The opinion of the court was delivered by: RICARDO URBINA, District Judge
GRANTING THE DEFENDANTS' MOTION TO DISMISS
Plaintiff Jerome Stevens Pharmaceuticals, Inc. ("Jerome") is a small
company that manufactures levothyroxine sodium ("LS") tablets under the
name of Unithroid. Jerome brings suit against the Food and Drug
Administration ("FDA"), Department of Health and Human Services ("HHS"),
and United States (collectively, "the defendants"*fn1) alleging
violations of the Federal Tort Claims Act ("FTCA"), 28 U.S.C. § 1346(b),
2671-2680; Administrative Procedure Act ("APA"), 5 U.S.C. § 701 et seq.;
and Fifth Amendment to the Constitution. The defendants moved to dismiss
Jerome's claims pursuant to Federal Rules of Civil Procedure 12(b)(1) and
(6). Because the court lacks subject-matter jurisdiction under the FTCA,
the APA and the Constitution, the court grants the defendants' motion to
dismiss. II. BACKGROUND
Since the 1950s, physicians have prescribed LS tablets for the
treatment of thyroid diseases. Compl. ¶ 8. In August 1997, however, FDA
issued a notice that new information had shown significant stability and
potency problems with currently marketed LS products, and that this lack
of stability and consistent potency had the potential to cause serious
public-health consequences. Id. ¶¶ 15-16 (citing 62 FED. REG. 43535 (Aug.
14, 1997)). Accordingly, notwithstanding the history of LS use, FDA
announced that orally administered LS products were "new drugs," and that
manufacturers wishing to continue marketing LS products would have to
submit New Drug Applications ("NDAs") for FDA approval by August 14, 2000
or be subject to adverse regulatory action. Id. ¶¶ 14, 17.
FDA initially set a deadline of August 14, 2000 for the NDA approval
date. Id. ¶ 17. In April 2000, however, a few months prior to the
deadline, FDA extended the deadline by one year, to August 14, 2001. Id.
¶ 29 (citing 65 FED. REG. 24488 (Apr. 26, 2000)). On August 21, 2000, FDA
approved Jerome's NDA, making Jerome's Unithroid the first LS drug
approved under the new requirements. Id. ¶ 30.
One day after the approval, FDA posted on its website information
that, according to Jerome, contained Jerome's confidential and
trade-secret information for Unithroid ("the Jerome information").*fn2
Id. ¶ 31. Jerome discovered this disclosure about four months later.
Id. ¶ 35. Jerome then notified FDA of the disclosure and demanded that
FDA remove the Jerome information from its website. Id. ¶¶ 35-37. FDA
removed some of the Jerome information on January 12, 2001, and, after receiving additional calls from Jerome,
removed the remaining information on January 23, 2001. Id. ¶¶ 38-41.
Meanwhile, in May 2001, PDA approved the NDA for Levoxyl, a competing
LS drug manufactured by Jones Pharma. Id. ¶¶ 51-52. Jones Pharma's Levoxyl
thereby became the second LS drug approved prior to the August 2001
deadline. Id. No other LS drugs including Synthroid, Abbott
Laboratories' LS drug that traditionally dominated the market received
NDA approval prior to the August 2001 deadline.*fn3 Id. ¶¶ 54-65.
In July 2001, one month before the August 2001 deadline, FDA announced
that it was "continu[ing] to exercise its enforcement discretion by
establishing a gradual phase-out of unapproved [LS] products." Id. ¶ 44
(quoting 66 FED. REG. 36794 (July 13, 2001)). Specifically, FDA stated
that those LS manufacturers who filed but did not receive approval for an
NDA ("the non-approved manufacturers") before the August 2001 deadline
could nonetheless continue marketing their LS products for another two
years through August 2003, although they had to gradually phase out
distribution during that period.*fn4 Id. ¶¶ 44-45. Jerome reports that
after FDA's announcement, Abbott Laboratories "flooded the retail market
with mass quantities of its then unstable LS drug product [Synthroid]."
Id. ¶ 47. Having lost de facto market exclusivity "due to PDA's
publication of its secrets and FDA's extensions of compliance deadlines," Jerome laid off 22 employees hired to supply the previously
anticipated demand for Unithroid, and Jerome's partner Watson
Laboratories destroyed drums of Unithroid valued at up to $33 million.
Jerome subsequently filed a six-count complaint in this courtz.*fn5
Id. ¶¶ 66-117. Counts one and two ("the tort claims") allege that the
defendants misappropriated Jerome's trade secrets and breached a
confidential relationship by disclosing the Jerome information via FDA's
website. Id. ¶¶ 66-86. Counts three and four ("the constitutional
claims") assert that the defendants violated Jerome's procedural and
substantive due-process Fifth Amendment rights by disclosing the Jerome
information. Id. ¶¶ 87-97. Finally, count five ("the APA disclosure
claim") and count six ("the APA deadline-extension claim") allege that
the defendants' failure to guard against disclosure of the Jerome
information and granting of the deadline extensions*fn6 qualify as
arbitrary and capricious under the APA. Id. ¶¶ 98-117. For relief, Jerome
seeks compensatory damages of more than $1.3 billion for the tort claims
and declaratory relief for the remaining claims. Id. ¶¶ 118-24. In
response, the defendants moved to dismiss for lack of subject-matter
jurisdiction and failure to state a claim on which relief may be
granted. The court now addresses the defendants' motion to dismiss. III. ANALYSIS
A. Legal Standard for a Motion to Dismiss Pursuant to
Federal courts are courts of limited jurisdiction and the law presumes
that "a cause lies outside this limited jurisdiction." Kokkonen v.
Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994); St. Paul Mercury
Indem. Co. v. Red Cab Co., 303 U.S. 283
, 288-89 (1938); see also Gen.
Motors Corp. v. Envtl. Prot. Agency, 363 F.3d 442
, 448 (D.C. Cir. 2004)
(noting that "[a]s a court of limited jurisdiction, we begin, and end,
with an examination of our jurisdiction").
Because "subject-matter jurisdiction is an `Art. III as well as a
statutory requirement[,] no action of the parties can confer
subject-matter jurisdiction upon a federal court.'" Akinseye v. District
of Columbia, 339 F.3d 970, 971 (D.C. Cir. 2003) (quoting Ins. Corp. of
Ir., Ltd. v. Compagnie des Bauxite de Guinea, 456 U.S. 694, 702 (1982)).
On a motion to dismiss for lack of subject-matter jurisdiction pursuant
to Rule 12(b)(1), the plaintiff bears the burden of establishing that the
court has subject-matter jurisdiction. Evans v. B.F. Perkins Co.,
166 F.3d 642, 647 (4th Cir. 1999); Rasul v. Bush, 215 F. Supp.2d 55, 61
(D.D.C. 2002) (citing McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178,
182-83 (1936)). The court may dismiss a complaint for lack of
subject-matter jurisdiction only if'"it appears beyond doubt that the
plaintiff can prove no set of facts in support of his claim which would
entitle him to relief" Empagran S.A. v. F. Hoffman-Laroche, Ltd.,
315 F.3d 338, 343 (D.C. Cir. 2003) (quoting Conley v. Gibson, 355 U.S. 41,
Because subject-matter jurisdiction focuses on the court's power to
hear the claim, however, the court must give the plaintiff's factual
allegations closer scrutiny when resolving a Rule 12(b)(1) motion than
would be required for a Rule 12(b)(6) motion for failure to state a
claim. Macharia v. United States, 334 F.3d 61, 64, 69 (D.C. Cir.
2003); Grand Lodge of Fraternal Order of Police v. Ashcroft, 185 F. Supp.2d 9, 13 (D.D.C.
2001). Moreover, the court is not limited to the allegations contained in
the complaint. Hohri v. United States, 782 F.2d 227, 241 (D.C. Cir.
1986), vacated on other grounds, 482 U.S. 64 (1987). Instead, to