Juul Labs, Inc. v. FDA, No. 22-2853, 2024 WL 1733043 (D.D.C. Apr. 23, 2024) (Moss, J.)

Juul Labs, Inc. v. FDA, No. 22-2853, 2024 WL 1733043 (D.D.C. Apr. 23, 2024) (Moss, J.)

Re:  Request for internal review documents related to FDA’s marketing denial order (“MDO”) letters with respect to requester’s premarket tobacco applications (“PMTA”) for certain e-cigarette products

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

• Exemption 5, Deliberative Process Privilege, Adoption and Incorporation; Litigation Considerations, “Reasonably Segregable” Showing :  “[T]he Court concludes that the FDA has met its burden of showing that most (but not all) of the materials it withheld are predecisional and deliberative and thus protected by Exemption 5.”  “In defending its application of the deliberative process privilege, the FDA asserts that the withheld materials – the second [Technical Project Lead (“TPL”)] Review Memo and the nineteen corresponding Discipline Review Memos – were all part of its ‘decision-making process on Plaintiff’s [premarket tobacco applications (“PMTAs”)], which resulted in a Marketing Denial Order . . . for the subject PMTAs issued on June 23, 2022.’”  “These documents are deliberative and predecisional, in the FDA’s view, because ‘[t]hey contain the thinking of [FDA’s Center for Tobacco Products (“CTP”)] scientists developed during review of Plaintiff’s PMTAs, for the purpose of helping the agency make its decision on whether to authorize marketing of Plaintiff’s products.’”  “The Discipline Review Memos, in particular, ‘contain CTP scientists’ recommendations to other [CTP’s Office of Science (“OS”)] scientists, and to their superiors, regarding each individual scientist’s views of the data and information that [the] scientist reviewed.’”  “And, in the case of the second TPL Review Memo, the withheld material ‘express[es] the TPL’s individual judgment regarding synthesis of the applicable Discipline Review Memos’ with respect to whether ‘the statutory standard required for marketing authorization’ has been met.”  “The CTP scientists that authored these materials did not have the authority to decide whether to approve [plaintiff’s] PMTAs or to issue an [Marketing Denial Order (“MDO”)]; that authority, the FDA explains, rests with the CTP Director, the CTP Deputy Director, and the Director of OS.”  “And, finally, the FDA explains that the memos were all predecisional; they were prepared ‘during [the agency’s] review of [plaintiff’s] PMTAs, for the purpose of helping the agency make its decision on whether to authorize marketing of [plaintiff’s] products,’ and they were ‘finalized before the decision to which they are relevant’ was made.”
  
  The court relates that “[plaintiff] first argues that FOIA Exemption 5 does not apply to the Additional Disciplines TPL Review Memo because that memo ‘postdates the FDA’s decision’ to deny [plaintiff’s] PMTAs, and, thus, it is not predecisional.”  “[Plaintiff] premises its argument, in large part, on an article published in the Wall Street Journal on June 22, 2022, which reported that, ‘according to people familiar with the matter,’ the FDA was ‘preparing to order [plaintiff] to take its e-cigarettes off the U.S. market.’”  The court finds that “[plaintiff] overstates the import of the Wall Street Journal article.”  “Here, even accepting the reporting contained in the Wall Street Journal article as fact, it merely shows that the FDA ‘was preparing’ to issue an MDO, not that the responsible agency official had already made a final decision to do so.”  Moreover, the court finds that “[t]o the extent [plaintiff] intends to argue that the Additional Disciplines TPL Review Memo was not deliberative because it could not have received meaningful review in the short interval between when that memo was finalized and when the MDO was issued, that argument fails as well.”  “Most notably, it does not matter whether the decisionmakers actually took the time to review the recommendations contained in that memo before acting; what matters is that the memo was prepared for the purpose of providing predecisional advice to them, regardless of whether they followed or even considered that advice.”  “[Plaintiff] further argues that the decision to deny its PMTAs based solely on toxicological deficiencies, in fact, came much earlier in the process . . . .”  “The Court is unpersuaded for many of the reasons provided above.”  “Most notably, so long as agency decisionmakers remain ‘free to change their minds,’ and so long as they have yet to issue a decision or to announce a policy, documents prepared to communicate candid advice within the agency are predecisional.”
  
  “[Plaintiff] argues, in the alternative, that the Additional Disciplines TPL Review Memo is not predecisional because it was signed by the Director of OS, ‘an agency official with authority to “approve or deny applications.”’”  “To [plaintiff], that signature demonstrates that the memo ‘reflected the agency’s “settled position” and “final view on an issue.”’”  “‘There would have been no reason for [the Director of OS] to sign or give his final concurrence,’ in [plaintiff’s] view, ‘if the document were only a draft, subject to further deliberation about whether a holistic review of the analysis performed by all the relevant scientific disciplines . . . supported granting or denying [plaintiff]’s applications.’”  “Or, simply put, ‘[a]gency officials do not sign working drafts.’”  “Thus, according to [plaintiff], the signed Additional Disciplines TPL Review Memo was adopted by the agency, regardless of whether the MDO itself ultimately relied on the reasoning it contained.”  “[Plaintiff] is correct that ‘a document can lose its predecisional character – and the protections of privilege – if an agency adopts the document as its own.’”  “But the soundness of [plaintiff’s] argument ends there.”  “As the D.C. Circuit has explained, to ‘adopt a deliberative document, it is not enough for an agency to make vague or equivocal statements implying that a position presented in a deliberative document has merit; instead, the agency must make an “express[ ]” choice to use a deliberative document as a source of agency guidance,’ . . . or whether it otherwise represents ‘the agency’s settled position’ on a matter within the agency’s authority.”  The court finds that “the evidence” does not support this conclusion.  That and defendant’s declarations “affirm that the ‘conclusions in the Additional Disciplines TPL Review Memo “have not been adopted by OCD and do not reflect complete agency considerations or a final agency decision.”’”
  
  “Finally, [plaintiff] argues that the withheld materials are not deliberative in nature because the review memos are ‘scientific reports, not policymaking documents.’”  “It follows, according to [plaintiff], that the reports must be released – or, at the very least, the factual material contained within them must be segregated and released.”  “Given the fact-intensive nature of this inquiry, the Court ordered (as [plaintiff] requested) that the FDA file the contested records ex parte and under seal, so the Court could ensure that the agency properly distinguished purely factual material, which reveals little or nothing about the agency’s deliberative process, from the selection and synthesis of factual material, which reveals internal, agency deliberations.”  “According to the FDA, it performed a ‘line-by-line, exacting re-review of the records that were withheld in full . . . to determine whether any portions of them are reasonably segregable,’ that is, whether the factual matter could be untangled from the analysis.”  “This efforts, according to the FDA, permitted the agency to ‘identify a limited amount of factual information that is not inextricably intertwined with deliberative information,’ ‘such as tables of contents; metadata; digital signatures and other agency identifiers; titles and headings; headers and footers; non-application-specific appendices; summaries of Plaintiff’s submission history; and a limited amount of introductory language, inspection summary information, and information from Plaintiff’s applications.’”  “After conducting an ex parte review of the withheld material, the Court concludes that the FDA’s characterization of the withheld material is largely – although not entirely – correct; the material either constitutes ‘predecisional and deliberative analysis of FDA staff scientists’ or consists of ‘factual information that cannot be segregated and disclosed without effectively revealing the substance of the protected analysis and deliberations.’”  “That said, there appears to be some material in the in camera submission that is purely descriptive in nature and that does not reveal agency deliberations.”  “The majority of the withheld material appears to be well-justified.”  “But to ensure that the FDA has met its ‘burden to disclose all reasonably segregable information’ within the withheld documents, . . . the Court will order the agency to conduct a further review to identify what, if any, material is simply lifted from [plaintiff’s] PMTAs without deliberative selection.”  “As for the remaining material, the Court concludes that the agency properly applied the deliberative process privilege.”  “The withheld portions of the Discipline Review Memos contain analyses in which agency scientists ‘distill[ed] the raw data and information submitted by [plaintiff] in its PMTAs,’ ‘separat[ed] the significant facts from the insignificant facts,’ ‘weigh[ed] the significance of various types of information against each other, and dr[ew] conclusions therefrom.’”  “Analysis of this type necessarily ‘requires [the] “exercise[ ] of discretion and judgment calls,”’ . . . and the Court, accordingly, concludes that many of the withheld portions of the Discipline Review Memos are deliberative in nature.”
   
• Exemption 5, Foreseeable Harm and Other Considerations:  The court relates that, “[h]ere, the FDA points to two types of harms to the deliberative process.”  “According to the agency:  (1) it is ‘reasonably foreseeable that revealing the substance of unfinished staff scientist-level deliberations would cause confusion regarding the basis of FDA’s MDO,’ . . . and (2) ‘it is reasonably foreseeable that the [its] current and future deliberations regarding the same data and information, as analyzed by scientists from various disciplines other than toxicology, would be adversely impacted’ by the release of the withheld documents.”  “The FDA first argues that release of the withheld information would cause foreseeable harm by confusing the public about important questions of public health.”  The court finds that “[t]he Deputy Director . . . does not rely on mere generalities but, instead, ties the release of the specific records at issue to a specific interest protected by Exemption 5.”  “[Defendant’s] detailed explanation satisfies the foreseeable harm requirement.”  “The explanation is neither conclusory nor boilerplate.”  “It is not based on ‘“abstract fears[ ] or fear of embarrassment.”’”  “It carries the required ‘link between the specified harm and specific information contained in the material withheld.’”  “And, most significantly, it satisfies the statutory nexus requirement by connecting the foreseeable harm to the ‘interest protected by [the FOIA] exemption’ at issue.”  “[T]he FDA is an expert, public health agency.”  “Its pronouncement that a product is safe or unsafe has serious consequences.”  “In addition, based on the FDA’s representations and the Court’s review of the withheld records, the Court is persuaded that their release would likely cause public confusion.”  “In the words of CTP’s Deputy Director, release of the deliberative memoranda at issue here ‘would likely give the public the wrong impression that FDA has reached a final decision on the issue[s] contained in them.’”  “After all, as the FDA emphasizes, its review of [plaintiff’s] PMTAs is ongoing in light of the supervisory review that [plaintiff] itself requested.”  “Release of the withheld records would risk misleading the public about the status of the agency’s ongoing review and about the significance of those internal, staff-level recommendations.”  “The Court, accordingly, is satisfied that the FDA has established that release of the withheld memos would cause foreseeable harm.”
  
  “Although that conclusion suffices, the Court is also persuaded that those involved in reviewing PMTAs would be ‘discourage[d] . . . from appropriately refining or revising [the agency’s] analysis based on further discussion and deliberation’ if the prior deliberations, enshrined in the withheld materials, were disclosed.”  “[Plaintiff] for its part, does not dispute that a well-founded assertion by an agency that internal agency deliberations would be chilled by the disclosure is ordinarily sufficient to meet the foreseeable-harm requirement.”  “Instead, it argues that the risk of chilling future deliberations is not present here because the withheld documents are of types that are routinely made available to the public – even if the PMTA is not approved and an MDO is issued.”  The court finds that “[h]ere, . . . the FDA is concerned that releasing the requested materials at this time will adversely affect the deliberations of the supervisors – including the new CTP Director – who are currently reviewing the MDO in light of ‘scientific issues unique to this application that warrant additional review[]’ . . . .”  “The FDA is concerned that publicly disclosing the internal agency materials, which agency officials are relying on now to inform their review of the MDO, will distort and hinder their review forcing the agency ‘to operate in a fishbowl[]’ . . . .”  “The FDA’s concern about this supervisory-review-focused chilling effect is well taken.”  “When the FDA conducts a supervisory review of a prior agency decision and reconsiders the administrative file, . . . disclosure of internal, working recommendations will likely impede robust agency deliberations.”  “Noting that the governing regulation limits a supervisory review to the ‘information in the administrative file,’ . . . and that a ‘interested’ third-party may request such review, . . . [plaintiff] contends that the ‘regulation[ ] contemplate[s] reassessing files that will have already been released’ – otherwise how could a third party effectively request a supervisory review.”  “And it then argues that public release of that file could not seriously undermine the supervisory review process.”  “But the premise of [plaintiff’s] argument – that the regulations necessarily contemplate release of the files, in their entirety, to third parties – is unsound.”  “Not only can a third party request supervisory review without access to the complete administrative file, but that is precisely what [plaintiff] did here, and [plaintiff] is not even a third party.”  “[Plaintiff] requested supervisory review of the MDO decision, without access to the withheld materials, and FDA agreed to conduct such a review.”  “[Plaintiff] offers one final retort:  it asserts that the FDA exaggerates the impact that releasing the withheld materials would have on the ongoing supervisory review.”  “[E]ven assuming [plaintiff’s] characterization of the records is correct – that is, that the administrative records include the ‘scientific discipline reviews and [the] TPL memo supporting’ each of the FDA’s MDOs – [plaintiff’s] argument is unconvincing.”  “The fact that the FDA was able to conduct a supervisory review, even though certain underlying documents were released, does not mean that the review was not considerably harder or that the quality of the decision was not lessened because of the availability of those materials.”  “The inquiry at issue is whether the release of the withheld materials would impair ‘the quality of agency decisions,’ . . . not whether disclosure would render agency decision-making impossible.”  “And, as to that former question, [plaintiff] has provided no basis from which to conclude that the agency’s discussion in its declaration of the challenges of conducting a supervisory review when all the materials that are part of that review are made public is inaccurate.”  “Accordingly, the Court is persuaded that the risk that the ongoing supervisory review process will be chilled by the release of these materials adds substantially to the FDA’s showing of foreseeable harm.”