Seaside Farm, Inc. v. US

Filing

PUBLISHED AUTHORED OPINION filed. Originating case number: 9:11-cv-01199-CWH. [999979604]. [15-2562]

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PUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

No. 15-2562

SEASIDE FARM, INC.,
Plaintiff - Appellant,
v.
UNITED STATES OF AMERICA,
Defendant - Appellee.

Appeal from the United States District Court for the District of
South Carolina, at Beaufort.
C. Weston Houck, Senior District
Judge. (9:11-cv-01199-CWH)

Argued:

October 26, 2016

Decided:

December 2, 2016

Before WILKINSON, NIEMEYER, and SHEDD, Circuit Judges.

Affirmed by published opinion. Judge Wilkinson wrote
opinion, in which Judge Niemeyer and Judge Shedd joined.

the

ARGUED: Daniel A. Speights, SPEIGHTS & RUNYAN, Hampton, South
Carolina, for Appellant. Michael Shih, UNITED STATES DEPARTMENT
OF JUSTICE, Washington, D.C., for Appellee.
ON BRIEF: A. G.
Solomons, III, SPEIGHTS & RUNYAN, Hampton, South Carolina, for
Appellant.
William B. Schultz, General Counsel, Daretia M.
Hawkins, Senior Attorney, UNITED STATES DEPARTMENT OF HEALTH AND
HUMAN SERVICES, Washington, D.C.; Elizabeth H. Dickinson, Chief
Counsel, Michael Shane, Associate Chief Counsel for Enforcement,
UNITED STATES FOOD AND DRUG ADMINISTRATION, Washington, D.C.;
Benjamin C. Mizer, Principal Deputy Assistant Attorney General,
Mark B. Stern, UNITED STATES DEPARTMENT OF JUSTICE, Washington,

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D.C.; William N. Nettles, United States Attorney, Barbara
Bowens, Assistant United States Attorney, OFFICE OF THE UNITED
STATES ATTORNEY, Columbia, South Carolina, for Appellee.

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WILKINSON, Circuit Judge:
This

case

involves

a

Federal

Tort

Claims

Act

(“FTCA”),

28 U.S.C. §§ 1346(b), 2671-2680, suit by a tomato farmer against
the United States. Seaside Farm, Inc., alleges that the Food and
Drug Administration negligently issued a contamination warning
in response to an outbreak of Salmonella Saintpaul that devalued
Seaside’s crop by $15,036,293.95. The district court held that
FDA was exercising a discretionary function in connection with
the contamination warning and dismissed the case under 28 U.S.C.
§ 2680(a). That ruling was essential to protect FDA’s vital role
in

safeguarding

the

public

food

supply,

and

we

affirm

the

judgment.
I.
Salmonella
causes

Saintpaul

moderate-to-severe

is

a

rare

illness

in

strain

of

humans.

bacteria

Symptoms

that

include

fever, diarrhea, nausea, and abdominal pain. Salmonella can also
enter

the

bloodstream

complications,
salmonella

a

and

including
“serious

cause

death.

health

more

FDA

serious

consequently

concern.”

74

Fed.

health

considers

Reg.

33,030,

33,031 (July 9, 2009).
A.
On

May

22,

2008,

the

New

Mexico

Department

of

Health

notified the Centers for Disease Control and Prevention that a
number

of

local

residents

had

been
3

infected

with

Salmonella

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Saintpaul. Similar reports soon arrived at CDC from Texas. After
interviewing

patients,

association”

between

J.A. 713.

This

association”

CDC

the

discovered

infections

observation

between

was

a

and

“strong
eating

supported

salmonella

and

statistical

raw

by

tomatoes.

a

“historical

tomatoes

generally.

J.A. 432. CDC subsequently notified FDA that tomatoes were the
“leading hypothosis” for the source of the outbreak. J.A. 660.
By

June

Salmonella

1,

2008,

Saintpaul

CDC

was

across

investigating

nine

states.

87

incidents

J.A.

147.

of

FDA,

including its various component parts such as the Center for
Food Safety and Applied Nutrition, decided to issue an initial
contamination warning to consumers in New Mexico and Texas. The
contamination warning informed consumers that the outbreak was
likely associated with tomatoes, but acknowledged that the exact
type and the origin of the contaminated tomatoes was unknown.
By June 6, 2008, reports of Salmonella Saintpaul had risen
to 145 incidents and 23 hospitalizations across sixteen states.
J.A.

149.

CDC

notified

FDA

that

the

outbreak

threatened

the

entire country.
On
warning

June

7,

titled,

2008,
“FDA

FDA

Warns

issued

an

Consumers

updated

contamination

Nationwide

Not

to

Eat

Certain Types of Raw Red Tomatoes.” J.A. 149. The contamination
warning

explained

the

nature

of

Salmonella

Saintpaul

and

specified certain types of tomato as the likely vehicles for the
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bacteria. It also provided a list of countries and seven states,
including South Carolina, whose tomatoes remained unassociated
with

the

outbreak.

The

media,

however,

reported

the

contamination warning without mentioning that some tomatoes were
not implicated. FDA officials also stressed the magnitude and
national scope of the outbreak but likewise failed to mention
any “safe” tomatoes.
Over the next month, CDC accumulated enough data to trace
Salmonella Saintpaul to jalapeño and serrano peppers imported
from Mexico. FDA withdrew the contamination warning as a result
and announced that fresh tomatoes were no longer associated with
the outbreak. At that point in time, Salmonella Saintpaul was
linked

to

1,220

infections

across

forty-two

states

and

the

District of Columbia. J.A. 150.
B.
Seaside
while

the

harvested

Salmonella

a

crop

of

Saintpaul

tomatoes

in

contamination

South

Carolina

warning

was

in

effect. On May 18, 2011, Seaside brought suit against the United
States under the FTCA alleging that FDA negligently issued the
contamination warning and impaired the value of Seaside’s crop
by

$15,036,293.95.

barred

by

the

The

FTCA

government
provision

claimed
protecting

that
the

the

suit

was

government’s

exercise of discretionary functions, see 28 U.S.C. § 2680(a),
and moved to dismiss the case. The district court denied the
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motion

as

discovery,

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premature
giving

and

Seaside

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ordered
the

limited

opportunity

to

jurisdictional
establish

some

nondiscretionary duty that FDA may have breached.
A three-year discovery fight ensued. The parties frequently
disagreed over the scope of authorized inquiry, although the
government ultimately produced over 12,000 pages of unredacted
FDA

guidance

reports,

and

manuals,

internal

confidential

deliberations,

emails

relevant

to

daily

situation

the

Salmonella

Saintpaul outbreak. Seaside also had the opportunity to take
multiple

depositions

government

provided

of
an

CDC

or

FDA

additional

employees.

13,000

pages

Finally,
of

the

discovery

material that was generated in a related case.
On December 15, 2015, the district court dismissed the case
for

lack

of

subject

matter

jurisdiction.

The

district

court

reasoned that FDA had broad discretion to warn the public about
a contaminated food supply, and that Seaside failed to allege
any statute, regulation, or policy that required FDA to proceed
in a particular manner. The district court also acknowledged
that

contamination

considerations

of

warnings

protecting

implicate
the

public

competing
from

serious

policy
health

risks and minimizing any adverse economic impact on associated
industries. Seaside appeals.

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II.
The FTCA provides a limited waiver of sovereign immunity
for

civil

actions

§§ 1346(b)(1),

against

2674.

This

the

United

waiver

States.

extends

U.S.C.

certain

to

28

claims

resulting from “the negligent or wrongful act or omission of any
employee of the Government while acting within the scope of his
office

or

function

employment.”

exception,

Id.

however,

§ 1346(b)(1).
preserves

The

discretionary

sovereign

immunity

and

insulates the government from liability for “the exercise or
performance [of] a discretionary function or duty on the part of
a federal agency or an employee of the Government, whether or
not

the

discretion

involved

be

abused.”

Id.

§ 2680(a).

FTCA

plaintiffs have the burden of showing that the discretionary
function

exception

does

not

foreclose

their

claim.

Welch

v.

United States, 409 F.3d 646, 651 (4th Cir. 2005); Williams v.
United States, 50 F.3d 299, 304 (4th Cir. 1995).
The

discretionary

function

exception

represents

“the

boundary between Congress’ willingness to impose tort liability
upon

the

United

governmental

States

activities

and
from

its

desire

exposure

to
to

protect
suit

by

certain
private

individuals.” United States v. S.A. Empresa de Viacao Aerea Rio
Grandense (Varig Airlines), 467 U.S. 797, 808 (1984). It was
meant

to

“protect

the

government

from

liability

that

would

seriously handicap efficient government operations.” Id. at 814
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(quoting United

States

v.

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Muniz,

374

U.S.

150,

163

(1963)).

Congress also wanted to “prevent judicial ‘second-guessing’ of
legislative

and

administrative

decisions

grounded

in

social,

economic, and political policy through the medium of an action
in

tort.”

Id.

Consequently,

federal

courts

lack

jurisdiction

over claims falling within the discretionary function exception.
Holbrook v. United States, 673 F.3d 341, 345 (4th Cir. 2012);
Williams, 50 F.3d at 304-05.
III.
Seaside
that

the

contends

the

discretionary

district

function

court

improperly

exception

barred

concluded

its

claim.

Seaside also argues that it did not receive adequate discovery
before the case was dismissed, and faults the district court for
improperly

limiting

the

scope

of

inquiry

to

jurisdictional

issues. We shall discuss each contention in turn.
A.
Government

conduct

is

protected

by

the

discretionary

function exception if it “involves an element of judgment or
choice,”

and

implicates

“considerations

of

public

policy.”

Berkovitz v. United States, 486 U.S. 531, 536-37 (1988); see
United

States

Airlines, 467

v.
U.S.

Gaubert, 499
at

U.S.

315,

813-14; Dalehite

322-25

v.

(1991); Varig

United

States, 346

U.S. 15, 32-36 (1953). We begin by asking whether any “federal
statute, regulation, or policy specifically prescribes a course
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of action.” Berkovitz, 486 U.S. at 536. If not, we consider
generally

“the

nature

of

the

actions

taken

and . . . whether

they are susceptible to policy analysis.” Gaubert, 499 U.S. at
325.

The

relevant

inquiry

is

whether

the

decision

“in

an

objective, or general sense, . . . is one which we would expect
inherently to be grounded in considerations of policy.” Baum v.
United States, 986 F.2d 716, 721 (4th Cir. 1993). We do not
examine, therefore, “whether policy considerations were actually
contemplated

in

making

[the]

decision.”

Smith

v.

Washington

Metro. Area Transit Authority, 290 F.3d 201, 208 (4th Cir. 2002)
(emphasis

in

original).

In

fact,

if

a

statute

or

regulation

permits discretion, “it must be presumed that [decisions] are
grounded in policy when exercising that discretion.” Holbrook,
673 F.3d at 345 (quoting Gaubert, 499 U.S. at 324).
The Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C.
§ 301 et seq., provides that FDA may “cause to be disseminated
information regarding food . . . in situations involving, in the
opinion

of

the

[Commissioner],

imminent

danger

to

health

or

gross deception of the consumer.” Id. § 375(b) (emphasis added).
A notice in the Federal Register emphasizes that “FDA's implicit
or

explicit

U.S.C.

authority

§ 375(b)]

is

to
not

disseminate
accompanied

information
by

any

under

[21

procedural

requirements.” 50 Fed. Reg. 43,060, 43,063 (Oct 23, 1985). The
FDCA plainly delegates broad discretion, and we presume FDA is
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firmly grounded in considerations of public policy when acting
pursuant to that discretion.
Seaside

argues

in

response

that

various

FDA

guidance

manuals eliminate this discretion and prescribe some mandatory
course of action. Seaside points to provisions that establish
standard operating procedures, contamination warning protocols,
“essential

steps,”

and

major

considerations

for

emergency

response activities.
It would be the rare guidance manual that did not contain
some arguably mandatory language. It is our duty, however, to
construe the nature of the statutory and regulatory regime as a
whole.

Indeed,

“[t]he

price

of

circulating

internal

guidance

should not be an exponential increase in exposure to a tort
suit.” Holbrook, 673 F.3d at 347. It is questionable, moreover,
whether something as informal as a guidance manual can overcome
a statutory consignment of agency discretion. But even if we
were to so assume, it would not aid appellant’s case. For after
reviewing the FDA guidance manuals, we still find the agency
possesses significant discretion.
The FDA Emergency Response Plan, for example, begins with a
qualification

that

“the

nature

and

severity

of

an

emergency . . . will determine . . . the specific actions . . .
for each emergency.” J.A. 923. It continues to explain that “the
exact

activities

performed . . . will
10

vary

by

the

type

and

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severity of the emergency,” J.A. 925, and that any given plan
may

“require[]

significant

adjustments

during

an

incident,”

J.A. 926 (emphasis added). There is even an express disclaimer:
“[T]hese identified steps do not comprise the entire scope of
the FDA emergency response. Emergencies are unpredictable and
dynamic; therefore, the Agency’s strategy, while containing core
activities, must

each situation.” 1 J.A. 925-26.

be unique to

Remaining provisions then speak in broad terms of what FDA “may”
or

“should”

do,

subject

to

the

overarching

nature

of

the

emergency. See Fortney v. United States, 714 F.Supp. 207, 208
(W.D.Va.

1989)

discretion),

(holding

aff’d,

912

that
F.2d

“should”

722

(4th

is
Cir.

indicative
1990).

The

of
FDA

Emergency Response Plan thus envisions a fluid combination of
variable responses and “real-time determination of the necessary
course of action.” J.A. 926.
The
warning

policy
are

also

considerations
evident.

The

inherent
FDCA

1

in

expressly

a

contamination

directs

FDA

to

The core activities that comprise the FDA Emergency
Response Plan, such as “Performing Initial and On-Going
Planning,” are all described at a high level of generality.
J.A. 926. But a general directive that does not “specifically
prescribe[] a course of action” likewise does not operate to
restrict the exercise of agency discretion. Berkovitz, 486 U.S.
at 536. Furthermore, “[t]he existence of some mandatory language
does not eliminate discretion when the broader goals sought to
be achieved necessarily involve an element of discretion.”
Holbrook, 673 F.3d at 348 (quoting Miller v. United States, 163
F.3d 591, 595 (9th Cir. 1998)).
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“protect

the

wholesome,

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public

[and]

health

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by

sanitary.”

ensuring
21

that

U.S.C.

foods

are

§ 393(b)(2)(A);

safe,
see

Gaubert, 499 U.S. at 324 (“It will most often be true that the
general aims and policies of the controlling statute will be
evident from its text.”). As the district court rightly noted,
decisions regarding contamination warnings are “grounded in the
policy of protecting the public from a health risk, and reducing
adverse economic impact.” J.A. 1077. Discretion is necessary to
evaluate

available

information,

assess

the

sufficiency

and

reliability of evidence, resolve conflicting data, determine the
overall nature of a health threat, and ultimately settle on a
course of action. Both the timing and content of a contamination
warning reflect this analysis. See Fisher Bros. Sales, Inc. v.
United States, 46 F.3d 279 (3d Cir. 1995) (en banc). Acting too
soon

or

waiting

too

late

each

entail

profound

potential

consequences.
Seaside insists that there remains a genuine dispute as to
whether the government ultimately executed its decision in a
reasonable

manner.

Seaside

complains

that

the

contamination

warning was overly broad, based on insufficient evidence, and
wholly

inadequate

to

notify

consumers

that

South

Carolina

tomatoes remained safe for consumption. Seaside then emphasizes
that no tomato in the United States ever tested positive for
Salmonella Saintpaul, and that FDA actually neglected to test
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sample

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tomatoes

Finally,

Seaside

before

issuing

asserts

that,

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the

contamination

warning.

considerable

evidence

despite

linking the outbreak to Mexico when the contamination warning
was issued, FDA omitted that information without a defensible
justification.
impermissible

Seaside

suggests

“political”

this

reasons

decision

beyond

the

was

made

scope

of

for
FDA’s

discretion. Reply Br. of Appellant at 20.
Unfortunately,
discretionary

Seaside

function

misunderstands

inquiry.

The

the

nature

of

to

issue

decision

the
a

contamination warning, especially in the middle of an escalating
salmonella

outbreak,

clearly

implicates

the

policy

considerations which FDA was established to weigh. The FDCA even
contemplates

considerations

regarding

our

commercial

relationship with foreign countries. See 21 U.S.C. § 393(b)(3).
Seaside fails to identify any mandatory requirements governing
FDA’s decision, including any directive to test sample tomatoes
before issuing the contamination warning. Not only is the FDA
Emergency

Response

Plan

phrased

in

permissive

terms,

but

it

envisions “[i]nvestigative, laboratory, and technical/scientific
staff”

pursuing

J.A. 929.
gathering

These
field

multiple
would

avenues

encompass,

reports

from

of
inter
state

obtaining
alia,

information.

such

agencies,

things

as

healthcare

providers, and affected patients, to employing FDA’s bank of
pre-existing scientific knowledge about the association between
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certain

foods

pursued

its

and

food-borne

investigation,

Pg: 14 of 19

illnesses.

interpreted

Whether

relevant

the

agency

evidence,

or

balanced policy considerations in what Seaside believes to be an
optimal

manner

does

not

affect

the

discretionary

function

analysis. Seaside essentially invites us to engage in the very
judicial

second

guessing

that

the

discretionary

function

exception forbids.
We

therefore

contamination
choice,”

that

conclude

warning

that

“involves

implicates

the
an

decision

element

“considerations

of

to

of

issue

judgment

public

a
or

policy.”

Berkovitz, 486 U.S. at 536-37. The government rightly observes
that contamination warnings -– in both timing and content -- are
a prototypical discretionary function. 2
B.
Seaside
discovery.

next
District

contends
courts

it

was

exercise

not

allowed

broad

sufficient

discretion

over

discovery issues. Carefirst of Md., Inc. v. Carefirst Pregnancy
Ctrs., Inc., 334 F.3d 390, 402-03 (4th Cir. 2003). A party is
not

entitled

to

discovery

that

would

be

futile

or

otherwise

inadequate to establish a sufficient basis for jurisdiction. See
Rich v. United States, 811 F.3d 140, 146 (4th Cir. 2015).
2

In view of our ruling on the discretionary function
exception, we have no need to address the government’s
contention that the contract rights exception to the FTCA
likewise forecloses Seaside’s claim. See 28 U.S.C. § 2680(h).
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The

Filed: 12/02/2016

district

court

was

Pg: 15 of 19

correct

to

recognize

that

the

discretionary function exception is a jurisdictional threshold
that must be considered before moving to the merits of an FTCA
claim. Williams, 50 F.3d at 308; Smith, 290 F.3d at 211. The
district

court

discovery

to

was

well

within

its

dispositive

this

thus

discretion

issue.

Rich,

811

to

F.3d

limit

at

146.

Indeed, unlike in Rich, policy would be inevitably implicated in
the issuance of the contamination warning and in drafting its
contents.

See

id.

at

147.

Other

circuits

considering

the

discretionary function exception agree –– if they even allow
discovery at all. See, e.g., Gonzalez v. United States, 814 F.3d
1022,

1031-32

available

(9th

agency

Cir.

2016)

guidelines

(refusing

established

discovery

discretion);

because
Baer

v.

United States, 722 F.3d 168, 176-77 (3d Cir. 2013) (refusing
discovery because available agency guidelines did not foreclose
discretion); Davila v. United States, 713 F.3d 248, 263-64 (5th
Cir. 2013) (refusing discovery because the plaintiff failed to
allege

any

government's

“well-pleaded

facts

or

evidence

to

refute

assertion . . . that

no

[nondiscretionary]

the

policy

exists”); Ignatiev v. United States, 238 F.3d 464, 467 (D.C.
Cir. 2001) (remanding for limited jurisdictional discovery); In
re Orthopedic Bone Screw Prod. Liability Litig., 264 F.3d 344,
365

(3d

Cir.

2001),

as

amended

limited jurisdictional discovery).
15

(Oct.

10,

2001)

(upholding

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In any event, Seaside had three years of discovery. The
government produced over 25,000 pages of material relevant to
FDA

practices

and

the

Salmonella

Saintpaul

outbreak.

Seaside

also had the opportunity to take multiple depositions of CDC or
FDA employees. This was more than adequate to determine whether
FDA

had

some

nondiscretionary

duty

or

otherwise

exercised

discretion that was not susceptible to policy analysis. While
Seaside

expresses

additional

frustration

information

at

relevant

to

its

inability

whether

the

to

obtain

contamination

warning was justified, that issue is separate and distinct from
the

question

of

jurisdiction

and

the

discretionary

function

exception.
Relying on Kerns v. United States, 585 F.3d 187 (4th Cir.
2009), Seaside insists that the facts necessary to determine
jurisdiction are “inextricably intertwined” with the merits of
the case and thus additional discovery was still necessary. See
id. at 195. We disagree. Kerns, in fact, acknowledged that the
discretionary function exception is a threshold issue that can
be “wholly unrelated to the basis for liability under the FTCA.”
Id. at 196. So it is here. Whether FDA was negligent is an
entirely

different

discretion
whether

to

draft

question

exercising

and

from

issue

that

a

whether

FDA

contamination

discretion

was

given

the

warning,

and

implicates

policy

considerations. While we do not suggest the agency’s attempt to
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warn the public of a major unfolding health crisis represented
an abuse of the discretion entrusted to it, the discretionary
function

exception

applies

“whether

or

not

the

discretion

involved be abused.” 28 U.S.C. § 2680(a); see Gaubert, 499 U.S.
at 322-25; Holbrook, 673 F.3d at 349-50.
The

value

jurisdictional

of

any

bar,

kind

of

declines

immunity,
as

applied

litigation

here

as

proceeds.

a

See

Mitchell v. Forsyth, 472 U.S. 511, 525-27 (1985) (explaining
that qualified immunity in 42 U.S.C. § 1983 litigation “is in
part

an

entitlement

consequences
matters

as

‘[i]nquiries

of

official

discovery
of

not

this

are
kind

to

be

forced

conduct”
to

be

can

and

“even

avoided

be

to

litigate
such

if

peculiarly

the

pretrial

possible,

as

disruptive

of

effective government’” (quoting Harlow v. Fitzgerald, 457 U.S.
800, 817 (1982)). Exposing FDA to extensive rounds of discovery
on

the

merits

would

undermine

the

discretionary

function

exception and introduce the very litigation pressures Congress
clearly meant to avoid. See Wu Tien Li-Shou v. United States,
777 F.3d 175, 186 (4th Cir. 2015); Holbrook, 673 F.3d at 349-50;
cf. Harlow, 457 U.S. at 818 (“Until this threshold [42 U.S.C.
§ 1983] immunity question is resolved, discovery should not be
allowed.”).

The

district

court

was

thus

well

within

discretion to order discovery in the manner that it did.

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IV.
We refuse to place FDA between a rock and a hard place. On
the one hand, if FDA issued a contamination warning that was
even arguably overbroad, premature, or of anything less than
perfect accuracy, injured companies would plague the agency with
lawsuits. On the other hand, delay in issuing a contamination
warning would lead to massive tort liability with respect to
consumers who suffer serious or even fatal consequences that a
timely

warning

might

have

averted.

All

this

would

loom

if

contamination warnings were not protected by the discretionary
function exception.
Every public health emergency is different. There is no
boilerplate warning that can account for the unknown variables
of

a

pathogenic

outbreak.

There

is

little

room

for

leisured

hindsight when the decision is one that must be made under the
pressure of events and, in many cases, on the basis of imperfect
information. After three years of discovery, Seaside failed to
identify any mandatory duty that FDA may have breached, or any
discretionary decision that was not firmly rooted in the very
policy considerations that FDA was intended to exercise. While
we acknowledge and regret any financial loss Seaside may have
incurred as a result of the Salmonella Saintpaul contamination
warning, allowing Seaside’s claim to proceed would allow the law

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of tort to distort one of the most critical of governmental
functions, that of safeguarding the public health and welfare.
The judgment is accordingly affirmed.
AFFIRMED

19