Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 1 of 7 PageID 180

IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF TEXASFORT WORTH DIVISIONPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCY
andCivil Action No. 4:22-cv-915-P

PATRICK AND STEPHANIE DE GARAY,Plaintiffs,v.

U.S. FOOD AND DRUG
ADMINISTRATION,Defendant.
JOINT SCHEDULING REPORTCounsel for Plaintiffs Public Health and Medical Professionals for Transparency (“PHMPT”)
and Patrick and Stephanie de Garay (together, the “de Garays”), and Defendant United States Foodand Drug Administration (“FDA”) submit the following joint report pursuant to this Court’s Order
dated January 13, 2023 (the “Order”). See Doc. 19. The parties have conferred regarding thesubjects set forth in Parts I and II of the Order and respectfully submit the following:
1. Scheduling Conference:
The parties conducted the scheduling conference on January 23, 2023, pursuant to thisCourt’s Order. The conference was held at the office of the United States Attorney for the Northern
District of Texas at 801 Cherry Street, Suite 1700, Fort Worth Texas, 76102. On behalf ofPlaintiffs, attorney John Sullivan appeared in person and attorneys Aaron Siri and Elizabeth Brehm
appeared by virtual means. On behalf of the Defendant, AUSA Clay Mahaffey appeared in personand FDA attorney Danli Song appeared by virtual means. Although a settlement was not reached,
Joint Sch. Report -- 1

Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 2 of 7 PageID 181

the parties made progress toward a potential settlement of the case and agreed to make efforts toexchange additional information about the nature of the requested documents to further futurediscussions about the scope of Plaintiffs’ Freedom of Information Act (“FOIA”) requests and an
appropriate production schedule for non-exempt portions of responsive records.
2. A brief statement of the claims and defenses:
a. Plaintiffs: This case involves Plaintiffs’ FOIA requests, which sought expedited
processing for: (1) “[a]ll data and information for the Moderna Vaccine enumerated
in 21 C.F.R. § 601.51(a), with the exception of publicly available reports on theVaccine Events Reporting System [‘VAERS’]”; and (2) “[a]ll data and informationfor the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R § 601.51(e), withthe exception of [public VAERS reports.]”b. Defendant: FDA raised five defenses in its answer: (1) Some or all of the requested
records or information may be exempt from disclosure, in whole or in part, under
5 U.S.C. § 552(b); (2) Plaintiffs’ FOIA request is improper and unduly burdensome
to the extent it does not reasonably describe the records sought as required by 5U.S.C. § 552(a)(3)(A); (3) Defendant is entitled to invoke all exemptions under theFOIA and any other applicable laws; (4) To the extent Plaintiffs’ complaint seeks
documents or information that were not asserted in their original FOIA requests.
such matters are barred as unexhausted; and (5) Plaintiffs are not entitled to
attorneys’ fees or costs. FDA further contends that Plaintiffs’ requests do not meetthe requirements for expedited processing under the FOIA, 5 U.S.C. § 552(a)(6)(E),and even if Plaintiffs were entitled to expedited processing, the FOIA only requires
an agency to “process as soon as practicable,” 552 U.S.C. § 552(a)(6)(E)(iii).

Joint Sch. Report -- 2

Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 3 of 7 PageID 182

3. A proposed time limit to amend pleadings and to join parties;
Plaintiffs reserve the right to amend the pleadings and join parties as provided in theFederal Rules of Civil Procedure. Defendant’s position is that no amendment to the pleadings orjoinder of parties will be necessary in this FOIA case.
4. A proposed time limit to file various types of motions, including dispositive motions;
There are no pending motions at this time. The parties agree that filing dispositive
motions prior to completion of production of non-exempt, responsive records would bepremature and the parties instead propose that, should the parties not reach agreement on thetimeframe for future steps, the parties will make efforts to reach agreement on an appropriate
briefing schedule and brief their positions on an appropriate production schedule.
5. A proposed time limit for initial designation of experts and responsive designationof experts;
At this time, the parties agree that designations of experts are likely unnecessary in thisFOIA action.
6. A proposed time limit for objections to experts (i.e., Daubert and similar motions);
The parties agree that objections to experts are likely unnecessary as designations ofexperts are likely unnecessary.
7. A proposed plan and schedule for discovery, a statement of the subjects on which
discovery may be needed, a time limit for completing factual and expert discovery,
and a statement of whether discovery should be conducted in phases;“‘Discovery is ‘generally inappropriate’ in FOIA cases.’” Brewer v. DOJ, No. 3:18-CV-1018,
2019 WL 3948351, at *5 n.8 (N.D. Tex. July 30, 2019), report and recommendation adopted, No.
3:18-CV-1018, 2019 WL 3947132 (N.D. Tex. Aug. 21, 2019); see also In re Clinton, 973 F.3d106, 113 (D.C. Cir. 2020) (“[A]s a general rule, discovery in a FOIA case is ‘rare.’”) (quotingBaker & Hostetler LLP v. U.S. Dep’t of Commerce, 473 F.3d 312, 318 (D.C. Cir. 2006)). The

Joint Sch. Report -- 3

Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 4 of 7 PageID 183

parties agree that discovery is not necessary at this time based on the information currently
available.
8. A statement on whether any limitations on discovery need to be imposed, and if so,
what limitations;
As explained in Paragraph 7, the parties agree that discovery is not necessary at this time.
9. A statement on how to disclose and conduct discovery on electronically stored
information (“ESI”) and any statement on disputes regarding disclosure and/ordiscovery of ESI;The parties do not anticipate any issues regarding disclosure or discovery of electronicallystored information. As explained above in Paragraph 7, the parties agree that discovery is notnecessary at this time.
10. Any proposals regarding handling and protection of privileged or trial-preparationmaterial that should be reflected in a Court Order;
As explained in Paragraph 7, the parties agree that discovery is not necessary at this time.
The parties do anticipate that some records sought by Plaintiffs will contain information exempt
from disclosure under the FOIA, including material that the government is required to protect fromdisclosure, such as material exempted by Exemption 4 (confidential commercial information/tradesecrets) or Exemption 6 (privacy). Consistent with the FOIA, the parties agree that, where FDA
contends that an exemption applies, it will produce “[a]ny reasonably segregable portion of [the]record . . . after [redaction or] deletion of the portions which are exempt.” 5 U.S.C. § 552(b).
11. A proposed trial date, the estimated number of days for trial, and whether a jury has
been demanded;
The parties believe the setting of a trial date is not necessary, as “the vast majority of FOIA
cases can be resolved on summary judgment.” Brayton v. Office of the U.S. Trade Representative,641 F.3d 521, 527 (D.C. Cir. 2011).
12. A proposed mediation deadline;

Joint Sch. Report -- 4

Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 5 of 7 PageID 184

The parties believe that they will be able to negotiate regarding the scope of the Plaintiffs’
FOIA requests and a production schedule without the assistance of a mediator or other ADR
provider. During the parties’ meet and confer, Plaintiffs asked Defendant to provide indices ortables of contents of the larger biological product file and the biologic license application (“BLA”)
for Moderna’s Spikevax vaccine and Pfizer’s Comirnaty vaccine for 12-15-year-olds, including
breakdowns of the approximate number of pages for each item in the indices or table of contents,
to the extent possible. Defendant agreed to make efforts to provide information to that end withrespect to the BLAs for both vaccines. Because the Complaint requests production in this case to
begin after the completion of production in a similar matter concerning documents related to theComirnaty vaccine for individuals above the age of 16 years, see Doc. 1 at 29 (citing Pub. Health& Med. Pros. for Transparency v. Food & Drug Admin., No. 4:21-CV-1058-P, 2022 WL 90237(N.D. Tex. Jan. 6, 2022) (“PHMPT 1”)), Plaintiffs also asked Defendant to provide an estimateddate of completion and/or a page count of records produced so far in PHMPT 1. In PHMPT 1, thenext joint status report (“JSR”), in which FDA expects to provide an estimated date by which
production will be completed, is due March 24, 2023.
Defendant’s position is that given that FDA expects to provide an estimated date ofcompletion for PHMPT 1 in the March 2023 JSR in that case, an initial JSR in this case regarding
the status of negotiations can be filed by April 14, 2023. Plaintiffs’ position is that the parties filean initial JSR in two weeks to keep the parties on track to reach a resolution and because itotherwise should not take two months for the FDA to get an approximate count of pages left toproduce in PHMPT 1. Additionally, Plaintiff notes that its request in the Complaint was made withthe understanding that production in PHMPT would be completed shortly.
13. A statement as to when and how disclosures under Fed. R. Civ. P. 26(a)(1) were madeor will be made;Joint Sch. Report -- 5

Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 6 of 7 PageID 185

As explained above in paragraph 7, the parties agree that discovery is not necessary at thistime. The parties agree that disclosures under Fed. R. Civ. P. 26(a)(1) are not required in this
FOIA case.
14. A statement as to whether the parties will consent to trial (jury or non-jury) before
United States Magistrate Judges Cureton or Ray;The parties respectfully do not consent to trial before a magistrate judge. For the reasons
set forth in paragraph 11, they believe a trial date is not needed.
15. Whether a conference with the Court is desired, and if so, a brief explanation why;
andPlaintiffs’ position is that having a conference with the Court on the calendar tends to focus
the parties towards resolving open issues and that conferences with the Court have been useful inthe past in related matters. Therefore, Plaintiffs respectfully request a conference with the Court.
Defendant is not requesting a conference with the Court at this time.
16. Any other proposals on scheduling and discovery that the parties believe will facilitate
expeditious and orderly preparation for trial, and other orders that the Court should
enter under Fed. R. Civ. P. 16(b), 16(c), and 26(c).
At this time, the parties believe no additional orders under Rules 16(b), 16(c), or 26(c) arenecessary at this time.
Respectfully submitted,/s/ Aaron Siri
Aaron Siri (pro hac vice)
Elizabeth A. Brehm (pro hac vice)
Colin Farnsworth (pro hac vice)
745 Fifth Ave, Suite 500
New York, NY 10151
Tel: (212) 532-1091
aaron@sirillp.com
ebrehm@sirillp.com
cfarnsworth@sirillp.com

Joint Sch. Report -- 6

Case 4:22-cv-00915-P Document 20 Filed 01/27/23

Page 7 of 7 PageID 186

Walker D. Moller (Texas Bar No. 24092851)
501 Congress Avenue, Suite 150 – #343
Austin, TX 78701
Tel : (512) 265-5622
wmoller@sirillp.com
Attorneys for Plaintiffs
LEIGHA SIMONTON
UNITED STATES ATTORNEY/s/ Clay R. Mahaffey
CLAY R. MAHAFFEY
Assistant United States Attorney
Wyoming State Bar No. 6-3355
801 Cherry Street, Suite 1700
Fort Worth, Texas 76102
Telephone: (817) 872-9127
Email: clay.mahaffey@usdoj.gov
Attorneys for Defendant

Joint Sch. Report -- 7