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Public Citizen v. United States Department of Health and Human Services

United States District Court, D. Columbia.

September 5, 2014

PUBLIC CITIZEN, Plaintiff,
v.
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant,
v.
PFIZER INC. and PURDUE PHARMA L.P., Defendant-Intervenors

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[Copyrighted Material Omitted]

Page 198

For PUBLIC CITIZEN, Plaintiff: Adina Rosenbaum, LEAD ATTORNEY, PUBLIC CITIZEN LITIGATION GROUP, Washington, DC; Allison Marcy Zieve, Julie A. Murray, PRO HAC VICE, PUBLIC CITIZEN LITIGATION GROUP, Washington, DC.

For DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant: Carl Ezekiel Ross, LEAD ATTORNEY, U.S. ATTORNEY'S OFFICE, Washington, DC.

For Washington, DC, Intervenor Defendant: Ronald J. Tenpas, LEAD ATTORNEY, David M. Kerr, MORGAN, LEWIS & BOCKIUS LLP, Washington, DC.

For PURDUE PHARMA L.P., Intervenor Defendant: Lee Calligaro, EPSTEIN, BECKER & GREEN, P.C., Washington, DC.

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MEMORANDUM OPINION

BERYL A. HOWELL, United States District Judge.

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,

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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 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 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

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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 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

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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 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.

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.

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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 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]

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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-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 § ...

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