Court Opinion

ID: 1034763
Source: CourtListenerOpinion
Date Created: 2013-07-23 15:01:48.484982+00
Date Added: 2024-06-11T15:25:58.508479
License: Public Domain

United States Court of Appeals
         FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 25, 2013                 Decided July 23, 2013

                        No. 12-5176

               DANIEL WAYNE COOK, ET AL.,
                       APPELLEES

                             v.

          FOOD & DRUG ADMINISTRATION, ET AL.,
                     APPELLANTS

                Consolidated with 12-5266

       Appeals from the United States District Court
               for the District of Columbia
                   (No. 1:11-cv-00289)

    Daniel Tenny, Attorney, U.S. Department of Justice,
argued the cause for appellants. With him on the briefs were
Stuart F. Delery, Principal Deputy Assistant Attorney
General, Ronald C. Machen Jr., U.S. Attorney, Scott R.
McIntosh, Attorney, William B. Schultz, Acting General
Counsel, U.S. Health and Human Services, and Eric M.
Blumberg, Deputy Chief Counsel.

    Kent S. Scheidegger was on the brief for amicus curiae
Criminal Justice Legal Foundation in support of appellant.
                              2

    Eric A. Shumsky argued the cause for appellees. With
him on the brief were Coleen Klasmeier and Dale A. Baich,
Assistant Federal Public Defender, Office of the Federal
Public Defender for the District of Arizona.

   Before: ROGERS, Circuit Judge, and GINSBURG and
SENTELLE, Senior Circuit Judges.

    Opinion for the Court filed by Senior Circuit Judge
GINSBURG.

     GINSBURG, Senior Circuit Judge: A group of prisoners
on death row in Arizona, California, and Tennessee sued the
Food and Drug Administration, the Department of Health and
Human Services, and the official in charge of each agency
(collectively, the FDA) for allowing state correctional
departments to import sodium thiopental (thiopental), a
misbranded and unapproved new drug used in lethal injection
protocols, in violation of the Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. § 381(a), and the Administrative
Procedure Act (APA), 5 U.S.C. § 706(2)(A). The district
court entered summary judgment for the plaintiffs,
permanently enjoined the FDA from allowing the importation
of apparently misbranded or unapproved thiopental, and
ordered the FDA to notify state correctional departments that
the use of imported thiopental is unlawful and that existing
stocks must be sent to the FDA. For the reasons that follow,
we affirm the judgment of the district court but vacate the
portion of its remedial order pertaining to thiopental already
in the possession of the states.
                                3
                         I. Background

     The Food, Drug, and Cosmetic Act (FDCA), makes it
unlawful to introduce into interstate commerce a misbranded
drug, 21 U.S.C. § 331(a), or an unapproved new drug, §
355(a).* A drug is misbranded if, among other things, it was
“manufactured, prepared, propagated, compounded, or
processed in an establishment not duly registered” with the
FDA. § 352(o). An unapproved new drug is one that is
neither “generally recognized, among experts ... as safe and
effective” for its labeled use, § 321(p)(1), nor approved by the
FDA as safe and effective for its proposed use, § 355(d).

    The FDCA also regulates the importation of drugs. 21
U.S.C. § 381(a) provides:

    The Secretary of the Treasury shall deliver to the
    Secretary of Health and Human Services [HHS], upon his
    request, samples of ... drugs ... being imported or offered
    for import into the United States .... The Secretary of
    [HHS] shall furnish to the Secretary of the Treasury a list
    of establishments registered [with the FDA] ... and shall
    request that if any drugs ... manufactured, prepared,
    propagated, compounded, or processed in an
    establishment not so registered are imported or offered
    for import into the United States, samples of such drugs
    ... be delivered to the Secretary of [HHS] .... If it appears
    from the examination of such samples or otherwise that
    ... such article is adulterated, misbranded, or [an
    unapproved new drug] ..., then such article shall be
    refused admission.

*
  The FDCA is codified at 21 U.S.C. § 301 et seq. For
convenience, we refer to sections of 21 U.S.C. as though they were
sections of the Act.
                               4

The duties of the Secretary of the Treasury under § 381(a) are
administered by Customs and Border Protection, a unit of the
Department of Homeland Security, see Del Monte Fresh
Produce N.A., Inc. v. United States, 706 F. Supp. 2d 116, 117
n.1 (D.D.C. 2010); those of the Secretary of HHS are
administered by the FDA, see FDA, 2 STAFF MANUAL
GUIDES 1410.10, at 1 (2012), http://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/StaffManualGuides/UCM
273771.pdf. In addition to physically examining samples, as
required by § 381(a), the FDA “receives notification from
[Customs] of all formal and informal entries of articles under
FDA jurisdiction at ports of entry” and “electronically
screen[s]” those entry data “against criteria developed by
FDA.” FDA, REGULATORY PROCEDURES MANUAL 9-2 to 9–3
(2013),    http://www.fda.gov/downloads/ICECI/Compliance
Manuals/RegulatoryProceduresManual/UCM074300.pdf.

     Each of the plaintiffs in this action has been sentenced to
death under the laws of Arizona, California, or Tennessee. At
the time of the complaint those states and many others
executed prisoners by injecting them with a sequence of three
drugs: (1) sodium thiopental, which induces anesthesia; (2)
pancuronium bromide, which causes paralysis; and (3)
potassium chloride, which stops the heart. Baze v. Rees, 553
U.S. 35, 44 (2008) (plurality opinion). The administration of
thiopental is critical because absent “a proper dose ...
render[ing] the prisoner unconscious, there is a substantial,
constitutionally unacceptable risk of suffocation from the
administration of pancuronium bromide and pain from the
injection of potassium chloride.” Id. at 53. Although
thiopental has been used as an anesthetic since the 1930s, it is
presently an unapproved new drug.
                              5
     In 2009 the last domestic manufacturer of thiopental
stopped making it. Several state departments of correction
then began ordering thiopental from Dream Pharma Ltd., a
wholesaler located in the United Kingdom. The thiopental
sold by Dream was prepared and marketed by Archimedes
Pharma UK, Ltd., which obtained unfinished thiopental from
a facility in Austria; neither Dream nor Archimedes was
registered with the FDA. The FDA therefore detained the
first two shipments from Dream because, per § 381(a), the
thiopental appeared to be a misbranded and unapproved new
drug. After state officials explained the purpose of the
imported thiopental, however, the FDA released the
shipments. Several states, including Arizona, California, and
Tennessee, thereafter imported thiopental from Dream
without interference from the FDA.

     In 2011 the FDA issued a policy statement concerning
the importation of thiopental for the execution of state
prisoners. The FDA stated that it “neither approves nor
reviews [thiopental] for use in lethal injections.” Rather, in
“defer[ence] to law enforcement” agencies, henceforth it
would exercise its “enforcement discretion not to review these
shipments and allow processing through [Customs’]
automated system for importation.”

     The plaintiffs then brought this suit alleging the FDA’s
policy statement and its failure to “refuse[] admission,” §
381(a), to certain specific shipments of thiopental coming
from Dream violated the APA. The FDA argued first that its
“decision not to take enforcement action with respect to
thiopental is not subject to judicial review because ‘agency
refusals to institute investigative or enforcement proceedings’
are ‘committed to agency discretion.’” Beaty v. FDA, 853 F.
Supp. 2d 30, 39 (D.D.C. 2012) (quoting Defendants’
Memorandum in Support of Motion to Dismiss and/or for
                                6
Summary Judgment and in Opposition to Plaintiffs’ Motion
for Summary Judgment at 1, 14–15). The district court,
however, reasoned the FDA’s conduct was reviewable
because it “did not involve a decision whether to initiate
enforcement proceedings ... [but rather its] duty to obey the
law and deny admission to a drug according to unambiguous
statutory provisions.” Id. at 40. On the merits of the dispute,
the district court held the FDA acted contrary to law because
§ 381(a) “impose[s] a mandatory obligation on [the FDA] to
refuse to admit the misbranded and unapproved drug,
thiopental, into the United States.” Id. at 39. The district
court also held the FDA had been arbitrary and capricious, in
violation of the APA, because it had “acted inconsistently
with FDA regulations, acted inconsistently with its
longstanding practices, and acted in a manner contrary to the
purpose of the FDCA, thereby threatening the public health.”
Id. at 41. The district court therefore granted summary
judgment for the plaintiffs.

     In a separate order, the district court granted the plaintiffs
declaratory and injunctive relief. It declared the thiopental
that had been imported already was a misbranded and
unapproved new drug that “cannot lawfully be ... imported
into the United States.” The district court permanently
enjoined the FDA from “permitting the entry of, or releasing
any future shipments of, foreign manufactured thiopental that
appears to be misbranded or [an unapproved new drug].”
Finally, the district court ordered the FDA to “immediately
notify any and all state correctional departments which it has
reason to believe are still in possession of any foreign
manufactured thiopental that the use of such drug is
prohibited by law and that, that thiopental must be returned
[sic] immediately to the FDA.”
                              7
                         II. Analysis

     The FDA’s principal contention on appeal is that its
“determination whether to invoke [§ 381(a)] and refuse
admission to any particular drug offered for import is ... not
subject to judicial review.” On the merits, the FDA briefly
argues its actions were neither arbitrary and capricious nor
otherwise contrary to law. Underlying both arguments is the
claim that § 381(a) gives the FDA unreviewable enforcement
discretion and that, pursuant to Chevron U.S.A. Inc. v. Natural
Resources Defense Council, Inc., 467 U.S. 837 (1984), the
court should defer to the FDA’s interpretation of the statute.

     Whether Chevron applies to an agency’s interpretation
that a statute commits a matter to its discretion and thereby
precludes judicial review is not entirely clear. Our recent
opinions on agency claims to unreviewable discretion make
no reference to Chevron. See, e.g., Sierra Club v. Jackson,
648 F.3d 848, 855–57 (D.C. Cir. 2011); Ass’n of Irritated
Residents v. EPA, 494 F.3d 1027, 1031–33 (D.C. Cir. 2007);
Drake v. FAA, 291 F.3d 59, 70–72 (D.C. Cir. 2002); but see
Nat’l Wildlife Fed’n v. EPA, 980 F.2d 765, 770–71 (D.C. Cir.
1992) (citing Chevron but refusing to defer to agency’s
“attempt to carve out ... discretion” because it could not “be
squared with the language of the statute”); see also Cornejo-
Barreto v. Seifert, 218 F.3d 1004, 1014 (9th Cir. 2000) (citing
Chevron but refusing to defer to agency’s claim of statutory
discretion because it was “contrary to Congressional intent”),
overruled by Trinidad y Garcia v. Thomas, 683 F.3d 952
(2012); Dubois v. Thomas, 820 F.2d 943, 951 (8th Cir. 1987)
(deferring to agency’s interpretation “impos[ing] only
discretionary duties” upon the agency). Whether Chevron
applies in this case, however, is of no moment because
Chevron itself instructs that if the agency has “violated
Congress’s precise instructions ... ‘that is the end of the
                              8
matter.’” Village of Barrington, Ill. v. Surface Transp. Bd.,
636 F.3d 650, 660 (D.C. Cir. 2011) (quoting Chevron, 467
U.S. at 842). Here, we proceed “without showing the agency
any special deference,” id., because, as we explain below, §
381(a) unambiguously imposes mandatory duties upon the
FDA.

     In addition to the arguments raised by the FDA, we
consider the argument of the amicus curiae that the case must
be dismissed because the states affected by the litigation were
required parties under Federal Rule of Civil Procedure 19.
Although ordinarily “we would not entertain an amicus’
argument if not presented by a party,” Michel v. Anderson, 14
F.3d 623, 625 (D.C. Cir. 1994) (emphasis deleted), in this
case the argument of the amicus is in aid of our “independent
duty to raise [a Rule 19(a) issue] sua sponte,” Wichita &
Affiliated Tribes v. Hodel, 788 F.2d 765, 772 n.6 (D.C. Cir.
1986); see also Republic of Philippines v. Pimentel, 553 U.S.
851, 861 (2008) (“A court with proper jurisdiction may ...
consider sua sponte the absence of a required person”).
Accordingly, we welcome the presentation of the amicus with
our thanks for its contribution to this case.

A. Justiciability

     Judicial review under the APA is unavailable insofar as
“agency action is committed to agency discretion by law.” 5
U.S.C. § 701(a)(2). This “very narrow exception” to the
general rule applies only “in those rare instances where
‘statutes are drawn in such broad terms that in a given case
there is no law to apply.’” Citizens to Preserve Overton Park,
Inc. v. Volpe, 401 U.S. 402, 410 (1971) (quoting S. REP. NO.
79-752, at 26 (1945)). “In such circumstances, the courts
have no legal norms pursuant to which to evaluate the
challenged action, and thus no concrete limitations to impose
                               9
on the agency’s exercise of discretion.” Drake, 291 F.3d at
70.

    1. The relevance of Heckler v. Chaney

    The leading Supreme Court case applying § 701(a)(2),
Heckler v. Chaney, is factually quite similar to the present
case. 470 U.S. 821 (1985). There, too, a group of death row
inmates claimed the drugs used for lethal injection were
misbranded and unapproved new drugs. They had asked the
FDA

    to affix warnings to the labels of all the drugs stating that
    they were unapproved and unsafe for human execution,
    to send statements to the drug manufacturers and prison
    administrators stating that the drugs should not be so
    used, and to adopt procedures for seizing the drugs from
    state prisons and to recommend the prosecution of all
    those in the chain of distribution.

Id. at 824. When the FDA refused to take the requested
actions the inmates sought judicial review under the APA.
The Supreme Court held “an agency’s decision not to take
enforcement action should be presumed immune from judicial
review under § 701(a)(2).” Id. at 832. Although “the
presumption may be rebutted where the substantive statute
has provided guidelines for the agency to follow in exercising
its enforcement powers,” id. at 832–33, the Court found no
such guidance in the relevant provisions of the FDCA; for
example, “the Act’s general provision for enforcement, [21
U.S.C.] § 372, provides only that ‘[t]he Secretary is
authorized to conduct examinations and investigations,’” id.
                                10
at 835.* Similarly, the Court refused to read the section
“stat[ing] baldly that any person who violates the Act’s
substantive prohibitions ‘shall be imprisoned ... or fined,’” as
requiring “criminal prosecution of every violator of the Act.”
Id. (quoting 21 U.S.C. § 333).

     Here the FDA argues Chaney applies straightforwardly to
§ 381(a), which provides that “[i]f it appears” an article
offered for import violates a substantive prohibition of the
FDCA, then “such article shall be refused admission.”
According to the agency, it has unreviewable discretion under
both the antecedent and the consequent phrases: The
antecedent “if it appears” implies the FDA may choose
whether to “make a formal determination that a statutory
obligation has been violated,” and the consequent “shall be
refused admission” provides a permissive sanction, as did the
criminal provision in Chaney itself.

     The plaintiffs respond that Chaney is inapposite because
the discrete actions here under challenge, viz., adoption of a
“general policy of automatically releasing all thiopental
shipments destined for correctional facilities” and “a series of
FDA determinations that [particular shipments of] foreign
thiopental ‘may proceed’ into domestic commerce,” are
affirmative acts of approval rather than refusals to take
enforcement action. We do not consider this jejune dispute
for, even assuming the presumption against judicial review
announced in Chaney does apply to the FDA’s refusal to
enforce § 381(a), that presumption is rebutted by the specific
“legislative direction in the statutory scheme.” Chaney, 470
U.S. at 833. Contrary to the FDA’s interpretation, § 381(a)

*
  Chaney concerned the FDCA’s enforcement provisions governing
“the use of drugs in interstate commerce,” 470 U.S. at 828, not the
provision governing importation, § 381(a), at issue here.
                               11
sets forth precisely when the agency must determine whether
a drug offered for import appears to violate the FDCA, and
what the agency must do with such a drug.

    2. Textual analysis

     Section 381(a) provides the FDA “shall furnish” to
Customs a list of registered establishments and “shall request”
from Customs samples of drugs offered for import that are
“manufactured, [etc.,] in an establishment not so registered.”
Customs, in turn, “shall deliver” to the FDA the requested
samples. Id. “If it appears from the examination of such
samples or otherwise” that a drug violates a substantive
prohibition of the FDCA, then the drug “shall be refused
admission.” Id. The plaintiffs argue each of these directives
is unambiguously binding: The FDA must request samples of
all drugs offered for import that have been made in an
unregistered establishment, must examine those samples for a
violation of the FDCA, and must refuse admission to any drug
that appears, through the sampling process or otherwise, to
violate the FDCA. We agree.

     The plaintiffs begin by arguing simply that “the ordinary
meaning of ‘shall’ is ‘must.’” The case law provides ample
support. See, e.g., Lexecon Inc. v. Milberg Weiss Bershad
Hynes & Lerach, 523 U.S. 26, 35 (1998) (“[T]he mandatory
‘shall’ ... normally creates an obligation impervious to judicial
discretion”); Ass’n of Civilian Technicians, Montana Air
Chapter No. 29 v. Fed. Labor Relations Auth., 22 F.3d 1150,
1153 (D.C. Cir. 1994) (“The word ‘shall’ generally indicates a
command that admits of no discretion on the part of the
person instructed to carry out the directive”). Citing Chaney,
the FDA objects that “in the enforcement context ... [the word
‘shall’] may not be properly read to curtail the agency’s
discretion.” In Chaney, however, the word “shall” appeared
                               12
in the consequent of a section providing for criminal
sanctions: A violator “shall be imprisoned ... or fined.” 470
U.S. at 835 (quoting 21 U.S.C. § 333). The criminal statute in
Chaney did not use “shall” in connection with the antecedent
condition of prosecution; in fact, the Court emphasized that
“[t]he Act’s general provision for enforcement, [21 U.S.C.] §
372, provides only that ‘[t]he Secretary is authorized to
conduct examinations and investigations;’” thus, “the Act
charges the Secretary only with recommending prosecution;
any criminal prosecutions must be instituted by the Attorney
General.”      Id.    The “enforcement” discretion held
unreviewable in Chaney, therefore, was whether to
recommend prosecution. Cf. Her Majesty the Queen in Right
of Ontario v. EPA, 912 F.2d 1525, 1533 (D.C. Cir. 1990)
(analyzing statute with a similar dichotomy between a
discretionary antecedent and a mandatory consequent). Here,
by contrast, the word “shall” appears in both an antecedent
(“shall request ... samples”) and the consequent (“shall be
refused admission”).

     The plaintiffs further argue, and again we agree, that
reading “shall be refused admission” as mandatory gives
meaning to the exception to that command, “except as
provided in subsection (b).” That subsection provides “[i]f it
appears to the [FDA] that ... an article ... can, by relabeling or
other action, be brought into compliance,” then “final
determination as to admission of such article may be
deferred” while the owner posts a bond and takes remedial
action. A permissive construction of “shall be refused
admission” would render “the express exception ...
insignificant, if not wholly superfluous.” TRW Inc. v.
Andrews, 534 U.S. 19, 31 (2001) (internal quotation marks
omitted).     The FDA objects that the Senate Report
recommending that the exception in § 381(b) be added to the
Act said it merely codified “a continuing administrative
                              13
practice of the [FDA],” S. REP. NO. 81-890, at 1 (1949);
therefore, the FDA argues, “the authority to take steps short of
outright refusing admission ... was inherent in the statutory
scheme from the very beginning.” On the contrary: The
Senate Report states § 381(b) was needed to “provide specific
authority” for the FDA’s procedure because “[u]nder ... the
act as it now stands, imports which are found to be
inadmissible into the United States by reason of mislabeling
... must be either reexported or destroyed.” Id. In other
words, § 381(b) was added precisely because “shall be
refused admission” left the agency with no discretion to make
an exception, no matter how sensible making a particular
exception might be.

     The FDA next objects that even if the agency lacks
discretion under the consequent “shall be refused admission,”
it at least has discretion under the antecedent condition “if it
appears.” “[B]y authorizing refusal of admission when ‘it
appears’ that the statutory requirements have not been met, [§
381(a)] contemplates a role for FDA in making a formal
judgment about the relevant facts. ... The provision does not
speak to, much less eliminate, FDA’s discretion whether to
make such a determination.” The FDA, however, omits the
second half of the relevant clause: “If it appears from the
examination of such samples or otherwise.” § 381(a). The
clear implication is the FDA must examine the samples that it
must request and determine whether they appear to violate the
FDCA. Indeed, it would make no sense for the Congress to
mandate the collection, but not the examination, of samples of
drugs made in an unregistered facility.

    Of course, the clause “[i]f it appears from the
examination of such samples or otherwise” may leave the
FDA enforcement discretion in other respects. For example,
the open-ended phrase “or otherwise” implies the FDA may
                               14
examine drugs it is not obligated to sample, such as those
made in a registered establishment. Indeed, the FDA
interprets § 381(a) as giving it general authority to examine
“drugs ... offered for entry into the United States.” FDA,
INVESTIGATIONS OPERATIONS MANUAL ch. 6.1.1 (2012),
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM
123512.pdf. The same phrase also implies the FDA may
detect a violation through a method other than “examination,”
such as electronic screening of entry data that importers
submit to Customs. Moreover, the phrase “if it appears”
implies discretion in making the substantive determination
whether a drug appears to violate the FDCA; a drug may
appear to violate the FDCA to one examining officer but not
to another.

     We identify these oases of possible agency discretion not
to suggest they are beyond judicial review, a question not
before us, but rather to delineate the bounds of our
interpretation. We do not say the FDA must sample and
examine every article under its jurisdiction that is offered for
import but only that it must sample and examine drugs
“manufactured, [etc.,]” in an unregistered establishment. Id.
Nor do we say the FDA must find any type of drug “appears”
to violate a substantive prohibition of the FDCA but only that,
having found a drug apparently violates the Act, the FDA
must “refuse[] [it] admission.” Id.

    3. Policy considerations

     Ordinarily, if a statute is “plain and unambiguous,” as is
the FDCA in relevant respects here, “our analysis ends with
the text.” Chao v. Day, 436 F.3d 234, 235 (D.C. Cir. 2006).
We may, however, in rare instances depart from the plain text
when “adherence to the plain text leads to an ‘absurd’ result.”
United States ex rel. Totten v. Bombardier Corp., 380 F.3d
                               15
488, 494 (D.C. Cir. 2004). Although the FDA does not use
the word “absurd,” perhaps because the doctrine of avoiding
absurd results is so rarely applied, see Barnhart v. Sigmon
Coal Co., Inc., 534 U.S. 438, 459 (2002) (“the Court rarely
invokes [the absurdity] test to override unambiguous
legislation”); Territory of Hawaii v. Mankichi, 190 U.S. 197,
223 (1903) (only in “rare cases” does “adherence to the letter
lead[] to manifest absurdity”), the FDA does argue the
practical consequences of reading § 381(a) as we do should
give us pause.

     The FDA argues the court should not read § 381(a) to
require enforcement because the agency is better able to
determine “how to most effectively allocate scarce resources.”
According to the FDA, § 381(a) “applies, by its terms, to the
21 million discrete ‘lines’ of FDA-regulated imports each
year ... [and] the agency understandably declines to take
enforcement action in every case in which it suspects that a
single importation may violate the statute.” Our reading of §
381(a), however, does not require the FDA to inspect 21
million articles offered for import; rather, it requires only the
FDA examine the samples of articles that it is obligated to
collect because they were “manufactured, [etc.,]” in an
unregistered facility. Of course the FDA is free to go further,
as it has chosen to do by electronically screening “formal and
informal entries of articles under FDA jurisdiction at ports of
entry.” FDA, REGULATORY PROCEDURES MANUAL 9-2.

    The FDA next argues it must have discretion not to
enforce § 381(a) in order to combat domestic shortages of
medically necessary drugs. According to a report cited by
both parties, the FDA has allowed “controlled importation of
similar products approved abroad but not approved in the
United States in 5% of” the drug shortages it studied. FDA, A
REVIEW OF FDA’S APPROACH TO MEDICAL PRODUCT
                              16
SHORTAGES 4 (2011), www.fda.gov/DrugShortageReport. By
its own account, however, the FDA has ways short of
allowing importation of inadmissible drugs to counteract a
drug shortage, including: “Asking other firms to increase
production (31%),” “Working with manufacturers” to
mitigate quality problems (28%), and “Expediting review of
regulatory submissions (26%).” Id. The FDA may exercise
enforcement discretion to allow the domestic distribution of a
misbranded or unapproved new drug, as the Supreme Court
recognized in Chaney, 470 U.S. at 837, and in some cases
may invoke its express statutory authority to permit the
importation of an unapproved new drug. For example, the
FDA may designate an unapproved foreign manufactured
drug as an investigational new drug (IND), thereby allowing
its lawful importation. 21 U.S.C. § 355(i); 21 C.F.R. §
314.410(a)(1)(ii); see also 21 C.F.R. 312.315(a)(3)(ii) (FDA
may expand access to an IND “contain[ing] the same active
moiety as an approved drug product that is unavailable
through ... a drug shortage”). In any event, even if reading §
381(a) by its terms, as we do, deprives the FDA of one
possible response to five percent of all drug shortages, that is
hardly an absurd result.

     In an effort to bolster its drug shortage argument, the
FDA points to two provisions in a 2012 statute that it says
reveal the Congress’s “understanding that FDA already has
authority to exercise enforcement discretion.” 21 U.S.C. §
356d(c) instructs the Secretary of HHS to “evaluate the risks
associated with the impact” of a drug shortage before taking
an enforcement action that “could reasonably cause or
exacerbate a shortage,” and § 356c-1(a)(5) directs the
Secretary to issue an annual report listing, among other
things, “instances in which the [FDA] exercised regulatory
flexibility and discretion to prevent or alleviate a drug
shortage.” The Congress enacting these directives may have
                              17
implicitly — and correctly — assumed the FDA already had
some discretion in combating a drug shortage, but the agency
gives us no reason to think the Congress was referring to the
discretion to ignore § 381(a) and not to the discretion to allow
the domestic distribution of a violative drug or to admit an
unapproved foreign manufactured drug as an IND.

     Finally, the FDA argues it must have discretion to ignore
§ 381(a) in order to allow the “importation of drugs that are
clearly for personal use.” As evidence that the Congress is
aware of and agrees with this view, the FDA points to a 2003
statute, not yet in effect, directing the Secretary of HHS to
“exercise discretion to permit individuals to make ...
importations” of prescription drugs for personal use. 21
U.S.C. § 384(j)(1)(B). The FDA, however, conveniently
overlooks the very next subsection, which effectuates the
statute by authorizing the Secretary to grant individual
waivers to import prescription drugs. § 384(j)(2). The
Congress would have had no reason to grant the FDA explicit
waiver authority if, as the FDA argues, the agency was
already authorized not to enforce § 381(a).

                             ***

     In sum, we hold 21 U.S.C. § 381(a) requires the FDA to
(1) sample “any drugs” that have been “manufactured,
prepared, propagated, compounded, or processed” in an
unregistered establishment and (2) examine the samples and
determine whether any “appears” to violate the prohibitions
listed in § 381(a)(1)–(4). If, “from the examination of such
samples or otherwise,” the FDA finds an apparent violation of
the Act, then it must (3) “refuse[] admission” to the prohibited
drug. Because these are clear statutory “guidelines for the
agency to follow in exercising its enforcement powers,”
                               18
Chaney, 470 U.S. at 833, the FDA’s compliance with § 381(a)
is subject to judicial review under the standards of the APA.

B. The APA on the Merits

     From the foregoing analysis it follows apodictically that
the FDA’s policy of admitting foreign manufactured
thiopental destined for state correctional facilities, as well as
the several individual admissions of such shipments
challenged by the plaintiffs, were “not in accordance with
law.” 5 U.S.C. § 706(2)(A). The FDA’s policy was not in
accordance with law because § 381(a) requires the agency to
sample and examine for violations any drug offered for
import that has been prepared in an unregistered facility; as
the FDA acknowledges, the preparer of the finished thiopental
identified in this case, Archimedes Pharma UK, Ltd., is not
registered with the FDA. The FDA’s individual admissions
of thiopental shipments were not in accordance with law
because § 381(a) requires the FDA to refuse admission to any
drug that appears to violate the substantive prohibitions of the
FDCA, and the FDA conceded before the district court that
the thiopental in these shipments “clearly ‘appears’ to be an
unapproved new drug.”

     Because our holding the FDA acted contrary to law
requires that we affirm the judgment of the district court, we
need not decide whether the FDA’s actions were also
arbitrary and capricious. See Duke Power Co. v. FERC, 864
F.2d 823, 831 (D.C. Cir. 1989).

C. Rule 19

    Federal Rule of Civil Procedure 19(a)(1)(B)(i) provides:
                              19
    A person who is subject to service of process and whose
    joinder will not deprive the court of subject-matter
    jurisdiction must be joined as a party if ... that person
    claims an interest relating to the subject of the action and
    is so situated that disposing of the action in the person’s
    absence may ... as a practical matter impair or impede the
    person’s ability to protect the interest.

The rule reflects the bedrock principle “that one is not bound
by a judgment in personam in a litigation in which he is not ...
a party,” Hansberry v. Lee, 311 U.S. 32, 40 (1940), or to put it
more simply, that “everyone should have his own day in
court.” 18A CHARLES ALAN WRIGHT, ARTHUR R. MILLER &
EDWARD H. COOPER, FEDERAL PRACTICE AND PROCEDURE §
4449 (2d ed. 2002). For this reason, the parties before a
district court, who “presumably know better than anyone else
the nature and scope of relief sought in the action, and at
whose expense such relief might be granted ..., [bear] a
burden of bringing in additional parties where such a step is
indicated.” Martin v. Wilks, 490 U.S. 755, 765 (1989). The
district court, too, “has an independent responsibility” to seek
the joinder of a required party, sua sponte if need be.
Weisberg v. Dep’t of Justice, 631 F.2d 824, 830 & n.40 (D.C.
Cir. 1980).

     The amicus argues, and we agree, the district court erred
by failing, when the complaint was filed, to seek the joinder
of the “state governments whose possession and use of
[foreign manufactured] thiopental [the court] declared
illegal.” In their complaint, the plaintiffs sought “[a]n order
compelling FDA to immediately take reasonable steps to
recover and remove from interstate commerce all shipments
of foreign thiopental that have been released by FDA into
interstate commerce during the preceding twelve months.”
The states that had received those shipments – Arizona,
                                 20
Arkansas, California, Georgia, South Carolina, and Tennessee
— had an obvious interest in keeping them and therefore had
“an interest relating to the subject of the action” within the
scope of Rule 19. Although the plaintiffs did not renew their
request for injunctive relief in their motion for summary
judgment, the district court nevertheless ordered the FDA to
notify the states that “the use of [foreign manufactured
thiopental] is prohibited by law and that, that thiopental must
be returned [sic] immediately to the FDA.” That order, “as a
practical matter” did “impair or impede” the named states’
“ability to protect the[ir] interest” in those shipments. FED. R.
CIV. P. 19(a)(1)(B)(i).

     Although we agree with the amicus that the affected
states were required parties, we do not agree their absence
means the case should have been dismissed. Under Rule 19 a
district court is to join a required party if feasible; if joinder is
not feasible, however, then the court is to consider, among
other things, whether “any prejudice could be lessened or
avoided by ... shaping the relief.” FED. R. CIV. P. 19(b)(2)(B).
Here, the district court neither assessed the feasibility of
joining the states as parties nor considered whether the
prejudice to their interests might be reduced by shaping the
relief.

      To remedy a departure from the strictures of Rule 19, “a
court of appeals may ... require suitable modification [of the
judgment] as a condition of affirmance.”             Provident
Tradesmens Bank & Trust Co. v. Patterson, 390 U.S. 102,
112 (1968). Accordingly, we shall vacate the remedial order
insofar as it directs the FDA to “notify any and all state
correctional departments which it has reason to believe are
still in possession of any foreign manufactured thiopental that
the use of such drug is prohibited by law and that, that
thiopental must be returned immediately to the FDA.”
                              21
                       III. Conclusion

     The FDCA imposes mandatory duties upon the agency
charged with its enforcement. The FDA acted in derogation
of those duties by permitting the importation of thiopental, a
concededly misbranded and unapproved new drug, and by
declaring that it would not in the future sample and examine
foreign shipments of the drug despite knowing they may have
been prepared in an unregistered establishment. The district
court could not remedy the FDA’s unlawful actions, however,
by imposing upon the interests of nonparties to this suit. The
order of the district court pertaining to the thiopental already
in the possession of the states, quoted in the paragraph above,
is therefore vacated, but the underlying judgment of the
district court is

                                                      Affirmed.