Ctr. for Inquiry, Inc. v. HHS, No. 21-3118, 2024 WL 1111299 (D.D.C. Mar. 14, 2024) (Boasberg, C.J.)

Ctr. for Inquiry, Inc. v. HHS, No. 21-3118, 2024 WL 1111299 (D.D.C. Mar. 14, 2024) (Boasberg, C.J.)

Re:  Request for certain information concerning homeopathic drugs

Disposition:  Granting in part and denying in part defendants’ motion for summary judgment; granting in part and denying in part plaintiff’s motion for summary judgment

• Litigation Considerations, Adequacy of Search:  “Because the Government’s declaration has neither averred that FDA searched all locations likely to contain responsive records nor justified its decision to exclude [certain former employee] emails, the Court cannot conclude that Defendants have satisfied their obligations under FOIA.”  “To begin, the Court agrees that the record ‘leaves substantial doubt’ as to whether certain [Center for Drug Evaluation and Research (“CDER”)] offices were the only places likely to contain responsive records.”  “Indeed, the declaration on which the Government relies admits that the Agency searched for records only in the three CDER offices ‘most likely to possess records responsive to’ [plaintiff’s] request.”  “Defendants have offered a credible reason for this initial focus on CDER alone – they explain that this center is the one in FDA responsible for regulating ‘homeopathic drug products,’ . . . [but] they never adequately explain their decision to cabin search locations even further to three offices within that center.”  “They never, for example, describe why other offices within CDER were not likely to contain responsive records.”  “Lest this seem like a dispute over mere ‘magic words,’ the Court also notes that the record in fact indicates that there was at least one more office within CDER where responsive records could have been found.”  Additionally, the court finds that “FDA did not just employ different methods for searching the records of current and former CDER employees.”  “It instead chose to barely search the records of the latter, even though it knew that this location was likely to house records responsive to CFI’s request.”  The court finds that defendant stated that “the Agency was simply following its ‘standard practice’ of having each employee manually search her own records, a task that a person no longer employed at FDA would not be able to complete.”  “[Defendant’s] description of the Agency’s eDiscovery capacities would adequately explain a decision to search only the portion of [certain] emails that was archived on its servers, but it does not explain what the Agency actually opted for here:  to not search any of its former employee’s actual emails.”  Finally, the court relates that “[b]ecause the Government was aware that [Homeopathic Convention of the United States (“HPCUS”)] members frequently communicated with FDA ‘using their business email addresses,’ . . . Plaintiff argues that the only reasonable search here would have been one that included these email addresses.”  The court finds that “[a]s the Agency’s declaration explains, its interactions with the Convention ‘are limited to a small number of active HPCUS members.’”  “Because many of these members are also employed by ‘well-known pharmaceutical companies and other organizations’ that frequently come before FDA . . . the Agency chose to search for member names instead of their business email addresses, believing that this was necessary to avoid search results that included the members’ work on non-homeopathic matters.”  “These search terms were thus ‘reasonably tailored to uncover documents responsive to’ CFI’s ask.”  “Plaintiff vigorously resists this conclusion, but offers no concrete reason for so doing.”  “It is true that ‘an agency cannot ignore what it cannot help but know,’ . . . but CFI merely supposes that FDA’s chosen search terms missed at least some emails sent by HPCUS members.”  “Simply put, CFI faults Defendants for not including a search term that would, at best, result in finding the very emails that the Agency already found and produced and could, at worst, have turned up a number of non-responsive records.”

• Exemption 4:  “[T]he Court finds that at least some of the material withheld by the Agency – viz., the material that contains portions or entire copies of draft [outside company] monographs – is commercial for purposes of Exemption 4.”  “Since there is a material dispute as to whether this or any of the withheld information is confidential, however, it will deny the Motions as to the applicability of this exemption.”  The court relates that at issue is the “redaction of the attachments to the email sent by the then-HPCUS chair to [a former employee].”  “These attachments include ‘[m]inutes’ from previous Standards and Controls Committee meetings and Committee notes on “common repetitive test procedures that appear in the [outside company’s] monographs.”
  
  Regarding whether the information is commercial or financial, the court finds that, “[a]t the outset, the Court’s task is unfortunately not made any easier by Defendants’ rather cursory Vaughn Index, which states that most of the redacted material comprises ‘recommendations, opinions, and proposals of’ [the outside company] committee tasked with ‘establish[ing] . . . standards and quality control tests for [the outside company’s]’ monographs.”  “Neither this nor anything else in the record, however, describes these categories in greater detail, so the Court has no way of knowing what exactly lies behind the Agency’s redactions.”  “In the absence of a description of the redacted information, the Court has a hard time determining which material (if any) qualifies as commercial for these purposes.”  “Despite these shortcomings, Defendants push ahead with their contention that all of the redacted information is commercial because it contains discussions of [the outside company’s] monographs, while the redacted material ‘literally constitutes the contents of the Homeopathic Pharmacopoeia.’”  “The Government’s theory for why this material is commercial is as follows:  the only way for the public to access [the outside company’s] monographs is by purchasing a subscription to the [outside company’s services], and these subscription fees make up ‘65 percent of the annual income of the [outside company].’”  “Release of the redacted materials would undermine this revenue source because it would reveal, for free, the content of these monographs.”  “[The outside company] thus has a clear commercial interest in the information the Agency kept from [plaintiff].”  “The Court agrees that, to the extent the redacted material contains portions or entire copies of draft monographs, this plainly qualifies as commercial because it is directly related to [the outside company’s] ‘making of a profit.’”  “To agree with Defendants as to that specific category of materials, though, is not to agree with them wholesale.”  “As [plaintiff] rightly notes, the Agency has a duty to show ‘how each withheld record’ fits within Exemption 4’s definition of ‘commercial.’”  “This it has not done.”  “As already explained, the remaining categories of withheld information are described in such general terms that the Court cannot determine whether or not anything in them qualifies as commercial under this FOIA exemption.”  “Some of the redacted materials, for instance, are described as ‘minutes from recently held’ committee meetings.”  “This label provides no insight into whether specific monograph contents were discussed at these meetings, whether that discussion in fact disclosed the content of the monographs – as opposed to, say, the formatting of that draft – or whether such a discussion made up the entirety of those meetings and the resultant minutes.”  “Defendants’ Vaughn Index gets them no further, since it simply states that the redacted material ‘contains recommendations, opinions, and proposals’ for revising [the outside company’s] US monographs.”  “What is the content of these ‘recommendations, opinions, and proposals’?”  “Do they threaten to reveal the contents of the draft monographs?”  “Or do they sometimes touch on non-substantive aspects of the monographs, or other topics unrelated?”  “It is impossible to answer any of these questions with what the parties have presented thus far.”  “Based on the record before it, therefore, the Court can only conclude that ‘some portion of’ the redacted material ‘likely contain[s] commercial information’ – i.e., the material that contains portions or entire drafts of [the outside company] monographs.”
  
  Regarding whether the information is privileged or confidential, “[t]he Court ultimately finds that there is a material dispute as to whether [the outside company] customarily treated the redacted materials as private, such that summary judgment for neither party is appropriate.”  “Starting with the biggest problem, the Government’s only source on this point, [the outside company’s] President . . . , has shown remarkable inconsistency [as to the question of whether the company treated this material as confidential] in his various declarations.”  “Similar problems surround [a] public webinar [at issue].”   “In his first discussion of the webinar, [the company’s president] stated that ‘two monographs were shown in their entirety, while portions of three more were shown,’ and he admitted that ‘material that [he] considered confidential was released to the public.’”  “In his fourth and final declaration, though, [the company’s president] changes his tune and now states that the webinar ‘did not reveal substantive information contained within the HPUS.’”  “And only in this declaration does [the outside company’s president] say, without explanation, that the release of the webinar to the public was ‘accidental.’”  “Those conflicting statements, ‘made by the same person,’ suffice to deny Defendants’ Motion.”  “All this being said, the Court cannot fully side with Plaintiff either because much in the record supports the Government’s contention that [the outside company] ‘actually and customarily keeps the withheld information confidential.’”  “For one, the email transmitting these particular materials to [defendant’s former employee] signaled that the Convention considered them ‘For [committee members’] Eyes Only’ and directed the former CDER employee to its Document Security and Retention policy.”  “So even if Plaintiff is right that [the outside company] ‘will not consider information confidential unless it is explicitly designated so,’ . . . the record establishes that [the outside company] did so with regard to the redacted materials.”  “What is more, there is little to support Plaintiff’s belief that [the outside company] ‘routinely’ discloses this information to anyone other than their volunteer members.”  “The fact that [the outside company] is staffed by individuals who work for private companies does not in itself prove that [it] freely disclosed the redacted materials to these corporate employers either.”