| Date Filed | Doc # | Docket Text |
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| 2022-09-20 | 1 | COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-9534392) filed by JUUL LABS, INC.. (Attachments: # 1 Civil Cover Sheet, # 2 Summons Food & Drug Administration, # 3 Summons U.S. Attorney General, # 4 Summons U.S. Attorney for DC)(Wilcox, Jason) (Entered: 09/20/2022) |
| 2022-09-20 | 2 | LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by JUUL LABS, INC. (Wilcox, Jason) (Entered: 09/20/2022) |
| 2022-09-20 | | Case Assigned to Judge Randolph D. Moss. (znmg) (Entered: 09/20/2022) |
| 2022-09-20 | 3 | SUMMONS (3) Issued Electronically as to FOOD & DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachment: # 1 Notice and Consent)(znmg) (Entered: 09/20/2022) |
| 2022-09-20 | 4 | STANDING ORDER: The parties are hereby ORDERED to comply with the directives set forth in the attached Standing Order. See document for details. Signed by Judge Randolph D. Moss on 09/20/2022. (lcrdm1) (Entered: 09/20/2022) |
| 2022-10-16 | 5 | NOTICE of Appearance by Antonia Marie Konkoly on behalf of FOOD & DRUG ADMINISTRATION (Konkoly, Antonia) (Entered: 10/16/2022) |
| 2022-10-16 | 6 | Consent MOTION for Extension of Time to File Answer re 1 Complaint, by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Konkoly, Antonia) (Entered: 10/16/2022) |
| 2022-10-17 | | MINUTE ORDER: Upon consideration of Defendant's consent motion for extension of time to file answer, Dkt. 6 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Defendant shall answer or otherwise respond to Plaintiff's complaint on or before November 4, 2022. Signed by Judge Randolph D. Moss on 10/17/2022. (lcrdm1) (Entered: 10/17/2022) |
| 2022-10-17 | 7 | RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 9/21/2022. Answer due for ALL FEDERAL DEFENDANTS by 10/21/2022. (Wilcox, Jason) (Entered: 10/17/2022) |
| 2022-10-17 | 8 | RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 9/26/2022. (Wilcox, Jason) (Entered: 10/17/2022) |
| 2022-11-04 | 9 | ANSWER to Complaint by FOOD & DRUG ADMINISTRATION.(Konkoly, Antonia) (Entered: 11/04/2022) |
| 2022-11-06 | | MINUTE ORDER: It is ORDERED that, on or before December 8, 2022, the parties shall confer and file a joint status report addressing (1) any documents still to be produced pursuant to FOIA; (2) an anticipated schedule for processing and producing any such documents; and (3) any substantive areas of disagreement between the parties. It is further ORDERED that the parties shall appear by video for an Initial Scheduling Conference on December 14, 2022, at 10:30 a.m. Signed by Judge Randolph D. Moss on 11/6/2022. (lcrdm1) (Entered: 11/06/2022) |
| 2022-12-08 | 10 | Joint STATUS REPORT by JUUL LABS, INC.. (Wilcox, Jason) (Entered: 12/08/2022) |
| 2022-12-14 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Video (Zoom) Initial Scheduling Conference held on 12/14/2022. Defendant shall provide Plaintiff with a draft Vaughn Index on or before 12/16/2022; Defendant's pre-motion statement due by 1/6/2023; Plaintiff's response due by 1/13/2023. Pre-motion Conference set for 1/19/2023, at 10:30 AM, by video, Judge Randolph D. Moss. (Court Reporter: Jeff Hook.) (kt) (Entered: 12/14/2022) |
| 2023-01-06 | 11 | NOTICE of the Anticipated Bases for Defendant's Proposed Motion for Summary Judgment by FOOD & DRUG ADMINISTRATION (Konkoly, Antonia) (Entered: 01/06/2023) |
| 2023-01-13 | 12 | TRANSCRIPT OF INITIAL SCHEDULING CONFERENCE before Judge Randolph D. Moss held on December 14, 2022. Page Numbers: 1 - 6. Date of Issuance: January 13, 2023. Court Reporter: Jeff Hook. Contact Information: 202-354-3373. Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the cour t reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 2/3/2023. Redacted Transcript Deadline set for 2/13/2023. Release of Transcript Restriction set for 4/13/2023.(Hook, Jeff) (Entered: 01/13/2023) |
| 2023-01-13 | 13 | NOTICE Notice of Summary Judgment Statement by JUUL LABS, INC. (Wilcox, Jason) (Entered: 01/13/2023) |
| 2023-01-19 | 14 | NOTICE of Appearance by Peter A. Farrell on behalf of JUUL LABS, INC. (Farrell, Peter) (Entered: 01/19/2023) |
| 2023-01-19 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Pre-Motion Conference held on 1/19/2023 via Zoom. Government's Motion due 3/2/23; Plaintiff's Response or Cross Motion due by 4/13/2023; Government's Response to Cross Motion due by 5/11/2023; Plaintiff's Reply to Cross Motion due by 6/8/2023. (Court Reporter Jeff Hook) (zglw) (Entered: 01/19/2023) |
| 2023-01-27 | 15 | TRANSCRIPT OF PRE-MOTION CONFERENCE (ZOOM) before Judge Randolph D. Moss held on January 19, 2023. Page Numbers: 1 - 6. Date of Issuance: January 27, 2023. Court Reporter: Jeff Hook. Telephone number: 202-354-3373. Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court r eporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 2/17/2023. Redacted Transcript Deadline set for 2/27/2023. Release of Transcript Restriction set for 4/27/2023.(Hook, Jeff) (Entered: 01/27/2023) |
| 2023-03-02 | 16 | MOTION for Summary Judgment by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Memorandum in Support, # 2 Declaration of Michele Mital, # 3 Declaration of Jennifer German, # 4 Statement of Facts, # 5 Text of Proposed Order)(Konkoly, Antonia) (Entered: 03/02/2023) |
| 2023-04-12 | 17 | NOTICE of Appearance by Steven Lindsay on behalf of JUUL LABS, INC. (Lindsay, Steven) (Entered: 04/12/2023) |
| 2023-04-12 | 18 | Emergency MOTION for expedited briefing and in camera review by JUUL LABS, INC.. (Attachments: # 1 Memorandum in Support, # 2 Text of Proposed Order)(Wilcox, Jason) (Entered: 04/12/2023) |
| 2023-04-12 | 19 | Cross MOTION for Summary Judgment by JUUL LABS, INC.. (Attachments: # 1 Memorandum in Support, # 2 Declaration, # 3 Exhibit, # 4 Exhibit, # 5 Exhibit, # 6 Exhibit, # 7 Exhibit, # 8 Exhibit, # 9 Exhibit, # 10 Exhibit, # 11 Exhibit, # 12 Exhibit, # 13 Exhibit, # 14 Exhibit, # 15 Exhibit, # 16 Exhibit, # 17 Exhibit, # 18 Exhibit, # 19 Exhibit, # 20 Exhibit, # 21 Exhibit, # 22 Exhibit, # 23 Exhibit, # 24 Exhibit, # 25 Exhibit, # 26 Exhibit, # 27 Exhibit, # 28 Exhibit, # 29 Exhibit, # 30 Exhibit, # 31 Exhibit, # 32 Exhibit, # 33 Exhibit, # 34 Exhibit, # 35 Exhibit, # 36 Exhibit, # 37 Exhibit, # 38 Exhibit, # 39 Exhibit, # 40 Exhibit, # 41 Exhibit, # 42 Exhibit, # 43 Statement of Facts, # 44 Statement of Facts, # 45 Text of Proposed Order)(Wilcox, Jason) (Entered: 04/12/2023) |
| 2023-04-12 | | MINUTE ORDER: Upon consideration of Plaintiff's emergency motion for expedited briefing and in camera review, Dkt. 18 , it is hereby ORDERED that Defendant shall respond to this motion on or before April 17, 2023. It is further ORDERED that the parties shall appear for a status conference on April 19, 2023, at 4:00 p.m., in Courtroom 8. Signed by Judge Randolph D. Moss on 4/12/2023. (lcrdm1) (Entered: 04/12/2023) |
| 2023-04-12 | 20 | Memorandum in opposition to re 16 Motion for Summary Judgment, filed by JUUL LABS, INC.. (See Docket Entry 19 to view document) (zjm) (Entered: 04/13/2023) |
| 2023-04-17 | 21 | RESPONSE re 18 Emergency MOTION for expedited briefing and in camera review filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Exhibit A)(Konkoly, Antonia) (Entered: 04/17/2023) |
| 2023-04-18 | 22 | NOTICE of Appearance by Donald Beaton Verrilli, Jr on behalf of JUUL LABS, INC. (Verrilli, Donald) (Entered: 04/18/2023) |
| 2023-04-18 | 23 | REPLY to opposition to motion re 18 Emergency MOTION for expedited briefing and in camera review filed by JUUL LABS, INC.. (Wilcox, Jason) (Entered: 04/18/2023) |
| 2023-04-19 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 4/19/2023. Minute Order to follow. (Court Reporter Tammi Sefrank.) (zglw) (Entered: 04/19/2023) |
| 2023-04-20 | | MINUTE ORDER: Upon consideration of Plaintiff's emergency motion for expedited briefing and ex parte , in camera review, Dkt. 18 , Defendant's opposition, Dkt. 21 , and Plaintiff's reply, Dkt. 23 , as well as the parties' submissions at oral argument, it is hereby ORDERED that the motion is DENIED. With the parties' input, the Court set a briefing schedule in January of this year. Although Plaintiff contends that it subsequently learned important new information that warrants revisiting that schedule (midway through the briefing process), the Court is unpersuaded. Plaintiff premises its request for expedition, in substantial part, on information that it says first came to its attention when Defendant filed the declaration of Michele Mital, along with its motion for summary judgment, on March 2, 2023. Plaintiff's motion for expedition says: "In its recently filed summary judgment motion, FDA for the first time revealed the CTP Director's extraordinary oversight over JLI's application and that she told the Office of Science what the grounds for its decision should be." Dkt. 18-1 at 15. For support, Plaintiff then cites to paragraphs 16-18 of the Mital Declaration. The most relevant information contained in those paragraphs, however, appeared months earlier, before the Court set the briefing schedule, in Defendant's Notice of the Anticipated Bases for Defendant's Proposed Motion for Summary Judgment. Dkt 11 at 4, 6. Paragraph 18 of the Mital Declaration, for example, says that "while the Additional Disciplines TPL Review Memo reflects that the Director of OS concurred with the TPL's findings and conclusion, it expressly explains that OCD advised OS that OCD would review any conclusions reached by OS for this bundle before those conclusions became a final agency decision, and that OCD has not reviewed the findings and conclusions in this TPL Review (Additional Disciplines)." Dkt. 16-2 at 5 (Mital Decl. para. 18) (cleaned up). That language parallels Defendant's earlier statement: "[W]hile the Additional Disciplines TPL reflects that the Director of OS concurred with the TPL's conclusions, it specifically explains that OCD advised OS that OCD would review any conclusions reached by OS for this bundle before those conclusions became a final agency decision, and that OCD has not reviewed the findings and conclusions in this TPL Review (Additional Disciplines)." Dkt. 11 at 6 (cleaned up). The Court also notes that Plaintiff has failed to identify any heightened need for expedition. To be sure, one of the goals of FOIA is to provide prompt transparency regarding the operation of the government, particularly on matters of substantial public interest, and the Court does not doubt that Plaintiff has a keen interest in obtaining access to the disputed record as soon as possible. But the Minnesota litigation that Plaintiff featured in its motion for emergency relief was recently settled, and Plaintiff has failed to identify any similarly pressing matter. As far as the Court can discern, no deadline is approaching in the administrative proceeding and, in any event, Plaintiff will not be without a remedy if an important portion of the administrative record is omitted. Moreover, notwithstanding FOIA's focus on the public interest - beyond the interest of an individual FOIA litigant - it is noteworthy that Plaintiff is not a party to the California litigation that it now invokes in support of its emergency motion. Nothing distinguishes this case from many other FOIA cases involving records of broad public interest, and, in any event, accelerating the briefing schedule in this case by a week or two will have no meaningful impact on the public interest. The Court, accordingly, DENIES Plaintiff's request to modify the existing briefing schedule. If Plaintiff would like to file its final brief early, it is, of course, welcome to do so. Plaintiff's request that the Court direct Defendant to file a copy of the record at issue with the Court for ex parte , in camera review presents a closer question. Courts have "broad discretion" in deciding whether to order such review. Larson v. Dep't of State , 565 F.3d 857, 870 (D.C Cir. 2009). That said, the D.C. Circuit has also cautioned that "a court should not resort to [ ex parte , in camera review] routinely on the theory that 'it can't hurt.'" Id. (quoting Ray v. Turner , 587 F.2d 1187, 1195 (D.C. Cir. 1978)). The D.C. Circuit has set forth a range of factors for courts to consider when exercising their discretion to order ex parte , in camera review : (a) judicial economy, (b) the conclusory nature (or not) of the agency affidavits, (c) bad faith on the part of the agency, (d) whether the actual content of the document is disputed, (e) whether the agency is the one who proposed in camera inspection, and (f) whether there is a strong public interest in disclosure. See Allen v. CIA , 636 F.2d 1287, 1298-99 (D.C Cir. 1980), overruled on other grounds by Founding Church of Scientology of Washington D.C. v. Smith , 721 F.2d 828 (D.C. Cir. 1983). On the present record, the Court is unpersuaded that ex parte , in camera review is warranted and therefore DENIES Plaintiff's request for the same. It will, however, deny that request without prejudice. If, after briefing is complete, the Court concludes that its resolution of this matter will be aided by ex parte , in camera review of the record at issue, the Court will at that time direct Defendant to file a copy the record under seal and ex parte . Signed by Judge Randolph D. Moss on 4/20/2023. (lcrdm1) (Entered: 04/20/2023) |
| 2023-04-26 | 24 | TRANSCRIPT OF PROCEEDINGS before Judge Randolph D. Moss held on 4/19/23; Page Numbers: 1-45. Date of Issuance:4/26/23. Court Reporter/Transcriber Tamara M. Sefranek, Telephone number 202-354-3246, Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 5/17/2023. Redacted Transcript Deadline set for 5/27/2023. Release of Transcript Restriction set for 7/25/2023.(Sefranek, Tamara) (Entered: 04/26/2023) |
| 2023-05-11 | 25 | Memorandum in opposition to re 19 Motion for Summary Judgment,,, filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Declaration Second Declaration of Jennifer German, # 2 Declaration Second Declaration of Michele Mital, # 3 Statement of Facts Response to Plaintiff's Statement of Facts & Supplemental Statement of Facts)(Konkoly, Antonia) (Entered: 05/11/2023) |
| 2023-05-16 | | NOTICE OF ERROR re 25 Memorandum in Opposition; emailed to antonia.konkoly@usdoj.gov, cc'd 8 associated attorneys -- The PDF file you docketed contained errors: 1. Please note the following deficiency and file/refile document as instructed , 2. Two-part document; second docket entry is required (zjm, ) (Entered: 05/16/2023) |
| 2023-05-16 | 26 | REPLY to opposition to motion re 16 MOTION for Summary Judgment filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Declaration Second Declaration of Jennifer German, # 2 Declaration Second Declaration of Michele Mital, # 3 Statement of Facts Response to Plaintiff's Statement of Facts & Supplemental Statement of Facts)(Konkoly, Antonia) (Entered: 05/16/2023) |
| 2023-05-26 | 27 | REPLY to opposition to motion re 19 Cross MOTION for Summary Judgment filed by JUUL LABS, INC.. (Attachments: # 1 Statement of Facts Response to Defendant's Supplemental Statement of Undisputed Material Fact)(Wilcox, Jason) (Entered: 05/26/2023) |
| 2023-10-16 | 28 | NOTICE OF SUPPLEMENTAL AUTHORITY by JUUL LABS, INC. (Attachments: # 1 Exhibit)(Wilcox, Jason) (Entered: 10/16/2023) |
| 2023-10-26 | 29 | RESPONSE re 28 NOTICE OF SUPPLEMENTAL AUTHORITY filed by FOOD & DRUG ADMINISTRATION. (Konkoly, Antonia) (Entered: 10/26/2023) |
| 2023-11-14 | | MINUTE ORDER: Upon consideration of the parties' cross-motions for summary judgment, Dkt. 16 ; Dkt. 19 , it is hereby ORDERED that the parties shall appear for a motions hearing on December 1, 2023, at 1:30 p.m., in Courtroom 8. Signed by Judge Randolph D. Moss on 11/14/2023. (lcrdm1) (Entered: 11/14/2023) |
| 2023-12-01 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Motion Hearing held on 12/1/2023 re 16 MOTION for Summary Judgment filed by FOOD & DRUG ADMINISTRATION, 19 Cross MOTION for Summary Judgment filed by JUUL LABS, INC. Parties to file supplemental declaration on or before 12/22/2023. (Court Reporter Tammi Sefranek) (zglw) (Entered: 12/01/2023) |
| 2023-12-20 | 30 | Consent MOTION for Extension of Time to Submit the Withheld Records for the Courts In Camera Review and to File Supplemental Declarations by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Konkoly, Antonia) (Entered: 12/20/2023) |
| 2023-12-21 | | MINUTE ORDER: Upon consideration of Defendant's Consent Motion for Extension of Time, Dkt. 30 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that, on or before January 5, 2024, Defendant shall submit for the Court's in camera review the records at issue in this Freedom of Information Act (FOIA) suit and file a supplemental declaration pertaining to the foreseeable harm that would be caused by the release of these records. Signed by Judge Randolph D. Moss on 12/21/23. (lcrdm2) (Entered: 12/21/2023) |
| 2024-01-05 | 31 | NOTICE by FOOD & DRUG ADMINISTRATION (Attachments: # 1 Third Declaration of Jennifer German, # 2 Third Declaration of Michelle Mital)(Konkoly, Antonia) (Entered: 01/05/2024) |
| 2024-01-15 | 32 | RESPONSE re 31 Notice (Other) Response to FDA's Supplemental Submission Regarding Summary Judgment filed by JUUL LABS, INC.. (Wilcox, Jason) (Entered: 01/15/2024) |
| 2024-01-31 | 33 | TRANSCRIPT OF MOTIONS HEARING before Judge Randolph D. Moss held on 12/1/23; Page Numbers: 1-85. Date of Issuance:1/31/24. Court Reporter/Transcriber Tamara Sefranek, Telephone number 202-354-3246, Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 2/21/2024. Redacted Transcript Deadline set for 3/2/2024. Release of Transcript Restriction set for 4/30/2024.(Sefranek, Tamara) (Entered: 01/31/2024) |
| 2024-03-29 | 34 | NOTICE OF SUBSTITUTION OF COUNSEL by Joshua Charles Abbuhl on behalf of FOOD & DRUG ADMINISTRATION Substituting for attorney Antonia Konkoly (Abbuhl, Joshua) (Entered: 03/29/2024) |
| 2024-04-23 | 35 | MEMORANDUM OPINION AND ORDER: For the reasons stated in the accompanying memorandum opinion and order, the Court GRANTS in part and DENIES in part the FDA's motion for summary judgment, Dkt. 16 , and GRANTS in part and DENIES in part Juul's cross-motion for summary judgment, Dkt. 19 . See document for details. In addition, the FDA is directed to conduct a further review of the withheld materials to identify what portions of that material (if any) simply parrot what Juul included in its PMTAs, without additional analysis or deliberative selection, and whether any such material includes trade secret information as to which Juul opposes release. The parties are ORDERED to submit a joint status report on the status of this review on or before May 24, 2024. Signed by Judge Randolph D. Moss on 4/23/2024. (lcrdm1) (Entered: 04/23/2024) |
| 2024-05-24 | 36 | Joint STATUS REPORT by FOOD & DRUG ADMINISTRATION. (Abbuhl, Joshua) (Entered: 05/24/2024) |
| 2024-05-24 | | MINUTE ORDER: Upon consideration of the parties' joint status report, Dkt. 36 , it is hereby ORDERED that the parties submit a further joint status report or stipulation of dismissal on or before June 7, 2024. Signed by Judge Randolph D. Moss on 5/24/2024. (lcrdm1) (Entered: 05/24/2024) |
| 2024-06-07 | 37 | STIPULATION of Dismissal by JUUL LABS, INC.. (Wilcox, Jason) (Entered: 06/07/2024) |
| 2024-06-13 | | MINUTE ORDER: Pursuant to the parties' stipulation of dismissal, Dkt. 37 , it is hereby ORDERED that the case is DISMISSED with prejudice, pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii). Each party is to bear its own costs and attorney's fees. The Clerk of Court is directed to terminate this case. Signed by Judge Randolph D. Moss on 6/13/2024. (lcrdm1) (Entered: 06/13/2024) |
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