citizen I, 975 F.
22
The parties dispute whether the actual contract between Pfizer and its market research firm must be submitted to
prove, pursuant to the best evidence rule, whether Pfizer is required to keep the verbatims confidential. See Pl.’s 2d
Mem. at 14–15; Pfizer’s Opp’n Pl.’s 2d Mot. (“Pfizer’s 2d Opp’n”) at 11–12, ECF No. 57; Pl.’s 2d Reply at 14.
Since the information at issue is confidential under the Worthington Compressors, Inc. rationale, resolution of this
dispute is unnecessary.
23
This ruling applies to the following documents, as identified by their Bates Range numbers (all of which begin
with the prefix OIG-):000132–000136; 001927; 001932–001944; 003833; 003838–003844; 005973; 005978–
005983; 007979; 007984–007989. See Suppl. Rec. Status A-2 to A-3.
24
Supp. 2d at 115. On the other hand, the Court awarded summary judgment to the plaintiff on the
“title and responsibilities of any person who is determined to be an Ineligible Person,” since the
information in question was not commercial. See id. at 105 (“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.”). At issue now is whether the
third category of information, the actions the companies took in response to the discovery of
Ineligible Person(s) (“Responsive Action(s)”), is commercial and confidential.
For substantially the same reasons that the Court found information pertaining to the
changes in process the companies used to screen for Ineligible Persons was protected by
Exemption 4, this Responsive Action information is similarly protected. First, just as the
information about changes in process “involve[d] the process by which the companies make
decisions about managing and conducting their business operations,” Public Citizen I, 975 F.
Supp. 2d at 105, so too is the process used by the companies if and when they discover such a
person. See 2d Nowicki Decl. ¶ 52 (“Disclosure would also reveal how Pfizer implements any
changes it makes to the process of identifying and removing Ineligible Persons.”). In the same
vein, revealing the actions a company took in response to the discovery of an Ineligible Person
would “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.” Public
Citizen I, 975 F. Supp. 2d at 115. It is this revelation that could easily lead to substantial
competitive harm, as Pfizer’s declarant points out. See 2d Nowicki Decl. ¶ 54 (“If details about
Pfizer’s screening system were made public, a competitor could copy Pfizer’s system and adopt
it for its own use . . . . thus obtain[ing] the benefit of Pfizer’s investment without having to incur
the cost itself.”).
25
The plaintiff’s arguments to the contrary are unpersuasive. The plaintiff again
oversimplifies the compliance environment in which pharmaceutical manufacturers work and the
value of a robust compliance program to them. According to the plaintiff, “[t]he CIA already
describes in great detail the process that Pfizer must use to identify Ineligible Persons and the
corrective actions that the company must take.” Pl.’s 2d Mem. at 13. While this is true, it is
equally true that each company “has made a significant investment of time and monies over the
course of the CIA to interpret the requirements of a CIA and to operationalize its requirements
within its own processes and practices.” 2d Suppl. Weinstein Decl. ¶ 5; see also 2d Nowicki
Decl. ¶ 54 (“If details about Pfizer’s screening system were made public, a competitor could
copy Pfizer’s system and adopt it for its own use. The competitor would thus obtain the benefit
of Pfizer’s investment without having to incur the cost itself.”). The difference between the
bare-bones requirements in the CIAs and the actual operational methods used by the defendant-
intervenors’ is, according to both companies’ declarants, significant and tailored to the individual
companies’ use. See id. 24 There is, therefore, little doubt that a competitor could make use of
the information to be gleaned about the defendant-intervenors’ compliance programs from the
reports of actions taken in response to the discovery of an Ineligible Person as well as the
information to be gleaned about the companies’ business practices and corporate structures.
The Court finds that the information required to be disclosed to HHS regarding actions
taken by the defendant-intervenors in response to the discovery of Ineligible Persons is
24
The plaintiff’s argument that this customization would render such information worthless to the defendant-
intervenors’ competitors, see Pl.’s 2d Mem. at 13; Pl.’s 2d Reply at 12, is equally unpersuasive. The plaintiff relies
in part on the declaration this Court noted was of little or no value due to its qualified statements and generally
vague nature, see Mem. & Order at 5–8 (noting the Rodondi Declaration was rife with qualified “observations”
including that “defendant-intervenors’ ineligible screening policies ‘are likely similar [to] the same actions and
processes taken by competing companies’”), and otherwise merely asserts that there is no “competitive market” for
information in Pfizer and Purdue’s processes that is not contained in their respective CIAs, see Pl.’s 2d Reply at 12.
This argument is belied by the importance the companies place on their compliance programs, see 2d Nowicki Decl.
¶¶ 4–5, 8–11; 2d Suppl. Weinstein Decl. ¶ 4, and the general importance all companies place on best practices in
corporate governance and structure.
26
commercial and confidential, 25 and the defendant-intervenors and defendant are entitled to
summary judgment as to this category of documents. 26
D. Segregability
The Court expressly instructed the defendant and defendant-intervenors regarding
segregability in Public Citizen I, 975 F. Supp. 2d at 118, stating that “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.” The defendant-
intervenors nonetheless failed to include in their supplemental declarations any discussion of
segregable portions of the documents at issue. See generally 2d Nowicki Decl.; 1st Suppl.
Weinstein Decl.; 2d Suppl. Weinstein Decl. In reviewing the supplemental Vaughn indices,
however, the Court is satisfied that any reasonably segregable portions of the records at issue
have already been released.
The supplemental Vaughn indices reveal that very few documents were withheld in full.
See generally Pfizer Suppl. Vaughn Index, ECF No. 48; Purdue Suppl. Vaughn Index, ECF No.
49. Those documents in dispute that were withheld in full are Purdue’s two Disclosure Log
summaries, Bates Nos. OIG-000398-000414 and OIG-001060-001076; Pfizer’s Disclosure Log
summary, Bates Nos. OIG-000112-000120; and Pfizer’s “Records Reflecting Content of
Detailing Sessions,” Bates Nos. OIG-000132-000136, OIG-001932-001944, OIG-003838-
003849, OIG-003842-003844, OIG-005978-005983, and OIG-007984-007989. Considering the
nature of these documents, it is reasonable to surmise that these documents do not contain any
25
Since this information is exempt from disclosure under Exemption 4, it is unnecessary for the Court to resolve
whether Purdue’s actions taken in regard to an Ineligible Person not discovered by the company’s screening process
are covered by the plaintiff’s request. See Pl.’s 2d. Mem. at 11–12.
26
The documents covered by this ruling are identified by the following Bates Numbers (each of which bears the
prefix OIG-); Pfizer Documents 001878–001880; 001882–001885; 003737–003738; 003740–003750; 005883;
007909; Purdue Documents 000023; 0000523. See Suppl. Rec. Status at A-1 to A-2, A-4.
27
reasonable segregable information, since the Disclosure Log summaries and the “verbatims” are
entirely exempt from disclosure under Exemption 4. See supra Parts III.B and III.C. The Court
is therefore satisfied, based on its review of the declarations and the supplemental Vaughn
indices that all reasonably segregable, non-exempt material has been released by the defendant
and the defendant-intervenors.
IV. CONCLUSION
For the foregoing reasons, since there are no disputed issues of material fact remaining,
the defendant and defendant-intervenors’ renewed motions for summary judgment are granted
and the plaintiff’s renewed motion for summary judgment is denied.
An appropriate Order accompanies this Memorandum Opinion.
Digitally signed by Beryl A. Howell
DN: cn=Beryl A. Howell, o=District
Date: September 5, 2014 Court for the District of Columbia,
ou=District Court Judge,
email=howell_chambers@dcd.usc
ourts.gov, c=US
__________________________
Date: 2014.09.05 17:47:24 -04'00'
BERYL A. HOWELL
United States District Judge
28