Beaty v. Food and Drug Administration

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
DONALD EDWARD BEATY, et al., )
)
Plaintiffs, )
)
v. ) Civil Case No. 11-289 (RJL)
)
FOOD AND DRUG )
ADMINISTRA TION, )
)
and )
)
V.S. DEPARTMENT OF HEALTH )
AND HUMAN SERVICES, )
)
and )
)
KATHLEEN SEBELIUS, in her official )
capacity as Secretary of the U.S. )
Department of Health and Human )
Services, )
)
and )
)
MARGARET A. HAMBURG, M.D., in )
her official capacity as Commissioner )
of Food and Drugs, )
)
Defendants. )
MEMO~M OPINION
(March2..1-, 2012) [#12 and #13]
Plaintiffs, a group of death row inmates currently incarcerated in Arizona,
California, and Tennessee, bring this action against the Food and Drug Administration
("FDA"), the United States Department of Health and Human Services ("HHS"),
Kathleen Sebelius in her official capacity as Secretary ofHHS "(Secretary"), and
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Margaret A. Hamburg, M.D. in her official capacity as Commissioner of Food and Drugs
("Commissioner") (collectively, "defendants"), alleging violations of the Administrative
Procedure Act ("APA"), 5 U.S.C. §§ 701, et seq. Specifically, plaintiffs allege that
defendants violated provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA" or
the "Act"), 21 U.S.C. §§ 301, et seq., by improperly allowing shipments of a misbranded
and unapproved new drug to enter the United States for use in state lethal injection
protocols, which will be used during plaintiffs' executions. Before the Court are
plaintiffs' Motion for Summary Judgment and Declaratory Relief on Counts I and III
[Dkt. # 12] and defendants' Motion to Dismiss and/or for Summary Judgment [Dkt. #13].
After careful consideration of the relevant law, the pleadings, and the entire record
herein, plaintiffs' motion is GRANTED and defendants' motion is DENIED.
BACKGROUND
J. The Federal Food, Drug, and Cosmetic Act
The FDA has the authority to regulate the production and distribution of drugs in
the United States to promote public health and safety. See Pis.' Statement of Undisputed
Material Facts in Supp. of Mot. for Summ. J. ("Pis.' SUMF"), Mar. 21. 2011, ~ 76 [Dkt.
# I 2]. Under the FDCA, it is unlawful to introduce "misbranded" drugs into interstate
commerce. 2 I U.S.C. § 331(a). A drug is deemed misbranded if: (1) it was
"manufactured, prepared, propagated, compounded, or processed in an establishment"
not registered with the FDA, id. §§ 352(0), 3600); (2) it is not properly listed with the
FDA, id. §§ 352(0), 360U); or (3) its packaging does not display the symbol "Rx only,"
id. § 353(b)(4)(A). It is also unlawful to introduce a "new drug"-a drug that has not
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been previously reviewed and approved by the FDA, id. § 321(p)-into interstate
commerce. ld. § 355(a). A "new drug" must have an effective application that has been
approved by the FDA. ld. An application for a new drug must provide the FDA with,
inter alia, information sufficient to determine whether (I) when used for its proposed
uses, the drug is safe and effective, (2) the benefits of the drug outweigh any risks, and
(3) the production and regulation methods in place can "ensure the [drug's] identity,
strength, quality, and purity." See 21 C.F.R. § 314.50 (2008); Mem. in SUpp. of PIs.'
Mot. for Summ. J. ("PIs.' Mot. Mem."), Mar. 21,2011, at 5 [Dkt. # 12].
The FDCA has separate provisions concerning the distribution of domestic and
foreign drugs. See 21 U.S.c. §§ 381(a), (e). With respect to imports, as originally
enacted, the FDCA gave the FDA the authority to inspect samples of imported drugs, but
it did not impose an affirmative obligation on the FDA to do so. See Pub. L. No. 75-717,
§ 801, 52 Stat. 1040, 1058 (1938) ("The Secretary of the Treasury shall deliver to the
Secretary of Agriculture, upon his request, samples of food, drugs, devices, and
cosmetics which are being imported or offered for import into the United States.")
(emphasis added). In 1962, however, Congress amended the FDCA in response to calls
for increased domestic and foreign drug regulation. PIs.' Mot. Mem. at 6. Pursuant to
the 1962 Amendments, Congress required any foreign establishment that manufactures,
prepares, propagates, compounds, or processes a drug to be imported into the United
States to both "immediately register" with the Secretary ofHHS, see 21 U.S.C. §§
321(a)(2)(d), 360(i)(I)(A), and provide the Secretary with a list of all its imported drugs
and devices, id. §§ 360(i)(2), 360U). Also under the amended Act, the Secretary ofHHS
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"shall furnish to the Secretary of the Treasury" a list of registered foreign establishments
and "shall request that if any drugs, devices, or tobacco products 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, devices, or tobacco
products be delivered to the Secretary of Health and Human Services." Id. § 381(a). "If
it appears" the imported product "is forbidden or restricted in sale in the country in which
it was produced or from which it was exported" or "is adulterated, misbranded, or in
violation of21 U.S.C. section 355, ... then such article shall be refused admission.") Id.
Finally, if an imported article is refused admission, the Secretary of the Treasury "shall
cause the destruction of any such article" unless it "is exported ... within ninety days."
Id.
The FDA is responsible for the obligations imposed by Section 381 of the FDCA.
See PIs.' Mot. for Summ. 1. ("PIs.' Mot. "), Mar. 21, 201, ~ 15 [Dkt. # 12]. As a result, the
FDA promulgated several regulations regarding the importation of drugs into the United
States that mirror the FDCA. First, new drugs may be imported after a new drug
Entities importing products into the U.S. must first file an entry notice with U.S.
Customs and Border Patrol ("CBP") identifying, inter alia, the product, manufacturer,
shipper, and country of origin. See Defs.' Mem. in SUpp. of Mot. to Dismiss and/or for
Summ. J. ("Defs.' Mot. "), Apr. 20, 2011, at 4 [Dkt. # 13-1]. Most importers file these
notices electronically, allowing CPB to review the notices via its automated system
before forwarding the information to the FDA. Id. The FDA reviewer can then decide to
admit the product, detain the product, or gather more information by physically
examining the product or requesting a sample. Id. at 4-5.
In 2004, there were 355 "points of entry" for access into the United States. Id. at
4. In 2010, over 21 million products were offered for importation into the United States.
See id. at 5. Of those products, the FDA physically examined approximately 1% and
refused admission to approximately 0.13 %. Id. When a product is refused admission, it
must be destroyed unless it is exported within 90 days. See 21 U.S.C. § 381(a).
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application has been submitted and approved by the FDA, or if the drugs comply with the
regulations regarding investigational new drugs. 21 C.F.R. § 314.410(a)(l) (2008).
Second, no drug may be legally imported unless it is both properly listed with the FDA
and comes from a properly registered foreign drug establishment. Id. § 207.40(b) (2001).
II. Thiopental
Sodium thiopental ("thiopental") is an intravenously-administered, short-acting
barbiturate used to induce general anesthesia. Am. CompI. ("CompI. "), July 1, 2011, ~
37 [Dkt. #20]. Substances used to induce general anesthesia, even as a part of an
euthanasia process, are considered "drugs" under the FDCA as they are "intended to
affect the structure or any function of the body of man." See 21 U.S.c. § 321(g)(l);
CompI. ~ 48. Multiple states have used thiopental as the first step in their lethal injection
protocols to render prisoners unconscious before administering pancuronium bromide-a
paralytic-and potassium chloride-which causes cardiac arrest and death. See Raze v.
Rees, 553 U.S. 35, 44 (2008); Pis.' Mot. Mem. at 12. Although once widely used by
anesthesiologists, the FDA neither approved nor reviewed thiopental for safety and
effectiveness. CompI. ~ 54. Beginning in the 1980s, thiopental use decreased
dramatically as anesthesiologists began using propofol-a drug approved by the FDA in
1989-to achieve the same results. Id. ~~ 40-42,44. In 2009, the U.S. manufacturer of
thiopental stopped producing the drug, id. ~ 45, prompting certain state departments of
correction ("DOC") to look abroad for suppliers, see Exs. 30-32 to Declaration of Sean
C. Griffin ("Griffin Decl."), PIs.' Mot., Mar. 21, 2011 [Dkt. #12-4].
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Dream Pharma, Ltd. ("Dream"), a London wholesaler that purchases thiopental
manufactured in Austria for distribution, shipped to the United States the thiopental at
issue here. CompI. ~~ 88-89. Dream has neither registered with the FDA nor listed its
thiopental product with the FDA. Id. ~~ 90-91. In total, the FDA released at least seven
shipments of Dream's thiopental-a "misbranded" and unapproved "new drug,,2-to
various states. 3 PIs.' Mot. Mem. at 14-15. In June 2010, Dream sent a shipment of
thiopental to the Georgia DOC, which the FDCA detained in July on the ground that the
thiopental was misbranded. See PIs.' SUMF ~~ 35-37. In August, however, the FDA
released the shipment to Georgia. Id. ~ 39. In September 20 I 0, Dream sent a shipment
of thiopental to the Arkansas DOC, which the FDA detained on the ground that
thiopental was an unapproved new drug. Id. ~~ 40-42. After receiving correspondence
from the Arkansas DOC indicating the drug was necessary for use in lethal injections, the
FDA released the shipment in late September 2010. Id. ~~ 43-44. Dream also sent a
shipment of thiopental to Arizona in September 2010, which the FDA released to Arizona
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It is undisputed that thiopental is both "misbranded" and an unapproved "new
drug" under the FDCA. Thiopental is clearly a new drug because the FDA has never
reviewed or approved the drug. See PIs.' SUMF ~ 15. Further, foreign thiopental is a
misbranded drug because it is not listed with the FDA, see id. ~~ 16-19, and it fails to
display the symbol "RX Only," id. ~ 20.
3 Although the U.S. Drug Enforcement Administration ("DEA") seized at least one
of these seven shipments as violative of the Controlled Substances Act, Arizona,
California, and Tennessee still possess the thiopental they purchased from Dream. PIs.'
Mot. Mem. at 15. Thiopental is a schedule III non-narcotic controlled substance under
the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513,
84 Stat. 1236 (1970). See 21 U.S.c. §§ 812(b)(3), 812(c) Schedule III(b)(l); 21 C.F.R. §
1308.13(b) (2012); see also Defs.' Mot. at 6. Any establishment that imports a schedule
III non-narcotic controlled substance without submitting the required import declaration
to the DEA may be prosecuted and the controlled substance may be seized. See 21
U.S.C. §§ 853, 881,960,970; see also Defs. Mot. at 6.
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the day after the shipment arrived. Id. ~~ 54-55. In October 2010, Dream sent and the
FDA released a shipment of thiopental to the Tennessee DOC. Id. ~ 64-65. In November
2010, Dream sent shipments of thiopental to the California and South Carolina DOCs,
which the FDA released in January 201l. Id. ~~ 66,69,71,74. In September 2010, the
FDA identified another shipment similar to the foreign thiopental shipped to Arizona. Id.~ 75.
In January 2011, the FDA released a statement explaining its position on the
importation of thiopental. Compl. ~ 103. Defending the release of the drug as an act of
"enforcement discretion," the FDA indicated it "deferred to law enforcement in the use of
substances for lethal injection." Id. ~ 104. It explained "[r]eviewing substances imported
or used for the purpose of state-authorized lethal. injection clearly falls outside of FDA's
explicit public health role.,,4 Id.On July L 2011, plaintiffs filed an amended complaint, seeking, inter alia, a
declaratory judgment that the defendants acted contrary to law, in an arbitrary and
capricious manner, and in abuse of their discretion when they allowed shipments of the
misbranded and unapproved new drug thiopental to be imported into the U.S .. and a
permanent injunction prohibiting the FDA from releasing any future shipments of
unapproved foreign drugs into interstate commerce. See Compl. On March 21, 2011,
plaintiffs filed a Motion for Summary Judgment and Declaratory Relief on Counts I and
4
Since the commencement of this litigation, several states-including Arizona-
have announced they will no longer use thiopental in their lethal injection protocols. See
Defs.' Mot. at 9-10. Additionally, news reports indicate that the Tennessee DOC has
relinquished its entire inventory of thiopental to the DEA. Id. at 10.
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III. See Dkt. #12. On April 20, 2011, defendants filed a Motion to Dismiss and/or for
Summary Judgment. See Dkt. #13. For the reasons stated below, plaintiffs' motion is
GRANTED and defendants' motion is DENIED.
STANDARD OF REVIEW
Under the APA, the Court must set aside an agency action that is "arbitrary and
capricious, an abuse of discretion, or otherwise not in accordance with law." Jicarilla
Apache Nation v. Us. Dep't o/the Interior, 613 F.3d 1112,1118 (D.C. Cir. 2010)
(quoting 5 U.S.c. § 706(2)(A)). Summary judgment is appropriate when the movant
demonstrates that there is no genuine issue of material fact in dispute and that the moving
party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56( a). The moving party
bears the burden, and the court will draw "all justifiable inferences" in the favor of the
non-moving party. Anderson v. Liberty Lbbby, Inc., 477 U.S. 242,255-56 (1986).
Nevertheless, the non-moving party "may not rest upon the mere allegations or denials of
his pleading, but ... must set forth specific facts showing that there is a genuine issue for
trial." Id. at 248 (internal quotation marks and citation omitted). Factual assertions in the
moving party's affidavits may be accepted as true unless the opposing party submits its
own affidavits, declarations, or documentary evidence to the contrary. Neal v. Kelly, 963
F.2d 453,456 (D.C. Cir. 1992).
LEGAL ANALYSIS
I. Standing
Defendants contend that plaintiffs lack Article III standing to bring their claims.
See Defs.' Mot. at 27-35. To have standing, a plaintiff must have suffered an injury that
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is "(a) concrete and particularized and (b) actual or imminent." Lujan v. Defenders of
Wildlife, 504 U.S. 555, 560 (1992) (internal quotation marks and citations omitted). A
plaintiff must further show "a causal connection between the injury and the conduct
complained of," making the injury "fairly traceable" to the defendant's action. Id.(citation omitted). Defendants contend that plaintiffs have not adequately shown injury
or causation. See Defs.' Mot. at 27-35. I disagree.
F or standing purposes, an increased risk of future harm is a category of the injury-
in-fact prong. NRDC v. EPA, 464 F.3d 1,6 (D.C. Cir. 2006). An increased risk of harm
constitutes an injury-in-fact where there is a substantially increased risk of harm and a
substantial probability of sustaining the threatened injury. See Public Citizen, Inc. v.
Nat 'I Highway Traffic Safety Admin., 489 FJd 1279. 1295 (D.C. Cir. 2007). While there
are no "hard-and-fast numerical rules," id. at 1295-96, for what constitutes a substantially
increased risk, our Circuit has held that where the threatened injury is "severe,"
"relatively modest increments in risk should qualifY for standing." Mountain States
Legal Found. v. Glickman, 92 FJd 1228, 1235 (D.C. Cir. 1996); see Baur v. Veneman,
352 F.3d 625,637 (2d Cir. 2003) ("Because the evaluation of risk is qualitative, the
probability of harm which a plaintiff must demonstrate in order to allege a cognizable
injury-in-fact logically varies with the severity of the probable harm.").
Here, the threatened injury-that unapproved foreign thiopental will fail to
anesthetize plaintiffs properly during execution, causing conscious suffocation, pain, and
cardiac arrest, see CompI. ~~ 17, 33, 127-29-is, to say the least, severe. Indeed, few in
our society are more vulnerable than a death row inmate facing lethal injection. Compare
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Mountain States, 92 F.3d at 1234 ("Plaintiffs' aesthetic and environmental interests in
having [forests] free of devastating forest fire are clearly sufficient for Article III
standing."). Thus, because the threatened injury is severe, plaintiffs are required to show
only a "relatively modest" increment of risk. Id. at 1235; see NRDC, 464 F.3d at 6-7, 11
(holding that a one in 200,000 lifetime risk of developing nonfatal skin cancer was
sufficient injury for standing).
It is undisputed that the FDA has never approved or even reviewed foreign
thiopental (let alone thiopental previously manufactured in the United States) for safety
and effectiveness. See PIs.' SUMF ~ 15. The FDCA protects consumers from drugs that
are "not generally recognized, among experts qualified by scientific training and
experience ... as safe and effective." 21 U.S.C. § 321(p); see id. § 381(a). This
protection exists because there is no guarantee that an unapproved or misbranded drug
will serve the purpose for which it was intended or that the drug itself will be safe for use.
According to the FDA, "FDA has long taken the position that consumers are exposed to a
number of risks when they purchase drugs from foreign sources" because the foreign
sources may, inter alia, "dispense expired, subpotent, contaminated or counterfeit
product, the wrong or a contraindicated product, an incorrect dose, or medication
unaccompanied by adequate directions for use." Safety of Prescription Drugs From
Foreign Sources, Before the Subcomm. on Human Rights and Wellness, House Comm. on
Government Reform (June 12,2003) (statement of William K. Hubbard, Associate
Commissioner for Policy and Planning) ("Hubbard Statement"); see FDA, Unapproved
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Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval,
available at http://www .fda.gov/Drugs/GuidanceComp lianceRegulatory Information/
EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.
htm ("The Agency has serious concerns that drugs marketed without required FDA
approval may not meet modem standards for safety, effectiveness, quality, and
labeling. "). Because unapproved thiopental exposes plaintiffs to the risk that the drug
will not function as intended, plaintiffs have shown at least a "modest" increment of risk
that the use of foreign thiopental in their executions would result in conscious
suffocation, pain, and cardiac arrest.
Defendants also contend that there is no causal connection between the FDA's
failure to reject unapproved foreign thiopental and plaintiffs' threatened injury. Defs.'
Mot. at 29-31. The threatened injury, however, arises directly from defendants' actions.
Defendants' admission of foreign thiopental shipments allows state DOCs to use
thiopental in their lethal injection protocols. In so doing, plaintiffs' risk of conscious
suffocation, pain, and cardiac arrest increases. Thus, plaintiffs have standing to pursue
their claims.
II. Plaintiffs are Entitled to Summary Judgment on Count I Because
Defendants Acted Contrary to Law.
A. The Word "Shall" Imposes a Mandatory Obligation.
Plaintiffs allege that defendants have violated the AP A by taking agency action
that is not in accordance with the FDCA-specifically, by improperly allowing shipments
of a misbranded and unapproved new drug to enter the United States. The FDCA
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requires that if an examined shipment even appears to violate the FDCA's misbranding
or new drug approval requirements, then the drug "shall be refused admission." 21
U.S.C. § 381(a). According to plaintiffs, the plain language of the statute thus clearly
required defendants to refuse to admit the shipments of thiopental-a drug that actually is
misbranded and unapproved-into the United States. See Pis.' Mot. Mem. at 21. By not
refusing the shipments, plaintiffs contend that defendants acted contrary to law. I agree.
Defendants contend that the statute does not impose a mandatory duty to refuse
admission. See Defs.' Mot. at 11. But, it is difficult to construe Section 381 as anything
but mandatory. Indeed, the plain language of the statute states that an article that appears
to be misbranded or unapproved "shall be refused admission." 21 U.S.C. § 381 (a)
(emphasis added). '" Shall' has long been understood as 'the language of command. '"
ZivotoJsky v. Sec'y o/State, 571 FJd 1227, 1243 (D.C. Cir. 2009) (citing Escoe v. Zerbst,
295 U.S. 490, 493 (1935)). "The word 'shall' generally indicates a command that admits
of no discretion on the part of the person instructed to carry out the directive." Ass 'n 0/
Civilian Technicians, Mont. Air Chapter No. 29 v. Fed. Labor Relations Auth., 22 F.3d
1150,1153 (D.C. Cir. 1994) (emphasis added).
The rule that the word "shall" is a mandatory command is subject to "rare
exceptions," which "apply only where it would make little sense to interpret 'shall' as
'must.'" ZivotoJsky, 571 FJd at 1243. Here, however, it makes little sense to interpret
Congress' use of the word "shall" as anything but "must." In the very same section of the
statute at issue here, Congress used both the language in question (shall) and permissive
language (may). For example, Congress directed that imported drugs that are misbranded
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or unapproved "shall be refused admission,"21 U.S.C. § 381(a), whereas an imported
drug that does not have a registration statement "may be refused admission," id. § 381 (0)
(emphasis added). 5 Given the structure of the statute, it is clear that Congress intended
for the word "shall" to have a different meaning than "may"-specifically, to be
mandatory rather than permissive. 6 See Jama v. Immigration & Customs Enforcement,
543 U.S. 335, 346 (2005) Uuxtaposing the permissive "may" with the mandatory "shall").
Indeed, Congress' intent is further revealed by the fact that it created an exception
to the command that misbranded and unapproved drugs "shall be refused admission." 21
5
Congress' use of the word "may" in Section 381 is not limited to this example.
For example, the statute allows for extensions of time for the re-exportation of offending
goods "as may be permitted pursuant to ... regulations." 21 U.S.C. § 381(a).
Additionally, the statute states that the Secretary of the Treasury "may authorize" the
delivery of an article pending FDA examination upon the posting ofa bond. Id. § 381(b).
As another example, the FDA "may authorize" the re-importation of certain articles "if
the drug is required for emergency medical care." Id. § 381(d)(2).
6 Defendants contend that interpreting "shall" as imposing a mandatory obligation
will produce "absurd results." See Defs.' Mot. at 46-47; Defs.' Reply in Supp. of Mot. to
Dismiss and/or for Summ. 1. ("Defs.' Reply"), July 8,2011, at 30-33 [Dkt. #21]. I
disagree. First, the FDA is not obligated to examine all imported goods; it is only
required to examine "drugs, devices, or tobacco products" that were "manufactured,
prepared, propagated, compounded, or processed" in an unregistered foreign
establishment. See 21 U.S.C. § 381(a). The FDA has a computerized system already in
place where foreign imports are "electronically screened against criteria developed by
FDA" and alerts can "identify problem commodities and/or shippers and/or importers."
FDA Regulatory Procedure Manual, Import Operations and Actions 9-3, 9-50 (2011).
Thus, any burden on defendants with respect to examining imported goods is, to say the
least, minimal. Indeed, this "burden" was one intended by Congress. The purpose of the
FDCA is to promote public health and safety, which, in the context of imported drugs,
requires the FDA to ensure that only drugs approved as safe and effective enter into the
country. See Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 69 (D.D.C. 1998)
(vacated on other grounds) (finding that the purpose of the FDCA is to "ensur[e] that
when a citizen takes a prescription drug, that individual has absolute assurance that the
product is safe and effective"). And although protecting the health of an inmate being put
to death may seem like an oxymoron to some, those vulnerable few have a right to die
with the dignity that an effective pain killer was intended, in part, to afford them.
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U.S.C. § 381(a). Section 381(a) states that these drugs "shall be refused admission,
except as provided in [21 U.S.C. § 381(b)]." Id (emphasis added). Accordingly, if the
owner of the offending drugs posts a "sufficient bond," and the FDA determines that the
drugs "can, by relabeling or other action,.be brought into compliance" with the FDCA,
./
then the drugs may be admitted after the owner brings them into compliance. Id. §
3 81 (b). The cannon of avoiding surplusage makes clear that if Congress intended "shall"
to be permissive, it would not have included any exceptions to the provision. Beverly
Health & Rehab. Servs. v. NLRB, 317 F.3d 316, 321 (D.C. Cir. 2003).
Further, Congress used the word "shall" several times in Section 381(a). For
example, Section 381 (a) states that the Secretary of HHS "shall furnish to the Secretary
of the Treasury a list of establishments registered pursuant to [21 U.S.C. § 360(i)]"; the
Secretary of HHS "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]"; the Secretary of the Treasury "shall deliver to the Secretary of
[HHS] upon his request, samples of ... drugs ... which are being imported or offered for
import into the United States"; and if a drug is refused admission, the Secretary of the
Treasury "shall cause the destruction of any such article." 21 U.S.C. § 381(a). Similarly,
Section 381 (c) provides that expenses related to the destruction of an illegal import "shall
be paid by the owner or consignee." Id. § 381(c). The "normal rule of statutory
construction" provides that "identical words used in different parts of the same act are
intended to have the same meaning." Dep't of Revenue of Or. v. ACF Indus., Inc., 510
14
U.S. 332, 342 (1994) (internal quotation marks and citation omitted). Under defendants'
theory, the phrases "shall furnish," "shall request," "shall deliver," "shall cause," and
"shall be paid" must be interpreted as permissive. The more reasonable interpretation,
however, is that "shall" in all of these phrases is mandatory, especially when it is used in
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conjunction with specified exceptions.
Thus, it is clear that in Section 381 (a), Congress' intent was for "shall" to impose
a mandatory obligation on defendants to refuse to admit the misbranded and unapproved
drug, thiopental, into the United States.
B. Heckler v. Chaney Does Not Control.
According to defendants, this case is controlled by Heckler v. Chaney, 470 U.S.
821 (1985). Specifically, defendants contend that under Heckler, the FDA's 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.''' Defs.' Mot. at 1, 14-15 (quoting 5 U.S.C. §
701(a)(2)). Plaintiffs, however, contend that the FDA did not make a decision about
whether to take enforcement action within the meaning of Heckler, and therefore,
7
Indeed, the FDA previously has agreed with such an interpretation. See United
States v. Eight Unlabled Cases, More or Less, a/an Article a/Food, 909 F. Supp. 129,
131 (E.D.N.Y. 1995) ("The parties agree that when the government acts under § 381 ...
it ... 'shall' destroy the goods unless they are exported."); Carl Borchsenius Co. v.
Gardner, 282 F. Supp. 396,403 (E.D. La. 1968) (FDA must give owners the opportunity
to export a refused article to avoid destruction); Dep't ofHHS, Report on Prescription
Drug Importation (Dec. 2004), at 27 (Section 381(a) "requires FDA to refuse to admit
into the U.S. any drug that appears to be misbranded.").
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Heckler does not control. Pis.' Reply in ~upp. of Pis.' Mot. ("Pis.' Reply"), June 3,
2011, at 27 [Dkt. #15]. Unfortunately for the defendants, I agree.
In Heckler, a group of death row inmates petitioned the FDA to take enforcement
actions relating to lethal injection drugs to prevent what they believed to be violations of
the FDCA's misbranding provisions. Heckler, 470 U.S. at 823-24. Specifically, the
inmates 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
who knowingly distribute or purchase the drugs with intent to use them for
human execution. I,
Id. at 824. Relying on its discretion to decline to pursue enforcement actions, the FDA
refused to take the requested actions. Id. at 824-25. The Supreme Court, comparing
agency enforcement discretion to the Executive Branch's prosecutorial discretion, agreed
and upheld the FDA's decision, holding that the FDA's refusal to commence an
enforcement action through the civil or criminal process was presumptively immune from
judicial review. Id. at 831-33.
Plaintiffs contend, however, and I agree, that a decision to admit or exclude an
imported product is not the type of discretion-like prosecutorial discretion-that the
Supreme Court considered in its decision in,Heckler. Id. at 832. Unlike in Heckler, here,
the FDA's decision did not involve a decision whether to initiate enforcement
proceedings against a violator of the Act; rather, it involved a decision to ignore an
administrative directive. Here, the FDA was not required to prove that a violation of the
16
FDCA has occurred. Instead, the FDA was being called on to follow an administrative
procedure established by Congress. Having taken the steps to detain and determine that
the foreign shipments contained a misbranded and unapproved new drug, the FDA was
.1
required under the FDCA to reject the shipments in the interest of public safety. Clearly,
the FDA's duty to obey the law and deny admission to a drug according to unambiguous
statutory provisions is not analogous to its decision in Heckler to prosecute statutory
violators.
Further, under Heckler, the FDA's decisions not to take enforcement actions are
only presumptively unreviewable decisions. See Heckler, 470 U.S. at 837. Even if
Heckler was controlling and a presumption against review applied, it has been rebutted
here and judicial review is available. The presumption against review is "rebutted where
the substantive statute has provided guidelines for the agency to follow in exercising its
enforcement powers." Id. at 832-33. When a statute provides a "meaningful standard
against which to judge" the agency's actions, those actions are not committed to agency
discretion within the meaning of the APA. Id. at 830. Such a standard exists, for
example, where the law establishes that the government's authority "should be used
universally" or provides a "basis for distinguishing between the instances in which
[those powers] should and should not be [exercised]." See Hinck v. United States, 550
U.S. 501, 504 (2007) (internal quotation marks and citation omitted).
Here, Section 381(a) of the FDCA gives substantial guidance as to when and how
imported drugs must be reviewed. The statute provides that the FDA shall request
samples of imported drugs when they are "manufactured, prepared, propagated,
17
compounded, or processed" in an unregistered establishment. 21 U.S.C. § 381(a). Under
the statute, the FDA must provide procedural protections in the form of notice to the
owner and an opportunity to testify. ld. Additionally, the statute provides the FDA with
a standard to apply during its examination of the imported drugs-specifically, to
determine whether the drug "appears" to be misbranded, adulterated, or unapproved. ld.
If an examination results in the imported drug appearing to be misbranded, adulterated, or
unapproved, the statute then informs the FDA that it "shall" refuse the admission of the
drug. ld. The statute then provides that the government must destroy or export the drug
within ninety days. ld. Accordingly, the statute both mandates the universal exclusion of
foreign drugs from unregistered establishments that appear misbranded, adulterated, or
unauthorized, and also provides a clear basis for distinguishing when government power
should or should not be exercised.
Thus, judicial review is available because there is a meaningful standard against
which to judge the agency's action. Because defendants failed to reject the misbranded
and unapproved drug, thiopental, into the United States. they have violated the AP A by
taking agency action that is not in accordance with the FDCA.
III. Plaintiffs are Entitled to Summary Judgment on Count III Because
Defendants Acted Arbitrarily and Capriciously and Abused Their Discretion.
Plaintiffs allege that defendants have acted arbitrarily and capriciously and have
abused their discretion by departing from longstanding FDA policies and undermining
the purpose of the FDCA. See PIs. Mot. Mem. at 3-4. I agree. An agency action is
arbitrary, capricious, or an abuse of discretion when it "depart[ s] from a prior policy sub
18
silentio or simply disregard[s] rules that are still on the books," FCC v. Fox Television
Stations, Inc., 129 S. Ct. 1800, 1811 (2009); irrationally departs from an agency's
governing policy, Venetian Casino Resort, LLC v. EEOC, 530 F.3d 925, 935 (D.C. Cir.
2008); or "frustrate[s] the policy that Congress sought to implement," FEC v. Democratic
Senatorial Campaign Comm., 454 U.S. 27, 32 (1981). Here, the FDA has 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.
First, FDA regulations state that (1) "[n]o drug may be imported or offered for
import into the United States unless it is listed [with the FDA]," 21 C.F.R. § 207.40(b);
and (2) new drugs may be imported into the United States if the drug is covered by an
approved application or complies with regulations pertaining to investigational new drugs
("INDs"), see 21 C.F.R. § 314.410(a)(1). Although thiopental is neither listed with the
FDA, covered by an approved application, nor in compliance with regulations pertaining
to INDs, defendants allowed at least seven shipments of foreign thiopental to enter the
United States, and they intend to continue to allow future shipments as well. See PIs.'
SUMF ~~ 35-76. The FDA's actions are clearly inconsistent with its own regulations.
Second, the defendants have departed from a longstanding policy of not allowing
the importation of unapproved prescripti(i)fl drugs. FDA policy reflects a cautionary
approach to importing foreign drugs. The FDA has expressed concern about "the safety
risks associated with the importation of prescription drugs from foreign countries," see
FDA Letter to the State of California Department of Justice ("FDA Letter") (Aug. 25,
19
2003), available at http://www.fda.gov/Drugs/DrugSafety/ucmI79893.htm. as foreign
drugs are more likely to be counterfeit or contaminated than FDA-approved products, see
FDA, Imported Drugs Raise Safety Concerns (Aug. 24, 20 11), available at,
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucmI43561.htm . Indeed, from
2003 to 2008, FDA officials blocked multiple efforts by state and local governments to
import cheaper versions of FDA-approved prescription drugs from foreign entities. See
Importing Prescription Drugs, FDA Letters to State and Local Officials (2003-2008),
available at http://www.fda.gov/Drugs/DrugSafety/ucmI70594.htm.Forexample.in
2003, the FDA rejected a proposal by the State of California to import lower-cost
prescription drugs from Canada and stated that if "any state, county, or city program" in
California "were to import prescription drugs into the State of California from Canada,"
such importation would violate the FDCA "in virtually every instance." FDA Letter.
When denying another such effort, the FDA made clear that it was unable to stray from
the clear language of the statute when it stated: "[T]he petition [for this program] requests
that FDA ignore the will of Congress and sanction the complete and systematic violation
of the statutory provisions that FDA was created to enforce. FDA cannot simply
substitute its (or your) judgment over the judgment of Congress as expressed in the Act."
See Ex. 1 to Griffin Decl. at 4. By denying these programs, the FDA has reiterated its
commitment to the FDCA. Here, however, defendants have created an exception for
thiopental, resulting in a policy by which FDA-approved drugs cannot enter the United
States, but thiopental-a drug that has never been approved by the FDA-can. This
departure from longstanding policy makes little sense in light of the fact that alternative
20
barbiturates for use in lethal injection protocols exist. For example, in response to the
end of U.S. thiopental production in 2009, several states, including Oklahoma, Texas, and
Ohio, successfully changed their protocols to employ a different barbiturate-
pentobarbital. See Declaration of Jennifer Moreno, Ex. 11 to Pis.' Mot., Mar. 18, 2011,
~~ 3-5 [Dkt. #12-15]. Put simply, this appears to be nothing more than the FDA, once
again, stubbornly clinging to every last ounce of its discretionary authority!
Finally, defendants have undermined the purpose of the FDCA and acted in a
manner contrary to the public health. The purpose of the FDCA is to "ensur[ e] that when
a citizen takes a prescription drug, that individual has absolute assurance that the product
is safe and effective." Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 69 (D.D.C.
1998) (vacated on other grounds). As the FDA has explained, by establishing a "'closed'
drug distribution system," the import provisions of the FDCA protect the public from the
risk that potentially unsafe drugs obtained from foreign sources will enter into the
marketplace. See FDA Letter. By opening up the "closed" drug system by allowing an
unapproved drug-thiopental-into the United States, defendants jeopardize their own
system and threaten the public health by creating a risk that thiopental could incorrectly
end up in the hands of the general pUblic. 8 Even when in the correct hands, prisoners on
death row have an unnecessary risk that they will not be anesthetized properly prior to
8
Indeed, the District Court for the Northern District of California has documented
instances in which thiopental went missing from the California DOC's facilities. See
Morales v. Tilton, 465 F. Supp. 2d 972, 979, 979 n.9 (N.D. Cal. 2006) (noting that the
person responsible for maintaining custody of thiopental was discovered to be an illicit
drug smuggler and that "substantial quantities" of thiopental had been diverted from San
Quentin prison). Further, at least one shipment of foreign thiopental was received by a
pharmacy in Georgia. See Defs.' Statement of Facts, Apr. 20, 2011, ~ 4 [Dkt. #13-2]
21
execution. Further, defendants' actions also create a slippery slope that other unapproved
foreign drugs may be allowed to enter into the United States to the detriment of the
general public.
Defendants have failed to provide a reasoned explanation for departing from the
FDA's own regulations, longstanding practices, and the purpose of the FDCA. Instead,
defendants provide two explanations for this departure: (1) that its resources would not
be best served in an area that it considers to be "distant from its public health mission,"
and (2) that its actions are consistent with a policy of deferring to law enforcement with
respect to drugs used for lethal injection. See Defs.' Mot. at 39-40. Simply stating that
the FDA decided it would be best not to expend resources to ensure illegal foreign
shipments of thiopental were not admitted into the United States is not a reasoned
explanation for disregarding the FDA's regulations, its longstanding practices, or the
purpose of the FDCA. 9 See Bluewater Network v. Salazar, 721 F. Supp. 2d 7, 15 (D.D.C.
2010) (a reasoned explanation must supply "a rational connection between the facts
found and the choice made") (internal quotation marks and citation omitted). Similarly,
asserting that the FDA is deferring to law enforcement does not provide a reasoned
explanation. Just as it is not a court's role "to 'correct' the text so that it better serves the
statute's purposes ... [nor] mayan agency avoid the Congressional intent clearly
expressed in the text simply by asserting that its preferred approach would be better
9
Further, the FDA's mission is to ensure that all drugs are safe and effective,
regardless of why the drug is being administered. See 21 U.S.C. § 393(b )(2)(B);
Colacicco v. Apotex Inc., 521 F.3d 253,257 (3d Cir. 2008) (vacated on other grounds).
The law does not create an exception for drugs purchased for use by a state DOC.
22
policy." Engine Mfrs. Ass'n v. EPA, 88 F.3d 1075, 1089 (D.C. Cir. 1996); see Nat'l
Ass 'n of Broadcasters v. FCC. 569 F .3d 416, 422 (D.C. Cir. 2009) ("[C]ourts have no
authority to enforce [a] principl[e] ... that has no statutory reference point.") (internal
quotation marks and citation omitted). In the final analysis, the FDA appears to be
simply wrapping itself in the flag of law enforcement discretion to justify its authority
and masquerade an otherwise seemingly callous indifference to the health consequences
of those imminently facing the executioner's needle. How utterly disappointing!
Thus, defendants have acted arbitrarily and capriciously, and have abused their
discretion both by departing from FDA's own regulations and longstanding policies and
by undermining the purpose of the FDCA.
CONCLUSION
Thus, for all of the foregoing reasons, plaintiffs' Motion for Summary Judgment
and Declaratory Relief on Counts I and III [Dkt. # 12] is GRANTED and defendants'
Motion to Dismiss and/or for Summary Judgment [Dkt. #13] is DENIED. An
appropriate order will accompany this memorandum opinion.
~
RICHARD . EON
United States District Judge
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