State of Florida v. Food and Drug Administration

UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF FLORIDA

TAMPA DIVISION

STATE OF FLORIDA and FLORIDA

AGENCY FOR HEALTH CARE

ADMINISTRATION,

Plaintiffs,

v. Case No: 8:22-cv-1981-TPB-JSS

FOOD AND DRUG

ADMINISTRATION, DEPARTMENT

OF HEALTH AND HUMAN

SERVICES, ROBERT M. CALIFF and

XAVIER BECERRA,

Defendants.

___________________________________/

ORDER

Plaintiffs move the court for an order directing Defendants to substantively

respond to Plaintiffs’ discovery requests. (Motion, Dkt. 46). The court held a hearing

on the Motion on February 17, 2023. For the reasons stated below, the Motion is

granted in part.

BACKGROUND

Plaintiffs State of Florida and Florida Agency for Health Care Administration

bring this action against Defendants, the U.S. Food & Drug Administration and its

Commissioner and the U.S. Department of Health and Human Services and its

Secretary, alleging that Defendants violated the Administrative Procedures Act by

unreasonably delaying and unlawfully withholding adjudication of Plaintiffs’ Section

804 Importation Program Proposal (SIP Proposal), which seeks to import prescription

drugs from Canada. Plaintiffs allege that the “SIP Proposal has been pending for over

700 days without adjudication, causing considerable damage to Plaintiffs and the

citizens of Florida.” (Dkt. 46 at 4.)

On October 25, 2022, Plaintiffs served their First Set of Interrogatories, First Set

of Requests for Production, and First Set of Requests for Admission, which Plaintiffs

claim are aimed at determining whether Defendants have unreasonably delayed or

withheld adjudication of the SIP Proposal. In response to these requests, Defendants

filed a motion for a protective order, arguing that Plaintiffs’ claim must be resolved

solely on the administrative record. In the order denying the motion for a protective

order, the court specifically noted:

The presumptive limit on the scope of discovery in agency

actions (including agency inaction cases) is the

administrative record. See, e.g., Tribe v. Bureau of Land

Management, 2022 WL 1778525, at *2 (E.D. Cal. June 1,

2022). However, Plaintiffs may be entitled to discovery on

their agency inaction claim depending upon the

circumstances. See id. at *3-5. As such, the Court will not

limit Plaintiffs’ ability to file discovery requests following

the filing of the administrative record, and any issues

concerning those specific requests may be addressed

through appropriate motion practice. The parties are

strongly encouraged to amicably resolve disputes as to the

scope and content of discovery.

(Dkt. 34.)

On December 29, 2022, Defendants filed the 4,616-page administrative record.

(Dkts. 37–42.) On January 6, 2023, Plaintiffs served their Second Set of Interrogatories

and Second Set of Requests for Production. Defendant opposed Plaintiffs requests

contending discovery is inappropriate in this Administrative Procedures Act action,

and alternatively, the information sought was produced as part of the administrative

record, irrelevant, or barred from discovery on the basis of privilege. In response,

Plaintiff filed the instant Motion. (Dkt. 46.)

APPLICABLE STANDARDS

The Administrative Procedures Act (APA) requires federal agencies to address

and conclude matters presented to them “within a reasonable time.” 5 U.S.C. § 555(b).

Under the APA, “[a] person suffering legal wrong because of agency action, or

adversely affected or aggrieved by agency action . . . is entitled to judicial review

thereof.” 5 U.S.C. § 702. Though the APA generally limits causes of action to those

challenging final agency action, “[i]f the agency action is ‘unlawfully withheld or

unreasonably delayed,’ the APA directs a reviewing federal court to compel the agency

to act.” Otto v. Mayorkas, No. 8:22-cv-1172-WFJ-SPF, 2023 WL 2078270, at *3 (M.D.

Fla. Feb. 17, 2023) (citing 5 U.S.C. §§ 702, 706(1)). In short, “under section 706,

federal courts may review two types of claims: those seeking to compel certain required

agency actions not yet taken (§ 706(1)), and those seeking to set aside arbitrary ‘agency

actions’ and determinations (§ 706(2)).” Ass’n of Civilian Technicians, Inc. v. United

States, 601 F. Supp. 2d 146, 159 (D.D.C. 2009), aff’d, 603 F.3d 989 (D.C. Cir. 2010)

(citation omitted). Plaintiffs’ claim is one of agency inaction/unreasonable delay

brought pursuant to 5 U.S.C. § 706(1).

Generally, courts are confined to a review of the administrative record in

determining actions under the APA. 5 U.S.C. § 706; Pres. Endangered Areas of Cobb’s

History, Inc. (PEACH) v. U.S. Army Corps of Engineers, 87 F.3d 1242 (11th Cir. 1996)

(noting that “while certain circumstances may justify going beyond the administrative

record, a court conducting a judicial review is not ‘generally empowered’ to do so”)

(quoting Fla. Power & Light Co. v. Lorion, 470 U.S. 729, 744 (1985)). Nevertheless,

discovery outside the administrative record in APA cases may be allowed in certain

circumstances. For example, courts may turn to extra-record evidence “where

agencies are sued under § 706(1) for a failure to take action.” Democracy Forward Found.

v. Pompeo, 474 F. Supp. 3d 138 (D.D.C. 2020) (citing Esch v. Yeutter, 876 F.2d 976, 991

& n.166 (D.C. Cir. 1989)). In these types of cases, courts have held that judicial review

cannot be “limited to the record as it existed at any single point in time, because there

is no final agency action to demarcate the limits of the record.” Nat’l Law Ctr. on

Homelessness & Poverty v. U.S. Dept. of Veterans Affairs, 842 F. Supp. 2d 127, 130–31

(D.D.C. 2012) (quoting Friends of the Clearwater v. Dombeck, 222 F.3d 552, 560 (9th Cir.

2000)); see also Cherokee Nation v. U.S. Dep’t of the Interior, 531 F. Supp. 3d 87, 97

(D.D.C. 2021) (finding that review under § 706(1) “is not limited to the administrative

record”; Nio v. DHS, 314 F. Supp. 3d 238, 242 (D.D.C. 2018) (noting that a § 706(1)

claim “entitles Plaintiffs to rely upon material that is outside the scope of the

administrative record” and moreover, that the court’s review will require a fact

intensive inquiry that applies the TRAC factors); W. Watersheds Project v. Pool, 942 F.

Supp. 2d 93, 100 (D.D.C. 2013) (“Because this case is about agency inaction . . . rather

than agency action, this case may not be resolved solely based on the administrative

record.”); Sierra Club v. Dep’t of Energy, 26 F. Supp. 2d 1268, 1271 (D. Co. 1998) (“Extra

record evidence may be allowed in cases where an agency is being sued for failure to

act if the record before the court is insufficient for the court to determine whether the

agency unlawfully withheld compliance with a statutory mandate.”).

This court has previously ruled that limited discovery is permissible in this

agency inaction case. See (Dkt. 34.) Accordingly, the issue before the court is whether

Plaintiffs’ discovery requests are appropriate in this case.

DISCUSSION

In their Motion, Plaintiffs contend that the requested discovery is relevant to the

determination of whether Defendants have unreasonably delayed or withheld

adjudication of the SIP Proposal. Plaintiffs seek to compel responses to their discovery

requests because, as they allege, the administrative record “contains no new

materials,” “consists of documents that Plaintiffs already attached to their Amended

Complaint,” and is “inadequate.” (Dkt. 46 at 5.) Specifically, Plaintiffs contend that

the information they seek would allow the court to meaningfully review the factors set

forth in Telecomms. Rsch. & Action Ctr. v. FCC (TRAC), 750 F.2d 70, 80 (D.C. Cir. 1984),

which courts look to when “consider[ing] whether a federal agency has followed a rule

of reason in how it reviews applications, whether human health and welfare are at

issue, the interests prejudiced by delay, and whether impropriety is present.” (Dkt. 46

at 2.)

“The central question in evaluating a claim of unreasonable delay is whether

the agency’s delay is so egregious as to warrant mandamus.” In re Core Commc’ns, Inc.,

531 F.3d 849, 855 (D.C. Cir. 2008) (quotation marks omitted). To determine whether

agency action has been unreasonably delayed, courts have applied the six-factor test

established by TRAC, 750 F.2d 70.1 Under that test, the court must balance the

following:

(1) The time agencies take to make decisions must be

governed by a “rule of reason”; (2) where Congress has

provided a timetable or other indication of the speed with

which it expects the agency to proceed in the enabling

statute, that statutory scheme may supply content for this

rule of reason; (3) delays that might be reasonable in the

sphere of economic regulation are less tolerable when

human health and welfare are at stake; (4) the court should

consider the effect of expediting delayed action on agency

activities of a higher or competing priority; (5) the court

should also take into account the nature and extent of the

interests prejudiced by delay; and (6) the court need not find

“any impropriety lurking behind agency lassitude” in order

to hold that agency action is unreasonably delayed.

750 F.2d at 80 (citations omitted). These factors “are not ‘ironclad,’ but rather are

intended to provide ‘useful guidance in assessing claims of agency delay.’” In re Core

Commc’ns, Inc., 531 F.3d at 855 (quoting TRAC, 750 F.2d at 80).

According to Plaintiffs, the discovery they seek is related to specific TRAC

factors. (Dkt. 46 at 9.) Although Defendants filed the 4,616-page administrative

record, Plaintiffs argue that “discovery is necessary because the [administrative record]

provides no new information relevant to the TRAC factors.” (Id. at 8). Specifically,

1 Although the Eleventh Circuit has not expressly adopted the TRAC factors, several district courts in

this circuit have used these factors to assess claims of agency delay. See Osechas Lopez v. Mayorkas, No.

22-cv-21733-WILLIAMS, 2023 WL 152640, at *5 (S.D. Fla. Jan. 10, 2023) (citing Santiago v.

Mayorkas, 554 F. Supp. 3d 1340, 1353 (N.D. Ga. 2021)); Mondragon Tinoco v. Mayorkas, No. 1:20-cv-

4787-MLB, 2021 WL 3603373, at *9 (N.D. Ga. Aug. 13, 2021).

Plaintiffs argue that “[t]he AR provides nothing that might shed light on why

Defendants sat on Plaintiffs’ SIP Proposal for nearly two years, what Defendants’

expected timeline is for review (either for Florida’s SIP Proposal or for SIP proposals

generally), whether human health and welfare is at stake, or why Defendants sent

Plaintiffs a lengthy Request for Information (RFI) months after litigation began in this

case.” (Id. at 9.)

As the court has previously decided that limited, “targeted discovery” will be

permitted, the court will consider whether the discovery sought should be compelled

under Federal Rule of Civil Procedure 26. See Edakunni v. Mayorkas, No. 2:21-cv-393-

TL, 2022 WL 16949330, at *4 (W.D. Wash. 2022) (limiting discovery in agency

inaction case “to the materials most relevant to determining whether relief should be

granted” and finding a Rule 30(b)(6) deposition request in an agency inaction case to

be overbroad); Cherokee Nation, 531 F. Supp. 3d at 100 (discussing discovery in APA

case and addressing plaintiff’s requests for production by evaluating relevancy and

proportionality of each request); Frito-Lay, Inc. v. U.S. Dep’t of Labor, No. 3:12-cv-1747-

B-BN, 2013 WL 12253035, at *3 (N.D. Tex. 2013) (reviewing a plaintiff’s discovery

requests in an APA inaction case using relevancy principles).

Parties may obtain discovery regarding any non-privileged matter that is

relevant to any party’s claim or defense and proportional to the needs of the case. Fed.

R. Civ. P. 26(b)(1). In determining proportionality, the court considers several factors,

including the importance of the issues at stake in the action, the amount in controversy,

the parties’ relative access to relevant information, the parties’ resources, the

importance of the discovery in resolving the issues, and whether the burden or expense

of the proposed discovery outweighs its likely benefit. Fed. R. Civ. P. 26(b)(1).

Information within this scope of discovery need not be admissible in evidence to be

discoverable. Fed. R. Civ. P. 26(b)(1). Notably, although the scope of discovery is

broad, “the discovery rules do not permit the [parties] to go on a fishing expedition.”

Porter v. Ray, 461 F.3d 1315, 1324 (11th Cir. 2006).

A party, “[o]n notice to other parties and all affected persons,” may move to

compel discovery. Fed. R. Civ. P. 37(a)(1). “The Federal Rules of Civil Procedure

strongly favor full discovery whenever possible,” but the trial court “is given wide

discretion in setting the limits of discovery.” Farnsworth v. Procter & Gamble Co., 758

F.2d 1545, 1547 (11th Cir. 1985); Com. Union Ins. Co. v. Westrope, 730 F.2d 729, 731

(11th Cir. 1984). “The party resisting discovery has the burden to show that the

requested discovery is not relevant and that the production of such discovery would be

unduly burdensome.” Benavides v. Velocity IQ, Inc., No. 8:05-cv-1536-T-30, 2006 WL

680656, at *2 (M.D. Fla. Mar. 15, 2006).

Plaintiffs’ discovery requests largely seek information that is included in the

administrative record provided by Defendants. See (Dkts. 37–42.) According to

Defendants, the discovery requested in Plaintiffs’ interrogatory numbers 3, 7–10, 12,

13, 20, requests for production 3–4 and requests for admissions 1–2, 7–9 are included

in the administrative record. Accordingly, Defendants shall supplement their

discovery responses by identifying the bates numbers corresponding to the discovery

requests within thirty days. See Cates v. Zeltiq Aesthetics, Inc., 6:19-cv-1670-Orl-40LRH,

2020 WL 13413676, at *5 (M.D. Fla. Dec. 4, 2020) (requiring defendant that produced

over 50,000 pages in discovery to identify relevant Bates numbers for various discovery

requests); Ecolab Inc. v. Int’l Chem. Corp., No. 6-18-cv-1910-Orl-41GJK, 2020 WL

109693, at *5 (M.D. Fla. Jan. 8, 2020) (directing the defendant, in the alternative, to

specify the records by Bates number or other mark sufficient to enable the plaintiff to

locate and identify records containing answer to discovery request); Pepperwood of

Naples Condo. Ass’n, Inc. v. Nationwide Mut. Fire Ins. Co., No. 2:10-cv-753-FTM-36, 2011

WL 4382104, at *6 (M.D. Fla. Sept. 20, 2011) (referencing documents produced

without pointing specifically to where in the files the information could be found does

not comply with Rule 33(d) of the Federal Rules of Civil Procedure); see also Haughton

v. Dist. of Columbia, No. 12-cv-1767 (KBJ-AK), 315 F.R.D. 424, 427 (D.D.C. 2014)

(same).

Additionally, Defendants maintain that Plaintiffs’ discovery requests seek

documents barred from disclosure based on privilege. Specifically, Defendants

maintain that interrogatory requests 16–19, 22–23 and requests for production 4 and 7

are predecisional documents that are exempt from disclosure. “[A]n agency’s

documents that are both predecisional and deliberative are exempt from disclosure and

immaterial to judicial review of an agency’s action.” Sierra Club v. U.S. Fish and Wildlife

Service, No. 2:20-cv-13-SPC-NPM, 2021 WL 4478329, at *3 (M.D. Fla. Sept. 30,

2021). “Documents are ‘predecisional’ if they were generated before the agency’s final

decision on the matter, and they are ‘deliberative’ if they were prepared to help the

agency formulate its position.” Sierra Club v. U.S. Fish and Wildlife Serv., 141 S. Ct. 777,

785–86 (2021). This principle exempting disclosure is known as the deliberative-

process privilege. As the Supreme Court has reasoned, “the deliberative process

privilege shields from disclosure ‘documents reflecting advisory opinions,

recommendations and deliberations comprising part of a process by which

governmental decisions and policies are formulated.’” Id. at 785 (quoting N.L.R.B. v.

Sears, Roebuck & Co., 421 U.S. 132, 150 (1975). As such, the privilege protects not only

documents, but also the integrity of the deliberative process itself. See Dudman

Commc’ns Corp. v. Dep’t of the Air Force, 815 F.2d 1565, 1568 (D.C. Cir. 1987); see also

Moye, O’Brien, O'Rourke, Hogan, & Pickert v. Nat’l R.R. Passenger Corp., 376 F.3d 1270,

1278 (11th Cir. 2004) (“the disclosure of deliberative documents would inhibit the

agency’s decision-making process and discourage candid discussion within the agency

and, thereby, undermine the agency’s ability to perform its functions”); Schell v. Health

& Hum. Servs., 843 F.2d 933, 940 (6th Cir. 1988) (“Because [the privilege] is concerned

with protecting the deliberative process itself, courts now focus less on the material

sought and more on the effect of the material’s release.”). Upon consideration and

review, the discovery requested in Plaintiffs’ interrogatory requests 16–19, 22–23 and

requests for production 4 and 7 seek predecisional documents that are exempt from

disclosure. As predecisional documents are privileged and exempt from disclosure,

discovery of the privileged documents is not permitted here.

Plaintiffs further seek documents that Defendants maintain are neither relevant

nor proportional to the needs of the case. Upon consideration and review,

interrogatory request 11, requests for production 6, 8, 9, and request for admissions 10

are not proportional to the needs of the case. See Gonzalez v. GEICO Gen. Ins. Co., No.

8:15-cv-240-T-30TBM, 2016 WL 7734076, at *2 (M.D. Fla. Apr. 15, 2016) (“Although

the federal rules generally allow for liberal discovery in civil matters, such is not

unbounded. The Court must consider proportionality to the needs of the case.”); Mey

v. Interstate Nat’l Dealer Servs., Inc., No. 1:14-cv-01846-ELR, 2015 WL 11257059, at *2

(N.D. Ga. June 23, 2015) (“While the Court is mindful that discovery is intended to

be an open process, so as to better facilitate the free flow of information between

litigants, parties are not permitted to go on ‘fishing expeditions’ which extend beyond

the legitimate scope of discovery.”). For example, interrogatory request 11 and request

for admissions 10 exceed the scope of Plaintiff’s agency inaction claim. See Norton v.

S. Utah Wilderness All., 542 U.S. 55, 64, 67 (2004). Request for production 6 also seeks

information outside the scope of APA review. See Sierra Club v. U.S. Dep’t of Energy,

26 F. Supp. 2d 1268, 1271–72 (D. Colo. 1998) (declining to permit discovery into “the

identities of agency personnel and all related documents involved with the decisions

made”). Requests for production 8 and 9 are overly broad, and Plaintiffs have failed

their initial burden of showing the documents it seeks are relevant and non-speculative.

See Salvato v. Miley, No. 5:12-cv-635-Oc-10PRL, 2013 WL 2712206, at *2 (M.D. Fla.

June 11, 2013) (holding that, without a clearer showing, plaintiff was not allowed

access to private material and was simply requesting permission to conduct a fishing

experiment with the mere hope that private statements and electronic communication

would expose relevant material).

Additionally, Defendants maintain that interrogatory requests 1, 2, 14, 15, 21,

24, requests for production 1, 5, 6, and requests for admissions 3–6 are not relevant to

the determination of whether Defendants unreasonably delayed or withheld

adjudication of the SIP Proposal. Fed. R. Civ. P. 26(b)(1); Washington v. Brown &

Williamson Tobacco Corp., 959 F.2d 1566, 1570 (11th Cir. 1992) (“Discovery should be

tailored to the issues involved in the particular case.”). Upon consideration and

review, the court agrees for similar reasons discussed above. For example,

interrogatory requests 1, 2, 21 and requests for production 1 and 6 seek information

that is not relevant to an agency inaction claim. See Sierra Club, 26 F. Supp. 2d at

1271–72. As for interrogatory request 24, Plaintiffs have failed to demonstrate that the

information they seek in this request is non-speculative and moreover, is more akin to

a fishing expedition with mere hopes of exposing relevant information. See Salvato,

2013 WL 2712206 at *2. Interrogatory requests 14, 15 and request for production 5

seek information relating to matters outside the scope of Plaintiffs’ agency inaction

claim, which the court finds would not be helpful to the court in determining the issue

of unreasonable delay. As for requests for admissions 3–6, the court finds these

requests are irrelevant as they will not lead to more discoverable evidence or narrow

the issues for the court to resolve.

Lastly, Defendants state that interrogatory requests 5, 6 and request for

production 2 seek information that would be in the record if it existed, had been

considered by FDA, and was properly part of the record. Upon consideration and

review, the court find these requests irrelevant to the issue before the court of whether

the delay thus far has been unreasonable.

Accordingly, Plaintiffs’ Motion to Compel (Dkt. 46) is GRANTED in part.

ORDERED in Tampa, Florida, on March 17, 2023.

JUEIE $. SNEED

UNITED STATES MAGISTRATE JUDGE

Copies furnished to:

Counsel of Record

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