Case Detail
| Case Title | New York Times Company et al v. U.S. Food and Drug Administration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| District | Southern District of New York | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| City | Foley Square | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Case Number | 1:2019cv04740 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Filed | 2019-05-22 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Closed | 2021-06-21 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Judge | Judge Valerie E. Caproni | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Plaintiff | New York Times Company | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Plaintiff | Sheila Kaplan | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Case Description | New York Times reporter Sheila Kaplan submitted two FOIA requests to the FDA for records concerning Juul Labs. The agency acknowledged receipt of the requests. The agency told Kaplan that her first request would require pre-disclosure notification to obtain the company's confidentiality claims. In response to Kaplan's second FOIA request, the agency withheld the records under Exemption 7(A) (interference with ongoing investigation or proceeding). Kaplan filed an administrative appeal of the agency's decision. After hearing nothing further from the agency pertaining to either request, Kaplan and the New York Times Company filed suit. Complaint issues: Failure to respond within statutory time limit, Adequacy - Search, Litigation - Attorney's fees | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Defendant | U.S. Food and Drug Administration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Documents | Docket Complaint Opinion/Order [15] Opinion/Order [38] FOIA Project Annotation: A recent decision from the Southern District of New York serves as a reminder of how unsettled some aspects of Exemption 4 (commercial and confidential) remain in the aftermath of the 2019 Supreme Court decision in Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356 (2019), in which the Court abandoned the substantial harm test that first appeared in the D.C. Circuit's 1974 National Parks decision because it was not supported by the plain language of Exemption 4, concluding instead that records were protected under Exemption 4 when they contained commercial information that had been submitted with an expectation of confidentiality. However, since the government had assured confidentiality for the data at issue in Argus Media if the Supreme Court ruled in favor of the trade association, the Court did not go into detail about what needed to be shown to establish confidentiality, indicating instead that it was more than just asserting that information was confidential but less than an explicit assurance of confidentiality from the agency. The case involved two requests from New York Times reporter Sheila Kaplan for records concerning Juul Labs, particularly the use of its products by minors. Kaplan submitted her requests after the FDA sent a letter to Juul requesting records under Section 904(b) of the Food, Drug and Cosmetic Act related to Juul's marketing practices, research on marketing, public health impact, and adverse experiences and complaints, Kaplan submitted a FOIA request to the agency for records obtained from Juul in response to the FDA's request. She submitted a second request for records concerning marketing, advertising, and sales strategy records obtained by the FDA from Juul during its inspection of the company's headquarters in September 2018. The agency told Kaplan that it had sent a pre-disclosure notification letter to Juul pertaining to records responsive to her first request but that because its inspection had not yet been completed, it was withholding records responsive her second request under Exemption 7(A) (interference with ongoing investigation or proceeding). Based on an Index of Document Categories provided by Juul to the FDA in response to its pre-disclosure notification letter, Kaplan told the agency the Times would contest the Exemption 4 claims for a category entitled Consumer Experience. District Court Judge Valerie Caproni found the FDA had "failed to demonstrate the commercial nature of these records. Neither customer nor non-customer complaints are properly classified as commercial information under Exemption 4, at least as described in this case. Juul's internal classification and analysis of these complaints may, however, be appropriately described as commercial and therefore entitled to protection under Exemption 4. Because the FDA has failed to provide sufficient details on the nature of any internal Juul communications or analysis, the Court cannot make a reasoned determination that this information qualifies as commercial. FDA has also failed entirely to address whether Juul's internal analysis can be segregated from the complaints themselves." The FDA argued that the complaints were protected under Public Citizen v. Dept of Health and Human Services, 66 F. Supp. 3d 196 (D.D.C. 2014), in which the court found that disclosure log summaries submitted by pharmaceutical companies in annual reports were commercial. But Caproni observed that "this Court does not read Public Citizen to stand for the extremely broad proposition suggested by the FDA that any interaction between a company and its customers is necessarily commercial information." Instead, she noted that "it is not the bare interaction between a company and its customer that makes the interaction commercial; the interaction is commercial because of what it reveals about the company's internal or income-producing activities." She indicated that "the same cannot be said for one-sided interactions to the company. Such a complaint, without more, does not threaten to reveal anything about a company's internal operations and is meaningfully different than a sales meeting between a salesperson and a customer." She also faulted the FDA's description of records characterized as internal Juul analysis and communications. She indicated that the agency's current Vaughn index was insufficient to carry its burden of proof on the issue of whether these records were commercial. She pointed out that "although these records may contain information appropriately classified as commercial under Exemption 4, because neither FDA's amended Vaughn index nor the [agency's] declaration provides an adequate foundation for Court review, summary judgment for the FDA is inappropriate at this time." Noting that the Supreme Court's decision in Argus Media had left unsettled the required assurances of confidentiality the agency and the business submitter needed to show, Caproni rejected the FDA's claim that Argus Media "instructs courts to focus on how the person who provides the documents to the Government treats them. Here, the FDA argues, Juul is the 'person' that provided the records to FDA, and Juul itself treats these records as confidential. That, FDA argues, ends the inquiry." Instead, Caproni noted that "it strains credulity to believe that Juul treats customer and non-customer complaints and Juul's responses as highly confidential information." She explained that "where third-party disclosure has been deemed consistent with the finding that a company treated the information as confidential, there has been some accompanying indication that the company took steps to ensure that the information remained closely held or guarded, or there was at least an implicit understanding that the information would remain limited to a select audience." She observed that "without any indication from FDA or Juul that complainants submitted their complaints to Juul with an understanding that the complaints were to be kept confidential, the Court finds no reason to stamp them with a label of 'confidential information.'" Caproni, however, agreed the agency had provided an explicit assurance of confidentiality to Juul in its letter requesting records under Section 904(b). The Times argued that the agency's assurances of privacy were nothing more than a recitation of the standard under Exemption 4 and that to satisfy the confidentiality prong of Argus Leader, the government needed to provide "a particularized promise of confidentiality, specific to the documents provided." The Times also contended that under the broad standard enunciated by the FDA, a company could claim confidentiality for any document submitted. Caproni noted that "but Plaintiffs ignore a third option, in which an agency's records collection is accompanied by an express notice of its intention to make public the collected records. In that scenario a company cannot reasonably claim to have received an assurance of privacy, because there would be no expectation that any information submitted, regardless of whether it otherwise meets the hallmarks of confidential commercial information under Exemption 4, would be kept private by the agency."
Issues: Exemption 4 - Confidential business information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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