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Joint Sch. Report -- 1 IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
FORT WORTH DIVISION
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY
and
PATRICK AND STEPHANIE DE GARAY,
Plaintiff s,
v.
U.S. FOOD AND DRUG
ADMINISTRATION ,
Defendant .
Civil Action No. 4:22- cv-915-P
JOINT SCHEDULING REPORT
C ounsel for Plaintiff s Public Health and Medical Professionals for Transparency (“PHMPT”)
and Patrick and Stephanie de Garay (together , the “de Garays”), and Defendant United States Food
and 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 the
subjects set forth in Parts I and II of the Order and respectfully submit the following:
1. Scheduling Conference :
The parties conducted the scheduling c onference on January 23, 2023, pursuant to this
Court ’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 of
Plaintiffs, a ttorney John Sullivan appeared in person and attorneys Aaron Sir i and Elizabeth Brehm
appeared by virtual means. On behalf of the Defendant, AUSA Clay Mahaffey appeared in person
and FDA attorney Danli Song appear ed by virtual means. Although a settlement was not reached, Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 1 of 7 PageID 180
Joint Sch. Report -- 2 the parties made progress toward a potential settlement of the case and agreed to make efforts to
exchange additional information about the nature of the requested documents to further future
discussions about the scope of Plaintiffs ’ Freedom of Information Act (“FOIA”) request s and a n
appropriate pr oduction schedule for non-exempt portions of responsive records.
2. A brief statement of the claims and defenses :
a. Plaintiff s: This case involves Plaintiffs ’ FOIA request s, 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 the Vaccine Events Reporting System [‘VAERS’]”; and (2) “[a]ll data and information
for the 12-15- Year -Old Pfizer Vaccine enumerated in 21 C.F.R § 601.51(e), with
the exception of [public VAERS reports.]”
b. D
efendant : 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 5
U.S.C. § 552(a)(3)(A); (3) Defendant is entitled to invoke all exemptions under the FOIA and any other applicable laws; (4) To the extent Plaintiffs’ complaint seeks documents or information that were not asserted in their original FOIA request s.
such matters are barred as unexhausted; and (5) Plaintiffs are not entitled to
attorneys’ fees or costs . FDA further contends that Plaintiff s’ requests do not meet
the requirements for expedited processing under the FOIA, 5 U.S.C. § 552(a)(6)(E),
and even if Plaintiff s 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). Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 2 of 7 PageID 181
Joint Sch. Report -- 3 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 the
Federal Rules of Civil Procedure . Defendant’s position is that no amendment to the pleadings or
joinder 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 be
premature and the parties instead propose that , should the parties not reach agreement on the
timeframe for future steps, the parties will make eff orts 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 designation
of experts ;
At this time, the parties agree that designations of experts are likely unnecessary in this
FOIA 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 of
experts 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.3d
106, 113 (D.C. Cir. 2020) (“[A]s a general rule, discovery in a FOIA case is ‘rare.’”) (quoting
Baker & Hostetler LLP v. U.S. Dep’t of Commerce , 473 F.3d 312, 318 (D.C. Cir. 2006) ). The Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 3 of 7 PageID 182
Joint Sch. Report -- 4 parties agree that discovery is not necessary at this time based on the information currently
available.
8. A statement on whether an y limitations on discovery need to be i mposed, and if so,
what limitations ;
As explained in P aragraph 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/or discovery of ESI;
The parties do not anticipate any issues regarding disclosure or discovery of electronically
stored information. As explained above in P aragraph 7, the parties agree that discovery is not
necessary at this time .
10. Any proposals regarding handling and protection of privilege d or trial -preparation
material that should be reflected in a Court Order ;
As explained in P aragraph 7, the parties agree that discovery is not necessary at this time .
The parties do anticipate that some records sought by Plaintiff s will contain information exempt
from disclosure under the FOIA, including material that the government is required to protect from
disclosure, such as material exempted by Exemption 4 (confidential comm ercial information/trade
secrets) 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] del etion 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 F OIA
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 ; Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 4 of 7 PageID 183
Joint Sch. Report -- 5 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 or
tables 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, incl uding
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 with
respect to the BLAs for both vaccines. Because the Com plaint requests production in this case to
begin after the completion of production in a similar matter concerning documents related to the
Comirnaty vaccine for individuals above the age of 16 years, s ee Doc. 1 at 29 (citing Pub. Health
& Med. Pros. for T ransparency v. Food & Drug Admin., No. 4:21- CV-1058- P, 2022 WL 90237
(N.D. Tex. Jan. 6, 2022) (“PHMPT 1 ”)), Plaintiff s also asked Defendant to provide an estimated
date of completion and/or a page count of records produced so far in PHMPT 1 . In PHMPT 1 , the
next 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 of
completion for PHMPT 1 in the March 2023 JSR in that case, an initial JSR in this case regarding
the status of negotiations can be file d by April 14, 2023. Plaintiffs’ position is that the parties file
an initial JSR in two weeks to keep the parties on track to reach a resolution and because it
otherwise should not take two months for the FDA to get an approximate count of pages left to produce in PHMPT 1. Additionally, Plaintiff notes that its request in the Complaint was made with
the understanding that production in PHMPT would be completed shortly.
13. A statemen t as to when and how disclosures under Fed. R. Civ. P. 26(a) (1) were made
or will be made; Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 5 of 7 PageID 184
Joint Sch. Report -- 6
As explained above in paragraph 7, the parties agree that discovery is not necessary at this
time. 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 w hether 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; and
Plaintiffs’ 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 in
the past in related matters. Therefore, Plaintiffs respectfully request a conference with the Court.
Defendant is not requesting a conference wi th 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) are
necessary at this time .
Respectfully submitted,
/s/ Aaron Si ri
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 [email protected]
[email protected]
[email protected]
Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 6 of 7 PageID 185
Joint Sch. Report -- 7
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 7 6102
Telephone: (817) 872-9127 Email: [email protected]
Attorneys for Defendant
Walker D. Moller (Texas Bar No. 24092851)
501 Congress Avenue, Suite 150 – #343 Austin, TX 78701 Tel : (512) 265-5622
[email protected]
Attorneys for Plaintiffs
Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 7 of 7 PageID 186