N.Y. Times Co. v. U.S. Food & Drug Admin., 19-CV-4740 (VEC)

CourtUnited States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
Writing for the CourtVALERIE CAPRONI, United States District Judge
Citation529 F.Supp.3d 260
Parties The NEW YORK TIMES COMPANY and Sheila Kaplan, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, Defendant.
Decision Date29 March 2021
Docket Number19-CV-4740 (VEC)

529 F.Supp.3d 260

The NEW YORK TIMES COMPANY and Sheila Kaplan, Plaintiffs,
v.
U.S. FOOD AND DRUG ADMINISTRATION, Defendant.

19-CV-4740 (VEC)

United States District Court, S.D. New York.

Signed March 29, 2021


529 F.Supp.3d 266

Alexandra Perloff-Giles, Gibson, Dunn & Crutcher LLP, Dana Robinson Green, David Edward McCraw, The New York Times Company, New York, NY, for Plaintiffs.

Charles Salim Jacob, United States Attorney's Office, New York, NY, for Defendant.

OPINION AND ORDER

VALERIE CAPRONI, United States District Judge:

Plaintiffs The New York Times Company and Sheila Kaplan, a reporter for The New York Times , have sued the Food and Drug Administration ("FDA") under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552. Plaintiffs seek disclosure of records JUUL Labs, Inc. ("Juul")1 submitted to FDA in response to a document request and during an on-site inspection of Juul's headquarters. See Compl. ¶¶ 8, 13, Dkt. 1. Animating Plaintiffs’ FOIA request is an attempt to gain additional information about the use of Juul products by minors, a growing concern for both FDA and the public at large. Pursuant to a stipulation between the parties, FDA produced close to 2,000 pages of records and several multimedia records; FDA withheld, however, more than 20,000 pages of records and many more records in their entirety. See Def. Mem. at 5. For all records withheld or redacted, FDA has invoked FOIA's Exemption 4, which covers "trade secrets and commercial or financial information obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4). Plaintiffs and FDA have cross-moved for summary judgment. For the reasons discussed below, both motions for summary judgment are DENIED.

BACKGROUND2

Juul manufactures electronic nicotine delivery system ("ENDS") products that are an alternative to combustible cigarettes. Engelke Decl. ¶ 3. In April 2018, FDA issued a request to Juul under Section 904(b) of the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 387d.

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Id. ¶ 6; see also Apr. 24, 2018 FDA Letter, Dkt. 23-1. Specifically, FDA requested "documents relating to marketing practices and research on marketing, effects of product design, public health impact, and adverse experiences and complaints related to Juul products." Apr. 24, 2018 FDA Letter at 1. FDA noted its request was animated by "growing concern about the popularity of Juul products among youth" and the "great public health concern" amid "[w]idespread reports of youth use of Juul products." Id. at 1–2. Among a wide range of information sought, FDA requested records reflecting "[c]onsumer perception studies/market testing," as well as records related to "[a]dverse experiences and complaints involving youth," such as "consumer complaints related to youth use associated with Juul products." Id. at 3–4. Juul produced to FDA documents responsive to its Section 904(b) request in June 2018. Engelke Decl. ¶ 8. Shortly thereafter, in September 2018, FDA conducted an inspection of Juul's headquarters, which lasted several days and covered multiple topics, including "product design, marketing plans, and studies relating to youth prevention." Id. ¶ 10. During the inspection, Juul provided FDA inspectors with additional records. Id.

On June 25, 2018, Plaintiffs submitted a FOIA request to FDA ("First FOIA Request") seeking "a copy of all materials that are submitted in any form, to the FDA, from Juul or its representatives, lawyers, lobbyists, and other parties, that are responsive to" the April 2018 letter request from FDA to Juul pursuant to Section 904(b). Kotler Decl. ¶ 11; Compl. ¶ 8; see also Dkt. 21-1 (June 25, 2018 FOIA request). On October 18, 2018, Plaintiffs submitted a second FOIA request to FDA ("Second FOIA Request") seeking "the marketing and advertising records, and sales strategy records, that the FDA obtained from Juul during its visit to headquarters the last week of September [2018]." Kotler Decl. ¶ 14; Compl. ¶ 13; see also Dkt. 21-3 (Oct. 18, 2018 FOIA request).

In November 2018, FDA responded to Plaintiffs’ first FOIA request, stating that it had found responsive records but that the records "may contain information that FOIA Exemption 4 prohibits from release as trade secrets and/or confidential commercial information." Compl. ¶ 11; see also Barnes Decl. ¶ 19. Also in November 2018, because FDA's September 2018 inspection of Juul remained open, FDA denied Plaintiffs’ Second FOIA Request, citing FOIA Exemption 7(A), 5 U.S.C. § 552(b)(7)(A), and related regulations. Compl. ¶ 14; Kotler Decl. ¶ 17. Plaintiffs appealed that decision to the U.S. Department of Health and Human Services ("HHS") in January 2019. Compl. ¶ 15.

On May 22, 2019, having failed to receive any records in response to either of its FOIA requests and not having received a decision on its appeal to HHS, Plaintiffs commenced this action pursuant to 5 U.S.C. § 552. See Compl. ¶ 1. After Plaintiffs filed suit, because FDA's inspection of Juul's headquarters had since closed, FDA reprocessed their Second FOIA Request, mooting Plaintiffs’ appeal to HHS. Barnes Decl. ¶ 16; Def. Mem. at 4.

Pursuant to an FDA regulation on public information, 21 C.F.R. § 20.61(e)(1), and Executive Order 12600, FDA sent Juul predisclosure notification letters concerning Plaintiffs’ FOIA requests, instructing Juul to review the responsive records and "provide a detailed justification as to whether any of this information is confidential business information that should be withheld pursuant to FOIA Exemption 4." Barnes Decl. ¶¶ 19, 25; Compl. ¶ 11; Nov. 9, 2018 FDA Letter, Dkt. 22-1; see also July 16, 2019 FDA Letter, Dkt. 22-2 (requesting

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that Juul "provide a detailed justification as to whether any of this information falls within Exemption 4"). Juul responded to FDA's letters designating certain records as exempt from disclosure under Exemption 4. Barnes Decl. ¶¶ 21, 25. FDA agreed with all of Juul's designations of material exempt under Exemption 4. Id. ¶¶ 22, 26. Although FDA produced to Plaintiffs records that Juul had deemed non-exempt, it withheld the vast majority of records that are responsive to Plaintiffs’ FOIA requests. See id. ¶¶ 23, 27.

In December 2019, FDA provided to Plaintiffs a one-page document drafted by Juul titled "Index of Document Categories." Perloff-Giles Decl. ¶ 2. The index represents Juul's attempt to group into nine categories the records it classified as protected under Exemption 4 in response to the First FOIA Request and provides brief descriptions of each category of records. Id. ¶ 2, Ex. A. After reviewing this index, Plaintiffs informed FDA that, because "[s]ome of those categories of documents seem especially likely to contain documents (and/or segregable portions of documents) that are not properly covered by Exemption 4," they would contest FDA's decision to withhold documents in five of the nine categories: (1) Marketing Strategy Documents; (2) Product Testing Documents; (3) Consumer Experience Documents; (4) Youth Prevention Documents; and (5) Regulatory Compliance Documents. Id. ¶ 3. Plaintiffs subsequently informed the Court of their intention not "to contest the adequacy of the search conducted by [FDA] or FDA's withholdings regarding certain categories of documents under Exemption 4." Dkt. 16 at 1. Plaintiffs made clear, however, that they intended to "contest the withholding in full" as to the five categories of documents listed above. Id. at 1–2.

On March 3, 2020, FDA filed its motion for summary judgment. See Notice of Mot., Dkt. 19. FDA submitted a Vaughn index with its motion, which identified each record withheld by "Record Category" and included a column for "Description of Record." See Vaughn Index. The "Record Category" column reflects Juul's categorization of the documents responsive to Plaintiffs’ First FOIA Request and FDA's good-faith efforts to place the records responsive to Plaintiffs’ Second FOIA Request into those same categories.3 Barnes Decl. ¶ 28. FDA independently drafted the brief information in the "Description of Record" column for all records, using its best efforts to describe "the nature of the record after reviewing it on its face." Id. ¶¶ 28–29.

On March 24, 2020, after FDA had filed its motion but before Plaintiffs had filed their cross-motion, the parties jointly informed the Court that they had narrowed the scope of the case even further; after reviewing FDA's Vaughn index, Plaintiffs "agreed to limit the case to certain documents tagged in the Vaughn index as ‘Consumer Experience’ documents responsive to [the First FOIA Request]." Dkt. 24 at 1. Thus, Plaintiffs agreed not to contest FDA's decision to withhold records from the other four categories of documents that they had initially identified and also agreed not to contest FDA's decision to withhold records responsive to Plaintiffs’ Second FOIA Request. On March 31, 2020, Plaintiffs filed their cross-motion for summary judgment. See Notice of Mot., Dkt. 25. In their motion, Plaintiffs identified six sets of documents within the "Consumer Experience" category of which they sought disclosure: (1) a consumer outreach study;

529 F.Supp.3d 269

(2) presentations regarding consumer survey results; (3) presentations...

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2 practice notes
  • Cui v. Fed. Bureau of Investigation, 19-CV-2904 (MKB)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • July 26, 2021
    ..., 181 F.3d 279, 292 (2d Cir. 1999) ; and then quoting Wilner , 592 F.3d at 73 ); see also N.Y. Times Co. v. U.S. Food & Drug Admin. , 529 F. Supp. 3d 260, 280 (S.D.N.Y. Mar. 29, 2021) ("A Vaughn affidavit should include "information that is not only specific enough to obviate the need for a......
  • U.S. Specialty Ins. Co. v. Wesco Ins. Co., 1:19-cv-4260-MKV, 1:19-cv-3295-MKV
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • March 29, 2021
    ...84, 435 N.Y.S.2d 972 (1980) ; General Accident Insurance Group v. Cirucci , 46 N.Y.2d 862, 414 N.Y.S.2d 512, 387 N.E.2d 223 (1979).529 F.Supp.3d 260 Finally, Colony asserts that it has no duty to defend Rockaway and 443 Developer in the Gomez action. Colony's assertion that it has no duty t......
2 cases
  • Cui v. Fed. Bureau of Investigation, 19-CV-2904 (MKB)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • July 26, 2021
    ..., 181 F.3d 279, 292 (2d Cir. 1999) ; and then quoting Wilner , 592 F.3d at 73 ); see also N.Y. Times Co. v. U.S. Food & Drug Admin. , 529 F. Supp. 3d 260, 280 (S.D.N.Y. Mar. 29, 2021) ("A Vaughn affidavit should include "information that is not only specific enough to obviate the need for a......
  • U.S. Specialty Ins. Co. v. Wesco Ins. Co., 1:19-cv-4260-MKV, 1:19-cv-3295-MKV
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • March 29, 2021
    ...84, 435 N.Y.S.2d 972 (1980) ; General Accident Insurance Group v. Cirucci , 46 N.Y.2d 862, 414 N.Y.S.2d 512, 387 N.E.2d 223 (1979).529 F.Supp.3d 260 Finally, Colony asserts that it has no duty to defend Rockaway and 443 Developer in the Gomez action. Colony's assertion that it has no duty t......

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