Informed Consent Action Network v. NIH, No. 20-01277, 2021 WL 2592609 (D. Ariz. June 24, 2021) (Tuchi, J.)

Informed Consent Action Network v. NIH, No. 20-01277, 2021 WL 2592609 (D. Ariz. June 24, 2021) (Tuchi, J.)

Re:  Requests for records concerning mRNA-1273 vaccine to combat SARS-COV-2 Infection

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

• Procedural Requirements, Searching for Responsive Records:  The court relates that "[plaintiff] contends that NIH improperly narrowed the search by using the term 'Phase I' because the Request asked for all data and information related to the safety and efficacy of the Vaccine rather than just Phase I data and information."  "The Court agrees that [plaintiff] did not limit the Request to Phase I but fails to see how NIH's inclusion of the term improperly limited the search."  "NIH avers, and [plaintiff] does not contest, that at the time of the search, NIH did not possess data on subsequent trial phases."  "Moreover, NIH's search included broader terms such as 'mRNA-1273' that would likely capture responsive documents not in Phase I."  "Therefore, [plaintiff] failed to produce evidence to support its contention that the search term 'Phase I' unduly restricted NIH's search and production of responsive documents."  "Likewise, [plaintiff] argues that NIH erred by neither searching for nor producing documents regarding 'efficacy.'"  "NIH contends that . . . it did not study the efficacy of the Vaccine until Phase III of the clinical trial, which did not start until July 27, 2020 and thus NIH could not search for or produce such documents."  The court relates that "[plaintiff] relies almost exclusively on a May 18, 2020 Moderna press release touting 'Positive Interim Phase I Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.'"  "[Plaintiff] focuses on Moderna's statement that the 'data [from Phase I] substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease' as well as the press release's discussion of seroconversion, binding antibody levels, neutralizing antibody titers, immunogenicity data, and immune responses, as well as 'a viral challenge study in mice' all of which [plaintiff] contends relate to efficacy."  "However, [plaintiff] does not cite any evidence to support the argument that these terms address efficacy."  The court relates that "[plaintiff] additionally contends that efficacy data always includes immunogenicity data and thus the immunogenicity data was responsive to the Request."  "However, [plaintiff] does not provide declarations or articles in support."  "Rather, it provides excerpts from four NIH peer reviewed publications that each use the phrase 'efficacy, including immunogenicity.'"  The court finds that "[t]his evidence is insufficient to overcome NIH's evidence distinguishing efficacy from immunogenicity."
   
• Litigation Considerations:  The court finds that "[plaintiff's] introduction of . . . new arguments is prejudicial to NIH."  "Therefore, the Court declines to consider them and finds that NIH met its obligation to conduct an adequate search for documents responsive to the Request."  The court explains that "[w]hile [plaintiff] argues that it should receive immunogenicity data in its Cross-Motion for Summary Judgment, it does not proffer this argument – that the Request for all information invariably included immunogenicity data – until the Reply."  Additionally, the court relates that "[plaintiff] never argued in its Cross-Motion that it was entitled to all information related to the Vaccine."  "Rather, it tied every argument to its request for safety and efficacy data and information."
   
• Exemption 6:  "[T]he Court will grant [plaintiff's] Cross-Motion for Summary Judgment regarding the redactions pursuant to Exemption 6."  The court relates that "[a]n adverse event is 'any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related.'"  "NIH contends that the patients' Adverse Event data should be redacted because 'it is a patient's medical diagnosis pulled directly from the patient's medical record.'"  "The Court agrees that this information, when connected with an identifiable individual, likely implicates a privacy interest warranting redaction pursuant to Exemption 6."  "However, there is no evidence, nor does NIH contend, that the Adverse Event data can be linked to any of the patients who participated in the Phase I trial."  The court relates that "NIH relies on the HIPAA Privacy Rule, 45 C.F.R. § 164.514, to argue that Adverse Event data implicates a non-trivial privacy interest."  "The Court remains unconvinced."  "For one, the HIPAA Privacy Rule lists 18 categories of information that must be removed in order for a dataset to be sufficiently de-identified but does not expressly list 'Adverse Events' as personally identifying information."  "Instead, NIH cites a TransCelerate Biopharma Inc. report on 'Clinical Data Transparency Initiative De-Identification and Anonymization of Individual Patient Data In Clinical Studies, A Model Approach' that lists 'Adverse Events' as an identifier 'commonly collected' in clinical studies."  "Importantly, however, NIH never contends that including a patient's Adverse Event data will increase the risk of identifying the patient."  "Rather, it cites to the HIPAA Privacy Rule and TransCelerate report to illustrate that the Adverse Event data is information 'concerning [a patient's] personal matters . . . typically treated as private information.'"  "But unless this data is tied to personally identifying information, it does not warrant redaction pursuant to Exemption 6."  "Moreover, the public has an interest in the disclosure of the Adverse Event data."  "Reviewing the data will allow the public to better understand NIH's actions and bases for its decisions."  "NIH further contends that the redacted information is provided elsewhere and thus there is no public interest in its release."  "However, the unredacted data provides substantially less information than the redacted information. NIH acknowledges that redacted Adverse Event data detailing 'throbbing pain inside my head behind my eye,' is simply coded as 'headache.'"  "Where there was a greater individual privacy interest, the unredacted version of the Adverse Event data may have sufficed."  "However, because of the de minimis privacy interest, the public interest in seeing the full data outweighs any individual privacy concerns."
  
  "For the same reasons, NIH cannot articulate a sufficient privacy interest to justify redacting the If Not Related, Alternative Etiology, Comments, or Reasons for Deviation and Deviation Resolution data."  "The data does not contain personally identifying information and the public has an interest in its release."  "Therefore, it does not meet the standard for redaction."
  
  "Unlike the other categories of redacted information, NIH contends that the Age data is personally identifying information."  "However, it fails to support the assertion with evidence."  "The Court is skeptical that age alone could identify an individual without more information."  "Similar to the other Phase I data, the public has an interest in the ages of the patients."  "NIH argues that the privacy interest outweighs the public interest because the Report provides 'specific age data' in other portions of the Report."  "However, the Report lists the unredacted age data in broad numerical ranges such as '18-55,' and '56-70.'"  "These ranges do not provide the same information as the specific ages of the trial participants."  "Because the privacy interest in the Age data is trivial and there is a public interest, the Court finds that the redactions are improper."