Beaty v. Food & Drug Admin.

• Decision Date: 27 March 2012
• Docket Number: Civil Case No. 11–289(RJL).
• Citation: 853 F.Supp.2d 30
• Parties: Donald Edward BEATY, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, and U.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.
• Court: U.S. District Court — District of Columbia

853 F.Supp.2d 30

Donald Edward BEATY, et al., Plaintiffs,

v.FOOD AND DRUG ADMINISTRATION, and U.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.

Civil Case No. 11–289(RJL).

United States District Court, District of Columbia.

March 27, 2012.

Bradford A. Berenson, Eric Alan Shumsky, Sean C. Griffin, Sidley Austin LLP, Washington, DC, for Plaintiffs.

Gerald Cooper Kell, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

RICHARD J. LEON, District Judge.

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 of HHS “(Secretary”), and 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

I. 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 Pls.' Statement of Undisputed Material Facts in Supp. of Mot. for Summ. J. (“Pls.' SUMF”), Mar. 21.2011, ¶ 76 [Dkt. # 12]. Under the FDCA, it is unlawful to introduce “misbranded” drugs into interstate commerce. 21 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( o ), 360(i); (2) it is not properly listed with the FDA, id. §§ 352( o ), 360(j); 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 been previously reviewed and approved by the FDA, id. § 321(p)—into interstate commerce. Id. § 355(a). A “new drug” must have an effective application that has been approved by the FDA. Id. An application for a new drug must provide the FDA with, inter alia, information sufficient to determine whether (1) 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.” See21 C.F.R. § 314.50 (2008); Mem. in Supp. of Pls.' Mot. for Summ. J. (“Pls.' Mot. Mem.”), Mar. 21, 2011, at 5 [Dkt. # 12].

The FDCA has separate provisions concerning the distribution of domestic and foreign drugs. See21 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. Pls.' 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 of HHS, see21 U.S.C. §§ 321(a)(2)(d), 360(i)(1)(A), and provide the Secretary with a list of all its imported drugs and devices, id. §§ 360(i)(2), 360(j). Also under the amended Act, the Secretary of HHS “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 of 21 U.S.C. section 355, ... then such article shall be refused admission.” ¹Id. 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 Pls.' Mot. for Summ. J. (“Pls.' 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 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)(1) (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. Compl. (“Compl.”), 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.” See21 U.S.C. § 321(g)(1); Compl. ¶ 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 Baze v. Rees, 553 U.S. 35, 44, 128 S.Ct. 1520, 170 L.Ed.2d 420 (2008); Pls.' Mot. Mem. at 12. Although once widely used by anesthesiologists, the FDA neither approved nor reviewed thiopental for safety and effectiveness. Compl. ¶ 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.”), Pls.' Mot., Mar. 21, 2011 [Dkt. # 12–4].

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. Compl. ¶¶ 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 Pls.' 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 Pls.' SUMF ¶¶ 35–37. In August, however, the FDA released the shipment to Georgia. Id. ¶ 39. In September 2010, 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 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 2011. Id. ¶¶ 66, 69, 71, 74. In September 2010, the FDA identified another shipment similar to the foreign thiopental shipped to Arizona. Id. 175.

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.” ⁴Id.

On July 1, 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...