Donald Cook, Plaintiff, v. KENNEDY JR (2026)

ORDER ON MOTION FOR PRELIMINARY INJUNCTION

I. INTRODUCTION

This case is before me on plaintiff Donald Cook's motion (Doc. 2) for preliminary injunction. The Government has filed a resistance (Doc. 11) and Cook has filed a reply (Doc. 13). On October 20, 2026, I heard oral arguments by teleconference. The written and oral arguments by both parties were well-presented and helpful.

II. BACKGROUND

Cook is a Medicare Part D beneficiary who suffers from a rare, life-threatening medical condition known as acquired angioedema (AAE). Doc. 1 ¶¶ 1, 16. AAE causes unpredictable episodes or “attacks” of severe swelling (known as edema) in various parts of the body. Id. ¶ 16. These attacks can cause fatal asphyxiation by obstructing the upper airway. Id. Cook has experienced recurrent AAE attacks since 2021. Id. The attacks frequently required him to visit the emergency room. Id. ¶ 26. Hospital staff prescribed him antihistamines, prednisone and plasma to treat his attacks, but these treatments did not resolve his symptoms. Id. ¶ 20.

Because Cook took an ACE inhibitor, Lisinopril, he was initially diagnosed with ACE-inhibitor-related angioedema. Id. ¶ 22. But his attacks continued even after he stopped using the ACE inhibitor in May 2023, ruling out that diagnosis. Id. Cook's immunologist performed laboratory tests and diagnosed him with AAE in February 2024. Id. ¶ 23. In September 2024, his immunologist prescribed him Icatibant ¹ to stop the AAE attacks. Id. ¶ 24. Icatibant effectively treats Cook's AAE attacks and resolves the swelling and pain within a few hours. Id. ¶ 25. Cook continues to have attacks but has not needed to visit the emergency room due to an attack since receiving his prescription for Icatibant. Id. ¶¶ 26–27.

Cook's Medicare Part D plan covered his Icatibant until December 2025, when it denied coverage for 2026, stating it was not prescribed for a medically accepted indication because his immunologist prescribed it for AAE. Id. ¶¶ 39, 41; Doc. 2-3 at 1. Without insurance coverage, each dose of Icatibant costs $3,000. Doc. 1 ¶ 28. Because Cook may need more than one dose to halt an AAE attack, his immunologist prescribes him a three-dose series. Id. ¶¶ 29–30. But Cook can afford to purchase only one dose at a time and rations his medication administration so that he can treat potentially fatal attacks. Id. ¶¶ 28, 31. Because of the cost, he “has refrained from administering Icatibant for approximately 80% of his AAE attacks,” forcing him to endure painful non-fatal attacks that can last up to three or four days. Id. ¶ 32.

As of the filing of his complaint on August 26, 2026, Cook had already suffered four “potentially fatal AAE attacks involving his face, lips, tongue, or throat” in 2026. Id. ¶ 54. Cook contends that as “AAE attacks occur unpredictably and can cause rapid upper airway obstruction and fatal asphyxiation within hours, denial of coverage leaves [him] without a reliable, on-demand abortive therapy.” Id. ¶ 52. He argues this coverage denial impacts his access to Icatibant and “poses an imminent, irreparable risk of severe physical harm or death.” Id. The price of the Icatibant has forced him “to ration his purchases of the drug.” Id. ¶ 54.

Cook contends that he is entitled to Medicare Part D coverage of Icatibant because his “use of Icatibant is for a medically accepted indication within the meaning of § 1927(k)(6) of the Social Security Act, codified at 42 U.S.C. § 1396r-8(k)(6).” Id. ¶ 51. To understand the issues at play, it is necessary to cover both the statutory and regulatory framework of Medicare Part D, as well as the facts and prior proceedings of this case.

A. Statutory and Regulatory Framework of Medicare Part D

In Dobson v. Secretary of Health & Human Services, No. 20-11996, 2022 WL 424813 (11th Cir. Feb. 11, 2022), the Eleventh Circuit Court of Appeal provided the following explanation of the applicable statutory and regulatory framework surrounding Medicare Part D:

In its current iteration, Medicare is a federal health-insurance program for those who are at least 65 years old and for the disabled, among others. 42 U.S.C. § 1395 et seq. Medicare traces its roots to 1965, when Congress, as part of the Social Security Act, originally created the program.

In 2003, Congress added Medicare Part D—a subsidized prescription drug benefit program. Jennifer O'Sullivan, Medicare Part D Prescription Drug Benefit: A Primer, Cong. Rsch. Serv. 1 (Aug. 20, 2008). https://www.everycrsreport.com/files/20080820_RL34280_e39d4ec97b38 63a3a1184d12f5aa790527fd3174.pdf. To administer Medicare Part D, the Centers for Medicare & Medicaid Services (“CMS”), a part of the U.S. Department of Health and Human Services, contracts with private insurers, called “plan sponsors,” to provide prescription drug coverage to Medicare beneficiaries for “covered part D drugs.” 42 U.S.C. §§ 1395w-111 to 1395w-112.

Beneficiaries who enroll in Part D select their preferred sponsor and pay out-of-pocket expenses, such as monthly premiums and deductibles. Id. § 1395w-102(b); see also Akebia Therapeutics, Inc. v. Azar, 976 F.3d 86, 89 (1st Cir. 2020) (providing background on Part D). The sponsors then receive reimbursements from the Medicare program for the cost of the covered drugs. Id. at 89.

A Medicare Part D plan will cover the cost of only those prescription drugs that are considered “covered part D drugs.” Id. § 1395w-102(e)(1). The statute defines “covered part D drug[s]” as those that are used “for a medically accepted indication.” Id. In turn, the statute defines “medically accepted indication” as “any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i).” 42 U.S.C. § 1396r-8(k)(6); see also id. § 1395w-102(e)(4)(A)(ii) (incorporating definition from § 1396r-8(k)(6)).

Uses approved by the FDA are called “on-label” uses, while those that are not are called “off-label” uses. So Medicare Part D covers (1) “on-label” uses and (2) “off-label” uses that are “supported by one or more citations included or approved for inclusion in” approved drug compendia. 42 U.S.C. § 1396r-8(k)(6).

The governing statute lists three approved compendia that may provide a supporting citation for an off-label use. The compendia are “large reference books that contain a variety of information about the prescription pharmaceuticals currently available on the American market—everything from their chemical makeup to potential side-effects to the age ranges of patients the drugs have been tested on.” United States v. King-Vassel, 728 F.3d 707, 715 (7th Cir. 2013). As relevant here, one of the three approved compendia is known as the DRUGDEX Information System (“DRUGDEX”). 42 U.S.C. § 1396r-8(g)(1)(B)(i).

Id. at *1–2 (alterations in original).

B. Factual Background and Prior Proceedings

Two types of angioedema are relevant to this case: hereditary angioedema (HAE) and AAE. Doc. 2-2 at 2. These conditions have identical pathophysiology – “C1 inhibitor deficiency leading to excess bradykinin production.” Id. “Bradykinin is the direct mediator of the vascular permeability changes that cause the clinical symptoms of angioedema in both conditions.” Id. at 3. “[I]catibant's mechanism of action is equally effective regardless of the etiology of C1 inhibitor deficiency.” Id. at 2. Regardless of the reason for bradykinin overproduction, “Icatibant blocks the same receptor and prevents the same downstream vascular effects. Id. at 3–4. While Icatibant is FDA-approved to treat HAE (Doc. 2-6 at 2), AAE is ten-fold rarer and no on-label treatment exists for the condition. Doc. 2-2 at 5. The compendium DRUGDEX lists the treatment of ACE-inhibitor-induced angioedema and adverse reaction to fibrinolytic drugs as off-label uses for Icatibant. Doc. 2-6 at 3.

When Cook applied for coverage of Icatibant for his 2026 plan, his plan provider denied coverage because he did not have HAE. Doc. 2-3 at 1. Following denials at the reconsideration, independent contractor and administrative law judge levels, Cook timely appealed the decision to the Medicare Appeals Council (MAC). Doc. 2-4 at 6; Doc. 2-5 at 3. The MAC adopted the administrative law judge's decision, stating “that the Plan is not required to preauthorize coverage for [Icatibant] because it is not prescribed to the appellant for a medically accepted indication and, as such, is not a covered Part D drug.” Doc. 2-5 at 3. The MAC observed that the only on-label use for Icatibant was to treat HAE and that it could be used off-label to treat ACE-inhibitor-induced angioedema. Id. at 5. The MAC determined that “because the compendia citations do not address the use of the drug to treat acquired angioedema and only include disease-specific indications for other forms of angioedema, we cannot conclude that the appellant's use of the drug is ‘supported by’ the compendia.” Id. at 6.

Cook brings this action pursuant to 42 U.S.C. § 1395w-104(h)(1), which incorporates the requirements of 42 U.S.C. §§ 405(g) and 1395w-22(g)(5). Doc. 1 ¶ 6. He seeks judicial review of the Government's decision to deny him Medicare Part D coverage of Icatibant. See id.

III. ANALYSIS

Cook seeks a preliminary injunction to enjoin the Government from denying him Medicare Part D coverage for Icatibant while this action is pending. Doc. 2 at 1. He contends (1) that the MAC erred by applying a “disease-matching” requirement and (2) that DRUGDEX supports off-label use for AAE because it shares a root pathology with HAE. Id. at 2. He alleges that he faces irreparable harm absent an injunction because Icatibant's price prevents him from purchasing complete fills, requiring him “to ration medication [and] exposing him to constant risk of fatal upper airway obstruction and asphyxiation.” Id. at 2–3. He argues that the balance of equities and public interest also favor him. Id. at 3. He further requests that I waive the security bond requirement. Id.

A. Preliminary Injunction Standard

The purpose of a preliminary injunction “is to preserve the status quo until, upon final hearing, a court may grant full, effective relief.” Cigna Corp. v. Bricker, 103 F.4th 1336, 1342 (8th Cir. 2024) (quoting Ferry-Morse Seed Co. v. Food Corn, Inc., 729 F.2d 589, 593 (8th Cir. 1984)). “The status quo is the last uncontested status which preceded the pending controversy.” Minn. Min. & Mfg. Co. v. Meter ex rel Nat'l. Lab. Rev. Bd., 385 F.2d 265, 273 (8th Cir. 1967) (citations omitted). The parties disagree on the nature of this uncontested status. I agree with Cook that the last uncontested status was the Government's authorization of coverage for Icatibant. Indeed, I find the Government's contention that the status quo magically resets each plan year to be downright foolish. Cook's immunologist diagnosed him with AAE in February 2024 and first prescribed Icatibant in September 2024. Thus, during the entire time the Government authorized Medicare Part D coverage for Cook's use of Icatibant, the drug was prescribed to treat AAE, not HAE or ACE-inhibitor-related angioedema. Having previously approved Icatibant to treat AAE, the Government created the current controversy by withdrawing that approval for the 2026 plan year. The preliminary injunction that Cook seeks would, if otherwise appropriate, properly return the parties to their “last uncontested status.”

Relatedly, but no more persuasively, the Government argues that Cook faces a higher burden because he seeks a mandatory injunction. Doc. 11 at 6. “[T]he burden is higher on a party that seeks a mandatory preliminary injunction—one which ‘alters the status quo by commanding some positive act, as opposed to a prohibitory injunction seeking only to maintain the status quo.’ ” TruStone Fin. Fed. Credit Union v. Fiserv, Inc., No. 14-CV-424, 2014 WL 12603061, at *1 (D. Minn. Feb. 24, 2014) (quoting Cacchillo v. Insmed, Inc., 638 F.3d 401, 406 (2d Cir. 2011)). Here, Cook seeks to maintain the status quo – coverage of Icatibant - pending the resolution of this matter. As such, he is not seeking a mandatory injunction but rather a prohibitory injunction.

Having defined the status quo, and the type of injunction Cook seeks, I will now consider the standard for a preliminary injunction. The Eighth Circuit Court of Appeals has stated:

When evaluating whether to issue a preliminary injunction, a district court should consider four factors: (1) the threat of irreparable harm to the movant; (2) the state of the balance between this harm and the injury that granting the injunction will inflict on other parties; (3) the probability that the movant will succeed on the merits; and (4) the public interest.

Roudachevski v. All–Am. Care Ctrs., Inc., 648 F.3d 701, 705 (8th Cir. 2011) (citing Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109, 114 (8th Cir. 1981) (en banc)). In this circuit, these are often referred to as the “Dataphase” factors. While no single factor is dispositive, the Eighth Circuit has stated that “likelihood of success on the merits is most significant.” Laclede Gas Co. v. St. Charles Cnty., Mo., 713 F.3d 413, 419 (8th Cir. 2013) (quoting Minn. Ass'n of Nurse Anesthetists v. Unity Hosp., 59 F.3d 80, 83 (8th Cir. 1995)).

In applying these factors, the court must keep in mind that a preliminary injunction is an “extraordinary remedy never awarded as of right.” Morehouse Enters., LLC v. Bureau of Alcohol, Tobacco, Firearms & Explosives, 78 F.4th 1011, 1016 (8th Cir. 2023) (citation omitted). As such, the party seeking injunctive relief bears the burden of proving that it is appropriate. Roudachevski, 648 F.3d at 705. “When there is an adequate remedy at law, a preliminary injunction is not appropriate.” Watkins Inc. v. Lewis, 346 F.3d 841, 844 (8th Cir. 2003) (citing Mod. Comput. Sys., Inc. v. Mod. Banking Sys., Inc., 871 F.2d 734, 738 (8th Cir. 1989)).

1. Irreparable Harm

Although likelihood of success on the merits is often described as the most significant factor in a preliminary injunction analysis, a failure to show irreparable harm may be dispositive. Adventist Health Sys./SunBelt, Inc. v. United States Dep't of Health & Hum. Servs., 17 F.4th 793, 806 (8th Cir. 2021) (“The failure to show irreparable harm is an ‘independently sufficient basis upon which to deny a preliminary injunction.’ ”) (citation omitted); see also Glenwood Bridge, Inc. v. City of Minneapolis, 940 F.2d 367, 371 (8th Cir. 1991) (irreparable harm is a “threshold inquiry” in granting or denying preliminary injunction). Thus, I will begin my analysis with this factor.

“It is well established that [i]rreparable harm occurs when a party has no adequate remedy at law, typically because its injuries cannot be fully compensated through an award of damages.’ ” Grasso Enters., LLC v. Express Scripts, Inc., 809 F.3d 1033, 1040 (8th Cir. 2016) (quoting Gen. Motors Corp. v. Harry Brown's, LLC, 563 F.3d 312, 319 (8th Cir.2009)) (alterations in original). “To demonstrate irreparable harm, ‘a party must show that the harm is certain and great and of such imminence that there is a clear and present need for equitable relief.’ ” Morehouse Enters., LLC, 78 F.4th at 1017 (quoting Dakotans for Health v. Noem, 52 F.4th 381, 392 (8th Cir. 2022)); see also Tumey v. Mycroft AI, Inc., 27 F.4th 657, 665 (8th Cir. 2022) (“The movant must show that ‘irreparable injury is likely in the absence of an injunction,’ not merely a ‘possibility’ of irreparable harm before a decision on the merits can be rendered.”) (emphasis in original) (quoting Winter v. Natural Resources Defense Council, Inc., 555 U.S. 7, 22, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008)). The irreparable harm requirement is demanding. See Am. Meat Inst. v. U.S. Dep't of Agric., 968 F. Supp. 2d 38, 75 (D.D.C. 2013) (“There is no doubt that ‘[t]he irreparable injury requirement erects a very high bar for a movant.’ ”) (quoting Coal. for Common Sense in Gov't Procurement v. United States, 576 F. Supp. 2d 162, 168 (D.D.C. 2008)).

Cook argues that he has shown irreparable injury. Doc. 2-1 at 14. He claims that he “has no remedy at law because he cannot recover damages from the Secretary due to sovereign immunity.” Id. at 15. He alleges that since the beginning of 2026, he has suffered four potentially fatal AAE attacks involving his tongue, throat, lips and face that required him to administer Icatibant. Id. He claims that because the medication is $3,000 per dose, he cannot afford a full three-dose prescription and “cannot continue to afford a single dose.” Id. He contends that the Government's denial of coverage forces him to ration the doses, exposing “him to the risk of sudden upper airway swelling, severe physical trauma, and fatal asphyxiation.” Id. Cook argues that “serious injury or death ․ is a certainty and not merely a possibility without Icatibant readily available in sufficient dosage.” Id. He contends that the Government's withholding of coverage that he needs to pay for treatment of his life-threatening illness causes irreparable injury. Id. at 15–16 (citing Kai v. Ross, 336 F.3d 650 (8th Cir. 2003) and Harris v. Blue Cross Blue Shield of Mo., 995 F.2d 877 (8th Cir. 1993)).

The Government contends that Cook does not face irreparable harm from the denial of coverage. Doc. 11 at 11. The Government argues that the denial of preauthorization is not irreparable harm because it is merely financial harm that can be remedied through money damages. Id. at 12. While the Government acknowledges that sovereign immunity prevents money damages in this case, it asserts that after purchasing the medication, he can litigate coverage. Id. at 13. The Government contends Cook “provides no evidence of his financial condition, the availability of Icatibant in an emergency, or the likelihood that treatment will require more than one dose.” Id. at 13. The Government argues that “[o]n this record, nothing prevents [Cook] from purchasing Icatibant himself and paying out of pocket.”² Id.

Cook distinguishes the cases cited by the Government, contending they “involved administrative claims where post-payment reimbursement offered a complete remedy without threatening the lives of Medicare beneficiaries.” Id. He argues that when “an unlawful coverage denial forces a beneficiary to forego or ration life-saving medication, the harm is physical and imminent, rendering monetary remedies wholly inadequate.” Id.

As to the Government's argument that Cook has failed to support his factual contentions, the Government overlooks that Cook filed a verified complaint signed under penalty of perjury. Doc. 1 at 18. This is sufficient evidence to support a preliminary injunction. See Doe v. S. Iron R-1 Sch. Dist., 498 F.3d 878, 880 (8th Cir. 2007) (affirming preliminary injunction a court granted based on verified complaint and other documents); St. Jude Med. S.C., Inc. v. Saxon, No. CIV. 13-2332, 2013 WL 6481440, at *6 n.2 (D. Minn. Dec. 10, 2013) (noting that the court could “consider the allegations in [the] verified complaint as evidence for the purposes of [a] preliminary injunction motion”); K-2 Ski Co. v. Head Ski Co., 467 F.2d 1087, 1088 (9th Cir. 1972) (“A verified complaint or supporting affidavits may afford the basis for a preliminary injunction ․”).

In his verified complaint, Cook alleges that the cost of Icatibant without coverage forces him to ration his drug purchases. Doc. 1 at ¶ 54. Cook contends that as “AAE attacks occur unpredictably and can cause rapid upper airway obstruction and fatal asphyxiation within hours, denial of coverage leaves [him] without a reliable, on-demand abortive therapy.” Id. ¶ 52. He argues this coverage denial impacts his access to Icatibant, posing “an imminent, irreparable risk of severe physical harm or death.” Id.

A coverage denial that prevents patients from purchasing medication needed to treat life-threatening illnesses causes an irreparable injury. In Harris v. Blue Cross Blue Shield of Missouri, 995 F.2d 877 (8th Cir. 1993), the Eighth Circuit observed that “the denial of coverage for treatment of a life[-]threatening illness” caused irreparable injury but remanded the appeal because the dispute was moot. Id. at 879–80. Similarly in Kai v. Ross, 336 F.3d 650 (8th Cir. 2003), the court considered whether individuals suffered an irreparable injury when Nebraska modified how it administered Medicaid benefits. Id. at 651–56. In granting the preliminary injunction, the court held that “the danger to plaintiffs' health, and perhaps even their lives, [gave] them a strong argument of irreparable injury.” Id. at 656.

The Government posits that while it “has not waived sovereign immunity to permit the payment of damages in a claim arising from Medicare, a participant can litigate whether an item or service is covered under a Part D Plan after the item is provided or the service is rendered.” Doc. 11 at 12–13. However, the issue is not whether Cook might someday be reimbursed for his purchases of Icatibant. Instead, Cook has made a sufficient showing at this stage of the case that without coverage, he cannot afford to purchase the amount of medication needed to treat an AAE attack, which could prove fatal. Considering these facts, Cook has shown irreparable injury.

2. Likelihood of Success on the Merits

Cook argues that he shows a high likelihood of success on the merits under two legal theories. Doc. 2 at 2. First, he contends that the MAC committed a reversible legal error by requiring a “disease-matching” standard to grant coverage. Id. Second, he claims that “the DRUGDEX compendium listing for Icatibant supports its off-label use for” AAE because HAE “and AAE share the identical root pathophysiology.” Id. The Government argues that Cook is unlikely to succeed on the merits because its decision is consistent with the statute's plain language. Doc. 11 at 8

“In considering the likelihood of success on the merits, a movant must show that it has at least a ‘fair chance of prevailing.’ ” Miller v. Honkamp Krueger Fin. Servs., Inc., 9 F.4th 1011, 1014 (8th Cir. 2021) (quoting Kroupa v. Nielsen, 731 F.3d 813, 818 (8th Cir. 2013)). “[A] showing of likelihood of success on the merits requires simply that the moving party find support for its position in the governing law.” Am. Express Fin. Advisors, Inc. v. Yantis, 358 F. Supp. 2d 818, 826 (N.D. Iowa 2005). A court reviews the MAC's final decision denying Part D coverage under 42 U.S.C. § 405(g). See 42 U.S.C. § 1395w-104(h) (incorporating Part C's judicial review provision, § 1395w–22(g), which provides for judicial review under § 405(g)). Courts “affirm the denial of benefits if the agency's decision is not based on any legal error and is supported by substantial evidence on the record as a whole.” Bradford v. O'Malley, 104 F.4th 1055, 1058 (8th Cir. 2024); Bruce v. Azar, 424 F. Supp. 3d 714, 718 (N.D. Cal. 2019), aff'd, 826 F. App'x 643 (9th Cir. 2020) (observing that in the context of Part D coverage, “[a] district court may disturb the decision to deny benefits only if the decision is either not supported by substantial evidence, or is based on legal error”).

Because there is no on-label prescription to treat AAE, the use of Icatibant to treat AAE has a medically accepted indication ³ only if it “is supported by one or more citations included or approved for inclusion in any of the compendia.” U.S.C. § 1396r-8(k)(6). The parties do not contest factual findings. Instead, the only issue is whether the use of Icatibant to treat AAE is “supported by” the relevant compendium, DRUGDEX. This “[s]tatutory interpretation is a question of law.” Roubideaux v. N.D. Dep't of Corr. & Rehab., 570 F.3d 966, 972 (8th Cir. 2009).

The MAC determined that “because the compendia citations do not address the use of [Icatibant] to treat [AAE] and only include disease-specific indications for other forms of angioedema, we cannot conclude that the appellant's use of the drug is ‘supported by’ the compendia.” Doc. 2-5 at 6. Few cases have addressed whether a disease-matching requirement exists. In Bruce, the district court held that a compendium must list the exact condition to support its off-label use. 424 F. Supp. 3d at 718. But in Dobson v. Secretary of Health & Human Services, No. 20-11996, 2022 WL 424813 (11th Cir. Feb. 11, 2022), the Eleventh Circuit reached the opposite conclusion, stating “that the governing statute's text and structure, as well its purpose, require the conclusion that the term ‘medically accepted indication’ includes those off-label uses for which an approved medical compendium tends to show or helps prove the efficacy and safety of the prescribed off-label use.” Id. at *1. Neither case is binding authority. The court in Bruce offered little analysis for its requirement of an exact name match, while the court in Dobson conducted extensive statutory analysis. I find the framework utilized in Dobson persuasive and that Cook has shown a fair chance of prevailing on his argument that there is no disease-matching requirement. As such, I will consider whether the compendium “tends to show or helps prove the efficacy and safety” of use. Id.

The DRUGDEX citation details Icatibant's mechanism of action, stating:

Icatibant is a bradykinin B2 receptor antagonist that binds with similar affinity as bradykinin. Hereditary angioedema (HAE) is caused by an absence or dysfunction of C1-esterase-inhibitor, a key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production.

Symptoms of hereditary angioedema (localized swelling, inflammation, pain) are thought to be caused by bradykinin vasodilation. Icatibant prevents bradykinin from binding the bradykinin B2 receptor, thereby inhibiting the effects of bradykinin which in turn treats the symptoms of an acute hereditary angioedema attack.

Doc. 2-6 at 14–15. This section does not address Icatibant's safety profile in treating AAE. Id. But it supports that the drug would effectively treat AAE because AAE and HAE have the same root pathophysiology and require the same treatment. Doc. 2-2. Because the mechanism of action is the same, I find this “tends to show or helps prove the efficacy” of Icatibant to treat AAE. As such, Cook has shown a fair likelihood that the compendium listing supports that the treatment of AAE with Icatibant is a medically accepted indication. Thus, I find that he has at least a fair likelihood of succeeding on the merits.

3. Balance of the Equities and Public Interest

The balance of the equities and considerations of the public interest are typically distinct factors, but they merge when the federal government is the party opposing the injunction. Nken v. Holder, 556 U.S. 418, 435, 129 S.Ct. 1749, 173 L.Ed.2d 550 (2009). Cook contends that this factor also weighs in his favor. Doc. 2-1 at 16. He argues that his “risk of asphyxiation and death ․ far outweighs any temporary administrative or financial burden” to the Government. Id. He argues that ensuring that the Government follows the laws benefits the public interest. Id. at 16–17. He alleges that granting a preliminary injunction “ensures that the federal agency charged with carrying out the mandates of the Medicare Act abides by it and lives up to its obligations to Medicare beneficiaries to provide medically necessary care and prevent avoidable suffering and loss of life.” Id. at 17.

The Government argues that its interest in enforcing the plain language of the statute makes this factor weigh in its favor, characterizing this as “a case about insurance coverage, not asphyxiation and death.” Doc. 11 at 14–15. In response, Cook contends that “[e]njoining an agency's erroneous statutory interpretation does not impair legitimate enforcement of federal statutes” and that it serves the public interest to ensure that “administrative agencies correctly apply the law.” Doc. 13 at 5.

Taken alone, the balance of the equities rests in Cook's favor. The coverage of Icatibant could prevent his serious injury or death. The Government argues that “[a]ny time a State is enjoined by a court from effectuating statutes enacted by representatives of its people, it suffers a form of irreparable injury.” Doc. 11 at 14 (quoting Trump v. CASA, Inc., 606 U.S. 831, 861, 145 S.Ct. 2540, 222 L.Ed.2d 930 (2025)) (citation omitted). While this is true, there is at least a fair likelihood that the Government is erroneously interpreting the statute. “There exists a ‘substantial public interest in ensuring that governmental agencies abide by federal laws.’ ” Iowa Ass'n of Bus. & Indus. v. Ommen, 799 F. Supp. 3d 795, 855 (S.D. Iowa 2025) (quoting Saxena v. Noem, 5:25-CV-0505-KES, 2025 WL 1149498, at *3 (D.S.D. Apr. 18, 2025)). As such, I also find that these considerations support a preliminary injunction.

B. The Bond Requirement

Cook requests that I waive the bond requirement and the Government has not resisted this request. Doc. 2-1 at 17–18; Doc. 11. Rule 65(c) of the Federal Rules of Civil Procedure states:

The court may issue a preliminary injunction or a temporary restraining order only if the movant gives security in an amount that the court considers proper to pay the costs and damages sustained by any party found to have been wrongfully enjoined or restrained. The United States, its officers, and its agencies are not required to give security.

“However, the ‘amount of the bond rests within the sound discretion of the trial court and will not be disturbed on appeal in the absence of an abuse of that discretion.’ ” Richland/Wilkin Joint Powers Auth. v. United States Army Corps of Eng'rs, 826 F.3d 1030, 1043 (8th Cir. 2016) (quoting Stockslager v. Carroll Elec. Coop. Corp., 528 F.2d 949, 951 (8th Cir. 1976)). Courts ordinarily require bond but have made exceptions “where the defendant has not objected to the failure to require a bond or where the damages resulting from a wrongful issuance of an injunction have not been shown.” Richland/Wilkin Joint Powers Auth., 826 F.3d at 1043. Courts also properly waive bond if it is in the public interest. Id.

In this case, I find that it is proper to waive the bond requirement. The Government has not objected to Cook's request to waive bond and it is in the public interest to allow individuals to challenge actions that place them at considerable risk of severe injury or death. Further, Cook seeks an injunction because he cannot afford the Icatibant needed to prevent potentially fatal AAE attacks. It is illogical to require Cook to pay a bond in the amount of the medication that he cannot afford.

IV. CONCLUSION

For the reasons set forth herein, plaintiff Donald Cook's motion (Doc. 2) for a preliminary injunction is granted, as follows:

1. The Government shall provide Cook with coverage under Medicare Part D for Icatibant during the pendency of this action, so long as Cook pays the required premium and otherwise complies with all requirements for coverage.

2. Cook is not required to post a bond in any amount in support of the preliminary injunction.

IT IS SO ORDERED this 23rd day of October, 2026.

FOOTNOTES

1.   Also known as Firazyr.

2.   The Government raises this argument as to irreparable harm only.

3.   Plaintiffs in other cases have argued that “ ‘medically accepted indication’ is merely ‘illustrative, not definitional’ ” but courts have rejected this argument. See, e.g., Azar, 424 F. Supp. 3d at 719 (listing cases). Because Cook does not make this argument, I need not address it further.

Leonard T. Strand, United States District Judge