AMA Systems, LLC v. FDA, No. 23-489, 2024 WL 712465 (D. Md. Feb. 21, 2024) (Boardman, J.)

AMA Systems, LLC v. FDA, No. 23-489, 2024 WL 712465 (D. Md. Feb. 21, 2024) (Boardman, J.)

Re:  Request for records concerning Emergency Use Authorizations (“EUA”) for personal protective equipment (“PPE”)

Disposition:  Denying plaintiff’s request for discovery; granting in part and denying in part plaintiff’s motion for summary judgment

• Litigation Considerations, Discovery:  The court holds that “plaintiffs have not demonstrated that discovery is necessary before the Court rules on the motion for summary judgment.”  “The plaintiffs’ Rule 56(d) affidavit does not establish a need for discovery.”  “The plaintiffs list six discrete facts they seek to discover.”  “None of them falls within the normal purview of FOIA discovery:  ‘whether an agency has [ ] taken adequate steps to uncover responsive documents.’”  “What’s more, the affidavit does not articulate any facts ‘essential to the opposition’ such that summary judgment before discovery is inappropriate.”  “First, the plaintiffs say that they ‘do not know what information is contained within the 43 pages of documents the FDA contends are responsive.’”  “The plaintiffs know that the file contains [a] request for an EUA for PPE, what information that sort of request generally includes, and the fact that the FDA did not authorize the request.”  “Sharing anything more in advance of summary judgment risks revealing the information this dispute concerns.”  “The second, third, and fourth facts the plaintiffs seek concern the FDA’s communication with [the submitter company]:  whether the agency advised the company to mark its documents confidential commercial information and the company did so . . . ; whether [the submitter company] remains in business and objected to the production of the file . . . ; and whether the FDA attempted to contact [the submitter company] and obtain consent to produce the file . . . .”  “The FDA has already informed the plaintiffs that it attempted to obtain [the submitter company’s] consent to disclose the file.”  “In any event, none of these facts is ‘essential’ to the plaintiffs’ opposition to summary judgment.”  “Whether the file falls within the scope of Exemption Four does not depend on whether [the submitter company] marked the files confidential commercial information because an ‘implied assurance of confidentiality fairly can be inferred’ from ‘generic circumstances.’”  “Fifth, the plaintiffs seek to discover whether individuals affiliated with other companies submitted the documents in the file to the FDA on [the submitter company’s] behalf.”  “The FDA already informed the plaintiffs that it did not have records for any EUA requests from the other companies the plaintiffs have named.”  “And whether [the submitter company], or someone on their behalf, made [the submitter company’s] submissions has no bearing on the question at hand:  whether the FDA lawfully declined to disclose the file pursuant to Exemption Four.”  “Sixth and finally, the plaintiffs seek to ‘authenticate the FDA Registration Certificate or the Certificate of FDA Registration’ that [the submitter company] or an affiliate provided the plaintiffs.”  “Whatever the plaintiffs might want this information for, the existence and authenticity of any such certificate is irrelevant to whether the FDA properly withheld the file.”

• Exemption 4:  The court holds that “[t]he vast majority of the information in the [EUA request] file is confidential . . . .”  “First, the record indicates that [the submitter company] actually and customarily treated the information as private.”  “The defendants aver that to their knowledge, [the submitter company] has never made the content of the file public.”  “When the defendants searched the internet for any public acknowledgment by [the submitter company] of its EUA request, they found none.”  “While the plaintiffs ultimately produced correspondence showing that [the submitter company] acknowledged the existence of that request to them, they did not produce any documents showing that [the submitter company] shared any of the content of the request.”  “The result would be no different even if [the submitter company] ‘publicly shared the information at issue when it collaborated with third parties’ like those the plaintiffs name, as long as [the submitter company] did not also share it with the general public.”  “Second, [the submitter company] submitted its request for an EUA to the FDA under an implied assurance of privacy created by FDA practice and regulations.”  “‘FDA does not make public any information about pending or unauthorized EUA requests for PPE.’”  “The agency does not disclose EUA request files ‘unless the sponsor expressly waives the confidentiality’ of the material.”  “Indeed, the FDA does not disclose even the existence of pending EUA requests unless the sponsor has already done so.”  “These practices implicitly assure applicants that the FDA will not disclose their information while their applications are pending.”  “FDA regulations bolster that assurance.”  “21 C.F.R. § 20.61 provides that ‘[d]ata and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.’”  “The FDA interprets 21 C.F.R. § 20.61 to cover the existence and content of a pending EUA request that has not been publicly disclosed by the sponsor.”  “FDA regulations also prohibit the disclosure of comparable material about medical devices submitted through other approval processes.”  “Together, these regulations and FDA practice give rise to an implied assurance of confidentiality.”  “The conclusion is simple.”  “The file consists primarily of information customarily and actually kept private by [the submitter company].”  “[The submitter company] submitted the information under an implied assurance of privacy.”  “As a result, the vast majority of the file is exempt from disclosure under Exemption Four.” 
  
  “The plaintiffs make two counterarguments.”  “First, they contend that because [the submitter company’s] masks were publicly available at the time of their FOIA request, the information in [the submitter company’s] application for an EUA is not confidential.”  “Even assuming that the EUA at issue is in fact an EUA for the masks [the submitter company] already sold in the United States, this argument falls short.”  “The plaintiffs cite no authority for the legal premise of their argument.”  “Nor could they.”  “Courts have consistently rejected the argument that the fact that a device is available to the public means the information contained in the application for regulatory authorization of the device is not confidential.”  “There is good reason for that.”  “‘If market presence alone were all that was required to trigger disclosure under FOIA, manufacturers would be loathe to provide data relevant to consideration of their [authorization] request[s], and the FDA’s ability to carry out its regulatory objectives would be thwarted.’”  “The availability of [the submitter company’s] masks does not take the content of [the submitter company’s] EUA application outside the scope of Exemption Four.”  “Second, the plaintiffs argue that the file does not contain confidential information because the FDA is authorized by statute to publish summaries of EUA applications that have been authorized, terminated, or revoked.”  “However, [the submitter company’s] application has not been authorized, terminated, or revoked, so that provision does not apply.
  
  Finally, the court finds that, “[w]ith the exception addressed in the next section, the disclosure of the file is prohibited by law.”  “The Trade Secrets Act provides that government employees may not disclose ‘information [that] concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association.’”  “The Fourth Circuit has held that ‘the scope of the Trade Secrets Act is co-extensive with that of exemption (4) of the FOIA.’”  “Because Exemption 4 covers the file (with the exception below), the Trade Secrets Act precludes the disclosure of the file.”  “And because the Trade Secrets Act bars federal employees from disclosing the file, the [FOIA Improvement Act] authorizes the defendants to withhold it from the plaintiffs.”
   
• Litigation Considerations, “Reasonably Segregable” Requirements:  The court relates that “defendants maintain that the entire file is exempt from disclosure and that no portion of the file is reasonably segregable from exempt information.”  “However, the only proof they submit in support of their segregability claim is the arguably conclusory statement in [defendant’s] affidavit that ‘there are no reasonably segregable portions of the file.’”  “To determine whether the exempt information is reasonably segregable from any non-exempt information, the Court requested the file and reviewed it in camera.”  “After diligent, line-by-line review, the Court finds that with one exception, any non-exempt information in the file is so ‘inextricably intertwined’ with exempt information that the defendants could not reasonably segregate it.”  “The exception is a single communication from the FDA to [the submitter company].”  “Exemption Four protects information from disclosure only if it was ‘obtained from a person outside the government.’”  “Because that communication was ‘generated within the Government,’ rather than ‘obtained from a person outside the government,’ Exemption Four does not exempt that communication as a whole from disclosure.”  “[D]efendants offer no account of how this communication from agency officials constitutes information ‘obtained from a person outside the government’ – a necessary condition for Exemption Four coverage.”  “To be sure, a document the government produces may nevertheless count as information ‘obtained from a person’ if the document essentially reproduces information that ‘was supplied to the agency by a person or could allow others to extrapolate such information.’”  “But ‘the key distinction . . . is between information that is either repeated verbatim or slightly modified by the agency,’ which constitutes information obtained from outside the government, ‘and information that is substantially reformulated by the agency,’ which does not.”  “Even if this communication from the FDA to [the submitter company] reflects information obtained from outside the government, the document as a whole falls squarely in the latter category.”  “So Exemption Four does not protect this communication from disclosure.”  “This non-exempt communication can reasonably be segregated from the rest of the file.”  “That leaves a final question:  whether any discrete information within this communication is protected by Exemption Four and eligible for redaction.”  “Lacking any guidance from the parties, the Court declines to answer this question in the first instance.”  “By March 8, 2024, the defendants must take one of two actions:  (i) disclose to the plaintiffs the communication in its entirety and advise the Court the communication has been disclosed; or (ii) submit to the Court for in camera review a proposed redacted version of the communication and file on the docket a declaration from an FDA employee explaining why the redacted information is being withheld.”