ATZE AKKERMAN EVELYN SCOGIN DIANNA LOPER POSTHAUER GARY SIMONE RACHEL SMALL TONY BUONFIGLIO DR TOBY WATSON v. UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION ROBERT CALIFF (2024)

CORRECTED ORDER GRANTING DEFENDANTS' MOTION TO DISMISS (Doc. 38)

Before the Court is a motion to dismiss filed by Defendants United States of America, the U.S. Food and Drug Administration, and Robert M. Califf. (Mot., Doc. 38.) Plaintiffs Atze Akkerman, Evelyn Scogin, Dianna Loper Posthauer, Gary Simone, Rachel Small, Tony Buonfiglio, and Toby Watson opposed, and Defendants replied. (Opp., Doc. 38; Reply, Doc. 40.) Having held oral argument and for the reasons stated below, the Court GRANTS Defendants' motion, DENIES Plaintiffs' request for leave to amend, and DISMISSES this action WITH PREJUDICE.

I. BACKGROUND

A. Regulatory Background

Under the Food, Drug, and Cosmetic Act (“FDCA”), the U.S. Food and Drug Administration (“FDA”) classifies medical devices into three different classes (I, II, or III) depending on the level of regulatory control “sufficient to provide reasonable assurance of the safety and effectiveness” of a given device for its intended uses. 21 U.S.C. § 360c(a)(1). Class I devices are the lowest risk and receive the least regulation, while Class III devices are the highest risk and receive the most regulation. Classification can occur on a use-by-use basis; the FDA may, for example, classify a particular device as Class I for certain of its intended uses and Class II or III for its other intended uses.

Generally, a Class III device “is required to have ․ an approval ․ of an application for premarket approval.” 21 U.S.C. § 360e(a)(2). However, devices that were “introduced ․ into interstate commerce for commercial distribution before ․ 1976” require approval only if the FDA has issued an “administrative order” requiring premarket approval. Id. § 360e(b)(1)(A) (authorizing FDA to issue administrative orders on pre-1976 devices); id. § 360e(a)(1) (extending approval requirement to pre-1976 “subject to an order issued under subsection (b)”). Congress became concerned about the FDA's pace of issuing administrative orders for pre-1976 devices and directed the FDA to review the remaining pre-1976 class III devices not subject to premarket approval and either revise them to Class I/II or retain their Class III status and require an application for premarket approval. See Safe Medical Devices Act of 1990, Pub. L. No. 101-629, sec. 4(b)(1), § 515(i), 104 Stat. 4511, 4515 (codified as amended at 21 U.S.C. § 360e(i) (FDA “shall ․ revis[e] the classification of the device so that the device is classified into class I or class II, unless the administrative order ․ requires the device to remain in class III”)).

B. Factual Background

This action concerns the FDA's regulation of electroconvulsive therapy (“ECT”) devices. In 1979, the FDA classified ECT devices as Class III. See Neurological Devices; Classification of Electroconvulsive Therapy Devices, 44 Fed. Reg. 51,776, 51,776–77 (Sept. 4, 1979). In December 2015, the FDA issued a Proposed Order that would take two actions regarding ECT devices. See Neurological Devices; Reclassification of Electroconvulsive Therapy Devices, 80 Fed. Reg. 81,223, 81,223 (Dec. 9, 2015). First, the Proposed Order, if finalized, would reclassify ECT devices as Class II for use in “treating severe major depressive episode[s] associated with bipolar disorder in patients 18 years of age or older who are treatment-resistant or who require a rapid response.” Id. (abbreviation omitted). Second, the Proposed Order, if finalized, would retain Class III classification for five specified intended uses—including the treatment of catatonia—and require premarket approval for those devices. Id. at 81,223, 81,225.

In August 2015, about nine months after the FDA issued its Proposed Order on ECT devices, Plaintiffs submitted a citizen petition, requesting that the FDA either outright ban ECT devices or “maintain [their] Class III classification” for all purposes and require their premarket approval. (Citizen Petition, Doc. 34-1 at 2.) A few months after that, Plaintiffs supplemented their citizen petition. (Supplement to Citizen Petition, Doc. 34-2.)

On December 21, 2018, the FDA issued a Final Order on ECT devices, which was published in the Federal Register on December 26, 2018. See Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses (“Final Order”), 83 Fed. Reg. 66,103 (Dec. 26, 2018). (See FAC, Doc. 34 ¶¶ 70–71 (noting that the Final Order was “issued contemporaneous[ly]” with the December 21, 2018, denial letter described below).) The Final Order reclassified ECT devices as Class II for treatment of major depressive episodes and catatonia (instead of just the former, as proposed) for patients thirteen and older (instead of eighteen and older, as proposed) who are “treatment-resistant” or “require a rapid response.” Id. at 66,103, 66,120, 66,123–24. The Final Order otherwise maintained ECT devices' Class III classification and required their premarket approval. Id. at 66,124.

Also on December 21, 2018, the FDA denied Plaintiffs' citizen petition—repeatedly incorporating the Final Order into the denial letter. (See FAC, Doc. 34 ¶¶ 70–71; Petition Denial, Doc. 34-3 at 2, 3, 5, 6, 7, 8, 9, 10, 12, 13.) The crux of the FDA's Petition Denial was that the agency rejected Plaintiffs' request to ban or classify ECT devices as Class III for all uses because, as the agency concluded in its Final Order, “the special controls established in this final order, including performance data, technical parameters of the device, and extensive labeling requirements, along with general controls, can provide reasonable assurances of safety and effectiveness of ECT devices for the specified class II indications.” (Denial Letter, Doc. 34-3 at 6–7 (quoting Final Order).)

C. Procedural History

In September 2022, nearly four years after the Final Order and Petition Denial, Plaintiffs brought this action. (Compl., Doc. 1.) Plaintiff's First Amended Complaint alleges three causes of action under the Administrative Procedure Act (“APA”): (1) that the FDA acted arbitrarily and capriciously by denying their citizen petition; (2) that the FDA acted arbitrarily and capriciously by not requiring premarket approval “for all ECT devices” and, in the Final Order, instead “reclassif[ying] ECT devices to Class II” for certain uses; and (3) that the Final Order was not a logical outgrowth of the Proposed Order. (See FAC, Doc. 34 ¶¶ 118–84.)

II. LEGAL STANDARD

“If the court determines at any time that it lacks subject-matter jurisdiction, the court must dismiss the action.” Fed. R. Civ. P. 12(h)(3). While the Court is to “freely give leave [to amend] when justice so requires,” Fed. R. Civ. P. 15(a)(2), it need not do so if a jurisdictional infirmity is incurable such that any amendment to the complaint “would be futile,” Ebner v. Fresh, Inc., 838 F.3d 958, 968 (9th Cir. 2016). “[A] federal court has leeway ‘to choose among threshold grounds for denying audience to a case on the merits.’ ” Sinochem Int'l Co. v. Malaysia Int'l Shipping Corp., 549 U.S. 422, 431 (2007) (quoting Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 585 (1999)).

III. ANALYSIS

When the FDA issues an order that requires medical devices to have premarket approval and/or revises the classification of a medical device, a lawsuit challenging such an order may be brought only in a court of appeals and within thirty days. See 21 U.S.C. §§ 360g(a)(4), 360g(a)(9), 360e(i)(2). Plaintiffs, however, have brought such a lawsuit in district court nearly four years after the FDA issued the Final Order that they are challenging and with which the FDA's Petition Denial is inescapably intertwined. Therefore, this Court lacks subject-matter jurisdiction, Defendants' motion to dismiss is GRANTED, and this action is DISMISSED WITH PREJUDICE.

A. Claim 3: Direct Challenge to the Final Order

The Court lacks subject-matter jurisdiction over Plaintiffs' Claim 3 because it is a direct challenge to the Final Order.

Generally, an individual who has “suffer[ed] legal wrong because of agency action” can file an APA lawsuit in district court challenging the agency action. See 5 U.S.C. §§ 702, 703 (“court of competent jurisdiction”). Again as a general matter, APA actions are subject to a six-year statute of limitations. 28 U.S.C. § 2401; Perez-Guzman v. Lynch, 835 F.3d 1066, 1077 (9th Cir. 2016). These venue and statute-of-limitations provisions are, however, only default rules. Where Congress has created a “special statutory review proceeding relevant to the subject matter” in question, an individual must bring his or her action in the “court specified by statute.” Id. § 703; see also United Aeronautical Corp. v. U.S. Air Force, 80 F.4th 1017, 1022 (9th Cir. 2023) (“Where a statute vests exclusive jurisdiction over a category of claims in a specialized court (e.g., the Court of Federal Claims), it ‘impliedly forbids’ an APA action brought in federal district court.”); Owner-Operators Indep. Drivers Ass'n of Am., Inc. v. Skinner, 931 F.2d 582, 589 (9th Cir. 1991) (“[C]ourts uniformly hold that statutory review in the agency's specially designated forum prevails over general federal question jurisdiction in the district courts.”).

The FDCA provides that “any person adversely affected” by nine enumerated types of actions “may file a petition with ․ the circuit [i.e., court of appeals] wherein such person resides or has his principal place of business for judicial review of such regulation or order.” 21 U.S.C. § 360g(a). Two of the nine enumerated actions are relevant here. One action is “the promulgation of a regulation under paragraph (3) of section 360e(b) of this title requiring a device to have an approval of a premarket application.” Id. § 360g(a)(4). Another is an order “revising the classification of [a] device so that the device is classified into class I or class II.” Id. § 360g(a)(9), 360e(i)(2). Challenges to these enumerated actions are subject to a 30-day statute of limitations. Id. § 360(a).

The Final Order at issue here is subject to the FDCA's special-review provisions. The Final Order “revis[ed] the classification” of ECT devices “into class ․ II” for the treatment of major depressive episodes and catatonia for patients thirteen and older who are “treatment-resistant” or “require a rapid response.” Id. §§ 360g(a)(9), 360e(i)(2); Final Rule, 83 Fed. Reg. at 66,103, 66,120, 66,123–24. And as to ECT devices' other uses, it maintained their class III status and “requir[ed] [them] to have an approval of a premarket application.” Id. § 360g(a)(4); Final Rule, 83 Fed. Reg. at 66,124. Therefore, if a claim challenges the Final Order, then it must have been brought in a court of appeals within thirty days of the Final Order's issuance.

Claim 3, by its own terms, directly challenges the Final Order by alleging that “[t]he FDA acted in violation of 5 U.S.C. § 553(b) because the Final Order materially differed from the Proposed Order, and those materially different components were not logical outgrowths of the Proposed Order.” (FAC, Doc. 34 ¶ 171–84.)

Plaintiffs make three primary arguments in attempt to resist the conclusion that this Court lacks subject-matter jurisdiction over Claim 3; none is persuasive. First, Plaintiffs argue that the “may” in the FDCA's special-review provision indicates that proceeding under that provision is “an additional, but not exclusive, remedy.” (Opp., Doc. 39 at 28–29 (capitalization standardized).) Plaintiffs argue in a conclusory manner that the “[t]he plain language” of the FDCA, as well as its legislative history, “makes clear that Congress intended to expand—not narrow—the ability of aggrieved persons to challenge specific FDA actions.” (Id. at 20–22.)¹ But Plaintiffs provide no explanation of how this Court could plausibly read a provision specifying a thirty-day window for bringing a lawsuit to allow a plaintiff to ignore that timeframe and instead bring a lawsuit up to six years later in a different forum than Congress designated. Such a reading would render the FDCA's special-review provision—and its corresponding statute of limitations—superfluous.

Second, and relatedly, Plaintiffs seem to contend that no court has interpreted a similar jurisdictional provision containing “may” to provide for exclusive jurisdiction. (Opp., Doc. 39 at 32-33.) But Plaintiffs overlook that one of the authorities they cite did just that and construed statutory language that a “person ․ may apply for review ․ by filing a petition for review ․ in the court[s] of appeals” as vesting “exclusive jurisdiction” in the courts of appeals. Latif v. Holder, 686 F.3d 1122, 1124 & n.1, 1127 (9th Cir. 2012) (quoting 49 U.S.C. § 46110(a)). (Opp., Doc. 39 at 28 (citing Latif).)

Third, Plaintiffs emphasize that the FDCA contains a savings clause, which provides that “[t]he remedies provided for in [the special-review] section shall be in addition to and not in lieu of any other remedies provided by law.” 21 U.S.C.A. § 360g(e). But the APA contains its own limitation that, where there is a “special statutory review proceeding relevant to the subject matter” in question, a litigant must bring its action in the “court specified by statute.” 5 U.S.C. § 703. The FDCA's savings clause cannot save a remedy for Plaintiffs when that remedy, by its own terms, does not apply.²

B. Claims 1 and 2: Challenges Inescapably Intertwined with the Final Order

The Court also lacks subject-matter jurisdiction over Plaintiffs' Claims 1and 2. Where, like here, a special-review provision vests exclusive jurisdiction in a forum over challenges to a particular category of agency action, that forum's “jurisdiction similarly extends to claims that are ‘inescapably intertwined with a review of the procedures and merits surrounding’ ” that category of agency action. Seraji v. Gowadia, No. 8:16-cv-01637-JLS-JCG, 2017 WL 2628545, at *7 (C.D. Cal. Apr. 28, 2017) (quoting Gilmore v. Gonzales, 435 F.3d 1125, 1133 n.9 (9th Cir. 2006)). When conducting this inquiry, courts ask whether the challenged agency action is “functionally similar or tantamount to th[e] specified action[ ]”or whether the plaintiff's lawsuit, “as a practical matter,” challenges the category of action subject to the special-review provision. Cal. Energy Comm'n v. Dep't of Energy, 585 F.3d 1143, 1148 (9th Cir. 2009) (cleaned up); Cal. Dump Truck Owners Ass'n v. Nichols, 784 F.3d 500, 502 (9th Cir. 2015). Such a functional approach is necessary to prevent litigants from sidestepping Congress's carefully prescribed limits on district courts' subject-matter jurisdiction “through clever pleading.” United Aeronautical Corp, 80 F.4th at1029; see also Nader v. EPA., 859 F.2d 747, 753 (9th Cir. 1988) (discussing concerns with the “deliberate flouting” of special-review provisions imposing shorter statutes of limitations).

Plaintiffs do not contest that the Ninth Circuit has previously interpreted special-review provisions to cover challenges “inescapably intertwined” with the regulatory actions enumerated by such provisions. (See Opp., Doc. 39 at 28.) Instead, Plaintiffs attempt to limit those Ninth Circuit decisions to their facts, arguing that the decisions simply “prevent a plaintiff from relitigating in tort the merits” of a TSA “administrative proceeding.” (Id.) The Court rejects Plaintiffs' argument. As an initial matter, the doctrine has not been applied in the limited manner Plaintiffs contend; agency decisions other than TSA administrative proceedings and lawsuits other than tort actions have been found to be inescapably intertwined. See Cal. Energy Comm'n, 585 F.3d at 1148 (Department of Energy's decision on petition for preemption waiver); Cal. Dump Truck Owners Ass'n v. Nichols, 784 F.3d at 502 (enforcement of EPA state implementation plan); Gilmore, 435 F.3d at 1133 n.9 (constitutional due process claim related to TSA action). More fundamentally, Plaintiffs point to nothing in these decisions' reasoning that supports their argument that the Ninth Circuit's decisions are agency-or fact-specific decisions that cannot be relied upon in analogous contexts.

At oral argument, Plaintiffs raised an argument not contained in their briefs: that the “inescapably intertwined” doctrine is categorically inapplicable to citizen petitions. While the Court rejects Plaintiffs' categorical argument, it does acknowledge that the “inescapably intertwined” doctrine must be applied with caution to agency denials of citizen petitions. A citizen petition is a request for an agency to address an issue it has not yet taken up or to revisit a prior decision and reach a different outcome. See 5 U.S.C. § 553(e) (“Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.”) Particularly in the latter context, there will be similarity between the prior agency action and the petition asking the agency to reverse course. In the normal run, such a petition should not be deemed “inescapably intertwined” with the prior agency action. Otherwise, the “inescapably intertwined” doctrine would displace the APA's provision of the right to petition agencies for action.

This lawsuit, however, does not involve a run-of-the-mill citizen petition. Plaintiffs' petition was not the prototypical one filed years after agency action asking an agency to change course on the basis of newly obtained evidence. Instead, Plaintiffs filed a citizen petition regarding the regulation of ECT devices after the FDA had promulgated a Proposed Order on the very same subject and while the FDA was soliciting comments on the very same subject. The FDA then issued its Petition Denial contemporaneously with its Final Order—while expressly incorporating the reasoning of the Final Order into its Petition Denial. (See FAC, Doc. 34 ¶¶ 70–71; Denial Letter, Doc. 34-3 at 2, 3, 5, 6, 7, 8, 9, 10, 12, 13.) At oral argument, Plaintiffs could not identify any evidence that was before the FDA for the petition but not before the FDA for the order (or visa-versa). And while Plaintiff's Claims 1 and 2 at times nominally challenge the Petition Denial, the allegations supporting those claims repeatedly discuss the Final Order. (See, e.g., FAC, Doc. 34 ¶ 90 (alleging that “[t]he Final Order conceded that FDA did not weigh material evidence”); id. ¶ 91 (alleging that “[t]he Final Order also revealed that FDA's decision ․ was based on the very same evidence that FDA possessed before it issued the Proposed Order”); id. ¶ 92 (alleging that “[t]he labelling requirements set forth in the Final Order misrepresent the body of science supporting the warnings provided”); id. ¶ 93 (alleging that the “Final Order ․ was not based on proper data”).)

Given this case's unique circumstances, the Court concludes this is an instance in which the “inescapably intertwined” doctrine can properly be applied to a lawsuit challenging the denial of a citizen petition. Indeed, the opposite outcome would allow parties to thwart Congress's decision to make certain FDA actions susceptible to challenge only in a court of appeals and subject only to an expedited thirty-day statute of limitations. If the Court were to accept Plaintiffs' position, a litigant could nullify Congress's decision to impose a thirty-day statute of limitations simply by taking a comment it submitted to the FDA regarding a proposed order and copy-pasting that comment into a citizen petition.

Such a result would contradict the Ninth Circuit's guidance not to allow litigants to sidestep limits on judicial review “through clever pleading.” United Aeronautical Corp, 80 F.4th at 1029. And it would run counter to the Ninth Circuit's specific instruction not to permit litigants to “deliberate[ly] flout[ ]” the FDCA's limitations on review through the use of citizen petitions filed simultaneously with related agency action:

If parties were free simply to file petitions, await their denial, and then be assured of jurisdiction ․, there would be little incentive to comply with the procedural provisions of the FDCA that require direct appeals from a regulation to be made within the statutory time period․ If Congress had intended such a result, it is unlikely it would have prescribed a fixed deadline for appeals from regulations․

Petitioners filed their petition while a proposed regulation on its very subject matter was open for comment. When their petition was denied and the Agency's regulation adopted, they chose not to object to the new regulation ․ nor to appeal from the regulation.

Nader, 859 F.2d at 753. The Court lacks subject-matter jurisdiction over Plaintiffs' Claims 1 and 2 because they are “inescapably intertwined” with the Final Order.

C. Dismissal, Not Transfer, is Appropriate

The Court DENIES Plaintiffs' request that this Court transfer this action to the Ninth Circuit instead of dismissing it. (Opp., Doc. 39 at 33–35.)

Where a “court finds that there is a want of jurisdiction, the court shall, if it is in the interest of justice, transfer such action or appeal to any other such court ․ in which the action or appeal could have been brought at the time it was filed or noticed.” 28 U.S.C. § 1631. The Ninth Circuit has held that transfer under this provision is “not ․ permitted” if, at the time the lawsuit was filed, the statute of limitations had already run. See Nuclear Info. & Res. Serv. v. U.S. Dep't of Transp. Rsch. & Special Programs Admin., 457 F.3d 956, 962 (9th Cir. 2006) (“The Hobbs Act requires that a challenge to an agency action be filed within sixty days. [Plaintiff] filed its district court action more than 60 days after DOT denied [Plaintiff's] administrative appeal. Accordingly, transfer to the court of appeals would not have been permitted under § 1631.”).

Here, the Final Order was published in the Federal Register on December 26, 2018. (See Final Order, 83 Fed. Reg. 66,103.) Plaintiffs, however, did not file this lawsuit until September 16, 2022—nearly four years after the Final Order. (See Compl., Doc. 1.) Therefore, Plaintiffs' lawsuit could not “have been brought” in the Ninth Circuit “at the time it was filed,” 28 U.S.C. § 1631, and transfer is “not ․ permitted,” Nuclear Info., 457 F.3d at 962. Plaintiffs make three arguments in support of their request for a transfer to the Ninth Circuit; the Court rejects each of them.

First, Plaintiffs argue that the FDCA's thirty-day statute of limitations had not lapsed because the “FDA never served [Plaintiff] Watson with the ․ Final Order.” (Opp., Doc. 39 at 34.) But the Final Order was published in the Federal Register, and 44 U.S.C. § 1507 provides that “publication in the Federal Register ․ is sufficient to give notice of the contents of the document to a person subject to or affected by it.” (Reply, Doc. 40 at 30.) Moreover, the out-of-circuit case that Plaintiffs cite for their notice argument does not help them. (See id. (citing Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993)). Consistent with the text of section 1507, the Seventh Circuit in Northwest Tissue simply held that “contents” of a document published in the Federal Register may have been sufficiently ambiguous to not put Plaintiffs on notice of the intended course of regulation. See Nw. Tissue, 1 F.3d at 536 (“We remand the case to the district court to examine whether the agency provided adequate notice of its intention to regulate allografts ․ The court should consider the content of the agency's publications in the Federal Register, including the scientific literature the agency cited.”). Plaintiffs do not make such an argument here. Nor could they, given the unambiguous nature of the Final Order, which reclassified ECT devices as Class II for treatment of major depressive episodes and catatonia for patients thirteen and older who are “treatment-resistant” or “require a rapid response,” and otherwise maintained ECT devices' Class III classification and required their premarket approval. (Final Order, 83 Fed. Reg. at 66,103 66,120, 66,123–24.)

Second, Plaintiffs argue that the FDCA's statute of limitations should not apply in this case because the FDA did not issue its Final Order by the target date that Congress set for the agency. (Opp., Doc. 39 at 35–37.) None of Plaintiffs' authorities support its novel argument that, where an agency misses a statutory deadline for a regulatory action, a court can overlook a different statutory deadline governing the judicial review of such an action. Instead, if Plaintiffs were dissatisfied with the speed of the FDA's regulation of ECT devices, they could have filed a lawsuit attempting to “compel agency action unlawfully withheld or unreasonably delayed.” 5 U.S.C. § 706(1).

Third, Plaintiffs argue that the Court should not consider the statute-of-limitations issue when deciding whether to transfer this action to the Ninth Circuit. (Opp., Doc. 39 at 35.) In support, Plaintiffs cite Pentax Corp. v. Myhra, 72 F.3d 708 (9th Cir. 1995), but the circumstances of that case are far removed from those here. In that case, the Ninth Circuit held that the district court lacked subject-matter jurisdiction and expressed only the provisional conclusion that, “if judicial review is available at all,” it would be in a specialized tribunal, the Court of International Trade (“CIT”). Id. at 710. Rather than wade into the unfamiliar jurisdictional and procedural limits of a specialized tribunal, the Ninth Circuit held that, “[i]n this circumstance,” the “prudent thing to do is to direct the district court to transfer the case to the CIT so that the CIT can determine” its jurisdiction and the application of any statute of limitations. Id. at 711. This case, by contrast, resembles Nuclear Info., 457 F.3d 956. Because it is plain that the 30-day statute of limitations had run by the time of filing and Plaintiffs' arguments to the contrary are easily rejected, transfer to the Ninth Circuit is “not ․ permitted.” Id. at 962.³

D. Leave to Amend is Denied

The Court DENIES Plaintiffs' request for leave to amend because any amendment “would be futile.” Ebner, 838 F.3d at 968. Plaintiffs make the conclusory argument that “Plaintiffs can ․ Cure deficiencies otherwise subject to dismissal.” (Opp., Doc. 39 at 39.) But Plaintiffs identify no specific amendments; nor can the Court envision any that would bring this action within the Court's subject-matter jurisdiction. Plaintiff's action is “inescapably intertwined” with the Final Order—a category of agency action that may be reviewed only in a court of appeals within 30 days of the Final Order's issuance.

IV. CONCLUSION

For the foregoing reasons, the Court GRANTS Defendants' motion to dismiss, DENIES Plaintiffs' request for leave to amend, and DISMISSES this action WITH PREJUDICE. Within five days of this Order, Defendants shall file a proposed Judgment.

FOOTNOTES

1.   Plaintiffs, for example, cite a committee report noting “that some actions to be taken under the proposed bill involve extremely significant economic and public health considerations.” (Opp., Doc. 22.) They do not, however, specify how this supports their interpretation.

2.   Plaintiffs also cite two cases that were filed directly in courts of appeals under a special-review provision in which the courts of appeal exercised original jurisdiction; according to Plaintiffs, these decisions support their interpretation of the FDCA because the courts of appeal did not go out of their way to specify that, had the suits been filed in district court, the district court would have lacked jurisdiction. (Opp., Doc. 39 at 33 (citing Cytori Therapeutics, Inc. v. FDA, 715 F.3d 922, 925 (D.C. Cir. 2013); Cal. Energy Comm'n v. Dep't of Energy, 585 F.3d 1143 (9th Cir. 2009).) For obvious reasons, the absence such a discussion in those cases does not provide a basis for concluding that district court jurisdiction exists.

3.   Alternatively, even if transfer were “permitted” under section 1631, the Court would conclude for the same reasons that transfer would not be “in the interest of justice.”

HON. JOSEPHINE L. STATON UNITED STATES DISTRICT JUDGE