Judge Rotenberg Educ. Ctr., Inc. v. FDA, No. 17-2092, 2025 WL 604977 (D.D.C. Feb. 25, 2025) (Howell, J.)

Judge Rotenberg Educ. Ctr., Inc. v. FDA, No. 17-2092, 2025 WL 604977 (D.D.C. Feb. 25, 2025) (Howell, J.)

Re:  Requests for records concerning proposed rule banning Graduated Electronic Decelerator (“GED”) – an “‘electronic stimulation device’”

Disposition:  Granting defendants’ motion for summary judgment; denying plaintiffs’ cross-motion for summary judgment

• Litigation Considerations, Adequacy of Search; Exemption 4; Exemption 6; Litigation Considerations, Evidentiary Showing, “Reasonably Segregable” Showing:  The court holds that “plaintiffs do not challenge defendants’ motion for summary judgment as to whether defendants:  . . . conducted a reasonable search for [Center for Devices and Radiological Health’s (“CDRH”)] records; . . . properly applied FOIA Exemption 4 to CDRH records; (4) properly applied FOIA Exemption 6 to CDRH records; and (5) properly evaluated CDRH records for segregability.”  “Accordingly, defendants are granted summary judgment as to those . . . issues.”
   
• Exemption 5, Foreseeable Harms and Other Considerations:  The court relates that “Plaintiffs argue that Exemption 5 does not ‘apply to records of ultra vires actions.’”  “As a consequence, in their view, the D.C. Circuit’s decision vacating the Final Rule because the ‘FDA[ ] lack[ed] . . . statutory authority’ to ban the use of GED to treat self-injurious or aggressive behavior . . . nullifies defendants’ invocation of Exemption 5 in toto . . . .” “As an initial matter, plaintiffs’ characterization of the FDA’s rulemaking for the Final Rule as consisting of ‘ultra vires acts’ merely because a majority of the D.C. Circuit panel vacated this rule upon finding the FDA lacked statutory authority to ban GEDs for particular uses, is a hyperbolic stretch.”  “Compounding the initial mistake in labeling the entirety of the FDA’s process as ultra vires, plaintiffs’ argument that the D.C. Circuit’s ruling that the FDA lacked the statutory authority to ban GEDs for a particular use voided its ability to invoke Exemption 5 stems from a highly strained reading of a nearly fifty-year-old D.C. Circuit decision in Weismann v. CIA, 565 F.2d 692 (D.C. Cir. 1977).”  “In Weismann, the D.C. Circuit rejected the CIA’s invocation of FOIA’s Exemption 7, 5 U.S.C. § 522(b)(7), which ‘shields from disclosure certain records for law-enforcement purposes,’ . . . to withhold records regarding its investigation into the plaintiff, an American citizen living in the United States, to determine whether he was a safe candidate for recruitment by the agency . . . .” “Pointing to language in the CIA’s organic statute that ‘specifically provided that the “Agency shall have no police, subpoena, law-enforcement powers, or internal-security functions[]”’ . . . the Court found this ‘directive was intended, at the very least, to prohibit the CIA from conducting secret investigations of United States citizens, in this country, who have no connection with the Agency[]’ . . . .”  “As such, the ‘full background check within the United States of a citizen who never had any relationship with the agency’ . . . could not qualify as having ‘law-enforcement purposes[]’ . . . .”  “Consequently, the CIA could not invoke Exemption 7 to withhold the records.”  “Plaintiffs analogize Weissman to apply to the facts of this case, contending that ‘like the agency in Weissman, FDA attempted to regulate an area which Congress had expressly and unambiguously prohibited and that is the traditional province of the states.’”  “Weissman, however, does not sweep so broadly as to swallow Exemption 5’s protections where, as here, an agency conducts a statutorily authorized and complete rulemaking but reaches an erroneous conclusion in a Final Rule based on a colorable interpretation of its organic statute, as confirmed by the divided panel of the D.C. Circuit.”  “Plaintiffs’ position faulters out of the gate because at issue in Weissman was the CIA’s statutory bar to satisfying Exemption 7’s threshold, statutory requirement that records must be compiled for law enforcement purposes . . . and that is fundamentally different from Exemption 5’s statutory protection for records falling within ‘the privileges available to Government agencies in civil litigation[]’ . . . .”
  
  “If the blanket holding regarding Exemption 5 that plaintiffs urge based on Weissman is rejected here, plaintiffs alternatively insist that the D.C. Circuit’s opinion vacating the Final Rule ‘void[ed]’ ‘all “decisions” concerning the rulemaking . . . ab initio,’ rendering all decisions the FDA made in its rulemaking process ‘legal nullit[ies].’”  “This, in plaintiffs’ view, means that an agency cannot invoke Exemption 5’s protection of the deliberative process privilege . . . because the privilege is inapplicable to ‘ultra vires “decisions”’ as no ‘“decisions” . . . existed as a matter of law’ ‘to pinpoint any agency decision or policy to which the document contributed[]’ . . . .”  “Yet, whether a ‘decision’ exists for purposes of application of the deliberative process privilege does not necessarily turn on a reviewing court’s critique of the agency action.”  “Rather, as precedent makes clear, this privilege requires that the documents be ‘“predecisional,”’ meaning that ‘they were generated before the agency’s final decision on the matter,’ and that they ‘are “deliberative,”’ capturing those records that ‘were prepared to help the agency formulate its position.’”  “While the D.C. Circuit concluded that ‘the FDA lacks the statutory authority to ban a medical device for a particular use,’ . . . nothing about that judicial holding undermines the natural conclusion that the Final Rule was, in fact, an agency ‘decision,’ albeit one that turned out to lack statutory authority, . . . or that the agency engaged in a number of other intermediary decisions in the rulemaking process . . . .”
  
  “Doubling down on their crusade against the availability of Exemption 5’s protection for attorney-client privilege, in particular, to withhold records regarding an agency action that the agency has been found to have taken without statutory authority, plaintiffs argue that ‘where an agency employee pursues ultra vires activities, he is not acting as a government agent.’”  “As support for this argument, plaintiffs rely on cases applying the Larson-Dugan exception to sovereign immunity and holding that ‘“suits for specific relief against officers of the sovereign” allegedly acting “beyond statutory authority or unconstitutionally” are not barred by sovereign immunity.’”  “Plaintiffs reason that, like the Larson-Dugan exception, an ‘agency employee is not acting on behalf of the agency client of the agency attorney,’ when a court has determined that an agency lacked authority to issue a final rule, and thus, ‘the [attorney-client] privilege,’ which is held by the agency-client, ‘cannot be invoked’ as a matter of law.”  “By this logic, plaintiffs seek to import the Larson-Dugan exception to sovereign immunity, which, if applied, subjects a government employee to injunctive relief, into a totally different context to create an exception to the attorney-client privilege otherwise held by an agency when agency employees reach a legally erroneous conclusion.”  “This reasoning is fatally flawed.”  “In the former context, the sovereign itself never suffers a loss of immunity because in circumstances where the Larson-Dugan exception is applied due to employees’ ultra vires conduct ‘there is no sovereign immunity to waive – it never attached in the first place.’”  “By contrast, in the latter context, plaintiffs’ position would result in an agency’s loss of the attorney-client privilege that otherwise undoubtedly applies when employees consult with agency counsel about actions to take on behalf of the agency, any time a reviewing court subsequently determines the agency employees and agency counsel made an incorrect call.”  “Nothing in the D.C. Circuit’s opinion vacating the Final Rule suggests that the work FDA employees performed in the rulemaking process was done on any basis but on behalf of the agency.”  “That the specific rule promulgated was subsequently found to be beyond the FDA’s authority does not make the internal deliberations any less subject to the privileges afforded to the agency.”
  
  “Plaintiffs offer various policy rationales to support their position that Exemption 5 is unavailable in this case.”  “Summed up, plaintiffs argue that ‘[t]here is no reason to “protect the process” by which an agency arrives at an ultra vires policy because the agency has no lawful reason to engage in that process or arrive at that policy.’”  “Not so.”  “‘Along the way to formulating a policy that is within its power to implement, an agency might legitimately identify and consider a host of alternatives, some within the agency’s power to effectuate and some without.’”  “For example, an ‘agency might . . . consider the boundaries of its own jurisdiction,’ . . . and ‘the need for staff to speak candidly and confidentially is perhaps most important when the discussion concerns unmapped and unexplored terrain at the border of agency authority.’”  “A backwards-looking test that nullifies Exemption 5’s protection of the deliberative process, which may include conversations with attorneys, would ‘discourage the kind of frank and appropriate policymaking discussions that the privilege[s] [were] meant to protect and promote.’”  “Rather than lend support to plaintiffs’ position, policy considerations thus demonstrate the need for agencies to retain the ability to invoke Exemption 5’s protections even when a reviewing court subsequently concludes an agency rule was not statutorily authorized.”
  
  “Plaintiffs further argue that defendants’ application of Exemption 5 should be nullified because the deliberative process and attorney-client privileges are unavailable ‘to an agency engaging in bad faith acts’ or ‘when regulators engage in misconduct.’”  “Notably, plaintiffs raise no accusation of bad faith at any stage of this case . . . .”  “Instead, as factual support for this argument, plaintiffs spill much ink over ten pages in their brief airing grievances against the FDA and citing instances they describe as misconduct in the rulemaking process.”  “Plaintiffs appear to have imported arguments made in challenging the legality of the Final Rule to support their view here that the FDA engaged in bad faith in its rulemaking.”  “Nothing in the record before this Court, which does not have the benefit of the administrative record in the rulemaking process, provides a basis to find that exceptions to the deliberative process or attorney-client privileges for either government misconduct or crime-fraud, respectively, should be applied here, even if those exceptions were available in evaluating the applicability of Exemption 5.”
   
• Exemption 5, Foreseeable Harms and Other Considerations:  The court relates that “Plaintiffs challenge the adequacy of defendants’ showing of compliance with the FOIA Improvement Act’s foreseeable harm standard with respect to Exemption 5 withholdings based on the deliberative process privilege for both CDRH records and non-CDRH records for which defendants were denied partial grant of summary judgment in JRC I.” “Specifically, plaintiffs contend that no ‘reasonably foreseeable harm’ can result from releasing records regarding ultra vires rulemaking . . . and posit that even if harm could flow from releasing records from ultra vires rulemaking, defendants’ descriptions of the harm are too general and boilerplate to withstand scrutiny.”  “In this case, defendants have withheld as protected by the deliberative process privilege two categories of records:  (1) ‘drafts’ (‘category 1’) and (2) ‘memoranda, email exchanges, and other non-draft records,’ (‘category 2’).”  “With respect to documents that fall within category 1, the FDA argues that release of the information ‘would confuse the public’ because ‘the public would mistake preliminary drafts as final agency policy.’” The court finds that “[w]hile alone, plaintiffs would be correct that this is ‘far too general and boiler plate’ for defendants to satisfy their burden . . . because ‘[r]ead in isolation, [this] description[ ] largely fail[s] to link the asserted harms to the “specific information contained in the material withheld[]” . . . .’”  “When considered in conjunction with the context of FDA rulemaking and the non-CDRH Index and CDRH Index, however, ‘the overall picture is sufficient to illustrate how the agency’s deliberations in particular would be harmed by disclosure.’”  “To begin with, ‘[t]he FDA is an expert, public health agency.’”  “‘Its pronouncement that a product is safe or unsafe has serious consequences.’”  “The same is true for draft documents, letters, memoranda, etc., relaying thoughts, opinions, analyses in the rulemaking process, none of which relay the FDA’s decision regarding the safety or propriety of GEDs, electronic stimulation devices, or banning GED to treat certain behaviors.”  “The detailed descriptions of draft records in the CDRH Index in conjunction with the affidavit, and the stakes involved in the FDA’s official pronouncement of the safety of medical devices, ‘explain[ ] why the information contained in the withheld drafts would confuse the public in such a way to undermine the agency’s internal processes.’”  “As such, defendants have satisfied the foreseeable harm standard for records that fall within category 1.”  “As to documents that fall within category 2, the FDA argues that disclosure ‘would harm FDA’s ability to openly and freely communicate about sensitive and complex regulatory issues that accompany regulation of devices.’” “Further, the FDA argues that ‘it is foreseeable that companies would attempt to leverage perceived disagreements within FDA for private or financial gain, potentially at the expense of the public health,’ . . . and that ‘[d]isclosure of these communications would adversely affect the public’s understanding of key messages regarding FDA’s regulation of [electric stimulation devices][]’ . . . .”  The court finds that “these harms ‘specifically focus[ ] on the information at issue’ regarding the FDA’s regulation of GEDs and then ‘conclude[ ] that disclosure of that information “would” chill future discussions.’”  “[D]efendants have satisfied the foreseeable harm standard for documents in category 2.”