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.
Pg: 8 of 19
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,
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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
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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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its
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Pg: 18 of 19
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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Pg: 19 of 19
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
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