Association for Accessible Medicines v. Raoul

CourtDistrict Court, N.D. Illinois
DecidedSeptember 26, 2025
Docket1:24-cv-00544
StatusUnknown

This text of Association for Accessible Medicines v. Raoul (Association for Accessible Medicines v. Raoul) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Association for Accessible Medicines v. Raoul, (N.D. Ill. 2025).

Opinion

THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION ASSOCIATION FOR ACCESSIBLE ) MEDICINES, ) ) Plaintiff, ) No. 24 C 544 v. ) ) Chief Judge Virginia M. Kendall KWAME RAOUL, in his official capacity ) as Attorney General of the State of Illinois, ) ) Defendant. )

MEMORANDUM OPINION AND ORDER Plaintiff, Association for Accessible Medicines (“AAM”), seeks to enjoin the Illinois Attorney General’s enforcement of House Bill 3957 (“the Act”) against its members based on out- of-state transactions claiming the Act violates the dormant Commerce Clause’s prohibition against extraterritorial state legislation. (Dkt. 51). For the below reasons, the Court denies AAM’s Motion for Preliminary Injunction [51]. BACKGROUND AAM is the leading trade association representing generic and biosimilar drug manufacturers and distributors. (Dkt. 35 ¶ 14). Several states—Illinois included—have passed laws regulating the price of generics and biosimilars. These measures have largely been responsive to skyrocketing drug prices, sometimes by more than 1,000%, and sometimes overnight. (See Dkt. 58 at 6). The Illinois legislature’s solution is to regulate the “wholesale acquisition cost” of certain generic and biosimilar products that are eventually sold in-state. (Id. at 7). Specifically, the Act— which took effect on January 1, 2024—prohibits manufacturers and wholesale drug distributors from “engag[ing] in price gouging.” 410 Ill. Comp. Stat. 725/10(a). The Act defines price gouging as: [A]n unconscionable increase in a prescription drug’s price that: (1) would result in the wholesale acquisition cost of a 30-day supply of the essential off-patent or generic drug exceeding $20 and would result in an increase in the wholesale acquisition cost of the essential off-patent or generic drug of: (A) 30% or more within the preceding year; (B) 50% or more within the preceding 3 years; or (C) 75% or more within the preceding 5 years; and (2) is otherwise excessive and unduly burdens consumers because of the importance of the essential off-patent or generic drug to their health and because of insufficient competition in the marketplace.

Id. § 5. Excluded from the definition are “reasonably justified” price hikes stemming from increased production costs or costs incurred to expand access to a specific drug. Id. The Act directs the Attorney General to investigate possible instances of price gouging and further provides that Illinois courts may order generic manufacturers to cease sales that violate the Act, disgorge money acquired because of a price increase that violates the Act, and pay a civil penalty of up to $10,000 per day for each violation of the Act. See id. § 10(c)(2), (3), (5). In regulating the wholesale acquisition cost of these drugs, Illinois targets upstream sales rather than direct sales to Illinois consumers. This is largely a function of how the U.S. prescription drug industry is structured. Drug manufacturers rarely sell their products directly to patients; indeed, they rarely even sell to pharmacies. (Dkt. 52 at 3). Instead, manufacturers ordinarily “sell nationally, to wholesale distributors, who resell to pharmacies, who in turn resell to patients.” (Dkt. 52 at 3). The price of that first sale, from manufacturer to distributor, is the wholesale acquisition cost and “serves as a benchmark for the price of a specific drug.” (Dkt. 58 at 2). Three companies control over 90% of the wholesale distribution market, and none of them are based in Illinois. (Dkt. 52 at 3). So, when an out-of-state generic manufacturer sells product X to a wholesale drug distributor, that transaction will almost always involve two non-resident entities and occur entirely outside of Illinois. But if the wholesaler sells product X to a pharmacy that, in turn, sells product X in Illinois, the Act can be enforced against the manufacturer based on the price of the initial sale. See 410 Ill. Comp. Stat. 725/10(c) (“[A] manufacturer or wholesale drug distributor who is alleged to have violated this Act may not assert as a defense that the manufacturer or wholesale drug distributor did not directly sell a product to a consumer residing in Illinois.”).

AAM claims the Act violates the dormant Commerce Clause, the Due Process Clause of the Fourteenth Amendment, and the Constitution’s horizontal separation of powers. (Dkt. 35 ¶¶ 78–108). The Court granted the Attorney General’s first Motion to Dismiss because AAM failed to allege facts sufficient to confer standing and likewise failed to allege a credible threat of prosecution. (Dkt. 32). The Court subsequently found that AAM’s First Amended Complaint cured these deficiencies. (Dkt. 46). While AAM’s Complaint alleges six independent causes of action, the throughline is whether the Constitution permits Illinois to regulate the prices of wholly out-of- state sales. (Dkt. 46 at 5). Now, in its renewed Motion for Preliminary Injunction, AAM asks the Court to enjoin the Act based on Count One of its Complaint, which alleges the Act violates the dormant Commerce

Clause’s prohibition against extraterritorial state legislation. (See Dkt. 52 at 8; Dkt. 62 at 2). Touching on the remaining Counts in its Complaint, AAM suggests that other parts of the Constitution prohibit “direct state regulation of out-of-state transactions.” (Dkt. 52 at 8 n.15). But AAM does not advance any of those separate theories in its Motion for Preliminary Injunction— they are thus surrendered for the purposes of this motion. See Cassell v. Snyders, 990 F.3d 539, 551 (7th Cir. 2021); see also Halgren v. City of Naperville, 577 F. Supp. 3d 700, 726–27 (N.D. Ill. 2021). DISCUSSION “A preliminary injunction is ‘an exercise of a very far-reaching power, never to be indulged in except in a case clearly demanding it.’ ” Finch v. Treto, 82 F.4th 572, 578 (7th Cir. 2023) (quoting Cassell, 990 F.3d at 544). To obtain a preliminary injunction, the moving party must

show that (1) it is reasonably likely to succeed on the merits; (2) no adequate remedy at law exists; and (3) it will suffer irreparable harm absent an injunction. Speech First, Inc. v. Killeen, 968 F.3d 628, 637 (7th Cir. 2020). If the moving party establishes these threshold requirements, the Court will balance the equities, “weighing the harm to the moving party if the requested injunction is denied against the harm to the nonmoving party and the public—including third parties—if it is granted.” Finch, 82 F.4th at 578; see also Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008). Likelihood of success on the merits is often the decisive factor. Braam v. Carr, 37 F.4th 1269, 1272 (7th Cir. 2022). I. Likelihood of Success on the Merits AAM contends Illinois’s direct regulation of out-of-state commerce is plainly

unconstitutional under the dormant Commerce Clause. Congress has the power to “regulate Commerce . . . among the several states.” U.S. Const. art. I, § 8, cl. 3. But the Commerce Clause has long been understood to include a negative command, one that prohibits states from passing laws that “unduly restrict interstate commerce.” Tenn. Wine & Spirits Retailers Ass’n v. Thomas, 588 U.S. 504, 514 (2019). The dormant Commerce Clause’s existence is uncontroversial; its boundaries are not. Two primary dormant Commerce Clause strands “guide the courts in adjudicating cases challenging state laws[.]” South Dakota v. Wayfair, 585 U.S. 162, 173 (2018). First, state laws may not “discriminate against interstate commerce.” Id. Second, state laws may not “impose undue burdens on interstate commerce.” Id. The “antidiscrimination principle lies at the ‘very core’ of . . . dormant Commerce Clause jurisprudence.” Nat’l Pork Prods. Council v.

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Bluebook (online)
Association for Accessible Medicines v. Raoul, Counsel Stack Legal Research, https://law.counselstack.com/opinion/association-for-accessible-medicines-v-raoul-ilnd-2025.